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Based on observation, interview, and record review, the facility failed to have an effective governing body (GB) that is legally responsible for the conduct of the hospital when:

1. The hospital did not ensure credentialing and privileging were appropriately carried out for physicians and non-physician providers appointed to the medical staff for three of three patients (Patients 37, 38 and 39) when multiple staff were identified as part of the surgical team for the procedures for Patients 37, 38, 39 and were not identified as having approved surgical privileges and/or not listed as non-physician providers. (Refer to A044).

2. The medical staff was not accountable to the governing body (GB) for the quality of patient care services as evidenced by not determining competency of approved privileges, not tracking and monitoring adverse events associated with providers and not conducting proctoring and peer reviews for 30 of 30 physicians and non-physician providers. (Refer to A049)

3. The hospital did not have an organized medical staff responsible for the quality of medical care provided to patients when the GB failed to ensure medical staff followed Medical Staff Bylaws, Rules and Regulations, and considered California state law, in the approval of Certified Registered Nurse Anesthetists (CRNAs- a nurse trained to provide anesthesia ([specialized care before for surgery, pain management, critical care and emergencies]). CRNAs were inappropriately approved to the Medical Staff as licensed to independently diagnose, prescribe and administer anesthesia services without an order from a physician. Five of five CRNAs (CRNA 1, 2, 3, 4 and 5 ), provided care to five of five Patients (Pt- Pt 1, 2, 3, 4 and 5) with the same authority as an anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic, and therapeutic authority) and without physician orders, and had the potential to endanger all hospitalized patients requiring anesthesia services. (Refer to A338)

Because of the serious actual harm to Patient 1 and the serious potential harm to Patients 2, 3 and 4 related to the unsafe practice of CRNAs providing anesthesia services outside of the scope of practice for CRNAs, and the hospital granting full prescriptive authority to CRNAs without having the authority to do so, and CRNAs diagnosing and treating patients without a physician order and establishing a treatment regimen which is outside of their scope of practice and the hospital not following Governing Body and Medical Staff bylaws in the credentialing and privileging process for CRNAs, an Immediate Jeopardy (IJ a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 5/23/24 at 10 a.m. with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditations Manager (AM) 1, and Accreditations Manager (AM) 2. The IJ (Immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 5/23/24 at 6:34 p.m. and it was unacceptable. The hospital submitted an IJ Plan of Removal (Version Two) on 5/26/24 at 10:44 a.m. which included actions to suspend the use of CRNAs until they could be credentialed and privileged according to GB and MS bylaws. The Plan of Removal was accepted on 5/28/24 at 11:30 a.m. with the CEO, CNO, DCQI and AM 1. On 5/29/24 at 6:15 p.m. the survey team validated that CRNAs were not working at this facility. The survey team validated all staff were educated on the IJ for the CRNAs and what to do if a CRNA comes to work; surgery schedules were reviewed to show no CRNAs were scheduled to provide anesthesia services; all staff in perioperative areas were aware that the CRNAs were only to use the approved order sets in the computer and all of the handwritten orders sets were removed from use. The IJ was removed onsite with the CEO, CNO, DCQI, AM 1 and AM 2 in attendance on 5/29/24 at 6:15 p.m. After removal of the IJ the hospital remained in substantial noncompliance.

3. The hospital did not have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases. (Refer to A 747)

Because of the potential of serious harm to all patients and the hospital lacking a comprehensive systemic approach to ensure effective infection control practices, surveillance, prevention monitoring and a system to maintain professional standards of practice, an Immediate Jeopardy (IJ- a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 5/21/24 at 11:30 a.m., under Code of Federal A-0750 §482.42(a)(3) with the Chief Executive Officer (CEO), Chief Operating Officer(COO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditation Manager (AM) 1, and AM 2. The IJ template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 2.2) on 5/24/24 at 8:00 a.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) Reeducated and trained staff on manufacturer's instructions for cleaning and disinfection, sterilization, and sanitary storage of surgical instruments, endoscopes, and arterial blood gas analyzers 2) Immediately removed unclean endoscopes and surgical instruments from use in procedures 3) Provided house-wide education to staff on hand hygiene, proper aseptic techniques for intravenous medication administration, and clean storage of patient supplies and equipment 3) Immediately cleaned and disinfected air vents, floor drain air gap, kitchen door frames, sinks, floors, rolling food carts and racks, and linen carts, and developed processes for recording and monitoring compliance. 4) Trained kitchen staff on manufacturer's guidelines for use of kitchen disinfectant solutions and proper cool down processes for patient food items. 5) Dietary staff discontinued the practice of storing pots and pans used for patient food service wet 6) The Infection Preventionist increased surveillance by rounding daily in areas affected by the deficient practices. The components of the IJ Plan of Removal, training, and competencies of staff were validated onsite through observations, interviews, and record review. The IJ was removed onsite on 5/27/24 at 10:48 a.m. with the facility CNO and AM 2.

4. The hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with state and federal statutes granting prescriptive authority, Medical Staff Bylaws, and credentialing standards for non-physician providers when the hospital granted CRNAs prescriptive authority without having the legal authority to do so; and the Pharmacy Department permitted CRNAs to write prescriptions; and filled medication orders written by CRNAs even when the CRNA was not acting according to a treatment regimen ordered by a physician; and did not have a system to double-check and ensure CRNAs could legally write prescriptions. (Refer to A 489)

5. The hospital failed to ensure the food and dietetic service department was organized in a manner appropriate to the scope and complexity of the food service operations and did not ensure the provision of dietetic services for the health and safety needs of patients was in compliance with the Condition of Participation for Food and Dietetic Services. (Refer to A 618)

6. The hospital failed to ensure effective maintenance of the physical plant when the dish machine was not working for approximately four months with no movement on the new dish machine when it was deemed non repairable, or timely acquisition of a temporary solution and there were multiple areas on the floor throughout the kitchen that had cracks and holes in the epoxy floor and missing or loose tiles. (Refer to A083)

7. The GB did not ensure a hospital wide data-driven quality assessment and performance improvement program. (Refer to A 263)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and professional manner.

Based on observation, interview, and record review, the hospital failed to protect and promote each patient's rights when:

1. One of three sampled patients (Pt) 6 was not protected from abuse. Clinical service tech (CST) 1 pushed Pt 6 into the wall and Pt 6 sustained a broken clavicle. (refer to A145)

2. The [Brand name 1] warmer for pre moistened wipes were not used in accordance with the operating instructions leading to potential for fire or other hazards and did not ensure the right to a safe environment for patients. (refer to A144)

3. Informed consent was not provided for two of four sampled patients (Pt 6 and Pt 11). Pt 6 did not have a consent form for antipsychotic medications (a type of drug used to treat severe mental disorder in which a person loses the ability to recognize reality or relate to others) administered during his hospitalization. Pt 11 was not provided with an interpreter during consent for an epidural per the hospital's policy and procedure (P&P). (refer to A131).

4. Two of three sampled patients (Pt 11 and Pt 12) preferred language was other than English and there was minimal (for informed consents) to no documentation an interpreter was used for either patient during their hospitalization. (refer to A117)

5. One of three sampled patients (Pt 8) was not provided care in accordance with the hospital P&P titled, "Restraints and Seclusion". Pt 8 was placed in five-point restraints, which was not least restrictive, the physician's order for four-point restraints was not followed and a physician did not perform a one-hour face to face after restraints were placed emergently. (refer to A154)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe setting.

Based on observation, interview, and record review, the hospital failed to have an effective on-going, hospital-wide data-driven Quality Assessment and Performance (QAPI) program when:

1. The hospital did provide evidence of a QAPI program for clinical nutrition and food services that accurately reflected the depth and complexity of the service. (Refer to A 273)

2. The infection preventionist (IP) was aware of infection control practices that did not meet the standard and failed to bring this to the attention QAPI program to implement an improvement project and QAPI was aware Certified Registered Nurse Anesthetists (CRNAs) were permitted to operate independently with full prescriptive and diagnostic authority for anesthesia services and failed to consider the scope of practice of CRNAs and whether this practice was consistent with Medical Staff Bylaws. (Refer to A 283)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and professional manner.

Based on observations, interview and record review, the hospital failed to have an organized medical staff responsible for the quality of medical care provided to patients when:

1. The Governing Body failed to ensure the medical staff followed Medical Staff Bylaws, Rules and Regulations, and California state law, when hospital approved Certified Registered Nurse Anesthetists (CRNAs- a nurse trained to provide anesthesia ([specialized care before for surgery, pain management, critical care and emergencies]) under the orders of a physician) to be added to the Medical Staff if they were licensed to independently diagnose, prescribe and administer provide anesthesia services without an order from a physician. Five of five CRNAs (CRNA 1, 2, 3, 4 and 5 ) non-physicians, provided care to 5 of 5 Patients (Pt- Pt 1, 2, 3, 4 and 5) with the same authority as an anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic, and therapeutic authority) to any patient without physician orders, and has the potential to endanger all hospitalized patients requiring anesthesia services. (Refer to A339)

Because of the serious actual harm to Patient 1 and the serious potential harm to Patients 2, 3 and 4 related to the unsafe practice of CRNA (identifiers) providing anesthesia services outside of the scope of practice for CRNAs, and the hospital granting full prescriptive authority to CRNAs without having the authority to do so, and CRNAs diagnosing and treating patients without a physician order establishing a treatment regimen which is outside of their scope of practice and the hospital not following Governing Body and Medical Staff bylaws in the credentialing and privileging process for CRNAs, Immediate Jeopardy (IJ a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 5/23/24 at 10:00 a.m. with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditations Manager (AM) 1, and Accreditations Manager (AM) 2. The IJ (Immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 5/23/24 at 6:34 p.m. and it was unacceptable. The hospital submitted an IJ Plan of Removal (Version Two) on 5/26/24 at 10:44 a.m. which included actions to suspend the use of CRNAs until they could be credentialed and privileged according to GB and MS bylaws. The survey team validated all staff were educated on the IJ for the CRNAs and what to do if a CRNA comes to work; surgery schedules were reviewed to show no CRNAs were scheduled to provide anesthesia services; all staff in perioperative areas were aware that the CRNAs were only to use the approved order sets in the computer and all of the handwritten orders sets were removed from use. The IJ was removed onsite with the CEO, CNO, DCQI, AM 1 and AM 2 in attendance on 5/29/24 at 6:15 p.m. After removal of the IJ the hospital remained in substantial noncompliance.

2. The Medical Staff failed to follow Medical Staff Bylaws, rules and regulations; and failed to consider scope of practice state laws in recommending candidates to the medical staff for 25 of 25 physicians and non-physician providers. The hospital failed to appropriately credential and privilege 13 of 13 CRNAs, three of three surgeons, one of one anesthesiologist, seven of seven Physician Assistants and one of one Nurse Practitioner. (Refer to A341)

3. Medical staff department failed to follow policy and ensure all individuals providing medical care and services in the hospital privileges were recommended by the Medical Executive Committee (MEC - oversight of safe and appropriate patient care by physician and non-physicians) and approved by the Governing Board for 25 of 25 physician and non-physician providers. (Refer to A347)

The cumulative effect of these systemic problems resulted in the inability of the hospital to ensure the provision of patient care in a safe setting.

Based on interview and record review, the hospital failed to have a well-organized and effective nursing service when:

1. Pt 29 was administered Labetalol (medication to slow heart rate and decrease blood pressure) outside the physician medication order parameters. Pt 29 had the potential for drop in blood pressure and heart rate leading to significant harm and adverse outcome. (Refer to 405)

2. Administration of Dexmedetomidine (medication to keep you asleep) continuous infusion was titrated (slowly increasing the dose of a medicine to see how your body will react to it) by RNs for Pt 35 at 0.2 [micrograms (mcg-unit of measurement) per kilogram (kg-unit of measurement) per hour (hour- time)] higher than the physician medication order to titrate administration at 0.1 mcg/kg/hr. Pt 35 was administered higher dose for titration than the physician order and had the potential for adverse outcome including hypotension (low blood pressure). (Refer to 405)

3. Registered Nurses administered insulin continuous intravenous drip (the administration of a fluid into a blood vessel, usually over a prolonged period of time) for Pt 36 to treat hyperglycemia and the insulin dose rate was not started in accordance with the physician medication order of Insulin Algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level) despite being verified by two nurses. RNs did not follow the "Insulin Algorithm" and started insulin at a higher dose without first notifying the physician and obtaining a physician order. (Refer to 405)

4. Three of six patients (Patient (Pt) 11, Pt 12, and Pt 14) did not have vital signs assessed and documented in accordance with the hospital policy and/or professional standards. (Refer to 398)

5. One of two patients (Pt 11) did not have her pain assessed and documented while she was receiving epidural pain medication according to hospital policy. (Refer to 398)

6.One of two sampled patients (Pt 61) was not offered pain medication prior to the start of a large wound dressing according to the hospital's pain policy and hand hygiene was not performed per hospital policy. (Refer to 398)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe setting.

Based on interview and record review, the hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with state and federal statutes granting prescriptive authority, Medical Staff Bylaws, and credentialing standards for non-physician providers when the hospital granted CRNAs (a non-physician provider) prescriptive authority without having the legal authority to do so; and the Pharmacy Department permitted CRNAs to write prescriptions; and filled medication orders written by CRNAs even when the CRNA was not acting according to a treatment regimen ordered by a physician; and did not have a system to double-check and ensure CRNAs could legally write prescriptions. These failures were evidenced by:

1. CRNA 3 ordered medications for Patient 3 prior to operation, during operation and in the PACU (Post Anesthesia Care Unit; after surgery) and managed the adverse events from the procedure or the drugs without a treatment regimen ordered by a physician. Pharmacy processed and approved medication use, and orders sent to them electronically.

2. CRNA 1 ordered medications for Patient 4 using an unauthorized order form for PACU orders and did not follow GI specialists' (a doctor specialized in stomach and colon disease) sedation plan (how to put patient to sleep or provide pain relief during procedure) and orders for medication use. Pharmacy approved CRNA 1's medication access and did not address discrepancy on medications removed from ADM (Automated Dispensing Machine, a computerize machine that stored and tracked medication removal with authorized access).

3. CRNA 4 ordered medications for Patient 2 prior to procedure, during the procedure and in the PACU and Pharmacy processed and approved medication use, and orders sent to them electronically without a treatment plan ordered by a physician.

4. CRNA 6 ordered medication for Patient 5 during the procedure and for the PACU unit. Pharmacy processed and approved electronic medication orders despite risk factors related to patient age and kidney function.

These failed practices did not comply with the requirement for safe pharmaceutical services, had the potential to cause harm, injury, and death to patients; and could contribute to the risk of drug diversion (drug loss).

The cumulative effects of this systemic failure resulted in the hospital's inability to ensure safe, legal, accountable, and quality pharmaceutical services.

Based on observation, staff interview, and review of hospital documents, the hospital failed to ensure the food and dietetic service department was organized in a manner appropriate to the scope and complexity of the food service operations by failure to ensure:

1. Full-time oversight by the Regional Director of Operations (RDO), a contracted service, to ensure food safety in accordance with 2022 Food and Drug Administration (FDA) Food Code standard of practice while acting as the Director of Food and Dietetic Services. (Refer to A-0620)

2. Effective organization of Food and Nutrition Services Department as evidenced by lack of operational oversight by a Registered Dietitian of food production and sanitation activities resulting in food safety hazards and an unsanitary kitchen environment . (Refer to A-0619)

3. Delayed nutrition assessment and medical nutrition therapy for three of seven sampled patients (Patients 49, 46, 53), in accordance with the hospital policy, all of whom had identified nutrition risk factors and ordered consults. (Refer to A-629)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of dietetic services for the health and safety needs of 358 patients admitted to the hospital in compliance with the Condition of Participation for Food and Dietetic Services.

Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases, when:

1.Surgical instruments, endoscopes (a thin, flexible tube-like instrument equipped with a camera used to look at tissues inside the body), and blood gas machines (A specialized equipment that takes a blood sample and measures the oxygen, carbon dioxide and pH of the blood sample. The pH is a measure of acid-base balance of the blood) were not maintained, cleaned, and disinfected, and/or stored in accordance with policies and procedures, manufacturer's guidelines, and standards established by nationally recognized organizations for perioperative practices and for the safe use and management of surgical instrumentation and medical devices. These failures had the potential to cause equipment or instrument failure and transmission of infectious diseases resulting in serious harm to patients. (Refer to A0750 findings 1- 4)

2. Sterile processing (SPD) and Endoscopy (Endo) Departments were not cleaned and maintained in a sanitary manner to prevent the generation and reproduction of molds (microscopic microorganism that live on plant or animal matter), bacteria (germs), and viruses (infectious organisms with both living and nonliving characteristics) within their environments and potential transmission of illnesses. (Refer to A0750 findings 6 and 7)

3. The kitchen responsible for patient food service was not maintained in a sanitary manner to prevent cross contamination (transfer of germs from one object to another) and foodborne illnesses (caused by consuming contaminated foods or beverages). Kitchen floors, sink backsplash, rolling and food racks, food carts, shelving, and door frames had black/ gray substances, rust, and/ or yellow sticky residue adhered to their surfaces. Pots and pans used for patient food service were stored wet and food trays were not cleaned per manufacturer's guidelines. Kitchen staff did not follow proper cool down processes for patient food items and policies for hair coverings. (Refer to A0750 findings 14A through 14J.)

4. Staff did not perform hand hygiene and utilize Personal Protective Equipment (PPE- equipment worn to minimize exposure to hazards that cause serious workplace injuries) in accordance with policies and procedures and nationally recognized infection prevention and control guidelines, which had the potential to compromise the health and safety of patients, staff, and visitors. Proper eyewear was not worn in accordance with hospital policy and procedures for PPE in the operating rooms (ORs). Staff did not maintain appropriate nail length and hygiene to prevent patient exposure to hospital acquired infections (HAIs). (Refer to A750 findings 5, 9, 10, and 11)

5. Trash and patient supplies were not stored in accordance with policy and procedure and best infection control practice to prevent cross contamination. Linen carts were not covered. Miscellaneous supplies, gloves, and storage containers were stored in the splash zone of a handwashing sink in a procedure room. Trash bags overflowed out of a trash bin and piled up against the wall and the floor of the utility room. (Refer to A0750 findings 8, 13, and 14)

6. Hospital policy and procedure and best infection control practice was not followed during the cleaning an occupied patient room. The housekeeper reached into a disinfectant solution bucket with contaminated gloves and the mop head was not changed between the room's bed A and bed B to prevent cross contamination. (Refer to A0750 finding 12)

7. The Infection Preventionist was not aware of the hospital-wide infection problems, did not have a systemic approach to track and monitor infection control practices and did not make rounds in all areas of the hospital. (Refer to A0750 finding 16)

Because of the potential of serious harm and the hospital lacking a comprehensive systemic approach to ensure effective infection control practices, surveillance, prevention monitoring and a system to maintain professional standards of practice an Immediate Jeopardy (IJ- a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 5/21/24 at 11:30 a.m., under Code of Federal A-0750 §482.42(a)(3) with the Chief Executive Officer (CEO), Chief Operating Officer(COO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditation Manager (AM) 1, and AM 2. The IJ template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 2.2) on 5/24/24 at 8:00 a.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) Reeducated and trained staff on manufacturer's instructions for cleaning and disinfection, sterilization, and sanitary storage of surgical instruments, endoscopes, and arterial blood gas analyzers 2) Immediately removed unclean endoscopes and surgical instruments from use in procedures 3) Provided house-wide education to staff on hand hygiene, proper aseptic techniques for intravenous medication administration, and clean storage of patient supplies and equipment 3) Immediately cleaned and disinfected air vents, floor drain air gap, kitchen door frames, sinks, floors, rolling food carts and racks, and linen carts, and developed processes for recording and monitoring compliance. 4) Trained kitchen staff on manufacturer's guidelines for use of kitchen disinfectant solutions and proper cool down processes for patient food items. 5) Dietary staff discontinued the practice of storing pots and pans used for patient food service wet 6) The Infection Preventionist increased surveillance by rounding daily in areas affected by the deficient practices. The components of the IJ Plan of Removal, training, and competencies of staff were validated onsite through observations, interviews, and record review. The IJ was removed onsite on 5/27/24 at 10:48 a.m. with the facility CNO and AM 2.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality foods and patient care in a safe and sanitary environment.

Based on observation, interview and record review, the hospital failed to provide a well-organized surgical service in accordance with acceptable standards of practice when;

1. The hospital failed to ensure the surgery department kept an accurate roster of privileged surgeons and non-physicians approved to be in Operating Rooms when surgery staff did not follow policies and procedures and permitted unidentifiable, unqualified and/or unprivileged individuals and physicians to provide surgical care in the operating rooms. (Refer to A945)

2. The hospital failed to obtain a History and Physical (H&P-a term used to describe a doctor's examination of the patient) updated within 24 hours of a surgery for one of two patients ((Pt) 12) in accordance with hospital policy and procedure. (Refer to A952)

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure quality healthcare in a safe setting.

Based on observation, interview and record review, the hospital failed to provide anesthesia services in a well-organized manner when the hospital failed to provide anesthesia services consistent with needs and resources when the hospital granted Certified Registered Nurse Anesthetists (CRNA) prescriptive authority and the ability to diagnose and treat patients without a treatment regimen ordered by a physician while providing anesthesia services and was not consistent with scope of practice laws and standards of practice for CRNAs. (Refer to A1002)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on interview and record review, the hospital failed to ensure emergency needs of patients were met in accordance with acceptable standards of practice when emergency services provided in the hospital were not supervised by a qualified member of the medical staff for four of four patients (Patients 1, 2, 3 and 5). Patients 1, 2, 3 and 5 experienced code blue situations (term generally used to indicate a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) in the surgical and procedural areas of the hospital and the code blue was not supervised by a qualified member of medical staff and the code blue did not follow established guidelines for Advanced Cardiac Life Support (ACLS) published by the American Heart Association (AHA) and hospital policy and procedure. (Refer to A1111)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide quality healthcare in a safe setting.

Based on interview and review of Hospital documents, the hospital failed to ensure:

1. The Regional Director of Operations (RDO) met the qualifications to fulfill the responsibilities of a dietetic service supervisor in accordance with the State of California Health and Safety Code (HSC) 1265.4b Statue. These requirements were not met when the RDO failed to receive at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming the role as a dietetic services supervisor at the health facility.

2. Oversight of food service operations by a Registered Dietitian (RD) for the purpose of providing guidance to the RDO and staff of the dietetic service at a sufficient duration and frequency in accordance with California Code of Regulations, Title 22 - General Acute Care Hospitals, 70275(a).

These failures placed patients at risk for food borne illness (illness caused by food contaminated with bacteria, viruses, parasites, or toxins) due to lack of oversight of the food service operation by qualified staff for a hospital census of 358.

Findings:

During the survey from 5/13/24 to 5/14/24, observations, interviews and document reviews identified multiple concerns related to food production operations. The concerns included a lack of: Effective food safety and sanitation systems and practices in the kitchen (Cross Reference A620, A750); Maintenance of Food Service equipment (A701); Development of a Departmental QAPI (Quality Assurance Performance Improvement) program for the hospital's food production operations. There was no evidence provided that patient meal satisfaction data was integrated into the hospital wide QAPI program. Additionally, there was no clinical nutrition QAPI program (Cross Reference A273).

1. According to the California Health and Safety Code (CA HSC) 1265.4(b), the dietetic services supervisor shall have completed one of seven recognized pathways, two of which include the completion of an education program approved by the Dietary Managers Association and successful completion of a certifying exam. In addition to the successful completion of a certifying exam the qualified manager must have received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.

During a review of the employee file for the Interim Director of Food and Nutrition Services, who also identified as the Regional Director of Operations (RDO), and concurrent interview on 5/22/24 at 12:01 p.m. in the presence of the Chief HR Officer (CHRO), Director of Professional Development & Education, Employee Labor Relations Manager and RDO, it was noted while the RDO received his Certified Dietary Manager credential from the Dietary Managers Association there was no evidence the RDO completed a six hour program specific to CCR Title 22 dietetic services regulations. The CHRO and RDO stated they were not aware of the HSC 1265.4 requirements. The RDO stated he thought he had some documentation to show he has completed that.

During a review of the DFNS job description, authored by the food service contract company, undated, revealed the required qualifications listed in the job description were not consistent with the Health and Safety Code 1265.4, for the position responsible for the daily by operation of the food service.

Review of the documentation of RDO continuing education and in-services showed there was nothing specific regarding Title 22 dietetic service requirements.

2. A Registered Dietitian/Nutritionist (RDN) is a health care professional educated in food and nutrition, who can translate scientific information into practical solutions. RDNs are food and nutrition experts with a minimum of a graduate degree from an accredited dietetics program and who completed a supervised practice requirement, passed a national exam and continue professional development throughout their careers. (Academy of Nutrition and Dietetics). The RDN has a scope of practice in California law. In contrast the CDM expertise is managing foodservice operations and ensuring food safety, usually in a healthcare facility. They are responsible for implementation of menus, foodservice purchasing, and food preparation. The CDM does not have a scope of practice in California Law.

The California Code of Regulations, Title 22, Section 70271 defines dietetic services as the provision of safe, satisfying and nutritionally adequate food for patients. Additionally, Section 70275 states (a) A registered dietitian shall be employed on a full-time, part-time or consulting basis. Part-time or consultant services shall be provided on the premises at appropriate times on a regularly scheduled basis and of sufficient duration and frequency to provide continuing liaison with medical and nursing staffs, advice to the administrator, patient counseling, guidance to the supervisor and staff of the dietetic service, approval of all menus and participation in development or revision of dietetic policies and procedures and in planning and conducting in-service education programs.

During a review of the Clinical Nutrition Manager job description, authored by the food service contract company, dated Jan 2019, signed by the CNM on 2/28/23, showed this position reports to the Director of Food and Nutrition Services (DFNS). The position's supervisory responsibilities was limited to the clinical nutrition staff. The job description did not outline all the areas that the CNM was responsible for in relationship to California Code of Regulations, Title 22, such as guidance to the supervisor (DFNS) and the staff of dietetic services.

During a review of the DFNS job description, authored by the food service contract company, undated, showed the DFNS reports to the Regional Director of Operations (RDO) of the contract company. There was no reporting to the hospital just the contract company. It showed the DFNS directs the operation of Food and Nutrition Services. The job description did not indicate this position received guidance from a Registered Dietitian (RD).

During an interview with the RDO on 5/14/24 at 12:22 p.m., in the kitchen, the RDO stated the CNM is the Registered Dietitian that has oversight in the kitchen.

During an interview with the CNM, on 5/14/24 at 12:47 p.m., she stated she is responsible for clinical nutrition and nutrition consults. CNM stated she reviews the therapeutic diets and looks over meal service. She informally ensures the patient menu is being followed and will modify menus if needed. The CNM stated she has not observed whether staff follows recipes during food production but thinks they do. The CNF has not reviewed or evaluated the department's sanitation practices. The CNM stated she communicates with the Patient Services Manager about things regarding meal service.

Based on interview and record review, the hospital's Governing Body failed to ensure credentialing and privileging were appropriately carried out for physicians and non-physician providers appointed to the medical staff for three of three patients (Patients 37, 38 and 39) when multiple staff were identified as part of the surgical team for the procedures for Patients 37, 38, 39 and were not identified as having approved surgical privileges and/or not listed as non-physician providers.

These failures resulted in the potential harm of physicians and non-physicians providing healthcare services to patients without first having the appropriate qualifications and approved privileges.

Findings:

During an interview and concurrent record review on 5/30/24, at 3:48 p.m., with Chief of Staff (COS, a Medical Doctor), accompanied by Accreditation Manager (AM 2), the hospital policies, and medical staff processes were discussed. The COS stated she was "familiar" and followed Medical Staff Bylaws (a set the framework for the working relationship of the medical staff, hospital administration and governing body, and assures legal protections were in place). The COS stated she participated in the following meetings: Credentialling Committee (CC), the first Thursday of each month, Medical Executive Committee (MEC) the 3rd Friday of each month and Governing Board (GB) the 4th Wednesday of each month. COS stated the CC, MEC and GB have "access" to the applicant's file for review." COS stated the "proof" of CC and MEC recommendations and GB approval were the dates entered into the meeting minutes. COS stated surgical providers participated in 3 months of proctoring and did not know the process for other departments. COS acknowledged the privilege process for applicants was not followed by the hospital.

During an interview and concurrent record review on 5/30/24, at 3:48 p.m., with the COS, accompanied by Accreditation Manager (AM 2), the hospital policies, and medical staff processes were discussed. The COS stated Physician Assistants (PA, an Allied Health Professional, AHP) could work "anywhere" in the hospital. The COS acknowledged that medical staff approved and confirmed the competency, qualifications, and skills of all AHPs. The COS stated regardless of AHP's specialty, they were required to provide medical care as "asked" by physician responsible for the AHP.

During an interview on 5/31/24, at 10:22 a.m., with Governing Board Members (GBM), which included: Accreditation Manager (AM 1), Director of Clinical Quality and Performance Improvement (DCQI), Accreditation Manager (AM 2), Chief Nursing Officer (CNO), Chief of Staff (COS), and Chief Operating Officer (COO), the GBM described the current privileging process. The GBM indicated it was the "same for all applicants" who applied for privileges. The applicant privilege request was signed by the Chief of the Department. The GBM stated the COS had access to the applicant file and "looked at" it. The credentialling committee will "look over" the file; the MEC will "look at" the file and after the GB "looks at" it. The GBM stated the "basic stuff" was a background check, education, and experience. The GBM acknowledged individuals, who were not privileged, were providing medical care to patients. The GBM stated the current privileging process was "not appropriate" and had a "serious issue".

During an interview on 5/31/24, at 10:22 a.m., with Governing Board Members (GBM), which included: Accreditation Manager (AM 1), Director of Clinical Quality and Performance Improvement (DCQI), Accreditation Manager (AM 2), Chief Nursing Officer (CNO), Chief of Staff (COS), and Chief Operating Officer (COO), the GBM stated that CRNAs were contracted to provide anesthesia care and "cover the ORs". The GBM stated the anesthesia services model was "CRNA based" with "supervision" by an anesthesiologist and defined physician supervision of a CRNA as "they always have to talk to a physician ...run it by the physician on call ...to help them".

During record review of two hospital's provider logs, titled "Revised Med Staff Roster" and "Revised AHP Roster", both dated from 5/2023 to 5/2024, the Medical Staff log listed 658 physician providers and the AHP log listed 121 AHP. Certified Registered Nurse Anesthetist or CRNA (Registered Nurse with specialized training that provides anesthesia services under the orders of a physician): 49 CRNA's were privileged to diagnose, treat and prescribe without orders from a physician establishing a treatment protocol not required to have physician oversight, and were able to orders tests and drugs without an order from a physician establishing a treatment regimen.

During an interview on 5/31/24, at 1:08 p.m., with Chief Operating Officer (CEO- responsible for hospital conduct and safety and care of patients), accompanied by Registered Nurse Quality (RNQ 2), the hospital policies, workflows, quality of care and medical staff role and responsibilities were discussed. The CEO stated he did not have a medical and clinical background and relied on physician's judgement when making decisions. The CEO stated he was "not familiar with staffing privileges" and was unaware the process was "not complete". The CEO stated he was not aware medical staff on rosters were not appropriately privileged according to Bylaws and had not been approved by the GB to provide medical services. The CEO stated the credentialling process needed to be addressed as soon as possible with a "thorough approach to the process". The CEO acknowledged there were inappropriately privileged individuals providing medical care in the hospital. The CEO stated there was "a lot of clean-ups across the board" to be done at the hospital.

During a concurrent record review and interview on 5/31/24, at 1:08 p.m., with Chief Executive Officer (CEO), accompanied by Registered Nurse Quality (RNQ 2), hospital policies, workflows, quality of care and medical staff were discussed. The CEO stated there were a number of physicians and non-physicians on the rosters (658 physicians and 121 AHPs) who were not privileged according to hospital's Bylaws reviewed with during the medical staff interview, COS, SUR 3, SUR 5, SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6 and PA 7 or NP 2. The CEO was asked about unauthorized individuals in the OR, for Patients 37, 38 and 39.

1. During a review of the Pt 37's nursing intra-operative notes, titled, "Surgical Documentation", dated 6/24/23, at 3:54 p.m., the nurse documented medical providers who entered the operating room and provided surgical services to Pt 37 as follows: "Operating surgeons, SUR 3, and SUR 9, "Coronary Artery Bypass". "Anesthesiologists, (ANS 4).
"Medical Doctor (MD) 11 , "Assistant Provider, Intraoperative" for "Coronary Artery Bypass", was not listed as a surgeon on the Medical Staff roster, but as an internal medicine doctor. "MD 12, "Assistant Provider, Intraoperative" for "Coronary Artery Bypass", was not listed as a surgeon on the Medical Staff roster, but internal medicine doctor. "RNFA 1, "First Assistant" for "Coronary Artery Bypass", was not listed on the APH Roster

2. During a review of the Pt 38's nursing intra-operative (during surgery) notes, titled "Surgical Documentation", dated 5/15/24, the nurse documented medical providers who entered the operating room and provided surgical services to Pt 38 as follows: "Operating surgeon, (SUR 5), listed on the medical staff roster. "Anesthesiologists, (ANS 1 and ANS 6). Both listed on the medical staff roster." "Additional staff intraoperative" Physician Assistant (PA 8), listed on AHP roster with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging);" "Assistant Provider, Intraoperative" Nurse Practitioner, (NP 1) - not on the medical staff or AHP roster;" "Assistant Provider, Intraoperative" physician, (DO 1) - Not on the medical staff roster."

3. During a record review of the Pt 39's nursing intra-operative notes titled, "Surgical Documentation", dated 12/13/2023, the nurse documented 21 different individuals entered the OR during Pt 39's case-" RNs- six total; Unknown status, the facility did npt provide documented evidence of employees working in the ORs; "Respiratory therapist -one. Unknown status, the facility did not provide documented evidence of employees working in the ORs. "Medical students-four. None were on a roster. "Vendor-- one."Perfusionists-three. Unknown status, the facility did not provide documented evidence of employees working in the ORs. "Anesthesiologist - two (ANS 8, ANS 2, "Surgeons-- four. Primary surgeon (SUR 3) and 3 Assistant Providers (SUR 8, SUR 10, and SUR 11 "Coronary Artery Bypass".
"RNFA-- one. RNFA 1 "First Assistant" for "Coronary Artery Bypass - Not listed on the APH Roster. "Physician Assistant - one. PA 8 "Anesthesia Tech [assistant to anesthesiologist, require a licensed. But not allowed to practice in California]". Listed on AHP roster as PA with a radiologist as the supervising physician.

The CEO stated that it was "absolutely serious" to have individuals in the OR who did not have the appropriate privileges or could not be identified by staff. CEO stated there should have been "stop gap measures" to prevent unauthorized individuals from entering the OR.

During record review of [Hospital] policy titled "Rules and Regulations of the Governing Board of [Hospital]", June 13, 2022, indicated that the "Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice".

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that " recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership".

Based on interview and record review, the hospital failed to ensure the medical staff was accountable for the quality of care to patients when the Medical Executive Committee and Medical Staff Office did not ensure providers demonstrated competency for approved privileges and the medical services provided were not monitored and tracked for adverse events, proctoring and peer reviews not completed for 30 of 30 providers (non-physicians and physicians): 13 Certified Registered Nurse Anesthetist (CRNA- type of AHP, Registered Nurse with specialized training that provides anesthesia services under the orders of a physician), [CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18], four surgeons (SUR) [3, 5, 8 and Chief of Medical Staff (COS)], one anesthesiologist (ANS) [4], Seven Physician Assistants (PA- type of AHP, an individual with specialized training that provided medical care under the supervisor of a physician), [PAs 1, 2, 3, 4, 5, 6 and 7], one Nurse Practitioner (NP- type of AHP Registered Nurse with specialized training that provides medical care under the supervision of a physician), [NP 2]; and four providers were not on the AHP or medical staff rosters (ANS 5, NP 1, physician (DO 1).

These failed practices of not proctoring, monitoring for competency, and tracking for adverse events may have contributed to unsafe medical care and missed opportunities to ensure patient safety and prevent patient harm.

Findings:

1. During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and on 5/28/24, at 1:50 p.m., with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical staff manager, the hospital's workflow, policies, patient record logs and staff files were discussed. The MST stated the newly approved privileged providers must have completed proctoring. The MST indicated medical staff Bylaws "expectation" was that all proctoring to be "direct" supervision and each specialty had its own requirements. The MST acknowledged proctoring of staff was not monitored and maybe not even done. The MST acknowledged there was no documented evidence that COS, SUR 3, SUR 5, SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6 and PA 7 or NP 2 completed all the required proctoring.

During an interview on 5/30/24, at 3:00 p.m., with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), the hospital policies, workflow and OR staff were discussed. SUR 4 stated she "helps"' the credentialing committee once a month. After privileges have been granted, proctoring occurred for medical staff.

During an interview on 5/30/24, at 3:48 p.m., with Chief of Medical Staff (COS), accompanied by AM 2, hospital policies, and medical staff processes were discussed. The COS stated she was "familiar" and "follows" Medical Staff Bylaws. The COS stated surgical providers participate in 3 months of proctoring but did not know the process for other departments. The COS acknowledged the privilege process for staff was not followed.

During three concurrent interviews and record reviews on 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and DCQI, on 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and on 5/29/24, at 4:14 p.m., with ANS 1, accompanied by RNQ 1, the hospital policies were discussed. ANS 1 indicated he was the Chief of the Anesthesia Department since September of 2023. ANS 1 stated his job as chief was to approve, monitor and sign-off on proctoring. ANS 1 described the proctoring process. ANS 1 and DCQI acknowledged proctoring was not done consistently. ANS 1 acknowledged that approved privileges and proctoring was not specific to case and procedures, nor the face-to-face proctoring was required. ANS 1 stated proctoring had been mostly retrospectively (after the fact), and if needed it was completed concurrently with the CRNA. ANS 1 stated CRNA competency can could be determined by the surgeon, chief of anesthesiology or the anesthesiologist in charge (AIC). ANS 1 stated the AIC could be an anesthesiologist or a CRNA. ANS 1 stated whether proctoring completed or not the case assignments could be simple, complex, or high-risk sick patients, including high-risk procedures that required specific skills. ANS 1 stated high-risk patients and procedures cases were "not part of proctoring". ANS 1 stated the applicant had 12 months to complete proctoring. ANS 1 stated once proctoring requirement satisfied the applicant's file would have been forwarded to Credential Committee (CC), Medical Staff Committee, and Governing Board (GB) for approval.

During a concurrent interview and record review on 5/20/24, at 3:40 p.m., with CRNA 1, accompanied by Registered Nurse for Quality (RNQ 1), the medical records and workflow were reviewed with CRNA 1. CRNA 1 stated he finished nurse anesthetist education in December of 2023, and this was "first job" as a CRNA. CRNA 1 stated he started taking calls (available anesthesia emergencies) in the hospital at night in April 2024, and working full time in May of 2024. CRNA 1 stated he was not required to undergo proctoring because he was "comfortable without proctoring" and "started off by myself ...on my own". CRNA 1 stated he turned in a months' worth of case logs to the Chief of Anesthesia (ANS 1) for "retrospective" review. CRNA 1 state he has not had any direct supervision or one-on-one proctoring. CRNA 1 stated he could do "all cases" for anesthesia. CRNA 1 stated all CRNAs signed orders and assessments the same way as the physicians on anesthesia records, and a treatment regimen ordered by a physician was not required for orders, patient evaluations, procedures or anesthesia records.

During an interview and concurrent record review on 5/20/24, at 5:12 p.m., with CRNA 5, accompanied by Patient Safety Officer (PSO), Patient 1's (Pt 1) medical record, workflow and policies were reviewed, and discussed. CRNA 5 stated proctoring consisted of completing a form and turning it in for the Chief of the Anesthesia department (ANS 1) for a signature. CRNA 5 stated the proctoring was done "retrospectively" and could not recall any cases or procedures which were done with an anesthesiologist present. CRNA 5 stated that "schooling" for procedures and anesthesia was completed; thus, certification and proctoring was not required. CRNA 5 stated she completed her proctoring and needed to turn the "forms" into the Chief of Anesthesia.

During an phone interview on 5/22/24, at 10:13 a.m., with CRNA 6, accompanied by Director of Clinical Quality Improvement (DCQI), the hospital policy, workflow and patient records were discussed. CRNA 6 stated he worked "independently" without regimen ordered by a physician. CRNA 6 stated he was proctored for "one case with ANS 1 [Chief of Anesthesia Department]" and after that was able to work independently. CRNA 6 stated his scope of practice is "whatever credentialing approved".

2. During three concurrent interviews and record reviews on 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by RNQ 1, Medical Staff Manager and DCQI, on 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and on 5/29/24, at 4:14 p.m., with ANS 1, accompanied by RNQ 1, the hospital policies, patient (Pt) charts and workflow were discussed. ANS 1 indicated he was the Chief of the Anesthesia Department since September of 2023. ANS 1 stated his job as chief was to monitor and review adverse events related to anesthesia services. ANS 1 stated CRNA competency could be determined by the surgeon, chief of anesthesiology or the anesthesiologist in charge (AIC). ANS 1 stated the AIC could be an anesthesiologist or a CRNA. ANS 1 stated whether proctoring completed or not the case assignments could be simple, complex, or high-risk sick patients, including high-risk procedures that required specific skills. ANS 1 stated the anesthesia department was "currently discussing" which high risk, and high acuity patients should be assigned to CRNAs. ANS 1 stated he was "aware" of the anesthesia complications of Pt 1, Pt 2, and Pt 3, but had no knowledge of any other adverse events or deaths which involved anesthesia services. ANS 1 acknowledged Pt 1 had a "Code Blue [hospital designation for lifesaving interventions and medications]" and expired in the operating room (OR) on 4/11/2024. Pt 2 had a post-operative (after surgery) anesthesia emergency on 10/27/23. ANS 1 acknowledge Pt 2 was found to be "hypotensive, tachycardic with respiratory acidosis and Could be related to right lung intubation during the procedure". Patient 3's had intra-operative anesthesia "Code Blue" on 10/25/2023. ANS 1 indicated he was unaware of the Pt 5's code and death in the OR on 11/15/2023 2023 or Pt 38's code and death on 5/15/2024.

During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with the MST, the hospital workflow, polices, patient record logs, death logs (list of patients that died in the hospital), and the medical staff files were discussed. MST stated they have reviewed "90%" ("%" means percent a fraction of 100) of the death records and the patient safety officer (PSO) had reviewed "all deaths" cases. MST indicated the death of an otherwise apparent healthy male (Pt 38) on 5/15/24 in the OR receiving anesthesia was not a reportable event. MST stated adverse events included mortality and morbidity. MST stated chiefs of departments, medical staff committees were "always monitoring safety".

During record review of hospital's deaths logs, titled "Revised Death Log ... with MDs", with date range of 5/2023 to 4/2024, the record indicated 904 deaths in the hospital and the common listed reason for the deaths included, "sepsis" (blood infection), "pneumonia" (lung infection), "cardiac arrest" (heart attack) and "respiratory failure" (breathing failure and disease). The OR logs indicated there were 357 cases of patients that "expired".

During a comparative record review of Operating Room (OR) case logs, titled "OR Log Revised", dated from 2/2023 to 5/15/2024, and the "Revised Med Staff Roster" and "Revised AHP Roster", dated 5/2023 to 5/2024, a sample staff names were compared to surgical patients that "expired [died]", for example:

SUR 3 was listed as the surgical provider for 19 deaths: Pt 1, Pt 37, Pt 39, Pt 69, Pt 70, Pt 71, Pt 72, Pt 73, Pt 74, Pt 75, Pt 76, Pt 77, Pt 78, Pt 79, Pt 80, Pt 102, Pt 103, and Pt 108.

SUR 5 was listed as the surgical provider for 6 deaths: Pt 38, Pt 93, Pt 94, Pt 95, Pt 96 and 97.

SUR 8 was listed as the surgical provider for 12 deaths: Pt 39, Pt 44, Pt 86, Pt 87, Pt 88, Pt 89, Pt 90, Pt 91, Pt 92, Pt 93, Pt 95, Pt 96, and Pt 97.

COS (Chief Of Staff) was listed as the surgical provider for the deaths of Pt 81, Pt 82, Pt 83, Pt 84, and Pt 85.

MD 11 was listed as the surgical provider for the deaths of Pt 39 (MD 11 was listed on the medical staff roster as internal medicine physician, not surgeon).

MD 10 was listed as the surgical provider for the deaths of Pt 39 (MD 11 was listed on the medical staff roster as internal medicine physician, not surgeon).

ANS 4 was listed as the anesthesia provider for 9 deaths: Pt 37, Pt 68, Pt 69, Pt 73, Pt 76, Pt 78, Pt 80, Pt 104, and Pt 105.

ANS 5 was listed as the anesthesia provider for 10 deaths: Pt 64, Pt 66, Pt 67, Pt 97, Pt 98, Pt 99, Pt 100, Pt 101, Pt 104, and Pt 105 (ANS 5 was not on Medical Staff Roster).

PA 2 was listed as the Physician Assistant, surgery provider, for five deaths: 41, Pt 43, Pt 44, Pt 47, Pt 48.

PA 4 was listed as the physician assistant, surgery provider, two deaths: Pt 40 and Pt 67.

CRNA 2 was listed as the anesthesia provider for 5 deaths: Pt 1, Pt 65, Pt 70, Pt 72, and Pt 113.

CRNA 3 was listed as the anesthesia provider for 4 deaths: Pt 96, Pt 106, Pt 111, and Pt 118.

CRNA 5 was listed as the anesthesia provider for one death: Pt 1.

CRNA 6 was listed as the anesthesia provider for 3 deaths: Pt 5, Pt 94 and Pt 96.

CRNA 18 was listed as the anesthesia provider for 3 deaths: Pt 112, Pt 115 and Pt 116

PA 8 was listed as additional staff intraoperative "Additional staff intraoperative" for Pt 39. On the AHP list with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging)

PA 8 listed as an "Anesthesia Tech [assistant to anesthesiologist, not allowed to practice in California]" for Pt 37. PA 8 was listed on AHP roster as PA with a radiologist as the supervising physician.

Nurse Practitioner 1 (NP 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39, but was not listed on the medical staff or AHP roster.

Physician, (DO 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39 but was not listed on the medical staff.

RN 1 was listed as RNFA registered nurse (RN), such as a RN First Assist (RNFA- RN with training that assists a surgeon during surgery), "First Assistant" for "Coronary Artery Bypass" for Pt 37 and Pt 39. RN 1 was not listed on the APH roster.

During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the MST stated no physicians or providers on staff have had adverse events (when a medical or drug error contributed to harm) , 805 report (805 report, a mechanism in which hospital's peer review bodies were required to report specific information regarding licensees to the Medical Board), diversion (drug loss or illegal use of drugs), peer review (medical peer review is the process by which health care professionals were evaluated for clinical performance) issues. MST stated if there was a "trend of greater than 3 cases" with concerns, then this will "trigger peer review" and will take "it seriously and review what needs to be reviewed". MST stated if there was a concern with a provider, they would "go directly to the chief" of the department. MST stated the hospital did not have any record for 24 of 24 providers for opportunity for improvements. MST stated physician's peer review, adverse events and report to the licensing boards were "protected because of 1157" (Code Section 1157, the California statute governing confidentiality of information generated during hospital medical peer review proceedings) and would not be released for review on any of 25 of 25 providers, COS, SUR 3, SUR 5, SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6 and PA 7 or NP 2.

During a phone interview on 5/23/24, at 12:42 p.m., with the hospital administration team which included, Director of Clinical Quality and Performance Improvement DCQI, Chief Nursing Officer (CNO), Chief Executive Officer, (CEO) and Accreditation Manager, the team acknowledged that unprivileged providers and unsupervised AHPs, including CRNAs, were providing independent medical care without the appropriate physician involvement according to their respective scopes of practice and hospital policy. They were diagnosing and treating medical conditions, plus ordering, prescribing, and administering medications, treatments, and therapeutics to patients without a treatment regimen ordered by a physician or other physician involvement appropriate according to their respective scopes of practice and hospital policy.

During record review of the hospital log, titled "Revised Med Staff Roster", and "Revised AHP Roster" for date range of 5/2023 to 5/2024, the record listed 658 physician providers and 124 AHPs. The following providers did not have documented evidence of specific privileges and/or were not on the Medical Staff or AHP rosters and were listed on the "OR Log Revised", 2/2023 to 5/15/2024 as part of a team with patient adverse events and death:

During a comparative record review of Operating Room (OR) case logs;
"MD 11 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon.

MD 12 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon.

ANS 5 was listed as the anesthesia provider for Pt 64, Pt 66, Pt 67, Pt 97, Pt 98, Pt 99, Pt 100, Pt 101, Pt 104 and Pt 105 but was not on Medical Staff Roster

PA 8 was listed as Additional staff intraoperative "Additional staff intraoperative" for Pt 39. On the AHP roster with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging)

PA 8 as listed as an "Anesthesia Tech [assistant to anesthesiologist, not allowed to practice in California]" for Pt 37. PA 8 was listed on AHP roster as PA with a radiologist as the supervising physician.

Nurse Practitioner 1 (NP 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39, but was not listed on the medical staff or AHP roster.

Physician, (DO 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39 but was not listed on the medical staff.

During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with the MST, the MST acknowledged privileges were granted for specific specialties and if additional privileges were desired, the request must be submitted to medical staff for review and approval. The MST stated that names of individuals who were not on the AHP or Medical Staff Rosters, did not have privileges. DCQI stated it was a "mix-up".

During an interview and concurrent record review on 5/30/24, at 3:48 p.m., Chief of Medical staff (COS), accompanied by Accreditation Manager (AM 2), the hospital policies and medical staff processes were discussed. COS stated PA privileges were "bases on education". COS stated PAs can work "anywhere" in the hospital. COS acknowledged that medical staff does confirm the competency, qualifications, and skills of AHPs. COS stated no matter the AHP's specialty or employment status, (hospital employee or contract provider), whatever physician "asked" the AHP to provide the medical care, and the physician was "responsible" for the care the AHP's provides.

During an interview on 5/30/2, at 3:00 p.m., with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed. SUR 4 stated anesthesiologist cover trauma and direct codes, not CRNAs. SUR 4 stated the only non-surgeon physicians that come to the ORs are, "intensivist [ICU physician]", who are called to the OR when assistance is needed running a code. SUR 4 indicated she was unaware that, non-surgeons, MD 11 and MD 12, were assisting in surgeries. During review of the medical staff logs indicated SUR 4 stated PA 8 was supervised by a radiologist, and "I don't know why his name is on a cardiac case" and assisting in surgeries or anesthesia. SUR 4 stated the "surgery department does not oversight of the anesthesia service. SUR 4 stated RNFAs were nurses and employees of the hospital, and surgery does not control what nurses are in the OR. SUR 4 stated she had "no idea" who some of the providers were MD 15, NP 1 or DO 1 or why they were assisting the in surgery. SUR 3 stated "poor documentation" may be why unidentifiable individuals were present in the OR. There was no documented policy available that described the entrance of non-privileged OR staff, visitors, or bystanders to enter the operating rooms.

During record review of [Hospital] policy titled "Rules and Regulations of the Governing Board of [Hospital]", June 13, 2022, indicated that the "Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice ... All practitioners granted appropriate membership and privileges by the Governing Board at this facility shall be proctored regardless of board certification and/or prior experience.

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that " recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership".

During record review of hospital titled, "AHP [Allied Health Professional] Rules and Regulations, version 2022" indicated that the "Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned ... Practitioners who desire to sponsor and supervise AHPs must apply and qualify for such sponsorship. Each AHP who is a Physician's assistant must be supervised by a Physician having the following qualifications: a. Is a Physician currently licensed by the State of California; Identify a sponsoring and supervising Medical Staff Member, in good standing on the Active staff, who has Privileges in the appropriate Department, and who has agreed to assume ongoing responsibility for sponsorship and direct supervision of the AHP at all times. When the sponsoring and supervising Practitioner is not available, an alternate supervising Medical Staff Member meeting all the requirements of the sponsoring Member must be predesignated and must provide direct supervision at all times in place of the absent Practitioner. ... Restriction of the Privileges of the sponsoring and supervising Practitioner, in which case the Practice Prerogatives of the AHP shall be restricted accordingly."

During record review of [Hospital] policy titled, "MOD CLN.4.04 MOD Operative and Invasive Procedures Appropriateness Review (CO-5.007.MOD)", approved 4/10/2024, stated the purpose of the policy was "to describe the minimum standards, review Cardiac Operative and Invasive procedures through effective use of evidence-based clinical criteria ... Quality Review ... The Facility shall conduct case reviews in accordance with the peer review and quality processes set forth in the Facility's Medical Staff Bylaws and state statutes.

During record review of California's Business and Professions Code, CA BPC, 2725(b)(2), it stipulated that "Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician".

During review of California 's Business and Professions Code, CA BPC 2827, it stipulated, the "utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist".

Based on observation, interview and record review, the hospital failed to have an effective governing body (GB) responsible for services furnished in the hospital when the dish machine was not working for approximately four months with no movement on the new dish machine or implementation of a timely solution, when it was deemed not repairable.

These failures reesulted in the pot and pan area being overused and containing black substances throughout the room, pans being stored wet, patient trays not being sanitized properly, patient meals being served on Styrofoam and plastic utensils which could affect the temperature of the food and could compromise the nutritional and medical status of the patients.

Findings:

1. During the initial tour of the kitchen an observation of the lunch meal service on 5/13/24 at 11:44 a.m., in the presence of the Patient Services Supervisor (PSS), there was the trays for the patient meals going down the line. In lieu of a plate, for the main entrée, each tray had a Styrofoam clamshell "to go" type container. The PSS stated the dish machine went down a couple months ago so they only thing that is not disposable is the trays.

During an observation and concurrent interview on 5/13/24 at 11:59 a.m., with Food Service Staff (FSS) 2 in the pot and pan room, he was currently washing all the pots and pans in the three-compartment sink. FSS 2 stated the dish machine had been down pretty much since November and it was a lot of work doing everything by hand. FSS 2 stated it was nonstop to keep up.

During an interview with the of Regional Director of Operations (RDO) on 5/13/24 at 12:06 p.m., he stated the dish machine has been down for 14 weeks however they have just gotten capital approval to purchase a new one. RDO stated they had not gone to HCAI (California Department of Health Care Access and Information) to get approval yet. Stated it has taken so long since the dish machine was old, and it was difficult to get parts. RDO stated he had not thought about getting a temporary dish machine trailer while this was going on.

During an observation and concurrent interview on 5/13/24 at 2:40 p.m., with FSS 1, in the pot and pan room, containing approximately five different sized containers of various sizes on the floor with many different utensils in them, one red bucket and approximately 15 to 20 large sheet pans stacked on each other with at least two cutting boards and five pans and a bowl on top of it on the ground. There were a couple carts with various pans, cutting boards and utensils on them. FSS 1 stated there are a lot of dishes to do by hand. FSS 1 stated the dishwasher has been down for months. At 2:44 p.m., FSS 1 stated the first sink could not hold water, so it was backing up more and hard to get everything cleaned.

During an observation and concurrent interview on 5/13/24 at 2:49 p.m., with FSS 3, in the dish machine room. There were meal trays drying on the dish machine rack. FSS 3 stated they dry the trays there and the dish machine has been down since the beginning of the year or so.

During an interview on 5/14/24 at 9:41 a.m., the Facility Services Manager (FSM), stated they maintained patient care equipment and provide services to the Food and Nutrition Department. The FSM stated if they need to get a vendor for a repair then they will coordinate and schedule it. The FSM stated they do preventative maintenance on equipment in the kitchen. The FSM stated there was parts no longer available for the dish machine. The FSM stated the vendor was last onsite last week continuing to repair. The FSM stated the maker of the dish machine has a propriety agreement, so it is hard to get parts. They have had third party vendor numerous times and it was a trial and error. The pump went down then it had a leak. The FSM stated the dish machine maker has been a challenging vendor and they are booked two to three months out. The FSM stated they are awaiting parts from another third-party vendor and that the administration may just get a replacement.

During an interview with the Director of Facilities (DOF) on 5/14/24 at 3:55 p.m., DOF stated the dish machine is needing repair. DOF stated the process is that the contract food services company will get quotes of the new dish machine, then it goes to the administration for funding. DOF stated the dish machine has aged out and broken down.

During an interview with the Contract Vendor Maintenance on 5/15/24 at 2:14 p.m., regarding the dish machine. The Contract Vendor Maintenance stated the hospital was told by the dish machine manufacturer that the dish machine is not repairable, and they just keep sinking money into it. He stated they knew it was not repairable back in February and on March 29th was the last time they were out there. The Contract Vendor Maintenance stated he was called back out May 7th and they ordered another part, but he was not sure why since they need to get a new one.

Review of emails from IDNFS and Vendor for a dish machine quote is dated 3/15/24 at 7:05 a.m., showed that the Vendor was "glad to hear this project was back on!" and the link for the quote was dated 3/12/24. On 3/18/24 the IDNFS forwarded the quote to AA and Corporate Hospital Health Informatics Manager. Review of the emails from DOF to AA and Corporate Hospital employes and the Corporate Hospital Health Informatics Manager, dated 3/20/24 until 3/25/24, showed they were trying to figure out who had better pricing from the suppliers either Contract Food service company or themselves, last email showed once they got the "CER including construction and permitting completed, please send me a copy so I can discuss with Lisa". Hospital was unable to demonstrate any movement or temporary solution for the dish machine forward prior to the survey entrance date or a temporary
Review of a hospital document titled, Opinion of Probable Cost, dated 3/29/24, showed the project scope was the replacement of the existing dishwasher with a quote dated 3/22/24 from an architecture firm.

The delay to move forward timely with a new dish machine or acquire a temporary dish machine trailer resulted in multiple infection control concerns in the kitchen that were identified during the survey on 5/13/24 to 5/14/24

During a review of the hospital policy and procedure titled "Utilities Management Plan", dated approved 5/24/23, indicated the Utility Systems Program is designed to ensure continual availability of safe, effective equipment through a plan of planned maintenance, timely repair .... that could have an adverse impact on the safety of patients and staff as applied to the building and services provided at the hospital.

Based on interview and record review, the hospital failed to ensure patient's rights were considered for two of three sampled patients ((Pt) 11 and Pt 12) when patients preferred language was other than English and there was minimal (for informed consents) to no documentation an interpreter was used for either patient during their hospitalization.

These failures had the potential for patients whose preferred language was other than English to not receive and fully understand procedures and/or education provided to them and could result in negative health outcomes when bilingual staff who were not competent interpreters communicated with patients and did not use the interpreting system to communicate with patients in accordance with the hospital's policies and procedures.

Findings:

1. During a concurrent interview and record review on 5/15/24 at 9:31 a.m. with Quality Nurse (RNQ) 4, Pt 11's "Electronic Health Record (EHR)," dated 5/14/24 and Pt 11's "Face Sheet (FS-a document that contains a summary of a patient's personal information and brief medical history)," ), " dated 5/14/24 were reviewed. The EHR indicated Pt 11 was admitted on 5/14/24 at 9:36 a.m. for induction of labor (the use of medications or other methods to bring on labor) at 34.4 weeks (in month eight of pregnancy). RNQ 4 stated the FS indicated Pt 11's preferred language was Spanish.

During a concurrent interview and record review on 5/22/24 at 12 p.m. with RNQ 4, Pt 11's "OB Anesthesia Flow Sheet (FS)," dated 5/15/24 was reviewed. RNQ 4 stated the FS indicated an epidural (a numbing medicine given by inserting a needle and a small, flexible tube into the lower part of a woman's back) was placed at 12:38 p.m.

During a concurrent interview and record review on 5/22/24 at 3:45 p.m. with RNQ 4, Pt 11's "Discharge Instructions and Signature Page (DI)," dated 5/18/24 and Pt 11's "Nurses Note (Note)," dated 5/18/24 were reviewed. RNQ 4 stated the DI indicated the instructions were in Spanish but there was no indication an interpreter was used to provide Pt 11 her discharge instructions. RNQ 4 stated the Note indicated, "Discussed discharge instructions with patient and patient verbalized understanding."

During a concurrent interview and record review on 5/22/23 at 4:00 p.m. with RNQ 4, Pt 11's "Consent for Anesthesia (Consent)," dated 5/15/24 and Pt 11's "EHR," undated were reviewed. RNQ 4 stated the EHR indicated there was no documentation an interpreter was used during Pt 11's hospitalization. RNQ 4 stated the anesthesiologist should have provided the informed consent and used an interpreter to consent for the anesthesia services to ensure the patient understood the procedure. RNQ 4 stated the Consent indicated an interpreter was not used to interpret the consent for the anesthesia, evidenced by the blank space where the interpreter utilized to interpret should have been documented. RNQ 4 stated the importance of utilizing an interpreter and/or interpreter services for consent forms was to explain the risks and benefits of the procedure and answer any questions the patient may have appropriately.

During a review of Pt 11's "Interdisciplinary Patient Education SMART Template (Template)," dated 5/15/24 to 5/18/24, the Template indicated, from 5/15/24 to 5/18/24, seven nurses documented, the "Barriers to Learning:-Language Barrier, Comments: Spanish speaking-RN speaks Spanish." The Template indicated six bilingual staff who were not certified interpreters used their interpreting skills to communicate with Pt 11 during her hospital stay and did not document the interaction. The Template indicated one staff who was not bilingual, documented, the "Barriers to Learning:-Language Barrier, Comments: Spanish speaking-RN speaks Spanish."

During a review of the hospital's policy and procedure (P&P) titled, "Interpretation Translation Services for Patients," dated 3/27/19, the P&P indicated, ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ... Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ..."

2. During a concurrent interview and record review on 5/15/24 at 10:00 a.m. with RNQ 4, Pt 12's "FS," dated 5/14/24 and Pt 12's "History and Physical (H&P)," dated 5/3/24 was reviewed. The FS indicated Pt 12 was admitted on 5/14/24 at 7:54 a.m. and her preferred language was Spanish. The H&P indicated Pt 12 was admitted for repeat cesarean section (the surgical delivery of a baby through a surgical incision made in the mother's abdomen).

During a concurrent interview and record review on 5/20/24 at 12:30 p.m. with RNQ 4 and RNQ 5, Pt 12's "EHR," dated 5/14/24 to 5/16/24 was reviewed. RNQ 5 stated when an interpreter was used, the nurses could document this in the rounding comments and frequent assessments. The EHR indicated there was no documentation of interpreter use in the round comments or frequent assessments. RNQ 4 stated the EHR indicated there was no interpreter documentation besides the time when Pt 12 was consented for surgery, anesthesia, and blood products on 5/14/24.

During a concurrent interview and record review on 5/20/24 at 1:00 p.m. with RNQ 4 and RNQ 5, Pt 12's "DI," dated 5/16/24 was reviewed. RNQ 4 stated the DI indicated the instructions were in Spanish but there was no indication an interpreter was utilized to provide Pt 12 her discharge instructions.

During an interview on 5/30/24 at 2:39 p.m. with the CNO, the CNO stated her expectations of hospital staff was to utilize an interpreter prior to medication administration, consents, teaching, assessments, discharges, and plan of care for patients who were non-English speaking. The CNO stated hospital staff should be utilizing interpreters and documenting their use of an interpreter in the EHR. The CNO stated the importance of using an interpreter was to ensure patients were receiving the appropriate care, risks and benefits of procedures and medications were explained, and patients were receiving the appropriate education prior to discharge so they could take care of themselves at home.

During a review of the hospital's P&P titled, "Interpretation Translation Services for Patients," dated 3/27/19, the P&P indicated, "PURPOSE: To provide interpretation/translation services to patients who do not speak English as their primary language and who have a limited ability to read, speak, or understand English so that the patient can participate in their care and communicate with their care providers ...Competency-Demonstrated proficiency in English and the other language. The ability to use the appropriate mode of interpreting ...and knowledge in both languages of specialized terms or concepts such as medical terminology, names of body parts, symptoms and injuries ...Bilingual-The ability to communicate effectively in a different language when communicating information directly in that language but may not be competent to interpret in and out of English. Likewise, they may not do written translation ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ...[name of interpreting service] is the designated interpretation services at [Hospital A]. [name of interpreting service] has documented competent interpreters in multiple languages ...The [name of interpreting service] interpreter's identification number will be documented on the consent form ...The [name of interpreting service] will be used for all informed consents, unless the Physician is bilingual and able to interpret the planned procedure adequately so that the patient completely understands the risks and benefits of the procedure to be performed. The Physician will document that he/she interpreted informed consent to the patient in the Patient Care Record ...The [name of interpreting service] system may be used for any routine procedures that does not require official informed consent but may be considered as invasive by the patient. Procedures may include insertion of urinary catheters, insertion of peripheral IVs, insertion of nasogastric tubes, laboratory blood draws ...The [name of interpreting service] system may also be utilized by health care providers in the admission and discharge process ...Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ..."

Based on observation, interview, and record review the hospital failed to ensure patients' rights were provided to patients so they could make informed decisions about their care for two of four sampled patients ((Pt) 6 and Pt 11) when there was no consent form for antipsychotic medications (a type of drug used to treat severe mental disorder in which a person loses the ability to recognize reality or relate to others) administered to Pt 6 during his hospitalization and Pt 11 was not provided with an interpreter during consent for an epidural per the hospital's policy and procedure.

These failures resulted in administration of antipsychotic medications to Pt 6 without Pt 6 (or the responsible party) having the opportunity to weigh the benefits and risks of the medication and right to refuse treatment; and did not provide Pt 11 the opportunity to weigh the benefits and risks of the procedure in a language she understands and documented preference; these failures could cause avoidable and unnecessary mental and emotional distress.

Findings:

1. During a concurrent interview and record review on 5/23/24 at 3:00 p.m. with the Assistant Director of Nursing (ADON), Pt 6's "History and Physical (H&P-complete assessment of the patient and the problem), dated 12/29/23 was reviewed. The H&P indicated, "66-year-old female with history of schizophrenia [a serious mental disorder that affects how a person thinks, feel, and behave], hypertension [high blood pressure-when the pressure your blood vessels is too high] not compliant with any medication is admitted here on a 5150 hold [allows for a person with a mental illness to be involuntarily detained in a psychiatric hospital for a 72 hour period] for [danger to self/danger to others]. Currently patient is compliant. Patient denies any fever chills nausea vomiting, cough, shortness of breath, or any sick contacts."

During a concurrent interview and record review on 5/23/24 at 3:25 p.m. with the ADON, Pt 6's "Physician Orders (PO)," dated 1/4/24 and 1/12/24 were reviewed. The ADON stated the PO indicated, on 1/4/24 at 2:22 p.m. haloperidol (medication used to treat nervous, emotional, and mental conditions) 5 milligrams (mg-unit of measure), Injection, Intramuscular, three times a day (TID) as needed (PRN) with comments from physician, "to be administered if patient refuses oral Depakote 500 mg." The ADON stated the PO indicated on 1/12/24 at 11:22 a.m. paliperidone (medication used to treat schizophrenia) 9 mg equals 1 tablet, extended-release (slowly released into the body over a period of time) tablet, Oral, Daily, with physician comment, "please give first dose today." The ADON stated the consent forms for the two medications were physical documents and were not able to be viewed via Pt 6's electronic health record (EHR).

During a review of Pt 6's "Patient Consent to Receive Psychotropic Medications (Consents)," undated, the Consents for Pt 6 that were provided by the hospital did not have consent forms for haloperidol and paliperidone.

During a review of Pt 6's "Medication Administration Record (MAR)," dated 1/4/24 to 1/15/24, the MAR indicated on 1/4/24 at 9:44 p.m. Pt 6 was administered one dose of haloperidol. The MAR indicated from 1/12/24 to 1/15/24, Pt 6 was administered paliperidone daily.

During an interview on 5/30/24 at 2:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectations for nursing staff was to ensure patients were consented appropriately for the psychotropic medications prescribed to them and the side effects monitored to ensure the safety of patients. The CNO stated her expectations of nursing staff was to follow hospital policies and procedures.

During a review of the hospital's policy and procedure (P&P) titled, "MOD DBHC.1.47 Monitoring of Psychiatric Medications," dated 8/23/23, the P&P indicated, " ...POLICY: It is the policy of [name of hospital] to maintain the right of the patients/conservator to be informed of the benefits and side effects each psychiatric medication intended to be prescribed for the treatment of their mental condition ...PURPOSE On admission, the attending psychiatrist will have a verbal discussion with their patient of the benefits and side effects of the proposed psychiatric medication/s and obtain a signed consent for each psychiatric medication on the medication consent form. The signed medications form will be filed in the patient's chart ...The licensed nurse will review the medical record or medication record prior to administration of any psychiatric medications. If the patient/guardian/conservator has not given consent, notify the physician to obtain informed consent for the patient ...Medications may not be given without consent except for emergency medications. Refer to the informed consent policy ...DOCUMENTATION OF SIDE EFFECTS ...The licensed nurse will monitor the patient each shift for side effects of psychiatric drugs, and document the presence/absence of side effects in the progress notes ...The licensed nurse will notify they responsible physician for initial onset of symptoms, and when there is an increase in symptoms ...DOCUMENTATION OF MOOD/AFFECT ...The licensed nurse will document the patient's progress daily ...Notify the MD if the patient is refusing medications and any other pertinent information related to the administering of psychiatric medications ..."

During a review of the hospital's P&P titled, "DBHC.1.04 Informed Consent to Receive Psychotropic Medications," dated 2/28/18, the P&P indicated, "Any patient treated at [Hospital B] will be informed of his/her right to accept or refuse psychotropic medication(s) unless there has been an adjudication of lack of capacity to refuse, or the existence of an emergency. The patient is to be provided with information regarding his or her diagnosis and the risks, benefits and alternatives of the prescribed medication(s) ...PURPOSE: To provide guidelines of obtaining and documenting consent of psychotropic medications recommended to the patient ...Physician Responsibility ...Informed consent given by a patient to one psychiatrist may be honored by another psychiatrist ...A Psychotropic Medication Informed Consent (one per medication to include anticipated dosage) is to be signed by the patient and psychiatrist when initiating any new psychotropic medication, e.g., standard antipsychotics, atypical antipsychotics, antidepressants, mood stabilizers/anticonvulsants, anxiolytics, sedatives, benzodiazepines and sedative hypnotics ...The Psychotropic Medication Informed Consent Form shall be signed by all patients age 18 or over ...For the inpatients on temporary conservatorship/LPS Conservatorship, consent for treatment with psychotropic medication shall be obtained from the patient's Conservator or Deputy Conservator ...Patients will be provided the following information in the patient's own language ...Their diagnosis ...The risks and benefits and alternatives of the medication ...The type, dose, frequency, route and duration of the medication ...The possible side effects of these medications and the possibility of Tardive Dyskinesia must be discussed with patients receiving antipsychotics. The patient shall be advised that such side effects may include persistent involuntary movements of the face, mouth or extremities and that the symptoms are potentially irreversible, and may appear after medications have been discontinued ...The patient may withdraw consent to medication at any time. This withdrawal will be documented in the chart ...Nursing Responsibility ...A patient has the right to refuse medications unless the situation meets the definition of an emergency situation or the patient has had a Riese Hearing in which the court has determined that the patient does not have the capacity to make an informed decision regarding medications ...The nurse shall assure that the patient has given informed consent prior to administration of any psychotropic medication(s). Even if the medication has been ordered by the psychiatrist, the informed consent must be confirmed on the medical record prior to administration of the psychotropic medication(s) ...If a patient refuses medications, the psychiatrist shall be notified as soon as possible and the reason documented in the medical record ...When there is an order for a medication and on consent form is signed, the nurse shall notify the prescribing psychiatrist to confer with the patient."

2. During a concurrent interview and record review on 5/15/24 at 9:31 a.m. with Quality Nurse (RNQ) 4, Pt 11's "Electronic Health Record (EHR)," dated 5/14/24 and Pt 11's "Face Sheet (FS), " dated 5/14/24 were reviewed. The EHR indicated Pt 11 was admitted on 5/14/24 at 9:36 a.m. for induction of labor (the use of medications or other methods to bring on labor) at 34.4 weeks (meaning in month eight of pregnancy) for cholestasis (a liver problem in pregnancy). RNQ 4 stated the FS indicated Pt 11's preferred language was Spanish.

During a concurrent interview and record review on 5/22/24 at 12:00 p.m. with RNQ 4, Pt 11's "OB Anesthesia Flow Sheet (FS)," dated 5/15/24 was reviewed. RNQ 4 stated the FS indicated an epidural (a numbing medicine given by inserting a needle and a small, flexible tube into the lower part of a woman's back) was placed at 12:38 p.m.

During a concurrent interview and record review on 5/22/23 at 4:00 p.m. with RNQ 4, Pt 11's "Consent for Anesthesia (Consent)," dated 5/15/24 was reviewed. RNQ 4 stated the anesthesiologist should have provided the informed consent and used an interpreter to consent for the anesthesia services to ensure the patient understood the procedure. RNQ 4 stated the Consent indicated an interpreter was not used to interpret the consent for the anesthesia, evidenced by the blank space where the interpreter utilized to interpret should have been documented. RNQ 4 stated the importance of utilizing an interpreter and/or interpreter services for consent forms was to appropriately explain the risks and benefits of the procedure and answer any questions the patient may have.

During an interview on 5/30/24 at 2:39 p.m. with the CNO, the CNO stated her expectations of hospital staff to utilize an interpreter should be prior to medication administration, consents, teaching, assessments, discharges, and plan of care for patients who were non-English speaking. The CNO stated hospital staff should be utilizing interpreters and documenting their use of an interpreter in the EHR. The CNO stated the importance of using an interpreter was to ensure patients were receiving the appropriate care, risks and benefits of procedures and or medications were explained, and patients were receiving the appropriate education prior to discharge so they could take care of themselves at home.

During a review of the hospital's P&P titled, "Informed Consent for Medical Treatment," dated 11/30/22, the P&P indicated, " ...every adult with decision making capacity has the fundamental right of self-determination over his or her body, which include the right to participate actively in decisions regarding his or her medical care and to decide whether to consent or to refuse to give consent for treatment or procedures recommended by his or her physicians ...Informed consent shall be obtained by the treating physician from the patient or an individual authorized to give such consent prior to initiating any invasive procedure ...The information that must be provided includes a description of: 1. The nature of the recommended treatment. 2. Its expected benefits or effects. 3. The associated risks and complications. 4. Any alternatives to the procedure, including refusing the treatment, and their expected benefits and associated risks ...An invasive procedure is any medical treatment or procedure which is not common, simple and low risk. Procedures that are considered to be "complicated" that require informed consent include ...Procedures that require anesthesia or moderate sedation ..."

During a review of the hospital's P&P titled, "Interpretation Translation Services for Patients," dated 3/27/19, the P&P indicated, "PURPOSE: To provide interpretation/translation services to patients who do not speak English as their primary language and who have a limited ability to read, speak, or understand English so that the patient can participate in their care and communicate with their care providers ...Competency-Demonstrated proficiency in English and the other language. The ability to use the appropriate mode of interpreting ...and knowledge in both languages of specialized terms or concepts such as medical terminology, names of body parts, symptoms and injuries ...Bilingual-The ability to communicate effectively in a different language when communicating information directly in that language but may not be competent to interpret in and out of English. Likewise, they may not do written translation ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ...[name of interpreting service] is the designated interpretation services at [Hospital A]. [name of interpreting service] has documented competent interpreters in multiple languages ...The [name of interpreting service] interpreter's identification number will be documented on the consent form ...The [name of interpreting service] will be use for all informed consents, unless the Physician is bilingual and able to interpret the planned procedure adequately so that the patient completely understands the risks and benefits of the procedure to be performed. The Physician will document that he/she interpreted informed consent to the patient in the Patient Care Record ...The [name of interpreting service] system may be used for any routine procedures that does not require official informed consent but may be considered as invasive by the patient. Procedures may include insertion of urinary catheters, insertion of peripheral IVs, insertion of nasogastric tubes, laboratory blood draws ...The [name of interpreting service] system may also be utilized by health care providers in the admission and discharge process ...Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ..."

Based on observation, interview, and record review, the hospital failed to ensure one of the three sample [Brand name 1] warmers for pre moistened was used in accordance with the operating instructions when [Brand name 1] warmer was storing non compatible wipes.

This failure had the potential for fire or other hazards and did not ensure the right to care in a safe environment.

Findings:

During an observation on 5/13/24 at 3:00 p.m. in Surgical Intensive Care unit (SICU -Unit that offers critical care treatment to unstable, severely, or potentially severely ill patients, who have life-threatening conditions and require comprehensive care, constant monitoring, and possible emergency interventions like surgery) with Registered Nurse Quality (RNQ 1), Registered Nurse (RN) 9, Registered Nurse Manager (RNM 2) and Director of Critical Care (DCC) observed [Brand name 1] warmer stocked with pre moistened wipes of [Brand name 1] and [Brand name 2]. Both [Brand name 1] wipes and [Brand name 2] wipes were stored right next to the warmer.

During an interview on 5/13/24 at 3:15 p.m. with RNM 2, RNM 2 stated the SICU team used [Brand name 1] and [Brand name 2] wipes in the [Brand name 1] warmer. RNM 2 stated as far as he knew, both brand wipes were compatible with [Brand name 1] warmer. RNM 2 stated he was unable to comment how long the wipes could stay in the warmer before the wipes were required to be removed and discarded . RNM 2 stated wipes got used every day and had to be restocked every day. RNM 2 stated it was unusual for any wipes to stay in the warmer for more than 24 hours. RNM 2 stated he was not made aware of any issues with using [Brand name 2] wipes in the [Brand name 1] warmer.

During an interview on 5/13/24 at 3:18 p.m. with RN 9, RN 9 stated she was the charge nurse for the shift. RN 9 stated both brand wipes were used with [Brand name 1] warmer and she was not made aware of any issues on the unit with using [Brand name 1] or [Brand name 2] wipes in the [Brand name 1 ] warmer. RN 9 stated staff would restock the warmer from the stock right next to the warmer with both types of wipes.

During a review of [Brand name 1] "Warmer Operating Instructions", undated, the "Warmer Operating Instructions" indicated, " ...Please read and understand these instructions completely prior to operating the warmers ...IMPORTANT SAFETY INSTRUCTIONS This product is to be used SOLELY for warming premoistened cloth and hair care products manufactured by [Brand name 1] LLC. The warmer has been designed and safety tested to be used exclusively with these products. ANY other use of the warmer by the facility including, but not limited to, use with other bathing products, can result in overheating, fire or other hazardous conditions and is expressly forbidden ..."

During a concurrent interview and record review on 5/14/24 at 2:10 p.m. with the Facilities Service Manager (FSM), "[Brand Name 1] Warmer Operating Instructions," undated were reviewed. The FSM stated in reviewing the instructions, the warmer was designed for [Brand 1] wipes and clearly stated use of other products in this warmer could result in overheating, fire, and other hazards.
During a concurrent interview and record review on 5/14/24 at 3:30 p.m. with the DCC, "[Brand Name 1] Warmer Operating Instructions," undated were reviewed. The DCC stated he had reviewed the [Brand 1] Warmer Operating instructions. The DCC stated the SICU was not using the [Brand name 1] warmer in accordance with instructions for use. The DCC stated he understood the fire risk and risk for other hazards with the use of [Brand name 2] wipes in the [Brand name 1] warmer. The DCC stated the practice had been stopped and going forward, the SICU team will only use [Brand name 1] wipes with the [Brand name 1] warmer.

Based on observation, interview, and record review, the hospital failed to ensure patients were free from physical abuse for one of three sampled patients (Pt) 6 when Certified Service Tech (CST) 1 pushed Pt 6 into the wall.

This failure resulted in Pt 6 sustaining a broken clavicle (collarbone) and placed all patients at Hospital B at risk for abuse.

Findings:

During a concurrent interview and record review on 5/23/24 at 2:58 p.m. with the Assistant Director of Nursing (ADON), Pt 6's "Emergency Department Physician Note," dated 12/28/23 was reviewed. The Note indicated, Pt 6 was "[brought in by ambulance] from [home] on 5150 hasn't been taken meds for several months, bit room mate's finger and threatened to kill him & herself/delusional. [blood pressure] 172/118, [heart rate] 114." The Note indicated, Pt 6 was medically cleared after labs for urine drug screen, complete blood count (blood test measures the red blood cells which carry oxygen), comprehensive metabolic panel (blood test that gives information about the body's fluid balance and electrolytes), and treponema pallidum (blood rest used to detect syphilis [bacterial sexually transmitted infection]) resulted. The Note indicated, "Medical Decision Making: Patient appears stable no acute distress nothing acute on labs or transplant." The ADON stated there was nurse to nurse report from [Hospital A to Hospital B], and the physical 5150 hold went with Pt 6 to [Hospital B].

During a concurrent interview and record review on 5/23/24 at 3:40 p.m. with the ADON, Pt 6's "Nurse Note," dated 1/4/24 was reviewed. The Note indicated, "Patient was received in her room laying in bed. She was covered from head to toe in her blanket. Writer called her name several times but she did not respond. She was moving around under her blanket. Writer called out to her and introduced myself as her nurse for the night. I asked if I could check her vitals and she did not reply. I placed my hand on the outline of what appeared to be her right knee, as she was laying on her left side, she whipped out her leg and kicked me on my left hip. The CST was standing by at the doorway and we both immediately moved back and told her to stop ...After she kicked me, she was instructed to stay on the bed and not get off. She stayed on the bed ...Writer informed her she would be back to give her her medications Depakote [used to decrease mood swings and aggressive outbursts] 500 [milligrams (mg-unit of measure)] [and] Zyprexa [used to regulate mood, behaviors, and thoughts] 15 mg [by mouth]. She stated "I don't want them, I don't need them." ... Writer informed her you are reiesed [when a patient is court ordered to receive intramuscular (IM-in the muscle) medications per the physician's orders when they refuse their by mouth medications] if you refuse your medication you will be getting an injection as ordered by the doctor ... Writer pulled the oral meds and came to the patient with the medications and offered them to her. She sat up and stated. "I don't take meds, I don't want them" and covered herself back up. Writer told her I would be back with the medications ordered the injections Zyprexa 15 mg [and] Haldol [used to treat nervous, emotional, and mental conditions] 5 mg ...IM's given after back up staff arrived. After we left her room, patient was instructed to stay in her room, but shortly after we left, she came out of her room and while she was walking out she walked past the CST in the hallway and then struck her in the head. Staff was called for and the patient was escorted to her room and write, and the manager went to talk to her, but she was belligerent and cursed at the manager and told us to get ...out of her room ...0600 oncall psychiatrist notified of the assaultive [physically aggressive] behavior patient had last night. Patient is already on [every] 5 [minute] rounds and is already on assaultive precautions ..."

During a concurrent interview and record review on 5/23/24 at 3:45 p.m. with the ADON, Pt 6's "Nurse Note," dated 1/5/24 was reviewed. The Note indicated, " ...After lunch patient approached this writer asking for pain medications, she showed to this writer her right shoulder. Noted big bruise and swollen shoulder when asked what happened she said they threw me on the wall and hit my shoulder and head". Manager made aware and interview patient per manager patient reported "a female staff threw her against the wall and hit her shoulder and head and happened in the hallway last night". Hospitalist made aware and [ordered] right shoulder Xray. Patient was also given ice pack and pain medication ...Medication given as ordered ..."

During a concurrent interview and record review on 5/23/24 at 4:00 p.m. with the ADON, Pt 6's "[X-ray] Shoulder Complete Right (Results)," dated 1/5/24 was reviewed. The Results indicated, " ...Comminuted fracture [a bone that is broken in at least two places] of the distal right clavicle [collarbone] ..." The ADON stated when the x-ray results have been read, it pops up in the patient's electronic health record (EHR) and the nurse notifies the physician of the results right away.

During a concurrent interview and record review on 5/23/24 at 4:10 p.m. with the ADON, Pt 6's "Nurse Note," dated 1/5/24 was reviewed. The Note indicated, "[Patient] came back from [Hospital A] X-ray dept at around [7:10 p.m.]. She is calm, cooperative, and coherent at this time ...Pt verbalized "My shoulder hurts right now. It's my fault though." Pt declined to discuss further ...At around 10 pm, this writer received her X-ray results. [Patient] referred to [name of physician assistant] with orders made and carried out. [Patient] referred to [Hospital A] [emergency room (ER)] for Ortho Evaluation ...At [1:55 a.m.] [patient] came back from ER with new Orders. Sling was applied to her in the [emergency department (ED)]; On call Psychiatrist informed with orders made and carried out ...Monitor [one to one] by a sitter for safety ..."

During a concurrent interview and record review on 5/24/24 at 1:35 p.m. with the Chief Human Resource Officer (CHRO), with RNQ 2 present, CST 1's "Employee File," undated was reviewed. The CHRO stated CST 1 was hired on 11/1/07, a background check was conducted on 10/23/07, CST 1's most recent performance evaluation indicated satisfactory performance, Abuse prevention and reporting training was completed on 2/2/24 and CPI training was current with an expiration date on 11/17/24.

During a concurrent interview and record review on 5/28/24 at 4:25 p.m. with Quality Nurse (RNQ) 3, Pt 6's "Physician Discharge Note," dated 2/9/24 was reviewed. The Note indicated, "Patient was provided with a safe secure environment ...During her stay here in the hospital she did have episodes of agitation requiring as needed medications. While she was here in the hospital patient did suspend injury to her clavicle. She was recommended and offered the use of sling which she ultimately refused to use however she did not have any significant complaints of pain. Patient is seen today on 2/9/2024, patient remains euthymic [a normal, mental state or mood], her mood remains stable and she continues to be free of any psychotic symptoms. It was agreed that she was appropriate discharged today home to her sister."

During an interview on 5/29/24 at 8 a.m. with the Director of Nursing (DON), the DON stated she tried to get ahold of CST 1, CST 2, RN 24, RN 27, and RN 28. The DON stated CST 2 and RN 28 were on vacation and only RN 24 returned her call and agreed to an interview.

During a telephone interview on 5/29/24 at 8:50 a.m. with RN 24, present was RNQ 3, RN 24 stated he remembered Pt 6 and the incident involving Pt 6. RN 24 stated he has worked at the Hospital B for 1.5 years. RN 24 stated he worked on 1/4/24 and assisted RN 27 in managing the incident with Pt 6. RN 24 stated he came back from his break, saw RN 27 preparing the IM medications for Pt 6. RN 24 stated Pt 6 was agitated and non-sensical. RN 24 stated, "We went to the room with other staff members and IM medications were given without incident. We left the room and I returned to the nurse's station. I heard a commotion and loud bang coming from the hallway. Other staff members went to the source of the noise, RN 27 followed him." RN 24 stated he saw Pt 6 sitting on the floor and RN 27 and RN 24 assisted Pt 6 to get up and brought her back to her room. RN 24 stated he did not know what happened prior to the incident. RN 24 stated RN 27 asked Pt 6 what happened, Pt 6 was still very agitated and angry but not combative, so he left the room and RN 27 stayed with Pt 6. RN 24 stated he did not see the video footage of what happened prior to Pt 6 being found sitting on the floor of the hallway.

During a telephone interview on 5/29/24 at 9 a.m. with RN 24, present was RNQ 3, RN 24 stated Pt 6 did not hit him and the next night after the incident, he was Pt 6's primary nurse but she was coherent and talked to him about her past experiences. RN 24 stated while working at Hospital B, no patients has tried to hit him, only verbally. RN 24 stated if a patient tried to hit him, he would try to de-escalate the situation by finding out why the patient was trying to hit him, while trying to avoid the patient by leaving their room and asking for help. RN 24 stated if he witnessed abuse to a patient, he was required to report to the authorities and the manager and or director right away. RN 24 stated he has had abuse training yearly.

During an interview on 5/29/24 at 11:20 a.m. with the DON, with RNQ 3 and the Patient Safety Officer (PSO) present, the DON stated she had a chance to review the video footage of what happened in the hallway with CST 1 and Pt 6. The DON stated her expectations for the staff at Hospital B was to take care of the patients and ensure the patients safety. The DON stated her expectations for staff when a patient became aggressive towards them was for staff to use de-escalation techniques. The DON stated an example of de-escalation was to distract, divert the patient and ask for someone who knew the patient and if those techniques were not effective call a Code Gray, call for help, and at night, there was a silent alarm code. The DON stated for CST 1, she should have been aware of her surroundings, and she should have removed herself from the situation and called for help. The DON stated CST 1's response to Pt 6 was inappropriate. The DON stated CST 1 was placed on paid administrative leave pending the results of the investigation. The DON stated the California Department of Public Health (CDPH), leadership, and policy department were notified of the incident. The DON stated a Root Cause Analysis (RCA) was conducted and Crisis Prevention Intervention (CPI) trainers were providing bi-monthly training on how to de-escalate. The DON stated CST 1 was no longer on administrative leave and had returned to work. The DON stated the patient right to a safe environment was violated.

During an interview and record review on 5/29/24 at 2:28 p.m. with the PSO, RNQ 2 was present, Pt 6's "Root Cause Analysis (RCA)," undated was reviewed. The PSO stated she was informed a little late on 1/5/24 and the incident occurred on 1/4/24. The PSO stated she did not remember if she was texted about the incident, but she thought the incident happened after hours at which time she would have received an email. The PSO stated when she was informed of the incident, she called the after-hours Hotline to the Operations Counsel which gave her guidance on what to do. The PSO stated she was instructed to call [name of city] Police Department (PD) and the PD came out to obtain statements from those involved but she had not seen the report. The PSO stated she interviewed Pt 6, watched the video, and once she watched the video, CST 1 was placed on leave pending their investigation. The PSO stated she interviewed all staff who worked on 1/4/24 when this incident occurred.

During an interview and record review on 5/29/24 at 2:45 p.m. with the PSO, RNQ 2 was present, Pt 6's "Root Cause Analysis (RCA)," undated was reviewed. The PSO stated she wrote up the RCA, interviewed CST 1 and came up with an action plan. The PSO stated the action plan was to work with staff who were apart of a new committee called the Assault Review Committee (ARC), they are front line staff who offered improvement with communication with nurses, psychiatrists, and CSTs. The PSO stated the ARC felt they were escalating too fast with IM medications and/or too slow when the CST were not informing anybody of their patients' behaviors. The PSO stated a lot of education was provided to include what behaviors to escalate and when. The PSO stated they were encouraging staff to be CPI trainers but as of yet they did not have any staff who would commit to the role but once they had CPI trainers, they planned to hold mock trials. The PSO stated this case did go through HR and CST 1 did not have previous experiences or altercations with patients and if the video was watched, CST 1 did not purposely push Pt 6, CST 1 got hit and she reacted. The PSO stated CST 1 did not recognize that Pt 6 was escalating and walking towards her in a hostile manner. The PSO stated another intervention implemented was the nurses and CSTs now had their own report sheets and were updated on each patient to include whether the patient had been assaultive or in isolation recently. The PSO stated CST 1 should have had a "refresher" course of the CPI training.

During a review of the hospital's document titled, "CST 1's CPI training and Return to Work Date," undated, the document indicated, CST 1 had retaken the CPI training on 4/18/24 and CST 1 returned to work on 2/13/24.

During an interview on 5/30/24 at 10:38 a.m. with the PSO, with DC 2 present, the PSO stated the video footage of the incident with CST 1 and Pt 6 occurred on 1/4/24 at 9:30 p.m. The PSO stated at 9:30 p.m., CST 1 was sitting in a chair in the hallway and five staff members went to Pt 6's room to administer the IM medication, at 9:32 p.m., five staff left the room, and CST 1 stayed in the hallway in her previous spot next to the double doors. The PSO stated at 9:33 p.m., Pt 6 came out of her room with a piece of paper, hit CST 1 on her face with the paper. The PSO stated CST 1 pushed Pt 6 to the wall causing Pt 6 to fall on the floor and Pt 6 was observed in a sitting position. The PSO stated RN 24 and two other nurses assisted Pt 6 to her room. The PSO stated Pt 6 stayed in her room for the night. The PSO stated on 1/5/24, the PSO and HR interviewed all staff involved and CST 1 was placed on leave. The PSO stated Pt 6 had an x-ray to her right shoulder after complaining of right shoulder pain on 1/5/24 and the x-ray showed fracture on the right clavicle. The PSO stated the incident was reported to CDPH on 1/9/24. The PSO stated CST 1 had no history of abuse or complaint against her and had been employed for 26 years.

During an interview on 5/30/24 at 2:45 p.m. with Chief Nursing Officer (CNO), with Director of Clinical Quality Performance Improvement (DCQI) present, the CNO stated her expectations of staff were to keep patients safe and free from abuse. The CNO stated employees should always be aware and pay attention to their surroundings, so they are aware of what the patient was doing and where the patient was currently. The CNO stated she wanted patients to leave their hospitals injury free.

During a review of the hospital's policy and procedure (P&P) titled, "COMP-RCC 4.60 Reporting of Allegations of Patient Neglect or Physical or Sexual Abuse or Assault," dated 2/28/24, the P&P indicated, " ...The purpose of this policy is to ensure the safety of any individual in a [name of corporation] and to ensure that Administrator on Call immediately and effectively reports allegations of sexual or physical abuse, neglect or assault to the appropriate authorities ...This policy is intended to cover the reporting of allegations that could involve potential criminal conduct ... "Immediate" means at the time of witnessing conduct or receiving an allegation of conduct that is the subject of this policy. The requirement of this policy for "immediate notification" apply even if the incident occurs after hours and/or on weekends or holidays ... "Abuse" means any intentional action which harms another person. Abuse includes physical or sexual abuse ...The Administrator on Call (AOC) or designee of each [name of corporate] Facility is responsible for immediately responding to allegations of abuse, neglect or assault occurring in the [name of corporate] Facility so that the appropriate investigation of alleged criminal or other inappropriate conduct may be conducted ...Any [corporate name] employee ...who witnesses or receives an allegation of sexual, or physical abuse, neglect or assault on any patient, or of any other individual in the [name of corporate] Facility must immediately ensure the safety of that individual and must immediately make contact with the Facility AOC or designee. The Facility AOC or designee must verify the safety of the individual ...shall immediately (within 24 hours) report the event to the local police department and/or other appropriate authorities ...Operations Counsel will advise on reporting to authorities, including law enforcement, state licensing agencies, and other agencies as appropriate or required by Federal, state or local law or regulation ...Operations Counsel will also advise whether circumstances necessitate removal of personnel who are alleged to have engaged in the abusive behavior ...During the investigation, past event reports may be consulted to determine whether allegations against the same individual have been reported previously ...Operations Counsel is responsible for evaluating and coordinating all actions as appropriate to respond to the allegations and ensure the proper resolution of the matter ...a review of whether prior allegations have been made that could be similar to or related to the current allegations (nature/type of allegation; location of alleged event; hospital personnel involved) ...Coordinating with Human Resources Department and ...Employment Counsel on taking appropriate actions with respect to any ...employee or contractor ...ensure that the appropriate notification has been made to the patient/family as required ...the [corporate name] Facility leadership team is responsible for ensuring that all individuals adhere to the requirements of this policy ...noncompliance with this policy are reported to the Chief Compliance Officer ...All employees whose responsibilities are affected by this policy are expected to be familiar with the basic procedures and responsibilities created by this policy. Failure to comply with this policy will be subject to appropriate performance management pursuant to all applicable policies and procedures, up to and including termination ..."

Based on interview and record review, the hospital failed to protect and promote each patient's rights for one of three sampled patients (Pt) 8 when the hospital policy and procedure (P&P) titled, "Restraints and Seclusion," was not followed. Pt 8 was placed in five-point restraints, which was not least restrictive. The physician's order for four-point restraints was not followed and a physician did not perform a one-hour face to face after restraints were placed emergently.

These failures caused Pt 8 to be restrained more than the physician's orders indicated and violated Pt 8's patient rights to care in a safe setting.

Findings:

During a concurrent interview and record review on 5/14/24 at 2:03 p.m. with Quality Nurse (RNQ 4), Pt 8's "Admission History and Physical (H&P)," dated 4/2/24 was reviewed. The H&P indicated, "Patient was placed on a 5150 for being a danger to self and danger to others and gravely disable ...Chief Complaint: "Getting healthier" ...Patient is a 22-year-old male with a prior psychiatric history significant for schizophrenia [a serious mental illness that affects how a person thinks, feels, and behaves] admitted to [Hospital B] on a 5150 for being a danger to self danger to others and gravely disabled. On psychiatric evaluation with the patient today he was seen in the seclusion room as he had to be placed in restraints due to self-injurious behavior wile in the inpatient psychiatric unit earlier this morning. Patient reports that he came to the hospital "to get healthier" and when asking as to what was occurring earlier this morning that resulted in him being placed in restraints he reports "I thought the gentleman in my room was my dad." When asking as to why patient removed his right eye and significant injury to his left eye prior to his hospitalization he reports "because I was trying to get the pepper spray out of my eyes." ...experiencing auditory hallucinations "that encourages me to hurt my eye" and he also endorses that these voices will tell him to harm others "but I would not act on it." Patient at this time denies having any suicidal or homicidal thoughts and he has difficulty recalling his most recent prescribed medication ..."

During a review of Pt 8's "Nurse Note (Note)," dated 4/23/24, the Note indicated, at 9:20 p.m., "Patient became uncooperative, hitting himself, wanted to take off his affected eye. Spitting at staff. Uncooperative, agitated, standing up on bed. Took out bathroom magnet door and climb bed to cover ceiling light. Yelling and screaming."

During a review of Pt 8's "Physician Orders (PO)," dated 4/23/24, the PO indicated, "Restraint Initiation Violent Adult routine, Imminent risk to self, No longer imminent risk to self, Hard limb, Restraint Points: 4 point restraint, All extremities at 9:30 p.m." The PO indicated, at 9:32 p.m., "Restraint Monitoring Violent Adult, routine, [every] 15 [minutes]-[intermittent] for 4 [hours]" and on 4/24/24 at 1:32 a.m., "Contact Physician for Evaluation of Restraint [Renewal]."

During a review of Pt 8's "Nurse Note (Note)," dated 4/23/24, the Note indicated, at 10:35 p.m., "patient released from 5 point restraints. Patient agrees to be safe and denies thoughts of hurting self and others." The note indicated Pt 8 was in 5 point restraints when the physician orders placed indicated 4 point restraints.

During a review of Pt 8's "Electronic Health Record (EHR)," dated 4/23/24, the EHR indicated there was no indication a physician performed a one-hour face to face after restraints were placed on Pt 8.

During a review of the hospital's P&P titled, "MOD CO 4.004 Restraints and Seclusion," dated 4/24/24, the P&P indicated, "For Restraints used to manage Violent or Self-Destructive Behavior, a physician, or other LIP responsible for the care of the patient must evaluate the patient in-person within one hour of the initiation of Restraint or Seclusion. The in-person evaluation and documentation must include ...Evaluation of the patient's immediate situation ...Patient reaction to the intervention ...Patient's medical and behavioral condition ...The need to continue or terminate the Restraint or Seclusion ..."

During an interview on 5/23/24 at 8:45 a.m. with the Assistant Director of Nursing (ADON), with RNQ 3 present, the ADON stated, when a patient was placed in 5 point restraints, the orders should match the correct restraints applied to the patient. The ADON stated the physician's orders were not followed when the patient was placed in 5 point restraints and the physician orders indicated 4 points. The ADON stated every four hours the restraint orders were required to be renewed, the physician did not need to do a face to face for renewals and depended on the patient's behaviors. The ADON stated the registered nurse (RN) reassessed the patient and if they felt the patient was not ready safety-wise to get out of the restraints, the RN updated the physician and renewal orders were placed. The ADON stated sometimes when there was an emergency, orders were obtained immediately from the physician with the reason for why the restraints were placed and physicians were not required to perform a one-hour face to face with the patient.

During a review of the hospital's policy and procedure (P&P) titled, "MOD CO 4.004 Restraints and Seclusion," dated 4/24/24, the P&P indicated, "Violent/Self-destructive Restraint or Seclusion orders may be renewed with the following limits for up to a total of 24 hours ...4 hours for adults 18 years of age and older ...A face-to-face physical examination is required by the physician or LIP responsible for the care of the patient and authorized to order Restraints or Seclusion every 24 hours for violent/self-destructive Restraint to determine the clinical justification for the continued use ..."

During an interview on 5/30/24 at 2:47 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectations of nurses were, nurses should follow and assess patients according to physician's orders. The CNO stated the importance of following physician's orders was nurses do not practice medicine, therefore when applying restraints to patients, the physician's orders should be followed as prescribed, keeping patients and staff safe. The CNO stated her expectations were nurses should follow the hospital's policies and procedures.

During a review of the hospital's policy and procedure (P&P) titled, "MOD CO 4.004 Restraints and Seclusion," dated 4/24/24, the P&P indicated, " ...PURPOSE: To define [name of Hospital] approach to the use of restraint and seclusion for patients in way that protects the patient's health and safety, and preserves their dignity, rights, and well-being ...Licensed Independent Practitioner (LIP): For the purposes of this policy, a Licensed Independent Practitioner (LIP) is any practitioner permitted by State law and in (accordance with Facility policy) as having the authority to order Restraints or Seclusion for patients ...Restraint ...Any manual method: physical or mechanical device, material, or equipment that immobilizes or reduces the patient's ability to move their arms, legs, body, or head freely ...A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition...It is the policy of this organization to limit the use of restraint or seclusion Violent or Self-Destructive Behavior: Behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others ...Note: Vest or belt type Restraints, and spit hood devices are prohibited in any population ...General Requirements ...Staff will apply Restraint or Seclusion only when less restrictive interventions are ineffective ...Staff will use the least restrictive form of Restraint or Seclusion that protects the physical safety of the patient, staff, or others ...Restraint and Seclusion require an order from a physician or other authorized LIP responsible for the care of the patient. The order must include reason for Restraint or Seclusion, type of Restraint, and duration of Restraint or Seclusion ...Staff must discontinue Restraint or Seclusion at the earliest possible time, regardless of the scheduled expiration of the order ...Authorizing and Ordering Restraints and Seclusion ...Staff will initiate or continue Restraint or Seclusion only upon the order of a physician or authorized LIP following the guidelines in this policy ...In an emergent situation, and when a physician or LIP is not readily available, a Registered Nurse competent in restraint usage may initiate restraint based on an appropriate assessment of patient needs. The comprehensive assessment shall include physical assessment to identify medical problems that may be causing a change in the patient' s behavior ...The order must be obtained either during the emergency application of the restraints or immediately (defined as without time interval) after the restraint has been applied ...All Restraint or Seclusion orders must be dated and timed when signed by the physician or LIP responsible for the care of the patient and include: 1) criteria for release; 2) type of Restraint used; 3) reason for Restraints or Seclusion; 4) and specify duration of Restraint or Seclusion order ...Violent/Self-Destructive Restraints ...the patient who is simultaneously Restraints or Secluded is continually monitored by trained staff either in-person or through the use of both video and audio equipment that is in close proximity to the patient ...At [Hospital B], a patient in restraints is monitored at least every two hours or sooner according to patient needs ...1 hour face to face is required by the RN ...When Restraint or Seclusion is used, there must be documentation in the patient's medical record of the following ...a description of the patient's behavior and the intervention used ...Alternatives or other less restrictive interventions attempted ... the patient's condition or symptom(s) that warranted the use of the Restraint or Seclusion ...The patient's response to the intervention(s) used, including the rationale for continued use of the intervention ...Individual patient assessments and reassessments ...use of Restraint or Seclusion in the Plan of Care ...A patient in 3- or 4-point restraints shall have continuous observation/monitoring ...Monitoring must include, but is not limited to ...skin integrity ...level of distress and agitation ...behavior ...patient safety and comfort, during and after Restraint is removed ...Care will not be compromised by the use of Restraints ...ENFORCEMENT: All employees whose responsibilities are affected by this policy are expected to be familiar with the basic procedures and responsibilities created by this policy. Failure to comply with this policy will be subject to appropriate performance management pursuant to all applicable policies and procedures, up to and including termination ..."

Based on interview and record review, the hospital failed to ensure specific program data requirements were met when the hospital failed to provide evidence of a Quality Assessment Performance Improvement (QAPI) program for clinical nutrition and food services that accurately reflected the depth and complexity of the service.

These failures had the potential to result in suboptimal patient care and outcomes.

Findings:

During a review of closed medical records the hospital failed to ensure individual nutritional needs were met for three patients (Patients 49, 46, and 53) in a sample of seven patients reviewed for nutrition care when the Registered Dietitian failed to complete timely nutrition assessments. All three patients were identified at increased nutritional risk at the time of admission as evidenced by poor nutritional intake, weight loss and documented nutrition consults. (refer to A-0629)

During an interview with the Clinical Nutrition Manager (CNM) on 5/17/24 at 12:05 p.m., CNM stated she does not evaluate the data since she knows they are short staffed of clinical Registered Dietitians (RD). CNM stated she does not collect, track or evaluate any type of data for Quality Assurance Performance Improvement for clinical nutrition.

During an interview with the Regional Director of Operations (RDO) on 5/20/24 at 12:34 p.m., the RDO stated the CNM sits on Quality Committee so can speak with her about the QAPI program for the department.

During an interview with the CNM and the RDO on 5/21/24 at 9:02 a.m., the CNM stated she would only attend the Quality Committee meetings if she was invited, and she had not attended. When asked about the QAPI measures that are done for Food and Dietetic Services, the CNM stated the only thing that is done is the Patient Satisfaction Scores regarding the patient experience and meals. The RDO stated the Director of the department (vacant position) attends Quality Committee. The RDO stated the departmental focus is limited to food service. The hospital was unable to demonstrate performance improvement activities related to clinical nutrition care.

During a review of the hospital document titled, Food & Dietary - Quality of Food, dated March 2024, for the period of October 2023 to March 2024, evaluated the quality and temperature of the food. The submitted data indicated the current quality and temperature of food was ranked at the 56th percentile. The departmental goal was to achieve a ranking of greater than or equal to 75th percentile. The root cause analysis indicated the quality of the food was due to a lack of understanding by patient diet orders and restrictions. The departmental plan was to increase patient awareness of menu options through rounding. The temperature of the food was affected due to dish machine constantly out of service resulting in patient meals being served on Styrofoam. Additionally, isolation patients did not receive meal trays in a timely manner and as well as meals served on disposable which does not hold temperature.

The action items indicated: 1. working with CNM to in-service all dining associates with the appropriate up to date education of diets along with scripting and menu processes and to work with nursing regarding patient preferences and timely delivery of isolation tray delivery. The responsible party was the patient services manager. 2. Daily supervisory rounding. The responsible party was director of the food and nutrition services, patient services manager and dietary supervisors. Both items showed the due date and status was on going. The hospital was unable to demonstrate implementation of the action plan.

During an interview with Director of Clinical Quality Improvement (DCQI) on 5/31/24 starting at 9:05 a.m., DCQI stated when she looked at Food and Nutrition Services they did not have any QAPI. The committee also indicated the goal is to ensure all areas are represented. DCQI stated at the time she began working with the food and nutrition services, the contract representatives were provided the hospital QAPI plan as well as their patient satisfaction scores. The contract was also advised they would be held accountable for the patient satisfaction scores. The DCQI also indicated the expectation would be for the FANS department to develop and implement a plan for improvement and forward to the DCQI committee. The DCQI acknowledged this was not done.

During a review of the Hospital policy and procedure titled with subject, "Quality Assessment Performance Improvement (QAPI)", authored by the contracted food service company, revised 1/23, showed the hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program. It showed the Food and Nutrition Services Department must participate as part of the hospital's QAPI program and have no less than TWO (2) active quality or performance-based measurements in place at any given time. It showed the Director and RD: to request to participate in the hospital's quality program, attends quality meetings, works with the hospital's QAPI team to assess QAPI opportunities and executes a minimum of two QAPI projects for Food and Nutrition Services department; provides the hospital Quality Department with a report of the QAPI projects that follows the hospital's approved format for the QAPI program.

During a review of the hospital's document titled, "Performance Improvement Annual Appraisal & Quality Assessment and Performance Improvement Plan 2024-2026", indicated, "Summary; This plan is a framework for an effective, comprehensive, data driven program that focuses on the indicators that reflect outcomes of care, quality and patient safety. ... The PI program is a hospital-wide program that monitors processes and functions to improve patient quality of care. It is designed to encourage prioritization and improvement in those areas where improvement opportunities exist.

Based on interview and record review, the hospital failed to take actions aimed at performance improvement when:

1. The infection preventionist (IP) was aware of infection control practices that did not meet the standard and failed to bring this to the attention of Quality Assurance and Performance Improvement (QAPI) program to implement an improvement project.

2. QAPI was aware Certified Registered Nurse Anesthetists (CRNAs) were permitted to operate independently with full prescriptive and diagnostic authority for anesthesia services and failed to consider the scope of practice of CRNAs and whether this practice was consistent with Medical Staff Bylaws.

These failures resulted in the potential to allow unsafe practices to go unnoticed and uncorrected and increased the risk of negative patient outcomes such as illness, harm, and injury.

Findings:

1. During an observation on 5/14/24 at 9:41 a.m., in the endoscopy storage room, two of two endoscopes (a thin, flexible tube-like instrument equipped with a camera used to look at tissues inside the body) were not stored in an endoscope cabinet in accordance with facility policy and the instructions for use (IFU). The two endoscopes were stored with the distal end (the part farthest from the origin) with the camera touching the bottom of the cabinet creating a potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect).

During observation on 5/17/24 at 10:30 a.m., in the sterile processing department (SPD) decontamination area, surgical instruments were not processed in accordance with standards published by the Association for the Advancement of Medical Instrumentation (ANSI/AAMI -a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) and the Centers for Disease Control and Prevention (CDC- a federal agency that focuses on controlling, containing, and eliminating diseases). Sterile Processing Technician (SPT) 1 did not scrub surgical instruments during the manual cleaning process (the first step in disinfection by which visible soil and gross debris are removed) and surgical instruments were stacked upon each other in trays, potentially damaging the surfaces of the instruments.

During an observation on 5/17/24 at 11:30 a.m., in the SPD clean area, three of five procedure trays (container that holds surgical instruments), that were sterilized and ready for use in surgical procedures, were opened and examined and contained unclean and unsafe surgical instruments. One of 91 instruments in the "Major" tray (T-1) and three of 75 surgical instruments in the "Minor" tray (T-2) had discoloration and pitting (damage to the protective layer of surgical instruments) on the instruments. No chemical indicator (a device used to monitor whether the parameters to achieve sterilization have been met for a specific sterilization process) in T-1 was observed when opened.

During an observation on 5/24/24 at 10:45 a.m., in the SPD clean area, one of 91 instruments in the "Major" tray (T-3) had red-brown residue (left over when a substance has been removed) on the shank (the extension from the handle to the working part of the instrument). This practice was not in accordance with ANSI/ AAMI which stated that surgical instruments should be free of residue, pitting, and corrosion (a process in which a solid is eaten away). The hospital's policy was not followed when the requirement for a chemical indicator was not present inside T-1. These failures could result in use of surgical instruments that were not completely sterile, possible post- surgical infection to the patient, and instrument failure.

During an observation on 5/13/24 at 1:55 p.m., one of three blood gas machines were not cleaned in accordance with manufacturer's instructions and was observed to have dried blood on the sample port. (A blood gas machine is specialized equipment that takes a blood sample and measures the oxygen, carbon dioxide and pH of the blood sample. The pH is a measure of acid-base balance of the blood).

During a concurrent observation and interview on 5/13/24, at 3:20 p.m., with the Shift Manager (SM) 1, while in Patient (Pt) 60's room, Pt 60 was seen with intravenous (IV- through a vein) fluids running through a pump into her PICC line. One of Pt 60's ports on her IV tubing was seen without a cap (curos disinfecting port protectors are alcohol-containing caps that twist onto IV access points for disinfection and protection) covering it and a new bag of caps hanging from the IV pole. SM 1 stated the ports should be capped to help prevent contamination of the port and then immediately placed one of the caps on the port.

During a concurrent observation and interview on 5/14/24 at 10:23 a.m., with the sterile processing department manager (SPDM) and Assistant Director of Surgery (ADS), in the Endoscopy decontamination room, the ceiling air vent (Vent 1) had paint chipped along the edges of the vent and pieces of chipped paint were loos and ready to fall from the ceiling. Vent 1 was located directly above the sink used for manual cleaning and scrubbing of endoscopes. Vent 2 was directly across from Vent 1 and had grey matter build-up and appeared to be full of dust. Vent 2 was located above the adenosine triphosphate testing station (Point-of care testing for adenosine triphosphate (ATP), a marker of microbial contamination, to assess the effectiveness of manual cleaning. ATP testing has recently been shown to correlate with quality of endoscope cleaning). The SPDM & ADS validated the observations, and both stated both ceiling vents needed cleaning and repair to the paint around Vent1. The SPDM stated both vents needed cleaning and appeared dirty. The room's log showed vents were being cleaned daily. These failures could potentially lead to cross-contamination.

During an observation on 5/17/24 at 11:30 a.m., in the SPD decontamination area, the floors, walls, and air gap were visibly in poor condition, unsanitary and not maintained in accordance with hospital policy and procedure. The floor beneath the rinse sink had rust-colored deposits, paper trash and other debris in the drain. The floor and backboard underneath the decontamination sink were scuffed, moist, with porous (water and air can pass through) drywall and wood exposed.

During concurrent observation and interview on 5/13/24 at 2:37 p.m., with the Director of Critical Care (DCC), in the Cardiac Intensive Care unit (CICU - Unit for critically ill patients [patients with vital organ dysfunction, high risk of imminent death if care is not provided] with heart, chest and blood vessel's conditions), one of the two linen carts had linen stored and was not covered in accordance with the hospital policy. The linen cart had the plastic cover rolled on top of the cart and patient equipment was stored on top of the plastic cover exposing the clean linen (there was no signage to indicate the equipment was clean). The DCC stated the equipment should not be stored on top of linen carts as it had the potential for cross contamination and spread infections to critically ill patients.

During observations on 5/15/24 at 1:10 p.m. and 5/27/24 at 8:10 a.m., three of 17 staff (Surgeon (SUR) 8, Resident Surgeon (RES) 1, and RES 2) were observed in the Operating rooms (ORs) not wearing appropriate eye wear as part of their surgical attire during surgical procedures.

During an observation on 5/13/24, at 2:38 p.m., in Pt 61's room, RN 11 changed Pt 61's wound dressing and did not perform hand hygiene after removing dirty gloves and then placing clean gloves on and placing a clean dressing on Pt 61's wound.

During an observation on 5/15/24, at 1:02 p.m., while in the OR during Pt 21's surgery, the anesthesiologist (ANS) 6 dropped a vial of medication, picked it up from the floor, tossed it, and then continued to give Pt 21 medication through her IV without performing hand hygiene and without cleaning the port on the IV site.

During an observation on 5/15/24 at 2:27 p.m., in the Post Anesthesia Care Unit (PACU), RN 14 did not perform hand hygiene prior to putting on clean gloves in the PACU.

During an observation on 5/24/24 at 12:50 p.m., HSK 1 cleaned bed B (the bed furthest from the door) of a two-bed room. HSK 1 collected the linen and discarded all trash in the room. Bags were replaced and the tops of the trash/ linen bin cleaned. Towels saturated with disinfectant solution were placed on furniture, bed, and tables. HSK 1 dusted the vents, furniture, walls, and window blinds then returned the soiled duster to the clean housekeeping cart. HSK 1 changed gloves and performed hand hygiene, then continued wiping all furniture and the bed. HSK 1 returned to the housekeeping cart wearing soiled gloves and retrieved two additional towels from the disinfectant solution bucket. HSK 1 squeezed the excess solution from the towels into the bucket, then cleaned the room's sink and bathroom. HSK 1 changed gloves and performed hand hygiene, then mopped the innermost part of the room. HSK 1 used the same mop head to cross bed A's floor space.

During a concurrent observation and interview on 5/24/24 at 1:04 p.m., in the "soiled" utility closet on the fourth floor, with HSK 1, HSK 1 discarded trash bags. Trash bags were observed overflowing from the trash bin and piled up against the wall's corner and floor. One trash bag was torn with trash (gloves, adult briefs, food items, etc.) exposed. HSK 1 stated the practice was to pile trash in a corner until collected by environmental services.

During an interview on 5/29/24 at 3:16 p.m., with the Infection Preventionist (IP), the IP stated the infection prevention and control program reported surveillance data to the quality council committee monthly. The IP stated the surveillance data reported to quality included hospital associated infections (HAIs- CLABSI [central line blood stream infections], CAUTI [urinary tract infections from urinary catheters], MRSA [infections caused by type of bacteria], clostridium difficile [infection of the intestine]), surgical site infections (SSIs- colon [large intestine] and hysterectomy [removal of the uterus through the abdominal wall], and hand hygiene. The IP stated the infection control and quality programs participated in environmental care rounds (tours of the hospital grounds to help identify actual and potential issues that affect patient safety), but the IP department did not track or report its findings, since issues were usually addressed within short periods of time. The IP stated HAI and SSI data he collected and analyzed was what determined the effectiveness of the hospital's infection prevention and control program and staff compliance with best practices.

During a review of "[Name of hospital] Quality Council Open Session Minutes" (QC meeting minutes) dated 7/24/23, the "QC meeting minutes" indicated, " ... Findings/ Conclusions/ Recommendations ... Quality Management ... Hand Hygiene ... 1MED, 3S [3 south], PAD, and ER [emergency room] not meeting goal ... Radiologist, MD [physician], and EVS [environmental services] need improvement ... Action/ Follow-Up [blank] ..."

During a review of "[Name of hospital] Quality Council Open Session Minutes" (QC meeting minutes) dated 8/28/23, the "QC meeting minutes" indicated, " ... New Business ... None Reported ..."

During a review of "[Name of hospital] Quality Council Open Session Minutes" (QC meeting minutes) dated 11/27/23, the "QC meeting minutes" indicated, " ... Findings/ Conclusions/ Recommendations ... Quality Management ... CLABSI 4 YTD, None in 3Qtr [third quarter] ... CDIFF 4 in Sept 2023 ... MERSA [MRSA] 1 in ICU [intensive care unit] ... Hand Hygiene ... Aug.2023 ... SICU [stepdown ICU], PAC, 2S [2 south], 3S, 1MED, MD, Radiologists, NP [nurse practitioner], PA [physician assistant] & Residents need improvement ... Sept. 2023 ... 2S, CCU [critical care unit], 1MED, 3W [3 west], Lab [laboratory], MD, NP, PA 7 Residents need improvement ... Will be getting names of providers/ staff that are repeat offenders and have one on one educational conversation .... Action/ Follow-up [blank] ..."

During a review of "[Name of hospital] Quality Council Open Session Minutes" (QC meeting minutes) dated 1/22/24, the "QC meeting minutes" indicated, " ... Findings/ Conclusions/ Recommendations ... Quality Management ... CLABSI 7 YTD/ 2 in Q4 ... CDIFF 21 YTD/ 3 in Q4 [fourth quarter] ... MRSA ... 0 in Q4 ... Hand Hygiene ... October 2023 Overall compliance by Unit ... CVICU [cardiovascular intensive care unit], 4S [4 south], 3S & 1Med need improvement ... October 2023 Overall compliance by Role ... MD, Radiologists, NP, PA & Residents need improvement ... November 2023 Overall compliance by unit ... SICU, 4S, PAC, 3S & 1M [blank] ... November 2023 Overall compliance by Role ... Other MD, MP, & Residents need improvement ... Will be getting names of providers/ staff that are repeat offenders and have one on one educational conversation .... Action/ Follow-up [blank] ..."

During a review of "[Name of hospital] Quality Council Open Session Minutes" (QC meeting minutes) dated 3/25/24, the "QC meeting minutes" indicated, " ... Findings/ Conclusions/ Recommendations ... Infection Control ... IPT Report 2023: 7 CAUTI, 9 CLABSI (due to Picc lines and Dialysis catheters), Hand Hygiene at 93%... IPT Report 2024 Running: Numbers Incorrect ... Action/ Follow-up [IP] to correct 2024 numbers and send updated version ... Quality Management ... Sepsis Mortality Rate 10.7%... Areas of Opportunity: CLABSI, CAUTI ... Action/ Follow-Up [blank] ..."

During a review of "[Name of hospital] Infection Prevention and Control Committee Minutes" (IPCC meeting minutes) dated 3/27/24, the "IPCC meeting minutes" indicated, " ... STERILE PROCESSING: Everything is running well, no failures ... EVS: Reviewed data: would like 50 observations, rounding on lower scoring areas, rounds on departments change monthly ..."

During an interview on 5/31/24, at 9:05 a.m., with the Director of Clinical Quality and Improvement (DCQI), the DCQI stated the "Quality Assessment and Performance Improvement [QAPI] Plan" was a "living" document that was reviewed every "two years" but could be updated at any time. The DCQI stated the data collected from the Sterile Processing and Endoscopy Departments did not accurately reflect the scope and complexity of the departments, which contributed to missed opportunities for performance improvement in infection control practices. The DCQI stated, as a result of the recent findings, the "QAPI" plan had to be changed to include these high-risk areas. The DCQI stated she was not familiar with the type of standardized tools utilized by the infection control program for facility rounding and observations.

2. During a review of "Quality monthly Operations Reporting March YTD [year to date] 2024" indicated, " ... AMI Mortality Rate ... State Average ... 0.93 ... Mar [march] 1.50 ... HF Mortality Rate ... State Average ... 0.61 ... MAR ... 1.32 ... COPD Mortality Rate ... State Average ... 0.32 ... MAR ... 1.20 ... Mortality O/E [O- observed deaths to E- expected deaths] Ratio ... State Average ... 1.00 ... O/E Achieved 1.07 ... Patient Safety and Complication Rate ... SURG- COMP [surgical complications] Death Rate among surgical inpt [inpatient] w/ [with] serious treatable complications per 1,000 elective surgical discharges or any surgery/procedure within 2 days YTD # [number] 65 ... Target 52 ... missed 13 ... Iatrogenic Pneumothorax [collapsed lung accidentally during a procedure] 3275 ... target 3274 ... missed 1 ... Postoperative hemorrhage [massive blood loss] or hematoma [clotted blood] rate involving a procedure to treat the hemorrhage or hematoma, following surgery per 1,000 surgical discharges... YTD# 701 ... Target 699 ... missed 2 ... Post-operative PE [pulmonary embolism- blood clot in lung or DVT [deep vein thrombosis- blood clot in vein] per 1,000 surgical discharges ... YTD # 719 ... Target 715 ... missed 4... "

During a review of "[Name of hospital] Quality Council Open Session Minutes" (QC meeting minutes) dated 11/27/23, the "QC meeting minutes" indicated, " ... Findings/ Conclusions/ Recommendations ... Patient Safety ... PE: 2, Going for Peer review ... DVT: 1, Going for Peer review ... In-Hospital Mortality ... Currently in Red due to three system that pull data are not matching ... Action/ Follow-Up [blank] ..."

During a review of "[Name of hospital] Quality Council Open Session Minutes" (QC meeting minutes) dated 1/22/24, the "QC meeting minutes" indicated, " ... Findings/ Conclusions/ Recommendations ... In-Hospital Mortality ... Currently in Red due to three system that pull data are not matching ... Action/ Follow-Up [blank] ..."

During a review of "[Name of hospital] Quality Council Open Session Minutes" (QC meeting minutes) dated 3/25/24, the "QC meeting minutes" indicated, " ... Findings/ Conclusions/ Recommendations ... Areas of Opportunity ... No Immediate post-op note prior to patient transfer, "Yes" box not marked on Post- Anesthesiology Evaluation & Unable to locate Post Anesthesiology Evaluation in chart ... Action/ Follow-Up ... Quality is working with Anesthesia group to correct issues ..."

During a review of "[Name of hospital] Performance Improvement Annual Appraisal & QAPI Plan" dated 2024- 2026, the "QAPI" plan indicated, " ... The QAPI plan guides the organization's performance improvement efforts ... The purpose of the Performance Improvement Plan at [name of hospital] is to ensure patients are provided high quality care in an environment of minimal risk ... The medical staff fulfils its joint executive responsibilities, along with the hospital's governing body and administrative officials, for ensuring that the hospital- specific QAPI program is ... Ongoing, defined, implemented, and maintained ... Addresses hospital- specific priorities for improved quality of care and patient safety, and that all improvements are evaluated ... establishes clear expectations for safety in the hospital ... Mandatory Data Collection .... Pre-operative and post-operative diagnosis ... Adverse events to moderate or deep sedation ... The results of resuscitation ... Significant medication errors ... Patient perception of safety and quality of care, treatment, and services ... Avoidable Hospital Acquired Infections (HAI) ... Reducing Avoidable Patient Harm ... Patient Harm- Falls ... Sepsis ... Focus for 2024- 2026 as approved by the Board of Governors ... Focus on achieving or exceeding national benchmarks for all publicly reported measures ... Focus on decreasing hospital-wide mortality rate ... Focus in 2024-2026 is to reduce all HAIs ... Focus on maintaining a reduction of serious safety events ..."

Based on observation, interview, and record review, the hospital and Governing Body failed to ensure medical staff followed Medical Staff Bylaws, Rules and Regulations, and California state law, when hospital approved Certified Registered Nurse Anesthetists (CRNAs- a registered nurse trained to provide anesthesia ([specialized care before for surgery, pain management, critical care and emergencies]) under the orders of a physician) to be added to the Medical Staff as if they were licensed to independently diagnose, prescribe and administer anesthesia services without an order from a physician.

These failures allowed five of five CRNAs (CRNA 1, 2, 3, 4 and 5 ) non-physicians, to provide care to five of five Patients (Pt- Pt 1, 2, 3, 4 and 5) with the same authority as an anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic, and therapeutic authority) to any patient without physician orders and has the potential to endanger all hospitalized patients requiring anesthesia services.

Because of the serious actual harm to Patient 1 and the serious potential harm to Patients 2, 3 and 4 related to the unsafe practice of CRNAs providing anesthesia services outside of the scope of practice for CRNAs, and the hospital granting full prescriptive authority to CRNAs without having the authority to do so, and CRNAs diagnosing and treating patients without a physician order and establishing a treatment regimen which is outside of their scope of practice and the hospital not following Governing Body and Medical Staff bylaws in the credentialing and privileging process for CRNAs, Immediate Jeopardy (IJ a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 5/23/24 at 10:00 a.m. with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditations Manager (AM) 1, and Accreditations Manager (AM) 2. The IJ (Immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 5/23/24 at 6:34 p.m. and it was unacceptable. The hospital submitted an IJ Plan of Removal (Version Two) on 5/26/24 at 10:44 a.m. which included actions to suspend the use of CRNAs until they could be credentialed and privileged according to GB and MS bylaws. Plan of Removal was accepted on 5/28/24 at 11:30 a.m. with the CEO, CNO, DCQI and AM 1. On 5/29/24 at 6:15 p.m. the survey team validated that CRNAs were suspended from working at this facility. The survey team validated all staff were educated on the IJ for the CRNAs and what to do if a CRNA comes to work; surgery schedules were reviewed to show no CRNAs were scheduled to provide anesthesia services; all staff in perioperative areas were aware that the CRNAs were only to use the approved order sets in the computer and all of the handwritten orders sets were removed from use.The IJ was removed onsite with the CEO, CNO, DCQI, AM 1 and AM 2 in attendance on 5/29/24 at 6:15 p.m. After removal of the IJ the hospital remained in substantial noncompliance.

Findings:

1. During an interview and concurrent record review on 5/22/24, at 12:42 p.m. and 5/29/24., with the Medical Staff Team (MST) which included, Director of Clinical Quality and Performance Improvement (DCQI), and Medical Staff Manager, the hospital polices, processes, patient records and staff files were reviewed. The MST stated they "follow all regulations". The MST stated CRNAs started applying for privileges at the hospital June 2023. The MST stated CRNAs were approved as "independent practitioners with full prescriptive authority. MST stated CRNAs were the "same ...physician ... anesthesiologist" and were "equivalent". MST stated CRNAs authorized to write and orders any medication, treatment or therapeutic and it was within their "scope of practice". The medical staff team acknowledged CRNAs were not employees of the hospital and worked as independent contractors. Medical Staff Team (MST) stated "CANA [ California Association of Nurse Anesthesiology, an advocacy group that supports nurse anesthetists] allows CRNA to work independently", and "in the state of California" CRNAs had prescriptive authority.

During a record review of hospital policy, titled "AHP [Allied Health Professional] Rules and Regulations, version 2022" indicated all AHPs required "direct supervision". MST defined "supervision" for CRNAs as an "anesthesiologist was available to provide support ...and help", if "requested" by the CRNA. The MST stated "new" regulations do not require CRNA to be supervised. MST stated that CRNAs were not required to have an anesthesiologist present to provide orders or medical direction for any aspect anesthesia services, including emergencies, obstetrics, life-threatening events, procedures, intensive care, or medical care of patients as required by hospital policy.

During a review of Patient 1's (Pt 1) medical record, titled "Consultation Notes", written by Surgeon 3 (SUR 3, surgery doctor), dated 4/11/24, at 6:18 PM, the note indicated Patient 1 was re-admitted to the hospital with bowel obstruction (when the bowels blocked by food or scar tissues) and a planned surgery to repair hernia (bulging of an organ or tissue through an abnormal opening) and clear the bowel obstruction.

During a record review of the Pt 1's medical record titled, "History and Physical Admission Notes", dated 4/11/24, at 2:00 a.m., written by Medical Doctor (MD 4), documented that Pt 1 presented to emergency department (ED) for "worsening nausea, vomiting ...abdominal pain ... The surgeon [SUR 3] was consulted ... and requested Nasogastric (NGT) placement ... It was attempted 4 times in ED but was unsuccessful." MD 4 diagnosed Pt 1 with "bowel obstruction ... atrial fibrillation (irregular and rapid heart rhythm) ... planned to decrease heart rate with medications, and obtain cardiac tests, troponins (lab test that monitors heart muscle injury), and heart ECHO (test to evaluate heart function, rate, and rhythm)."

During a record review of the Pt 1's medical record, titled "Electrocardiogram (EKG- tracing of the heart's rate and rhythm)", dated 4/11/24 at 12:09 a.m., the EKG record indicated a heart rate of 148 (HR- normal 60 to 100) and "atrial fibrillation [A-fib-life threating rapid and irregular heartbeat and rhythm)".

During a record review of the Pt 1's medical record, titled "Assessment- Gastrointestinal [stomach and intestine]" nursing evaluation, dated 4/11/24, at 6:30 a.m. and 8:30 a.m., on the day of surgery, the record indicated Pt 1's stomach was tender, bloated, "distended, firm, rounded".

During a record review of the Pt 1's medical record, titled "Computed Tomography" [CT- scans body parts for abnormalities] of the stomach and intestine, dated 4/10/24, at 11:42 p.m., the record indicted Pt 1 had a "bowel [intestine] obstruction...Significant dilatation [swelling] of the stomach with reflux [fluid] into the distal esophagus (a tube-like organ that connects mouth to the stomach)".

During a record review of the Pt 1's medical record, titled "Preoperative (before surgery and anesthesia form titled "Anesthesiologist [physician that provides anesthesia] Evaluation", dated 4/11/24, at 4:45 p.m., handwritten by CRNA 5, the record did not indicate if an anesthesiologist or other physician reviewed and evaluated Patient 1's status prior to surgery and there is no documented evidence of a physician's order for a treatment regimen including anesthesia services provided by a CRNA.

During an interview and concurrent record review on 5/22/24, at 10:13 a.m., with CRNA 6, accompanied by scribe and Director of Clinical Quality Improvement (DCQI), the medical records of Patient 1 who had anesthesia and surgical services on 4/11/2024, was discussed. CRNA 6 stated he discussed the case with CRNA 5, and she was "conformable" with the acuity/illness of the patient. CRNA 6 stated SUR 3 ordered an NGT, but CRNA 5 was "not going to place an NGT ...not going to do it" to remove gastric fluid. CRNA 6 stated, he nor CRNA 5, spoke with SUR 3 about the CRNA 5's refusal to place the NGT. CRNA 6 stated he helped CRNA 5 bring the patient into the OR to "hang-out". CRNA 6 stated he left the OR before Pt 1 was intubated. After he gave report to anesthesiology (ANS 2) who was the AIC for the night shift.

There was no documented evidence, why the placement of a gastric tube (NGT) into the mouth or nose to empty the stomach was not attempted or completed as ordered by physicians. There was no documented evidence CRNA reviewed Pt 1's EKG or abdominal CT scans. There was no documented evidence CRNA 5 considered the recommendations of the admitting physician (MD 4) to obtain cardiac (heart) evaluation. There was no documented evidence CRNA 5 discussed the decision not to place a gastric tube to empty the stomach before surgery to decrease the risk of aspiration (life threatening event when stomach contents enter the lungs) or the anesthetic plan with the operating surgeon (SUR 3) and/or an anesthesiologist.

During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1's (Pt 1) admission on 4/10/23 and hospital policies were discussed. Sur 3 stated the surgery was not an emergency and if the anesthesiologist had "cardiac concerns ... then they should have paused and proceeded with anesthesiologists' recommendations" for cardiac work up prior to surgery.

During an interview and concurrent record review on 5/20/24, at 5:12 p.m. with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1's (Pt 1) medical record for the admission dates from 4/10/2024 to 4/11/24, and policies provided by the hospital, were reviewed, and discussed. On preoperative evaluation, the CRNA 5 stated she was "aware" of Pt 1's findings by MD 4 and SUR 3 on cardiac work-up, the bowel obstruction and large collection of fluid in the stomach and esophagus. CRNA 5 indicated she was not in agreement with MD 4 and stated Pt 1 "looked great ... didn't concern me ...not needed". CRNA 5 stated she spent "35 minutes ...having a heart to heart" with Pt 1. CRNA 5 stated Pt 1 "seemed off ...confused ...rambled" during the pre-operative evaluation. CRNA 5 stated she consented Pt 1 for anesthesia. CRNA 5 stated she documented that NGT placement failed four times, but this occurred in the ED. CRNA stated she did not attempt to place an NGT in the Pt 1 prior to surgery. CRNA 5 stated the patient "refused" an NGT tube. CRNA 5 acknowledged she did not document patient refusal or confusion, nor discussed any concerns with the surgeon or anesthesiologist. CRNA 5 acknowledged she did not discuss MD 4s finding and plans for a cardiac work-up, or the abnormal EKG, or CT scans with the surgeon or anesthesiologist.

During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), the records of surgical Patient 1's (Pt 1) admission on 4/10/2023 and the recommendation for cardiac workup by heart doctor were discussed. ANS 2 stated in "cases like this are elective, not an emergency". ANS 2 stated if a patient has a "new onset A-fib" (a dangerous heart rhythm) and a physician recommends a cardiac work-up. The patient "need cardiac clearance before going to surgery". ANS 2 indicated Pt 1 was at "high risk for aspiration". Before surgery the stomach needed to be "decompressed" by placing a gastric tube to remove the contents of the stomach. ANS 2 stated to "protect the airway" and maintain patient breathing, the anesthesiologist should have proceeded with an "awake intubation".

During an interview and concurrent record review on 5/22/24, at 10:13 a.m., with CRNA 6, accompanied by scribe and Director of Clinical Quality Improvement (DCQI), the medical records of Patient 1 who had anesthesia and surgical services on 4/11/2024, was discussed. CRNA 6 stated he reviewed Pt 1's chart and could recall the events without the chart. Sections of the chart were reviewed and read to CRNA 6. CRNA 6 stated he was the Anesthesiologist in Charge (AIC) for the day. CRNA 6 stated he assigned CRNA 5 to Pt 1's case and assigned CRNA 2 to assist her after finishing a current case. CRNA 6 stated Pt 1's case was not an emergency and "good to go" ahead with surgery. CRNA 6 stated he did not consult with the Chief of Anesthesia (ANS 1) or requested anesthesiologists' presence for the case.

During review of the Pt 1's intraoperative (events during surgery) medical record, titled "Anesthesia Record" dated 4/11/24, at 7:09 p.m., handwritten by CRNA 5, the record indicated Pt 1 entered the operating room at 7:09 p.m. There was no documented evidence of an order from a physician for anesthesia services. The record indicated starting at 7:15 p.m., CRNA 5 procured, prescribed, and administered "High Risk Medications" (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body's movement as follow: Fentanyl (strong opioids/narcotics that can decrease or stop breathing), propofol (high risk sedative that can decrease or stop breathing), lidocaine (local anesthetic that can slow heart rate and breathing), rocuronium (medication that cause paralyses all muscle function, such as breathing), and etomidate (sedating medication that helps put a patient to sleep for surgery and could contribute to abnormal heart rates and low blood pressure). CRNA 5 did not document continuous monitoring of the blood pressure, heart rate, heart rhythm, oxygen saturation (estimated percent of oxygen in patient's blood), respiratory rate, or the delivery of oxygen. Further review of the documented intra-operative events indicated that CRNA 5 attempted to intubate (place a breathing tube into the lungs) three times. There was no documented evidence, with each attempt, the presence of carbon dioxide (gas expelled during exhalation and indicates a breathing tube in the lungs), lung sounds of air flow, respiratory rate, delivery of oxygen or oxygen saturation (percent of oxygen in blood) indicating a successful intubation(s). There was no documentation of why CRNA 5 attempted to intubate Pt 1 three times. There was no documented evidence CRNA 5 recorded the medication used and response to interventions and treatment. There was no documented evidence CRNA 5 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures or anesthesia guidelines for securing an airway. At the end of anesthesia, medications (such as opioids, propofol, local anesthetics, heart medication, blood pressure medications and so forth) given to Pt 1 were not reconciled by CRNA 5.

During an interview and concurrent record review on 5/20/24, at 5:12 p.m. with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1's (Pt 1) medical record for the admission dates from 4/10/2024 to 4/11/24, and polies provided by the hospital, were reviewed, and discussed. Review of the Pt 1's intraoperative (events during surgery) medical record, titled "Anesthesia Record" on 4/11/24 with CRNA 5, CRNA 5 stated that SUR 3 was "doing another case" when she started anesthesia for Pt 1. CRNA 5 stated that the "Chief CRNA [CRNA 6] helped" her with anesthesia care. After he left, CRNA 2 entered the Operating Room to help her. CRNA 5 acknowledged she did not document assistance from CRNA 6 or CRNA 2 on the intra-operative record. CRNA 5 indicated CRNA 6 was not present during intubation. CRNA 5 stated "within minutes of pushing [intravenous, IV] medications, patient vomited 1.5 liters [measurement of volume] of fluid ...fecal matter ...called for help". CRNA 5 stated that she intubated Pt 1, but it was in the "esophagus, and tried again". CRNA 5 stated ANS 2 intubated the patient. CRNA 5 acknowledged there was no documented evidence that ANS 2 intubated Pt 1. CRNA 5 acknowledged she documented that she intubated three times. CRNA 5 stated throughout the intra-operative period, there was "no gas exchange (evidence pt was receiving oxygen", and "no CO2 (evidence of pt exhalation)" documented because of water in the CO2 line.

During a record review of the Pt 1's medical record, "Code Blue Record [events, medications and treatment during cardiopulmonary resuscitation, life saving measures], dated 4/11/24 from 7:40 to 8:25 p.m., and handwritten by a nurse. The nursing documentation indicated "medications administered by Anesthesia team, see OR (Operating Room, surgery room) record ... intubated time: see anesthesia record" written by CRNA 5. The Code Blue record indicated that there were "multiple intubation [place a breathing tube to deliver oxygen and respirations] attempts during and before code".

The nurse documented medications in the follow order:

i. Epinephrine 1 mg (used IV in emergency when heart or breathing stops) given at 7:40 PM, 7:42 PM, 7:43 PM, 7:44 PM, 7:46 PM
ii. Sodium Bicarbonate 50 meq (the treatment of metabolic acidosis or when acids build up in body; "meq" is Milliequivalent, a unit of measure) and Calcium Chloride 1 gm (used for emergency treatment of high potassium and magnesium level in the blood) were given at 7:47 PM.
iii. Epinephrine 1mg given at 7:48 PM
iv. Vasopressin 20 Units given at 7:52 PM
v. Epinephrine 1 mg given and Sodium Bicarbonate 50 meq given at 7:55
vi. Epinephrine 1mg given at 7:56 PM
vii. Bicarbonate 50 meq given at 7:57
viii. Epinephrine 1mg given at 7:59 PM, 8:01 PM, 8:08 PM, 8:24 PM, 8:24 PM

During the Code Blue here was no documented evidence of heart rhythm, respiratory rate, or deliverance of oxygen by CRNA 5 or the nursing staff. The following was documented periodically: Blood pressure (BP- normal average 120/80), heart rate (HR- normal 60-100 beats per minute, bpm) and oxygen saturation. (SpO2- estimated percent of oxygen in the blood, normal 95 to 100%)

SpO2 90% at 7:56 p.m., 100% at 8:02 p.m. and 94% at 8:06 p.m. 85% at 8:03 p.m.,
BP 67/29 at 7:44 p.m., 92/46 at 7:55 p.m., 174/146 at 8:01 p.m., 173/77 at 8:02 p.m., 159/27 at 8:09 p.m., 208/157 at 8:12 p.m., 200/140 at 8:16 p.m.,
HR bpm was 81 at 8:01 p.m., 128 at 8:02 p.m. 129 at 8:03 p.m., 134 at 8:09 p.m., 159 at 8:12 p.m., 138 at 8:16 p.m. There was no documented heart rhythm for any of the heart rates.
At 8:19 p.m. was the last recorded BP 127/40 and HR 150.
At 8:25 p.m. compressions stopped and SURG 3 sopped the lifesaving measures.

The Code Blue record further indicated the SUR 3 arrived at code event at approximately 8 PM and the ICU team (Intensive Care Unit; specialized team that treated critical patients) and MD 3 arrived at 8:03 PM. The code blue record indicated at 8:11 p.m., Pt 1 was "bronch (a long tube-like probe with a light and camera at the end, was used to look for issues)" to investigate Pt 1's lungs and found the breathing tube in the esophagus. Further review of the code blue sheet documentation indicated no documented evidence CRNA 5 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures or anesthesia guideline for securing an airway.

During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1's (Pt 1) admission on 4/10/23 and hospital policies were discussed. SUR 3 stated there was "no anesthesiologist in the room". SUR 3 stated he was "unaware" Pt 1 was in the OR and was called to the operating room (OR, surgery room) 25 minutes after the patient was put to sleep, and the anesthesiologist (ANS 2) arrived about the same time. SUR 3 stated the patient was in "distress" had a "pulse" and there were "bowel fluids" on the floor. SUR 3 stated he put a camera into the patient's lung and determined the breathing tube was "in the esophagus". SUR 3 stated two CRNAs were "grappling" with the airway and the patient lost her pulse. SUR 3 indicated that an ICU physician arrived in the OR and determined that ETT was in the esophagus. SUR 3 stated the ICU physician intubated the patient. SUR 3 stated the case was reviewed and discussed to determine the root cause of the events. SUR 3 stated the CRNA told him "Patient refused the NG tube". SUR 4 stated there was recommendation for Pt 1's abdomen to be "decompressed [contents emptied]" by placing an NGT and do an awake intubation. SUR 3 stated that from his "understanding", CRNAs were "not independent" and "supported" by the anesthesiologists. SUR 3 stated, it was his "opinion", if an anesthesiologist wasn't available, the "case stops and can't proceed".

During an interview on 5/20/24, at 5:12 p.m., and concurrent record review of code blue record events, with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1's (Pt 1) medical record for the admission dates from 4/10/2024 to 4/11/24, and polies provided by the hospital, were reviewed, and discussed. CRNA 5 stated ANS 2 and SUR 3 entered the OR room at the "same time". CRNA 5 stated SUR 3 "Bronch" and established that the breathing tube was "in the esophagus and removed it". CRNA 5 stated she reintubated Pt 1 and "tube in [the trachea, windpipe]", and was in the "right place, and was holding it in place with her hand so it would not move". CRNA 5 acknowledged, after confirmation breathing tube had been confirmed and in the correct position, it was secured. CRNA 5 acknowledged the intensive care physician (MD 3), arrive in the OR after ANS 2 and SUR 3. CRNA 5 stated MD 3 "Bronch" the patient and determined the tube was "in the esophagus", removed the tube and reintubated Pt 1. CRNA 5 stated SUR 3 and MD 3 stopped the lifesaving efforts at 8:25 p.m.

During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), the records of surgical Patient 1's (Pt 1) admission on 4/10/2023 and hospital policies were discussed. ANS 2 stated he was familiar with some of the events of Pt 1's care. ANS 2 stated he started at 7:00 p.m. on 4/11/2024 and was the Anesthesiologist In Charge (AIC) for the evening. ANS 2 stated he received hand-off from the daytime AIC (CRNA 6), and Pt 1's case was in progress in OR. ANS 2 stated CRNA 6 "did not mention" concerns or problems" or the acuity (how critical the medical issues were) of Pt 1. ANS 2 indicated he was called to help with Pt 1 in the OR and when he arrived, it was "chaotic". ANS 2 stated SUR 3 was in the OR and informed the CRNA 5 the breathing "tube was in the esophagus". After, the CRNA had reintubated the patient. ANS 2 stated the SpO2 (oxygen levels) was not improving and there were no CO2 readings [sign of breathing, exhaling]. ANS 2 stated CRNA 5 oversaw the case and there were 2-3 CRNA "managing the airway", so he did not help intubate the patient. ANS 2 stated CRNA 5 "assured me" the ETT was in the "right place". ANS 2 stated that he asked the CRNA to reassess the breathing tube because the patient had "no pulse and low blood pressure ...patient crumbling". ANS 2 stated the intensive care medical doctor (MD 3) was called to help. MD 3 "discovered the ETT was in the esophagus", removed the tube and replaced it. ANS 2 stated the patient "deteriorated", and there was nothing more that could be done.

During a concurrent interview and record review of Pt'1 code blue record, on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2), accompanied by Patient Safety Officer (PSO), ANS 2 stated "I tried to run the code", but other people giving medication orders, and the CRNA was in charge, and did not know what medications the patient received. ANS 2 stated he inserted an IV line but did not assist in the management of the airway.

During an interview and concurrent record review on 5/22/24, at 10:13 a.m., with CRNA 6, accompanied by scribe and Director of Clinical Quality Improvement (DCQI), the medical records of Patient 1 who had anesthesia and surgical services on 4/11/2024, was discussed. CRNA 6 stated when he arrived, there were "many individuals" in the room and it was "pure chaos". There were gastric contents "a lot on the floor" and Pt 1 had "soft vital signs [ flags or signs of patient deterioration] ... some SPO2 [readings of oxygen content of blood]". CRNA 6 stated he noted there was, "no CO2 reading" on the monitors, and "no" signs indicating air exchange and the breathing tube was in the lungs. CRNA 6 stated CRNA 5 was managing the airway, and "assured" him it was in the lungs. CRNA 6 stated CRNA 5 explained there was "no CO2" because of fluid in the CO2 line. CRNA 6 acknowledged fluid can clog the tube that connects the patient to the machine that measured CO2. But CRNA 6 stated it was "fast and easy" to change the tube to a clean one. CRNA stated that "basic knowledge" is "knowing the anesthesia tools and machine", and how they work and use them.

During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with Surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1's (Pt 1) admission on 4/10/23 and hospital policies were discussed. SUR 4 stated the surgery department was "not involved" with CRNAs. SUR 4 stated surgeons were "not responsible" for CRNAs and did not provide "supervision ...direction ... orders" for them. CRNAs were "supervised" by anesthesiologist, and not the surgeons. SUR 4 indicated if there was a code blue in the OR, the physician directed the code, and the anesthesiologist would be called. If there is no physician, the CRNA will start it. SUR 4 indicated the death of the patient had resulted in "corrective actions as quick as possible" of CRNAs providing anesthesia care independently in surgical cases. SUR 4 stated CRNA will provide anesthesia services for "small cases". An anesthesiologist should have provided anesthesia care for ill patients and "complex cases".

During an interview and concurrent record review on 5/20/24, at 5:12 p.m. with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1's (Pt 1) medical record for the admission dates from 4/10/2024 to 4/11/2024, and policies provided by the hospital, were reviewed, and discussed. CRNA 5 stated she had been a nurse anesthetist for one year. CRNA stated that AANA (American Association of Nurse Anesthetists', a professional organization) and the hospital bylaws determined the "scope of practice" of nurse anesthetist. CRNA 5 stated that CRNAs were "independent and not medically supervised or directed" by a physician and were the "responsible provider" of medical care. CRNA 5 indicated CRNAs provided anesthesia care and procedures to patients without physician orders. CRNA 5 stated CRNAs could run codes (direct staff to provide emergent lifesaving measures) and order medications and procedures. CRNA 5 stated anesthesiologist were "available", if the CRNA "asks for help", and each CRNA determines when and if an anesthesiologist was required in a case. CRNA 5 stated the CRNAs are "very, very similar" and "at the end of the day deliver" anesthesia care was provided the same way as a physician.

During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), the records of surgical Patient 1's (Pt 1) admission on 4/10/2023 and hospital policies were discussed. ANS 2 stated he had been an anesthesiologist for 25 years and has specialized training for heart cases. ANS 2 indicated the hospital bylaws defined the role and scope of practice of CRNAs. ANS 2 stated CRNAs "practice independently ...practice on own", write orders, and prescribe medications. ANS 2 stated anesthesiologist are "not responsible" for the medical care provided by CRNAs. ANS 2 stated an anesthesiologist's participation in a case is "loose supervision" and the anesthesiologist does not provide medical direction, oversight, or orders for CRNAs. ANS 2 stated he "assumed CRNAs are competent".

During an interview and concurrent record review on 5/22/24, at 5:10 p.m., with anesthesiologist (ANS 3) accompanied by Patient Safety Officer (PSS), the medical records for anesthesia care and hospital policies were reviewed and discussed. ANS 3 stated has "never worked with CRNAs ... never taken responsibility for the patient care of CRNA ... never provide orders for CRNAs". ANS 3 stated, if he is available will help other anesthesia providers, physicians and CRNAs. ANS 3 stated, CRNAs "do not ask me for help". ANS 3 stated if there was a code (emergency life-saving interventions) in the operating room (OR), the anesthesia provider would document the events, medications, interventions, and treatments, during the code or right after it. ANS 3 stated the nursing staff will also document the events on the "Code Bule Record" form per policy.

During a concurrent interviews and record review in the following 3 days with Chief of Anesthesia (ANS 1) on:

1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1) accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), and 5/29/24, at 10:10 a.m., with ANS 1 accompanied by DCQI, 3. 5/29/2024 at 4:14 p.m. with ANS 1 accompanied by RNQ 1, the hospital policies, processes, and patient medical records (Pt 1, 2, 3, 4, 5 and 38) were discussed. ANS 1 stated the anesthesia department followed ASA (American Society of Anesthesiology) guidelines and ACLS guidelines for patient care and documentation. During review of the Pt 1's intraoperative (events during surgery) medical record, titled "Anesthesia Record" dated 4/11/24, at 7:09 p.m., and "Code Blue Record", dated 4/11/24, were discussed with ANS 1. ANS 1 stated that he was familiar with Patient 1 and reviewed the records and care provided by CRNA 5. ANS 1 stated CRNAs are "qualified to run a code" order medications and direct medical care. ANS 1 stated the "primary" anesthesia provider for Pt 1 was the CRNA 5. If the CRNA 5 had "any concerns with a case will discuss with an anesthesiologist."

2. During a review of the Patient 2's medical record, titled "Consultation Progress Note", written by MD 5, dated 10/26/23, at 10:56 PM, the record indicated Patient 2 had a history of dementia (problem with memory and forgetfulness; impaired ability to think or make decisions), diabetes (blood sugar disease), heart disease with CAD (Coronary Artery Disease caused by the clogged arteries), lung disease (breathing difficulties), high blood pressure and chronic pain and was approved to go to surgery for hip fracture on 10/26/23 after a fall at home.

During a record review of the Patient 2's medical record, titled "Preoperative Anesthesiologist Evaluation" (evaluation before surgery by physician that provides anesthesia), dated 10/26/23, at 4:25 p.m., handwritten by CRNA 4 there was no documented evidence of an order by a physician for anesthesia services.

During a record review of the Patient 2's intraoperative (events during surgery) record, titled "Anesthesia Record", dated 10/26/23, timed from 4:33 p.m. to 5:50 p.m., handwritten by CRNA 4 the record indicated that CRNA 4 provided anesthesia services during surgery without the medical orders from an anesthesiologist or other physician. The record indicated during the intra-operative period CRNA 4 procured, prescribed, and administered "High Risk Medications" (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body's movement. The medications administered by CRNA 4 were as follow:
i. Sevoflurane anesthesia medical gas (volatile anesthetic that provides hypnosis, amnesia during surgery and can decrease blood pressure and heart rate)
ii. Fentanyl (strong opioids/narcotics that can decrease or stop breathing),
iii. Propofol (high risk sedative that can decrease or stop breathing),
iv. Lactated Ringers IV fluid (a type of fluid with electrolytes, given IV, Into the Vein)
v. Pocuronium (medication that cause paralyses all muscle function, such as breathing),
vi. Precedex (sedating medication that can slow the heart rate, and lower blood pressure),
vi

Based on interview and record review, the Medical Staff failed to follow Medical Staff Bylaws, rules and regulations; and failed to consider scope of practice state laws in recommending candidates to the medical staff for 25 of 25 physicians and non-physician providers. The hospital failed to appropriately credential and privilege 13 of 13 CRNAs, three of three surgeons, one of one anesthesiologist, seven of seven Physician Assistants and one of one Nurse Practitioner.

These failures resulted in the potential harm of approving medical staff privileges to provide healthcare services to patients who may not be qualified to do so.

Findings:

During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff Manger, the hospital workflow, polices, patient record logs and staff files were discussed and reviewed. The MST stated the privileging process started with applicants completed an application and specify specialty on the request form. The MST stated according to Bylaws, the granted privileges were based on experience, certification, education, and skill sets as determined by case logs (the number of times provider performed certain tasks or surgery) from school and/or prior jobs, in addition to professional references and criminal background check. The MST stated all the paperwork is placed in the applicant's file and was passed to the Chief of Department the candidate applied to. The MST acknowledged applicants usually request every privilege listed on the form and the Chief of the Department approved privileges requested usually without stipulation. The MST stated approved privileges should have correlated with education, experience, and the case log. The MST stated the new applicant file was "available" for Governing Board (GB- hold the ultimate responsibility for the hospital's compliance), the credential committee (CC- review candidate application files and provided recommendations to the GB), and MEC to view.

During record review of the privileging staff records the following were noted:


" CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17, and 18 were authorized to diagnosis, order treatments, medications, and therapeutics for patients without a treatment regimen ordered by a physician when they did not have a medical license.


" CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17, and 18 were not required to have physician orders to provide anesthesia care, medications, treatments, and therapeutics.

" CRNA 1, CRNA 2, CRNA 5, CRNA 6, CRNA 13. CRNA 18, PA 1, PA 5, and SUR 8 had procedure logs for privileges, but they did correlate with privileges.

" CRNAs 6, 11, 13 and 17 did not have primary verification of nurse anesthetist education.

" CRNA 3, CRNA 4, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, and NP 2 did not have signed service agreements by supervising physicians.

" PA 6, PA 7, NP 2, SUR 3, SUR 5, and COS did not have documented evidence of procedures logs required for privileges.

" CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, NP 2, COS, SUR 3, SUR 5, and SUR 8 did not have documented evidence of the "direct" supervised proctoring for privileges required by Medical Staff bylaws.

" CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, NP 2, COS, SUR 3, SUR 5, and SUR 8 did not have documented evidence of professional references.

During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the hospital workflow, polices, patient record logs and staff files were discussed and reviewed. The MST stated that they could not determine competency, training, or experience for each provider's approved privilege for medical services of the 25 of 25 privileging files. The MST stated that they could not determine competency, training or experience because of limited information, confusing entries, and unfamiliar terms. The team acknowledged that the approved privileges were not always consistent with case logs, education, and experience. The MST acknowledged some staff files did not contain case logs from prior employment, school, or residency, professional references, signed service agreements by the supervising physicians. The MST stated case logs were not always obtained for all candidates, education was not always obtained from a primary source, and professional references were only checked if needed by the chief of the department. The MST stated if an AHP or Registered Nurse (RN), such as a RN First Assist (RNFA- RN with training that assists a surgeon during surgery), were employed by the hospital, the medical staff team should have had information regarding scope of practice, education, qualifications, or training. The MST stated the information was needed to be obtained from Human Resources.

During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the MST stated there was no written documentation that the CC, MEC or GB reviewed and discussed each applicant's competency, education, training, certification, or experience. The MST stated the privileging form is approved and signed by the Chief of the Department. The MST acknowledged if the required documents were not present, such as professional references, certifications, case logs, education and training, the privileges would still be granted. The MST indicated there was no documented evidence that each candidate's file was discussed and recommended by the CC or MEC to the GB. The MST acknowledged there was no documented evidence the GB approved each provider.

During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the MST stated CRNAs started applying for privileges at the hospital in June 2023. The MST stated CRNAs were approved as "independent practitioners" with full prescriptive authority. The MST stated CRNAs were the "same as a physician ... anesthesiologist" and were "equivalent".

During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the hospital policy titled, "AHP Rules and Regulations, version 2022" was reviewed which indicated all AHPs required "direct supervision". The MST stated the definition of "supervision" for CRNAs was that an "anesthesiologist was available to provide support ...and help ... if" requested by the CRNA. The MST stated "new" hospital regulations did not require CRNA to be supervised. The MST indicated that CRNAs were not required to have physician orders or for any aspect of providing anesthesia services, including emergencies, life-threatening events (known as "Code Blue" at the hospital), procedures, or medical care of patients.

During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the MST stated CRNAs were permitted prescribe medication without the physician orders required for CRNAs to act within the scope of their practice The MST stated CRNAs could diagnosis, write orders for any medication, treatment or therapeutics and it was within their "scope of practice".
During a phone interview on 5/23/24, at 12:42 p.m., with the hospital administration team which included, Director of Clinical Quality and Performance Improvement DCQI, Chief Nursing Officer (CNO), Chief Executive Officer, (CEO) and Accreditation Manager, the team acknowledged that unprivileged providers and unsupervised AHPs, including CRNAs, were providing independent medical care. They were diagnosing and treating medical conditions, plus ordering, prescribing, and administering medications, treatments, and therapeutics to patients.

During an interview on 5/30/24, at 3:48 p.m., with Chief Of Medical Staff (COS), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and medical staff processes were discussed. The COS stated she was "familiar" and "follows" Medical Staff Bylaws. The COS stated she reviewed the applicants' files for "red flags", background check and if "certification match with residency". The COS stated the "proof" of CC and MEC recommendations and GB approval were the dates entered into the meeting minutes. The COS acknowledged there was no documented evidence of MEC recommendations and GB approval for each candidate. The COS stated she "relies on" the department chiefs to determine and approve physician and AHP applicants for privileges. The COS stated approval of PA privileges were "based on education" while PAs were employed by the hospital and their practice were determined by the hospital. The COS stated PA who provide surgical services should have had specific privileges areas of the surgical services. The COS stated PAs had privilege to work "anywhere" in the hospital. The COS acknowledged that medical staff did not confirm the competency, qualifications, and skills of AHPs. The COS stated, no matter the AHP's specialty or employment status, whatever physician "asked" the AHP to provide medical care, was "responsible" for the care the AHP's providers.

During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with ANS 1, accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and DCQI, 2. 5/29/24, at 10:10 a.m., with ANS 1 accompanied by DCQI, 3. 5/29/24, at 4:14 p.m., with ANS 1 accompanied by RNQ 1, the hospital policies, workflow, and patient medical records were discussed. ANS 1 described the privilege process. ANS 1 stated after education, case logs, criminal background, resume and application have been gathered by medical staff team, the information was passed to the chief of anesthesia. ANS 1 stated if there were any "concerns" he would call references and interviewed the applicant. ANS 1 and DCQI acknowledged the applicant case logs were not always available for review for privileging. ANS 1 stated he would signed the privilege forms for approval. ANS 1 acknowledged approved privileges may not have been consistent with logs, education, or experience. ANS 1 stated CRNA competency could be determined by the surgeon, chief of anesthesiology or the Anesthesiologist In Charge (AIC). ANS 1 stated the AIC could be an anesthesiologist or a CRNA. ANS 1 stated once proctoring requirement satisfied the applicant's file would have been forwarded to Credential Committee (CC), Medical Staff Committee, and Governing Board (GB) for approval.

During an interview on 5/30/24, at 3:00 p.m., with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed. SUR 4 stated some of her responsibilities as "Chief" was to ensure that surgical workflow and department services "flow well ...coordinate patient care ...communicate with staff". In addition, SUR 4 stated she reviewed surgical providers applications files for education background, case logs, training, and experience. SUR 4 stated one of her duties was to recommend surgical provider applicants for staff privileges. SUR 4 stated that she was "absolutely not" involved with the anesthesiology departments approval of privileges for anesthesiologist or CRNAs. SUR 4 stated she "helps"' the credentialing committee once a month.

During record review of [Hospital] policy titled "Rules and Regulations of the Governing Board of [Hospital]", June 13, 2022, indicated that the "Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority.
and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice".

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that " recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership".

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that "Medical staff membership (1) to have a current unrestricted California license to practice medicine, dentistry, or podiatry; (2) to maintain an unrestricted Drug Enforcement Administration certificate ...only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] The Governing Board grants appointments to the medical staff ... Every member practicing the medical profession at [Hospital name] shall exercise those clinical privileges specifically granted by the Governing Board.. Hold a current, unrestricted license, certificate or other appropriate legal credential ... the authorized individual shall write the order ... Practitioners are legally and professionally responsible for the ongoing monitoring and appropriate adjustment of the duration and dose of the medications ordered in the Hospital".

During record review of [Hospital] policy titled, "MEDICAL STAFF RULES AND REGULATIONS", approved Governing Board, August 24, 2022, indicated that, prescribing providers "maintain an unrestricted Drug Enforcement Administration certificate ...authorized individual shall write the order, followed by the name of the practitioner, date and time, name, and signature of the writer".

During record review of hospital titled, "AHP [Allied Health Professional] Rules and Regulations, version 2022" indicated that the "Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned ... Practitioners who desire to sponsor and supervise AHPs must apply and qualify for such sponsorship. Each AHP who is a Physician's assistant must be supervised by a Physician having the following qualifications: a. Is a Physician currently licensed by the State of California; Identify a sponsoring and supervising Medical Staff Member, in good standing on the Active staff, who has Privileges in the appropriate Department, and who has agreed to assume ongoing responsibility for sponsorship and direct supervision of the AHP at all times. When the sponsoring and supervising Practitioner is not available, an alternate supervising Medical Staff Member meeting all the requirements of the sponsoring Member must be predesignated and must provide direct supervision at all times in place of the absent Practitioner. ... Restriction of the Privileges of the sponsoring and supervising Practitioner, in which case the Practice Prerogatives of the AHP shall be restricted accordingly."

During record review of [Hospital] policy titled, "PHARM.1.04 Controlled Substances Policy Schedule II - V, approved: 6/23/2021, indicated that "Issuing, Dispensing and Distributing Controlled Substances ...Only licensed personnel per state law and regulation may have access to controlled substances ... Strict accountability shall be maintained and recorded for all controlled substances".

During record review of [Hospital] policy titled, "OR.1.29 Provision of Anesthesia Services", approved 10/27/2021, stated the purpose of the policy was "to establish a consistent standard-of-care for patients receiving anesthesia services ... The director of anesthesia services is responsible for ... Evaluating the quality and appropriateness of the anesthesia patient care ... The anesthesia service is responsible for developing policies and procedures governing the provision of all categories of anesthesia services ... Individuals Permitted to Administer Anesthesia ... Only those individuals privileged by the medical staff shall be permitted to administer anesthesia. These individuals may include A qualified anesthesiologist, A Doctor of Medicine or osteopathy (other than an anesthesiologist); A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law ... The privileges granted must be in accordance with State law and organization policy. The type and complexity of procedures for which the practitioner may administer anesthesia, or supervise another practitioner supervising anesthesia, must be specified in the privileges granted to the individual practitioner".

During record review of California (CA) Business and Professions Code, (BPC) 2826, it stipulated that a "Nurse anesthetist' means a person who is a registered nurse licensed by the board who has met standards for certification from the board".

During record review of California's Business and Professions Code, CA BPC, 2725(b)(2), it stipulated that "Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician".

During review of California 's Business and Professions Code, CA BPC 2827, it stipulated, the "utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist".

During review of California 's Business and Professions Code, CA BPC 2833.5, it stipulated that "the practice of nurse anesthetist does not confer authority to practice medicine or surgery".

Based on interview and record review, Medical staff department failed to follow policy and ensure all individuals providing medical care and services in the hospital privileges were recommended by the Medical Executive Committee (MEC - oversight of safe and appropriate patient care by physician and non-physicians) and approved by the Governing Board.

The failure to appropriately privilege and approve medical staff privileges allowed 25 of 25 physicians and non-physicians (AHP- Advance Health care Providers):

1. Thirteen Certified Registered Nurse Anesthetist (CRNA- type of AHP, Registered Nurse with specialized training that provides anesthesia services under the orders and discretion of a physician), [CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18].

2. Four surgeons (SUR) ]3, 5 and Chief of Medical Staff (COS)];

3. One anesthesiologist (ANS) [4];

4. Seven physician Assistants (PA- type of AHP, an individual with specialized training that provided medical care under the supervisor of a physician), [PAs 1, 2, 3, 4, 5, 6 and 7];

5. One Nurse Practioner (NP- type of AHP Registered Nurse with specialized training that provides medical care under the supervision of a physician), [NP 2]; and

6. Four providers were not on the AHP or medical staff rosters (ANS 5, NP 1, physician (DO 1), and RN registered nurse (RN) 1, (listed as First Assist [RNFA- RN with training that assists a surgeon during surgery]) to furnish medical care, surgical services , anesthesia services and/or emergency medical to patients which they may not have been qualified to do so and placed all patients' health and safety in jeopardy.

Findings:

During two concurrent interviews and record reviews on 5/22/2024 at 12:42 p.m. and 5/28/2024 at 1:50 p.m. with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff manger, hospital workflow, polices, patient record logs and staff files were discussed. MST explained privileging process that the hospital is supposed to follow. The applicant completes an application and request privileges listed on the privilege form. The MST indicated privileges are to be granted are based on experience, education and skill sets as determined by case logs from school and/or prior jobs. The hospital Bylaws also require evaluation references and criminal background. The applicant's privilege request form is approved and signed by the Chief of the Department. All the paperwork is placed in the applicant's file, and it is "available" for the credential committee (CC), Medical Staff Committee (MEC) and Governing Board (GB). MST indicated the privileges for each candidate is not discussed or approved by the CC, MEC or GB. The team indicated there is no written documentation by the CC, MEC or GB regarding each applicant and privileges requested. MST stated "sometimes, someone" places dates on the privilege forms, but MST does not know who the individual is. MST stated only the Chief of the Department signs the privilege form for approval and this becomes the record of provider privileges. The MST stated the official active date of providers privileges is determined by the "date" listed in the meeting "minutes", and a letter is sent to the provider. MST stated "all" applications are processed the "same way". MST acknowledged 25 of 25 privileged files for COS, SUR 3, SUR 5 SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6 and PA 7 or NP 2 did not have written recommendations from CC and MEC, nor written approval by the MEC.

During record review of the hospital titled log, "Revised Med Staff Roster 5/2023 to 5/2024 " listed 658 physician providers, and the hospital titled logs "Revised AHP Roster 5/2023 to 5/2024 listed 124 AHPs:

" Nurse Practitioner 1 (NP 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39. NP 1 was not listed on the medical staff or AHP roster.

" Physician, (DO 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39. DO 1was not listed on the medical staff.

" ANS 5 provided anesthesia services to patients and anesthesia call (available for emergencies) 9/24/23, 9/27/23, 10/23-25/23. ANS 5 was not listed on the Medical staff Roster.

" CRNA 20 provided anesthesia call on 12/16/23. CRNA 20's appointment date on the AHP roster was 4/4/24.

During two concurrent interviews and record reviews on 5/22/2024 at 12:42 p.m. and 5/28/2024 at 1:50 p.m. with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff manger, MST stated that names of individuals listed who were not AHP or Medical Staff Rosters did not have privileges or were unfamiliar to medical staff. DCQI stated it was a "mix-up". MST acknowledge privileges were granted for specific specialties and if additional privileges were desired, and requested must be submitted to medical staff for review and approval.
During record review of the hospital titled log, "Revised Med Staff Roster 5/2023 to 5/2024 " listed 658 physician providers, and the hospital titled logs "Revised AHP Roster 5/2023 to 5/2024 listed 124 AHPs.

During a comparative record review of Operating Room (OR) case logs titled, "OR Log Revised", dated 2/2023 to 5/15/2024 and record review of the hospital log, titled "Revised Med Staff Roster", and "Revised AHP Roster" for date range of 5/2023 to 5/2024, the record listed 658 physician providers and 124 AHPs. The following providers were listed as surgical staff providers, but did not have documented evidence specific privileges and/or were not on the Medical Staff or AHP rosters a as follows:

" MD 11 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon.

" MD 12 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon.

" ANS 5 was listed as the anesthesia provider for Pt 64, Pt 66, Pt 67, Pt 97, Pt 98, Pt 99, Pt 100, Pt 101, Pt 104 and Pt 105 but was not on Medical Staff Roster

" PA 8 was listed as Additional staff intraoperative "Additional staff intraoperative" for Pt 39. On the AHP roster with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging)

" PA 8 as listed as an "Anesthesia Tech [assistant to anesthesiologist, not allowed to practice in California]" for Pt 37. PA 8 was listed on AHP roster as PA with a radiologist as the supervising physician.

" Nurse Practitioner 1 (NP 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39, but was not listed on the medical staff or AHP roster.

" Physician, (DO 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39 but was not listed on the medical staff.

" RN 1 was listed as RNFA, "First Assistant" for "Coronary Artery Bypass" for Pt 37 and Pt 39. RN 1 was not listed on the APH roster.

During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with the MST, the MST acknowledged privileges were granted for specific specialties and if additional privileges were desired, the request must be submitted to medical staff for review and approval. The MST stated that names of individuals who were not on the AHP or Medical Staff Rosters, did not have privileges. DCQI stated it was a "mix-up".

During a phone interview on 5/23/2024 at 12:42 p.m., with the CDPH District Office hospital administration team which included, DCQI, Chief Nursing Officer (CNO), Chief Executive Officer, (CEO) and Accreditation Manager, the team acknowledged that medical staff were "not" being appropriately credentialed for privileges, and it there was an "opportunity" to correct it.

During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), 2. 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and 3. 5/29/2024 at 4:14 p.m. with ANS 1, accompanied by RNQ 1, the hospital policies, workflow, and patient medical records were discussed. ANS 1 stated his job as chief was to approve anesthesia applicant files for privileges, monitor and sign-off on proctoring, monitor and review adverse events related to anesthesia services. ANS 1 stated after education, case logs, criminal background, resume and application have been gathered by medical staff team, the information was passed to the chief of anesthesia. ANS 1 stated if there were any "concerns" he will call references and interviewed the applicant. ANS 1 and DCQI acknowledged the applicant case logs were not always available for review for privileging. ANS 1 stated he signed the privilege forms for approval. ANS 1 acknowledged approved privileges may not have been consistent with logs, education, or experience. ANS 1 stated the applicant had 12 months to complete proctoring. ANS 1 stated once proctoring requirement satisfied the applicant's file would have been forwarded to Credential Committee (CC), Medical Staff Committee, and Governing Board (GB) for approval.

During a phone interview on 5/23/24, at 12:42 p.m., with the hospital administration team which included, Director of Clinical Quality and Performance Improvement DCQI, Chief Nursing Officer (CNO), Chief Executive Officer, (CEO) and Accreditation Manager, the team acknowledged that unprivileged providers and unsupervised AHPs, including CRNAs, were providing independent medical care. They were diagnosing and treating medical conditions, plus ordering, prescribing, and administering medications, treatments, and therapeutics to patients.

During an interview and concurrent record review on 5/30/2024 at 3:48 p.m. Chief of Medical Staff (COS), accompanied by Accreditation Manager (AM 2), hospital policies, and medical staff processes were discussed. COS stated she is "familiar" and "follows" with Medical Staff Bylaws. COS stated she participates in the following meetings-- Credentialling committee (CC), the first Thursday of each month, Medical Executive Committee (MEC) the 3rd Friday of each month and Governing Board (GB) the 4th Wednesday of each month. COS stated the CC, MEC and GB have "access" to the applicant's file for review. COS states application files are reviewed by the department chairs. COS stated she "relies on" the department chiefs to determine and approve physician and AHP applicants for privileges. COS indicated she reviews the applicants' files for "red flags", background check and if "certification match with residency".
COS acknowledged the privileging process for applicants is not followed.

During an interview and concurrent record review on 5/30/2024 at 3:48 p.m. COS chief of medical staff (COS), accompanied by Accreditation Manager (AM 2), hospital policies, and medical staff processes were discussed. COS acknowledged she was not aware which AHP, including surgical assistants, are eligible for privileges. COS stated PA are "not independent". COS stated, PAs who are employed by a medical group will submit an application to medical staff. The applications are reviewed by the chief of the department. COS stated approval of PA privileges are "based on education". On the other hand, PAs employed by the hospital, their practice is determined by the hospital. COS stated PA who provide surgical services should have specific privileges, where they can work, for example trauma, general surgery, cardiovascular, orthopedics. COS stated if a nurse (RN) or other AHP is a hospital employee, the hospital has jurisdiction over reviewing qualification, training, and monitoring, Medical staff does not approve the privilege forms. COS stated Registered Nurse First Assistants (RNFA) were nurses and employed by the hospital. The hospital is responsible for privileges and practice, not medical staff. COS stated first assists, RNFAs should have "specific training". COS indicated the hospital determines their training.

During an interview on 5/30/2024 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed.
SUR 4 stated some of her responsibilities as "Chief" is to review surgical providers applications files for education background, case logs, training, and experience. SUR 4 stated she will recommend applicants for staff privileges. SUR 4 stated she "helps"' the credentialling committee once a month. After privileges have been granted, proctoring occurs for medical staff.

During record review of [Hospital] policy titled "Rules and Regulations of the Governing Board of [Hospital]", June 13, 2022, indicated that the "Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority.
and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice".

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that " recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership".

During record review of [Hospital] policy titled, "MOD CLN.4.04 MOD Operative and Invasive Procedures Appropriateness Review (CO-5.007.MOD)", approved 4/10/2024, stated the purpose of the policy was "to describe the minimum standards, review Cardiac Operative and Invasive procedures through effective use of evidence-based clinical criteria ... Quality Review ... The Facility shall conduct case reviews in accordance with the peer review and quality processes set forth in the Facility's Medical Staff Bylaws and state statutes.

During record review of [Hospital] policy titled, "CO-5.007 Operative and Invasive Procedures Appropriateness Review", approved 10/24/2018, described "the minimum standards for prospective and retrospective review of the appropriateness of operative and invasive procedures through effective use of evidence-based clinical criteria, to appropriately and accurately identify performance trends and patterns, and to monitor and improve ... Hospital's Peer Review Committee is responsible for providing oversight and peer review of the Operative and Invasive Procedures provided at the Hospital to confirm appropriateness of the Procedures being performed ... Physician documentation that validates the appropriateness of the procedure, including but not limited to: patient clinical condition, non-invasive study results, findings from diagnostic procedures ... shall provide a summary of its findings to the Hospital's Medical Executive Committee (MEC), which shall report such findings to the Hospital Governing Board", as outlined in Medical Staff Bylaws.

During record review of [Hospital] policy titled, "MEDICAL STAFF RULES AND REGULATIONS", approved Governing Board, August 24, 2022, indicated that, prescribing providers "maintain an unrestricted Drug Enforcement Administration certificate ...authorized individual shall write the order, followed by the name of the practitioner, date and time, name, and signature of the writer".

During record review of hospital titled, "AHP [Allied Health Professional] Rules and Regulations, version 2022" indicated that the "Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned ... Practitioners who desire to sponsor and supervise AHPs must apply and qualify for such sponsorship. Each AHP who is a Physician's assistant must be supervised by a Physician having the following qualifications: a. Is a Physician currently licensed by the State of California; Identify a sponsoring and supervising Medical Staff Member, in good standing on the Active staff, who has Privileges in the appropriate Department, and who has agreed to assume ongoing responsibility for sponsorship and direct supervision of the AHP at all times. When the sponsoring and supervising Practitioner is not available, an alternate supervising Medical Staff Member meeting all the requirements of the sponsoring Member must be predesignated and must provide direct supervision at all times in place of the absent Practitioner. ... Restriction of the Privileges of the sponsoring and supervising Practitioner, in which case the Practice Prerogatives of the AHP shall be restricted accordingly."

During record review of California (CA) Business and Professions Code, (BPC) 2826, it stipulated that a "Nurse anesthetist' means a person who is a registered nurse licensed by the board who has met standards for certification from the board".

During record review of California's Business and Professions Code, CA BPC, 2725(b)(2), it stipulated that "Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician".

During review of California 's Business and Professions Code, CA BPC 2827, it stipulated, the "utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist".

During review of California 's Business and Professions Code, CA BPC 2833.5, it stipulated that "the practice of nurse anesthetist does not confer authority to practice medicine or surgery".

Based on observation, interview, and record review the hospital failed to ensure hospital policies and procedures (P&P) were followed when:

1. Three of six sampled patients (Patient (Pt) 11, Pt 12, and Pt 14) did not have vital signs assessed and documented in accordance with the hospital policy and/or professional standards.

2. One of two sampled patients (Pt 11) did not have her pain assessed and documented while she was receiving epidural pain medication according to hospital policy.

3. One of two sampled patients (Pt 61) was not offered pain medication prior to the start of a large wound dressing according to the hospital's pain policy and hand hygiene was not performed per hospital policy.

These failures placed patients at risk for decline and increased pain which could cause patients to experience pain, suffering, and delayed interventions.

4. Two of three sampled patients (Pt 11 and Pt 12) when patients preferred language was other than English and there was minimal (for informed consents) to no documentation an interpreter was used for either patient during their hospitalization in accordance with the hospital policy.

These failures had the potential for patients whose preferred language was other than English to not receive and fully understand procedures and/or education provided to them and could result in negative health outcomes when bilingual staff who were not competent interpreters communicated with patients and did not use the interpreting system to communicate with patients.

5. Two of four sampled patients (Pt 6 and Pt 11) when there was no consent form for antipsychotic medications (a type of drug used to treat severe mental disorder in which a person loses the ability to recognize reality or relate to others) administered to Pt 6 during his hospitalization and Pt 11 was not provided with an interpreter during consent for an epidural per the hospital's P&P.

These failures resulted in administration of antipsychotic medications to Pt 6 without Pt 6 (or the responsible party) having the opportunity to weigh the benefits and risks of the medication and right to refuse treatment; and did not provide Pt 11 the opportunity to weigh the benefits and risks of the procedure in a language she understands and documented preference; these failures could cause avoidable and unnecessary mental and emotional distress.

6. One of three sampled patients (Pt 8) when the hospital P&P titled, "Restraints and Seclusion," was not followed. Pt 8 was placed in five-point restraints, which was not least restrictive, the physician's order for four-point restraints was not followed and a physician did not perform a one-hour face to face after restraints were placed emergently.

This failure caused Pt 8 to be restrained more than the physician's orders indicated and violated Pt 8's patient rights.

Findings:

1a. During a concurrent interview and record review on 5/15/24 at 9:31 a.m. with Quality Nurse (RNQ) 4, Pt 11's "Electronic Health Record (EHR-electronic version of a patient's medical history)," dated 5/14/24 was reviewed. The EHR indicated Pt 11 was admitted on 5/14/24 at 9:36 a.m. for induction of labor (the use of medications or other methods to bring on labor) at 34.4 weeks (in month eight of pregnancy) for cholestasis (a liver problem in pregnancy).

During a concurrent interview and record review on 5/22/24 at 12 p.m. with RNQ 4, Pt 11's "EHR," dated 5/15/24, Pt 11's "Vital Signs (VS)," dated 5/15/24 and the hospital's policy and procedure (P&P) titled, "L&D.1.15 Epidural Management for the Laboring Patient," dated 1/25/23 were reviewed. The EHR indicated Pt 11 had an epidural placed at 12:38 p.m. The VS indicated vital signs were taken at 12:30 p.m., 12:45 p.m., 12:47 p.m., 1 p.m., 1:15 p.m., 1:30 p.m., 1:45 p.m., 2 p.m., 2:30 p.m., 3:53 p.m., and 4 p.m. RNQ 4 stated the pulse oximetry was not documented and monitored prior to and after the epidural placement. The P&P indicated, "Vital Signs: include assessment of maternal heart rate, respiratory rate, blood pressure, pulse oximetry, and fetal well-being ... Assess ...maternal vital signs, signs of high spinal or ascending block, perception and level of pain relief once regional analgesia or anesthesia is initiated. Then every 3 minutes for the first 15 minutes, then every 5 for the next 15 min, then every 15 minutes thereafter ..." RNQ 4 stated the vital signs were not assessed and documented according to the P&P when the pulse oximetry was not documented, and the frequency was not assessed according to the P&P. RNQ 4 stated the importance of assessing a patient's vital signs during a procedure was to ensure the patient was tolerating the procedure and or medications. RNQ 4 stated monitoring the patient's pulse oximetry could help assist the nurse to determine if the patient was overly sedated and intervene if needed.

During a concurrent interview and record review on 5/22/24 at 2:25 p.m. with RNQ 4, Pt 11's "VS," dated 5/16/24 and the hospital's reference obtained from the American College of Obstetricians and Gynecologists (ACOG) titled, "Postpartum Care of the Mother," undated was reviewed. The VS indicated Pt 11 delivered at 6:28 p.m., documented vital signs started at 6:45 p.m., 7 p.m., 7:42 p.m., and the 8:42 p.m. RNQ 4 stated the ACOG indicated, "Blood pressure levels and pulse should be monitored at least every 15 minutes for 2 hours, but more frequently and for longer duration if there are complications." RNQ 4 stated the first two hours after delivery the vital signs were not assessed and documented according to the ACOG guidelines.

1b. During a concurrent interview and record review on 5/22/24 at 10:53 a.m. with RNQ 4, Pt 12's "Face Sheet (FS-a document that contains a summary of a patient's personal information and brief medical history)," dated 5/14/24 and Pt 12's "History and Physical (H&P)," dated 5/3/24 was reviewed. The Face Sheet indicated Pt 12 was admitted on 5/14/24 at 7:54 a.m. The H&P indicated Pt 12 was admitted for repeat cesarean section (the surgical delivery of a baby through a cut made in the mother's abdomen).

During a concurrent interview and record review on 5/22/24 at 10:53 a.m. with RNQ 4, Pt 12's "Physician Orders (PO)," dated 5/14/24 and Pt 12's "VS," dated 5/14/24 were reviewed. RNQ 4 stated the PO indicated, "Vital Signs every 15 minutes for 1 hour, then every 1 hour for 5 hours then per post-op protocol." The VS indicated at 11:10 a.m., 11:15 a.m., 11:20 a.m., 11:25 a.m., 11:30 a.m., 11:35 a.m., 11:40 a.m., 11:45 a.m., 11:50 a.m., 11:55 a.m., 12 p.m., 12:15 p.m., 12:30 p.m., 12:45 p.m., 1 p.m., 1:33 p.m., 2:45 p.m., 5:10 p.m., and 9 p.m. RNQ 4 stated Pt 12's hourly vital signs for five hours was completed late. RNQ 4 stated the importance of following physician's orders was to ensure the patient was recovering and there was no decline in the patient's health after birth.

1c. During a concurrent interview and record review on 5/21/24 at 3:42 p.m. with RNQ 4, Pt 14's "H&P," dated 4/9/24 was reviewed. RNQ 4 stated the H&P indicated, Pt 14 was delivered at 9:49 a.m. by vaginal birth at 40.4 weeks gestation and admission diagnoses of respiratory insufficiency, suspected transposition of the Great Arteries, Suspected ectodermal dysplasia, and sepsis evaluation.

During a concurrent interview and record review on 5/21/24 at 3:55 p.m. with RNQ 4, Pt 14's "PO," dated 4/8/24 was reviewed. RNQ 4 stated the PO indicated, "For full term babies, assess and document vital signs [every] 30 [minutes] [times] 4 from time of birth, then [every] 1 [hour-intermittent] [times] 2, the [every] 8 [hour-intermittent]."

During a concurrent interview and record review on 5/21/24 at 4:20 p.m. with RNQ 4, Pt 14's "VS," dated 4/9/24 was reviewed. RNQ 4 stated the VS indicated the first vital signs were documented at 9:50 a.m., then 10:10 a.m., and 10:50 a.m. RNQ 4 stated the fourth vital sign was missing and the first three vital signs were not assessed every 30 minutes according to the physician orders. RNQ 4 stated the importance of assessing and documenting a newborn's vitals was to ensure the baby was stable or declining.

During a concurrent interview and record review on 5/21/24 at 4:25 p.m. with RNQ 4, Pt 14's "Physical Assessment (PA)," dated 4/9/24 was reviewed. RNQ 4 stated the PA indicated there was no full physical assessment documented for Pt 14 within two hours after birth.

During a concurrent interview and record review on 5/22/24 at 10:19 a.m. with Director of Women and Childrens (DWC), Pt 14's "PA," dated 4/9/24 was reviewed. DWC stated in labor and delivery (L&D) the nurses only complete a focused physical assessment and not a full physical assessment. The DWC stated the first full physical assessment would be completed in Postpartum Unit (department where mother and baby are transferred after delivery).

During a review of the hospital's reference from Guidelines for Perinatal Care, 8th Edition titled, "Newborn Vitals & Assessments," dated 9/2017 and the hospital's "Labor and Delivery RN Skill Assessment and Competency Validation (Comp)," dated 9/18/2023, the reference indicated, "Stable Term Transitional [Vital Signs] Well Baby Care ...1st [vital sign (VS)] within 15 [minutes] of birth (axillary [temperature], [pulse], [respirations] ...Initial Assessment within 2 [hours] of birth then [every] shift." The Comp indicated, " ...Newborn assessment following delivery ...Performs Initial Physical Assessment, including vital signs initial [every] 30 [minutes] [times] 4. Documents findings appropriately ..."

During an interview on 5/30/24 at 2:35 p.m., with the Chief Nursing Officer (CNO), the CNO stated her expectations for vital signs for patients was to follow evidence-based practice and for each department, the specific professional standard followed. The CNO stated there were opportunities for tightening up their policies and have conversations about what best practices meant to the hospital.

During a review of the hospital's policy and procedure (P&P) titled, "L&D.1.15 Epidural Management for the Laboring Patient," dated 1/25/23, the P&P indicated, "PURPOSE: The purpose of this policy is to provide guidelines for nursing practice and patient advocacy related to pregnant women receiving pain management through epidural analgesia ...Vital Signs: include assessment of maternal heart rate, respiratory rate, blood pressure, pulse oximetry, and fetal well-being ...it is the responsibility of the registered nurse to communicate the patient's need for pain management. The primary care provider and/or anesthesia provider may determine that epidural analgesia is contraindicated in certain conditions ...A qualified, credentialed, license anesthesia-care provider is responsible for the following (the non-anesthetist registered nurse may not perform these tasks): 1. Obtain informed consent from the patient. 2. Insertion of the epidural catheter. 3. Verification of correct catheter placement. 4. Initial injection and/or initiation of a continuous infusion of analgesia. 5. Connecting epidural catheter. 6. Re-bolus of an epidural catheter. 7. Manipulate patient-controlled epidural analgesia (PCEA) doses or dosage intervals. 8. Increase or decrease the rate of the continuous infusion ...During the care of the pregnant woman, the registered nurse may perform the following: 1. Witness the informed consent. 2. Monitor the patient's vital signs, level of consciousness, mobility, and perception of pain and level of pain relief. 3. Monitor the fetal heart rate. 4. Stop the infusion if there is a safety concern or the woman has given birth. 5. Replace the infusion if there is a safety concern or the woman has given birth ...PROCEDURE EPIDURAL INITIATION ...Assess and document baseline maternal vital signs and fetal heart rate patter ...Perform a "Time Out" prior to procedure and document in medical record ...Remain in the patient's room throughout the procedure ...Assess ...maternal vital signs, signs of high spinal or ascending block, perception and level of pain relief once regional analgesia or anesthesia is initiated. Then every 3 minutes for the first 15 minutes, then every 5 for the next 15 min, then every 15 minutes thereafter. The frequency of subsequent assessment should be based on maternal-fetal response to medication, maternal-fetal condition, and the stage of labor ...re-bolus ...Assess for complications that may be associated with epidural initiation ...Continue to evaluate maternal pain level with ongoing patient assessments. Educate patient regarding her increased risk for falls. Patients on bed rest should be assisted to change position every half-hour ...Document all interventions, assessments, and education in the electronic medical record ..."

2. During a concurrent interview and record review on 5/22/24 at 2:40 p.m. with RNQ 4, Pt 11's "Pain Assessments (PA)," dated 5/15/24 and 5/16/24 were reviewed. The PA indicated on 5/15/24 at 11:26 a.m., Pt 11 was administered fentanyl (pain medication) 100 micrograms (mcg-unit of measure) and there was no reassessment of Pt 11's pain until 2 p.m., a time lapse of two hours and 34 minutes. The PA indicated on 5/16/24 at 7:37 p.m., Pt 11 was administered hydrocodone with acetaminophen (used to relieve moderate to severe pain) and ibuprofen (used to treat pain, fever and swelling) for pain but Pt 11's pain assessment was not assessed. RNQ 4 stated Pt 11's pain should have been assessed to obtain a baseline, so when Pt 11's pain was reassessed, the nurse would know if the pain medications helped with Pt 11's pain. RNQ 4 stated the importance of assessing and reassessing a patient's pain was to ensure the pain medication or intervention implemented was working.

During an interview on 5/30/24 at 2:37 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectations of staff when pain medication was given was, the patient's pain should be assessed and within an hour of the pain medication administration, the patient's pain should be reassessed. The CNO stated the importance of reassessing a patient's pain was to ensure the patient's pain was under control and monitoring the patient's response to pain medications such as low blood pressure or lower respiratory rate.

During a review of a professional resource from Johns Hopkins Medicine, an article titled, "Pain Management," dated November 2017, the article indicated, "Pain assessment is done upon admission, at least every shift and as needed. If pain medication is administered, the patient is reassessed within 60 minutes ..."

During a review of the hospital's P&P titled, "PC.AD.1.24 Pain Management Policy," dated 4/27/22, the P&P indicated, " ...Critical Note: Recommend the use of pain assessment/reassessment and sedation scales in the electronic health record (EHR) ...PURPOSE: To assure that patients receive assessment and management of their pain consistent with the scope of care, treatment, and service provided by the organization in its various care settings ...Nursing will follow hospital approved procedure and skill resource manual for the care of the patient ...experiencing pain ...Patients have the right to pain management ...Conduct an appropriate assessment and/or reassessment of a patient's pain consistent with the scope of care, treatment, and service provided in the specific care setting in which the patient is being managed ...The 0-10 Numeric Rating scale shall be used to score pain as appropriate using the "Mild, Moderate, and Severe" pain indications ...Assess the patient's response to care, treatment, and service implemented to address pain ...The Richmond Agitation and Sedation Scare (RASS) is a validated and reliable method to assess patients' level of sedation ...When assessment and documentation of pain is completed, a RASS should be completed and documented ...Treat the patient's pain ...A focused reassessment for the presence and intensity of pain shall be performed as a component of the shift assessment for inpatients and following any interventions intended to lessen the patient's pain ...Such reassessment is dynamic and ongoing process which shall take place within a clinically appropriate time frame, depending on the type of intervention, the route of medication administration, the clinical condition and age of the patient ..."

3.During a review of Pt 61's Admission Record (AR) dated 4/23/24 at 5:51 a.m., the AR indicated Pt 11 was a 59-year-old female admitted on 4/22/24 at 7:41 p.m. with a chief complaint of Necrotizing Fasciitis (A serious bacterial infection that destroys tissue under the skin. The condition spreads quickly. Symptoms include blisters, fever, fatigue, and pain worse than a person would expect based on the wound's appearance.)

During a concurrent observation and interview on 5/13/24, at 2:38 p.m., with Pt 61 and RN 11, while in Pt 61's room RN 11 was seen changing Pt 61's dressing to her right inner thigh. Pt 61 stated her pain level was a 10/10 and the last time she received pain medication was approximately three hours ago. RN 11 stated she believed Pt 61 had break through pain medication and would offer it to her after she was finished changing Pt 61's dressing. RN 11 was seen removing the dressing from Pt 61's right inner thigh and at 2:39 p.m. removed her dirty gloves and place clean blue gloves on without performing hand hygiene in-between. RN 11 was then observed cleaning Pt 61's open wound and stated Pt 61's order was to clean with normal saline (sterile solution), place 4x4's (sterile gauze pad), abd pad (Abdominal gauze pads, known as ABD pads, are non-woven, thick, and absorbent) and tape daily. At that time the Director of Medical Surgical area (DMS) entered the room and observed RN 11 clean Pt 61's wound and RN 11 removed her dirty gloves and placed clean gloves on without hand hygiene. DMS stated she did see this since RN 11 had to reach over the DMS at Pt 61's sink to grab the clean gloves from the box. After placing the clean gloves on RN 11 placed a clean dressing on Pt 61's thigh. DMS stated the expectation is that hand hygiene be done when dirty gloves are removed and clean ones being placed on, this is an infection control risk to the patient and staff when hand hygiene is not done appropriately it can spread germs. DMS stated Pt 61's pain should have been addressed prior to starting Pt 61's dressing change.

During a review of the hospital's P&P titled, "PC.AD.1.24 Pain Management Policy," dated 4/27/22, the P&P indicated, " ...Critical Note: Recommend the use of pain assessment/reassessment and sedation scales in the electronic health record (EHR) ...PURPOSE: To assure that patients receive assessment and management of their pain consistent with the scope of care, treatment, and service provided by the organization in its various care settings ...Nursing will follow hospital approved procedure and skill resource manual for the care of the patient ...experiencing pain ...Patients have the right to pain management ...Conduct an appropriate assessment and/or reassessment of a patient's pain consistent with the scope of care, treatment, and service provided in the specific care setting in which the patient is being managed ...The 0-10 Numeric Rating scale shall be used to score pain as appropriate using the "Mild, Moderate, and Severe" pain indications ...Assess the patient's response to care, treatment, and service implemented to address pain ..."

During a review of the facility's policy titled, "Hand Hygiene Policy," approved on 10/26/22, indicated, " ... II. PURPOSE: The purpose of this policy is to outline hand hygiene requirements to reduce the risk of infection transmission from patient to patient. Patient to health care provider and health care provider to patient. III. DEFINITIONS A. Hand hygiene means hand washing, antiseptic hand wash, antiseptic hand rub or surgical antisepsis.... IV. POLICY: The hospital has adopted the Centers for Disease Control and Prevention (CDC) Guidelines for hand hygiene in healthcare settings with enhanced comments from the World Health Organization (WHO) 1. Hand hygiene and healthcare.... Indications for hand washing and hand antisepsis include At the beginning of the workday. Before entering and when exiting a patient's room or cubicle.... Between patients and a multi bedroom. Before and after direct contact with patient blood, body fluids or equipment, and environmental items touched by patients. Before handling medication or food. Before and after eating and drinking and smoking. After coughing and sneezing and using the restroom. Prior to donning gloves and after removing gloves... G. Decontaminate hands after contact with body fluid or excretions, mucous membranes, non-intact skin and wound dressings if hands are not visibly soiled. H. Decontaminate hands if moving from a contaminated body site to a clean body site during patient care... K. Decontaminate hands after moving gloves. NOTE: gloves are not a substitute for hand hygiene..."

4a. During a concurrent interview and record review on 5/15/24 at 9:31 a.m. with RNQ 4, Pt 11's "EHR," dated 5/14/24 and Pt 11's "FS, " dated 5/14/24 were reviewed. The EHR indicated Pt 11 was admitted on 5/14/24 at 5:19 a.m. for induction of labor at 34.4 weeks. RNQ 4 stated the FS indicated Pt 11's preferred language was Spanish.

During a concurrent interview and record review on 5/22/24 at 12:00 p.m. with RNQ 4, Pt 11's "OB Anesthesia Flow Sheet (FLS)," dated 5/15/24 was reviewed. RNQ 4 stated the FLS indicated an epidural (a numbing medicine given by inserting a needle and a small, flexible tube into the lower part of a woman's back) was placed at 12:38 p.m.

During a concurrent interview and record review on 5/22/24 at 3:45 p.m. with RNQ 4, Pt 11's "Discharge Instructions and Signature Page (DI)," dated 5/18/24 and Pt 11's "Nurses Note (Note)," dated 5/18/24 were reviewed. RNQ 4 stated the DI indicated the instructions were in Spanish but there was no indication an interpreter was used to provide Pt 11 her discharge instructions. RNQ 4 stated the Note indicated, "Discussed discharge instructions with patient and patient verbalized understanding."

During a concurrent interview and record review on 5/22/23 at 4:00 p.m. with RNQ 4, Pt 11's "Consent for Anesthesia (Consent)," dated 5/15/24 and Pt 11's "EHR," undated were reviewed. RNQ 4 stated the EHR indicated there was no documentation an interpreter was used during Pt 11's hospitalization. RNQ 4 stated the anesthesiologist should have provided the informed consent and used an interpreter to consent for the anesthesia services to ensure the patient understood the procedure. RNQ 4 stated the Consent indicated an interpreter was not used to interpret the consent for the anesthesia, evidenced by the blank space where the interpreter utilized to interpret should have been documented. RNQ 4 stated the importance of utilizing an interpreter and/or interpreter services for consent forms was to explain the risks and benefits of the procedure and answer any questions the patient may have appropriately.

During a review of Pt 11's "Interdisciplinary Patient Education SMART Template (Template)," dated 5/15/24 to 5/18/24, the Template indicated, from 5/15/24 to 5/18/24, seven nurses documented, the "Barriers to Learning:-Language Barrier, Comments: Spanish speaking-RN speaks Spanish." The Template indicated six bilingual staff who were not certified interpreters used their interpreting skills to communicate with Pt 11 during her hospital stay and did not document the interaction. The Template indicated one staff who was not bilingual, documented, the "Barriers to Learning:-Language Barrier, Comments: Spanish speaking-RN speaks Spanish."

During a review of the hospital's P&P titled, "Interpretation Translation Services for Patients," dated 3/27/19, the P&P indicated, ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ... Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ..."

4b. During a concurrent interview and record review on 5/15/24 at 10:00 a.m. with RNQ 4, Pt 12's "FS," dated 5/14/24 and Pt 12's "H&P," dated 5/3/24 was reviewed. The FS indicated Pt 12 was admitted on 5/14/24 at 7:54 a.m. and her preferred language was Spanish. The H&P indicated Pt 12 was admitted for repeat cesarean section (the surgical delivery of a baby through a surgical incision made in the mother's abdomen).

During a concurrent interview and record review on 5/20/24 at 12:30 p.m. with RNQ 4 and RNQ 5, Pt 12's "EHR," dated 5/14/24 to 5/16/24 was reviewed. RNQ 5 stated when an interpreter was used, the nurses could document this in the rounding comments and frequent assessments. The EHR indicated there was no documentation of interpreter use in the round comments or frequent assessments. RNQ 4 stated the EHR indicated there was no interpreter documentation besides the time when Pt 12 was consented for surgery, anesthesia, and blood products on 5/14/24.

During a concurrent interview and record review on 5/20/24 at 1 p.m. with RNQ 4 and RNQ 5, Pt 12's "DI," dated 5/16/24 was reviewed. RNQ 4 stated the DI indicated the instructions were in Spanish but there was no indication an interpreter was utilized to provide Pt 12 her discharge instructions.

During an interview on 5/30/24 at 2:39 p.m. with the CNO, the CNO stated her expectations of hospital staff was to utilize an interpreter prior to medication administration, consents, teaching, assessments, discharges, and plan of care for patients who were non-English speaking. The CNO stated hospital staff should be utilizing interpreters and documenting their use of an interpreter in the EHR. The CNO stated the importance of following hospital policy regarding the use of an interpreter was to ensure patients were receiving the appropriate care, risks and benefits of procedures and medications were explained, and patients were receiving the appropriate education prior to discharge so they could take care of themselves at home.

During a review of the hospital's P&P titled, "Interpretation Translation Services for Patients," dated 3/27/19, the P&P indicated, "PURPOSE: To provide interpretation/translation services to patients who do not speak English as their primary language and who have a limited ability to read, speak, or understand English so that the patient can participate in their care and communicate with their care providers ...Competency-Demonstrated proficiency in English and the other language. The ability to use the appropriate mode of interpreting ...and knowledge in both languages of specialized terms or concepts such as medical terminology, names of body parts, symptoms and injuries ...Bilingual-The ability to communicate effectively in a different language when communicating information directly in that language but may not be competent to interpret in and out of English. Likewise, they may not do written translation ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ...[name of interpreting service] is the designated interpretation services at [Hospital A]. [name of interpreting service] has documented competent interpreters in multiple languages ...The [name of interpreting service] interpreter's identification number will be documented on the consent form ...The [name of interpreting service] will be used for all informed consents, unless the Physician is bilingual and able to interpret the planned procedure adequately so that the patient completely understands the risks and benefits of the procedure to be performed. The Physician will document that he/she interpreted informed consent to the patient in the Patient Care Record ...The [name of interpreting service] system may be used for any routine procedures that does not require official informed consent but may be considered as invasive by the patient. Procedures may include insertion of urinary catheters, insertion of peripheral IVs, insertion of nasogastric tubes, laboratory blood draws ...The [name of interpreting service] system may also be utilized by health care providers in the admission and discharge process ...Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ..."

5a. During a concurrent interview and record review on 5/23/24 at 3:00 p.m. with the Assistant Director of Nursing (ADON), Pt 6's "H&P-), dated 12/29/23 was reviewed. The H&P indicated, "66-year-old female with history of schizophrenia [a serious mental disorder that affects how a person thinks, feel, and behave], hypertension [high blood pressure-when the pressure your blood vessels is too high] not compliant with any medication is admitted here on a 5150 hold [allows for a person with a mental illness to be involuntarily detained in a psychiatric hospital for a 72 hour period] for [danger to self/danger to others]. Currently patient is compliant. Patient denies any fever chills nausea vomiting, cough, shortness of breath, or any sick contacts."

During a concurrent interview and record review on 5/23/24 at 3:25 p.m. with the ADON, Pt 6's "Physician Orders (PO)," dated 1/4/24 and 1/12/24 were reviewed. The ADON stated the PO indicated, on 1/4/24 at 2:22 p.m. haloperidol (medication used to treat nervous, emotional, and mental conditions) 5 milligrams (mg-unit of measure), Injection, Intramuscular, three times a day (TID) as needed (PRN) with comments from physician, "to be administered if patient refuses oral Depakote 500 mg." The ADON stated the PO indicated on 1/12/24 at 11:22 a.m. paliperidone (medication used to treat schizophrenia) 9 mg equals 1 tablet, extended release (slowly released into the body over a period of time) tablet, Oral, Daily, with physician comment, "please give first dose today." The ADON stated the consent forms for the two medications were physical documents and were not able to be viewed via Pt 6's electronic health record (EHR).

During a review of Pt 6's "Patient Consent to Receive Psychotropic Medications (Consents)," undated, the Consents for Pt 6 that were provided by the hospital did not have consent forms for haloperidol and paliperidone.

During a review of Pt 6's "Medication Administration Record (MAR)," dated 1/4/24 to 1/15/24, the MAR indicated on 1/4/24 at 9:44 p.m. Pt 6 was administered one dose of haloperidol. The MAR indicated from 1/12/24 to 1/15/24, Pt 6 was administered paliperidone daily.

During an interview on 5/30/24 at 2:30 p.m. with the CNO, the CNO stated her expectations for nursing staff was to ensure patients were consented appropriately for the psychotropic medications prescribed to them and the side effects monitored to ensure the safety of patients. The CNO stated her expectations of nursing staff was to follow hospital policies and procedures.

During a review of the hospital's P&P titled, "MOD DBHC.1.47 Monitoring of Psychiatric Medications," dated 8/23/23, the P&P indicated, " ...POLICY: It is the policy of [name of hospital] to maintain the right of the patients/conservator to be informed of the benefits and side effects each psychiatric medication intended to be prescribed for the treatment of their mental condition ...PURPOSE On admission, the attending psychiatrist will have a verbal discussion with their patient of the benefits and side effects of the proposed psychiatric medication/s and obtain a signed consent for each psychiatric medication on the medication consent form. The signed medications form will be filed in the patient's chart ...The licensed nurse will review the medical record or medication record prior to administration of any psychiatric medications. If the patient/guardian/conservator has not given consent, notify the physician to obtain informed consent for the patient ...Medications may not be given without consent except

Based on interview and record review, the hospital failed to ensure registered nurses (RNs) administered medications in accordance with physician orders for three of three patients, (Patient [Pt] 29, Pt 35, and Pt 36 when:

1. Pt 29 was administered Labetalol (medication to slow heart rate and decrease blood pressure) outside the physician medication order parameters. Pt 29 had the potential for drop in blood pressure and heart rate leading to significant harm and adverse outcome.

2. Administration of Dexmedetomidine (medication to keep you asleep) continuous infusion was titrated (slowly increasing the dose of a medicine to see how your body will react to it) by RNs for Pt 35 at 0.2 [micrograms (mcg-unit of measurement) per kilogram (kg-unit of measurement) per hour (hour- time)] higher than the physician medication order to titrate administration at 0.1 mcg/kg/hr. Pt 35 was administered higher dose for titration than the physician order and had the potential for adverse outcome including hypotension (low blood pressure).

3. Registered Nurses administered insulin continuous intravenous drip (the administration of a fluid into a blood vessel, usually over a prolonged period of time) for Pt 36 to treat hyperglycemia and the insulin dose rate was not started in accordance with the physician medication order of Insulin Algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level) despite being verified by two nurses. RNs did not follow the "Insulin Algorithm" and started insulin at a higher dose without first notifying the physician and obtaining a physician order.

These failures resulted in not providing the medication as written by physicians and placed patients at risk of harm, injury, and adverse outcomes.

Findings:

1. During a review of Pt 29's "Admission H&P EMR *Final Report*", dated 5/12/24, the "Admission H&P EMR *Final Report*" indicated, Pt 29 was a 74 year old male with history of Coronary artery disease (CAD - condition which limits blood flow in your coronary arteries, which deliver blood to your heart muscle), Coronary artery bypass grafting (CABG-heart bypass surgery, is a medical procedure to improve blood flow to the heart), hypertension (high blood pressure), hyperlipidemia (condition in which there are high levels of fat particles (lipids) in the blood). Pt 29 was transferred to the hospital from another hospital on 5/18/24.


During review of Pt 29's physician "Medication Orders" dated 4/29/24, the "Medication Order" for "labetalol (medication to slow heart rate and decrease blood pressure)" indicated, " ...Labetalol 5 mg/ml injection..[every ]2 (hr - hours) [as needed] Blood Pressure ...Order comments: First-line for [Systolic blood pressure - First number of the blood pressure, pressure caused by heart contracting and pushing ] greater than 160. Hold for heart rate less than 60".


During a concurrent interview and record review on 5/23/24 at 8:55 a.m. with the Quality Registered Nurse (RNQ) 5, Pt 29's physician "Medication Orders" dated 4/29/24, "medication administration record (MAR)" for labetalol on 5/4/24 at 4:27 a.m. and patient vitals four hours before and after the administration of labetalol were reviewed. The MAR indicated Pt 29 was administered labetalol by RN 26 on 5/4/24 at 4:27a.m. The review of Pt 29's vitals on 5/4/24 indicated SBP was between 120-140 four hours before the administration. The next documented vitals after the administration of labetalol was on 5/4/27 at 5:00 a.m. indicated SBP down to 107 from 120-140 before the administration of labetalol on 5/4/24 at 4:27 a.m. RNQ 5 stated physician medication order clearly states labetalol is to be administered for SBP greater than 160. RNQ 5 stated she was not able to find any documentation in Pt 29's medical record that indicated SBP greater than 160 during the time of the administration of labetalol on 5/4/24 at 4:27 a.m. RNQ 5 stated there were no notes by nurses or physicians in the patient medical record regarding the administration of labetalol. RNQ 5 stated she was not able to comment on the rationale for administration of labetalol.


During a concurrent interview and record review on 5/23/24 at 9:15 a.m. with the Director of Critical Care (DCC), the DCC stated he had reviewed the chart for Pt 29 and was not able to find any documentation that supports the administration of labetalol on 5/4/24 at 4:27 a.m. The DCC stated administration of labetalol was not done in accordance with physician medication order. The DCC stated he was unable to find SBP greater than 160 before the administration of labetalol on 5/4/24 at 4:27 a.m.


During a review of the facility' policy and procedure (P&P) titled, "PC.AD.1.08 Documentation Policy", with an approval date of 9/8/22, the P&P indicated, " ...Purpose ...To outline responsibilities related to documentation of patient care from admission through discharge ...Clinical Documentation is taken to mean a process of recording and communicating a written rationale of intervention, and as such becomes part of the patient medical record ....The patient medical record reflects the complete picture of the patient's health status, treatment and progress from admission to discharge from which other health professionals can take over responsibility for the patient concerned and for the retrieval of data for research and management. It should include a comprehensive assessment; identified problems; expected outcomes; the plan of care and care delivered (or not delivered); teaching given; advice sought in decision-making; the patient's response to treatment; discharge and plans for ongoing care ...Charting by exception is to be utilized as a method of charting designed to minimize clerical activities; a notation (annotation) is made only when there is a deviation from the baseline or expected outcome, or when a procedure or expected activity is to be omitted ...Clinical record is taken to mean a record reflecting the complete picture of the patient's health status, treatment and progress from admission to discharge ..."


During a review of the facility's policy and procedure (P&P) titled, "PC.AD.1.21 Medication Administration Policy", with an approval date of 2/23/23, the P&P indicated, " ...Basic Safe Medication Administration Practices ...Staff shall confirm the following prior to administering each medication ...Patient identification ...The patient's name and medical record number are used to identify the patient when administering medications ...Identifiers must be confirmed using the patient's wrist band, patient's identification card, patient's statement (when possible) or other means outlined in the hospital's policy ...The correct medication ...To ensure that the medication being given to the patient matches that ordered for the patient ...The correct dose ...To ensure that the dosage of the medication matches the ordered dose and does not reflect an unsafe dosage level ...Cardiac and blood pressure monitoring is required for any continuous intravenous or intravenous push medication that directly affects the cardiovascular system ..."


2. During a review of Pt 35's "Admission H&P EMR *Final Report*", dated 5/12/24, the "Admission H&P EMR *Final Report*" indicated, Pt 35 was a 72 year old female with history of hypertension (high blood pressure), diabetes (chronic disease that occurs either when the body does not produce enough insulin or when the body cannot effectively use the insulin it produces), hyperlipidemia (condition in which there are high levels of fat particles (lipids) in the blood) present to hospital from nursing home with altered mental status. Pt 35 was in hypoxic respiratory failure (happens when you don't have enough oxygen in your blood)) and hypercapnic respiratory failure ( presence of too much carbon dioxide in blood) requiring intubation (flexible plastic tube into the trachea to maintain an open airway).


During review of Pt 35's Physician "Medication Orders "dated 5/12/24, the "Medication order" for dexmedetomidine indicated, " ...dexmedetomidine (medication to keep you asleep) IV (intravenous - medical technique that administers fluids, medications and nutrients directly into a person's vein) additive 400 [Microgram]mcg +NS 0.9% (solution of salt and water mixed with medication to administer IV) Premix Diluent 100 [Milliliter (mL- unit of measurement)]..Indications: For sedation ...Start at 0.7mcg/kg/hr ...TITRATE by 0.1 mcg/kg/hr every 15 minute until goal ([Richmond Agitation-Sedation Scale - RASS is a medical scale used to measure the agitation or sedation level of a person ]-2) is achieved ..."


During a concurrent interview and record review on 5/28/24 at 4:35 p.m. with the Quality Registered Nurse (RNQ) 1, Pt 35's "Medication Administration Record (MAR)," dated 5/13/24 and Physician "Medication Orders" for dexmedetomidine dated 5/12/24 were reviewed. The MAR indicated on 5/13/24 at 11:00 a.m. medication administration dose was titrated from 0 mcg/kg/hr to 0.2 mcg/kg/hr. The MAR indicated dexmedetomidine medication administration does was titrated to 0 mcg from 1 mcg/kg/hr on 5/13/24 at 3:40 a.m. The RNQ 1 stated physician "Medication Order" states to start medication administration at 0.7 mcg/kg/hr and titration by 0.1 mcg/kg/hr. RNQ 1 stated titration dose of dexmedetomidine on 5/13/24 at 11:00 a.m. was done at higher rate than the 0.1 mcg/kg/hr. RNQ 1 stated she was unable to find any documentation in the medical record by nurses or physicians that supports this titration.


During a concurrent interview and record review on 5/28/24 at 4:45 p.m. with the DCC, the DCC stated he had reviewed the medical record for the Pt 35. The DCC stated the titration for dexmedetomidine on 5/13/24 at 11:00 a.m. was not done in accordance with physician medication orders and stated, "it does not make any sense". The DCC stated he was unable to find any documentation by a nurse or by physician that reflects the rationale for titration outside the physician order. The DCC stated it appears that medication was stopped and restarted outside the physician medication administration order.


During a review of the facility' policy and procedure (P&P) titled, "MOD CO.2.034 High Alert Medication Administration Double Checks and Other Safety Precautions", with an approved date of 1/26/22, the P&P indicated, " ...The purpose of this evidence based policy is to increase safety by avoiding preventable injuries associated with high alert medication and to provide standardized drug safety practices for "high alert" medications ... "High Alert Medications" mean medication that bear a heightened risk of causing significant patient harm when they are used in error... "Independent Double Check" means a procedure in which two practitioners separately check (alone and apart from each other, then compare results ) each component of prescribing, dispensing , and verifying the high-alert medication before administering it to the patient ...The following should be verified independently but are not limited to...For all medication, is the following correct when compared to the prescriber's order?...Patient ...Medication ...This includes viewing the vial or packaging and verifying the strength/concentration and formulation ...Dose - This includes a review of pertinent laboratory or other values, dose calculations. Also, if draw into syringe, the dose or amount drawn up ... Are there parameters (such as hold parameters) or special instructions?...This procedure will be followed when ...Initiating a drug from Independent Double Check High Alert Medication list...High Alert Medication ...Moderate Sedation Agents ...for continuous IV infusion (e.g. dexmedetomidine ...) ...Independent Double Check?...Yes ...Summary Of Requirements ...Two nurses shall perform an independent double check anytime nurse prepares a dose of a continuous IV infusion for moderate sedation ...Two nurses shall perform an independent double check with every new bag and at handoff ..."


3. During a review of Pt 36's "Final Report -Family Medicine Service Admission H&P", dated 5/11/24, the "Final Report -Family Medicine Service Admission H&P" indicated, Pt 36 was a 56 year old male with history of type 2 diabetes (when body does not produce enough insulin - a hormone that regulates the movement of sugar into the cells. And cells respond poorly to insulin and take in less sugar) and hypertension (high blood pressure) who was brought in by ambulance to the Emergency Department (ED) for shortness of breath on 5/11/24 and was found to have large pneumonic infiltrate (something denser than air like pus or blood seen on imaging studies of lungs, associated with conditions like infection of lungs) with sepsis (serious condition in which the body responds improperly to an infection and the infection-fighting processes turn on the body, causing the organs to work poorly).


During review of Pt 36's Physician "Medication Orders "dated 5/13/24, the "Medication order" for insulin indicated, " ...Insulin regular (medication used to control blood sugar) IV (intravenous - medical technique that administers fluids, medications and nutrients directly into a person's vein) additive 100 unit(s) (unit of measurement)+NS 0.9% (solution of salt and water mixed with medication to administer IV) Premix diluent 100 [milliliter (ml -unit of measurement)] 100 ml, IV, Titrate, Start date 5/13/24 ...order comment: Initiate Insulin Infusion with ALGORITHM 1 [Table with 4 levels, each level have blood glucose (BG) value ranges and required insulin dose adjustment for that BG value range next to it. Instructions with algorithm which dose level to start and how to move up or down dosage based on BG level] ..."


During a review of facility's " ...Insulin Algorithm", the "insulin algorithm indicated", " ...Goal blood glucose (BG) 140-180 [milligram (mg-unit of measurement) per deciliter (dL- unit of measurement of volume)] ..."


During a concurrent interview and record review on 5/28/24 at 4:00 p.m. with the Quality Registered Nurse (RNQ) 1, Pt 36's "Medication Administration Record (MAR)," dated 5/13/24, physician "Medication Order" for insulin dated 5/13/24 and lab results for blood glucose dated 5/13/24 were reviewed. The MAR indicated Insulin IV administration to Pt 36 was started on 5/13/24 at 6:56 a.m. at the dose rate of 6 units/hour (hr - Unit of measurement for time). The MAR indicated insulin dose rate was started at 6 units/hour by RN 13 and dose rate was witnessed/verified by RN 14. The lab results for blood glucose on 5/13/24 at 6:27 a.m. indicated blood glucose level of 357. The physician "Medication order" for insulin "ALOGORITHM 1" indicated for blood glucose of 357 insulin should be started at 4 units/hour. RNQ 1 stated insulin was started at the higher dose at 6 units/hour. RNQ 1 stated unable to find any documentation in the medical record why the administration dose for insulin was started at a higher dose of 6units/hour than the physician ordered "ALGORITHM 1" dose of 4 units/hour. The RNQ 1 stated she was unable to find any other physician order to start insulin higher than the Physician "Medication order" for insulin "ALOGORITHM 1".


During an interview on 5/28/24 at 4:30 p.m. with the Director of Critical Care (DCC), the DCC stated he had reviewed the medical record for Pt 36. The DCC stated insulin dose rate was started at incorrect dose and he was not able to find any documentation that reflect the need for higher starting dose at 6 units/hour than the Physician "Medication Order" for insulin "ALOGORITHM" 1 of 4 units/hour. The DCC stated insulin administration requires independent double check (where two individuals separately check (alone and apart from each other, then compare results) the medication before administration to a patient) and both nurses missed this and insulin was started at a higher dose. The DCC stated insulin it is important to ensure correct dosage to avoid fluctuations in blood sugar and any harm to patient by administering wrong dose.


During an interview on 5/30/24 at 2:45 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectations of staff when high alert medications were given was, the staff was performing independent double check "where two nurses separately check right medication, right dose, right patient and then compare with each other" the medication before administration to a patient. CNO stated it was her expectation that staff was following the hospital policy. The CNO stated it was important to ensure medications were administered in accordance with physician orders and safely.


During a review of the facility' policy and procedure (P&P) titled, "MOD CO.2.034 High Alert Medication Administration Double Checks and Other Safety Precautions", with an approved date of 1/26/22, the P&P indicated, " ...The purpose of this evidence based policy is to increase safety by avoiding preventable injuries associated with high alert medication and to provide standardized drug safety practices for "high alert" medications ... "High Alert Medications" mean medication that bear a heightened risk of causing significant patient harm when they are used in error... "Independent Double Check" means a procedure in which two practitioners separately check (alone and apart from each other, then compare results ) each component of prescribing, dispensing , and verifying the high-alert medication before administering it to the patient ...The following should be verified independently but are not limited to...For all medication, is the following correct when compared to the prescriber's order?..Patient..Medication..This includes viewing the vial or packaging and verifying the strength/concentration and formulation ...Dose - This includes a review of pertinent laboratory or other values, dose calculations. Also, if draw into syringe, the dose or amount drawn up ... Are there parameters (such as hold parameters) or special instructions?...This procedure will be followed when ...Initiating a drug from Independent Double Check High Alert Medication list ...High Alert Medication Insulin ...Independent Double Check?...Yes ...Summary Of Requirements ...Ensure the correct type and concentration of Insulin is dispensed and administered. Refer to additional policies regarding U-500 Insulin ...Two nurses shall perform an independent double check anytime insulin drip is initiated or adjusted ..."

Based on interview and record review, the hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with state and federal statutes granting prescriptive authority, Medical Staff Bylaws, and credentialing standards for non-physician providers when the hospital granted CRNAs (a non-physician provider) prescriptive authority without having the legal authority to do so; and the Pharmacy Department permitted CRNAs to write prescriptions and filled medication orders written by CRNAs even when the CRNA was not acting according to a treatment regimen ordered by a physician; and did not have a system to double-check and ensure CRNAs could legally write prescriptions. These failures were evidenced by:

1. CRNA 3 ordered medications for Patient 3 prior to operation, during operation and in the PACU (Post Anesthesia Care Unit; after surgery) and managed the adverse events from the procedure or the drugs without a treatment regimen ordered by a physician. Pharmacy processed and approved medication use, and orders sent to them electronically.

2. CRNA 1 ordered medications for Patient 4 using an unauthorized order form for PACU orders and did not follow GI specialists' (a doctor specialized in stomach and colon disease) sedation plan (how to put patient to sleep or provide pain relief during procedure) or orders for and medication use. Pharmacy approved CRNA 1's medication access and did not address discrepancy on medications removed from ADM (Automated Dispensing Machine, a computerize machine that stored and tracked medication removal with authorized access).

3. CRNA 4 ordered medications for Patient 2 prior to procedure, during the procedure and in the PACU and Pharmacy processed and approved medication use, and orders sent to them electronically.

4. CRNA 6 ordered medication for Patient 5 during the procedure and for the PACU unit. Pharmacy processed and approved electronic medication orders despite risk factors related to patient age and kidney function.

These failed practices did not comply with the requirement for safe pharmaceutical services, had the potential to cause harm, injury and death to patients; and could contribute to the risk of drug diversion (drug loss).

Findings:

1. During review of Patient 3's medical record, titled "Final Report", dated 10/13/23, at 12:48 PM, written by Medical Doctor 7 (MD 7) in ICU (Intensive Care Unit), the record indicated Patient 3 was admitted to hospital for elective knee surgery, but the surgery was not performed due to "anaphylactic shock ( a type of allergic reaction), cardiac arrest (heart stopped beating), and acute respiratory failure with hypoxia (unable to breath with drop in blood oxygen)" right after anesthesia induction (start of anesthesia which uses drugs called anesthetics to keep patient comfortable and prevent from feeling pain during medical procedures) in the Operating Room (OR).

During a review of the Patient 3's electronic order record, titled "Orders", dated 10/13/23, at 5:39 AM, the record listed medication orders prior to surgery ordered by Certified Registered Nurse Anesthetic 3 (CRNA 3) as follow: acetaminophen 1000 mg IV (same as Tylenol in IV form for pain; "mg" is milligram, a unit of measure), celecoxib 200 mg capsule (a pain medication that reduced inflammation), gabapentin 400 mg capsule( a pain medication help with nerve pain) and IV fluid called Lactated Ringers (an IV fluid used to replace water and electrolyte loss in patients). The orders were verified by a pharmacist on 10/13/23, at 5:44 AM. The document further indicated "Doctor Cosign: Not Required".

During a review of the Patient 3's electronic medication order records, dated 10/13/23, at 8:43 AM, the record indicated CRNA 3 entered and electronically signed an order for propofol IV (a sedative medication given intravenously or "IV" into the Vein) and verified by a pharmacist on 10/13/23 at 8:47 AM.

During Review of Resident 3's medical Record, titled "SOAP Note" (SOAP stands for Subjective, Objective, Assessment and Plan, a format to explain facts and events in the medical record), dated 10/15/23, at 9: 32 AM, written by Certified Registered Nurse Anesthetic 3 (CRNA 3), the note indicated Patient 3 experienced low Blood Pressure (or BP, means the force of blood pushing against the walls of arteries with each heart beats blood pumped into the arteries) and an apparent allergic reaction after anesthesia induction (means putting patient to sleep by use of drugs to prevent from feeling pain during the procedure or surgery while monitoring the breathing) in preparation for surgery. CRNA 3's note indicated prior to start of anesthesia, an antibiotic called "Ancef" (or cefazolin, used to prevent or treat infection), and a steroid called "Decadron" (medication used to reduce inflammation) was administered concurrently. The CRNA note described the medications used and events during emergency resuscitation (medical efforts to start the heartbeat and breathing) of Patient 3. The CRNA's note further indicated when Resident 3 was transferred to PACU (Post-Anesthesia Care Unit; a hospital that stabilized the patient right after the surgery) "The patient still had significant tongue swelling ... In response, I gave 1 gram of Tranexamic Acid (also known as TXA, a drug used to treat bleeding or control bleeding) and ordered FFP (Fresh Frozen Plasma; a blood product given for bleeding or at risk of bleeding) as well as relevant lab test and imaging." The note did not describe the clinical reason for use of TXA and FFP in the setting of apparent allergic reaction and was not approved by a medical doctor or surgeon.

Further review of Patient 3's medication uses and removal report from the ADM (Automated Dispensing Machine- an electronic drug storage unit), dated 10/13/23, the record indicated CRNA 3 removed tranexamic acid 1000 mg ("mg" or milligram, a unit of measure) from the ADM in the Operating Room (OR, surgery room), on 10/13/23, at 9:10 AM for administration in the PACU. The record did not show if an order for TXA was written and approved by a medical doctor or verified by pharmacy.

During a review of the Patient 3's electronic medication order records, dated 10/13/23, at 9:35 AM, the record indicated CRNA 3 gave a verbal order to a Registered Nurse for an IV (Intravenous, Into the Vein) medication called norepinephrine (drug used to increase and maintain blood pressure) for low blood pressure in the PACU unit. The record indicated "Responsible Party" was CRNA 3. The order was electronically verified and approved for use by pharmacist on 10/13/23, at 9:37 AM.

During a review of Patient 3's medication use and removal record from the ADM (Automated Dispensing Machine- an electronic drug storage unit), dated 10/13/23, the record indicated CRNA 3 removed controlled (opioid narcotic drugs with restrictive use and prescribing authority) medications including fentanyl IV (a strong opioid medication), midazolam IV (a sedative medication), and propofol IV (sedative medication) on 10/13/23, at 7:00 AM, in addition to non-controlled medications for use in the Operating Room (OR).

Review of Patient 3's paper record, titled "Anesthesia Record" (record of medications given and monitoring performed during the surgery when the patient was put to sleep), dated 10/13/23, written by CRNA 3, the record indicated a wide range of medications administered during the time period of 7:06 AM to 8:45 AM on 10/13/23. The following medications marked as given:

i. Sevoflurane Anesthesia gas (an inhalation gas used to put patient to sleep during surgery),
ii. Fentanyl 100 mcg ("mcg", microgram, a unit of measure; opioid pain medication),
iii. Versed (midazolam) 2 mg ("mg" or milligram, a unit of measure; a sedative and anti-anxiety medication),
iv. Propofol a total of 200 mg,
v. Anectine (succinylcholine; a muscle paralyzing agent) 100 mg,
vi. Albumin 25%- 25 mL (a human blood component; "%" or percent was a measure of concentration and "mL" is milliliter, a measure of volume)
vii. Ancef (or cefazolin, an antibiotic) 2 gm,
viii. Norepinephrine (or Levophed, used to raise the blood pressure) no dosage indicated,
ix. Epinephrine (used to treat low blood pressure and allergic reaction) entered as "100" for the dosage,
x. Hydrocortisone (a steroid, anti-inflammation drug) 100 mg,
xi. Epinephrine IV drip; No marked dosage or concentration,
xii. IV fluid, Lactated Ringers 3 liter ("liter" is measure of volume),
xiii. Benadryl (or Diphenhydramine, used for allergy) 100mg,
xiv. Famotidine 20mg (ulcer medication, also used for allergy),
xv. Tranexamic acid (or TXA- used to stop or prevent bleeding) 1 gm,
The medications used in the OR and subsequent emergency code were overlapped and it was unclear or out of sequence. CRNA 3 was not available to comment on the sequence of events. The record did not indicate any physician involvement.

During a joint interview with ADOP, RPH 1 and RPH 3, on 5/30/24, between 11:03 AM to 12:07 PM, the RPH 3 stated the intra-op (inside surgery room) records of medication use was not online (available in computer) and was only available after it was scanned in the medical records. When asked if pharmacy would have questioned use of TXA in setting on an allergic reaction without bleeding incident, RPH 3 stated she will "definitely questioned" the use due to risk and complications when TXA was not used based on standards of practice and approved indication. When asked if pharmacy would question use of epinephrine in the setting of having heartbeat and reasonable blood pressure, RPH 3 stated "no, not indicated" to give epinephrine, and the record of use needed to be reviewed. When asked how the reports of the drug allergy or reaction was processed by pharmacy, RPH 3 stated the allergy reported via electronic reporting system or pharmacy find it when reversal drugs used to counter allergy. RPH 3 stated the hospital was not able to review or find every single drug related allergy happening in the hospital. RPH 3 stated the providers could enter the drug reaction in the computer system.

Review of the hospital's record on Patient 3's "Adverse Drug Reaction (ADR) Report", dated 10/13/23, reviewed by a pharmacist, the record indicated the "action" taken with drug reaction was "Patient was given CPR, epinephrine, dexamethasone, tranexamic acid (TXA), and three liters of normal saline (salt solution in IV form)." The record further indicated "Ordering Doctor: Unknown." The record indicated Ancef was the probable cause of the drug reaction. The record did not address if a medical doctor reviewed the ADR event and the conclusion.

2. During a review of Patient 4's "History and Physical (H&P)", dated 5/15/24, the "H&P" indicated Patient 4 was a 71 year with a past medical history of hiatal hernia (when part of the stomach stick out up into the chest through the sheet of muscle called the diaphragm), hypertension (high blood pressure inside vessels in the body), sleep apnea (serious sleep disorder that happens when breathing stops and starts while you are asleep). Patient 4 presented to the hospital on 5/15/24 for planned Esophagogastroduodenoscopy (EGD - The test involves an endoscope, a lighted camera on the end of a tube, which is passed down throat to visualize esophagus, stomach and tube connecting stomach to the middle part of the small intestine)/Colonoscopy (procedure done using long flexible tube with camera to check inside the entire large intestine) procedure.

During review of Patient 4's medical record, titled "Anesthesia Record", dated 5/15/24, handwritten by CRNA 1, the record indicated CRNA 1 used propofol 200 mg (one vial, "mg" or milligram, a unit of measure) and Versed 2 mg (midazolam, a sedative controlled drug) in addition to ondansetron 4 mg (or Zofran, anti-nausea drug), metoclopramide 10mg (or Reglan, drug to treat nausea), and Robinul (or glycopyrrolate, used to reduce salivary secretions during surgery) medications during a 37 minutes endoscopy procedure (a procedure to look inside the stomach and colon via a tube with camera on it).

In an interview with CRNA 1, on 5/20/24, at 4:30 PM, the CRNA 1 stated he hand pushed (via a syringe) 200 mg dose of propofol in the span of 15-20 minutes. The CRNA 1 stated the dosage was a standard dose and he decided to use propofol and versed combination for sedation as opposed to Gastroenterologist (or GI) specialist (doctor specialized in stomach disease) order for Versed and fentanyl (an opioid pain medication) for sedation during the procedure. CRNA 1 stated he was aware of sedative medication risks with Sleep Apnea diagnosis (serious sleep disorder in which breathing repeatedly stops and starts) which he did not address during pre-procedure notes for Patient 4. CRNA 1 stated he could have done a better job in documenting pre-procedure assessments and review of Patient 4. CRNA 1 acknowledged he did not follow the surgeon's sedation plan and medication use for the procedure. CRNA 1 stated all CRNAs work independently and an anesthesia in charge was available if they had any questions or help with emergency code blues (code blue when patient stop breathing and heart stopped). CRNA 1 stated he was authorized to order any labs, administer, and prescribe narcotics, without physician co-signature in preoperative (before surgery), intra-operative (during surgery) and post anesthesia care unit (PACU - Specialized unit where patients are sent after surgery to recover from anesthesia and wake up).

Further review of Patient 4's medication uses and removal report from the ADM (Automated Dispensing Machine- an electronic drug storage unit with electronic tracking of drug use), dated 5/15/24, the record indicated CRNA 1 removed two vials of propofol 200mg from ADM on 5/15/24, at 12:24 PM. The ADM record did not show any waste or return of the extra bottle of propofol in Patient 4's ADM report.

In a concurrent interview and record review, with Assistant Director of Pharmacy (ADOP), and review of CRNA 1's propofol removal from ADM for Patient 4, on 5/30/24, at 11:00 AM, the ADOP stated the discrepancy in propofol use and removal from the ADM often required deeper dive into the overall use of medication during the whole shift. ADOP stated not all medication and narcotics used by CRNA's were audited for accountability. ADOP stated the weekly spot check of anesthesia record was focused on propofol and controlled medications. The ADOP could not provide a document that CRNA 1 returned the extra unused propofol vial to the ADM under Patient 4 records.

During a concurrent interview with Registered Nurse 6 (RN 6) and review of Patient 4's medical record, titled "Physician Orders: Routine Post-Anesthesia Orders for PACU/POCU" [PACU or Post Anesthesia Care Unit; POCU or Post Operation Care Unit), dated 5/15/24, at 1:35 PM, signed by CRNA 1, the paper-based record stamped with word "Faxed" (faxed to pharmacy), indicated orders for ondansetron (Zofran, anti-nausea drug), IV fluid Lactated Ringers, and three hand-written orders as follow:

i. Labetalol 5 mg ("mg" is milligram, a unit of measure; med used to lower blood pressure) for SBP (or Systolic Blood Pressure; the pressure blood pushing against artery walls when the heart beats; normal level is between 120-129) more than 180; every 10 minutes up to 20 mg total dose.
ii. Hydralazine (drug to treat high blood pressure) 5mg if Heart Rate (or heartbeat; normal level is between 60-100 beats per minute) less than 60; as needed; SBP more than 180; every 10 minutes up to 20 mg total dose.
iii. Fentanyl 25 mcg ("mcg" is microgram, a unit of measure) IV for mild to moderate pain; every 10 minutes up to 100 mcg total dose.
The order sheet was noted by a nurse and did not have clear direction on how to use the blood pressure medications sequentially. The orders were not documented in the Electronic Medical Record for verification and approval by a pharmacist. RN 6 stated no physician signature needed when CRNA's signed the order. RN 6 stated if pharmacy did not verify the orders in timely manner, the nurses could get the drugs from the ADM by override function under the patient's name.

In an interview with CRNA 1, on 5/20/24, at 3:25 PM, the CRNA 1 confirmed he signed the PACU order sheet for Patient 4 and stated the order sheet was a pre-printed form used by all CRNA's for transfer to post operative recovery area or PACU. The CRNA acknowledged that the pre-copied handwritten orders may not be appropriate for every patient. The CRNA stated Patient 4's order for fentanyl probably was not needed as the endoscopy procedure (look inside stomach and colon) was not a painful procedure. The CRNA stated the order sheet filled out by nurses by putting the CRNA's name responsible for the case and then signed by CRNA.

In an interview with CRNA 1, on 5/20/24, at 3:57 PM, the CRNA 1 stated he practiced independently and had authority to prescribe, put orders in the computer, and order any medication needed to care for the surgical patients in their care.

In an interview with Director of Pharmacy (DOP), in the Pharmacy, on 5/20/24, at 11:33 AM, the DOP stated the hospital had instituted restricted system on use on propofol and the drug was kept in the ADM with authorized access. The DOP stated most Operating Rooms (OR) had ADM stocked with medications and narcotics needed during the surgery. The DOP stated anesthesia providers, including CRNA's, were given ADM access to remove the medications during the surgery. The DOP stated the pharmacy did not have much control and did not review all medications used or prescribed during surgery in the OR.

In an interview with Director of Pharmacy (DOP), in the Pharmacy, on 5/20/24, at 11:38 AM, the DOP stated the pharmacy performed random audits of anesthesia records for controlled drug medication used during the surgery. The DOP stated a report with outliers and unresolved cases go to a hospital committee called "Drug Diversion Prevention Committee" and the committee made the final decision on how to address the drug loss, discrepancy, and provider access.

In an interview with Pharmacy Technician (PharmTech) responsible for controlled drug audits, on 5/29/24, at 2:19 PM, PharmTech stated on weekly basis he reviewed handful of random anesthesia records with focus on narcotics and propofol use. PharmTech stated he matched the ADM removal with paper form of the anesthesia records. If no match discovered, he requested clarification from the provider and documented his finding in a tracking sheet for pharmacy management for follow up. PharmTech stated he had noticed more propofol discrepancy in the surgery areas.

Review of facility's meeting minutes from "Drug Diversion Prevention Committee", dated 3/26/24, the record indicated the facility reported "excessive dispensing of propofol" and "#25 vials of propofol 200 mg were unaccounted for" on CRNA 17 and "21 vials of propofol 200mg were unaccounted for" on CRNA 2. The record contributed the unaccounted loss of propofol to workflow practices rather than diversion. The record indicated the CRNA's were required to complete ADM re-training.

In an interview with Registered Nurse 7 (RN 7), in the endoscopy PACU, on 5/20/24, at 5:05 PM, RN 7 stated after procedure a paper copy of orders signed by CRNA were faxed to pharmacy for input. RN 7 stated the nursing staff had access to most medications via override (override means the nurse could remove from the drug from ADM without order reviewed or verified by pharmacy) for urgent needs of the patients for pain, nausea, blood pressure control medications.

During a review of facility's undated document, titled "Override Meds List" (approved medication list that could be removed from ADM without pharmacist verification process), for PACU unit, provided by the facility on 5/22/24, the record included list of medications including labetalol, hydralazine, fentanyl, propofol, and midazolam as they were used during procedure and those listed in the PACU order sheet by CRNA 1.

During a concurrent interview and record review of the hospital's medication override and control policy, with ADOP and RPH 1, on 5/30/24, at 10:30 AM, RPH 1 stated as the nursing staff or providers removed medication via override, the ADM system tracked the use and matched it with existing orders in the Electronic Medical Record. RPH 1 stated the unresolved medication use without a doctor order was logged in the hospital's error reporting system or if the pharmacy saw a concern or trend in override. ADOP stated the non-controlled medications (regular non-narcotic prescription drugs) override without an order was not tracked unless it was a high-cost drug. The ADOP stated the ADM machines were inspected by pharmacy on quarterly basis for accuracy of contents and expiration date of drugs (when drug no longer good to be used). RPH 1 stated the hospital had approved areas that were not required to have drug orders approved by pharmacy prior to removal from ADM, the approved areas were designated by hospital policy when the provider or doctor had control of ordering and administration inclding Operating Room (OR).

Review of hospital policy, titled "Dispensing Medication from [ADM]", last revised on 2/18/18, the policy on section related to "override" indicated "Override Medications - Override function built into Omnicell machines that allow a nurse to remove a medication from the Automatic Dispensing Cabinet (ADCs) even if the order has not yet been added to the patient's profile by Pharmacy. Medications available via the critical override function in the ADCs shall be limited to urgent and emergent drugs which may result in patient harm or suffering due to a delay in administration. These override lists shall be reviewed, revised, and approved at least every 3 years by the Infection, Pharmacy and Therapeutics Committee (I, P&T- a committee that oversea pharmacy and drug use): 1. Physician orders for medication administration must be reviewed by a pharmacist prior to administration of the medication. 2. Exceptions to the requirement for pharmacist review of physician orders for medication administration include: When the physician controls the ordering, preparation, and administration of the medication; examples are the operating room, endoscopy suite (where colonoscopy performed), Cath lab (a cardiac room for heart procedures), emergency room, or during a bedside procedure." The policy did not include the PACU as an area with override of medication without pharmacy order verification.

3. During a review of the Patient 2's medical record, titled "Consultation Progress Note", written by MD 5, dated 10/26/23, at 10:56 PM, the record indicated Patient 2 had a history of dementia (problem with memory and forgetfulness; impaired ability to think or make decisions), diabetes (blood sugar disease), heart disease with CAD (Coronary Artery Disease caused by the clogged arteries), lung disease (breathing difficulties), chronic pain and was approved to go to surgery for hip fracture on 10/26/23 after a fall at home.

During review of Patient 2's medical record, titled "Orders", dated 10/26/23, with the time frame of 5:03 PM to 6:14 PM, the records indicated CRNA 4, ordered the nurses to administer "High Risk Medications" (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing including opioid (drugs as narcotic that could affect mental and breathing issues) pain medications called fentanyl (strong opioid drug which could affect and suppress breathing) and Dilaudid (or hydromorphone, a strong opioids/narcotics that can decrease or stop breathing). The CRNA 4 additionally orders medications to prevent nausea including Reglan 10mg (or metoclopramide, anti-nausea drug with high risk on use in elderly with higher doses due to side effects). There was no documented evidence CRNA 4 discussed the medications orders for Patient 2 with an anesthesiologist, considered Patient 2's past medical history or post-operative emergent medical condition. The record under "Orders" indicated CRNA 4 was described in Electronic Medical Record (EMR) as the "Ordering Physician", "Responsible Provider", "Supervising Provider: none listed", and a "Doctor Cosign: Not required". CRNA 4 was authorized by the hospital to place orders for medication, treatments, and studies without restrictions for patients care and nurses to administer.

Review of Patient 2's medical record, titled "Orders", for PACU unit, dated 10/26/24, the record indicated orders were written by CRNA 4, and verified by a pharmacist through Electronic Medical Records as follow:
i. Acetaminophen 1000 mg (Ofirmev a pain medication in IV form),
ii. Zofran 4mg IV (Ondansetron - anti-nausea medication) first choice,
iii. Metoclopramide 10mg IV (anti-nausea medication) second choice,
iv. Fentanyl 25-50 mg (opioid pain medication) for mild to moderate pain,
v. Hydromorphone 0.5 mg (Dilaudid, Strong Opioid pain medication) for severe pain,
vi. Lactated Ringers IV solution ongoing infusion.
There was no documentation if Pharmacist questioned the use of Reglan in a 77-year-old patient.

During a record review of the Patient 2's medical record, titled "Preoperative Anesthesiologist Evaluation" (evaluation before surgery by physician that provides anesthesia), dated 10/26/23, at 4:25 p.m., handwritten by CRNA 4, the record indicated CRNA provided a pre-operative evaluation without a physician. The anesthesia evaluation plan by CRNA 4 did not address assessment of Patient 2's history of heart attack and use of blood thinner called Plavix (clopidogrel, by thinning blood could cause internal bleeding) before a major surgery. There was no documented evidence CRNA 4 discussed the patient status or plan of care with an anesthesiologist. There was no documented evidence if CRNA 4 contacted pharmacy for risks involved with use of Plavix prior to surgery.


4. During review of Patient 5's medical record, titled "History and Physical/Admission Notes", dated 11/15/23, written by Medical Doctor 10 (MD 10), the record indicated Patient 5 was a 91 year old with diagnosis of end-stage renal disease on dialysis (kidney was not working well and blood had to be filtered by a machine and process called dialysis) was admitted to hospital to be evaluated for rectal (or rectum) bleeding and anemia (low blood counts). The record further indicated the heart doctor recommended "conservative treatment" due to age and other medical conditions.

During a review of Patient 5's medical record, titled "Orders", dated 11/19/23, written by CRNA 6, the record indicated CRNA 6 was the "Ordering Physician", "Responsible Provider", "Supervising Provider: none listed", and did not require a "Doctor Cosign: Not required" was authorized by the hospital to place orders for medication, treatments, and tests without restrictions. The record indicated CRNA 6 ordered the nurses in PACU to administer "High Risk Medications" (drugs with highest risk of causing significant patient harm or death) that could have contributed to patient compromise: Demerol (opioid pain medication, not recommended for elderly and kidney disease), morphine (opioid pain drug with risk of accumulation in kidney disease) , Dilaudid (strong opioids/narcotics that can decrease or stop breathing), Versed for agitation (strong sedative, with risk of breathing problem ) and Phenergan ( treatment for nausea and vomiting with risk associated with injection and breathing issues when used with opioids). There was no documentation CRNA 6 considered Patient 5's past medical history of renal disease, low blood pressure, age, active bleeding, or potential post-operative medical condition when placing the orders. There was no documented evidence CRNA 6 discussed the medications orders for Patient 5 with an anesthesiologist before ordering them.

Review of Patient 5's medical record, titled "Orders", for PACU unit, dated 11/19/23, the record indicated orders were written by CRNA 6, and verified by a pharmacist through Electronic Medical Records as follow:
1. Meperidine 12.5 mg IV (Demerol, an Opioid pain medication, not recommended for elderly and kidney disease),
2. Midazolam 2mg IV (versed, a strong sedative with risk of breathing issues) for agitation,
3. Hydromorphone 0.5 mg IV (Dilaudid, a strong opioid pain medication) with no pain level assessment for administration,
4. Morphine 2 mg IV (opioid pain medication with risk of accumulation in older people with kidney disease),
5. Promethazine 12.5 mg IM (or Phenergan, injected into muscle, with high risk of injection site damage and breathing issues when used with opioids),
6. Ondansetron 4mg IV (Zofran, an anti-nausea drug),
7. Normal Saline IV (salt solution for infusion),
The record did not indicate if there was a pharmacy intervention to question use and dosages of high-risk drugs in the 91-year-old sick elderly.

In a concurrent interview and record review, with RPH 1 , on 5/20/24, at 5:15 PM, in pharmacy office, RPH 1 stated the pharmacy staff verified orders electronically and/or based on paper-based orders for appropriateness, dose range and drug-drug interactions. RPH 1 was able to process and verify PACU order set, including fentanyl, written by a CRNA 21, in the computer system with no alert by the computer system if they were authorized to prescribe medications including narcotic controlled medications. RPH 1 stated Pharmacist can verify and authorize medication orders from any provider privileged by hospital's medical staff. RPH 1 was not familiar how medical staff granted privilege to prescribe prescription medications including controlled narcotic drugs.

In a joint interview with DOP and RPH 1, in the pharmacy office hallway, on 5/20/24, at 6:02 PM, the DOP stated the pharmacy relied of hospital's credential and privilege system to check provider's qualification and up to date licenses to practice and prescribe drugs. The DOP stated, the pharmacy assumed the provider's DEA and California license to prescribe were routinely checked for updated status. RPH 1 stated the scope of practice by mid-level providers (non-physician providers authorized to provide care and prescribe) were not limited to drug class and computer allowed the pharmacist to verify their orders.

In a telephone interview and concurrent record review, with DOP and RPH 1, on 5/22/24, at 12:30 PM, the DOP stated all order sets were reviewed and approved by hospital committees including Pharmacy and Therapeutic Committee (P&T committee; had oversight of safe medication use and policies). The DOP was not aware of altered PACU order sheet with handwritten orders used by CRNA's. The DOP stated the original order set was approved in 2014 by P&T as noted at the bottom of the order sheet. The DOP stated the pharmacy encouraged all providers to use the electronic medication ordering for a safer and efficient system to verify and timely processing.

In an interview with RPH-2 on 5/28/24, at 4:30 PM, in the pharmacy, RPH 2 stated her understanding was that the providers that prescribed medications had to practice within their scope and certification allowed by the law. RPH 2 stated she had verified orders written by CRNA. RPH 2 stated she had never spoken to a CRNA and assumed they had some type of agreement that allowed them to prescribe medication.

During a joint interview with ADOP, RPH 1 and RPH 3, on 5/30/24, between 11:03 AM to 12:07 PM, the RPH 3 stated the intra-op (inside surgery room records and drug records) records of medication use was not online (available in computer) and was only available after use and administration or when it was scanned in the medical records. When asked if pharmacy would question use of epinephrine in the setting of having heartbeat and reasonable blood pressure, RPH 3 stated "no, not indicated" to give epinephrine, and the code record needed to be reviewed. When asked if a respiratory rate (breathing pattern) was required to be monitored when a provider administered a combination of opiates, benzodiazepine (sedative drugs that could affect breathing) and high dose propofol in span of 15-20 minutes to an elderly patient with history of sleep apnea, RPH 3 responded "it must be monitored" and stated there was a need to look into these practices as a team of nursing, pharmacy and providers.

Review of the facility's policy, titled "Controlled Substance Diversion Prevention and Detection", last approved on 2/28/24, the policy on controlled substance access indicated "If users with Automated Dispensing Machine have changes in employment, contract stat

Based on interview and record review, the facility failed to ensure effective organization of the Food and Nutrition Services Department as evidenced by lack of operational oversight by a Registered Dietitian. This lack of oversight resulted in food safety hazards as evidenced by improper handling of foods associated with foodborne illness (an illness that comes from eating contaminated food) and an unsanitary kitchen environment as evidenced by greater than three areas in the pot and pan room covered with a black substance. This had the potential to place the 358 patients admitted to the hospital at an increased risk for foodborne illness. (Reference to A0620, A0750, A0701)

Findings:

During a review of the Academy of Nutrition and Dietetics, showed a Registered Dietitian/Nutritionist (RDN) is a health care professional educated in nutrition and foods who can translate scientific information into practical solutions. RDNs are food and nutrition experts with a minimum of a graduate degree from an accredited dietetics program and who completed a supervised practice requirement, passed a national exam, and continued professional development throughout their careers. (Academy of Nutrition and Dietetics).

During multiple observations in the kitchen from 5/13/24 to 5/14/24, concerns were identified in relationship to the provision of patient food services in accordance with standards of practice. The concerns included: food safety and sanitation practices in the kitchen such as but not limited to: a black substance on surfaces throughout the pot and pan room and walk-in refrigerator; staff not following cleaning procedures in the pot and pan room; improper cooling of leftover food, d. cooking equipment stored wet-nested; food trays and carts were not appropriately cleaned. (Reference to A0620, A0750); non-functional dish machine (Reference to A0701); lack of a Departmental QAPI (Quality Assurance Performances Improvement) program for food services. The Food and Nutrition Services Department conducted data gathering , with respect to patient meal satisfaction, which demonstrated a need for improvement. During a review of the Food and Nutrition Services QAPI report dated March 2024, showed patients had 23.67% meal satisfaction. There was no evidence the data was acted upon, or the information was integrated into the hospital wide QAPI program. There was no development of a clinical nutrition QAPI program. (Reference to A0273).
During an interview on 5/13/24 at 11:33 a.m., the Patient Services Supervisor (PSS), stated the position of Director of Food and Nutrition Services (DFNS) was vacant and the Regional Director of Operations (RDO) came in on Wednesdays.

During an interview on 5/13/24 at 12:06 p.m., in the kitchen, the RDO stated as of three weeks ago, the DFNS position became vacant. The RDO stated he was not a RDN, rather was a Certified Dietary Manager (CDM).

During an interview with the RDO on 5/14/24 at 12:22 p.m., in the kitchen, he stated the Clinical Nutrition Manager (CNM), a Registered Dietitian, has oversight in the kitchen.
During an interview with the CNM, on 5/14/24 at 12:47 p.m., she stated she is responsible for clinical nutrition and nutrition consults. CNM stated she looks over the therapeutic diets and looks over meal service. She informally ensures the menu is followed by observation of meal service and will modify menus if needed. Stated she has not observed whether staff follows recipes during food production but thinks they do. CNM stated she has not observed food production activities, looked at sanitation or done any type of sanitation audit in the kitchen. The CNM stated her food service evaluation is limited to communication with the Patient Services Manager about issues regarding meal service.

During an interview with the RDO on 5/14/24 at 4:12 p.m., the RDO stated the Executive Chef oversees the kitchen and the sanitation and food safety falls under this direction.
During a review of the hospital organizational chart, revised 4/24/24, showed the DFNS reported to the Associate Administrator (AA). Review of the departmental organizational structure titled, "FNS Management Organizational Chart", undated, showed the DNFS supervised the Executive Chef, Patient Services Manager, Retail/Café Manager, Clinical Nutrition Manager, Behavioral Health Chef/Manager. On the chart there is not direct line from the clinical nutrition manager to food and dietetic services operations.

During a review of the Clinical Nutrition Manager job description, authored by the food service contract company, dated Jan 2019, signed 2/28/23, showed the CNM reports to the DFNS. It showed the CNM is responsible to direct the functions of clinical nutrition services (such as nutrition assessment, nutrition counseling/consultation, performance improvement) and the management of the clinical nutrition team to ensure high quality nutrition care is provide to patients. The responsibilities and essential functions of the CNM did not direct any responsibility for oversight of food services. Additionally, the RDN is the profession with the most education and experience to provide guidance and oversight to the CDM and foodservice operations. The CDM does not have the education or professional skill set to supervise the RDN.

During a review of the Director of Food and Nutrition Services (DFNS) job description, authored by the food service contract company, undated, showed the DFNS reports to the RDO. It showed the DFNS solely directs the operation of Food and Nutrition Services. The organizational structure and position description did not support regular consultative guidance to the DFNS, dietetic service staff or the Administrator (Reference to A0023).

Based on observation, interview and record review, the hospital failed to ensure comprehensive oversight by the Regional Director of Operations (RDO), a contracted service, to ensure food safety in accordance with standards of practice as evidenced by lack of:

1. A full-time Director of Food Services. The RDO, was acting as the Director of Food Services, however, was not at the hospital full-time.

2. Effective daily management of Food and Dietetic Services related to food safety and sanitation within food and dietetic services such as: lack of food safety and sanitation systems that included: a. a black substance on surfaces throughout the pot and pan room and walk-in refrigerator, b. staff not following cleaning procedures in the pot and pan room, c. improper cooling of leftover food, d. cooking equipment stored wet-nested, e. food trays and carts were not appropriately cleaned. (Reference to A0750)

3. Involvement and effective integration of Food and Nutrition Services with the hospital's QAPI (Quality Assurance Performance Improvement). (Reference to A0273)

These failures resulted in potential for the growth of microorganisms and cross contamination that placed the 358 patients admitted to the hospital at risk of foodborne illness (illness caused by food contaminated with bacteria, viruses, parasites, or toxins), and for patient's nutritional needs to not be met in a timely manner.

Findings:

1. During an interview on 5/13/24 at 11:33 a.m., the Patient Services Supervisor (PSS), stated the Director of the department was gone and the Regional Director (RDO) came in weekly, on Wednesdays.

During an interview on 5/13/24 at 12:06 p.m., with the Regional Director of Operations (RDO) of the contract food service company, in the kitchen, the RDO stated he was currently the acting or interim director of food and nutrition services. The RDO stated he is onsite at the hospital two to three days a week. The RDO stated a new director would start on 6/3/24. As of 5/31/24 the hospital was unable to provide documentation of the information.

During a review of the Director of Food and Nutrition Services (DFNS) job description, authored by the food service contract company, undated, showed the DFNS reports to the RDO. It showed the DFNS is intended as a full-time position with the responsibility to direct the daily operation of Food and Nutrition Services.

2. During multiple observations in the kitchen between 5/13/24 and 5/14/24, concerns were identified including: lack of food safety and sanitation systems that included: a. a black substance on surfaces throughout the pot and pan room and walk-in refrigerator, b. staff not following cleaning procedures in the pot and pan room, c. improper cooling of leftover food, d. cooking equipment stored wet-nested, e. food trays and carts were not appropriately cleaned.

a. An observation on 5/13/24 at 2:50 p.m., showed a three (3)-compartment sink, housed in the pot and pan dish room within the kitchen, was used for cleaning cooking equipment. The environment in the pot and pan room was moist, such that surfaces were wet including the floor, the metal backsplash of the sink, and the sheet metal that covered the wall behind the sink. There was a significant amount of black residue on surfaces throughout the pot and pan room, including on the sheet metal covering the wall behind the sink, on metal backsplash behind the sink, on the wall between the pot and pan room passageway frame and the metal backsplash, and on a square metal plate with a rough surface attached to the wall by passageway. In addition, the wall behind the sink was visible through two holes in the metal backsplash, larger than the size of a quarter. A black substance was visible on the wall through the holes in the backsplash.

An observation and interview with Food Service Utility Staff (FSUS) 1, on 5/13/24 at 3:21 p.m., who was working in the pot and pan room, stated when he cleaned the backsplash and metal covering on the walls, he used "degreaser". FSUS1 provided the container of chemical labeled "D9.6 Foam Free Oven & Fryer Cleaner", which he stated he used to clean these areas. When FSUS1 was asked how he cleaned the wall behind the backsplash which was visible through the two holes. FSUS1 stated water did get into the holes but he did not know how it was possible to clean the wall behind the backsplash.

Review of "[product brand] D9.6 Foam Free Oven & Fryer Cleaner" manufacturer description, showed the product was "a ready-to-use liquid oven cleaner and general degreaser that effectively cleans greasy ... Can be used to clean ovens, grills, hoods, and deep fryers".

During an observation on 5/14/24 at 9:35 a.m. in the presence of the Patient Services Manager (PSM), showed staff in the pot and pan room using the 3-compartment sink to wash cooking equipment. The black residue remained on surfaces including the metal wall and backsplash behind the sink, the wall behind the backsplash, which was visible through two holes in the backsplash, the wall between the pot and pan passageway frame and the metal backsplash, and the square metal plate with a rough surface attached to the wall by passageway.

During a concurrent interview on 5/14/24 at 9:35 a.m., the Patient Services Manager (PSM) stated the pot and pan room was cleaned daily by kitchen staff. PSM also stated an outside vendor "takes care of" the black on the walls. When PSM was asked the product kitchen staff used to clean the pot and pan room surfaces, she stated staff used detergent and quaternary ammonia sanitizer (Quat - a type of chemical that is used to kill bacteria, viruses and mold) for cleaning all areas in the kitchen.

During an interview on 5/14/24 at 9:40 a.m., the Executive Chef (EC) stated there was a contract with an outside vendor to clean the pot and pan room once a month. EC stated kitchen staff did not clean walls in the pot and pan room.

b. During an interview on 5/13/24 at 3:00 p.m., the RDO stated there was a deep cleaning of the kitchen once a week. When the RDO was asked if there was documentation to show when cleaning was completed, RDO stated he would ask EC if there was a log to show document the completion of cleaning tasks. While the cleaning log was requested, it was not provided.

c. During a review of the 2022 US Food and Drug Administration (FDA) Food Code, showed Potentially Hazardous Foods (PHFs) are those capable of supporting bacterial growth associated with foodborne illness. These foods require time/temperature control (TCS) for food safety. Protein and starch-based foods such as cooked eggs, meat and pasta are considered PHFs. TCS foods require specific temperature controls as specified intervals to mitigate the bacterial growth. Hot foods must reach a temperature of 135 degrees Fahrenheit (F) to 70 degrees F within two hours and to 41 degrees F or below within an additional 4 hours. Food prepared from room temperature items, such as cooked and rinsed pasta must reach a temperature of 41 degrees F or below within 4 hours.

During an observation on 5/13/24 at 12:09 p.m., showed racks of raw and cooked food inside walk-in refrigerator "Diet 075". On one rack was a metal pan containing scrambled eggs. The pan was warm to the touch and a label on the cover of the pan showed the dated 5/13-5/15. Another pan on the rack contained cooked breakfast sausage and a label on the cover of the pan also showed the dates 5/13-5/15. The temperature of the food was measured with a food thermometer. The eggs were 91.6 degrees Fahrenheit (F) and the sausage was 72.3 degrees F.

During a concurrent interview and review of the cooling log with Dietary Supervisor (DS) 1 on 5/13/24, DS1 stated the scrambled eggs and breakfast sausage were leftovers from the breakfast tray line that morning and the items were placed in the refrigerator around 10:30 a.m. DS1 stated the leftovers were good to use for three days. DS1 stated cooked, cooling food was monitored for appropriate cooldown on a log. DS1 looked at the cooling log and confirmed the scrambled eggs and breakfast sausage were not on the log. DS1 stated the scrambled eggs and breakfast sausage were not being monitored for appropriate cooldown.
During a review of the "Cooling Log" showed documentation of multiple food items from 5/9/24 to 5/13/24. It was noted scrambled eggs and sausage were not documented on the cooling log on 5/13/24.

During an interview with concurrent review of the cooling log hanging on the wall, on 5/14/24 at 9:36 a.m., with Food Service Staff 4 (FSS), he stated he made a macaroni salad and put it on the cooling log. He stated he cooked the macaroni noodles then did an ice bath to cool it then took temperatures. FSS 4 stated he put that temperature on the log and only placed it on the bottom part of the log since he was making it for macaroni salad. FSS 4 stated he had four hours to get it to 41 degrees after the salad was prepared. FSS 4 confirmed what was on the log was five hours not four hours.

During an interview on 5/14/24 at 4:40 p.m., PSM and RDO stated leftover food should not be stored for later use, including leftover food from trayline food service.

During a review of the "Cooling Log" showed documentation of multiple food items from 5/9/24 to 5/13/24. One item documented on 5/9/24 included "Hoisin Pork". The first cooling temperature documented for the pork was 91 degrees F. Another food documented on the log on 5/9/24 was rice. The first cooling temperature documented was 75 degrees F.

During an interview with RDO and EC on 5/20/24 at 1:15 p.m., RDO stated it did not appear cooling was documented correctly for the Hoisin pork and the rice. RDO stated the starting cooling temperature was not documented. RDO stated cooldown documentation was supposed to start when the cooked food was 140 degrees F.

During a further review of the Cooling Log showed "Mac Salad" was documented for cooling on 5/13/24. The first temperature documented was 75 degrees F at 11 a.m., and the second temperature documented was 38 degrees F at 4 p.m.

During an interview with RDO and EC on 5/20/24 at 1:15 p.m., RDO stated the cooling for the Mac Salad was not documented appropriately. RDO confirmed there was 5 hours between the first and last temperature and the last temperature should have been measured at four hours to determine proper cooling. EC stated he checked logs daily. EC stated the incorrect cooling documentation on the Cooling Log were things that "caught his eye" but he did not notice cooling was not documented correctly on this cooling log. RDO and EC stated if corrective action was taken regarding improper cooling, the expectation was to document the action taking on the log. It was noted there was no corrective action documented on the Cooling Log.

During a review of the "Food Safety Quick Check" report dated 5/14/24, showed documentation of a kitchen inspection conducted by PSM. The document showed a photo of the cooling log with entries from 5/9/24 to 5/14/24 which included the Hoisin Pork and rice on 5/9/24, and Mac Salad on 5/13/24. Documentation on the report read "Food handler is able to describe steps needed to be taken if the temperature of the cold food is warmer than 41F, or if hot food is cooler than 135F ... Cooling logs are in place and completed to the end of the cooling cycle." PSM did not indicate on the report that staff did not follow proper cooling procedures according to the cooling documentation.

d. During an observation on 5/13/24 at 2:40 p.m., showed metal pans of various sizes used for cooking and serving food stored on racks in the food preparation area. The pans were stacked and nested in one another. The pans appeared and felt wet. A spot check of more than 15 pans stacked and nested were significantly wet on the inside surface.

During an observation and concurrent interview with the RDO on 5/13/24 at 2:45 p.m., showed the pot and pan room, was filled with soiled utensils stacked on racks, a countertop, and on the floor. RDO stated all pans should be air dried in the pot and pan room. RDO confirmed the pans stored on the racks in the food preparation area were wet.
During an observation and concurrent interview with FSS 3, on 5/13/24 at 2:49 p.m., FSS 3 stated there was no room for all the equipment to air dry.

During an observation and interview on 5/13/24 at 2:49 p.m., FSS 3 was working in the pot and pan room, washing cooking equipment. FSS 3 stated there was no room for all the equipment to air dry.

During a review of the hospital's policy and procedure titled "F018-Sanitizing Food Contact Surfaces" approved 9/22/21, showed after sanitizing food contact surfaces, do not store or stack wet food contact equipment, such as pots and pans; allow to air dry.

e. During an interview with a concurrent observation with FSS 3 on 5/13/24 at 3:30 p.m., in the dish machine room, FSS 3 was cleaning meal carts. FSS 3 stated he rinses the carts with water then uses Virex ® (according to the manufacturer's label, Virex is an "all purpose disinfectant cleaner") to wipe them down. The Virex® is in a bucket or bin and then he wipes the entire cart and allows to air dry. FSS 3 stated the chemical is changed every two hours. FSS 3 stated he also cleans patient meal trays with the Virex®. FSS 3 stated the process is to use soap and water in a bin then put it in the bin with the Virex and then air dries the trays. FSS 3 stated they used to use a quaternary ammonium product but awhile back they changed to the Virex®. FSS 3 showed surveyor the Virex in the dispenser in the chemical room in the dish machine room in the kitchen.

During an observation on 5/14/24 at 12:24 p.m., showed multiple containers of J-512 Sanitizer (according to the manufacturer this is a no rinse sanitizer for food contact surfaces) stored on a rack in the kitchen and available for use.

During an interview on 5/14/24 at 2:52 p.m., Infection Preventionist (IP) stated cleaning and disinfecting procedures needed approval. IP stated the chemical "Virex®" was not for use on patient food trays. IP stated this chemical could leave trace elements on the surface of the trays. He stated this chemical was typically used for patient care areas such as beds, high touch areas, and patient side tables. IP stated the patient food trays should be sanitized and the sanitizing process should not be substituted.

During an interview on 5/14/24 at 4:15 p.m., RDO stated the use of "Virex®" for patient trays was a "business" decision due to supply chain issues. RDO stated the prior executive chef made the decision to use the chemical for patient trays.

During an interview on 5/20/24 at 1:30 p.m., RDO stated a food tray was a food-contact surface.

During a review of the hospital's policy and procedure titled "F018-Sanitizing Food Contact Surfaces" approved 9/22/21, showed each work area shall be equipped with sanitizing solution. Two sanitizers were mentioned including "J-512 Sanitizer" and "Foodbuy-approved no-rinse sanitizing disposable wipes". Procedures showed to sanitize food contact surfaces after they have been thoroughly washed and rinsed.

During a review of the manufacturer's instructions for "Virex®", showed "a potable water rinse is required for food contact surfaces."

During an interview on 5/20/24 at 12:34 p.m., with the RDO and Accreditation Manager 2 (AM2) as the scribe, the surveyor asked the hospital to describe the evaluation of foodservice operations. The RDO stated internal inspections or audits were done monthly, food safety quick checks done weekly then they have an outside third-party vendor audit done semi-annual or annually. RDO stated there is an Operations Business Excellence Review done quarterly. He stated the monthly food safety reviews were completed, on a rotating basis, by different management staff from the hospital's food services department. When asked about the quarterly Operations Business Excellence Review, RDO stated there was food safety and sanitation components which is done by the director of food services. Surveyor asked for documentation of all types of audits done for food services. Only food safety quick check reports were received.

During a review of the daily "Food Safety Quick Check" reports, there were six completed (dated 4/15, 4/18, 4/19, 4/22, 4/25, 4/29/24) prior to the start of the survey. Only one was completed by the prior director. These were the only audits provided to the surveyor.
3. During an interview with concurrent record review of the electronic patient records (Patient 49, 46, and 53) with the Clinical Nutrition Manager (CNM) on 5/17/24 at 12:12 p.m., the CNM stated the Clinical RDs have been short staffed. The CNM stated the Clinical RDs fill out a productivity log that tracks the patients they see and asked if the patients they see are assessed timely. The CNM stated she has not evaluated the data that she collects. The CNM stated she does not collect or do any evaluation of anything for QAPI for clinical nutrition services. (Reference to A0629)

During a review of the hospital policy and procedure titled "Quality Assessment Performance Improvement (QAPI)", authored by the contracted food service company, revised 1/23, showed the hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program. It showed the Food and Nutrition Services Department must participate as part of the hospital's QAPI program and have no less than TWO (2) active quality or performance-based measurements in place at any given time. It showed the Director and RD: to request to participate in the hospital's quality program, attends quality meetings, works with the hospital's QAPI team to assess QAPI opportunities and executes a minimum of two QAPI projects for Food and Nutrition Services department; provides the hospital Quality Department with a report of the QAPI projects that follows the hospital's approved format for the QAPI program.

Based on interview and review of medical records and hospital documents, the hospital failed to ensure individual nutritional needs were met for three patients (Patients 49, 46, and 53) in a sample of seven patients reviewed for nutrition care when the Registered Dietitian failed to complete timely nutrition assessments. All three patients were identified at increased nutritional risk at the time of admission as evidenced by poor nutritional intake, weight loss and documented nutrition consults.

The failure to ensure patients nutritional needs are met, and in a safe and timely manner, could negatively impact the health and safety of medically fragile patients.

Findings:

During a review of the August 2019 Journal of Clinical Medicine, showed Malnutrition is a common condition in hospitalized patients that is often underdiagnosed and undertreated. Hospital malnutrition has multifactorial (involving or depending on several factors) causes and is associated with negative clinical and economic outcomes. There is growing evidence for the efficiency and efficacy (ability to produce a desired or intended result) of nutritional support in the medical inpatient population. Early start of nutritional support (within 48 h ours after hospital admission) is recommended to maintain or improve patient's nutritional and functional status and prevent sarcopenia (muscle wasting). Continued nutritional intervention is known to increase patients' quality of life and nutritional and functional status, and in the older (greater than 65 years) polymorbid patients (patients with multiple medical diagnosis) it results in lower mortality (death) rates.

During an interview on 5/17/24 at 11:09 a.m., the Clinical Nutrition Manager (CNM) stated the hospital policy for Nutrition Assessments specified physician ordered consults were to be seen within 24 hours, nursing consults within 48 hours, and patients who continued to be hospitalized on day seven (7). CNM stated nursing does the nutrition screen. Those patients with a Malnutrition Screening Score of two or above would automatically trigger as a nursing consult and those patients would need to be seen within 48 hours.

During a review of the Academy of Nutrition and Dietetics Evidence Analysis Library regarding Nutrition Screening Adults/Nutrition Screening Adults (NSA) Systematic Review (2016-2018), indicated the Malnutrition Screening Tool (MST) is a simple, quick, valid, and reliable tool developed for use in adult hospitalized patients, now used to identify patients at risk for malnutrition. Patients are considered to be at risk for malnutrition if they receive a score of two or more (Ferguson et al, 1999).

1. During the closed (discharged from the hospital) electronic medical record review for Patient 49, the Admission Record, indicated Patient 49 was admitted to the hospital on 2/28/24, with a chief complaint of end stage renal disease (final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). Patient 49 was also on hemodialysis (a treatment to filter wastes and water from your blood).

Review of the Admission H&P (History and Physical) Final Report dated 2/29/24, indicated Patient 49 had a past medical history of diabetes (a disease in which the body's ability to produce or respond to the hormone insulin is impaired resulting from abnormal metabolism of carbohydrates and ele vated levels of blood glucose or blood sugar), hypertension (high blood pressure) and patient was "eating supper" when she started to "choke and cough".
During an interview with the CNM in conjunction with review of the closed medical record for Patient 49 on 5/17/24 at 11:15 a.m., the CNM stated Patient 49 had at MST score of three, dated 2/29/24 at 1:24 p.m. The MST indicated Patient 49 also had a weight loss of 24-33 pounds.

Review of the physician's orders, showed a dietary consult ordered secondary to nutritional risk factors documented, dated 2/29/24 at 4:01 p.m. A review of the Nutrition Assessment dated 3/4/24, showed the Registered Dietitian (RD) documented it was an initial assessment, consult and the referral source was a nurse. RD documented the current nutrition risk level was moderate. The RD documented the current diet order was nothing by mouth and the prior diet was a cardiac (heart), renal (kidney), no added salt, chopped and the patient oral intake was 41% for four meals. The nutrition diagnosis was inadequate oral intake related to poor appetite as evidenced by oral intake less than 50%. The RD documented a proposed order for Nepro (nutrition supplement for patients with renal disease) twice a day with meals. Review of the physician orders dated 3/5/24, Nepro twice a day with meals. The CNM confirmed the nutrition assessment was late, despite being an ordered consult, and the patient should have been seen on 3/2/24. The CNM stated they only have coverage for one RD on the weekend and the RD will only focus on the enteral (nutrition through a tube), parenteral (nutrition through the vein) and physician consults. The CNM stated they are usually short staffed with 3.5 Full time RDs and need 4.5, as they also cover for another hospital.

2. During the review of the admission H&P dated 10/14/23 indicated Patient 46 came to emergency room with weakness and confusion with a past medical history of Chronic Obstructive Pulmonary Disease (COPD -chronic inflammatory lung disease that causes obstructed airflow from the lungs), pneumonia (infection that inflames the air sacs in one or both lungs) in June with bronchoscopy (a technique used to look at your air passages with a small camera that is located at the end of a flexible tube) with biopsy positive for lung cancer and no treatment to date. The physician documented under assessment/plan, "10. probably moderate protein calorie malnutrition " (protein calorie malnutrition refers to a nutritional status in which reduced availability of nutrients leads to changes in body composition and function).
During an interview with the CNM in conjunction with review of the closed medical record for Patient 46 on 5/17/24 at 11:28 a.m., Patient 46 was admitted to the hospital on 10/14/23. Review of the Nutrition Screen dated 10/15/23, showed MST score of 3, recent unintended weight loss and poor appetite. Review of the orders dated 10/15/23 requested a dietary consult secondary to the documented nutritional risk factors.

Review of the Nutrition Assessment dated 10/18/23, showed it was an initial assessment, consult. The RD documented there was a wound care note on 10/16/23 with coccyx ( small triangular bone at base of spinal column) community acquired unstageable pressure injury (type of bed sore that occurs due to prolonged pressure on a specific area of the skin and it is a full thickness tissue loss where the depth of the wound or bed sore is completely obscured by the eschar or dead tissue in the wound bed) and a stage two community acquired pressure injury (partial thickness loss of dermis [middle layer of skin] presenting as a shallow open ulcer with a red or pink wound bed, without slough [nonviable tissue that occurs as a byproduct of the inflammatory process] or bruising) to right upper buttock. RD documented Patient 46 weighed 33.7 kg (74 pounds) and a body mass index of 12 (BMI under 18.5 indicate underweight). RD documented malnutrition assessment and patient meets criteria for severe protein calorie malnutrition (context: chronic) as evidenced by BMI of 12, disease burden/information - lung cancer and community acquired pressure injuries, reduced variable (not consistent) oral intake and weight loss of 5.3kg (14%) in four months). RD recommended Ensure Plus High Protein (Nutrition supplement) four times a day, Juven® (wound healing supplement) daily. The CNM stated the nutrition assessment was supposed to be one day earlier.

3. During a review of the admission H&P dated 2/8/24, indicated Patient 53 came in with shortness of breath and had a history of diagnoses including hypertension, atrial fibrillation (irregular and often very rapid heart rhythm). The emergency room workup showed the symptoms to be consistent with pneumonia (an infection in the lungs).

During an interview with the CNM in conjunction with a review of the closed medical record for Patient 53, on 5/17/24 at 12:05 p.m., Patient 53 was admitted to the hospital on 2/8/24. Review of the orders dated 2/8/24, requested a dietary consult secondary to documented nutritional risk factors documented.

Review of the nutrition screen dated 2/8/24 showed a MST score of 3 with based on a history of decreased appetite and potential weight loss. Review of the Nutrition Assessment dated 2/11/24, RD documented it was the initial assessment, requested as a nursing consult. RD documented the nutrition diagnosis was inadequate oral intake related to patients' mentation (ability, activity or result of using your mind to think) as evidenced by oral intake less than 25%. The RD documented the nutrition plan to monitor patient: diet/supplement tolerance, oral intake, calorie and protein intake, lab results, weight. The CNM confirmed the nutrition assessment was supposed to be done on Saturday 2/10/24 but it was the weekend. The CNM stated the RDs fill out a productivity log and they usually see 10 to 15 patients a day. The productivity log monitors the patients that are seen, and if patient is seen timely. The CNM stated she does not evaluate the data since she knows they are short staffed. CNM stated she does not collect, track or evaluate any type of data for Quality Assurance Performance Improvement for clinical nutrition. On 5/17/24 at 11:25 a.m., CNM stated corporate has been recruiting for the hospital and starting on 5/20/24 a new RD will start for the other hospital they provide coverage. (Reference to A0273)

During the review of the hospital policy and procedure titled "F&N.1.79 Nutrition Screening, Prioritization and Assessment (D003A)", approved 5/27/20, indicated nursing will do the initial screening within 24 hours of admission and based on the results a nutrition consult will be automatically generated. It indicated the RD acts on consults using the prioritization table. The prioritization table indicated a Registered Dietitian would assess the patient by the next day for physician referral, new enteral nutrition order or new parenteral orders. The table also indicated patients would receive a nutrition assessment within two days as a result of a nurse referral for a MST score of two or greater, a pressure injury stage two or greater, or a BMI less than 18.

During a review of the hospital policy and procedure titled, "F&N.1.59 Nutrition Care Process (Screening Assessment and Prioritizing)", approved 11/28/18, revealed it was not consistent with the policy titled F&N.1.79 Nutrition Screening, Prioritization and Assessment. It indicated different levels of care with nutrition assessment and reassessment time frames that were different time frames than the other hospital policy.

Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment to avoid sources and transmission of infections for all patients, visitors, and staff when:

1. Two of two endoscopes (a thin, flexible tube-like instrument equipped with a camera used to look at tissues inside the body) were not stored in an endoscope cabinet in accordance with facility policy and the instructions for use (IFU). The two endoscopes were stored with the distal end (the part farthest from the origin) with the camera touching the bottom of the cabinet creating a potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect).

2. Surgical instruments were not processed in accordance with standards published by the American National Standards Institute and the Association for the Advancement of Medical Instrumentation (ANSI/AAMI -a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) and the Centers for Disease Control and Prevention (CDC- a federal agency that focuses on controlling, containing, and eliminating diseases). Sterile Processing Technician (SPT) 1 did not scrub surgical instruments during the manual cleaning process (the first step in disinfection by which visible soil and gross debris are removed) and surgical instruments were stacked upon each other in trays, potentially damaging the surfaces of the instruments.

3. Three of five procedure trays (container that holds surgical instruments), that were sterilized and ready for use in surgical procedures, were opened and examined and contained unclean and unsafe surgical instruments. On 5/17/24, one of 91 instruments in the "Major" tray (T-1) and three of 75 surgical instruments in the "Minor" tray (T-2) had discoloration and pitting (damage to the protective layer of surgical instruments) on the instruments. No chemical indicator (a device used to monitor whether the parameters to achieve sterilization have been met for a specific sterilization process) in T-1 was observed when opened. On 5/24/24, one of 91 instruments in the "Major" tray (T-3) had red-brown residue (left over when a substance has been removed) on the shank (the extension from the handle to the working part of the instrument). This practice was not in accordance with ANSI/ AAMI which stated that surgical instruments should be free of residue, pitting, and corrosion (a process in which a solid is eaten away). The hospital's policy was not followed when the requirement for a chemical indicator was not present inside T-1. These failures could result in use of surgical instruments that were not completely sterile, possible post- surgical infection to the patient, and instrument failure.

4. One of three blood gas machines were not cleaned in accordance with manufacturer's instructions and was observed to have dried blood on the sample port. (A blood gas machine is specialized equipment that takes a blood sample and measures the oxygen, carbon dioxide and pH of the blood sample. The pH is a measure of acid-base balance of the blood).

5. One of three patients (Pt 60) was observed to have a peripherally inserted central catheter line (PICC line -small, thin plastic tube that is placed in a vein and threaded into the large vein outside of the heart) and the intravenous (IV - through the vein) hub did not have a sterile cap in place to prevent contamination of this hub per hospital policy and procedure.

6. Air vents in the Endoscopy decontamination room directly above the clean scope testing counter were observed to have gray matter build-up, chipped paint, and were not routinely maintained in accordance with the hospital's policy. The room log showed vents were being cleaned daily. These failures could potentially lead to cross-contamination.

7. In the Sterile Processing Department (SPD) decontamination area, the floors, walls, and air gap were visibly in poor condition, unsanitary and not maintained in accordance with hospital policy and procedure. The floor beneath the rinse sink had rust-colored deposits, paper trash and other debris in the drain. The floor and backboard underneath the decontamination sink were scuffed, moist, with porous (water and air can pass through) drywall and wood exposed.

8. One of the two linen carts had linen stored and was not covered in accordance with the hospital policy. The linen cart had the plastic cover rolled on top of the cart and patient equipment was stored on top of the plastic cover exposing the clean linen (there was no signage to indicate the equipment was clean).

9. Three of 17 staff (Surgeon (SUR) 8, Resident Surgeon (RES) 1, and RES 2) were observed in the Operating rooms (ORs) not wearing appropriate eye wear in accordance with the hospital's policy.

10. Three of 10 staff members (Registered Nurse (RN) 11, RN 14 and Anesthesiologists (ANS) 6) did not perform hand hygiene during patient care: RN 11 changed Pt 61's wound dressing and did not perform hand hygiene after removing dirty gloves and then placing clean gloves on and placing a clean dressing on Pt 61's wound; RN 14 did not perform hand hygiene prior to putting on clean gloves in the Post Anesthesia Care Unit (PACU); ANS 6 dropped a vial of medication and picked it up from the floor, tossed it and then continued to give Pt 21 medication through her IV without performing hand hygiene and without cleaning the port on the IV site in accordance with hospital policy and procedures.

11. Two of 10 staff members (RN 12 and RN 13) were seen with their fingernails painted and multiple chips and nails that passed the tips of RN 12's fingers, which could potentially expose patients to hospital acquired infections and did not follow the hospital's policy and procedures.

12. One of two "soiled" utility rooms on the fourth floor was observed to have trash that was not disposed of in a clean and sanitary manner to prevent cross contamination when trash bags overflowed out of the trash bin, some bags were torn and open (gloves, adult briefs, food items, etc.) were seen coming out of one of the trash bags and were piled up against the wall and the floor.

13. In the Endoscopy procedure room, miscellaneous supplies, gloves, biohazard bags and a storage box were stored within the designated splash zone of the handwashing sink and leading to potential risk for cross contamination.

14. In the kitchen responsible for patient food storage, preparation, and service :

14.A A black substance was on surfaces throughout the pot and pan room where food preparation utensils and equipment were cleaned; the facility did not follow the recommendations of the Infection Preventionist and the contracted service, who found the substance to be mold; and the facility did not follow their policy and procedures for monitoring and maintaining a clean kitchen ;

14. B. A Black substance was on the surface of the walk-in food storage refrigerator door frame and rubber gasket (a rubber strip around the circumference of the door and/or door frame to help produce an air-tight seal to keep the outside temperatures from entering while simultaneously keeping cool air inside) which was not in accordance with the facility's Sanitation Program policy and procedure.

14.C. Floors in food preparation areas were dirty and were in poor condition and maintenance of the floor was not in accordance with policy and procedure and standards of practice.

14. D. Walk-in refrigerator food storage shelving was not clean and in poor condition and not in accordance with the facility's policy and procedure for kitchen sanitation and maintenance.

14. E. Walk-in food storage refrigerator fan guards were not clean and were not maintained in accordance with the facility's policy and procedure for maintenance and sanitation of the kitchen.

14. F. Food was not cooled safely in accordance with the facility's food handling policy and procedure.

14. G. Cooking equipment was stored wet-nested (when items such as pots and pans are wet and stacked, preventing them from drying, and creating a condition for microbial growth) and not in accordance with the facility's sanitizing policy and procedure for sanitizing food contact surfaces.

14. H. Food service trays were not cleaned in accordance with the facility's policy and procedure as well as the manufacturer's instructions for the chemical used;

14. I. Food service carts were not cleaned appropriately and had yellow residue on the inside and outside surfaces and were not cleaned in accordance with the facility's policy and procedure as well as the manufacturer's instructions for the chemical used; and

14. J. Staff facial hair was not covered which was not in accordance with the facility's policy and procedure for staff personal hygiene.

15. The Infection Preventionist was not aware of the hospital-wide infection problems, did not have a systemic approach to track and monitor infection control practices and did not make rounds in all areas of the hospital.

As a result of these failures all patients, visitors and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses.

Because of the serious potential harm related to staff in many areas and departments of the hospital not practicing standards of infection control to reduce infections and cross contamination, such as endoscopes not being properly stored, surgical instruments not being appropriately processed and disinfected, the environment of hospital areas being visibly unsanitary, specialized equipment not being properly disinfected and maintained, staff not adhering to perioperative surgical attire requirements, hand hygiene procedures not being followed and a hospital-wide infection control program not having a systematic method to track, monitor, and surveil infection control practices to reduce the sources of infection and prevent cross contamination, an Immediate Jeopardy (IJ- a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 5/21/24 at 11:30 a.m., under Code of Federal A-0750 §482.42(a)(3) with the Chief Executive Officer (CEO), Chief Operating Officer(COO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditation Manager (AM) 1, and AM 2. The IJ template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 2.2) on 5/24/24 at 8:00 a.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) Reeducated and trained staff on manufacturer's instructions for cleaning and disinfection, sterilization, and sanitary storage of surgical instruments, endoscopes, and arterial blood gas analyzers ( measures the amount of oxygen and carbon dioxide in the blood) 2) Immediately removed unclean endoscopes and surgical instruments from use in procedures 3) Provided house-wide education to staff on hand hygiene, proper aseptic techniques (a method used to prevent contamination with micro-organisms) for intravenous medication administration, and clean storage of patient supplies and equipment 3) Immediately cleaned and disinfected air vents, floor drain air gap, kitchen door frames, sinks, floors, rolling food carts and racks, and linen carts, and developed processes for recording and monitoring compliance. 4) Trained kitchen staff on manufacturer's guidelines for use of kitchen disinfectant solutions and proper cool down processes for patient food items. 5) Dietary staff discontinued the practice of storing pots and pans used for patient food service wet 6) The Infection Preventionist increased surveillance by rounding daily in areas affected by the deficient practices. The components of the IJ Plan of Removal, training, and competencies of staff were validated onsite through observations, interviews, and record review. The IJ was removed onsite on 5/27/24 at 10:48 a.m. with the facility CNO and AM 2.

Findings:

1. During a concurrent observation and interview on 5/14/24 at 9:41 a.m., with Clinical Resource Specialist Registered Nurse (CRS), Sterile Processing Department Manager (SPDM), and Quality Nurse (RNQ) 1 in the endoscopy storage room (ESR), two endoscopes with the distal end of the scopes were touching the bottom of the endoscope cabinet. The CRS & SPDM validated the observation and stated would need to review the policy.

During an interview on 5/14/24 at 10:25 a.m., with the Director of Surgery (DOS), the DOS stated the scopes were not stored in accordance with the Instructions for Use (IFU) and potential for patient safety risk through cross-contamination. The DOS stated staff had been made aware of the inappropriate storage of endoscopes and the department would be reminded of the importance of safely storing scopes "freely hanging" to ensure the distal end of the scope did not touch the bottom of the cabinet.

During an interview on 5/15/24 at 9:55 a.m., with Registered Nurse Manager (RNM 1), RNM 1 stated scopes should be hung freely, and distal end should not touch any surfaces with or without a tip guard (help protect the delicate components of scope) on distal end. RNM 1 stated endoscopy staff members were made aware of the correct storage requirement and were re-educated on the importance of storing correctly to prevent infections.

During a review of facility's document sterile processing manual procedure (SPMP) titled, "ST.P.1.34 Flexible Scopes", with the approval date of 5/23/18, the SPMP indicated, " ...Ensure cleaning and processing is conducted by the individuals who have received education and completed competency verification activities related to endoscope processing ....STORING ...Store mechanically processed flexible endoscopes in a cabinet that is both designed and intended for horizontal storage of flexible endoscopes or is of sufficient height, width, and depth to allow the endoscopes to hang vertically, without coiling and without touching the bottom of the cabinet ..."

During a review of the [Endoscope Brand Name] IFU for "[Brand Name] Ultrasonic Gastrovideo Scope (special endoscope that uses high frequency sound waves to examine all major organ of digestive system)", the IFU indicated, "...reprocessing and storage after use ...After using this instrument, reprocess and store it according to the instructions given ...Improper and/or incomplete reprocessing or storage can present an infection control risk ...Storage and Disposal ... Keep the reprocessed endoscope and accessories away from the contaminated equipment after cleaning and disinfection or sterilization. If the clean endoscope and accessories become contaminated between procedures, they could present an infection control risk to patients and/or operators in the subsequent procedures ...Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion tube hangs vertically and as straight as possible ..."

During a professional reference review retrieved from (https://www.aami.org/docs/default-source/bi-t/bit/drying-storing-endoscopes---bit-may-june-2020.pdf) titled, " Drying and storage of Flexible Endoscopes: An Area of Growing Concern", dated 2020, the reference indicated " ...Store endoscopes and accessories in a manner that prevents recontamination, protects equipment from damage, and promotes drying ... Store processed flexible endoscopes in a cabinet of sufficient height, width and depth to allow flexible endoscopes to hang vertically without coiling or touching the bottom of the cabinet or in one designed and intended for horizontal storage..."

2. During a concurrent observation and interview on 5/17/24 at 10:30 a.m., in the SPD decontamination area, with the Sterile Processing Department Manager (SPDM) and SPT 1, SPT 1 demonstrated the manual cleaning of surgical instruments before sterilization (process of making something free from germs). SPT 1 pulled a "Laparoscopic GYN [gynecologic]" tray (a set of instruments used to operate and examine abdominal, pelvic, and reproductive organs) from the cart and removed the camera and scope from the instrument tray. SPT 1 submerged the instrument tray in water mixed with an enzymatic detergent (special cleaner to breakdown soil and stains) solution. The hinged instruments (two-piece instrument attached by a joint that allows limited movement) remained strung on the instrument stringer (adjustable tool designed for organizing ring-handled instruments and keep hinged instruments in an open position during sterilization). The instruments soaked in the water solution for two minutes, then SPT 1 transferred the instrument tray to the rinse sink filled with tap water. The instrument tray soaked in the tap water for one minute before transfer into the ultrasonic cleaner (a machine that uses high frequency sound to agitate fluid, with a cleaning effect). Pockets of water from the contaminated sink pooled on the sink's surfaces, backsplash, handle, and floor. The instrument tray was removed from the ultrasonic cleaner and set near the automatic washer for cleaning. The instruments were not opened, inspected, nor manually scrubbed during this process. The instruments were stacked upon each other in the tray. Other trays were observed being washed that had instruments stacked upon each other. SPDM stated she expected staff to manually clean and inspect all instruments, regardless of not being used in any particular procedure. The SPDM stated it was important to manually scrub the instruments under water to remove any tissue or debris that may adhere to instruments during surgery. The SPDM stated instruments should be opened and evenly spread apart in the trays to be adequately washed and prepared for sterilization. The SPDM stated instruments stacked upon each other disrupted the cleaning process of the automated washers and increased the risk of damaging the instruments. The SPDM stated the sink and surrounding area should be disinfected between each wash to prevent cross contamination (transfer of germs from one object to another) and transmission (spread) of disease. The SPDM stated SPT 1 did not follow policy and procedure during the cleaning process of the surgical instruments. SPT 1 denied any error in her cleaning procedures and stated she followed the cleaning process as trained.

During an interview on 5/20/24 at 3:45 p.m., with the Infection Preventionist (IP), the IP stated enzymatic detergents removed "the majority" of biological remains (tissue and/ or bioburden [germs living on a surface]) left on surgical instruments and equipment however, the cleaning process used a three step approach to ensure instruments were cleaned and prepared for sterilization by 1) manual cleaning (physical action to wipe, scrub, and/or flush to remove gross organic material); 2) ultrasonic cleaning; and 3) automated cleaning (machine washed and rinsed, thermal rinse included), and thus rendered safe to handle before sterilization. The IP stated instruments had to be scrubbed to ensure bioburden was not left behind to eliminate the risk of cross contamination (that could lead to transmission of infection) and instrument failure. The IP stated unclean instruments could not be properly sterilized. The IP also stated the cleaning environment should remain dry, clean, and sanitary to prevent moisture build up, mold spores, and germs from reproducing.

During a review of the professional reference titled "ANSI/ AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities", dated 2017, the professional reference indicated, " ... Instrument damage is often due to care and handling issues ... Keeping the instrumentation in an orderly fashion will help prevent instrument damage ... The first and most important step in reprocessing reusable medical devices is thorough cleaning and rinsing. Cleaning removes microorganisms and other organic and inorganic materials ... All microorganisms in health care facilities should be considered potentially pathogenic ... Medical devices, instruments, and equipment used in patient care become contaminated with microorganisms and should be decontaminated ... To ensure patient safety, a reusable device needs to be capable of being thoroughly cleaned and sterilized... Because effective sterilization depends on minimizing the contamination present on items before the sterilization cycle, thorough cleaning procedures are essential during pre-sterilization processing... instruments should be presoaked as soon as possible after use with a product intended to loosen soil... The presoak solution manufacturer's written IFU should be reviewed and followed for the correct dilution, temperature, and contact time ... Presoaking instruments moistens and loosens the soil, thus making the cleaning step more effective and efficient. Thorough rinsing removes potentially harmful residues and blood and other potentially infectious material... The volume and temperature of water used in the cleaning sink or other cleaning container is very important for the efficacy of the process. The appropriate dilution should be calculated according to the volume of the sink to ensure consistent and accurate cleaning solution concentration ... clean immersible devices under water to minimize aerosolization (disperse a substance) ... clean devices that cannot be immersed in a manner that will not produce aerosols ... Position devices to prevent damage. Heavy devices should be placed on the bottom. Position items such as rigid sterilization container and basins to avoid the accumulation and retention of water ..."

During a review of the professional reference titled, "CDC Cleaning Guideline for Disinfection and Sterilization in Health Care Facilities (2008)" dated 9/18/2016, indicated, "Cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Also, if soiled materials dry or bake onto the instruments, the removal process becomes more difficult and the disinfection or sterilization process less effective or ineffective. Surgical instruments should be presoaked or rinsed to prevent drying of blood and to soften or remove blood from the instruments ... With manual cleaning, the two essential components are friction and fluidics. Friction (e.g., rubbing/scrubbing the soiled area with a brush) is an old and dependable method. Fluidics (i.e., fluids under pressure) is used to remove soil and debris from internal channels after brushing and when the design does not allow passage of a brush through a channel. When a washer-disinfector is used, care should be taken in loading instruments: hinged instruments should be opened fully to allow adequate contact with the detergent solution; stacking of instruments in washers should be avoided; and instruments should be disassembled as much as possible ..."

During a review of the professional reference titled, "There's More to Keeping Scopes and Other Tools in Good Working Order Than Just Thorough Reprocessing," dated 10/10/2007, the reference indicated, " ...If it's properly cared for, an instrument should last about 20 years. That's if. There are many opportunities for and causes of damage. The top three: misuse (the instrument isn't used as intended by its design), abuse (dumping, stacking, and improperly cleaning and sterilizing instruments) and exposure (to chemicals and detergents, including saline, chlorine bleach, blood and even water) ...Stainless steel can corrode by pitting, crevice corrosion and stress corrosion cracking (also known as hydrogen cracking). This is usually caused by exposure to blood ...The effect is deep pockets or pits that look like black holes on the surface. You can't repair pitting- rather, you have to replace instruments when pitting occurs ..."

During a review of the hospital's policy and procedure (P&P) titled "PC.AD.1.11 Guidelines for Cleaning, Disinfection & Sterilizing Patient Care Environment & Equipment Policy" dated 9/28/22, indicted, " ... Accumulation of dust, soil, and microbial contaminants on environmental surfaces may create a reservoir of microorganisms, that when transmitted via hands or equipment can contribute to hospital associated infections ... Failure to properly store supplies, disinfect, or sterilize reusable medical equipment intended for use with patient care can potentially introduce pathogenic microorganisms to patient and cause infections... Critical Items... Objects that enter sterile tissue or the vascular system are defined by the CDC as critical items. They carry a high risk of infection if they become contaminated. Critical items must be sterile ... Examples of critical items include but are not limited to the following: surgical instruments... Cleaning is the removal of organic and inorganic material from objects and surfaces. This is normally accomplished by using detergents or enzymatic products. Thorough cleaning is necessary before disinfection and sterilization because organic and inorganic materials that remain on the surface of instruments interfere with the effectiveness of these processes ... Decontamination is the use of physical or chemical means to remove, inactivate, or destroy microorganisms on a surface or item so they are not infectious and the surface or item is rendered safe for handling, use, or disposal ... Sterilization is the complete destruction of all microbial life. It is accomplished by either a physical or chemical process such as steam under pressure, dry heat, and low temperature gas plasma (ionized gases generated under deep low pressure conditions). All items that enter sterile tissue or the vascular system must be sterile, (i.e., implants, surgical instruments, etc.). (Critical items) ..."

During a review of the hospital's P&P titled "ST.P.1.36 MOD ST.P.1.36 Sterilization" dated 4/24/19, indicated, " ... the SPD will provide for the terminal sterilization of reusable medical devices using saturated steam under pressure and Sterrad [machine used to sterilize medical devices] ... It is recognized that efficacy of the sterilization process is dependent upon proper cleaning, assembly wrapping, and sterilizer loading ... Preparation of items for sterilization ... Items must be: Thoroughly cleaned and decontaminated ... Correctly assembled ... Loaded such that all surfaces will be directly exposed to sterilant ..."

3. During concurrent observation and interview on 5/17/24 at 11:30 a.m., in the SPD clean area, with the SPDM, Sterile Processing Department Supervisor (SPDS), and Director of Surgery (DOS), the SPDM and the SPDS demonstrated the "Instrument Quality Check Process." SPDM opened "T-2" tray that was sterilized and stored for use. The "T-2" tray contained a total of 75 surgical instruments. The following surgical instruments were observed to have brown and white discoloration, notches and pitting: one towel clip perf 5.25 (perforating clamp used for grasping tissue, securing towels or drapes, and holding or reducing small bone fractures), one knife handle #7, and one knife handle #3 (used for holding sharp blades; #7 is used for more delicate cuts). The SPDS inspected the instruments and stated discoloration was caused by hard water which stained the instruments. The SPDS stated the hospital struggled to maintain water quality. The DOS stated the notches (indentation and/ or groove) and pitting noted on the instruments were acceptable and could be disinfected with the facility's current practice for processing surgical instruments. The DOS stated pitting did not pose an infection control risk for patients. The SPDS opened "T-1" tray for inspection of surgical instruments, and there was an orange chemical indicator (used to monitor whether the parameters to achieve sterilization have been met for a specific sterilization process) outside the tray and once the tray was opened, a chemical indicator could not be found in the tray. The SPDS stated when auditing a tray, he ensured there was a chemical indicator outside the tray, which should be orange and once he opened the tray, he checked to see if there was another chemical indicator inside as well. The SPDS stated there should have been a chemical indicator inside the tray. The SSPD stated the importance of the chemical indicator was to ensure the surgical instruments were appropriately sanitized. The SPDS stated if there was no chemical indicator in the tray, the instruments could possibly not have been sanitized appropriately.

During a concurrent observation and interview on 5/17/24 at 11:45 p.m., in SPD, with the SPDS, the SPDS removed instruments from the "T-1" tray and inspected the instruments. The "T-1" tray contained 91 instruments. The SPDS held up one retractor Richardson 1.5 x 2 blade 9.75 (surgical instrument used during procedures, such as for chest or abdomen, to grasp soft tissue using the curved blade) which had red-brown residue on the instrument. The SPDS stated the residue could potentially cause an infection to a patient if used on the patient during surgery. The SPDS stated the surgical instruments should be thoroughly cleaned and there should not be any staining or residue left on the instruments after they have been thoroughly cleaned and sanitized. The SPDS stated the importance of cleaning surgical instruments appropriately was to prevent infections.

During an interview on 5/20/24 at 3:45 p.m., with the IP, the IP stated the purpose for chemical indicators was to make sure steam reached the instruments during the sterilization process. The IP stated all trays should have indicators to ensure the instruments were sterilized. The IP stated instruments went through a rigorous process of sterilization and pitting and/ or corrosion did not pose an infection control risk, rather corrosion increased the risk for the instruments to become non-functional or cause the instrument to fail during a surgical procedure.

During an interview on 5/24/24 at 10:08 a.m. with SPT 2, SPT 2 stated sterile processing technicians were trained to inspect instruments before instruments were packaged and sterilized. SPT 2 stated it was expected for technicians who packaged instruments to remove instruments from trays if the instruments had functional issues, pitting, or residue. SPT 2 stated it was uncertain why stained and pitted instruments were found in "T-1" and "T-2."

During a concurrent observation and interview on 5/24/24 at 10:45 a.m., in the SPD clean area, with SPDS, SPDS opened "T-3" tray that was sterilized and stored for use. The "T-3" tray contained a total of 75 surgical instruments. One needle holder mayo- hegar 8.0 (used to drive curved needles during surgery) had red-brown residue on the shank. The residue material lifted when scratched with fingernail. The SPDS validated the instrument was not properly sterilized.

During an interview on 5/29/24 at 3:16 p.m., with the Infection Preventionist (IP), the IP stated residue left on an instrument did not increase the risk for transmission of diseases. The IP stated residue was caused by steam during the sterilization process and risk of infection for patients was low. The IP stated "hardwater" caused the residue stains on instruments. The IP did not comment on the residue material lifted from the instrument.

During a review of the professional reference titled, "ANSI/ AAMI ST79:2017," indicated, " ... have a process in place to identify instruments in need of repair/maintenance and removal from service ... inspected for cleanliness, flaws, and damage... Surgical instruments and other medical devices and equipment could pose a significant risk of transmitting infection to patients or health ca

Based on interview and record review, the hospital failed to ensure the surgery department kept an accurate roster of privileged surgeons and non-physicians approved to be in Operating Rooms when surgery staff did not follow policies and procedures and permitted unidentifiable, unqualified and/or unprivileged individuals and physicians to provide surgical care in the operating rooms.

These failures to ensure all surgical patients received surgical care from qualified, competent, and experienced surgeons, anesthesiologist, and Allied Health Providers (AHP- nonphysician provider), may have contributed to patient harm and placed surgical patients in jeopardy of receiving safe medical care.

Findings:

During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with surgeon (SUR) 3 and the Chief of Surgery (SUR) 4, the records of surgical patients, hospital policies and workflow were discussed. Surgeon (SUR) 3 stated that from his "understanding", Certified Registered Nurse Anesthetists, CRNA (type of AHP, Registered Nurse with specialized training that provides anesthesia services under the orders of a physician), were "not independent" and "supported" by the anesthesiologists. SUR 3 stated, it was his "opinion", if an anesthesiologist wasn't available, the "case stops and can't proceed". SUR 4 stated the surgery department is "not involved" with CRNAs. SUR 4 stated surgeons are "not responsible" for CRNAs and do not provide "direction ... orders" for them.

During two concurrent interviews and record review on 5/22/24 at 12:42 p.m. and 5/28/24 at 1:50 p.m. with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff Manger, hospital workflow, polices, patient record logs and staff files were discussed and reviewed. MST explained the privileging process. The MST indicated, according to Bylaws, granted privileges are based on experience, certification, education, and skill sets as determined by case logs from school and/or prior jobs. MST indicated approved privileges should correlate with education, experience, and case. MST stated the file is "available" for Governing Board (GB- hold the ultimate responsibility for the hospital's compliance) , the credential committee (CC- review candidate application files and provided recommendations to the GB ), and MEC to review and recommend.

During record review of the privileging staff records who provided surgical services, including non-physician anesthesia providers, the following were noted:

CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 did not have DEA (Drug Enforcement Administration licensee which authorized providers to prescribe, procure and administer medications) licenses, but were allowed to prescribe, procure, and administer controlled substances without a treatment regimen ordered by a physician.

CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 were authorized to diagnosis, order treatments, medications and therapeutics for patients and nurses to instate, but did not have a medical license.

CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 were not required to have physician orders to provide anesthesia care, medications, treatments, and therapeutics.

CRNA 1, CRNA 2, CRNA 5, CRNA 6, CRNA 13. CRNA 18, Physician Assistants (PA- type of AHP, an individual with specialized training that provides medical under the supervisor of a physician ) 5, and SUR 8 had procedure logs for privileges, but they did not correlate with requested or chief approved privileges.

PA 2, PA 3, PA 4, PA 5, PA 6, and PA 7 did not have signed service agreements by supervising physicians.

CRNA 3, CRNA 4, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17 PA 6, PA 7, NP 2, SUR 3, SUR 5, and Chief of Medical Staff (COS) did not have documented evidence of procedures logs required for privileges.

COS, SUR 3, SUR 5 SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, PA 2, PA 3, PA 4, PA 5, PA 6, and PA 7 did not have documented evidence of professional references that were required.

CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17, CRNA 13, CRNA 18, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, COS, SUR 3, SUR 5, and SUR 8 did not have documented evidence of the required "direct" supervised proctoring required for privileges.

CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, COS, SUR 3, SUR 5, and SUR 8 did not have documented evidence of professional references.

MD 11 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon.

MD 12 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon.

PA 8 was listed as additional staff intraoperative "Additional staff intraoperative" for Pt 39. On the AHP list with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging) and not a surgeon as the supervising physician.

PA 8 listed as an "Anesthesia Tech [assistant to anesthesiologist, not allowed to practice in California]" for Pt 37. PA 8 was listed on AHP roster as PA with a radiologist as the supervising physician.

Nurse Practitioner 1 (NP 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39, but was not listed on the medical staff or AHP roster.

Physician, (DO 1) was listed as an "Assistant Provider, Intraoperative" for Pt 39 but was not listed on the medical staff.

RN 1 was listed as RNFA registered nurse (RN), such as a RN First Assist (RNFA- RN with training that assists a surgeon during surgery), "First Assistant" for "Coronary Artery Bypass" for Pt 37 and Pt 39. RN 1 was not listed on the APH roster.

During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, MST acknowledge privileges were granted for specific specialties and if additional privileges were desired, and requested must be submitted to medical staff for review and approval. MST stated that names of individuals listed who were not AHP or Medical Staff Rosters did not have privileges or were unfamiliar to medical, was a "mix-up".

During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1) and accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and DCQI, 2. 5/29/24, at 10:10 a.m., with ANS 1 and accompanied by DCQI, 3. 5/29/2024 at 4:14 p.m. with ANS 1 and accompanied by RNQ 1, the hospital policies, and patient medical records were discussed. ANS 1 stated CRNA competency could be determined by the surgeon, chief of anesthesiology or the Anesthesiologist in Charge (AIC- a anesthesiologist or CRNA).

During an interview on 5/30/2024 at 3:48 p.m. Chief of Medical Staff (COS), accompanied by Accreditation Manager (AM 2), hospital policies, and medical staff processes were discussed. COS acknowledged the privileging process for applicants is not followed. COS acknowledged she was not aware which AHP, including surgical assistants, are eligible for privileges. COS stated PA are "not independent". COS stated, PAs who are employed by a medical group will submit an application to medical staff. The applications are reviewed by the chief of the department. COS stated approval of PA privileges are "based on education". On the other hand, PAs employed by the hospital, their practice is determined by the hospital. COS stated PA who provide surgical services should have specific privileges, where they can work, for example trauma, general surgery, cardiovascular, orthopedics. COS stated PAs can work "anywhere" in the hospital. COS acknowledged that medical staff does confirm the competency, qualifications, and skills of AHPs. COS stated, no matter the AHP's specialty or employment status, (hospital employee or contract provider), whatever physician "asked" the AHP to provide medical care, is "responsible" for the care the AHP's provides.

During an interview on 5/30/2024 at 3:48 p.m. with COS accompanied by Accreditation Manager (AM 2), hospital policies, and medical staff processes were discussed. COS stated she is "familiar" and "follows" with Medical Staff Bylaws. COS stated if a nurse (RN) or other AHP are hospital employees, the hospital has jurisdiction over reviewing qualification, training, and monitoring. Medical staff does not approve their privilege forms. COS stated Registered Nurse First Assistants (RNFA) were nurses and employed by the hospital. The hospital is responsible for privileges and practice, not medical staff. COS stated first assists, RNFAs should have "specific training". COS indicated the hospital determines their training.

During an interview on 5/30/2024 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed. SUR 4 stated some of her responsibilities as "Chief" is to ensure that surgical workflow and department services "flow well ...coordinate patient care ...communicate with staff". In addition, SUR 4 reviews surgical providers applications files for education background, case logs, training, and experience. SUR 4 stated she will recommend applicants for staff privileges. SUR 4 stated she "helps"' the credentialing committee once a month.

During a review of the Pt 37's nursing intra-operative notes, titled, "Surgical Documentation", dated 6/24/23, at 3:54 p.m., the nurse documented medical providers who entered the operating room and provided surgical services to Pt 37 as follow:

Operating surgeons, SUR 3, and SUR 9, "Coronary Artery Bypass".

Anesthesiologists, (ANS 4).

Medical Doctor (MD) 11 , "Assistant Provider, Intraoperative" for "Coronary Artery Bypass", was not listed as a surgeon on the Medical Staff roster, but internal medicine doctor.

MD 12, "Assistant Provider, Intraoperative" for "Coronary Artery Bypass", was not listed as a surgeon on the Medical Staff roster, but internal medicine doctor.

RNFA 1, "First Assistant" for "Coronary Artery Bypass", was not listed on the APH Roster.
The nursing documented that "PATIENT EXPIRED.

During record review of the titled document, "Operative/Procedure Report", dated 6/24/2023 at 3:54 p.m. for Pt 37., written by the operating surgeon (SUR 3), SURG 3 indicated the following individuals were members of the operative team surgeons, SUR 3, SUR 9, and SUR 8. SUR 3 wrote " we invited the cardiologist [MD 12] and elicit his help ...aid in decompression of the left ventricle [heart chamber] ... intensivist [MD 11] came to the operating room and assistance ...weaning the patient from cardiopulmonary bypass ... all attempts of salvaging the patient have been futile and the patient ...expired " in the OR.

During a review of the Pt 38's nursing intra-operative (during surgery) notes, titled "Surgical Documentation", dated 5/15/24, the nurse documented medical providers who entered the operating room and provided surgical services to Pt 38 as follow:

Operating surgeon, (SUR 5), listed on the medical staff roster.

Anesthesiologists, (ANS 1 and ANS 6). Both listed on the medical staff roster.

Additional staff intraoperative" Physician Assistant (PA 8), listed on AHP roster with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging) and not a surgeon as the supervising physician.

Assistant Provider, Intraoperative" Nurse Practitioner, (NP 1) was not on the medical staff or AHP roster.

Assistant Provider, Intraoperative" physician, (DO 1) was not on the medical staff roster.

During a record review of the Pt 39's nursing intra-operative notes titled, "Surgical Documentation", dated 12/13/2023, the nurse documented those 21 different individuals entered the OR during Pt 39's case: six RNs, one Respiratory Therapist, four medical students, one vendor, three perfusionists, two anesthesiologists (ANS 8, ANS 2), four surgeons (SUR, SUR 8, SUR 10 and SUR 11), and one RNFA 1 who was not listed on the APH roster.

During an interview on 5/30/24 at 3:00 p.m. with SUR 4 accompanied by AM 2, hospital policies, workflows, some of the findings for Patients 37, 28 and 39 records, and OR staff were discussed. SUR 4 stated the only non-surgeon physicians that come to the ORs are, "intensivist [ICU physician]", who would be called to the OR to assist the anesthesiologist in a code. SUR 4 indicated she was unaware that, non-surgeons, MD 11, and MD 12 were assisting in surgeries. PA 8 was listed as a "Anesthesia Tech" and surgical "Assistant Provider. SUR 4 stated PA 8 was supervised by a radiologist, and "I don't know why his name is on a cardiac case" and assisting in surgeries or anesthesia. SUR 4 stated the "surgery department does not oversight of the anesthesia service". SUR 4 stated RNFAs are nurses and employees of the hospital, and surgery does not control what nurses are in the OR. SUR 4 stated she has "no idea" who some of the providers were-- MD 15, NP 1 or DO 1-- or why they were assisting in surgeries. SUR 3 stated "poor documentation" may be why unidentifiable individuals were present in the OR. There was no documented policy available that described the entrance of non-privileged OR staff, visitors, or bystanders to enter the operating rooms.

During record review of [Hospital] policy titled "Rules and Regulations of the Governing Board of [Hospital]", June 13, 2022, indicated that the "Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice".

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that " recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board."

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that "only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] ... The Governing Board grants appointments to the medical staff ... Medical staff membership (1) to have a current unrestricted California license to practice medicine, dentistry, or podiatry; (2) to maintain an unrestricted Drug Enforcement Administration certificate ... Every member practicing the medical profession at [Hospital name] shall exercise those clinical privileges specifically granted by the Governing Board".

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that "Medical staff membership (1) to have a current unrestricted California license to practice medicine, dentistry, or podiatry; (2) to maintain an unrestricted Drug Enforcement Administration certificate ...only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] The Governing Board grants appointments to the medical staff ... Every member practicing the medical profession at [Hospital name] shall exercise those clinical privileges specifically granted by the Governing Board ... Hold a current, unrestricted license, certificate or other appropriate legal credential ... the authorized individual shall write the order, followed by the name of the Practitioner, date and time, name, and signature of the writer ... Practitioners are legally and professionally responsible for the ongoing monitoring and appropriate adjustment of the duration and dose of the medications ordered in the Hospital".

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that " recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a "practitioner" ... who provides defined direct patient care services ... consistent with applicable law, these bylaws and the medical staff rules and regulations ...Authorized Categories ... Categories of AHPs presently providing patient care services in the Hospital are as follows: (1)Certified Registered Nurse Anesthetist, (2)Certified Nurse Midwife, (3)Clinical Psychologist, (4)Dental Assistant, (5)Nurse Practitioner, (6)Oral Surgery Assistant, (7)Orthopedic Technologist, (8)Pathology Assistant, (9)Perfusionist, (10)Physician Assistant, (11)Surgical Scrub Second Assistant AHPs are not eligible for medical staff membership".

During record review of hospital titled, "AHP [Allied Health Professional] Rules and Regulations, version 2022" indicated that the "Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned ... Practitioners who desire to sponsor and supervise AHPs must apply and qualify for such sponsorship. "During record review of [Hospital] policy titled, "CO-5.007 Operative and Invasive Procedures Appropriateness Review", approved 10/24/2018, described "the minimum standards for prospective and retrospective review of the appropriateness of operative and invasive procedures through effective use of evidence-based clinical criteria, to appropriately and accurately identify performance trends and patterns, and to monitor and improve ... Hospital's Peer Review Committee is responsible for providing oversight and peer review of the Operative and Invasive Procedures provided at the Hospital to confirm appropriateness of the Procedures being performed ... Physician documentation that validates the appropriateness of the procedure, including but not limited to: patient clinical condition, non-invasive study results, findings from diagnostic procedures ... shall provide a summary of its findings to the Hospital's Medical Executive Committee (MEC), which shall report such findings to the Hospital Governing Board", as outlined in Medical Staff Bylaws.

During record review of [Hospital] policy titled, "MOD CLN.4.04 MOD Operative and Invasive Procedures Appropriateness Review (CO-5.007.MOD)", approved 4/10/2024, stated the purpose of the policy was "to describe the minimum standards, review Cardiac Operative and Invasive procedures through effective use of evidence-based clinical criteria ... Quality Review ... The Facility shall conduct case reviews in accordance with the peer review and quality processes set forth in the Facility's Medical Staff Bylaws and state statutes ... The Facility shall review, at minimum ...the OR/procedure room or other vascular complications requiring treatment ... Bleeding events with treatment or drop of > 3gm/dL ...Dissection or perforation ...Infections ...Return to the OR/procedure room for re-operations ... Cases with Mortality".

During record review of [Hospital] policy titled, "CO.2.010.05 Disclosure of Outcomes to Patients", approved 7/22/2020, indicated that "unanticipated outcomes of care, including errors, also referred to as preventable events ... Patients and, when appropriate, their families shall be promptly informed about the outcomes of care, including preventable events. All preventable events resulting in harm or shall be disclosed to the patient".

Based on interview and record review the hospital failed to obtain a History and Physical (H&P-a term used to describe a doctor's examination of the patient) updated within 24 hours of a surgery for one of two patients (Pt), Pt 12, in accordance with hospital policy and procedure.

The failure to assess the appropriateness of the surgery and determine the surgical needs of Pt 12 prior to surgery, placed Pt 12 at risk for potential complication and harm.

Findings:

During a concurrent interview and record review on 5/22/24 at 10:53 a.m. with RNQ 4, Pt 12's "Face Sheet (FS-a document that contains a summary of a patient's personal information and brief medical history)," dated 5/14/24 and Pt 12's "History and Physical (H&P)," dated 5/3/24 was reviewed. The Face Sheet indicated Pt 12 was admitted on 5/14/24 at 7:54 a.m. The H&P indicated Pt 12 was admitted for repeat cesarean section (the surgical delivery of a baby through a cut made in the mother's abdomen). RNQ 4 stated she could not find an updated H&P for Pt 12. RNQ 4 stated there should be an updated H&P on the day of surgery, but it was not done. RNQ 4 stated the importance of an updated H&P was to ensure Pt 12's health information was still the same or had changed since the previous H&P.

During an interview on 5/30/24 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), SUR 4 stated all surgeons were expected to complete the following for surgical patients: write in-patient pre-surgical consults, "activate" surgical orders, obtain a consent after the surgeon has discussed the risk and benefits of surgery, mark the surgical sight, complete a time-out in the OR, "immediately, within an hour" complete an operative procedure note before the patient is transferred to the next level of care and post operative notes. SUR 4 stated, if there was an intra-operative death, the surgeon was "responsible to write a full note ...code participation was noted" and describe the patient's outcome.

During a review of hospital's policy and procedure (P&P) titled, "Rules and Regulations of the Governing Board of [Hospital A]", June 13, 2022, the P&P indicated, the "Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... Recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations ... Governing Board's duty to protect patients and all other individuals at the Hospital ... QUALITY OF PROFESSIONAL SERVICES AND PATIENT CARE EVALUATION ... ensure appropriate professional care to Hospital patients ..."

During a review of the hospital's P&P titled, "MEDICAL STAFF RULES AND REGULATIONS", dated August 24, 2022, the P&P indicated, " ...When a medical history and physical examination is completed within the 30 days before admission, an updated medical record entry documenting an examination for any changes in the patient's current condition must be completed. This updated examination must be completed and documented by a physician in the patient's medical record within 24-hours after admission, but before a surgical invasive procedure, even if the surgery or procedure occurs less than 24-hours after admission or registration. The practitioner completing the update is responsible for ensuring the history and physical documented in the medical record is complete and accurate ...Any staff member failing to provide a complete history and physical within 24-hours after admission shall be subjected to automatic suspension for medical record deficiencies pursuant to Medical Staff Bylaws ...Prior to commencing surgery the person responsible for administering anesthesia, or the surgeon if a general anesthetic is not to be administered, shall verify the patient's identity, the site and side of the body to be operated on, and ascertain that it is recorded in the patient's medical record and re-evaluate the patient's vital signs immediately prior to moderate or deep sedation use and before anesthesia induction ..."

During a review of the hospital's P&P titled, "CO-5.007 Operative and Invasive Procedures Appropriateness Review", dated 10/24/2018, the P&P indicated, " ...the minimum standards for prospective and retrospective review of the appropriateness of operative and invasive procedures ..."

Based on interview and record review, the hospital failed to provide anesthesia services consistent with needs and resources when the hospital granted Certified Registered Nurse Anesthetists (CRNA) prescriptive authority and the ability to diagnose and treat patients without a treatment regimen ordered by a physician while providing anesthesia services and was not consistent with scope of practice laws and standards of practice for CRNAs.

These failures resulted in CRNAs providing anesthesia services to patients for which they could possibly not be qualified to provide.

Findings:

During a joint interview with DOP and RPH 1, in the pharmacy office hallway, on 5/20/24, at 6:02 PM, the DOP stated the pharmacy relied of hospital's credential and privilege system to check provider's qualification and up to date licenses to practice and prescribe drugs. The DOP stated, the pharmacy assumed the provider's DEA and California license to prescribe were routinely checked for updated status. RPH 1 stated the scope of practice by mid-level providers (non-physician providers authorized to provide care and prescribe) were not limited to drug class and computer allowed the pharmacist to verify their orders.

During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), patient records, workflow and hospital policies were discussed. ANS 2 indicated the hospital bylaws defined the role and scope of practice of CRNAs. ANS 2 stated CRNAs "practice independently ... practice on own", write orders, and prescribe medications. ANS 2 stated anesthesiologist are "not responsible" for the medical care provided by CRNAs. ANS 2 stated an anesthesiologist's participation in a case is "loose supervision" and the anesthesiologist does not provide medical direction, oversight, or orders for CRNAs.

During an interview and concurrent record review on 5/21/2024 at 2:30 p.m. with Medical Doctor (MD 1) accompanied by Quality Registered Nurse (RNQ 1), the medical records and workflow were reviewed and discussed. MD 1 stated she does not provide medical direction or write orders for CRNAs. MD 1 stated the "anesthesia department is in charge of CRNAs and monitoring". MD 1 stated that, "I don't think CRNA can diagnosis, prescribe, write orders." MD 1 indicated if CRNA is providing anesthesia care, she will have a "conversation" with CRNA, but the anesthesiologist is "responsible for the care provided by CRNAs".

During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), 2. 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and 3. 5/29/24 at 4:14 p.m. with ANS 1, accompanied by RNQ 1, the hospital policies, workflow, and patient medical records were discussed. ANS 1 stated the " primary" anesthesia provider can be a CRNA or anesthesiologist. ANS 1 stated CRNAs are "independent", and do not require physician review, direction, or orders. ANS 1 CRNAs are authorized to diagnosis, determine the treatment plan, write orders for medications, treatments and therapeutics for patients and nurses to instate. ANS 1 CRNAs are "qualified to run a code" order medications and direct medical care. ANS 1 explained the "supervising" anesthesiologist's role is to be "available to help" the CRNA if specifically asked by the CRNA. ANS 1 stated that a CRNA will determine if anesthesiologist needs to be present, and if the CRNAs have "any concerns" an anesthesiologist will be an "available" resource. ANS 1 indicated the anesthesiologist is not responsible for the medical care CRNAs provide or be responsible for signing orders.

During two concurrent interviews and record review on 5/22/24 at 12:42 p.m. and 5/28/24 at 1:50 p.m. with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff Manger, hospital workflow, polices, patient record logs and staff files were discussed and reviewed. MST indicated CRNAs are approved as "independent practitioners with full prescriptive authority. MST stated CRNAs are the "same as a physician ... anesthesiologist" and are "equivalent". MST acknowledged there was no documented evidence Governing Board (GB- hold the ultimate responsibility for the hospital's compliance), approved CRNAs hospital privileges to provide patient care.

During record review of the privileging staff records the following were noted:

" CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 did not have DEA (Drug Enforcement Administration licensee which authorized providers to prescribe, procure and administer medications) licenses, but were allowed to prescribe, procure, and administer controlled substances without orders from a physician establishing a treatment regimen.

" CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 were authorized to diagnosis, order treatments, medications and therapeutics for patients and nurses to instate without orders from a physician establishing a treatment regimen but did not have a medical license.

" CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 were not required to have physician orders to provide anesthesia care, medications, treatments, and therapeutics.

" CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, and CRNA 18 did not have documented evidence of the required "direct" supervised proctoring required for privileges.

During two concurrent interviews and record reviews on 5/22/24 at 12:42 p.m. and 5/28/2024 at 1:50 p.m. with MST, MST stated CRNAs are not required to have individual DEA numbers and according to "title 22 regulations and 1301.22 [ Federal regulation practitioner that allows an agent or employee with a DEA to prescribe medications ], CRNA are allowed to use the hospital DEA number". Medical staff team stated "CANA [California Association of Nurse Anesthesiologist, an advocacy group that supports nurse anesthetists] allows CRNAs to work independently, and "in the state of California" CRNAs have prescriptive authority. MST stated CRNAs can diagnosis, write orders any medication, treatment or therapeutic. It is within their "scope of practice". MST acknowledged that CRNAs are not employees of the hospital and work as independent contractor. MST acknowledged none of the CRNAs ordering, prescribing, procuring, and administering medications had a DEA license. MST indicated, anesthesiologists are not required to sign an attestation, swearing that he/she was present for key portions of anesthesia care and procedures. The hospital policy titled, "AHP [Allied Health Professional] Rules and Regulations, version 2022" was reviewed with MST which indicated all AHPs required "direct supervision". MST stated the definition of "supervision" for CRNAs was that an "anesthesiologist was available to provide support ...and help ... if" requested by the CRNA. The MST stated "new" hospital regulations did not require CRNA to be supervised. MST indicated that CRNAs were not required to have an anesthesiology present to provide orders or medical direction for any aspect an anesthesia, including emergencies, or life-threatening events, procedures, or medical care of patients.

During an interview and concurrent record review on 5/22/24 at 5:10 p.m., with anesthesiologist (ANS 3) accompanied by Patient safety officer (PSS), medical records of Patient 2 (Pt 2), workflow and hospital policies were reviewed and discussed. ANS indicated recently the hospital transitioned to a CRNA and anesthesiologist-based service. ANS 3 stated has "never worked with CRNAs ... never taken responsibility for the patient care of CRNA ... never provide orders for CRNAs". ANS 3 indicated, if he is available will help other anesthesia providers, physicians and CRNAs. But he stated, CRNAs "do not ask me for help".

During an interview on 5/30/2024 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed. SUR 4 stated that she is "absolutely not" involved with the anesthesiology departments approval of privileges for anesthesiologist or CRNAs. SUR 4 stated anesthesiologist cover trauma and direct codes (life-saving medical interventions and medications), not CRNAs.

During a concurrent interview and record review on 5/20/24 at 3:40 p.m., with CRNA 1 and accompanied by nurse of Quality (RNQ 1), the medical records, workflow and policy were reviewed with CRNA 1. CRNA 1 stated this was his "first job" as a CRNA. CRNA 1 stated he started taking call (available for emergencies) in the hospital at night in April 2024, and working fulltime in May of 2024. CRNA 1 stated he can do "all cases" for anesthesia. CRNA 1 stated the CRNA the plan of care and medication are "decided by the CRNA", not the surgeon. CRNA 1 indicated CRNAs sign as the physician on anesthesia records, and an anesthesiologist signature is not required on orders, patient evaluations, procedures, or anesthesia records. CRNA 1 acknowledge he does not have a DEA license. CRNA 1 stated he has the "authority" to "optimize" patients and write orders for medications, labs, treatments, and procedures.

During an interview and concurrent record review on 5/20/2024 at 5:12 p.m. with CRNA 5, accompanied by a scribe, Patient Safety Officer (PSO), medical records for the admission, workflows, and polies were reviewed, and discussed. CRNA 5 that AANA (American Association of Nurse Anesthetists', an advocacy group for nurse anesthetists) and the hospital bylaws determined the "scope of practice" of nurse anesthetist. CRNA 5 stated that CRNAs are "independent and not medically supervised or directed" by a physician and are the "responsible provider" of medical care. CRNAs bill as an "independent" physician provider. CRNA indicated CRNA write orders and do not require a physician signature or approval. CRNAs provide anesthesia care and procedures to patients without physician orders or direction. CRNA 5 stated she does not have a DEA license, because CRNAs "are not required to have DEA". CRNA 5 stated that CRNAs are authorized to use the hospital DEA to order medications with "no limitations". CRNA 5 indicated CRNA 5 stated CRNAs can directs the medical care of codes and order medications and procedures. CRNA 5 stated anesthesiologist are "available", if the CRNA "asks for help", and each CRNA determines when and if and anesthesiologist is required in a case. CRNA 5 stated the CRNAs are "very, very similar" and "at the end of the day deliver" anesthesia care by CRNAs is the "same" as a physician.

During a phone interview on 5/22/2024at 10:13 a.m., with CRNA 6, accompanied by scribe and Director of Clinical Quality Improvement (DCQI), the hospital policy, workflow and patient records were discussed. CRNA 6 stated he was the "Chief CRNA". CRNA 6 stated the anesthetist can diagnose, prescribe, and order medications, order labs, order treatments, and render medical services to patients; it is all "within [CRNAs] scope of practice" and there are "no limitations" inside the hospital. CRNA 6 indicated he works "independently" without physician orders, supervision, or directions. CRNA 6 stated CRNAs have "independent practice" and the role of the anesthesiologist is to be "available anytime as a resource". CRNA 6 acknowledged he does not have a DEA license.

During a phone interview on 5/29/24 at 1:40 p.m. with CRNA 4, CRNA 4 stated he has been working at the hospital since July 2023. CRNA 4 stated CRNA's practice independently both in the hospital and outside of the hospital in places like surgery center. CRNA 4 stated he does not review cases with an anesthesiologist, and it was not the practice at the hospital. CRNA 4 stated he can adjust anesthesia plan for patients independently. CRNA 4 stated he does not have DEA license but can order medications and testing as deemed necessary for patients.

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that "only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] The Governing Board grants appointments to the medical staff ... Medical staff membership (1) to have a current unrestricted California license to practice medicine, dentistry, or podiatry; (2) to maintain an unrestricted Drug Enforcement Administration certificate ... Every member practicing the medical profession at [Hospital name] shall exercise those clinical privileges specifically granted by the Governing Board ... the authorized individual shall write the order, followed by the name of the Practitioner, date and time, name, and signature of the writer ... All drugs and medications administered to patients shall have been approved by the Federal Drug Administration or listed in the latest edition of United States Pharmacopeia, National Formulary, American Hospital Formulary Service or A.M.A. Drug Evaluations ... Investigational or experimental drugs shall be used only under the direct supervision of a Physician Member of the Medical Staff, who is responsible for securing the necessary consents ... Practitioners are legally and professionally responsible for the ongoing monitoring and appropriate adjustment of the duration and dose of the medications ordered in the Hospital".

During record review of [Hospital] policy titled, "OR.1.29 Provision of Anesthesia Services", approved 10/27/2021, stated the purpose of the policy was "to establish a consistent standard-of-care for patients receiving anesthesia services ... The director of anesthesia services is responsible for ... Evaluating the quality and appropriateness of the anesthesia patient care ... The anesthesia service is responsible for developing policies and procedures governing the provision of all categories of anesthesia services ... Individuals Permitted to Administer Anesthesia ... Only those individuals privileged by the medical staff shall be permitted to administer anesthesia. These individuals may include A qualified anesthesiologist, A Doctor of Medicine or osteopathy (other than an anesthesiologist); A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law ... The privileges granted must be in accordance with State law and organization policy. The type and complexity of procedures for which the practitioner may administer anesthesia, or supervise another practitioner supervising anesthesia, must be specified in the privileges granted to the individual practitioner".

During record review of [Hospital] policy titled, "PHARM.1.04 Controlled Substances Policy Schedule II - V, approved: 6/23/2021, indicted that "Issuing, Dispensing and Distributing Controlled Substances ...Only licensed personnel per state law and regulation may have access to controlled substances ... Strict accountability shall be maintained and recorded for all controlled substances".

During record review of [Hospital] policy titled, "MEDICAL STAFF RULES AND REGULATIONS", approved Governing Board, August 24, 2022, indicated that, prescribing providers "maintain an unrestricted Drug Enforcement Administration certificate ...authorized individual shall write the order, followed by the name of the Practitioner, date and time, name, and signature of the writer".

During record review of [Hospital] policy titled "Medical Staff Bylaws", approved Governing Board, August 24, 2022, indicated that " recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a "practitioner" as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a "practitioner" ... who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership".

During record review of hospital titled, "AHP [Allied Health Professional] Rules and Regulations, version 2022" indicated that the "Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned".

During record review of California (CA) Business and Professions Code, (BPC) 2826, it stipulated that a "Nurse anesthetist' means a person who is a registered nurse licensed by the board who has met standards for certification from the board".

During record review of California's Business and Professions Code, CA BPC, 2725(b)(2), it stipulated that "Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician".

During review of California 's Business and Professions Code, CA BPC 2827, it stipulated, the "utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist".

During review of California 's Business and Professions Code, CA BPC 2833.5, it stipulated that "the practice of nurse anesthetist does not confer authority to practice medicine or surgery".

Based on interview and record review, the hospital failed to ensure emergency services provided in the hospital were supervised by a qualified member of the medical staff for four of four patients (Patients 1, 2, 3 and 5) when Patients 1, 2, 3 and 5 experienced code blue situations (term generally used to indicate a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) in the surgical and procedural areas of the hospital and the code blue was not supervised by a qualified member of medical staff and the code blue did not follow established guidelines for Advanced Cardiac Life Support (ACLS) published by the American Heart Association (AHA) and hospital policy and procedure.

These failed practices may have contributed to unsafe emergency care practices, medication use and patient harm.

Findings:

During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with Surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1's (Pt 1) admission on 4/10/23 and hospital policies were discussed indicated if there was a code blue in the OR, the physician directed the code, and the anesthesiologist would be called. If there is no physician, the CRNA will start it.

During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), 2. 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and 3. 5/29/2024 at 4:14 p.m. with ANS 1, accompanied by RNQ 1, the hospital policies, workflow, and patient medical records were discussed. ANS 1 stated the anesthesia department followed ASA (American Society of Anesthesiology) guidelines and ACLS guidelines for patient care and documentation. ANS 1 stated CRNAs are "independent", and do not require physician review, supervision, direction, or orders. ANS 1 CRNAs are "qualified to run a code" order medications and direct medical care. ANS 1 stated that CRNA would determine if anesthesiologist needs to be present, and if the CRNAs have "any concerns" an anesthesiologist would be an "available" resource. ANS 1 indicated the anesthesiologist is not responsible for the medical care CRNAs provide or responsible for signing orders.

During an interview on 5/30/24 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflows, patient records, and OR staff were discussed, SUR 4 stated if there is a code in the OR, the CRNA may start it, but the anesthesiologist "runs" the code. If additional physician hands are needed, an intensive care (ICU- critical care unit) physician is called to the OR to assist. SUR 4 indicated intensive care doctors who are called to assist with codes enter the OR.

During a joint interview with ADOP, RPH 1 and RPH 3, on 5/30/24, between 11:03 AM to 12:07 PM, the RPH 3 stated the intra-op (inside surgery room records and drug records) records of medication use was not online (available in computer) and was only available after use and administration or when it was scanned in the medical records. When asked if pharmacy would have questioned use of TXA in setting on an allergic reaction without bleeding incident, RPH 3 stated she would "definitely questioned" the use due to risk and complications when TXA was not used based on standards of practice and approved indication. When asked if pharmacy would question use of epinephrine in the setting of having heartbeat and reasonable blood pressure, RPH 3 stated "no, not indicated" to give epinephrine, and the code record needed to be reviewed. When asked how the reports of the drug allergy or reaction was processed by pharmacy, RPH 3 stated the allergy reported via electronic reporting system or pharmacy find it when reversal drugs used to counter allergy. RPH 3 stated the hospital was not able to review or find every single drug related allergy happening in the hospital. RPH 3 stated the providers could enter the drug reaction in the computer system.

1. During a review of Patient 1's (Pt 1) medical record, titled "Consultation Notes", written by Surgeon 3 (SUR 3, surgery doctor), dated 4/11/24, at 6:18 PM, the note indicated Patient 1 was re-admitted to the hospital with bowel obstruction (when the bowels blocked by food or scar tissues) and recurrence of large paraoesophageal hernia (when stomach protrudes up into the chest through the sheet of muscle called the diaphragm in the body) and a planned surgery to repair hernia and clear the bowel obstruction.


During review of the Pt 1's intraoperative (events during surgery) medical record, titled "Anesthesia Record" dated 4/11/24, at 7:09 p.m., handwritten by CRNA 5, the record indicated Pt 1 entered the operating room at 7:09 p.m. and CRNA 5 provided anesthesia services during surgery without orders from a physician. There was no documented evidence that additional CRNAs, or a physician entered the OR with CRNA 5 and Pt 1. The record indicated starting at 7:15 p.m., CRNA 5 procured, prescribed, and administered "High Risk Medications" (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body's movement. CRNA 5 did not document continuous monitoring of the blood pressure, heart rate, heart rhythm, oxygen saturation (estimated percent of oxygen in patient's blood), respiratory rate, or the delivery of oxygen. Further review of the documented intra-operative events indicated that CRNA 5 attempted to intubate (place a breathing tube into the lungs) three times. There was no documented evidence, with each attempt, the presence of carbon dioxide (gas expelled during exhalation and indicates a breathing tube in the lungs), lung sounds of air flow, respiratory rate, delivery of oxygen or oxygen saturation (percent of oxygen in blood) indicating a successful intubation(s). There was no documented evidence CRNA 5 recorded the medication used and response to interventions and treatment. There was no documented evidence CRNA 5 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines.

During an interview and concurrent record review on 5/20/24, at 5:12 p.m. with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1's (Pt 1) medical record for the admission dates from 4/10/24 to 4/11/24, and policies provided by the hospital, were reviewed, and discussed. Review of the Pt 1's intraoperative (events during surgery) medical record, titled "Anesthesia Record" on 4/11/24 with CRNA 5, CRNA 5 stated "within minutes of pushing [intravenous, IV] medications, patient vomited 1.5 liters [measurement of volume] of fluid ...fecal matter ...called for help". CRNA 5 stated that she intubated Pt 1, but it was in the "esophagus, and tried again. CRNA 5 acknowledged she documented that she intubated three times. CRNA 5 stated throughout the intra-operative period, there was "no gas exchange (evidence pt was receiving oxygen", and "no CO2 (evidence of pt exhalation)".

During a record review of the Pt 1's medical record, "Code Blue Record [events, medications and treatment during cardiopulmonary resuscitation, life saving measures], dated 4/11/24 from 7:40 to 8:25 p.m., and handwritten by a nurse. The nursing documentation indicated "medications administered by Anesthesia team, see OR (Operating Room, surgery room) record ... intubated time: see anesthesia record" written by CRNA 5. The Code Blue record indicated that there were "multiple intubation [place a breathing tube to deliver oxygen and respirations] attempts during and before code."

The nurse documented medications in the follow order:

i. Epinephrine 1 mg (used IV in emergency situation when heart or breathing stops) given at 7:40 PM, 7:42 PM, 7:43 PM, 7:44 PM, 7:46 PM

ii. Sodium Bicarbonate 50 meq (the treatment of metabolic acidosis or when acids build up in body; "meq" is Milliequivalent, a unit of measure) and Calcium Chloride 1 gm (used for emergency treatment of high potassium and magnesium level in the blood) were given at 7:47 PM.

iii. Epinephrine 1mg given at 7:48 PM

iv. Vasopressin 20 Units given at 7:52 PM

v. Epinephrine 1 mg given and Sodium Bicarbonate 50 meq given at 7:55

vi. Epinephrine 1mg given at 7:56 PM

vii. Bicarbonate 50 meq given at 7:57

viii. Epinephrine 1mg given at 7:59 PM, 8:01 PM, 8:08 PM, 8:24 PM, 8:24 PM

During the Code Blue here was no documented evidence of heart rhythm, respiratory rate, or deliverance of oxygen by CRNA 5 or the nursing staff. The following was documented periodically: Blood pressure (BP- normal average 120/80), heart rate (HR- normal 60-100 beats per minute, bpm) and oxygen saturation. (SpO2- estimated percent of oxygen in the blood, normal 95 to 100%)

SpO2 90% at 7:56 p.m., 100% at 8:02 p.m. and 94% at 8:06 p.m. 85% at 8:03 p.m.,
BP 67/29 at 7:44 p.m., 92/46 at 7:55 p.m., 174/146 at 8:01 p.m., 173/77 at 8:02 p.m., 159/27 at 8:09 p.m., 208/157 at 8:12 p.m., 200/140 at 8:16 p.m.,
HR bpm was 81 at 8:01 p.m., 128 at 8:02 p.m. 129 at 8:03 p.m., 134 at 8:09 p.m., 159 at 8:12 p.m., 138 at 8:16 p.m. There was no documented heart rhythm for any of the heart rates.

At 8:19 p.m. was the last recorded BP 127/40 and HR 150.

At 8:25 p.m. compressions stopped and SURG 3 sopped the lifesaving measures.

The Code Blue record further indicated the SUR 3 arrived at code event at approximately 8 PM and the ICU team (Intensive Care Unit; specialized team that treated critical patients) and MD 3 arrived at 8:03 PM. Further review of the code blue sheet documentation indicated no documented evidence CRNA 5 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures or anesthesia guideline for securing an airway.

During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1's (Pt 1) admission on 4/10/23 and hospital policies were discussed. SUR 3 stated there was "no anesthesiologist in the room" when he arrived in the OR. SUR 3 stated the patient was in "distress" had a "pulse" and there were "bowel fluids" on the floor. SUR 3 stated he put a camera into the patient's lung and determined the breathing tube was "in the esophagus". SUR 3 stated two CRNAs were "grappling" with the airway and the patient lost her pulse. Later, SUR 3 indicated that an ICU physician arrived in the OR and determined that ETT was in the esophagus. SUR 3 stated the ICU physician intubated the patient. SUR 3 stated the case was reviewed. SUR 4 stated there was an order to "decompressed [contents emptied]" by placing an NGT and do an awake intubation. SUR 3 stated that from his "understanding", CRNAs were "not independent" and "supported" by the anesthesiologists. SUR 3 stated, it was his "opinion", if an anesthesiologist wasn't available, the "case stops and can't proceed".

During an interview on 5/20/24, at 5:12 p.m., and concurrent record review of code blue record events, with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1's (Pt 1) medical record for the admission dates from 4/10/24 to 4/11/24, and polies provided by the hospital, were reviewed, and discussed. CRNA 5 stated that CRNAs were "independent and not medically supervised or directed" by a physician and were the "responsible provider" of medical care. CRNA 5 stated she was "in charge of the code". CRNA 5 stated that she "started pushing epi" and ordered the nurses to give "plenty of epi(epinephrine), vasopressin, bicarb (Sodium Bicarbonate)". CRNA 5 acknowledged on the anesthesia record and code sheet there was no ongoing data recorded reflecting-- blood pressure, respiratory rate, cardiac rhythm and rhythm, pulse. oxygen saturation, oxygen delivery, carbon dioxide-- when she was giving medication orders and directions. CRNA 5 stated cardiac monitoring and rhythm strips are not used in the operating room or during codes. CRNA 5 stated per ACLS, heart compression rates were 126 to 150 per minute, as the nurse recorded. CRNA 5 acknowledged during a code and intra-operative events, it was necessary to document patient status, vitals, medications and response to procedures and medications. CRNA acknowledged this type of information was required on the intraoperative anesthesia record. CRNA 5 stated vital signs and medications were not documented by the CRNA, "It was the nurse's job". CRNA 5 stated it was the nurse's responsibility to recorded intra-operative events, "not my shortfall ...can't do other's jobs". CRNA 5 indicated after her attempts to intubate on two separate occasions SUR 3 and MD 3 determined the tube was "in the esophagus", removed the tube and reintubated Pt 1 with success. CRNA 5 stated SUR 3 and MD 3 stopped the lifesaving efforts at 8:25 p.m.

During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), the records of surgical Patient 1's (Pt 1) admission on 4/10/2023 and hospital policies were discussed. ANS 2 stated he was familiar with some of the events of Pt 1's care. ANS 2 indicated he was called to help with Pt 1 in the OR and when he arrived, it was "chaotic". ANS 2 stated SUR 3 was in the OR and informed the CRNA 5 the breathing "tube was in the esophagus". ANS 2 stated CRNA 5 oversaw the case and there were 2-3 CRNA "managing the airway", so he did not help intubate the patient. ANS 2 stated "I tried to run the code", but other people giving medication orders, and the CRNA was in charge. ANS 2 stated he did not know what medications the patient had received. After, the CRNA had reintubated the patient. ANS 2 stated the SpO2 (oxygen levels) was not improving and there were no CO2 readings [sign of breathing, exhaling]. ANS 2 stated CRNA 5 "assured me" the ETT was in the "right place". ANS 2 stated that he asked the CRNA to reassess the breathing tube because the patient had "no pulse and low blood pressure ...patient crumbling". ANS 2 stated the intensive care medical doctor (MD 3) was called to help. MD 3 "discovered the ETT was in the esophagus", removed the tube and replaced it. ANS 2 stated the patient "deteriorated", and there was nothing more that could be done. ANS 2 stated he "assumed CRNAs are competent."

During a record review of the Pt 1's medical record, titled "Operative/Procedure Reports", dated 4/11/24, at 8:29 p.m., was written by the intensive care physician (doctor trained to care for critically ill patients) Medical Doctor 8 (MD 8), the record indicated MD 8 was in the operating room during the Pt 1's code and placed a breathing tube into Pt's 1 lungs to supply oxygen. MD 8 documented that there was a "massive aspiration with large amount of gastric [stomach] content in the lungs bilaterally ... Unfortunately, patient remained in asystole and passed away, time of death is 08:29 pm".


2. During a review of the Patient 2's medical record, titled "Consultation Notes" Progress Note", written by MD 5, dated 10/26/23 at 10:56 PM, the record indicated Patient 2 had a history of dementia (problem with memory and forgetfulness; impaired ability to think or make decisions), diabetes (blood sugar disease), heart disease with CAD (Coronary Artery Disease caused by the clogged arteries), lung disease (breathing difficulties), high blood pressure and chronic pain was approved to go to surgery for hip fracture on 10/26/23 after a fall at home.

During a record review of the Patient 2's intraoperative (events during surgery) record, titled "Anesthesia Record", dated 10/26/23, timed from 4:33 p.m. to 5:50 p.m., handwritten by CRNA 4 the record indicated that CRNA 4 provided anesthesia services during surgery without the medical orders or direction from a physician.

During record review of the PACU (Post Anesthesia Care Unit, where patient transferred after surgery to recover from anesthesia) nursing documentation, titled "Communication and Notification", dated 10/26/23, at 5:55 p.m., five minutes after CRNA 4 dropped Pt 2 into the PACU, starting at 6:00 p.m., the nursing note indicated Patient 2's abnormal respiratory rate (RR) of 26 and SPO2 at 91% (RR, how fast one breath, Normal range was 12-16 breaths per minute; "SPO2" is oxygen level in the blood, the normal level is between 96 to 99%, ("%" or percent is a unit of measure) while on supplemental oxygen. The record further indicated while in PACU, Patient 2's vital signs (clinical measurements, specifically heart rate, temperature, respiration rate, and blood pressure, that indicate the state of a patient's essential body functions) needed an urgent response and medical intervention. The records indicated Patient 2's Respiratory rate increased as high as 34, HR increased as high as 202 (heart Rate or Heartbeat, normal between 60-100 beats per minute), blood pressure dropped as low as 82/52 (or BP, the normal is 120/80) which resulted in respiratory acidosis (accumulation of acid in the blood and life threatening due to ineffective breathing), and respiratory failure (unable to breath). There is no documented evidence Patient 2's orthopedic surgeon (SURG 8) evaluated and provided emergent medical care to Patient 2 in the PACU. After 5:55 p.m. there is no documented evidence CRNA 4 returned to the Patient 2's bedside to address Patient 2's emergent medical needs.

During a record review of Patient 2's medical record, titled "Physician Progress Note" and "Discharge Summery", dated 10/27/23 at 2:47 p.m. and 10/31/23 at 10:48 a.m., respectively, written by ICU physician (MD 5), the notes indicated MD 5 cared for Patient 2 in the ICU. The notes indicated "Postop (after surgery) found to be hypotensive (low blood pressure), tachycardic (irregular heartbeat) potassium of 7.2 (normal potassium blood level is between 3.5 to 5; high level can damage the heart or cause heart attack), with respiratory acidosis (when lung unable to remove or exhale extra gases such as carbon dioxide [CO2] from lung). The Note written by MD 5 indicated "chest x-ray (picture or images of inside body taken a special machine) found volume loss on the left side suggestive of right lung intubation (when a tube placed inside the breathing airway into the left lung; breathing tube was only providing oxygen to the right lung; with normal intubation, placing of the breathing tube, must supply the right and the left lungs) during procedure, patient was transferred to ICU". The record further indicated "Acute hypercapnic respiratory failure (when lung unable to exhale CO2 gases and end up increasing the level in the blood and causing breathing failure) after the surgery: Could be related to right lung intubation during the procedure." The record additionally indicated during surgery, Patient 2 suffered, "Acute blood loss anemia: related to surgical intervention and IV fluids. received 2 units PRBC (Packed Red Blood Cell, or PRBC is unit of blood given; 2 bags of blood)". The record further indicated Patient 2 "eventually got extubated (breathing tube removed)".

In a telephone interview with CRNA 4, on 5/29/24, at 1:40 p.m., CRNA 4 indicated CRNAs are independent and do not require physician orders or supervision. CRNA 4 acknowledged he provided anesthesia services to Patient 2 and was allowed to order medications and tests as needed. CRNA 4 stated he does not review his cases with anesthesiologist and was not the practice at the hospital. CRNA 4 stated he does remember Pt 2 but unable to comment on details without looking at the Pt 2's medical record. CRNA 4 stated he remembers that he transferred Pt 2 to PACU and left the Pt 2 without any distress.

3. Review of Patient 3's, titled "Anesthesia Record" (record of medications given and monitoring performed during the surgery when the patient was put to sleep), dated 10/13/23 was written by CRNA 3. The record indicated Pt 3 was having knee surgery. Before surgery started and after CRNA 3 started giving medications, the record indicated "CPR [cardiopulmonary resuscitation, life saving measures to restart the heartbeat]" were started around 7:30 a.m. The record indicated a wide range of medications were administered during the period of 7:06 AM to 8:45 AM on 10/13/23. The following medications marked as given:
i. Sevoflurane Anesthesia gas (an inhalation gas used to put patient to sleep during surgery and can decrease blood pressure and heart rate),
ii. Fentanyl 100 mcg ("mcg", microgram, a unit of measure; opioid pain medication that can decrease or stop breathing),
iii. Versed (midazolam) 2 mg ("mg" or milligram, a unit of measure; a sedative and anti-anxiety medication; slow heart rate and lower blood pressure),
iv. Propofol a total of 200 mg (high risk sedative that can decrease or stop breathing),
v. Anectine 100mg (succinylcholine; a muscle paralyzing agent; cause paralyses all muscle function, such as breathing),
vi. Albumin 25%- 25 mL (a human blood component; "%" or percent was a measure of concentration and "mL" is milliliter, a measure of volume),
vii. Ancef (or cefazolin, an antibiotic) 2 gm,
viii. Norepinephrine (or Levophed, used to raise the blood pressure) no dosage indicated,
ix. Epinephrine (used to treat low blood pressure and allergic reaction) entered as "100" for the dosage,
x. Hydrocortisone (a steroid, anti-inflammation drug) 100 mg,
xi. Epinephrine IV drip; No marked dosage or concentration,
xii. IV fluid, Lactated Ringers 3 liter ("liter" is measure of volume,
xiii. Benadryl (or Diphenhydramine, used for allergy) 100mg,
xiv. Famotidine 20mg (ulcer medication, also used for allergy),
xv. Tranexamic acid (or TXA- used to stop or prevent bleeding) 1 gm.

The record further indicated surgery was never started. The record indicated that CRNA 3 provided anesthesia services in the OR without the medical orders or direction from an anesthesiologist. The document timeline after 7:15 a.m., did not document presence of carbon dioxide (gas expelled during exhalation and indicates a breathing tube in the lungs), respirations (breathing in oxygen and breathing out carbon dioxide), ventilation (machine delivery of oxygen and respirations), oxygen saturation (percent level of blood oxygen), and heart rhythm. The record did not show any documented evidence on difficulties with placing the breathing tube or supplying oxygen to Patient 3. There is no documented evidence CRNA 3 followed ACLS (Advanced Cardiac Life Support, life saving measures and medications) per hospital policy.

Review of Patient 3's medical record, titled "Code Blue Record" ( Code blue, a medical emergency that requires immediate intervention when breathing or heart stopped working in a patient), hand recorded by the OR nurse, dated 10/13/23, with time range of 7:36 a.m. to 8:15 a.m., the record indicated that at CPR started at 7:36 AM, and after two minutes, a recorded Heart Rate (HR or heartbeat) of 123 and a normal blood pressure range was recorded. The record written by OR nurse, documented from 7:38 a.m. to 815 a.m., CRNA 3 continued to give medication in rapid succession as follows:
At 7:47 Am- Epinephrine drip (given as ongoing infusion)
7:53 AM- Vasopressin 3 units
7:54 AM Phenylephrine 200 mg IV
7: 56 AM - Atropine 0.4 mg IV
7:57 AM- Levophed 4mg drip
7:57 AM- Hydrocortisone 100mg IV
0800 AM- HR 131 and BP was 180/85
08:03 AM- Albumin 25%- 50 mL
8:12 AM- Sodium Bicarbonate 1 amp
8:15 AM- Pepcid 20 mg IV
8:29 AM- "Patient transferred to PACU in stable but critical condition."
The documented code blue record did not provide any evidence that CRNA 3 followed hospital's policy and the ACLS guidelines on medications and procedures for code blue.
During a review of Patient 3's medical record, titled "Orders" (medication, tests, and treatment orders), dated 10/13/23, the record indicated CRNA 3 was described in Electronic Medical Record (EMR) as the "Ordering Physician", "Responsible Provider", "Supervising Provider: none listed", and a "Doctor Cosign: Not required". In addition, CRNA 3 wrote "Orders" for Patient 3 to receive "routine Fresh Frozen Plasma" (FFP- blood product given to patients with abnormal clotting or active bleeding and can have life-threatening reactions) for "active bleed" and "angioedema [systemic swelling under the skin]". The record further indicated a verbal order to nursing staff in PACU to start a "routine" infusion of "Norepi (or Norepinephrine, medication to increase blood pressure)". There was no documented evidence Patient 3 had surgery or bleeding. There was no documented evidence that CRNA 3 discussed his medications orders with anesthesiologist or another physician for giving blood products for reasons unapproved by Food and Drug Administration (FDA, a federal agency that regulate the drug use and approve indication for use of medications).
During Review of Resident 3's medical Record, two days after anesthesia record titled, "SOAP Note" (SOAP stands for Subjective, Objective, Assessment and Plan, a format to explain facts and events in the medical record), dated 10/15/23, at 9: 32 AM, written CRNA 3. The note indicated Patient 3 experienced low Blood Pressure (or BP, means the force of blood pushing against the walls of arteries with each heart beats blood pumped into the arteries) and an apparent allergic reaction after anesthesia induction (means putting patient to sleep by use of drugs to prevent from feeling pain during the procedure or surgery while monitoring the breathing) in preparation for surgery. The CRNA 3's documented intra operative events indicated that there were difficulties with the airway and had to "pin the tongue ... and perform a digit intubation ...ventilation proved challenging ...with peak pressures exceeding 50 [resistance to giving oxygen via a breathing tube. Allowing pressures over 40 can cause lung injury] to the patient". CRNA 3 documented that "successful return of spontaneous circulation was achieved after one round [one dose] of epinephrine and chest compressions. The CRNA's note further indicated when Resident 3 was transferred to PACU (Post-Anesthesia Care Unit; a hospital that stabilized the patient right after the surgery) "The patient still had significant tongue swelling ... In response, I gave 1 gram of Tranexamic Acid (also known as TXA, a drug used to treat bleeding or control bleeding) and ordered FFP (Fresh Frozen Plasma; a blood product given for bleeding or at risk of bleeding) as well as relevant lab test and imaging." The note did not describe the clinical reason for use of TXA and FFP in the setting of apparent allergic reaction and was not approved by a medical doctor or surgeon.

During review of the Patient 3's medical record, titled "Consultation Note", dated 10/16/23, at 11:31 a.m., written by MD 7, the record indicated Patient 3 suffered a "Pneumothorax [puncture of the lung], right" as evidenced on chest x-ray. The record further indicated "Review of OR records do not show any clear cardiac arrest records etc. and raises suspicion of anaphylaxis or at least a drug reaction". There was no documented evidence of a lung procedures to cause pneumothorax, except for intubation performed by CRNA 3 on 10/13/23.
On 5/20/24 at 10:30 a.m. 5/17/24 at 8:30 a.m., 5/24/24 at 4:00 p.m. and 5/29/24 at 8:13 p.m., the hospital's, Accreditation Manager, attempted to schedule an interview with CRNA, but she stated he has not been available.

4. During review of Patient 5's medical record, titled "History and Physical/Admission Notes", dated 11/15/23, written by Medical Doctor 10 (MD 10), the record indicated Patient 5 was a 91 year old with diagnosis of end-stage renal disease on dialysis (kidney was not working well and blood had to be filtered by a machine called dialysis) was admitted to hospital to be evaluated for rectal (or rectum) bleeding and anemia (low blood counts). The record further indicated the heart doctor recommended "conservative treatment" due to age and other medical conditions.

During a record review of the Pt 5's intraoperative (events during surgery) medical record, titled "Anesthesia Record", dated 11/19/23, with anesthesia time range of 12:28 p.m. to 1:32 p.m., and surgery time 12:42 to 12:59 p.m., was handwritten by CRNA 6. The record indicated that CRNA 6 provided anesthesia services during surgery without the medical orders or direction from an anesthesiologist. The handwritten record was difficult to read and illegible to detail of dose and drug name. The record indicated during the intra-operative period CRNA 6 procured, prescribed, and administered "High Risk Medications" (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body's movement as follow: Propofol (high risk sedative that can decrease or stop breathing), an anesthesia gas called Sevoflurane (volatile anesthetic that provides hypnosis, amnesia during surgery and can decrease blood pressure and heart rate), and glycopyrrolate (medication to decrease secretions. It can decrease or stop heartbeat, and not used in patients that are bleeding with heart problems). Further review of the documented intra-operative events, glycopyrrolate was given. The record indicated right after glycopyrrolate administration, Pt 5's heart rate and blood pressure were not recorded, and "CPR [cardiopulmonary resuscitation, lifesaving efforts]" was started. The record indicated a breathing tube was insert at 1:00 p.m. during CPR, the chart indicated CRNA 6 prescribed and administered multiple medications, but the names and times were illegible.

During a record review of the Pt 5's medical record, titled, "Nursing/Clinical Info", dated 11/19/23, at 8:43 p.m., the nursing documentation indicated that Pt 5 became "hypotensive [low blood pressure] and bradycardic [slow heart rate, below 60] despite medical interventions by CRNA 6 ... The record indicated Anesthesiologists (ANS 3 and ANS 6) and another CRNA arrived to help. The OR nurse documented "Intervention medications initiated by anesthesia team at 12:59 p.m. which included 8 rounds of Epinephrine (helped raise the blood pressure), 5 rounds of bicarb ("bicarb" is same as Sodium Bicarbonate, used to help with blood acidity), 2 doses of cacl ("cacl" same as Calcium Chloride, a high dose of calcium used to reverse high potassium level in body), 4 doses of atropine (drug used to treat slow heartbeat), 1 dose of vasopressin (drug used to raise blood pressure), fluid bolus (giving IV fluid), and Epi drip( infusion of Epinephrine)". The OR nurse documented that ANS 3, ANS 6, and MD 6 ended life saving measures "due to no pulse and no ETCO2." There was no documented evidence of a title "Code Blue Record" form was completed per policy. There was no documented evidence indicating the amount, dose, or times of medications, nor patient response to treatment, such as blood pressure, heart rate, heart rhythm, respiration, oxygen levels, etc. There was no documented evidence CRNA 6 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures.


During an interview with CRNA 6 on 5/22/24, at 10:13 AM, and record review of the Pt 5's medical records titled "Anesthesia Record", the nursing "Surgical Documentation", dated 11/19/23, at 8:43 p.m., and the "Nursing/Clinical Info" dated 11/19/23 were discussed with CRNA 6. CRNA 6 stated the anesthetist can diagnose, prescribe medications, order labs, order treatments, and render medical services to patients; it was all "within [CRNAs] scope of practice" and there are "no limitations" inside the hospital. CRNA 6 indicated he works "independently" without physician orders, supervision, or directions. CRNA 6 stated he was not in agreement with the nursing entries indicating Pt 5 became unstable during the case, the procedure was "attempted", but was "unable to complete" due to Pt 5's low blood pressure and heart rate. CRNA 6 stated he recalled Pt 5, and there were "no problems" during the case. CRNA 6 indicated, he obtained and administered propofol to Pt 5 and a few minutes later gave Glycopyrrolate. The record indicated the blood pressure and heart rate dropped. CRNA 6 stated "at the end of the case", Pt 5 lost pulses and blood pressure. CRNA 6 in