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Based on observation, interview and record review, the facility failed to be in compliance with Federal, State and Local laws when:

1. The hospital failed to adhere to required Cardiovascular Surgery Service Staff as set forth in the California Code of Regulations Title 22 section 70435 (b)(2) when three of the three sampled patients, (Patient (Pt) 1, Pt 2 and Pt 3), did not have a minimum of three surgeons constitute a surgical team for the performance of cardiovascular operative procedures which require extracorporeal [outside the body] bypass [a procedure that temporarily takes over the functions of the heart and lungs during open-heart surgery]. The hospital also failed to meet the conditions set forth in the program flex (allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass) approved by California Department of Public Health (CDPH) with a condition requiring first assistant to be an independent and fully qualified surgeon and a Physician Assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures. (Refer to A021)

2. The hospital failed to ensure the contracted vendor for Food and Nutrition Services met the organizational standards as required by State laws and regulations as specified in the State Health and Safety Code (HSC)1265.4 statue when the Executive Chef Manager, the position responsible for the day-to-day supervision of dietetic services at BHC Campus 2 was not qualified. (Refer to A023 finding 1)

3. The hospital failed to ensure the contracted vendor for Food and Nutrition Services met the organizational standards as required by State laws and regulations as specified in the Title 22, Section 70275(a), when the hospital did not have a Registered Dietitian (RD) provide guidance and oversight to the food service operations manager and staff of the dietetic service at a sufficient duration and frequency at two of two campuses (Main Hospital Campus 1 and BHC Campus 2). (Refer to A023 finding 2)

4. The hospital failed to ensure the contracted vendor for Food and Nutrition Services met the organizational standards as required by State laws and regulations as specified in the Title 22, Section 70275(a), when the hospital did not have a RD reporting to hospital administration. (Refer to A023 finding 3)


The cumulative effect of this systemic failure resulted in the facility's substantial noncompliance with federal, state and local laws.

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

1. The GB did not provide sufficient oversight and resources to ensure the hospital's contracted service for Food and Nutrition Services employed full-time equivalent (FTEs) Registered Dietitians (RD) to provide clinical nutrition care. Four of five full-time equivalent (FTEs) Registered Dietitians (RDs - Lead RD, RD 2, RD 3, RD 4, RD 5) did not work on the premises or conduct face-to-face patient nutritional physical assessments which resulted in the provision of medical nutrition therapy that was not in accordance with the hospital's position description for the Registered Dietitian or the current standards of practice. (refer to A083)

1a. The medical staff office did not have a system in place to ensure adequate and qualified personnel performed open heart surgery with bypass and complied with the written agreement for the 3-surgeon rule in accordance with medical staff bylaws and California Code of Regulations, Title 22 Division 5 article 6 section 70435(b) (2). The hospital failed to evaluate on an annual basis personnel who performed open heart surgeries with bypass. The hospital failed to have an on-going quality assurance program that included a methodology for periodic review of the effectiveness of the 3-surgeon rule. The hospital failed to maintain a record of emergent cases where the 3-surgeon rule was not applied. (Refer to A347, findings 1, 2 and 3)

2. The GB did not provide oversight and resources to ensure the hospital provided surgical services in a well-organized manner in accordance with hospital policy and professional standards of practice when:

2a. The hospital did not have program requirements for residents (RS - physicians who have completed medical school and are undergoing postgraduate training in a specific specialty) listed, did not have a process to validate before procedures if two of the two sampled residents RS 1 and RS 2 and one of the one registered nurse first assistants (RNFA) 1 performing the surgery were competent and meets the credentialing and residency program requirements. The hospital did not have active standardized procedure as required by board of registered nurses to support RNFA performing Endoscopic Vein Harvesting (EVH -is a minimally invasive technique used during open heart surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries). (Refer to A-0945)

2b. The hospital failed to ensure that operative reports included description of the significant surgical tasks that were conducted by practitioners other than the primary surgeon when two of two sampled patients, Patient (Pt) 1 and Pt 2 underwent open heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure and Endoscopic Vein Harvesting ( EVH -is a minimally invasive technique used during CABG surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries) part of the procedure was completed by the assistant and their operative report did not describe the EVH portion of the procedure was completed by a practitioner other than the surgeon. (Refer to A-0959)

3. The GB did not provide sufficient oversight and resources to ensure the hospital had a well-organized and effective nursing service when:

3a. Nursing staff did not administer medications in accordance with physician's order for Patient 5 and Patient 6 (refer to A405, Findings 1 and 2).

3b. Nursing staff at the Behavioral Healthcare Campus 2 did not review the clinical nutritional care of patients and did not complete meal intake documentation in the medical records in accordance with hospital policies. (Refer to A-0398 Finding 1)

3c. One of two patients (Pt 31) did not have vital signs completed every two hours when Pt 31 was given an Emergency Severity Index (ESI-a 5 level scale used by triage nurses to indicate the seriousness of the patient's condition and the resources needed, ESI 1 being the most serious) of 2 according to the hospital's P&P titled, "MOD ED.1.04 Standard of Care Policy." (Refer to A-0398 Finding 4)

3d. One of one patients (Pt 10) did not have urine output measured and recorded in the medical record for a 24 hour period, a physical assessment performed by a student nurse was not validated by a registered nurse, and the events preceding a stroke alert activation and a rapid response team call were not documented by Pt 10's nurse, in accordance with the hospital's P&P titled, "PC.AD.1.08 Documentation Policy." (Refer to A-0398 Finding 5)

4. The GB did not provide sufficient oversight and resources to ensure the hospital protected and promoted each patient's rights when:

4a. Hospital staff did not provide Patient 10 care in a safe setting and did not treat Patient 10 and Patient 10's family members with respect and dignity. Hospital staff did not acknowledge and act promptly on a written grievance submitted by the family on behalf of Patient 10. (Refer to A144 and A119)

4b. Two of two sampled patients (Pt 28 and 29) were not given the right to make informed decisions when consents and discharge instructions were not interpreted by a qualified interpreter to ensure the patient could fully understand the information provided according to the hospital's policy and procedure (P&P) titled, "MOD.EAC.01.04.PR.01 Language Assistance Services (Including Interpreters) Procedure." (Refer to A131)

5. The GB did not provide sufficient oversight and resources to ensure the hospital met the regulatory requirements for the Condition of Participation for Infection Prevention and Control Programs as evidenced by multiple situations where staff did not follow infection control policies and procedures or standards of practice to keep a sanitary environment and reduce the risk of cross-contamination and infections in patient, staff and visitors. (refer to A750, Findings 1 through 7)

6. The GB did not provide sufficient oversight and resources to ensure the hospital's pharmaceutical services met the needs of patients when:

6a. Drugs in the pharmacy medication freezer were not stored in accordance with manufacturer instructions and room temperatures were not monitored in four of four medication storage rooms containing non-refrigerated medications. These failures had the potential to expose patients to unstable and/or unsterile medications potentially leading to therapeutic failure in patients. (Refer to A-0491)

6b. The hospital failed to have an effective system in place to identify loss or theft of all controlled drugs (drugs that are regulated by the federal government due to potential of abuse/addiction) dispensed from 25 of 25 operating room (OR) Anesthesia Workstations (AWS, a type of automated dispensing cabinet [ADC]). In addition, the hospital was unable to facilitate the Drug Diversion Prevention Committee's ability to accurately review controlled drug usage trends and patterns according to hospital policy for anesthesia providers (highly trained healthcare professionals who administer drugs during surgery). These failures had the potential for unsafe controlled drug use, lack of accountability, risk of controlled drug theft or unauthorized use and patient harm. (Refer to A-0494)

6c. The hospital failed to ensure documentation of a completed AIMS assessment (AIMS, a formalized rating scale used to assess unusual movements) for Patient 9 who was administered multiple antipsychotics (drugs used to treat symptoms of psychosis in conditions like schizophrenia). This failure had the potential to increase Patient 9's risk of side effects including involuntary/jerky movements, muscle stiffness, and tremors that could interfere with daily activities, cause distress and/or overall reduced quality of life. (Refer to A-0500)

6d. The hospital failed to ensure that the IV (intravenous, through the vein) sterile (germ free) compounding (mixing) room had walls that were cleanable, and compounding pharmacy staff had completed required competencies consistent with standards of practice. This failure had the potential to expose patients to contaminated IV drugs. (Refer to A-0501)

6e. The hospital failed to ensure that outdated or unusable medications were not available for use. This had the potential for exposing patients to contaminated or ineffective medications. (Refer to A-0505)

7. The GB did not provide sufficient oversight and resources to ensure the hospital had an organized food and nutrition services when:

7. a. The position for the Registered Dietitian (Lead RD) did not have a role in providing oversight to the food service operations or guidance to the Director of Food and Nutrition Services (DFNS) at two of two campuses (Main Hospital Campus 1 and BHC Campus 2); (Refer to A- 0619 Finding 1)

7b. Professional standards of practice were not followed when the Clinical Nutrition Manager (CNM) position and Lead RD position were supervised by the DNFS. The DNFS was not a Registered Dietitian, had no healthcare credentials and would not be qualified to evaluate the professional skills of a RD. It is the responsibility of the Registered Dietitian to provide guidance and oversight to the DNFS. (Refer to A- 0619, Finding 2)

7c. The clinical nutrition screening, prioritization and assessment policy did not address the specialized nutritional needs for patients at the BHC Campus 2 when the nutrition risk screening policy was based on patients admitted to the general acute care hospital and did not reflect the nutrition risk factors specific to a behavioral health inpatient. As a result, the RDs would only assess the nutritional needs of behavioral health when they received a consult. (Refer to A- 0619, Finding 3)

7d. A system was not in place to recruit and hire Registered Dietitian's in accordance with the published job description and the professional standard to support face-to-face nutritional physical assessments of patients. Four of five full-time equivalent positions for RDs were hired with the knowledge the RDs were unable to be on the hospital premises, would perform their jobs remotely and not be able to conduct nutrition-focused physical exams (NFPE) on patients. (Refer to A-0619, Finding 4)

7e. Two food service workers (FSW 1 and FSW 2) were not competent in their job duties when incorrect portion sizes were used during a lunch meal observation on May 20, 2025, at the Main Hospital Campus 1 and May 22, 2025, at the BHC Campus 2. (Refer to A-0622)

8. The GB did not provide sufficient oversight and resources to ensure the hospital had a hospital-wide Quality Assessment and Performance Improvement Program (QAPI- is a systematic approach to improving the quality of care and services delivered to patients) when:

8a.The Director of Quality (DQ) could not provide the data that was being used to monitor the effectiveness of the approved Program Flex (a request to change or modify or deviate from the standard regulations) from 2022 that allowed the Cardiovascular (CV) Surgical Department to use an Advanced Practice Practitioner (APP-healthcare professional with advanced education such as a nurse practitioner or physician assistant) as the 2nd assistant during cardiac surgeries that require bypass. (Refer to A-283 & A-308)

8b. Health Information Management (HIM) Department (manages patients' data, ensuring its quality, integrity, and security) was not reporting their quality data to the quality department and thus it was not being monitored and tracked by Quality. (Refer to A-283 & A-308)

9. The GB did not provide sufficient oversight and resources to ensure the hospital had medical record services under qualified supervision, safeguarding protected sensitive health information and adequately supporting prompt completion of medical records, with a patient census of 332 at Campus 1 and 38 at campus 2 as evidenced by:

9a. The facility failed to employ a qualified individual to supervise the medical record services, as the assigned Director of Health Information Management (HIM) lacked the required credential. (Refer to tag A-0432).

9b. The facility failed to identify and implement safeguards for special categories of sensitive health information, specifically genetic testing results and reproductive health information, as required under state and federal law. (Refer to tag A-0441).

9c. The facility failed to ensure that medical records were completed promptly following patient encounters in three clinics operating under the hospital's license. In three of three sampled outpatient specialty clinic records, physician documentation was incomplete or lacking for days following the date of service visit. (Refer to tag A-0450).

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

Based on observation interview and record review the facility failed to protect and promote each patient's rights when;

1. Patient 10 experienced a change in level of consciousness, and a respiratory arrest and the circumstances leading up to the events were not clearly explained in either instance to Pt 10's daughter or documented in the medical record; Pt 10 was left soiled in her bed for over two hours despite Pt 10's daughter asking the staff to change Pt 10; The nursing staff in the ICU were laughing and talking during the time Pt 10's family was there to say goodbye to Pt 10; Pt 10 bit her tongue at the time her breathing tube was removed (extubation) resulting in pain and bleeding, the nursing staff did not administer an adequate amount of the medications ordered for comfort care after Pt 10 experienced extreme distress following extubation; and Pt 10's body was removed from the hospital approximately five hours after her death and transported to a mortuary in a nearby city without the hospital first notifying Pt 10's daughter and obtaining consent. Pt 10's daughter was informed by the hospital Pt 10 was transported due to patient being too big for the hospital's morgue. (Refer to A144)

2. Two of two sampled patients (Pt 28 and 29) were not given the right to make informed decisions when consents and discharge instructions were not interpreted by a qualified interpreter to ensure the patient could fully understand the information provided according to the hospital's policy and procedure (P&P) titled, "MOD.EAC.01.04.PR.01 Language Assistance Services (Including Interpreters) Procedure." (Refer to A131)

3. The facility grievance process was not implemented for prompt resolution when Patient (Pt) 10's family member sent a grievance through certified mail, and it was not acknowledged for sixteen days after it was received by the hospital. (Refer to A119)

The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.

Based on interview and record review the hospital failed to create a hospital-wide Quality Assessment and Performance Improvement Program (QAPI- is a systematic approach to improving the quality of care and services delivered to patients) when:

1.The Director of Quality (DQ) could not provide the data that was being used to monitor the effectiveness of the approved Program Flex (a request to change or modify or deviate from the standard regulations) from 2022 that allowed the Cardiovascular (CV) Surgical Department to use an Advanced Practice Practitioner (APP-healthcare professional with advanced education such as a nurse practitioner or physician assistant) as the 2nd assistant during cardiac surgeries that require bypass. (Refer to A-283 & A-308)

2.Health Information Management (HIM) Department (manages patients' data, ensuring its quality, integrity, and security) was not reporting their quality data to the quality department and thus it was not being monitored and tracked by Quality. (Refer to A-283 & A-308)

The cumulative effect of these systemic problems resulted in the facility's inability to comply with statutory requirements for Quality Assessment and Performance Improvement and placed all patients at risk of not receiving care in a safe setting.

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. Three of three cardiovascular (heart and blood vessels) surgery cases requiring the use of an extracorporeal (outside the human body) coronary (heart) bypass machine (a machine that temporarily takes over the function of the heart and lungs, putting oxygen in the blood and pumping that blood throughout the body) did not have the required three members of the Cardiovascular (CV) surgical team in the Operating Room (OR) during a CV surgery requiring a coronary bypass machine. (Refer to A-0347 Finding 1.)

2. The medical staff failed to ensure that an annual review of all qualified non-surgeons who participated in CV surgery requiring a coronary bypass machine was performed and that the annual review included letters of competency from the supervising physician(s). (Refer to A-0347 Finding 2.)

3. The medical staff failed to ensure that the hospital's on-going quality assurance program included a methodology for periodic review of the effectiveness of the required three members of the CV surgical team in the OR during a CV surgery requiring a coronary bypass machine. (Refer to A-0347 Finding 3.)

4. The medical staff failed to ensure the hospital created and maintained a record of any emergency situations in which the required three members of the CV surgical team in the OR during a CV surgery requiring a coronary bypass machine were not present. (Refer to A-0347 Finding 4.)


The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality care in a safe environment and placed patients undergoing CV surgery at risk for many types of adverse events, including; but not limited to, strokes, heart attacks, and death.

Based on observations, interviews and record reviews the hospital failed to have a well-organized and effective nursing service when:

1. Three of three patients (Patient 45, 46, and 47) were reviewed for clinical nutrition care at BHC Campus 2 and had incomplete meal intake documentation in the medical record. (Refer to A-0398 Finding 1)

2. One of five sampled Glucometers (a device for measuring the concentration of glucose in the blood) had controls performed (a way to check the blood glucose meter and test strips are working together properly to deliver accurate results) with expired control solutions (solution use to test the functionality of meter and strips) not in accordance with the hospital's P&P titled " PC.AD.1.38 Blood Glucose Monitoring,"(Refer to A-0398 Finding 2)

3. One of one patient (Pt 27) did not have a temperature and respiration rate assessed and documented every one hour while receiving intravenous (IV-in a vein) magnesium sulfate (a high-risk medication to help prevent seizures [sudden uncontrolled bursts of electrical activity in the brain]) according to the hospital's P&P titled, "MOD L&D.1.18 Magnesium Sulfate Management In Obstetrics."(Refer to A-0398 Finding 3)

4. One of two patients (Pt 31) did not have vital signs completed every two hours when Pt 31 was given an Emergency Severity Index (ESI-a 5 level scale used by triage nurses to indicate the seriousness of the patient's condition and the resources needed, ESI 1 being the most serious) of 2 according to the hospital's P&P titled, "MOD ED.1.04 Standard of Care Policy."(Refer to A-0398 Finding 4)

5. One of one patients (Pt 10) did not have urine output measured and recorded in the medical record for a 24 hour period, a physical assessment performed by a student nurse was not validated by a registered nurse, and the events preceding a stroke alert activation and a rapid response team call were not documented by Pt 10's nurse, in accordance with the hospital's P&P titled, "PC.AD.1.08 Documentation Policy."(Refer to A-0398 Finding 5)

6. One of six sampled patients (Patient (Pt) 5's Nozin (a nasal sanitizer swab used to kill germs in the nose) nasal swab was not administered with the correct number of swabs in each nostril as ordered by the physician and as instructed by the manufacturer. (Refer to A-0405 Finding 1)

7. One of six sampled patients (Pt 6) propofol (a potent drug used for sedation with a high potential for abuse/misuse) was administered without an independent double check (second nurse witness/co-sign) in accordance with the hospital's policy and the propofol dose was adjusted without documentation of the Richmond Agitation-Sedation Scale score (RASS, a medical scale used to measure the agitation or sedation level) as ordered by the physician. (Refer to A-0405 Finding 2)

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

Based on observation, interview and record review the hospital failed to provide medical record services under qualified supervision, safeguarding protected sensitive health information and adequately supporting prompt completion of medical records, with a patient census of 332 at DMC-Campus 1 and 38 at DBHC-campus 2 as evidenced by:

1. The facility failed to employ a qualified individual to supervise the medical record services, as the assigned Director of Health Information Management (HIM) lacked the required credential.

This failure resulted in the facility's inability to ensure professional oversight of medical records/health information management, placing patients at risk for documentation errors, legal noncompliance, and privacy violations (Refer to tag A-0432).

2. The facility failed to identify and implement safeguards for special categories of sensitive health information, specifically genetic testing results and reproductive health information, as required under state and federal law.

This failure resulted in the potential unauthorized access, use, or disclosure of legally protected information, violating patient rights and increasing the risk of discrimination and legal liability (Refer to tag A-0441).

3. The facility failed to ensure that medical records were completed promptly following patient encounters in three clinics operating under the hospital's license. In three of three sampled outpatient specialty clinic records, physician documentation was incomplete or lacking for days following the date of service visit.

This failure resulted in delayed entry or validation of clinical information, which jeopardized continuity of care, delayed billing, and increased the risk of omitted details or errors in documentation accuracy (Refer to tag A-0450).

The cumulative effect of these systemic failures resulted in improper oversight of the facility's documentation practices, inadequate protection of sensitive health information, and delays in medical record completion-ultimately compromising patient care, privacy, and organizational compliance. Credentialed HIM leadership is essential to ensuring regulatory compliance, safeguarding protected health information, and maintaining a timely and accurate medical record system. The facility's failure to assign qualified personnel in this key role contributed to broad noncompliance under this Condition of Participation.

Based on observation, interview and record review, the hospital failed to have pharmaceutical services meet the needs of patients when:

1. Drugs in the pharmacy medication freezer were not stored in accordance with manufacturer instructions and room temperatures were not monitored in four of four medication storage rooms containing non-refrigerated medications. These failures had the potential to expose patients to unstable and/or unsterile medications potentially leading to therapeutic failure in patients. (Refer to A-0491)

2. The hospital failed to have an effective system in place to identify loss or theft of all controlled drugs (drugs that are regulated by the federal government due to potential of abuse/addiction) dispensed from 25 of 25 operating room (OR) Anesthesia Workstations (AWS, a type of automated dispensing cabinet [ADC]). In addition, the hospital was unable to facilitate the Drug Diversion Prevention Committee's ability to accurately review controlled drug usage trends and patterns according to hospital policy for anesthesia providers (highly trained healthcare professionals who administer drugs during surgery). These failures had the potential for unsafe controlled drug use, lack of accountability, risk of controlled drug theft or unauthorized use and patient harm. (Refer to A-0494)

3. The hospital failed to ensure documentation of a completed AIMS assessment (AIMS, a formalized rating scale used to assess unusual movements) for Patient 9 who was administered multiple antipsychotics (drugs used to treat symptoms of psychosis in conditions like schizophrenia). This failure had the potential to increase Patient 9's risk of side effects including involuntary/jerky movements, muscle stiffness, and tremors that could interfere with daily activities, cause distress and/or overall reduced quality of life. (Refer to A-0500)

4. The hospital failed to ensure that the IV (intravenous, through the vein) sterile (germ free) compounding (mixing) room had walls that were cleanable, and compounding pharmacy staff had completed required competencies consistent with standards of practice. This failure had the potential to expose patients to contaminated IV drugs. (Refer to A-0501)

5. The hospital failed to ensure that outdated or unusable medications were not available for use. This had the potential for exposing patients to contaminated or ineffective medications. (Refer to A-0505)

The cumulative effects of these systemic failures resulted in the hospital's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the Conditions of Participation: Pharmaceutical Services.

Based on observation, interview and record review, the hospital failed to ensure an organized food and nutrition services when:

1. a. The position for the Registered Dietitian (Lead RD) did not have a role in providing oversight to the food service operations or guidance to the Director of Food and Nutrition Services (DFNS) at two of two campuses (Main Hospital Campus 1 and BHC Campus 2); (Refer to A- 0619 Finding 1)

b. Professional standards of practice were not followed when the Clinical Nutrition Manager (CNM) position and Lead RD position were supervised by the DNFS. The DNFS was not a Registered Dietitian, had no healthcare credentials and would not be qualified to evaluate the professional skills of a RD. It is the responsibility of the Registered Dietitian to provide guidance and oversight to the DNFS.(Refer to A- 0619, Finding 2)

c. The clinical nutrition screening, prioritization and assessment policy did not address the specialized nutritional needs for patients at the BHC Campus 2 when the nutrition risk screening policy was based on patients admitted to the general acute care hospital and did not reflect the nutrition risk factors specific to a behavioral health inpatient. As a result, the RDs would only assess the nutritional needs of behavioral health when they received a consult. (Refer to A- 0619, Finding 3)

d. A system was not in place to recruit and hire Registered Dietitian's in accordance with the published job description and the professional standard to support face-to-face nutritional physical assessments of patients. Four of five full-time equivalent positions for RDs were hired with the knowledge the RDs were unable to be on the hospital premises, would perform their jobs remotely and not be able to conduct nutrition-focused physical exams (NFPE) on patients. (Refer to A-0619, Finding 4)

2. Two food service workers (FSW 1 and FSW 2) were not competent in their job duties when incorrect portion sizes were used during a lunch meal observation on May 20, 2025, at the Main Hospital Campus 1 and May 22, 2025, at the BHC Campus 2. (Refer to A-0622)


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 patients in compliance with the Condition of Participation for Food and Dietetic Services.

Based on observations, interview and record review, the hospital failed to meet the regulatory requirements for the Condition of Participation for Infection Prevention and Control Programs as evidenced by:

1. Two of four ice machines were not maintained according to the hospital's policy titled, "Ice Machines Cleaning". (Refer to A-0750 Finding 1)

2. Ice was found in two open plastic cups in the patient nutrition freezer in the Labor and Delivery patient nutrition room and not according to the hospital's P&P titled, "Ice Handling." (Refer to A-0750 Finding 2)

3. There was no monitoring of potentially hazardous foods prepared from ingredients stored at ambient (temperature of the surrounding environment) room temperature at the Behavioral Healthcare (BHC) Campus 2. (Refer to A-750 Finding 3)

4. Food Service Worker (FSW) 2 did not restrain facial hair when serving food for the lunch meal service on May 22, 2025, at the BHC Campus 2. (Refer to A-750 Finding 4)

5. Raw meat was stored above ready to eat food in a reach-in refrigerator at the Main Hospital Campus 1 retail area. (Refer to A-750 Finding 5)

6. The hospital failed to ensure that Gastroenterologist (DR 4 - medical doctor specializing in the digestive system and related organs) had eye protection during the entire colonoscopy procedure for Patient (Pt) 11. (Refer to A-750 Finding 6)

7. Pt 1's open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) was performed in Operating Room (OR) 15 that had flooring with cracks. (Refer to A-750 Finding 7)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality care in a safe and sanitary environment and place patients and staff at risk of cross contamination and post operative infection.

Based on observation, interview and record review, the hospital failed to provide surgical services in a well-organized manner in accordance with hospital policy and professional standards of practice when:

1. The hospital did not have program requirements for residents (RS - physicians who have completed medical school and are undergoing postgraduate training in a specific specialty) listed, did not have a process to validate before procedures for two of two sampled residents RS 1 and RS 2 performing the surgery were competent and meets the credentialing and residency program requirements. The hospital did not have active standardized procedure as required by board of registered nurses for one of one registered nurse first assistants (RNFA) 1 to support RNFA performing Endoscopic Vein Harvesting (EVH -is a minimally invasive technique used during open heart surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries). (Refer to A-0945)

2. The hospital failed to ensure that operative reports included description of the significant surgical tasks that were conducted by practitioners other than the primary surgeon when two of two sampled patients, Patient (Pt) 1 and Pt 2 underwent open heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure and Endoscopic Vein Harvesting ( EVH -is a minimally invasive technique used during CABG surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries) part of the procedure was completed by the assistant and their operative report did not describe the EVH portion of the procedure was completed by a practitioner other than the primary surgeon. (Refer to A-0959)

The cumulative effect of these systemic problems resulted in the failure to assure surgical services achieved high standards of care jeopardizing the health and safety of surgical patients.

Based on observation, interviews and record review, the hospital failed to adhere to required Cardiovascular Surgery Service Staff as set forth in the California Code of Regulations Title 22 section 70435 (b)(2) when:

Three of the three sampled patients, Patient (Pt 1, Pt 2 and Pt 3), did not have a minimum of three surgeons constitute a surgical team for the performance of cardiovascular operative procedures which require extracorporeal [outside the body] bypass [a procedure that temporarily takes over the functions of the heart and lungs during open-heart surgery]. The hospital also failed to meet the conditions set forth in the program flex (allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass) approved by California Department of Public Health (CDPH) with a condition requiring first assistant to be an independent and fully qualified surgeon and a Physician Assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures.

These failures resulted in potential risk to patients' life, health, and well-being during open-heart surgical procedures.

Findings:

During a concurrent observation and interview on 5/22/25 at 8:55 a.m. with the Registered Nurse Quality (QRN) 3 and Assistant Director of Nursing Surgical Services (ADON) in operating room (OR) 15, Patient (Pt) 1's surgical procedure was observed. Pt 1 underwent an open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure with three separate bypass were created during the surgery. The ADON validated and verified the staffing in the room for the entire procedure included a primary cardio thoracic surgeon (SUR -a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity) 1, resident surgeon (RS -a physician who has completed medical school and is undergoing supervised training in a specific surgical specialty to become a board-certified surgeon ) 1, Anesthesiologist (ANS - a medical doctor specializing in administering anesthesia and managing pain during medical procedures and surgeries) 1, Perfusionist (PER - healthcare professional who operates the heart-lung machine during certain surgeries, like open heart surgery, to maintain the patient's blood flow and oxygenation while the heart is stopped) 1, Registered Nurse First Assist (RNFA -is a Registered Nurse (RN) who works in an expanded role as a surgical first assistant and is responsible for working with the surgical team, in surgery, at the direction of the surgeon) 1, two RNs working as scrub nurses (work within the sterile field, directly assisting the surgeon with instruments and supplies during the procedure) and a circulating nurse (nurse who works outside the sterile field, managing patient care, coordinating with the surgical team, and ensuring a safe environment). The ADON stated that was the normal staffing for cardiovascular surgical cases at their hospital. The ADON stated that resident surgeon was the first assisting surgeon, and they typically have RNFA or Physician Assistant (PA -licensed medical professionals who work under the supervision of a licensed physician) as second assistant surgeon in the room. The ADON stated the hospital does not normally require scheduling two surgeons for the CABG procedures as the hospital has resident surgeons working with the primary surgeons. The ADON stated as far as he was aware, the resident surgeon was okay to be in the room as first assisting surgeon under the supervision of primary board-certified cardiothoracic surgeon. The ADON was unable to comment on what a resident surgeon can and cannot do at the hospital or during the surgical procedure. The ADON also was not able to comment on what year or specialty (specific area of training) residents were and stated the OR team does not have access or any way to validate, or to see or check program requirements (define the specific types and scope of surgical procedures they are authorized to perform at a hospital). The ADON stated he would have to defer to Director of Surgical Services (DSS) regarding residents and person in charge of residency program, however, his understanding was the surgeon was responsible for overseeing the residents.

During an interview on 5/22/25 at 10:55 a.m. with the DSS, the DSS stated he was aware of the state regulation and staffing requirement for cardiac vascular operative surgery cases. The DSS stated CABG cases must have a second physician in OR and do not require the second physician to be board certified cardiac surgeon. The DSS stated the hospital has cardiovascular surgery fifth year residents as second physician in the OR. The DSS stated the facility also has California Department of Public Health approved flex [program flexibility, which allows a hospital to temporarily deviate from specific regulatory requirements while still meeting the intent and purpose of those regulations] that allows them to staff mid-level providers [Physician assistant or RNFA] as third surgeon in cardiovascular cases requiring bypass. The DSS stated the resident surgeon's credentialing, privileges and program requirements were with "Hospital B" and not currently listed in their system. The DSS stated medical staff, and human resources would be able to speak about the process.

During a concurrent interview and record review on 5/22/25 at 11:00 a.m. with the ADON and DSS, Pt 2's electronic medical record (EMR) was reviewed for the "OR Intraoperative record". A review of Pt 2 's "OR intraoperative record" indicated Pt 2 had CABG surgery on 3/31/25. Pt 2 went in to the OR at 7:15 a.m., surgery start time was 8:13 a.m. and end time was 11:37 a.m. SUR 2 was the primary surgeon and was in the OR from 7:15 a.m. to 11:37 a.m. RS 2 was in the room from 7:45 a.m. to 8:15 a.m. [RS 2 left 2 minutes after the case started]. The ADON stated that record does not reflect any other surgeon was in the operating room besides SUR 1 during the entire surgical procedure and RS 2 was in the room for only two minutes at the start of surgery. The ADON stated the "OR Intraoperative report" indicated RNFA 1 and PA 1 were assisting SUR 1 with the case as well. The ADON stated PA 1 was in Pt 2's surgery from 7:15 a.m. to 11:37 a.m., same as SUR 1. The ADON stated RNFA 1 was in Pt 2's surgery from 7:15 a.m. to 9:51 a.m. The ADON stated he was unable to comment if the hospital had another surgeon available or on call for the duration of Pt 2's surgery, however, [he believed] the approved program flex allows them to have a PA or RNFA as third surgeon.

During a concurrent interview and record review on 5/22/25 at 11:05 a.m. with the ADON and DSS, Pt 3's EMR was reviewed for the "OR Intraoperative record". The review of Pt 3's "OR Intraoperative record" indicated Pt 3 had MITRAL VALVE (located between the left heart chamber) repair [removes and repairs part of the damaged mitral valve to allow the valve to fully close and stop leaking] and TRICUSPID VALVE (located on the right side of the heart between the right atrium and right ventricle) repair surgery on 3/31/25. Pt 3 went in to the OR on 3/31/25 at 7:42 a.m., surgery started at 8:47 a.m. and ended at 2:00 p.m. SUR 3 was the primary surgeon and was in the OR from 7:42 a.m. until 2:10 p.m. RS 2 was also listed as being present in the room from 7:42 a.m. until 2:10 p.m. The ADON stated he was not able to find any other surgeon listed as being present in the room during the procedure. The ADON stated he was unable to comment how RS 2 was present for both Pt 2 and Pt 3 as first assistant [second surgeon] at the same time. The ADON stated he could only go by the record, and it appears to him that RS 2 just went to check in Pt 2's room and stayed with Pt 3's procedure. The ADON stated the entry times do not appear correct as they are overlapping. The ADON validated even with overlapping of time RS 2 was only in the room for Pt 2 for two minutes after the surgery was started and no other independent and qualified surgeon except RNFA or PA was in the room during the procedure for both Pt 2 and Pt 3.

During an interview on 5/22/25 at 2:15 p.m. with SUR1, SUR 1 stated surgery for Pt 1 was uneventful and had no concerns with RS 1's performance. SUR 1 stated he was board certified in cardiac surgery and his understanding for number of surgeons in OR for CABG was, "As soon as you anticipate or as soon as patient goes on bypass [medical device that temporarily takes over the functions of the heart and lungs during surgery, especially open-heart surgery], expectation is to have two surgeons in the room and PA or RNFA could be the third". SUR 1 stated he was informed that residents could be assisting surgeon. SUR 1 stated he performs surgeries at a different facility in the town as well and they are, "Required to have two independent surgeons not residents" in operating room at all times for CABG procedures. SUR 1 stated he always has challenges getting the second surgeon at this hospital and has to call his colleagues from another hospital to assist him. SUR 1 stated the facility started using resident surgeons and it allowed some consistency in assuring first assistant as resident surgeon. SUR 1 stated he has not experienced any adverse outcomes with residents assisting. SUR 1 stated RS 1 currently requires supervision and would be practicing independently next year.

During a concurrent interview and record review on 5/22/25 at 4:37 p.m. with the DSS and Manager Accreditation and regulatory (MA) 1, Title 22 of the California Code of Regulations (CCR -is a comprehensive set of rules and regulations that govern various aspects of programs in California) section 70435 Cardiovascular Surgery Service Staff was reviewed, and the program flex document was reviewed. Title 22 CCR section 70435 indicated " ... (b) Cardiovascular operative service. (1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery. He shall be responsible for: (A) Implementing established policies and procedures. (B) Training and supervising the nurses and technicians in special techniques. (C) Training and supervising the clinical perfusionists. (2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b) (1) above ...". The review of "APPROVAL OF PROGRAM FLEXIBILITY" by CDPH dated October 18, 2022, indicated, " ... This letter is in response to the request submitted by [Hospital name] for program flexibility for California Code of Regulations T22 DIV5 CH1 ART6-70435(b)(2). The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass ... The use of the PA as a second assistant is at the discretion of the primary surgeon ... The facility is required to have a 3-team cardiovascular surgical team in the OR ... The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures ..." The DSS stated he was aware of the requirements set forth in CCR and conditions in the program flex. The DSS stated he was not able to comment if the RS 1 was an independent and qualified surgeon as required per CCR and flex approval conditions for first assistant to primary surgeon for CABG procedure. The DSS stated he was in charge of the surgery scheduling team [individuals responsible for coordinating all aspects of scheduling surgical procedures] and it was not standard practice at the hospital to identify first assistant in cardiac surgery cases during scheduling process. The DSS stated he was not able to comment on what criteria was used to determine that RS 1 or surgery residents were able to be scheduled as first assistant or second surgeon in the CABG. The DSS stated he would have to defer to Medical staff office for all the surgery resident requirements and would have to look into this practice. The MA 1 stated she was aware of the program flex and CCR staffing requirements and the MA 1 stated approved flex was addressed to her name. The MA 1 stated that she posted it in the lobby upon receiving the approval of program flex and shared with leadership team. The MA 1 stated she cannot comment if the hospital was in compliance with the condition set fourth in the approved flex. The MA 1 stated she does not know if it was appropriate to schedule RS 1 as first assistant to the primary surgeon and as a second surgeon in the CABG case. Both MA 1 and DSS stated they both understood and were aware that program flex authorization was to use mid-level provider as second assistant or third surgeon, they were still required to have second qualified surgeon in the room as first assist.

During an interview on 5/22/25 at 5:35 p.m. with the Chief Nursing Officer (CNO), the CNO stated she has reviewed the approved program flex and it was her understanding that surgery residents were not independently qualified surgeons to be the first assistant [second surgeon] in a cardiac surgery. The CNO stated surgery residents need supervision but she was not aware who was responsible at the facility for the oversight of the residency program. The CNO agreed that surgical staff should know what residents can and cannot do while the residents are at their facility assisting with surgeries in the OR. The CNO stated she would need to follow up with her leadership team and do additional research prior to commenting on compliance with state regulations for number of surgeons and conditions listed in the program flex to use mid-level provider [PA or FNP] as a third surgeon [second assistant to primary surgeon].

During an interview on 5/23/25 at 8:05 a.m. with the Chief Executive Officer (CEO) and the CNO, the CEO stated the hospital leadership team did their research, and had also reached out to "Hospital B" for guidance on surgical resident requirements. The CEO stated that they have reached out to their hospital's legal counsel and realized that the hospital leadership misunderstood the approved flex. The CEO stated the cardiovascular surgery team at this time was not meeting the CCR and program flex conditions. The CEO stated effective immediately, the OR team had made changes and now the hospital requires the second independent and qualified surgeon (first assistant) to be identified ahead of the scheduled surgery and present for the entire surgical procedure. The CEO stated that hospital will not be using surgical residents as first assistant moving forward.

During a concurrent interview and record review on 5/23/25 at 10:39 a.m. with the SUR 1 and Director of Quality (DQ), the SUR 1 stated he was the division chief for Cardiac Surgery. SUR 1 stated he had been the division chief for two years. SUR 1 stated he was just made aware of the approved program flex and he was not previously aware of the conditions in the flex. SUR 1 stated this was his first time looking at the conditions set forth in the approved program flex. SUR 1 stated he now understands that the program flex is for the use of PA or RNFA for the third surgeon requirement. SUR 1 stated, the hospital, moving forward, will set up a schedule for the surgeons and will have a qualified person as second surgeon or first assistant and their name will also be listed on the surgery schedule moving forward. SUR 1 stated it was his practice to always have a second surgeon in the room and it was his understanding that a second surgeon was required when patients go on bypass. SUR 1 stated he started working with the residents as second surgeon (first assistant) approximately eight months ago. SUR 1 stated he was informed it was okay to have residents as first assistant as these were fifth year cardiac surgery resident. SUR 1 stated these residents were one year away from being independent surgeons. SUR 1 stated although residents were safe and very good in assisting, these residents were not independent and fully qualified surgeons as required in conditions of program flex approval.

During an interview on 5/27/25 at 1:53 p.m. with the perfusionist (PER) 2, PER 2 stated that he has been working at the facility since 2013. PER 2 stated he also works at another facility across town. PER 2 stated that at this hospital it was common not to have a second surgeon or first assist that was a surgeon in the room during cardiac surgical procedures. PER 2 stated, "Many times, perhaps half of the time," a second surgeon is not available or present in the OR during the CABG procedure. PER 2 also stated when he worked across town in a different hospital, that facility always has second surgeon in the operating room during the entire duration while the patient is on a heart lung machine.

During a concurrent interview and record review on 5/28/25 at 2:01 p.m. with the SUR 3, Pt 3's EMR was reviewed for the "OR Intraoperative record" dated 3/31/25. SUR 3 stated he had been operating at the hospital since 2017. SUR 3 stated he was a board-certified cardiothoracic surgeon. SUR 3 stated he was not aware of the conditions or requirements of the program flex. SUR 3 stated it was his understanding that he was required to have another physician as a second surgeon during his procedures and cardio thoracic surgery residents meet that requirement. SUR 3 stated he had spoken with other teaching institutions, and it was a standard practice to have cardiac surgery residents as first assistant surgeon. SUR 3 stated he requires his residents to stay with him during the entire surgical procedure. SUR 3 validated RS 2 was with him for the entire surgical procedure for Pt 3.

During a concurrent interview and record review on 5/29/25 at 3:30 p.m. with RN 5, Pt 2's EMR was reviewed. RN 5 stated she was in the OR for Pt 2's surgery and was responsible for documentation of times when everyone was entering and leaving OR during the surgery. RN 5 stated she does not recall Pt 2 specifics, but she always documented exact times. RN 5 reviewed the EMR and Pt 2's "OR Intraoperative record" and stated that Pt 2's record reflects that RS 2 was in the room from 7:45 a.m. to 8:15 a.m., surgery start time was 8:13 a.m. RN 5 validated that EMR reflects she was the one that documented times for RS 2. RN 5 stated that she was unable to comment on cardiovascular surgery staffing requirements, however, she was not aware that second surgeon [first assistant] have to be in the operating room at all times. RN 5 stated that as long as someone was available she thought it was okay to proceed with the surgical procedure.

During a concurrent interview and record review on 5/30/25 at 12:47 p.m. with SUR 2, Pt 2's EMR was reviewed for the "OR Intraoperative record" dated 3/31/25. SUR 2 stated he was unable to comment on RS 2 times in the OR. SUR 2 stated the times listed may or may not be accurate. SUR 2 stated he does not recall who was in the room during the surgery. SUR 2 stated he was not aware of any program flex that hospital had in place, however, he was aware of the surgery staffing requirements for cardiac surgeries. SUR 2 stated he expected to have second surgeon in the OR during surgery. SUR 2 stated as far as he was aware, residents can function as first assistant [second surgeon] in the room and RNFA or PA can function as third surgeon. SUR 2 stated if the record reflects RS 2 left two minutes after procedure start, then it could not be accurate.

During a concurrent interview and record review on 5/30/25 at 2:25 p.m. with the DSS and MA 1, OR case logs [systematic record of individual patient cases] for month of March 2025, April 2025 and May 2025 were reviewed for the cardiovascular surgeries. The review of OR case logs for the whole month of March 2025 indicated total of 22 open heart surgeries were done, and out of 22 cases 15 cases had resident surgeon as first assistant (second surgeon), two cases did not have any second surgeon that was a physician or resident. Out of 22 cases in March 2025, five cases did have second surgeon that was independent and qualified surgeon, however, three of those cases second surgeon was only in the room for less than 10 minutes. A review of April 2025 case log for cardiac surgeries indicated a total of 28 open heart surgeries were done at the hospital. Out of the 28 cases, 17 cases had a resident as first assistant (second surgeon), and two cases did not have any second surgeon that was a physician or resident. Out of 28 cases, nine cases did have second independent and qualified surgeon, however, six out of eight cases, that surgeon was in the room for ten or less minutes. The DSS and MA 1 both stated that this reported data was accurate and DQ validated it by manually counting it. The DSS stated the hospital team did not have a good understanding of the approved program flex and were not compliant with the conditions of approved program flex and requirement for cardiac surgery staffing under CCR. The DSS stated he now understands the CCR requirement and approved program flex. The DSS stated effective 5/23/25 changes have been put in place to ensure second independent and qualified surgeon would be present during all open-heart surgeries. The DSS stated going forward the second surgeon would be scheduled, and the OR team would be able to validate and confirm presence of independent and qualified second surgeon [first assistant] prior to patient's surgery.

Based on observation, interviews, and review of hospital documents, the hospital failed to ensure the contracted vendor for Food and Nutrition Services met the organizational standards as required by State laws and regulations as specified in:

1. The State Health and Safety Code (HSC)1265.4 statue when the Executive Chef Manager, the position responsible for the day-to-day supervision of dietetic services at BHC Campus 2 was not qualified;

2. Title 22, Section 70275(a), when the hospital did not have a Registered Dietitian (RD) provide guidance and oversight to the food service operations manager and staff of the dietetic service at a sufficient duration and frequency at two of two campuses (Main Hospital Campus 1 and BHC Campus 2); and

3. Title 22, Section 70275(a), when the hospital did not have a RD reporting to hospital administration.

This failure put patients at risk of compromised nutritional outcomes for a combined hospital census of 370 on May 20,2025.

Findings:

During the survey from 5/20/25 to 5/27/25, observations, interviews and document reviews indicated multiple concerns related to food safety and sanitation operations including: incorrect portions were served during lunch meal service at both campuses; there was no monitoring for cooling of ambient foods and facial hair was not restrained during meal service at BHC Campus 2, lack of competencies on food service staff (Cross refer A-0622 and A-0750).

California regulations, Title 22 Section 70271 defines Dietetic service as the provision of safe, satisfying and nutritious foods with appropriate staff. Additionally, California regulation, Title 22 Section 70275(b) requires that, if a dietitian is not employed full-time, managing the day-to-day operations of dietetic services, a full-time person who has completed a supervisor's training program shall be employed to be responsible for the operation of the food service.

1. During a review of the hospital organizational structure for the Food and Nutrition Services department, the Director of Food and Nutrition Services had the following positions reporting to the position: Operations Manager, Patient Services Manager, Retail Manager, Executive Chef Manager from BHC Campus 2, Executive Chef and Lead RD.

During a review of the personnel file for the Executive Chef Manager (ECM) at BHC Campus 2, showed that ECM was not qualified for the position in accordance with the Health and Safety Code 1265.4 (b). During a concurrent interview on 5/22/25 at 2:49 p.m. the Interim Director of Food and Nutrition Services (IDFNS) confirmed the ECM was not qualified in accordance with State requirements to manage the day-to-day operations of dietetic services. California Health and Safety Code 1265.4 describes seven qualification pathways of the full-time position responsible for the day-to-day operation of dietetic services.
(1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility.
(2) A graduate of a dietetic technician training program approved by the American Dietetic Association, accredited by the Commission on Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration.
(3) A graduate of a dietetic assistant training program approved by the Dietetic Association.
(4) Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has 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.
(5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor led interactive web-based instruction in dietetic service supervision.
(7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6).

During a review of the ECM job description, it showed under "Summary", oversees kitchen operation while maintaining a safe and sanitary work environment for the staff and that they prepare or direct preparation of meals in accordance with corporate programs and guidelines. It showed ECM reports to the Director of Food and Nutrition and that complies with regulatory agencies, including federal, state, and Joint Commission. This job description was for an executive Chef in general and qualifications for this type of position at the campus.

2. California Code of Regulations, Title 22, 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 (NCM) position description, dated August 2017, showed the CNM reported to the Director of Food and Nutrition Services (DFNS), however supervisory and oversight responsibilities of the CNM was limited to the clinical nutrition staff. The CNM position duties which required a Registered Dietitian did not include any oversight responsibilities for dietetic services such as guidance to the supervisor (DNFS) and the staff of the dietetic service. It was also noted the CNM position is currently vacant.
During a review of the position description for the DNFS, dated March 2006, showed the DNFS position reported to the contracted vendors Regional Director of Operations. The position description did not reflect any direct reporting structure to hospital leadership. The position description did not indicate the DNFS received guidance from a Registered Dietitian (RD).

3. In contrast, during a review of the hospital organization chart, the reporting structure indicated the DFNS was under the hospital's Chief Operating Officer (COO) however, it did not show how the vacant CNM position would report to hospital leadership indicate how the CNM or Lead RD would give advice to the administrator.

During an interview with the Lead RD on 5/21/25 at 2:19 p.m., Lead RD stated she has been in the position for two months and her job responsibilities were limited to functions in clinical nutrition. The Lead RD also stated she was based out of state and traveled to the hospital for approximately one week each month. While onsite she stated she introduced herself to others, attended ICU rounds, met with pharmacy, food service staff and the patient service manager as well as attended a director meeting with the IDNFS. The Lead RD stated she had not closely looked at or inspected food services, observations of meal service or patient meal tray audits yet as she had other priority items to do while onsite.

Based on staff interviews and review of hospital documents, the hospital failed to ensure the contracted service for Food and Nutrition Services was met when the contract employed four of five full-time equivalent (FTEs) Registered Dietitians (RDs - Lead RD, RD 2, RD 3, RD 4, RD 5), to provide clinical nutrition care, that did not work on the premises or conduct face-to-face patient nutritional physical assessments which resulted in the provision of medical nutrition therapy that was not in accordance with the hospital's position description for the Registered Dietitian or the current standards of practice.

These failures resulted in not following standards of practice for clinical nutrition services for a hospital census of 370 patients; and could result in patients receiving suboptimal nutrition services and decreased nutrition and could lead to increased hospital readmission rates.

Findings:

During the course of the full validation survey from 5/20/25 to 5/28/25, eight patient records (Patient 40, 41, 42, 43, 44, 45, 46, 47) were reviewed for clinical nutrition care at both campuses.

During an interview and concurrent review of patient records on 5/21/25 starting at 10:24 a.m., the RD (RD 1) stated she started working at the hospital one month ago and she also wanted to include the Lead RD for the interview since she was newer. RD 1 stated the Lead RD lived out of state and was in Michigan. The Lead RD stated she has worked in a remote capacity at the hospital for two years and about two months ago became the interim clinical nutrition manager. The Lead RD stated since RDs are not at the hospital in person they are not able to do nutrition focused physical exams (NFPE) on the patients when conducting the nutrition assessments. RD 1 stated she does conduct NFPE when she does nutrition assessments on the patients.

During an interview with the Lead RD at 5/21/25 at 2:19 p.m., she stated she was onsite in for 4 to 5 days in each month of March and April. The activities she conducted during that time were introducing herself to staff, attending the rounds in the Intensive Care Unit (ICU) and meeting with the Pharmacy director.

During an interview with RD 2 on 5/21/25 at 2:51 p.m., RD 2 stated she is physically located in Kentucky and works part time at the hospital reviewing the medical records of patients on the units including the neonatal intensive care unit (NICU) and behavioral health hospital.

During a review of the RD schedule dated May 2025, showed there were two RDs that were located in Eastern Standard Time (EST), two that were in Central Standard Time (CST), three that were in Pacific Standard Time (PST), one of which was RD 1 who was onsite.

During a review of the RD roster for the Main Hospital Campus 1, it indicated there were 5 RD FTEs, one of which was onsite. During a review of a document from the Interim Director of Food and Nutrition Services, it indicated 80% of the medical nutrition therapy was provided by offsite Registered Dietitians accomplished through a paper review of the electronic medical record.

During a review of the RD position description dated 2017, indicated essential functions and responsibilities included "Assesses the nutritional status of neonates/ infants, pediatric, adolescent, adult and/or geriatric patient ...Uses parameters such as ...nutrition-focused physical assessment."

During a review of the Commission on Dietetic Registration, the credentialing agency for the Academy of Nutrition and Dietetics document, titled, "Revised 2024 Scope and Standards of Practice for the Registered Dietitian Nutritionist" indicated under Standard 7, Providing Person-Population-Centered Nutrition Care, the RD conducts nutrition assessment and obtains and assesses findings from nutrition-focused physical exam (NFPE).

During an interview on 5/27/25 at 3:34 p.m. with the Chief Operating Officer (COO) regarding Food and Nutrition Services (FANS) Contract. The COO stated FANS reports up to him. The COO stated he was aware that the Clinical RDs are not physically located onsite except for the one new hire. He stated there has been challenges regarding recruiting for onsite positions. The COO stated he did not think there were any other allied health professionals that worked at the hospital that were not seeing patients in person. COO stated he thought the contract had policies and procedures regarding protocols when the RDs worked remotely. COO acknowledged the hospital had similar concerns with the RDs being remote and they were trying to offer more to attract more in person RDs. COO stated he was not aware of any other patient facing disciplines that function remotely since they all require a physical component. COO stated the physicians would state that patients cannot do surgery on themselves therefore they need to see patients in person.

During a review of the hospital contract for Food and Nutrition Services, dated effective 10/1/19, indicated the 4.45 FTEs for inpatient dietitians (RDs) were employees of the contractor/vendor. The contract did not include the responsibility of the contractor to provide and meet professional standards.

Based on interview and record review, the facility failed to implement a grievance process for prompt resolution of patient grievances when Patient (Pt) 10's family member sent a grievance through certified mail and it was not acknowledged for sixteen days after it was received by the hospital.

This resulted in a delay in the investigation and response to Pt 10's family member's grievance.

Findings:

During an interview on 5/29/25 at 11:10 a.m. with Pt 10's family member, Pt 10's family member stated she sent a grievance letter to the hospital through certified mail on 5/9/25. Pt 10's family member stated she received the return receipt indicating the hospital signed for the certified mail on 5/14/25 and she has not heard from the hospital regarding the grievance.

During a concurrent interview and record review on 5/30/25 at 11:32 a.m. with the Director of Quality (DQ) and Data Coordinator (DC) 1, the hospital's "2025 Grievance Log," was reviewed. DC 1 stated Pt 10's family member's grievance was received on 5/21/25. DC 1 stated part of job duties included logging patient grievances. DC 1 stated she was the main person who checked the department's mailbox in the hospital but other staff who went to the mail room could check for mail. DC 1 stated mail could get placed into the wrong department's mailbox which delayed the mail getting to the department. DC 1 stated the mailbox was checked daily, except on weekends. DC 1 stated a grievance did not get logged until the letter was physically opened and read.

During a concurrent interview and record review on 5/30/25 at 11:40 a.m. with the DQ and DC 1, Pt 10's family member's certified mail was reviewed. The envelope indicated the certified mail was mailed on 5/10/25 and addressed to "Patient Relations/Risk Management/Quality D. [Name of hospital]." DC 1 stated the envelope was addressed to the department and would have been placed into the department's mailbox. DC 1 stated she was unaware of how certified mail was received at the hospital. The DQ stated she did not know certified mail was received in the mail room.

During a concurrent interview and record review on 5/30/25 at 11:45 a.m. with the DQ and DC 1, Pt 10's "Seven Day Letter (SDL)," dated 5/28/25 was reviewed. The "SDL" indicated, " ... Thank you for contacting us on May 21, 2025, concerning your mother's visit to [name of hospital]. We have received your grievance and are in the process of investigating your concern. You will be notified of our findings and actions upon completion of our investigation. Should you have any questions, please feel free to contact us at [telephone number] ..." The DQ stated a grievance should be completed within seven days after it has been received. The DQ stated if a grievance could not be completed within seven days, a seven-day letter was sent to the patient or family member to acknowledge receipt of their grievance, and an investigation was being conducted. The DQ stated the "SDL" was a template and did not address how long it would take to complete the investigation. The DQ stated the hospital staff knew it had 30 days to complete the investigation and send a resolution letter to the patient or family member. The DQ stated, "We normally don't let them know how long."

During an interview on 5/30/25 at 12:10 p.m. with the Health Information Management Operations Manager (HIMOM), the HIMOM stated her department was in charge of receiving mail sent to the hospital. The HIMOM stated the hospital received mail like "regular mail." The HIMOM stated mail was placed in a basket and then sorted out to the departments in their mailbox. The HIMOM stated if an envelope was addressed to the quality department, it would be placed into their mailbox. The HIMOM stated she did not know who signed for certified mail.

During an interview on 5/30/25 at 12:24 p.m. with the Manager of Accreditation (MA) 1, MA 1 stated a courier picked up the hospital's mail daily and signed for certified mail. MA 1 stated the courier then dropped the certified mail into the basket to be sorted out by the mail room staff. MA 1 stated she did not know if the courier kept a log of certified mail. MA 1 stated she did not know why it would take six days for the department to receive mail.

During a review of the hospital's P&P titled, "CLN.11.01.MOD Patient Complaints & Grievances," dated 4/24/25, the P&P indicated, " ... "Grievance" is a formal written or verbal complaint that is made to the hospital by a patient, or the patient's representative (these include any request that their complaint be handled as a formal grievance with a response) ... POLICY: ... The hospital's process for managing complaints and grievances must incorporate the following objectives: ... Provide a planned, systematic mechanism for receiving and promptly acting upon issues expressed by patients and/or patient representatives ... If the resolution of the grievance is determined to take longer than seven days, the Grievance Committee or designee will send a response to the patient informing him/her that the hospital is still working to resolve the grievance and that the hospital will follow-up with a written response within a stated number of days (a "Deferral Letter") ..."

Based on interview and record review, the hospital failed to ensure patient's had the right to make informed decisions about care for two of two sampled patients (Pt 28 and 29) when:

1. Consents and discharge instructions were not interpreted by a qualified interpreter to ensure the patient could fully understand the information provided according to the hospital's policy and procedure (P&P) titled, "MOD.EAC.01.04.PR.01 Language Assistance Services (Including Interpreters) Procedure."

This failure denied Pt 28 and 29 of their right to make informed decisions about, participate in their care and potentially could affect all non-English speaking patient treated at the hospital.

Findings:

1. During a concurrent interview and record review on 5/27/25 at 11:30 a.m. with Quality Review Nurse (QRN) 1, Pt 28's "History and Physical (H&P-a comprehensive assessment of a patient, combining a medical history with a physical examination)," dated 3/27/25 was reviewed. The "H&P" indicated, " ... Date/Time of Admission/Birth: 3/27/2025 at [12:15 p.m.] ... ADMISSION DIAGNOSES: Preterm ELBW [extremely low birth weight-babies born weighing less than 1000 grams] AGA [appropriate for gestational age-an infant whose size is considered appropriate for their AGA] female infant [status post] cesarean delivery [a surgical procedure where a baby is delivered through an incision in the mother's abdomen and uterus] at 28 3/7 weeks gestation [the period of time between conception and birth; average length is 40 weeks], birthweight 940 g [grams-unit of measure]; Respiratory distress [a condition where a person struggles to breathe due to inadequate oxygen exchange in the lungs]; Hypoglycemia [low blood sugar]; Sepsis [a serious condition in which the body responds improperly to an infection] evaluation ... MATERNAL HISTORY: ... Language preference: Spanish. Interpreter required: YES ... PSYCHOSOCIAL: ... Parents updated in PACU [Post-Anesthesia Care Unit-the recovery room where patients are taken after surgery or procedures that involve anesthesia (medicine that is used to put you in a state like deep sleep during surgery)] and at bedside using Spanish speaking RN. Consent obtained for central lines and donor breast milk ..." QRN 1 stated Pt 28's mother's preferred language was Spanish, and a Spanish speaking nurse interpreted for the physician to obtain the consents.

During a concurrent interview and record review on 5/27/25 at 11:35 a.m. with QRN 1, Pt 28's "Consent to Surgery/Special Procedures (Informed Consent)," dated 3/27/25 and "Consent for the Use of Donor Human Milk in the Neonatal Intensive Care Unit (Donor Milk Consent)," dated 3/27/25 were reviewed. The "Informed Consent" indicated Pt 28's mother signed the form. QRN 1 stated the "Informed Consent" was written in Spanish, but no interpreter signature was on the form. The "Donor Milk Consent" indicated Pt 28's mother signed the form. QRN 1 stated the "Donor Milk Consent" was written in Spanish but no interpreter signature was on the form.

During a concurrent interview and record review on 5/27/25 at 11:40 a.m. with QRN 1, Pt 28's "Interpreter Flowsheet (IF)," dated 3/27/25 and "Form Browser (FB)," dated 3/27/25 were reviewed. QRN 1 stated the "IF" and "FB" indicated no interpreter was used to explain the "Informed Consent" and "Donor Milk Consent." QRN 1 stated the hospital's policy indicated a qualified interpreter should have been used. QRN 1 stated hospital staff were not qualified interpreters, and the hospital used qualified interpreters through a video call. QRN 1 stated a qualified interpreter went through a program to ensure he or she could translate accurately. QRN 1 stated a qualified interpreter should be used for any consent and invasive (breaking the skin or inserting an instrument into the body) procedure.

During a concurrent interview and record review on 5/27/25 at 2:10 p.m. with Registered Nurse Educator (RNE) 1, Pt 29's "Face Sheet," undated, and "Consent for Anesthesia Services (CAS)," dated 3/15/25 were reviewed. The "Face Sheet" indicated Pt 29's preferred language was Spanish. The "CAS" indicated no interpreter was used to translate the form. RNE 1 stated the "CAS" was written in Spanish, but no interpreter signature was present on the form.

During a concurrent interview and record review on 5/27/25 at 2:15 p.m. with RNE 1, Pt 29's "Electronic Medical Record (EMR-a digital version of a patient's paper medical chart)," dated 3/15/25 was reviewed. RNE 1 stated there was no interpreter documentation in the "EMR" that an interpreter was used for Pt 29's "CAS." RNE 1 stated an interpreter should be used to ensure the patient understood what was to be done.

During a concurrent interview and record review on 5/27/25 at 2:20 p.m. with RNE 1, Pt 29's "Discharge Instructions (DI)," dated 3/17/25 and "EMR," dated 3/17/25 were reviewed. RNE 1 stated the "DI" was written in Spanish and was signed by Pt 29. RNE 1 stated there was no interpreter documented on the "DI." RNE 1 stated the "EMR" indicated RN 6 interpreted the discharge instructions to Pt 29 since RN 6 spoke Spanish. RNE 1 stated discharge instructions did not need to be interpreted by a certified interpreter. RNE 1 stated hospital staff were able to interpret discharge instructions if they spoke the same language as the patient.

During an interview on 5/29/25 at 2:32 p.m. with the Director of Obstetrics (DB), the DB stated she expected nurses to use an interpreter when obtaining an epidural consent and document the interpreter on the consent form. The DB stated she expected nurses to use a qualified interpreter when providing discharge instructions.

During an interview on 5/29/25 at 2:35 p.m. with the Director of NICU and Pediatrics (DP), the DP stated she expected nurses to use the hospital's translation device only and to document the interpreter in the medical record.

During a review of the hospital's P&P titled, "MOD.EAC.01.04.PR.01 Language Assistance Services (Including Interpreters) Procedure," dated 7/24/24, the P&P indicated, " ... Interpreting Services ... Prompt Call for Interpreters ... The health care professional in charge of coordinating the care for an LEP [Limited English Proficient-Individuals who do not speak English as their primary language and who may have a limited ability to read, write, speak, or understand English] Patient shall continue to assess in consultation with the Patient (and, where appropriate, the Patient's family members or close friends) the need for Qualified Interpreters ...throughout the Patient's receipt of Facility services ... provision of Patient rights, informed consent or permission for treatment ... explanation of procedures, tests, treatment, treatment options or surgery ... discharge instructions ..."

During a review of the hospital's P&P titled, "MOD.EAC.01.04 Language Assistance Services (Including Interpreters) (Model Policy)," dated 7/24/24, the P&P indicated, " ... PURPOSE: To establish guidelines to accommodate Limited English Proficient Individuals in the delivery of healthcare services. Limited English Proficient Individuals will be provided with language assistance services at no cost to allow them an equal opportunity to participate in and benefit from healthcare services ... DEFINITIONS: Limited English Proficient (LEP) Individuals: Individuals who do not speak English as their primary language and who may have a limited ability to read, write, speak, or understand English ... Qualified Interpreter: Is an interpreter who, via a Video Remote Interpreting (VRI) Service or an on-site appearance, can interpret effectively, accurately, and impartially, both receptively and expressively, using any necessary specialized vocabulary. Qualified Interpreters include, for example, oral transliterators, and cued-language transliterators ..."

Based on interview and record review, the hospital failed to ensure care was provided in a safe setting for 1 of 1 sampled patients, Patient (Pt) 10 and failed to ensure the patient's and the patient's surrogate's right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) when:

Patient 10 experienced a change in level of consciousness, and a respiratory arrest and the circumstances leading up to the events were not clearly explained in either instance to Pt 10's daughter or documented in the medical record;

Pt 10 was left soiled in her bed for over two hours despite Pt 10's daughter asking the staff to change Pt 10;
The nursing staff in the ICU were laughing and talking during the time Pt 10's family was there to say goodbye to Pt 10;

Pt 10 bit her tongue at the time her breathing tube was removed (extubation) resulting in pain and bleeding, the nursing staff did not administer an adequate amount of the medications ordered for comfort care after Pt 10 experienced extreme distress following extubation; and

Pt 10's body was removed from the hospital approximately five hours after her death and transported to a mortuary in a nearby city without the hospital first notifying Pt 10's daughter and obtaining consent. Pt 10's daughter was informed by the hospital Pt 10 was transported due to patient being too big for the hospital's morgue.

These failures resulted in Pt 10 experiencing fear and physical distress, and her family experiencing emotional distress.

Findings:

During an interview on 5/29/25 at 11:06 a.m. with Pt 10's daughter (FM 3), FM 3's concerns about Pt 10's care were discussed. FM 3 stated Pt 10 was brought to the hospital on 11/20/24 after she was noted to be confused and showed signs of a possible stroke. The work up did not show an acute stroke just signs of the old one. FM 3 stated the doctor told her that her mother could go home or be admitted to the hospital to observe her and even though her mom did not want to stay FM 3 agreed to Pt 10 being admitted. FM 3 stated her mom had a previous stroke and was left with left sided weakness and some difficulty with speech, and other residual effects and came to live with FM 3 in 2021. FM 3 stated she is her mom's durable power of attorney (DPOA- has decision-making authority). FM 3 stated throughout Pt 10's hospitalization there were "multiple failures in care, communication and basic human dignity. The most distressing part of this experience was witnessing my mother visibly suffer during what should have been her final moments of peace. The inadequate and uncoordinated execution of comfort care left lasting emotional trauma on our family." FM 3 stated on 11/22/24 in the afternoon her mom was doing better and was working with the speech therapist, so FM 3 left the hospital to drop off her son. FM 3 stated she received a call while she was gone and was told her mom had a seizure. FM 3 stated she returned to the hospital and found that Pt 10 was unresponsive, and staff told her Pt 10 might wake up. FM 3 stated she still did not understand what happened but stated her mom was never ok after that. FM 3 stated she was told Pt 10 had new small strokes. She said that evening FM 3 thought her mom needed to be changed because it smelled and asked the staff to change her, but the nurse told her it was just gas. FM 3 stated her mom was left so long sitting in her bowel movement (BM) it was dried onto her skin. FM 3 stated the sheets were not even on the mattress under her mom. FM 3 stated the Certified Nursing Assistant (CNA) on the night shift changed and bathed her mom. The next morning on 11/23/24, she called really early to check on her mom and was told she was doing fine, so she stopped to get a coffee on the way into the hospital. When she arrived around 6:15 a.m. they were calling a code (Code blue- a life threatening medical emergency where the patient's heart has stopped beating or patient has stopped breathing) on her mom. FM 3 stated she overheard the nurses debating about whether her mom was a DNR (Do Not Resuscitate- a legally recognized order that means a patient does not want to be revived if they stop breathing or their heart stops beating.) or full code (a medical term that indicates patient's preference for full resuscitation and all life saving measures if they stop breathing or their heart stops). FM 3 stated her mom was a full code and she had just discussed this with the staff the previous night, but Pt 10 had a DNR wrist band on. FM 3 stated she was told Pt 10 coded because when she had a seizure the previous day she bit her tongue, and it was swollen and obstructed her airway, so she had a respiratory arrest (stopped breathing). FM 3 stated she still does not fully understand what happened. FM 3 stated her mom's tongue was bloody and swollen and over the next few days ended up looking infected and smelled really bad. FM 3 stated Pt 10 was in Intensive Care Unit (ICU) after that and then one thing after another happened, and her kidneys were failing. FM 3 stated the doctor talked to her about the code status and questioned Pt 10's quality of life. FM 3 stated she told the doctor her mom "survived a previous stroke and had a life, her mom got around in her scooter, took her dog on a leash to the park, and went to Walmart independently. FM 3 stated her mom was artistic and painted. FM 3 stated she felt the staff was disrespectful when she wanted to give her mom a chance to see if she could recover. FM 3 stated one staff member made comments that if he couldn't use the bathroom independently he wouldn't want to live like that. FM 3 stated the ICU had curtains in between the patient rooms so you can hear everything, and the nursing staff could be heard laughing and talking during the ICU stay, and FM 3 stated a family member said something to the staff about that but did not feel the staff cared. FM 3 stated when her mom had another stroke and there was no chance she would recover she made the decision for comfort care (specialized medical care aimed at easing suffering and improving quality of life with people with serious medical conditions). FM 3 stated it was such a hard decision, but she did not want her mom to suffer. FM 3 stated the nurse practitioner that talked to her about the process, explained Pt 10 would receive continuous medication and Intravenous (IV-directly in the vein) push medication so she would not suffer when the breathing tube was removed. FM 3 stated her husband and Pt 10's sister were with her at Pt 10's bedside. FM 3 stated when the breathing tube was removed her mom bit her swollen tongue again and they did not have a bite block, they had to get it from another floor, so there was a delay in getting in in her mouth to prevent her from biting down. FM 3 stated her mom's eyes were bulging out, she looked scared, was gasping for air and squeezing her hand and her husband's hand. FM 3 stated it was so awful, Pt 10's sister screamed and left the room. FM 3 stated she asked the staff to please give her mom more medication because she was suffering, but Pt 10's nurse told her this was normal. FM 3 stated she kept asking them for more medication for her mom, but it was an hour before the nurse brought more medication for her mom. She stated soon after the nurse gave her the medications, her mom passed away. FM 3 stated someone came in to check her mother to verify she had passed but that was almost 10 minutes after it happened. FM 3 stated she made the difficult decision to go to comfort care because she did not want her mom to suffer and wanted her to be able to die with dignity, and then had the opposite happen. FM 3 stated watching her mom suffer and struggle for air like she did, has left her and her family traumatized. FM 3 stated some time after her mom died she left the hospital and went home. Since no one asked her about what mortuary she wanted before she left the hospital she assumed they would call her the next day. When she did not get a call she called the hospital. FM 3 stated she was told "your mother is no longer here." FM 3 stated she was told "due to her mother's size she was taken to an overflow mortuary in Salida." FM 3 stated she was very surprised her mother was transported to a mortuary she (FM 3) did not choose without someone informing her beforehand. FM 3 stated telling someone who has just lost a loved one that their family member was moved because they were too big was disrespectful.

During a concurrent interview and record review on 5/29/25 at 12:30 p.m. with the Stroke Coordinator (SC), Pt 10's medical record was reviewed. The record indicated Pt 10 was a 59 year old female who was admitted on 11/20/24 with symptoms of a stroke (a loss of blood flow to part of the brain, which damages brain tissue). Pt 10 had a history of a previous stroke with residual left sided weakness, hypertension (elevated blood pressure), atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), diabetes, and chronic kidney disease. The stroke protocol was initiated, the imaging studies did not reveal an acute (new, recent) stroke initially, and Pt 10 was admitted to the 1 Med Telemetry unit. The SC stated 1 Med Telemetry is also one of the designated units where patients who have had a stroke are admitted.

The medical record indicated on 11/22/24 at 3:40 p.m., RN 20 sent an electronic message to MD 15, "Patient was screaming, unable to tell us what was wrong. Then she had some flatulence and an emesis (vomit) episode. There were some bright streaks of blood in the emesis. Lung sounds a bit coarse; she might have aspirated (vomited in her lungs). I will give her some Zofran [medication for nausea and vomiting]." The record does not indicate whether there was a response from MD 15, and the medication administration record indicated Pt 10 did not receive Zofran. The record indicated on 11/22/24 at 3:51 p.m. an "Internal [Inpatient] Stroke Alert" was initiated. The SC stated when a hospitalized patient shows signs of a potential stroke, an "Internal" stroke alert is activated as opposed to when a person with a possible stroke comes to the ED then a "Stroke Alert" is activated. When an internal stroke alert is initiated, a specially trained nurse, a neurocritical response nurse (NCRN), responds and assesses the patient following the stroke alert protocol. A review of the "Rapid Response Team (RRT) record" dated 11/22/24, indicated at 3:51 p.m. the NCRN assessed Pt 10 and noted Pt 10 was "Comatose. Decrease level of consciousness, sudden loss of movement/weakness in face, arm, leg" with a National Institute of Health Stroke Scale (NIHSS- a tool used by healthcare providers to objectively quantify the impairment caused by a stroke) score of 38 (Severe stroke). Pt 10's Glasgow Coma Scale (GCS- a neurological assessment tool used to measure a patient's level of consciousness) score was 5 (on a scale from 3 to 15, with 3 being the lowest [comatose state] and 15 being the highest [normal, alert state]) with Pt 10 exhibiting decorticate posturing (a reflex body position which is usually a sign of a severe injury or disruption to the brain). The SC stated neither the RRT record, or the nurses notes indicate who activated the Internal Stroke Alert, or what occurred after the 3:40 p.m. message sent by RN 20 to MD 15 to prompt the stroke alert call. Review of the order report for 11/22/24, indicated at 3:49 p.m. RN 20 obtained telephone orders for a Computed tomography (CT- a medical imaging technique used to obtain detailed internal images of the body) scan of the brain for "altered level of consciousness," and at 3:53 p.m. orders were obtained for a chest x-ray for "respiratory distress," and a CT scan of the chest for "shortness of breath." At 15:55 Pt 10's respiratory rate was 26 breaths (respirations) per minute (rpm- normal 14-20 per minute), oxygen saturation 98%, and Pt 10 noted to be snoring, with labored respirations. At 3:58 p.m. the stroke alert protocol orders including lab tests and imaging were initiated. At 4 p.m. RN 20 obtained telephone orders for Lorazepam (a medication given for anxiety, seizures, agitation) 1 mg IV push and Keppra 500 mg IV (a medication for the treatment of seizures) and both medications were given. There was no documentation in the record indicating what if any seizure activity was observed.

During a record review on 5/29/25 beginning at 1:15 p.m. with the Stroke Coordinator (SC), Pt 10's medical record was reviewed. Review of the nursing assistant's note dated 11/22/24 at 8:25 p.m., indicated, "Pt was left soiled, and family was very unhappy. Pt bed was not properly placed, bedding was very dirty. Nurse and I did a full bed change and bathe pt with family member. Pt family was happy how well we clean, and bathe pt. Addressed to charge Nurse. They waited for dayshift 2 hours to clean pt family requested. During report CNA did not address this situation with me in report."

The medical record indicated on 11/23/24 at 6:06 a.m., a RRT call was initiated. The RRT record indicated, "RRT Comment: RRT called for agonal breathing/biting on tongue/recent stroke alert. Physician Assistant [PA] at bedside. RRT Interventions: Appropriate protocol initiated. RRT Physician contacted at 6:10 a.m. Intensivist consulted for intubation/transfer to Cardiovascular Intensive Care Unit (CVICU). RRT Intubation Time: 6:20 a.m. RRT Outcome: Transfer to ICU/CCU. See PA prog. notes/orders, see nursing documentation ..." The SC stated although the RRT note indicated to refer to the nursing notes and the PA notes, she is unable to find any documentation regarding if Pt 10 was observed during this time (4 a.m. to 6:06 a.m.), if vital signs were obtained, or who initiated the RRT call.

During a concurrent interview and record review on 5/29/25 at 1:45 p.m. with the Stroke Coordinator (SC), Pt 10's medical record was reviewed. Review of the nurse practitioner's note dated 11/29/24 at 7:32 p.m., indicated, "Called to bedside by nursing staff, patient's family request to make patient Do Not Resuscitate, discussed with patient's daughter and her aunt at bedside. Patient daughter states that she does not want her mom to suffer and wants to take her off of life support, discussed comfort care. Will proceed with comfort care once medications are ready, will start morphine drip and as needed pushes and then will extubate patient and patient's daughter is aware that patient will die however she does not want her mother to suffer, discussed with nursing staff. Patient is DNR and comfort care."

During a concurrent interview and record review on 5/29/25 at 2 p.m. with the stroke coordinator, Pt 10's orders dated 11/29/24, indicated "Comfort Care Orders" were placed at 7:48 p.m. and included orders for Morphine 2 mg IV push every hour as needed for pain and a continuous IV infusion of Morphine 100mg/100ml 0.9% saline for Pain/Respiratory discomfort, start at 2 mg per hour, Titrate (adjust dose) every 30 minutes by 1 mg to patient comfort. Maximum rate 15 mg per hour. The comfort care orders also included an order for Lorazepam 1 mg IV every two hours as needed for nausea and vomiting. In addition to the comfort care orders, at 7:50 p.m. a separate order for Morphine 2 milligrams [mg] intravenous (IV) was ordered to be given Stat (immediately, without delay). Review of the Medication Administration Record (MAR) dated 11/29/24, indicated the Stat dose of Morphine 2 mg IV push was given at 8:30 p.m., and at 9:22 p.m. the morphine infusion was started at 2 mg per hour. Review of the respiratory care notes dated 11/29/24 at 10:28 p.m., indicated at 9:49 p.m. Pt 10 was extubated (breathing tube removed), and a bite block was placed. The MAR indicated morphine 2 mg IV push was not given again when the orders allowed at 9:30 p.m., and was not given again after the initial dose at 8:30 p.m. The MAR indicated the morphine infusion was not titrated up 1 mg when the orders allowed at 9:52 p.m., and was not increased to 3 mg per hour until 10:32 p.m. Review of Communication/Notification notes dated 11/29/24, indicated at 10:30 p.m., "Physician Communication Notified Of: Patient condition, Patient/proxy request. Physician Communication Comments: Patient is tachypneic and requires increased rate on morphine drip. Okay to max drip." The MAR indicated at 10:32 p.m. Lorazepam 1 mg was given IV push, and at 10:40 p.m. the morphine infusion was increased to the maximum dose of 15 mg per hour, and at 10:45 the infusion was discontinued. Pt 10 was pronounced dead at 10:46 p.m. Review of the nurses notes indicated there was no documentation in the record from the time Pt 10 was extubated at 9:49 p.m. until the time Pt 10 was pronounced dead. There was nothing in the record regarding what occurred when Pt 10 was extubated, how Pt 10 looked and responded to the extubation and subsequent dying process, or what measures were implemented to provide comfort including medications given to address any patient distress.

During a concurrent interview and record review on 5/29/25 at 3 p.m. with the Patient Safety Officer (PSO), a document from Pt 10's medical record titled, "Mortuary-Autopsy Consent" was reviewed. The top section of the document consisted of the notification of death and indicated Pt 10's daughter, a physician assistant, and the supervisor received notification of Pt 10's death from Pt 10's nurse on 11/29/24 at 10:46 p.m. The next section of the document "Authorization and Release" was supposed to indicate consent to deliver the remains of the deceased to the mortuary chosen by the family, and was to include the name, address and phone number of the chosen mortuary, and the name, relationship, and signature of the responsible person who authorized the release of the deceased to the mortuary, the date, time, and method of the authorization (phone, signed permit, other), and the name of two witnesses, however this section was left blank. There was a space indicating "Family: Contact Name, Telephone number" which listed Pt 10's daughter and her telephone number. Toward the bottom of the page was space to document the date and time that "The above authorized mortuary was notified and instructions given for pick up within 72 hours," and the signature of person who notified them, however this section was left blank. Finally, the last section of the form was "Coroner/Mortuary's Receipt" to indicate the printed name of the mortuary representative or coroner's badge number who received the body, which was also left blank, and the received date and time which indicated 11/30/24 at 3:37 a.m. There was an unreadable signature in the space for "Signature Mortuary Representative/Coroner," the "ID Band Check," box was left blank, and there was an unreadable signature in the space for "Security Signature." There was no information on the document that identified what mortuary Pt 10 was transported to and no evidence Pt 10's daughter was contacted about mortuary choice, or that authorization or consent for transport to a mortuary was obtained. The PSO stated she was able to find out that the person who signed as the Mortuary Representative/Coroner was an employee of [Name of Mortuary], and the person who signed as Security was [Name of Security Officer], who worked for the hospital. The PSO provided an untitled document with Pt 10's hospital identification at the top, the date and time of death (11/29/24 at 10:46 p.m.), DOB [Pt 10's date of birth], weight [Pt 10's weight], the unit (CVICU), the date and time picked up (11/30/24 at 1:15 a.m.) and time placed in holding location (1:25 a.m.). The document had a place to indicate the name and phone number of the mortuary, and the date and time the mortuary was contacted, however this was left blank. The document indicated "Name of Next of Kin Authorizing Release: [Name of Pt 10's daughter], Phone number and relationship: [Pt 10's daughter's phone number]. The document indicated, "Releasing to [Prepopulated Name of Mortuary] (Family verification): 1st call attempt Next of Kin, 2nd call attempt Next of Kin," and both the first call attempt and the second call attempt were blank. The document indicated the "Date and Time Released to Mortuary or Coroner," was 11/30/24 at 3:37 a.m., and the "Picking up Officer" and the "Releasing Officer," were both identified as [last name of Security Officer], who worked for the hospital. There were handwritten comments at the bottom of the document which indicated, "No mortuary selected. Called [Name of Mortuary] due to overweight." There was no documentation that Pt 10's daughter gave consent or authorization for her mother (Pt 10) to be taken to [Name of Mortuary], or that an attempt to notify Pt 10's daughter before or after Pt 10 was transported to [Name of Mortuary] was made. The PSO was asked what the comment about "overweight" meant. The PSO stated the spaces in the hospital's morgue are not large so "bariatric" (extremely overweight) patients can't fit there so the hospital uses [Name of Mortuary] as overflow. The PSO stated she is not positive of the exact name of the mortuary because it may have changed. The PSO stated she is not sure what the weight limit is, but thinks it is less than 300 lbs. The contract with [Name of Mortuary] was requested, however the hospital was unable to find one.

During an interview on 5/30/25 at 4 p.m. with the Security Supervisor (SS 2), SS 2 stated patients that weigh over 250 pounds are taken to [Name of Mortuary] in Salida. SS 2 stated the hospital morgue had spaces that cannot support weight that exceeds that amount so once the security officer is told the weight they know if they will need to transfer the body to [Name of Mortuary]. SS 2 stated the security officer is supposed to contact the next of kin, explain the situation and get their consent before the patient is transported.

During an interview on 6/2/25 at 1:40 p.m. with a nurse from the stroke team (NCRN 2), the NCRN stated when she is taking care of someone who is going to be extubated and receive comfort care during the dying process, she ensures the orders for medications are written and she has the IV medication infusing prior to the patient being extubated. NCRN 2 stated she also makes sure she has the medication for IV push readily available as well as the medication prescribed for anxiety so that if her patient needs medication she will be prepared. NCRN 2 stated every patient's response is different and she observes her patients response and vital signs to be alerted to patient distress. She will also help the family understand what they are seeing and answer questions if needed. If the patient was in distress she would document that. NCRN stated she is not sure why medication would not have been given if the patient was in distress and medication was ordered.

Review of the hospital's P&P titled. "MOD SS.1.05 Patient Rights," dated 9/24/24, indicated, " ... [Name of Hospital] and its staff protect and promote each patient's rights. These rights apply to all patients, or when applicable, their representatives ... All patients' rights apply to the person who has legal responsibility to make decisions regarding medical care on your behalf ...You have the right to: Considerate and respectful care, and to be made comfortable. You have the right to respect for your cultural psychosocial, spiritual, and personal values, beliefs and preferences ... Receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care ... Reasonable responses to any reasonable requests made for service ...Receive care in a safe setting, free from mental, physical, sexual or verbal abuse and neglect, exploitation or harassment ..."

Review of the P&P titled "Comfort Measures Only [CMO] Policy And Protocol, dated 8/28/19, indicated, " ...Each patient's case and situation is unique and decisions about each patient's care should reflect this. Care will be individualized to suit the circumstances of each patient and, all care should be planned with the patient's comfort as the primary focus. This care should be provided in the least stressful setting and, therefore, these patients generally should not require an ICU environment ... Medications: The guiding principle in providing medication to a patient who is to receive CMO is that the aim of the medication is to provide palliation of symptoms for the patient. High on this list would be analgesics, antipyretics, sedatives, anxiolytics and seizure medications. Other relief of symptoms medications may be given for the goal of patient comfort ..."

Review of the hospital's P&P titled, "Documentation Policy" dated 9/28/22, indicated, " ...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 ...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; and the patient's response to treatment ...All Clinical Staff Members are responsible for documentation of clinical care given and ensuring that the standard of that documentation meets all legal and professional requirements. Documentation shall be completed timely ...Assessments will be completed and signed by licensed personnel. Assessments may be completed by a student extern, and then confirmed and signed by licensed personnel...All assessment data collected from a licensed vocational nurse [LVN] or student nurse will be reviewed, checked for accuracy, and co-signed by licensed personnel ...Patients are reassessed a minimum of every shift and as needed by an RN. LVNs and non-licensed personnel may collect and record data ...Changes in patient condition are documented within the appropriate electronic health record [EHR] system review, along with physician notifications ... Chart "annotation" may be used for narrative charting ..."


Review of the American College of Chest Physicians article titled, "Compassionate Extubation In Adult ICUs," dated 10/20, indicated, " ...Interdisciplinary protocols should be developed to standardize practices surrounding compassionate extubation, to improve symptom control and reduce the presence of agonal breathing ...Using standardized compassionate extubation process could alleviate patient suffering at the end of life and cause less emotional discomfort to the clinicians ..."


Review of the article in Mayo Clinic Proceedings titled, "Ethical Decision Making With End-of-Life Care: Palliative Sedation and Withholding or Withdrawing Life-Sustaining Treatments," dated 10/2010, indicated, " ...Palliative sedation [PS]has an important place on the continuum of appropriate palliative care at the end of life. It is appropriate therapy for refractory and unacceptably severe suffering. At the end of life, patient goals often shift to comfort, and removal of burdens and relief of suffering become paramount. The sedation level should be balanced according to the patient or surrogate's value placed on the effectiveness of symptom relief, and perceived benefits of such relief ...Because intensive care units are specially equipped and attended by highly specialized staff with the goal of preserving life, these rooms are in high demand and should be reserved for the critically ill whose primary goal is survival. Furthermore, the intensive care setting can be hectic and uncomfortable for families. For those who prioritize comfort at the time of inevitable death, intensive care units are generally a suboptimal setting for palliative sedation. If, however, goals of care shift from life prolongation to comfort and a short interval to death precludes transfer from the intensive setting, PS can be effectively implemented in this setting ..."

Based on interview and record review, the hospital failed to collect data on the Cardiovascular Program Flex that was approved in 2022 to May 2025.

This failure resulted in the quality department's inability to identify if there were opportunities for improvement in this high-risk area that affects patients' safety.

Findings:

During an interview on 5/30/25, at 3:48 p.m., with the Director of Quality Improvement (DQ), the DQ stated there was not an official project in place to monitor the use of the Program Flex (a request to change or modify or deviate from the standard regulations) for Cardiothoracic surgery first and second assists (first assist must be an independent qualified surgeon and second assist can be physician assistant or a registered nurse first assistant). The DQ stated the hospital was not following the Program Flex approved for Cardiothoracic use of first and second assistants.

During a review of the Hospital's program flex approval letter for California Code of Regulations T22 (Title 22) DIV5 (Division 5) CH1 (Chapter 1) ART (Article) 6-70435(b)(2), dated 10/18/22, indicated, "The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass. Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: ... 4. The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non- surgeon cannot be the first assist for cardiovascular operative procedures ... 14. As part of the hospital's on-going quality assurance program, a methodology for periodic evaluation of the effectiveness of this alternate method shall be developed. There shall be provisions for recommendations to be made to the administration and medical staff and any follow-up action ..."

During a review of the hospital's "Performance Improvement Annual Appraisal & Quality Assessment and Performance Improvement Plan 2024-2026," the plan indicated, "The QAPI plan guides the organization's performance improvement efforts. The QAPI regulation requires a written plan. 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 purpose of the Performance Improvement Program at [name of this hospital] is to ensure patients are provided high quality care in an environment of minimal risk. This is accomplished through the collaborative efforts of staff in different areas, disciplines and professional backgrounds consistent with the hospital's mission, vision and goals ..."

Based on interview and record review the hospital's Governing Body failed to ensure that the Quality Assessment and Performance Program (QAPI- is a systematic approach to improving the quality of care and services delivered to patients) involved all hospital departments and services when:

1. The Program Flex (a request to change or modify or deviate from the standard regulations) for the Cardiovascular Department approved in 2022, was not followed and the hospital allowed a fifth year resident in cardiothoracic surgery as the surgical first assist ,and

2.The Health Information Management (HIM) Departments (manages patients' data, ensuring its quality, integrity, and security) were not being monitored by the quality department's program.

These failures resulted in the Governing Body's inability to ensure that the QAPI program reflected the complexity of the hospitals organization and services.

Findings:

During a review of hospital's Governing Body minutes and Quality minutes from October 2024 to April of 2025, there was no mention of the Program Flex for the Cardiovascular Department approved in 2022 and no mention of the Health Information Management (HIM) Department's quality data.

1. A review of Title 22 of the California Code of Regulations (CCR -is a comprehensive set of rules and regulations that govern various aspects of programs in California) section 70435 Cardiovascular Surgery Service Staff was conducted, and the program flex document was reviewed. Title 22 CCR section 70435 indicated " ... (b) Cardiovascular operative service. (1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery. He shall be responsible for: (A) Implementing established policies and procedures. (B) Training and supervising the nurses and technicians in special techniques. (C) Training and supervising the clinical perfusionists. (2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b) (1) above ...". The review of "APPROVAL OF PROGRAM FLEXIBILITY" by CDPH dated October 18, 2022, indicated, " ... This letter is in response to the request submitted by [Hospital name] for program flexibility for California Code of Regulations T22 DIV5 CH1 ART6-70435(b)(2). The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass ... The use of the PA as a second assistant is at the discretion of the primary surgeon ... The facility is required to have a 3-team cardiovascular surgical team in the OR ... The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures ..."

During an interview on 5/27/25 at 4:30 p.m., with the Hospital's Governing Body (GB) representatives, the GB representatives stated that they were informed about the use of a fifth year resident in cardiothoracic surgery as the first assist on this last Thursday 5/22/25. A fifth year resident would not be considered an independent and fully functioning surgeon as stated in the Program Flex. The GB representatives stated the Program Flex was reviewed with them and it was explained to them that the hospital had not been following the flex. The GB representatives stated they did not know the hospital was not following this Program Flex until that day. The GB representatives stated the GB expect the hospital to follow the flex, and the hospital has already started making changes. The GB stated the GB is responsible for the quality of care provided at this hospital.


2. During an interview on 5/30/25, at 3:48 p.m., with the Director of Quality Improvement (DQ), the DQ stated there was not an official project in place to monitor the use of the Program Flex for Cardiothoracic surgery first and second assists. The DQ stated the hospital was not following the Flex approved for Cardiothoracic use of first and second assistants. The DQ stated although HIM was monitoring its own projects HIM was not reporting to the Quality Department at all. The DQ stated she has all departments color coded and each color meets quarterly and HIM was missed (HIM was never assigned a color code). The DQ stated she uses data from the HIM department all the time and now she plans to include them during her quarterly meetings for Quality.

During a review of the Hospital's Quality Program Binder, created and updated by the DQ, the binder had no quality data mentioning the conditions approved by the Cardiothoracic Program Flex and had no quality data from the HIM Department.

During a review of the hospital's "Performance Improvement Annual Appraisal & Quality Assessment and Performance Improvement Plan 2024-2026," the plan indicated, "The QAPI plan guides the organization's performance improvement efforts. The QAPI regulation requires a written plan. 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 purpose of the Performance Improvement Program at [name of this hospital] is to ensure patients are provided high quality care in an environment of minimal risk. This is accomplished through the collaborative efforts of staff in different areas, disciplines and professional backgrounds consistent with the hospital's mission, vision and goals ..."

Based on interview and record review, the hospital failed to ensure the Medical Staff was accountable to the Governing Body when:

1. The Medical Staff office did not have a system in place to ensure adequate and appropriate staff in the Operating Room (OR) for cardiovascular (heart and blood vessels) surgical procedures that require the use of an extracorporeal (outside the living body) coronary (heart) bypass machine (a machine that temporarily takes over the function of the heart and lungs, putting oxygen in the blood and pumping that blood throughout the body) in accordance with a signed agreement to comply with California Code of Regulations, Title 22 Division 5 article 6 section 70435(b) (2).

2. The medical staff failed to ensure that an annual review of all qualified non-surgeons who participated in CV surgery requiring a coronary bypass machine was performed and that the annual review included letters of competency from the supervising physician(s). The hospital did not comply with the provision of ensuring CV open heart surgery with bypass consisted of a 3-surgeon team, one of which is board certified or board eligible by the American Board of Thoracic Surgery, one member could be an independent and qualified surgeon and the third member could be a physician assistant (PA), registered nurse first assistant (RNFA) or other qualified non-surgeon. However, a PA or RNFA could not be the first assistant for CV procedures. The hospital did not have a system in place to evaluate the qualifications of the RNFA and PAs on an annual basis. The hospital did not ensure each CV open heart surgery with bypass had a first assistant that was an independent qualified surgeon.

3. The medical staff failed to ensure that the hospital's on-going quality assurance program included a methodology for periodic review of the effectiveness of the required three members of the CV surgical team in the OR during a CV surgery requiring a coronary bypass machine.

4. The medical staff failed to ensure the hospital created and maintained a record of any emergency situations in which the required three members of the CV surgical team in the OR during a CV surgery requiring a coronary bypass machine were not present.

These failures had the potential to result in harm to patients undergoing CV surgery, including the possibility of many types of adverse events, including but not limited to strokes, heart attacks, and death.

Findings:

1. During a concurrent observation and interview on 5/22/25 at 8:55 a.m. with the Registered Nurse Quality (QRN) 3 & Assistant Director of Nursing Surgical Services (ADON) in operating room (OR) 15, Patient (Pt) 1's surgical procedure was observed. Pt 1 underwent an open-heart Coronary Artery Bypass Graft (CABG - is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) surgical procedure that included three separate bypass grafts. The ADON validated and verified the staffing in the room for the entire procedure included a primary cardio thoracic surgeon (SUR - a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity) 1, resident surgeon (RS - a physician who has completed medical school and is undergoing supervised training in a specific surgical specialty to become a board-certified surgeon ) 1, Anesthesiologist (ANS - a medical doctor specializing in administering anesthesia and managing pain during medical procedures and surgeries) 1, Perfusionist (PER - healthcare professional who operates the heart-lung machine during certain surgeries, like open heart surgery, to maintain the patient's blood flow and oxygenation while the heart is stopped) 1, Registered Nurse First Assist (RNFA - is a Registered Nurse (RN) who works in an expanded role as a surgical first assistant and is responsible for working with the surgical team during surgery, at the direction of the primary surgeon) 1, two RNs working as scrub nurses (work within the sterile field, directly assisting the surgeon(s) with instruments and supplies during the procedure) and a circulating nurse (nurse who works outside the sterile field, managing patient care, coordinating with the surgical team, and ensuring a safe environment). The ADON stated that was the normal staffing for cardiovascular surgical cases at their hospital. The ADON stated that resident surgeon was the first assisting surgeon, and they typically have RNFA or Physician Assistant (PA - a licensed medical professional who works under the supervision of a licensed physician) as second assistant surgeon in the room. The ADON stated the hospital does not normally require scheduling two independent, fully qualified surgeons for the CABG procedures as the hospital has resident surgeons working with the primary surgeons. The ADON stated as far as he was aware, the resident surgeon was okay to be in the room as first assisting surgeon under the direct supervision of a primary board-certified cardiothoracic surgeon. The ADON was unable to comment on what a resident surgeon can and cannot do at the hospital or during the surgical procedure. The ADON also was not able to comment on what year or specialty (specific area of training) residents were and stated the OR team does not have access or any way to validate, or to see or check privileges (define the specific types and scope of surgical procedures they are authorized to perform at a hospital). The ADON stated he would have to defer to Director of Surgical Services (DSS) regarding residents and person in charge of residency program, however, his understanding was the surgeon was responsible for overseeing the residents.

During an interview on 5/22/25 at 10:55 a.m. with the DSS, the DSS stated he was aware of the state regulation and staffing requirement for cardiac vascular operative surgery cases. The DSS stated CABG cases must have a second physician in OR and do not require the second physician to be a board certified cardiac surgeon. The DSS stated the hospital has cardiovascular surgery fifth year residents as the second physician in the OR. The DSS stated the facility also has a California Department of Public Health approved Program Flex that allows them to staff mid-level providers [Physician assistant or RNFA] to replace a third surgeon in cardiovascular cases requiring bypass. The DSS stated the resident surgeon's credentialing and privileges were with "Hospital B" and not currently listed in their system. The DSS stated medical staff and human resources would be able to speak about the process.

During a concurrent interview and record review on 5/22/25 at 11:00 a.m. with the ADON & DSS, Pt 2's electronic medical record (EMR) was reviewed for the "OR Intraoperative record". A review of Pt 2 's "OR intraoperative record" indicated Pt 2 had CABG surgery on 3/31/25. Pt 2 went in to the OR at 7:15 a.m., surgery start time was 8:13 a.m. and end time was 11:37 a.m. SUR 2 was the primary surgeon and was in the OR from 7:15 a.m. to 11:37 a.m. RS 2 was in the room from 7:45 a.m. to 8:15 a.m. [RS 2 left 2 minutes after the case started]. The ADON stated that record does not reflect any other surgeon was in the operating room besides SUR 1 during the entire surgical procedure and RS 2 was in the room for only two minutes at the start of surgery. The ADON stated the "OR Intraoperative report" indicated RNFA 1 and PA 1 were assisting SUR 1 with the case as well. The ADON stated PA 1 was in Pt 2's surgery from 7:15 a.m. to 11:37 a.m., same as SUR 1. The ADON stated RNFA 1 was in Pt 2's surgery from 7:15 a.m. to 9:51 a.m. The ADON stated he was unable to comment if the hospital had another surgeon available or on call for the duration of Pt 2's surgery, however, [he believed] the approved program flex allows them to have a PA or RNFA as third surgeon.

During a concurrent interview and record review on 5/22/25 at 11:05 a.m. with the ADON & DSS, Pt 3's EMR was reviewed for the "OR Intraoperative record". The review of Pt 3's "OR Intraoperative record" indicated Pt 3 had MITRAL VALVE (located between the left atrium and left ventricle) repair [removes and repairs part of the damaged mitral valve to allow the valve to fully close and stop leaking] and TRICUSPID VALVE (located on the right side of the heart between the right atrium and right ventricle) repair surgery on 3/31/25. Pt 3 went in to the OR on 3/31/25 at 7:42 a.m., surgery started at 8:47 a.m. and ended at 2:00 p.m. SUR 3 was the primary surgeon and was in the OR from 7:42 a.m. until 2:10 p.m. RS 2 was also listed as being present in the room from 7:42 a.m. until 2:10 p.m. The ADON stated he was not able to find any other surgeon listed as being present in the room during the procedure. The ADON stated he was unable to comment how RS 2 was present for both Pt 2 and Pt 3 as first assistant [second surgeon] at the same time. The ADON stated he could only go by the record, and it appears to him that RS 2 just went to check in Pt 2's room and stayed with Pt 3's procedure. The ADON stated the entry times do not appear correct as they are overlapping. The ADON validated even with overlapping of time RS 2 was only in the room for Pt 2 for two minutes after the surgery was started and no other independent and qualified surgeon except RNFA or PA was in the room during the procedure for both Pt 2 and Pt 3.

During an interview on 5/22/25 at 2:15 p.m. with SUR1, SUR 1 stated surgery for Pt 1 was uneventful and had no concerns with RS 1's performance. SUR 1 stated he was board certified in cardiac surgery and his understanding for number of surgeons in OR for CABG was, "As soon as you anticipate or as soon as patient goes on bypass [medical device that temporarily takes over the functions of the heart and lungs during surgery, especially open-heart surgery], expectation is to have two surgeons in the room and PA or RNFA could be the third". SUR 1 stated he was informed that residents could be assisting surgeon. SUR 1 stated he performs surgeries at a different facility in the town as well and they are, "Required to have two independent surgeons not residents" in operating room at all times for CABG procedures. SUR 1 stated he always has challenges getting the second surgeon at this hospital and has to call his colleagues from another hospital to assist him. SUR 1 stated the facility started using resident surgeons and it allowed some consistency in assuring first assistant as resident surgeon. SUR 1 stated he has not experienced any adverse outcomes with residents assisting. SUR 1 stated RS 1 currently requires supervision and would be practicing independently next year.

During a concurrent interview and record review on 5/22/25 at 4:37 p.m. with the DSS & the Manager Accreditation and regulatory (MA) 1, Title 22 of the California Code of Regulations (CCR - is a comprehensive set of rules and regulations that govern various aspects of programs in California) section 70435 Cardiovascular Surgery Service Staff was reviewed, and the program flex document was reviewed. Title 22 CCR section 70435 indicated " ... (b) Cardiovascular operative service. (1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery. He shall be responsible for: (A) Implementing established policies and procedures. (B) Training and supervising the nurses and technicians in special techniques. (C) Training and supervising the clinical perfusionists. (2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b) (1) above ...". The review of "APPROVAL OF PROGRAM FLEXIBILITY" by CDPH dated October 18, 2022, indicated, " ... This letter is in response to the request submitted by [Hospital name] for program flexibility for California Code of Regulations T22 DIV5 CH1 ART6-70435(b)(2). The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass ... The use of the PA as a second assistant is at the discretion of the primary surgeon ... The facility is required to have a 3-team cardiovascular surgical team in the OR ... The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures ..." The DSS stated he was aware of the requirements set forth in CCR and conditions in the program flex. The DSS stated he was not able to comment if the RS 1 was an independent and qualified surgeon as required per CCR and flex approval conditions for first assistant to primary surgeon for CABG procedure. The DSS stated he was in charge of the surgery scheduling team [individuals responsible for coordinating all aspects of scheduling surgical procedures] and it was not standard practice at the hospital to identify first assistant in cardiac surgery cases during scheduling process. The DSS stated he was not able to comment on what criteria was used to determine that RS 1 or surgery residents were able to be scheduled as first assistant or second surgeon in the CABG. The DSS stated he would have to defer to Medical staff office for all the surgery resident requirements and would have to look into this practice. The MA 1 stated she was aware of the program flex and CCR staffing requirements and the MA 1 stated approved flex was addressed to her name. The MA 1 stated that she posted it in the lobby upon receiving the approval of program flex and shared with leadership team. The MA 1 stated she cannot comment if the hospital was in compliance with the condition set forth in the approved Program Flex. The MA 1 stated she does not know if it was appropriate to schedule RS 1 as first assistant to the primary surgeon and as a second surgeon in the CABG case. Both MA 1 & DSS stated they both understood and were aware the program flex authorization was to use mid-level provider as second assistant or third surgeon; and, that they were still required to have second independent and fully qualified surgeon in the room as first assist.

During an interview on 5/22/25 at 5:35 p.m. with the Chief Nursing Officer (CNO), the CNO stated she has reviewed the approved program flex and it was her understanding that surgery residents were not independent and fully qualified surgeons and therefore were not qualified to be the first assistant [second surgeon] in a cardiac surgery case requiring bypass. The CNO stated surgery residents need supervision but she was not aware who was responsible at the facility for the oversight of the residency program. The CNO agreed that surgical staff should know what residents can and cannot do while the residents are at their facility assisting with surgeries in the OR. The CNO stated she would need to follow up with her leadership team and do additional research prior to commenting on compliance with state regulations for number of surgeons and conditions listed in the program flex to use mid-level provider [PA or FNP] as a third surgeon [second assistant to primary surgeon].

During an interview on 5/23/25 at 8:05 a.m. with the Chief Executive Officer (CEO) and the CNO, the CEO stated the hospital leadership team did their research, including reaching out to "Hospital B" for guidance on surgical resident requirements. The CEO stated that they have reached out to their hospital's legal counsel and realized that the hospital leadership misunderstood the approved flex. The CEO stated the cardiovascular surgery team at this time was not meeting the CCR and Program Flex conditions. The CEO stated effective immediately- and now the hospital requires the second independent and fully qualified surgeon (first assistant) to be identified ahead of the scheduled surgery and present for the entire surgical procedure. The CEO stated the hospital will not be using surgical residents as first assistants in cardiovascular surgeries moving forward.

During a concurrent interview and review on 5/23/25 at 9:45 a.m. with the CCS, the CNO and the Director of Quality (DQ), the facility's Approval of Program Flexibility for California Code of Regulations T22 DIV5 CH1 ART 6-70435(b)(2) dated 3/10/2023 (Program Flex document) was reviewed. The CCS stated he was not familiar with the Approval of a Program Flex and then read the document. After reading the document, the CCS stated, "I was told this morning that there will be a surgeon as first assistant for every case of surgery requiring bypass." The CCS was asked to read the 4th condition of approval, "The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for the CV operative procedure." When asked whether a resident was an independent, fully qualified surgeon, the CSS stated, "No, a resident is not an independent and fully qualified surgeon." The CCS stated "No" when asked whether a 5th year resident (a Doctor of Medicine or Doctor of Osteopathy who is a student in a Graduate Medical Education Program), a fellow (a Doctor of Medicine or Doctor of Osteopathy who is a student in a Graduate Medical Education Program) or an interventional cardiologist met the criteria to be a first assistant. The CCS stated an independent and fully qualified surgeon would be a licensed surgeon with full privileges to be a first assistant based on experience operating in body cavities. When asked what an independent and fully qualified surgeon was, the CNO stated someone who, "is fully qualified as a surgeon with a license to practice independently." The CNO stated a 5th year resident is not an independent and fully qualified surgeon, is not credentialed by the hospital and is not privileged by the hospital.

During a concurrent interview and record review on 5/23/25 at 10:39 a.m. with the SUR 1 and Director of Quality (DQ), the SUR 1 stated he was the division chief for Cardiac Surgery. SUR 1 stated he had been the division chief for two years. SUR 1 stated he was just made aware of the approved program flex and he was not previously aware of the conditions in the flex. SUR 1 stated this was his first time looking at the conditions set forth in the approved program flex. SUR 1 stated he now understands that the program flex is for the use of PA or RNFA for the third surgeon requirement. SUR 1 stated, the hospital, moving forward, will set up a schedule for the surgeons and will have a qualified person as second surgeon or first assistant and their name will also be listed on the surgery schedule moving forward. SUR 1 stated it was his practice to always have a second surgeon in the room and it was his understanding that a second surgeon was required when patients go on bypass. SUR 1 stated he started working with the residents as second surgeon (first assistant) approximately eight months ago. SUR 1 stated he was informed it was okay to have residents as first assistant as these were fifth year cardiac surgery resident. SUR 1 stated these residents were one year away from being independent surgeons. SUR 1 stated although residents were safe and very good in assisting, these residents were not independent and fully qualified surgeons as required in conditions of program flex approval.

During an interview on 5/27/25 at 1:53 p.m. with the perfusionist (PER) 2, PER 2 stated that he has been working at the facility since 2013. PER 2 stated he also works at another facility across town. PER 2 stated that at this hospital it was common not to have a second surgeon or first assist that was a surgeon in the room during cardiac surgical procedures. PER 2 stated, "Many times, perhaps half of the time," a second surgeon is not available or present in the OR during the CABG procedure. PER 2 also stated when he worked across town in a different hospital, that facility always has second surgeon in the operating room during the entire duration while the patient is on a heart lung machine.

During an interview on 5/27/2025 at 4:30 p.m. with three representatives of the Board of Trustees, when asked about their knowledge of the Program Flex approval, the Chair stated she had only learned about it, "the night before." The GB representatives stated that they were informed about the use of a 5th year resident in cardiothoracic surgery as the first assist on this last Thursday 5/22/25. The GB representatives stated the Flex was reviewed with them and it was explained to them that the hospital had not been following the flex. The GB representatives stated they did not know the hospital was not following this Flex until that day. The GB representatives stated the GB expect the hospital to follow the flex, and the hospital has already started making changes. The GB stated the GB is responsible for the quality of care provided at this hospital.
During a review of hospital's Governing Body minutes and Quality minutes from October 2024 to April of 2025, there was no mention of the Program Flex for the Cardiovascular Department approved in 2022 and no mention of the Health Information Management (HIM) Department's quality data.

During a concurrent interview and record review on 5/28/25 at 2:01 p.m. with the SUR 3, Pt 3's EMR was reviewed for the "OR Intraoperative record" dated 3/31/25. SUR 3 stated he had been operating at the hospital since 2017. SUR 3 stated he was a board-certified cardiothoracic surgeon. SUR 3 stated he was not aware of the conditions or requirements of the program flex. SUR 3 stated it was his understanding that he was required to have another physician as a second surgeon during his procedures and cardio thoracic surgery residents meet that requirement. SUR 3 stated he had spoken with other teaching institutions, and it was a standard practice to have cardiac surgery residents as first assistant surgeon. SUR 3 stated he requires his residents to stay with him during the entire surgical procedure. SUR 3 validated RS 2 was with him for the entire surgical procedure for Pt 3.

During a concurrent interview and record review on 5/29/25 at 3:30 p.m. with RN 5, Pt 2's EMR was reviewed. RN 5 stated she was in the OR for Pt 2's surgery and was responsible for documentation of times when everyone was entering and leaving OR during the surgery. RN 5 stated she does not recall Pt 2 specifics, but she always documented exact times. RN 5 reviewed the EMR and Pt 2's "OR Intraoperative record" and stated that Pt 2's record reflects that RS 2 was in the room from 7:45 a.m. to 8:15 a.m., surgery start time was 8:13 a.m. RN 5 validated that EMR reflects she was the one that documented times for RS 2. RN 5 stated that she was unable to comment on cardiovascular surgery staffing requirements, however, she was not aware that second surgeon [first assistant] have to be in the operating room at all times. RN 5 stated that as long as someone was available she thought it was okay to proceed with the surgical procedure.

During a concurrent interview and record review on 5/30/25 at 12:47 p.m. with SUR 2, Pt 2's EMR was reviewed for the "OR Intraoperative record" dated 3/31/25. SUR 2 stated he was unable to comment on RS 2 times in the OR. SUR 2 stated the times listed may or may not be accurate. SUR 2 stated he does not recall who was in the room during the surgery. SUR 2 stated he was not aware of any program flex that hospital had in place, however, he was aware of the surgery staffing requirements for cardiac surgeries. SUR 2 stated he expects to have second surgeon in the OR during surgery. SUR 2 stated as far as he was aware, residents can function as first assistant [second surgeon] in the room and RNFA or PA can function as third surgeon. SUR 2 stated if the record reflects RS 2 left two minutes after procedure start, then it could not be accurate.

During a concurrent interview and record review on 5/30/25 at 2:25 p.m. with the DSS & MA 1, OR case logs [systematic record of individual patient cases] for month of March 2025, April 2025 and May 2025 were reviewed for the cardiovascular surgeries. The review of OR case logs for the whole month of March 2025 indicated total of 22 open heart surgeries were done, and out of 22 cases 15 cases had a resident as the first assistant (second surgeon), two cases did not have any second surgeon that was a physician or resident. Out of 22 cases in March 2025, five cases did have second surgeon that was independent and qualified surgeon, however, in three of those cases the second surgeon was only in the room for less than 10 minutes. A review of April 2025 case log for cardiac surgeries indicated a total of 28 open heart surgeries were done at the hospital. Out of the 28 cases, 17 cases had a resident as first assistant (second surgeon), and two cases did not have any second surgeon that was a physician or resident. Out of 28 cases, nine cases did have a second independent and qualified surgeon; however, in six of eight cases, that surgeon was in the room for ten or fewer minutes. The DSS and MA 1 both stated that this reported data was accurate and DQ validated it by manually counting it. The DSS stated the hospital team did not have a good understanding of the approved Program Flex and were not compliant with the conditions of approved program flex and requirement for cardiac surgery staffing under CCR. The DSS stated he now understands the CCR requirement and approved program flex. The DSS stated effective 5/23/25 changes have been put in place to ensure a second independent and qualified surgeon would be present during all open-heart surgeries. The DSS stated going forward the second surgeon would be scheduled, and the OR team would be able to validate and confirm presence of an independent and qualified second surgeon [first assistant] prior to patient's surgery.
During review of the OR case log for cases requiring extracorporeal bypass provided by the hospital for dates March 1, 2025 through 5/21/25, a random sample of 10 of the 63 cases found 10 of the 10 cases sampled did not have an independent, fully qualified surgeon other than the Primary Surgeon in the operating room. Each of the 10 cases also listed the first assistant as either a PA or an RNFA.

2. During continued concurrent interview and review on 5/23/25 at 9:45 a.m. with the CCS, CNO and DQ, the facility's Program Flex document was reviewed. The CCS read Condition #9, "Annual review of all qualified non-surgeon (sic) used in this capacity will include letters of competency from the supervising physician and routine chart review will be conducted." When asked whether he, as supervising physician, had written letters of competency annually, CCS stated, "No, I have not" written such letters. Nor was the CCS aware that any other Primary Surgeon had written such letters. When asked about annual chart reviews, the CCS stated neither a PA nor an RNFA documents anything in the chart, so there was never any chart review that he performed. The Medical Staff Manager (MSM) was then contacted and by phone stated that for PAs, "Not performing annually, only at recredentialing, so every 2 years." During an interview on 5/20/2025 at 2:05 p.m. Credentialing Coordinator 1 in the Medical Staff Office, stated RNFAs are not privileged through the Medical Staff Office but rather through Human Resources; and, the timeline for review was every two years.

3. During continued concurrent interview and review on 5/23/25 at 9:45 a.m. with the CCS, CNO and DQ, the facility's Program Flex document was reviewed. CCS read Condition 14, "As part of the hospital's on-going quality assurance program, a methodology for periodic evaluation of the effectiveness of this alternate method shall be developed. There shall be provisions for recommendations to be made to the administration and medical staff and follow-up." The CCS stated he was neither familiar with a methodology nor any evaluation performed. The DQ stated, "QAPI had not been monitoring."

During an interview on 5/30/25, at 3:48 p.m., with the Director of Quality Improvement (DQ), the DQ stated there was not an official project in place to monitor the use of the Program Flex (a request to change or modify or deviate from the standard regulations) for Cardiothoracic surgery first and second assists (first assist must be an independent qualified surgeon and second assist can be physician assistant or a registered nurse first assistant). The DQ stated the hospital was not following the Program Flex approved for Cardiothoracic use of first and second assistants.

During a review of the Hospital's program flex approval letter for California Code of Regulations T22 (Title 22) DIV5 (Division 5) CH1 (Chapter 1) ART (Article) 6-70435(b)(2), dated 10/18/22, indicated, "The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass. Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: ... 4. The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non- surgeon cannot be the first assist for cardiovascular operative procedures ... 14. As part of the hospital's on-going quality assurance program, a methodology for periodic evaluation of the effectiveness of this alternate method shall be developed. There shall be provisions for recommendations to be made to the administration and medical staff and any follow-up action ..."

During a review of the hospital's "Performance Improvement Annual Appraisal & Quality Assessment and Performance Improvement Plan 2024-2026," the plan indicated, "The QAPI plan guides the organization's performance improvement efforts. The QAPI regulation requires a written plan. 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 purpose of the Performance Improvement Program at [name of this hospital] is to ensure patients are provided high quality care in an environment of minimal risk. This is accomplished through the collaborative efforts of staff in different areas, disciplines and professional backgrounds consistent with the hospital's mission, vision and goals ..."

During a review of the Hospital's Quality Program Binder, created and updated by the DQ, the binder had no quality data mentioning the conditions approved by the Cardiothoracic Program Flex.

4. During continued concurrent interview and review on 5/23/25 at 9:45 a.m. with the CCS, CNO and DQ, the facility's Program Flex document was reviewed. The CCS read Condition 17, "The facility shall maintain a record of any emergency situation in which the first assistant is not a physician. This record shall be available to CDPH upon request." The CCS stated he was not familiar with such a record and could not provide that to me upon my request. The CCS stated he did not know whether there was no list because there was no list or because there had been no emergency situations in which the first assistant was not a physician. The DQ stated, "QAPI has not been monitoring."

Based on observation, interview and record review, the facility failed to ensure all licensed nurses adhered to the hospital's policies and procedures (P&P), when:

1. Three of three patients (Patient 45, 46, and 47) were reviewed for clinical nutrition care at BHC Campus 2 and had incomplete meal intake documentation in the medical record.

This failure had the potential to result in patient safety risks including poor intake to go unnoticed, causing delayed intervention by dietitians or physicians leading to malnutrition, dehydration, or other complications. Changes in appetite or intake can be early signs of medical issues and lack of documentation may delay recognition and treatment.

2. One of five sampled Glucometers (a device for measuring the concentration of glucose in the blood) had controls performed (a way to check the blood glucose meter and test strips are working together properly to deliver accurate results) with expired control solutions (solution use to test the functionality of meter and strips) not in accordance with the hospital's P&P titled " PC.AD.1.38 Blood Glucose Monitoring,"

This failure placed patients at risk for inadequate blood glucose monitoring and management and could negatively affect physical and emotional wellbeing of patients that are already vulnerable.

3. One of one patient (Pt 27) did not have a temperature and respiration rate assessed and documented every one hour while receiving intravenous (IV-in a vein) magnesium sulfate (a high-risk medication to help prevent seizures [sudden uncontrolled bursts of electrical activity in the brain]) according to the hospital's P&P titled, "MOD L&D.1.18 Magnesium Sulfate Management In Obstetrics."

This failure placed Pt 27 at risk for respiratory depression (when you breathe too slowly or too shallowly), hypothermia (a condition in which the body's core temperature drops below 95 degrees Fahrenheit), and magnesium toxicity (a condition where there is too much magnesium in the blood).

4. One of two patients (Pt 31) did not have vital signs completed every two hours when Pt 31 was given an Emergency Severity Index (ESI-a 5 level scale used by triage nurses to indicate the seriousness of the patient's condition and the resources needed, ESI 1 being the most serious) of 2 according to the hospital's P&P titled, "MOD ED.1.04 Standard of Care Policy."This failure placed Pt 31 at risk for delay detection of changes in condition and delayed care.

5. One of one patients (Pt 10) did not have urine output measured and recorded in the medical record for a 24 hour period, a physical assessment performed by a student nurse was not validated by a registered nurse, and the events preceding a stroke alert activation and a rapid response team call were not documented by Pt 10's nurse, in accordance with the hospital's P&P titled, "PC.AD.1.08 Documentation Policy."

These failures resulted in the potential for delayed detection of acute kidney injury, dehydration or fluid overload, delayed detection of a change of condition, incomplete and/or inaccurate nursing assessment, and an incomplete medical record.

Findings:

1. During a clinical record review of Patient 45 in the presence of Shift Manager (SMDBH) DBH Campus 2, Patient 45 was admitted to the campus on 5/16/25 with a past medical history of Diabetes Mellitus (a chronic metabolic disorder characterized by persistent high blood sugar levels). During a review of physician diet orders dated 5/16/25, a consistent carbohydrate diet (CCD) was ordered. Review of meal intakes dated 5/16 to 5/22/25, indicated no intake documented for breakfast. During a concurrent interview on 5/22/25 at 10:45 a.m. with SMDBH, he stated nursing would document if there were refusals of the meals and would let psych or medical know as well.

During a clinical record review of Patient 46, in the presence of SMDBH, Patient 46 was admitted on 4/23/25 and discharged on 5/22/25. Physician's orders dated 4/23/25, indicated Patient 46 was ordered a CCD. Review of meal intakes for Patient 46, showed incomplete documentation, and nursing would document meal consumption in two different areas in the chart. A concurrent interview with SMDBH on 5/22/25 at 11:10 a.m., SMDBH stated staff is supposed to document in the meal percentages for each meal in the electronic medical record. SMDBH acknowledged the staff was documenting in two separate areas but stated the staff are supposed to document under meal intake section.

During a clinical record review of Patient 47, in the presence of SMDBH, Patient 47 was admitted on 5/15/25 with a modified sodium diet. Review of meal intakes for Patient 47, showed very few intakes were documented. During a concurrent interview with SMDBH on 5/22/25 at 12:23 p.m., SMDBH acknowledged very little meal intakes were documented, and the nursing policy was that staff were to document meal intakes for each meal.

During an interview with the Director of Patient Care Services (DPCDBH) at DBH Campus 2 on 5/23/25 at 9:12 a.m., DPCDBH stated the meal intake section should be entered in the patient chart by the clinical technician and she became aware this was a concern.

During a review of the hospital policy and procedures titled "PC.AC.108 Documentation Policy", dated approved 9/28/22, indicated the purpose is to outline responsibilities related to documentation of patient care from admission through discharge. It indicated documentation shall be completed timely. It indicated under assessment and interventions, "Activities of daily living are documented as applicable (e.g. ... diet and amount taken...) Nursing Assistants (NA) will assist in documenting such findings.


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2. During a concurrent observation and interview on 5/20/25 at 11:30 a.m. with Director of NICU and Pediatrics (DP) and Registered Nurse Educator (RNE) 1, in the Obstetrics Triage department, a glucometer kit was observed to have two vials of expired glucose control solution. The DP validated the observation and stated the labeled expiration date on the glucose control solution vials were 5/17/25. RNE 1 stated the glucose control solution should be changed every three months according to the standard recommendation from the manufacturer. The DP stated it was important to not use expired glucose control solutions because it can give inaccurate results.

During a review of the facility's P&P titled, "PC.AD.1.38 Blood Glucose Monitoring," dated 7/24/24, the P&P indicated, " ... Quality control testing is to be performed sequentially with low and high control solutions. Quality control must be performed: a. Daily or when requested by the [brand name Glucometer]. b. When a new vial of test strips is opened. c. If a test result's validity is in question. d. Whenever a vial of test strips is left uncapped. e. To recertify an operator (Recertification once a year. QUALITY CONTROL TESTING. 1. To ensure the [brand name Glucometer] meter is functioning properly, QC [quality control] will be required every 24 hours. Both a level 1 and level 2 will need to be done prior to continuing to use the meter. The meter will lock out until QC has been completed. 2. Controls are good for 3 months. Each vial should be dated with the open date and expiration date ... 4. Discard outdated strips and controls ... "

During a review of facility's Glucometer "Operators Manual (OM)," dated 3/2013, the "OM" indicated, "... Accurately testing known levels of glucose ensures that the system and your technique used in testing give accurate results on patient tests. Glucose control solutions have defined (known) values. The results for solutions must first fall within a certain acceptable range in order to allow valid patient testing ... Intervals between running glucose control tests are determined by your facility. These intervals are entered when the system is configured ... Glucose control tests should be run in the following circumstances: Before using the meter for patient testing the first time ...At the glucose control intervals established by your facility, if established ...When using a new test strip vial for the first time... When using a new test strip lot for the first time (and as a result a new test strip code) ...If a test strip vial was left open ... If questionable test results are displayed repeatedly ...If you wish to test the performance of the system ..."

3. During a review of Pt 27's "History and Physical (H&P-a comprehensive assessment of a patient, combining a medical history with a physical examination)," dated 5/20/25 was reviewed. The "H&P" indicated, " ... 40-year-old G [gravida-the total number of confirmed pregnancies that a female has had] 3 P [para-the number of births that a female has had] 0 ... at 32 weeks and 1 day ... history of chronic hypertension [HTN- high blood pressure] and left-sided CVA [cerebrovascular accident-stroke, loss of blood flow to a part of the brain] in 2021 ... presents as a transfer ... for superimposed severe preeclampsia [a disorder that can occur during pregnancy or after childbirth in which there is high blood pressure and other signs of organ injury] on chronic hypertension ..."

During a concurrent interview and record review on 5/23/25 at 10:40 a.m. with Registered Nurse Educator (RNE) 1 and Quality Review Nurse (QRN) 1, Pt 27's "Medication Administration Record (MAR-a record of drugs administered to a patient)," dated 5/20/25 to 5/21/25 and "Vital Signs Flowsheet (VSF)," dated 5/20/25 to 5/21/25 were reviewed. The "MAR" indicated Pt 27 was started on IV magnesium sulfate on 5/20/25 at 4 p.m. and stopped on 5/21/25 at 2:45 p.m. The "VSF" indicated Pt 27 had a temperature assessed on 5/20/25 at 3:52 p.m., 7:30 p.m., 8:10 p.m., 11:29 p.m., 5/21/25 at 3:30 a.m., 7:29 a.m., 11:30 a.m., 1:30 p.m. The "MAR" indicated Pt 27 had a respiratory rate assessed on 5/20/25 at 9 p.m., 11:29 p.m., 5/21/25 at 3:30 a.m., 7:29 a.m. RNE 1 stated Pt 27's temperature and respiratory rate should have been assessed and documented every hour while on IV magnesium sulfate. RNE 1 stated it was important to assess the respiratory rate since magnesium sulfate was a muscle relaxer and depressed the central nervous system. RNE 1 stated nurses should assess and document a respiratory rate and temperature hourly per the hospital's policy.

During an interview on 5/29/25 at 2:32 p.m. with the Director of Obstetrics (DB), the DB stated she expected nurses to follow the hospital's policy to check respiratory rate and temperature hourly when a patient is on IV magnesium sulfate.

During a review of the hospital's P&P titled, "MOD L&D.1.18 Magnesium Sulfate Management In Obstetrics," dated 2/28/24, the P&P indicated, " ... PURPOSE: The purpose of this policy is to provide guidelines for the safe and effective administration of Magnesium Sulfate for obstetrical patients. Magnesium sulfate is used for prevention and treatment of seizures in women with severe preeclampsia, eclampsia, to provide fetal neuro-protection when preterm birth is anticipated or likely in 24 hours (after 24 weeks' gestation but before 32 weeks' gestation) ... PROCEDURE: ... Assessment, Monitoring and Documentation: ... Antepartum/Intrapartum - Assess and document maternal and fetal status parameters ... Maternal status parameters: Vital Signs (HR [heart rate], BP [blood pressure], RR [respiration rate], Temp [temperature]) ... every hour ..."

4. During a review of Pt 31's "Emergency Department Note-Physician (EDNP)," dated 3/30/25, the "EDNP" indicated, " ... 27 [year old female] presenting to the [emergency department] for 10 day history of chest tightness, dry cough, and shortness of breath."

During a concurrent interview and record review on 5/29/25 at 11 a.m. with Shift Manager (SM) 1, Pt 31's "Emergency Department Triage Form (EDTF)," dated 3/29/25 and "Vital Signs Flowsheet (VSF)," dated 3/29/25 to 3/30/25 were reviewed. The "EDTF" indicated, "Chief Complaint: Chest tightness, dry cough, SOB [shortness of breath], for a week ... ESI level: 2 ..." The "VSF" indicated Pt 31 had vital signs completed on 3/29/25 at 7:10 p.m. and was blood pressure (BP) was 131/86 millimeters of mercury (mmHg-unit of measure; normal 120/80 mmHg), respiratory rate (RR) 18 breaths per minute (normal 12-18 breaths per minute), heart rate (HR) 94 beats per minute (bpm; normal 60-100 bpm), temperature 36.5 degrees Fahrenheit (normal 97-99 degrees Fahrenheit), oxygen saturation 100% (normal 95-100%). The "EDTF" indicated Pt 31's next set of vital signs were completed on 3/30/25 at 12:49 a.m. SM 1 stated an ESI of 2, vital signs should be completed every two hours if the patient's "condition warrants" according to the hospital's "Standard of Care" policy. SM 1 stated Pt 31's chief complaint, "vital signs on arrival was fine and EKG looks good," it did not warrant more vital signs monitoring.

During an interview on 5/30/25 at 3:22 p.m. with the Director of Emergency Department (DED), the DED stated a patient with an ESI of 2 should have vital signs completed at a minimum of every two hours per the hospital's policy. The DED stated he expected nurses to follow the policy.

During a review of the hospital's P&P titled, "MOD ED.1.04 Standard of Care Policy," dated 1/23/25, the P&P indicated, " ... PURPOSE/EXPECTED OUTCOME: A. To provide a standard of care for persons presenting to the emergency department for care ... POLICY: ... Triage: Initial Patient Assessment ... The Emergency Severity Index (ESI) is utilized to assign patient triage priority/urgency ... Based upon patients presenting problem, needed resources for care, and physical assessment, the patient is assigned one of five levels of priority/urgency: ... Level 2 - Patient is unstable and requires timely response by physician and nurses ... Patient Reassessment: ... Reassessment may include, but is not limited to: ... Patient's current condition/status ... Vital signs ... Reassessment times are as follows unless warranted more frequently: .. Level 2 - minimally every 2 hours ..."











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5. During a concurrent interview and record review on 5/29/24 at 12:30 p.m. with the Stroke Coordinator (SC), Pt 10's medical record was reviewed. The record indicated Pt 10 was a 59 year old female who was admitted on 11/20/24 with symptoms of a stroke (a loss of blood flow to part of the brain, which damages brain tissue). Pt 10 had a history of a previous stroke with residual left sided weakness, hypertension (elevated blood pressure), atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), diabetes, and chronic kidney disease. The stroke protocol was initiated, the imaging studies did not reveal an acute (new, recent) stroke initially, and Pt 10 was admitted to the 1 Med Telemetry unit. The SC stated 1 Med Telemetry is also one of the designated units where patients who have had a stroke are admitted. On 11/22/24 at 9:10 a.m. Pt 10 had a Magnetic Resonance Imaging scan [MRI-a medical imaging technique] which indicated the presence of small acute strokes, and this critical result was communicated by the radiologist to Pt 10's nurse (RN 20) at 10:54 a.m. Review of the "Communication and Notification" documentation indicated on 11/22/24 at 10:55 a.m. RN 20 sent an electronic message to Pt 10's physician (Medical Doctor [MD] 15), "Magnetic Resonance Imaging [MRI-a medical imaging technique] showed acute infarct [blockage in a blood vessel in the brain, an ischemic stroke] to L middle cerebral artery [MCA one of the main arteries supplying blood to the brain], as well as small infarcts to left parietal [lobe of the brain]," and the record did not indicate whether there was a response from the physician. Review of the "Neurology Tele-Medicine Consultation," dated 11/22/24 at 1:24 p.m. indicated a neurologist consult was done via an audio and video telehealth system with assistance from the nurse. The neurologist's consult note indicated, "Date/Time Patient Seen: 11/22/24 from 13:10 to 13:24 [1:10 p.m. to 1:24 p.m.] REASON FOR CONSULTATION: Acute MCA stroke ...General: No acute distress ...Respirations are non-labored ... Neurologic Examination: Level of alertness: Alert and awake Affect: Appropriate Phonation: Normal audible speech. No dysarthria noted. Orientation: Oriented to her name and city but not month or age. Language: Dysfluent but follows simple commands. Attention and Concentration: Normal ... National Institute of Health Stroke Scale score 16. [NIHSS-a standardized tool used to assess the severity of a stroke. Scores range from 0- 42, with 16-20 indicating moderate to severe stroke, 21-42 indicating severe stroke]."

Continued record review with the SC indicated on 11/22/24 at 1:35 p.m., RN 20 sent an electronic message to MD 15 informing him Pt 10 had a headache, and that [brand name] (acetaminophen) was not ordered for pain. The nurses notes do not indicate whether there was a response from MD 15, but a review of the orders report indicated at 1:35 p.m. MD 15 ordered [brand name] for mild pain and [brand name] (hydrocodone 5mg/acetaminophen 325 mg) every four hours as needed for moderate pain, however the medication administration record (MAR) dated 11/22/24 indicated Pt 10 did not receive [brand name] or [brand name].

Review of the nursing assessments indicated on 11/22/24 at 1:45 p.m., a nursing student completed a head to toe assessment, however the content of the assessment had not been validated and signed by a registered nurse, so it remained as a pending note.

The record indicated at 3:40 p.m., RN 20 sent an electronic message to MD 15, "Patient was screaming, unable to tell us what was wrong. Then she had some flatulence and an emesis episode. There were some bright streaks of blood in the emesis. Lung sounds a bit coarse; she might have aspirated. I will give her some [brand name, medication for nausea and vomiting]." The record does not indicate whether there was a response from MD 15, and the medication administration record indicated Pt 10 did not receive [Brand name]. The record indicated on 11/22/24 at 3:51 p.m. an "Internal [Inpatient] Stroke Alert" was initiated. The SC stated when a hospitalized patient shows signs of a potential stroke, an "Internal" stroke alert is activated as opposed to when a person with a possible stroke comes to the ED then a "Stroke Alert" is activated. When an internal stroke alert is initiated, a specially trained nurse, a neurocritical response nurse (NCRN), responds and assesses the patient following the stroke alert protocol. Review of the "Rapid Response Team (RRT) record" dated 11/22/24, indicated at 3:51 p.m. the NCRN assessed Pt 10 and noted Pt 10 was "Comatose. Decrease level of consciousness, sudden loss of movement/weakness in face, arm, leg" with a NIHSS score of 38 (Severe stroke). Pt 10's Glasgow Coma Scale (GCS a neurological assessment tool used to measure a patient's level of consciousness) score was 5 (on a scale from 3 to 15, with 3 being the lowest [comatose state] and 15 being the highest [normal, alert state]) with Pt 10 exhibiting decorticate posturing (a reflex body position which is usually a sign of a severe injury or disruption to the brain). The SC stated neither the RRT record, or the nurses notes indicate who activated the Internal Stroke Alert, or what occurred after the 3:40 p.m. message sent by RN 20 to MD 15 to prompt the stroke alert call. Review of the order report for 11/22/24, indicated at 3:49 p.m. RN 20 obtained telephone orders for a CT scan of the brain for "altered level of consciousness," and at 3:53 p.m. orders were obtained for a chest x-ray for "respiratory distress," and a CT scan of the chest for "shortness of breath." At 15:55 Pt 10's respiratory rate was 26 breaths (respirations) per minute (rpm- normal 14-20 per minute), oxygen saturation 98%, and Pt 10 noted to be snoring, with labored respirations. At 3:58 p.m. the stroke alert protocol orders including lab tests and imaging were initiated. At 4 p.m. RN 20 obtained telephone orders for [brand name] (a medication given for anxiety, seizures, agitation) 1 mg IV push and [brand name] 500 mg IV (a medication for the treatment of seizures) and both medications were given. There was no documentation in the record indicating what if any seizure activity was observed. The record indicated the NCRN spoke with the stroke team physician, imaging was completed, and by 4:36 p.m. the stroke team physician had determined there was no large vessel occlusion (LVO-a major blood vessel in the brain is blocked causing a sudden interruption of blood flow to the brain) he could safely access (for clot removal). Pt 10 remained on the telemetry unit.

Continued record review with the SC indicated on 11/22/24 at 8 p.m. Pt 10's respiratory rate was 25 rpm, GCS was 6, and NIHSS was 36, and a large amount of oral secretions were suctioned. At 10:30 p.m. and midnight the vital signs were obtained however there was no respiratory rate documented either time. On 11/23/24 at 4 a.m. the respiratory rate was 24 rpm, and the neurological assessment remained abnormal. At 6:06 a.m., a RRT call was initiated. The RRT record indicated, "RRT Comment: RRT called for agonal breathing/biting on tongue/recent stroke alert. Physician Assistant [PA] at bedside. RRT Interventions: Appropriate protocol initiated. RRT Physician Contacted at 6:10 a.m. Intensivist consulted for intubation/transfer to CVICU. RRT Intubation Time: 6:20 a.m. RRT Outcome: Transfer to ICU/CCU. See PA prog. notes/orders, see nursing documentation ..." The RRT record does not include a place for documentation of vital signs or patient assessment. The RRT record was completed by the RRT nurse and signed by the RRT nurse and the RRT Respiratory Therapist at 6:44 a.m. The record was reviewed for narrative nurses notes, vital signs, patient assessments, physician communication notes for the period of time from 11/23/24 at 4 a.m. to 6:06 a.m. when the RRT activation occurred, and the SC was unable to find any documentation by Pt 10's nurse (RN 21) or any other nursing staff. The SC stated although the RRT note indicated to refer to the nursing notes and the PA notes, she is unable to find any documentation regarding if Pt 10 was observed during this time (4 a.m. to 6:06 a.m.), if vital signs were obtained, or who initiated the RRT call.

Review of the Intake and Output (I&O) record (documentation of the time and amount of Intake-all fluids [oral, intravenous, tube feeding] and Output- urine, emesis [vomit], liquid stool) dated 11/22/24 from 7 a.m. through 11/23/24 at 6:59 a.m. indicated there was no urine output for that twenty-four hour period. The physician's orders dated 11/20/24 at 6:37 p.m., indicated, "Intake and Output."

Review of the nephrologist's (a physician who specializes in kidney care) consultation note dated 11/23/2024 at 2:42 p.m. indicated, " ...Made her [Pt 10's daughter] aware that the patient has advanced renal insufficiency and will need close monitoring. Monitor strict urine output ...Did make the daughter aware the patient could end up needing dialysis in the near future...Will follow closely." Review of the lab test results dated 11/21/24-11/25/24 indicated on 11/21/24 Pt 10's creatinine (a waste product normally removed from the blood by the kidneys) level was 4.2 milligrams per deciliter (mg/dL, normal range 0.6 - 1.1), and 4.8 mg/dL on 11/23/24, and 6.4 mg/dL on 11/25/24. On 11/27/24, Pt 10 was started on hemodialysis (a procedure that filters waste and excess fluid from the blood when the kidneys are unable to).

During a concurrent interview and record review on 5/29/25 at 3:25 p.m. with the director of the 1 Med Telemetry unit (DTU), Pt 10's record was reviewed. Regarding the lack of output documented for 11/22/24 from 7 a.m. through 11/23/24 at 6:59 a.m., the DTU stated having no urine output recorded for 24 hours is definitely concerning, and stated the urine output should have been recorded and totaled each shift. The student nurse's unvalidated assessment on 11/22/24 at 1:45 p.m. was reviewed and the DTU stated the nurse was supposed to review and validate the accuracy of the assessment and indicate that in the designated place in the electronic record. If that was not done, the assessment remains incomplete. The Stroke Alert call documentation on 11/22/24 and the RRT call on 11/23/24 were reviewed with the DTU and the lack of nursing documentation preceding the events was discussed. The DTU stated "we chart by exception," but was unable to explain what that means specific to the two events in question.

Review of the policy and procedure P&P titled, "PC.AD.1.08 Documentation Policy," dated 9/28/22, indicated, "Totals for intake and output (I&O) are documented each shift or more frequently depending on the patient's condition."

Review of the P&P titled, "PC.AD.1.08 Documentation Policy," dated 9/28/22, indicated," ...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 ...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; and the patient's response to treatment ...All Clinical Staff Members are responsible for documentation of clinical care given and ensuring that the standard of that documentation meets all legal and professional requirements. Documentation shall be completed timely ...Assessments will be completed and signed by licensed personnel. Assessments may be completed by a student extern, and then confirmed and signed by licensed personnel...All assessment data collected from a licensed vocational nurse [LVN] or student nurse will be reviewed, checked for accuracy, and co-signed by licensed personnel ...Patients are reassessed a minimum of every shift and as needed by an RN. LVNs and non-licensed personnel may collect and record data ...Changes in patient condition are documented within the appropriate electronic health record [EHR] system review, along with physician notifications ... Chart "annotation" may be used for narrative charting ..."

Based on observation, interview, and record review, the hospital failed to ensure medications were administered in accordance with the physician orders, hospital policies and accepted standards of practice for two of six patients sampled (Patient 5 and 6) when:

1. Patient (Pt) 5's Nozin (a nasal sanitizer swab used to kill germs in the nose) nasal swab was not administered with the correct number of swabs in each nostril as ordered by the physician and as instructed by the manufacturer.

This failure had the potential to result in Pt 5 receiving less effective nasal treatment, in addition increasing Pt 5's risk of developing a preventable nasal infection.

2. Pt 6's propofol (a potent drug used for sedation with a high potential for abuse/misuse) was administered without an independent double check (second nurse witness/co-sign) in accordance with the hospital's policy and the propofol dose was adjusted without documentation of the Richmond Agitation-Sedation Scale score (RASS, a medical scale used to measure the agitation or sedation level) as ordered by the physician.

These failures had the potential to increase risk of misuse or abuse of propofol, in addition increasing Pt 6's risk for excessive agitation or sedation potentially causing Pt 6 pain and/or discomfort.

Findings:

1. During a medication pass observation on 5/21/25 at 9:30 a.m., with Registered Nurse (RN) 3, in the presence of the Shift Manager at Campus 1 (SMDMC), RN 3 was observed administering a Nozin nasal swab medication to Pt 5 by applying five (5) swabs in one circular motion in each nostril.

During a record review of Pt 5's physician order for "ethanol topical (Nozin)," dated 5/5/25, indicated, "one application swab each nostril q (every) 12 h (hours)...Instructions...insert swab tip into the right nostril and with moderate pressure, swab 8 times clockwise and then 8 times counter-clockwise ensuring to swab the inside front pocket of the right nare. Resaturate swab, repeat process in left nare swabbing 8 times clockwise and then 8 times counter-clockwise..."

During an interview on 5/21/25 at 2:20 p.m., RN 3 acknowledged she should have swabbed Pt 5 nostrils with the Nozin nasal swab 8 times clockwise and counter-clockwise as prescribed and stated she only swabbed each nostril 5 times. RN 3 stated, "I thought it was [ordered] for 4 to 5 seconds."

During an interview on 5/22/25 at 3:23 p.m. with Director of Pharmacy (DOP), she stated nursing staff should have administered the Nozin nasal swab as prescribed and according to the manufacturer's instructions to prevent infection or growth of bacteria. The DOP stated, the medication only worked if used as prescribed and as instructed by the manufacturer.

During a review of the hospital's policy and procedure (P&P) titled, "PC.AD.1.21 Medication Administration Policy," dated 3/27/25 indicated, "Basic Safe Medication Administration Practices...Staff shall confirm the following prior to administering each medication...The correct dose: To ensure that the dosage matches the ordered dose...All parts of the medication order shall be reviewed, including additional instructions and parameters for use..."

During a review of Nozin drug information, dated 5/2025, provided by the hospital, indicated, "Application steps...1. Insert swab tip into RIGHT nostril. Do not go deeper than tip of swab...2. With moderate pressure, swab around nostril eight (8) times clockwise. Cover all surfaces including inside tip of nostril...3. squeeze to resaturate swab tip...4. insert ampule into RIGHT nostril again and swab eight (8) times counterclockwise...5. repeat steps 1, 2, 3, 4 in LEFT nostril..."

2a. During a review of Pt 6's "ED (Emergency Department) Note," dated 4/21/25, the "ED Note" indicated, Pt 6 was admitted to the hospital on 4/21/25.

During a review of Pt 6's physician's order for propofol titratable (adjustable) IV (intravenous, into the vein) infusion (directly into the bloodstream), dated 4/21/25 at 11:44 a.m., indicated, "Propofol IV additive 1,000 mg (milligrams, unit of measure)...5 mcg (micrograms, unit of measure)/ kg (kilograms, unit of measure)/min (minute)]..."

During a group concurrent interview and clinical record review on 5/21/25 at 3:52 p.m. with the ICU Director (ICUD) and the Quality Review Nurse (QRN) 2, Pt 6's "Medication Administration Record (MAR) Summary," dated 4/21/25 at 12:45 p.m. was reviewed. The MAR Summary indicated, the first bag of propofol was administered on 4/21/25 at 12:45 p.m. at 5 mcg/kg/min, by one nurse, without documentation of a second nurse witness/co-sign on the MAR. The group acknowledged there was no documentation that a second nurse witnessed/co-signed the first propofol administration on 4/21/25 at 12:45 p.m. The ICUD stated a second licensed nurse should have witnessed/co-signed on the MAR when the first bag of propofol was administered according to the hospital's policy.

During a review of the hospital's P&P titled, "PC.AD.1.21 Medication Administration Policy," dated 3/27/25 indicated, "...High Alert medications are identified on the High Alert Medication Administration Independent Double Check, & Related Safety Precautions Policy and require a second licensed nurse independent double check prior to the administration of the medication..."

During a review of the hospital's P&P titled, "MOD CO.2034.PR.01 MOD High Alert Medication Administration Independent Double Check, & Related Safety Precautions," dated 4/24/24 indicated, "Independent Double Check...Certain High-alert Medications require an Independent Double Check...A Practitioner and a second Practitioner shall separately and independently check the physician order and/or the medication administration record (MAR) with the medication dose prepared for the patient to determine it is correct before the administration of these medications and when any key therapeutic changes are performed...Procedure applies when...Initiating a High-alert, Independent Double Check Medication...Both Practitioners shall document the verification process on the MAR or other designated documentation location...Table 1: Additional Considerations & Specific Requirements...High alert medication...Anesthetic Agents [used for sedation or to prevent pain during surgery or procedures]...General, inhaled, and IV (e.g. [example] propofol ...)...Nursing independent double check...Two nurses shall perform an independent double check with every new bag..."

2b. During a review of Pt 6's physician's order for propofol titratable IV infusion, dated 4/21/25 at 11:44 a.m., indicated, "Propofol IV additive 1,000 mg...5 mcg/kg/min...start at 5 mcg/mg/min, titrate [Adjust] by 5 mcg/kg/min every 5 min...For goal RASS score of -1 [Richmond Agitation-Sedation Scale- a medical scale used to measure the agitation or sedation level on a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation is apprehension and anxiety, and highest level of agitation is combative and violent. RASS level 0 is "alert and calm." RASS -1 is "drowsy not fully alert, but has sustained awakening."]

During a group concurrent interview and clinical record review on 5/21/25 at 3:52 p.m. with the ICUD and the QRN 2, Pt 6's "MAR Summary," dated 4/21/25 at 12:45 p.m. was reviewed. The MAR Summary indicated, propofol was increased from 5 mcg/kg/min to 10 mcg/kg/min on 4/21/25 at 16:40 (or 4:40 p.m.) but the RASS score was not documented. The group acknowledged the RASS was not documented. The ICUD stated that the RASS should have been documented on 4/21/25 at 16:40 (or 4:40 p.m.) when the propofol administration was increased.

During an interview on 5/22/25 at 3:26 p.m. with the Director of Pharmacy (DOP), she stated the RASS score should have been documented for Pt 6's propofol IV infusion and stated for any titratable drip the goal on the physician's order is what should haven monitored and documented by hospital staff.

During a review of the hospital's P&P titled, "MOD.CC.1.08 Pain Management, IV Sedation and Delirium Prevention & Treatment Procedure (PAD)," dated 9/24/24, indicated, "Pain, Sedation, and Delirium Monitoring and Management...A RN (Registered Nurse) will perform level of sedation assessments and record the results at a minimum of every 4 hours. Sedation assessments will be done utilizing the Richmond Agitation and Sedation Scale (RASS), with a target sedation score of 0 to -2...A sedation score will be documented upon administration of any sedative."

A review of the Prescribing Information for propofol dated 9/2022, retrieved from DailyMed (a public website maintained by the U.S. Food and Drug Administration), indicated, "Failure to reduce the infusion rate in patients receiving [propofol] for extended periods may result in excessively high blood concentrations (levels) of the drug. Thus, titration to clinical response and daily evaluation of sedation levels are important during use of propofol..."

Based on interview and record review, the facility failed to employ a qualified individual to supervise the medical record services, as the assigned Director of Health Information Management (HIM) lacked the required credential.

This failure resulted in the facility's inability to ensure professional oversight of medical records/health information management, placing patients at risk for documentation errors, legal noncompliance, and privacy violations.

Findings:

1. During an interview on 5/20//25 at 11:08 a.m.with the DHIM (Director Health Information Management), she stated she has worked 34 years for the health system. The DHIM at the facility has responsibility for not only Medical Records/Health Information Management but also Centralized Scheduling, Communications/Switchboard and the Mail Room. The DHIM stated she reports to the Chief Financial Officer (CFO). The "Initial Documents Request" for HIM/Medical Records provided to the facility during the entrance conference was reviewed with the DHIM and included item E. "AHIMA(American Health Information Management Association)/AAPC (formerly American Academy of Professional Coders, now known as just AAPC) Continuing Education Validation of Credentials for Directors, Managers, Supervisors, Coders, CDI Specialists, etc. if Job Description requires credential." The DHIM verbalized that she understood this requested item. Acceptable options for providing credentials validation were explained to the DHIM. The DHIM did not offer which credential she possessed nor was a credential listed on her business card.

2. During a review of a document titled "[Name of Facility] Job Title - Director of HIM" the job description's "Position Qualifications" were found to include under "License/Certificates/Credentials" the requirement for an "Accredited Record Technician or Registered Record administrator - American Health Information Association or equivalent (requirement can be satisfied if noted level of certification is maintained by individual in the line of authority for appropriate oversight)."

3. During a review on the AHIMA website https://www.ahima.org it was noted that the correct name for this credential-granting entity should be "American Health Information Management Association," that the Accredited Record Technician and Registered Record Administrator credentials were revised in the year 2000 and became Registered Health Information Technician and Registered Health Information Administrator, respectively, and that there is no existing acceptable equivalent for these credentials.

4. During a review of a document titled "DMC HIM Org Chart 2025" it showed that the facility's HIM Director has a solid line accountability to the facility's Chief Financial Officer, and a dotted line of communication to the Director, HIM Hospital OPS (Operations) over Arizona/California corporate health system hospitals.

5. During a review of credentials produced by the facility for HIM staff, the validated RHIT credential belonged to the corporate level HIM Director. A valid credential was not supplied by the facility for their Director HIM employee directly responsible for daily HIM operations.

6. During a review of federal and state laws pertaining to requirements for the individual supervising HIM/Medical Records, under 42 CFR (Code of Federal Regulations) Section 482.24(a) "The hospital must employ adequate personnel" for the medical record service. More stringent (strict) state law, CCR (California Code of Regulations), Title 22, Division 5, Chapter 1, Article 7, Section 70747 Medical Records Service, Paragraph (b) requires "The medical records service shall be under the supervision of a registered health information administrator or registered health information technician."

Based on observation, interview and record review, the facility failed to identify and implement safeguards for special categories of sensitive health information, specifically genetic testing results and reproductive health information, as required under state and federal law.

This failure resulted in the potential unauthorized access, use, or disclosure of legally protected information, violating patient rights and increasing the risk of discrimination and legal liability.

Findings:

1. During a concurrent interview and record review on 5/20/25 at 1:30 pm with the the facility's patient authorization form titled, "Release of Information - ROI (1) EDEMF2236 - REV 10/2022" was noted to have a checklist of highly confidential information listed for which the patient must specifically authorize the use and/or disclosure. The checklist does not include genetic testing results or reproductive health information. When asked regarding these omissions, the Director, Health Information Management (DHIM) stated she was unaware of specific legal requirements for special handling of these two additional classes of protected sensitive health information.

2. During a concurrent observation and interview on 5/21/25 at 9:45 am with the Clerk, Health Information Management (CHIM) in the Health Information Management (HIM) department at her Release of Information Desk, the CHIM demonstrated the process used for preparing a release of medical records. The CHIM stated she has worked 14 years handling Release of Information functions. When asked to identify the categories of highly confidential information, the CHIM acknowledged the existence of the checklist on the facility's patient authorization form but was unaware of specific legal requirements for special handling of records containing genetic testing or reproductive health sensitive information. When asked how she stays current with legal updates regarding protected health information, the CHIM responded that she does computer modules training and consults her immediate supervisor Manager, Health Information Management (MHIM) or if not available, the DHIM.

During a review of the United States Department of Health and Human Services (DHHS) website covering Genetic Information, found at https://www.hhs.gov/hipaa/for-professionals/special-topics/genetic-information/index.html, the Genetic Information Nondiscrimination Act (GINA) was noted as signed into law in May of 2008, with two Titles (sections) enacted during 2009. The Final Rule implementing GINA became effective January 10, 2011. In 29 CFR (Code of Federal Regulations) Part 1635, Section 1635.3(c) Genetic Information is defined to include results of genetic tests, family medical history, and participation in genetic services or research. The website's home page further advises that on January 25, 2013, DHHS published a final rule entitled "Modifications to the HIPAA [Health Information Portability and Accountability Act] Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act, and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules" (2013 Omnibus Rule) modifying HIPAA to classify genetic information as Protected Health Information (PHI).

During a review of the California Legislative Information website addressing Genetic Information legislation, found at https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201120120SB559, the California Genetic Information Nondiscrimination Act (CalGINA) was signed into law in September 2011 and took effect on January 1, 2012. CalGINA amends anti-discrimination laws already in effect to prohibit genetic discrimination in areas such as housing; mortgage lending; employment; education; and public accommodations. CalGINA provides broader protections from genetic discrimination than does the federal Genetic Information Nondiscrimination Act (GINA) of 2008, which is limited to employment and health insurance coverage. Unlike GINA, CalGINA has no cap on damages which may be sought for genetic discrimination.

During a review of the DHHS website covering Reproductive Health Care, found at https://www.hhs.gov/hipaa/for-professionals/special-topics/reproductive-health/index.html, the Office for Civil Rights (OCR) was noted to have issued a Final Rule in April 2024, entitled "HIPAA Privacy Rule to Support Reproductive Health Care Privacy." The Final Rule strengthens the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule by prohibiting the disclosure of protected health information related to lawful reproductive health care in certain circumstances. The effective date was June 25, 2024. The compliance date, the date persons subject to this regulation must comply with the applicable requirements of this Final Rule, was December 23, 2024, except for the Notice of Privacy Practices. The compliance date for the Notice of Privacy Practices is February 16, 2026. Regulated entities are required to obtain an attestation when they receive a request for PHI (protected health information) potentially related to reproductive health care from the requestor that the use or disclosure is not for a prohibited purpose. Such attestation is required when the request for PHI is for health oversight activities, judicial and administrative proceedings, law enforcement purposes or disclosures to coroners and medical examiners.

During a review of the California Department of Public Health's (CDPH's) website listing their All Facilities Letters (AFLs) it was noted that on January 16, 2024 CDPH issued AFL 24-03, to inform all licensed health care facilities about the provisions of AB (Assembly Bill) 352 and the associated requirements. AB 352 was signed into law in 2023, amending California's Confidentiality of Medical Information Act (CMIA) to enhance privacy protections for sensitive services, including abortion and abortion-related care. Specifically, it prohibits health care providers from knowingly disclosing, transmitting, transferring, sharing or granting access to medical information related to lawful abortion services to any individual or entity from another state, unless a valid authorization is obtained under CMIA.

During a review of a website post by the California Hospital Association placed on May 16, 2024, it was noted that hospitals were advised that DHHS's Office for Civil Rights finalized a Privacy Rule to Protect Reproductive Health Information, effective June 25, 2024 with compliance required by December 23, 2024. Hospitals were also advised that covered entities were required to obtain a signed attestation that certain requests for PHI related to reproductive health care are not for any of the prohibited purposes. Reference was made to OCR's Model Attestation form which can be given to persons requesting such PHI.

Based on interview and record review, the facility failed to ensure that medical records were completed promptly following patient encounters in three clinics operating under the hospital's license. In three of three sampled outpatient specialty clinic records, physician documentation was incomplete or lacking for days following the date of service visit.

This failure resulted in delayed entry or validation of clinical information, which jeopardized continuity of care, delayed billing, and increased the risk of omitted details or errors in documentation accuracy.

Findings:

During concurrent interview and record review on 5/21/25 at 2:15 pm AND on 5/22/25 at 10:16 am with the Director, Health Information Management (DHIM), selecting one random record from each of three specialty clinics on the hospital's license, the following were the findings:

Patient 37 was seen in the CV (Cardiovascular) Clinic on 5/16/25 with the chief complaint of palpitations (irregular heart beat), chest pain and dyspnea (difficulty breathing). Testing was ordered in addition to an echocardiogram obtained the month prior and the patient was scheduled to return in two weeks. The Clinic utilizes the NextGen EHR (electronic health record) and the DHIM advised that the cardiologist does a separate dictation. At the time of record review, five days following the patient's visit, no documentation by the cardiologist was found.

Patient 38 was seen in the Darroch Brain and Spine Institute (DBSI-spine/pain management) Clinic on 5/16/25 with the chief complaint of pain due to lumbar stenosis. This was a new patient with a seven month history of back pain and x-rays were obtained on 5/21/25. The Clinic utilizes the Athena EHR, a system which does not show a referral for new patients not already in the database, requiring identification by patient matching. The physician initiated a History and Physical Exam report which was not finalized and authenticated at the time of record review, six days following the patient's visit.

Patient 39 was seen in the Maternal-Fetal Medicine Clinic on 5/20/25 with the chief complaint of gestational diabetes mellitus uncontrolled at 31 weeks gestation (the process of baby's development occurring in the uterus before birth) and a history of C-section (Caesarean section, a surgical procedure where a baby is delivered through an incision in the mother's abdomen). Ultrasounds were obtained and reported back. The Clinic was opened one month ago for high risk mothers and babies and utilizes the Cerner/ Horizon Patient Folder (HPF) EHR, which is integrated with the hospital's EHR. At the time of record review, two days following the patient's visit, no documentation by the physician was found.

When asked how long the clinic physicians have to document patient encounters, the DHIM responded "fourteen days."

During a review of a document titled "Medical Staff Rules and Regulations, Doctors Medical Center," 2021 final version, under Section B. Medical Records, paragraph 1, it states that "The attending physician is responsible for the electronic preparation of a complete, accurate and legible medical record for each patient. This applies to all practitioners credentialed by the medical staff. Such record shall be adequate for purposes of use for the continuity of care for the patient." Under paragraph 2, it states "A complete medical history and physical examination must be completed ...24-hours after admission for each patient." Under paragraph 5, it states "Pertinent progress notes shall be recorded timely in the health record and shall provide information required for continuity of care and transferability." "If transcribed progress notes are used in lieu of electronic progress notes, the turnaround time shall be 2 hours. If the mandated turnaround time cannot be met, the physician must augment the electronic medical record to ensure continuity of care. Any critical treatment information shall be part of the note even if the transcribed note is expected shortly." Under paragraph 21, it states "All of the patient's medical records shall be completed, dated/timed and authenticated, insofar as possible, at the time of discharge, including progress notes ...." Under Section E. Consultations, paragraph 2, it states "Consultations are expected to be provided within 24 hours."

During a review of Doctors Medical Center Patient Care - Administrative Manual Policy titled "PC.AD.1.08 Documentation Policy," under Section III. POLICY: paragraph 3, item 1, All Medical Record entries should be made as soon as possible after the care is provided, or an event or observation is made."

During a review of federal and state requirements for medical record completion, it was noted that under federal law, 42 CFR (Code of Federal Regulations) Section 482.24(c)(1) "All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures." Under State law, Title 22, Division 5, Chapter 1. General Acute Care Hospitals, Article 7. Administration, Section 70751 Medical Record Availability, paragraph (g) "Medical records shall be completed promptly and authenticated or signed by a licensed healthcare practitioner acting within the scope of his or her professional licensure within two weeks following the patient's discharge." Such a time frame applies to inpatient discharges rather than ambulatory clinic visits for specialty care with documentation relied upon for care continuity by the patients' primary care practitioners.

Based on observation, interview and record review, the hospital failed to maintain drug storage areas in accordance with acceptable standards of practice and hospital policies when:

1. At Campus 1, one box of Gliadel Wafers (a wafer-like chemotherapy implant used for brain cancer), containing three wafers, was identified stored inside the pharmacy medication freezer at a higher temperature than instructed by the manufacturer.

2. At Campus 2, the hospital failed to ensure controlled room temperature was monitored and documented in four of four medication storage rooms containing non-refrigerated medications.

These failures had the potential to expose patients to unstable and/or unsterile medications potentially leading to therapeutic failure in patients.

Findings:

1. During an observation on 5/20/25 at 11:45 a.m. in the hospital pharmacy at Campus 1 there was one opened box of Gliadel Wafers (eight wafers per box), containing three Gliadel Wafers, identified stored inside the pharmacy medication freezer.

During a concurrent interview and record review on 5/22/25 at 3:18 p.m., with the Director of Pharmacy (DOP), the Gliadel Wafer manufacturer storage instructions and the pharmacy freezer temperature logs for April and May 2025 were reviewed. The DOP acknowledged the Gliadel Wafers should have been stored at or below -4 degree Fahrenheit (F, a temperature measurement) according to the manufacturer instructions. The DOP confirmed the pharmacy medication freezer temperature was higher than the manufacturer's instructions on the following dates and times:

- On 4/6/25 at 20:07 (8:07 p.m.), -2.6 degree F;
- On 4/7/25 at 17:28 (5:28 p.m.), 0 degree F;
- On 4/11/25 17:34 (5:34 p.m.), -3.8 degree F;
- On 4/15/25 11:24 a.m., -1.3 degree F;
- On 4/22/25 17:41 (5:41 p.m.), -1.7 degree F;
- On 4/30/25 17:28 (5:28 p.m.), -3.6 degree F;
- On 5/4/25 16:48 (4:48 p.m.), -0.3 degree F; and
- On 5/15/25 18:08 (6:08 p.m.), -0.1 degree F.

During the same concurrent interview and record review on 5/22/25 at 3:18 p.m., the DOP stated it was important to store medications at the manufacturer specified temperature to ensure the medication maintained its potency and stability.

During a review of the hospital's policy and procedure (P&P) titled, "PHARM.1.21 Medication Storage Access and Security Policy," dated 2/27/25, indicated, "Medications are stored under conditions suitable for product stability...Any medication which is not maintained according to special storage requirements are not to be administered and should be disposed of in the appropriate pharmaceutical waste container."

A review of Gliadel Wafers manufacturer's instructions provided by the hospital, dated May 2022, indicated, "Store Gliadel Wafer at or below -20 degree Celsius [C, a temperature measurement] (-4 degree F)."

2. During a visit to Campus 2 on 5/23/25 at 9:30 a.m., controlled room temperature was not observed to have been monitored or documented in four of four medication rooms containing non-refrigerated medications as follows:

2a. During an observation on 5/23/25 at 9:46 a.m. in the C1 building medication room, there was no room temperature thermostat, and no room temperature monitoring log observed that indicated daily room temperature was monitored and documented.

During an interview on 5/23/25 at 9:54 a.m. with Registered Nurse (RN) 4, when asked to describe how the controlled room temperature monitoring for the C1 building medication room was done, RN 4 stated, "I haven't done that before on day shift."

During an interview on 5/23/25 at 9:56 a.m. with the DOP, the DOP stated the hospital had not monitored or documented daily room temperature in the C1 Building medication room.

2b. During an observation on 5/23/25 at 10:00 a.m. in the C2 Building medication room, there was no room temperature thermostat, and no room temperature monitoring log observed that indicated daily room temperature was monitored and documented.

During an interview on 5/23/25 at 10:06 a.m. with the DOP, the DOP stated the hospital had not monitored or documented daily room temperature in the C2 Building medication room.

2c. During an observation on 5/23/25 at 10:08 a.m. in the D Building medication room, there was no room temperature thermostat, and no room temperature monitoring log observed that indicated daily room temperature was monitored and documented.

During an interview on 5/23/25 at 10:15 a.m. with the DOP, the DOP stated the hospital had not monitored or documented daily room temperature in the D Building medication room.

2d. During a concurrent observation and interview on 5/23/25 at 10:25 a.m. with the DOP and the Shift Manager at Campus 2 (SMDBH), in the Intake Building medication room, there was no room temperature thermostat, and no room temperature monitoring log observed that indicated daily room temperature was monitored and documented. The DOP stated the hospital had not monitored or documented daily room temperature in the Intake Building medication room.

During a follow-up interview on 5/23/25 at 12:20 p.m. with the DOP, she stated it was important to have monitored and documented controlled room temperature in medication storage rooms because medications needed to be stored at the required temperatures according to manufacturer's instructions for optimal stability and sterility.

Further review of the hospital's P&P titled, "PHARM.1.21 Medication Storage Access and Security Policy," dated 2/27/25, indicated, "Controlled Room Temperature Range: 20 C (68 F) to 25 C (77 F)..."

Based on interview and record review, the hospital failed to ensure there was an effective system in place to identify loss or theft of all controlled drugs (drugs that are regulated by the federal government due to potential of abuse/addiction) dispensed from 25 of 25 operating room (OR) Anesthesia Workstations (AWS, a type of automated dispensing cabinet [ADC]) when:

1a. For one of four patients reviewed for controlled drug discrepancies, Patient (Pt) 7, the hospital was unable to account for one midazolam (a controlled drug used as a sedative) vial dispensed from OR 9 AWS; and

1b. The hospital was unable to facilitate the Drug Diversion Prevention Committee's ability to accurately review controlled drugs usage trends and patterns in the hospital, according to hospital policy, for anesthesia providers (highly trained healthcare professionals who administer drugs in the OR).

These failures had the potential for unsafe controlled drug use, lack of accountability, risk of controlled drug theft or unauthorized use and patient harm.

Findings:

1a. During an interview on 5/22/25 at 10:42 a.m., with the Director of Pharmacy (DOP), when asked about the process for reconciliation of controlled drugs dispensed in the hospital, the DOP stated there were four (4) specific pharmacy technicians (RXT) assigned the responsibility of reconciling controlled drug discrepancies (records of drugs taken out of an automated dispensing cabinet [ADC, machine containing controlled drugs] by nurses or providers but are not accounted for by administration or waste records) in the hospital. The DOP stated the assigned RXTs performed daily reviews of the following four controlled drug discrepancy reports generated electronically from the ADC:

(i) Controlled drug dispensed from ADC but not documented as administered to a patient in the electronic medical record (EHR);

(ii) Dose reconciliations from ADC if the dose ordered did not match the dose administered and/or wasted;

(iii) Pending unresolved ADC discrepancies by nursing staff that were not closed by the end of their shift; and

(iv) Controlled Substance Manager (CSM, the machine in the pharmacy securely stores and tracks all controlled drugs in the hospital) Exceptions Report which included any controlled drug that was dispensed from the CSM in the pharmacy to be delivered to the nursing units.

During the same interview on 5/22/25 at 10:42 a.m., the DOP stated the RXTs reported any unresolved controlled drug discrepancies to her for follow-up with the Nursing Director responsible for overseeing the staff involved with the unresolved discrepancy.

During a concurrent interview and record review on 5/22/25 at 11:35 a.m., Pt 7's medical record and the ADC report titled, "Transactions by Item/Procedure," dated 1/9/25, were reviewed with the DOP. The ADC report indicated one midazolam 2 mg (milligram, unit of measurement) / 2 ml (milliliter, unit of measurement) injection vial was dispensed on 1/3/25 at 9:19 a.m. from the OR 9 AWS for Pt 7 by an anesthesiologist. The DOP was unable to locate an anesthesia record in Pt 7's medical record with documentation that indicated a midazolam injection was administered to the patient. The DOP stated the unresolved controlled drug discrepancy for midazolam 2mg/2ml injection vial was entered into the hospital's risk management system by RXT 2. The DOP stated she emailed the Chief of Anesthesiology about the unresolved controlled drug discrepancy on 1/13/25. The DOP stated the last email communication related to the unresolved controlled drug discrepancy was on 1/23/25. The DOP acknowledged the discrepancy had remained unresolved without additional follow-up since 1/23/25 and the midazolam 2mg/2ml injection vial was still unaccounted for. The DOP stated pharmacy staff were responsible for following up with unresolved controlled drug discrepancies.

A review of the hospital's policy and procedure (P&P) titled, "MOD CLN.10.04 MOD Controlled Substance Diversion Prevention and Detection (AD 1.27)," dated 2/28/24, indicated, "Controlled Substance Surveillance and Audits...The Pharmacy Department shall conduct operating room post case reconciliation of Controlled Substances. Anesthesia patient records shall be reviewed and reconciled to confirm Controlled Substance ordering, administration, and waste, if applicable, are properly documented. If a Controlled Substance documentation issue cannot be resolved, it shall be documented in the hospital's risk management system for review and action and a Compliance Matter opened if diversion is suspected..."

1b. During an interview on 5/22/25 at 10:42 a.m., the DOP stated the hospital used a computer software system that tracked controlled medication use to monitor staff behavior based on controlled drug usage, including dispense and wastage trends. The DOP stated the software was interfaced (connected) to the ADC's controlled drug dispense history and the controlled drug administration history from the patients' electronic health record (EHR) to allow monitoring of staff behaviors related to controlled drug usage. The software reconciled the dispense and the administration for every controlled drug transaction. The DOP stated the software generated an Individual Risk Identification Score (IRIS) to proactively identify behavior abnormalities such as: wasting with the same person, dispensing more of one drug, taking too long to dispense, and administering/wasting the full package of medications. The DOP stated, any staff (doctors and nurses) identified with a high IRIS (score above 5) generated by the system was considered an individual with a high usage of controlled drugs. The DOP stated individuals with high usage were discussed with the Nursing Director.

During an interview on 5/22/25 at 11:29 a.m., the DOP stated the process for reconciliation of controlled drugs dispensed from the 25 OR AWS in the hospital was not the same as for all other nursing units in the hospital because the administration of controlled drugs in the OR was manually documented on paper "Anesthesia Records" by the anesthesia providers (including Anesthesiologists and Certified Registered Nurse Anesthetists [CRNAs]). Due to the manual paper documentation of controlled drug administration in the OR, the pharmacy was unable to obtain the same electronic discrepancy reports from the ADC for controlled drugs dispensed from the 25 OR AWS in the hospital. The DOP stated the process for reconciliation of controlled drugs dispensed from the 25 OR AWS was done manually by RXT 2 during weekly audits. The DOP stated not every controlled drug dispensed from the OR AWS were audited by RXT 2. The DOP stated RXT 2 completed random audits by generating a report from the ADS of the controlled drugs dispensed from the 25 OR AWS and randomly picked approximately 300 to 400 of the controlled drugs dispensed every month to be audited. The DOP stated RXT 2 documented the total number of controlled drug transactions he audited on a document titled, "Anesthesia Audit Sheet 2025."

During an interview on 5/22/25 at 3:32 p.m. with the DOP, the DOP stated, the controlled drug monitoring system was ineffective to accurately track and trend all the controlled drugs dispensed from the 25 OR AWS in the hospital. When asked if the pharmacy could have identified every time an anesthesia provider dispensed a controlled drug from the OR AWS but had not administered or wasted it, the DOP stated, "No." The DOP stated the current controlled drug monitoring system for the 25 OR AWS relied on a manual random audit which was unable to identify and report every controlled drug discrepancy from the 25 OR AWS in the hospital. The DOP acknowledged it was the pharmacy's responsibility to ensure there was an effective system in place for reconciliation and accountability of all controlled drugs in the hospital.

During a concurrent interview and record review on 5/22/25 at 3:40 p.m., RXT 2's "Anesthesia Audit Sheet 2025 (audit sheet)," and the ADS controlled drug dispense reports for the 25 OR AWS dated January, February, March, and April 2025 were reviewed with the DOP. The DOP confirmed the following:

- In January 2025, the dispense report indicated there were 1,987 controlled drugs dispensed from the 25 OR AWS and the audit sheet indicated 574 (or 29% [percent, unit of measurement]) of the controlled drugs dispensed were audited by RXT 2;

- In February 2025, the dispense report indicated there were 1,866 controlled drugs dispensed from the 25 OR AWS and the audit sheet indicated 227 (or 12%) of the controlled substances dispensed were audited by RXT 2;

- In March 2025, the dispense report indicated there were 1,846 controlled substances dispensed from the 25 OR AWS the audit sheet indicated 561 (or 30%) of the controlled drugs dispensed were audited by RXT 2; and

- In April 2025, the dispense report indicated there were 1,789 controlled drugs dispensed from the 25 OR AWS and the audit sheet indicated 441 (or 25%) of the controlled drugs dispensed were audited by RXT 2.

During the same interview and record review on 5/22/25 at 3:40 p.m., the DOP stated it was important to accurately reconcile all controlled drugs dispensed from the ADS (including the OR AWS) because controlled drugs could have been given to the wrong person for which it was not prescribed, making it an illegal medication. Additionally, the DOP stated, if controlled drugs were not accounted, the patient could have received medication that had been tampered with that could have led to a patient safety issue.

During a follow-up interview and record review on 5/23/25 at 11:55 a.m., a further review of the "Anesthesia Audit Sheet 2025 (audit sheet)," dated January, February, March, and April of 2025 was conducted with the DOP. The audit sheet indicated, the number of anesthesia providers (out of 77 total) audited each month by RXT 2 were as follows:

- In January 2025, 40 anesthesia providers (52%);

- In February 2025, 26 anesthesia providers (34%);

- In March 2025, 54 anesthesia providers (70%); and

- In April 2025, 51 anesthesia providers (66%).

During the same interview and record review on 5/23/25 at 11:55 a.m., the DOP confirmed the number of anesthesia providers audited in January through April 2025 by RXT 2 as listed above.

During an interview on 5/23/25 at 12 p.m. with the DOP, the DOP stated she did not review all the related anesthesia records that were audited every month by RXT 2. The DOP stated she only reviewed the numbers documented on the "Anesthesia Audit Sheet 2025." The DOP was unable to locate the anesthesia records that were audited by RXT 2. The DOP stated it was important to have an effective system to monitor and prevent controlled drug diversion to prevent controlled drugs from getting into the community and causing harm. When asked how an ineffective system for controlled drug monitoring affected the Drug Diversion Prevention Committee's ability to accurately review controlled drug trends and usage patterns for anesthesia providers, the DOP stated when the committee was provided incomplete data, the committee was unable to make an effective assessment of how the diversion prevention program is going.

Further review of the hospital's P&P titled, "MOD CLN.10.04 MOD Controlled Substance Diversion Prevention and Detection (AD 1.27)," dated 2/28/24, indicated, "The Drug Diversion Prevention Committee and/or Authorized Personnel assigned by the Tenet Entity's chief executive shall review Controlled Substance trend and usage pattern reports at least quarterly."

Based on interview and record review, the hospital failed to ensure an Abnormal Involuntary Movement Scale (AIMS, a formalized rating scale used to assess unusual movements) assessment was completed in accordance with the hospital's policy, for one of one patient (Pt) reviewed for antipsychotic use at Campus 2, Pt 9. Pt 9 was administered multiple antipsychotics (medications used to treat symptoms of psychosis in conditions like schizophrenia) for over one year without documentation of a completed AIMS assessment.

This failure had the potential to increase Pt 9's risk of experiencing serious and sometimes irreversible side effects commonly associated with antipsychotics such as involuntary/jerky movements, muscle stiffness, and tremors, that could interfere with daily activities and cause distress and/or overall reduced quality of life.

Finding:

During a group concurrent interview and record review on 5/23/25 at 9:25 a.m., with the Shift Manager at Campus 2 (SMDBH) and the Director of Patient Care Services at Campus 2 (DPCDBH), Pt 9's medical record was reviewed. They stated Pt 9 was admitted over one year ago, on 3/9/24, to Campus 2. They acknowledged Pt 9 had been administered multiple antipsychotics, including quetiapine (brand name Seroquel, an antipsychotic medication for bipolar disorder, depression, and schizophrenia) and haloperidol (brand name Haldol, an antipsychotic medication for mental illness such as schizophrenia). When asked if an AIMS assessment was completed when Pt 9 was admitted to Campus 2, they were unable to locate documentation of a completed AIMS assessment in the patient's electronic medical record. They both stated an AIMS assessment should have been completed and stated they needed to check the patient's hard chart (the physical, paper-based version of a health record).

During a review of Pt 9's "Admission Record," dated 5/1/25, indicated Pt 9 was initially admitted to the hospital at Campus 2 on 3/9/24. Her medical record indicated she had diagnoses including schizoaffective disorder (a mental health condition that combines symptoms of schizophrenia [hallucinations and delusions] with symptoms of a mood disorder [depression or mania]).

During a review of Pt 9's "Medication Reconciliation," dated 3/10/25, indicated a provider order for: haloperidol 20 mg (milligram, unit of measurement) one tablet by mouth three times a day, start date 1/18/25. Her medical record indicated she had been administered haloperidol in various doses, since 3/9/24 (over one year), and had current provider's orders for haloperidol as follows:

- Haloperidol decanoate 100 mg intramuscular (directly into the muscle) injection every 4 weeks, start date 12/2/24; and

- Haloperidol 10 mg by mouth three times a day, start date 5/21/25.

During a review of Pt 9's "Medication Reconciliation," dated 3/10/25, indicated a provider order for: quetiapine 100 mg by mouth at bedtime, start date 2/3/25. Her medical record indicated she had been administered quetiapine since 4/19/24 (over one year) and had a current provider order for quetiapine 100 mg by mouth at bedtime, start date 2/13/25.

During a review of Pt 9's "Medication Reconciliation," dated 12/2/24, indicated she had been administered other antipsychotic medications, including olanzapine (used for schizophrenia) and clozapine (used for schizophrenia). Her medical record indicated she was administered various doses of olanzapine between March to December 2024 and various doses of clozapine between March to November 2024. Pt 9's medical record did not indicate current provider's orders for olanzapine or clozapine.

During a review of Pt 9's "Medication Administration," dated 5/1/25 to 5/27/25, indicated, she had been administered the following antipsychotic medications between 5/1/25 to 5/27/25:

- Haloperidol 10 mg by mouth three times a day;

- Quetiapine 100 mg by mouth at bedtime; and

- Haloperidol decanoate 100 mg by IM injection (monthly IM injection administered on 5/19/25).

During a follow-up interview on 5/23/25 at 9:38 a.m., the DPCDBH stated she was unable to locate documentation of a completed AIMS assessment in Pt 9's hard chart and stated she needed to check if the document was scanned into the hospital's medical record database. She stated an AIMS assessment would have been completed by the nurse and the physician would have verified it.

During a follow-up interview on 5/23/25 at 10:16 a.m., the DPCDBH stated she was unable to locate documentation of a completed AIMS assessment in Pt 9's medical record (electronic, hard chart, or scanned database).

During a follow-up interview on 5/23/35 at 10:22 a.m., the DPCDBH stated an AIMS assessment was important for monitoring for EPS side effects from antipsychotics. She stated an AIMS assessment should have been completed for Pt 9 when she was admitted to Campus 2.

During a concurrent interview and record review on 5/23/25 at 12:15 p.m., the drug information for quetiapine was reviewed with the Director of Pharmacy (DOP) from Lexicomp (a comprehensive drug information resource), dated 5/20/25, provided by the hospital, indicated "...Monitoring parameters...extrapyramidal symptoms (EPS, drug-induced movement disorders such as tardive dyskinesia [TD, involuntary/jerky movements] when taking antipsychotics)...Use a formalized rating scale at least annually (once a year)..." The DOP acknowledged Pt 9 should have been monitored for EPS movement side effects when administered antipsychotics, including quetiapine.

During a review of the hospital's P&P titled, "MOD.DBHC.1.46 Abnormal Involuntary Movement Scale (AIMS) Assessment for Tardive Dyskinesia," dated 8/23/23, indicated, "On admission, all patients admitted to [Campus 2] will be assessed by their RN [Registered Nurse] utilizing the Abnormal Involuntary Movement Scale (AIMS- attachment A). If the patient develops Tardive Dyskinesia [TD, a movement disorder] and/or other abnormal involuntary movements during their hospitalization, a second AIMS assessment will be completed. Assessments will be documented on the AIMS form."

During a review of Lexicomp's haloperidol drug information, dated 5/27/25, provided by the hospital, indicated, "Haloperidol causes extrapyramidal symptoms (EPS), also known as drug-induced movement disorders, in all ages...Haloperidol has a high propensity [tendency] to cause EPS...Monitoring parameters...extrapyramidal symptoms...Use a formalized rating scale at least annually..."

A review of the Prescribing Information (PI, detailed description of a drug's uses, doses, warnings, side effects, and drug-drug interactions) for olanzapine tablets, dated 9/2022, retrieved from DailyMed (a public website maintained by the U.S. Food and Drug Administration), indicated, "Tardive dyskinesia...A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs."

A review of the PI for clozapine tablets, dated 1/2024, retrieved from DailyMed, indicated, "Tardive dyskinesia (TD) has occurred in patients treated with antipsychotic drugs, including clozapine. The syndrome consists of potentially irreversible, involuntary, dyskinetic movements."

Based on observation, interview and record review, the hospital failed to ensure sterile (germ-free) compounding (mixing) of IV (intravenous, into the vein) drugs met the standards required by USP 797 (United States Pharmacopeia Convention chapter describing conditions and practices for compounding sterile drugs) when:

1. The pharmacy's Cleanroom Suite (where sterile IV drugs are made) non-hazardous buffer room (room to mix IV drugs) had damaged wall areas that were uncleanable,

2. The initial garbing competency (the ability to properly put on and take off protective clothing) evaluation was not successfully completed three times in a row by one staff pharmacist.

These failures had the potential of exposing patients to contaminated IV drugs leading to hospital acquired infections.

Findings:

1. During a concurrent observation and interview on 5/20/25 at 2:26 p.m., with Pharmacy Technician (RXT) 1 and the Director of Pharmacy (DOP), the hospital pharmacy's IV Cleanroom Suite was visually inspected. In the non-hazardous buffer room, a wall was identified containing three areas of damaged drywall. RXT 1 and the DOP acknowledged and confirmed the above observations. The RXT 1 and DOP both stated the damaged drywall areas were not smooth and therefore, were uncleanable. RXT 1 and the DOP stated they were unable to determine how long the wall had been damaged. The DOP stated she was not informed by pharmacy staff regarding the damage on the wall.

During a review of photos from the non-hazardous buffer room provided by the hospital on 5/20/25, the photos indicated the three damaged drywall areas on the wall measured between two (2) centimeters (cm, unit of measurement) and four (4) cm long and/or wide.

During a follow-up interview on 5/22/25 at 3:19 p.m. with the DOP, the DOP stated the DOP stated the USP 797 standards required walls to be smooth to allow efficient and appropriate cleaning to prevent microbial growth. The DOP stated microbial growth could have caused a negative impact on patients if they received unsterile compounded medications.

According to the most recently updated USP 797, which became effective on November 1, 2023:

"...The surfaces of ceilings, walls, floors, doors, door frames, fixtures, shelving, work surfaces, counters, and cabinets in the classified area must be smooth, impervious, free from cracks and crevices, and nonshedding so they can be cleaned and disinfected and to minimize spaces in which microorganisms and other contaminants can accumulate. Surfaces should be resistant to damage (e.g. [example], rust) by cleaning agents, sporicidal and other types of disinfectants, and tools used to clean. Junctures between the ceiling and the walls and between the walls and the floor must be sealed to eliminate cracks and crevices where dirt can accumulate...Walls must be constructed of, or may be covered with, durable material...and the integrity of the surface must be maintained..."

2. During a concurrent interview and record review on 5/20/25 at 3:28 p.m. with the DOP, the Pharmacist's (RPH) initial garbing competency evaluation titled, "Competency Assessment: Hand Hygiene and Garbing for Nonhazardous Sterile Compounding," dated 3/21/25, indicated, the RPH failed one out of three gloved fingertip and thumb sampling (GFT) on 3/21/25 and repeated one successful GFT on 3/31/25. The DOP acknowledged the RPH had not successfully completed three initial garbing competency evaluations in a row, including GFT, on 3/31/25 and stated the RPH should have.

During a follow-up interview on 5/22/25 at 3:21 p.m. with the DOP, the DOP stated the USP 797 standards required compounding staff to successfully complete initial garbing competency evaluations in a row, including GFT, and stated it was important to follow the requirements to ensure compounding staff had efficient hand hygiene and garbing practices.

According to the most recently updated USP 797, which became effective on November 1, 2023:

"Demonstrating Competency in Garbing and Hand Hygiene...Before beginning to compound...or have direct oversight of compounding personnel, personnel must successfully complete an evaluation no fewer than 3 separate times. The 3 successful completions must be in succession-failure of any of the 3 initial garbing competency evaluations requires repeat testing until personnel successfully complete 3 evaluations in a row. The garbing competency evaluation consists of a visual observation and gloved fingertip and thumb sampling (GFT) of both hands...Each of the 3 initial competency evaluations must occur after performing a separate and complete hand hygiene and full garbing procedure. All garbing competencies must be completed with gloved fingertip and thumb sampling after garbing...and a documented visual audit while performing hand hygiene and garbing procedures..."

Based on observation, interview, and record review the hospital failed to ensure that medications were kept locked and secured to prevent unauthorized access when two of the four Cardiac Catheterization Laboratory (Cath Lab - specialized area in a hospital equipped with imaging technology used for diagnosing and treating heart and blood vessel conditions) room, Cath Lab "Red" and Cath Lab "Purple", were not in use and had anesthesia carts (carts arranged or customized with supplies, medication and equipment to administer anesthesia) that were left open and had unlocked medication drawers.

This failure had the potential for unmonitored and unauthorized access to medications in anesthesia carts by unauthorized individuals, placing the hospital at risk for diversion of medications.

Findings:

During a concurrent observation and interview on 5/21/25 at 4:15 p.m. in Cardiac Catheterization Laboratory with the Director of Cath Lab (DCL) and Registered Nurse (RN) 16 all Cath Lab rooms were toured. RN 16 stated the hospital has a total of five Cath Lab rooms, however the hospital only has four operational rooms that were used for patient care. During the observation Cath Lab room "Red" and Cath Lab room " Purple" were empty with no one inside and had open and unlocked Anesthesia Carts (carts arranged or customized with supplies, medication and equipment to administer anesthesia). Both anesthesia carts had medication drawers left open, slightly pulled out and open with access to all medications. RN 16 validated the Cath Lab schedule and stated that Cath lab room "Red" had last case at 3:15 p.m. and had been cleaned by Environmental Service (EVS - responsible for maintaining a clean and sanitary environment) and ready to use for next patient. RN 16 stated the cart had been sitting open for more than an hour and a half. RN 15 stated that Cath Lab room "Purple" had been sitting open for more than 10 minutes and last case was completed around 4:30 p.m. RN 16 stated EVS team and all Cath Lab employees had access to any of the Cath Lab rooms. RN 16 stated EVS team did go in and clean the "Red" room and had it set up for the tomorrow's cases. RN 16 stated the medications should be kept locked and secured. RN 16 stated Anesthesia team was responsible for securing the carts.

During an interview on 5/22/25 at 10:45 a.m. with the Chief of Anesthesia (DR 2), DR 2 stated it was not acceptable to have the anesthesia carts unlocked and unattended after the cases. DR 4 stated that he was made aware of the findings from yesterday in Cath Labs where two carts were left opened and unattended. DR 4 stated that he expects all anesthesia providers to ensure carts were locked prior to leaving the Cath Lab rooms.

During an interview on 5/22/25 at 3:45 p.m. with the DCL, the DCL stated he expected Anesthesia carts to be kept locked when anesthesia staff was not present and expected it to be locked by anesthesia providers prior to leaving Cath lab rooms after each case. The DCL stated Cath Lab rooms were not staffed in the evenings, nights or weekends and it was not acceptable to leave open and unlocked anesthesia carts with access to medications.

During a concurrent interview and record review on 5/23/25 at 8:30 a.m. with the Manager of Accreditation and Regulatory (MA) 1, anesthesia cart medication drawer content list was reviewed. That list indicated the carts in Cath Lab "Red" and Cath Lab "Purple" were stocked with medication that included succinylcholine (helps relax muscles during surgery or while a patient is on a breathing machine), rocuronium (Paralyzing agent- Used during surgery or Anesthesia ) and other medications. MA 1 stated EVS and other staff should not be able to access these medications. MA 1 stated succinylcholine and rocuronium had the potential to cause serious harm and she expected these medications to be kept locked up.

During a review of Statement on "Security of Medications in the Operating Room" with the last amended date 10/18/23 by American Society of Anesthesiologist, retrieved from "https://www.asahq.org/standards-and-practice-parameters/statement-on-security-of-medications-in-the-operating-room" , statement indicated, " ... A secure environment of care is necessary for medication safety ... Recommended Policies ... Anesthesia carts and anesthesia machines may remain unlocked, and non-controlled* medications may be left in or on top of unlocked anesthesia carts or anesthesia machines immediately prior to, during, and immediately following surgical cases in a secure anesthetizing location, so long as there are authorized personnel present ... "

Based on observation, interview, and record review, the hospital failed to ensure outdated or unusable medications were not available for use in two of four medication rooms at Campus 2, when:

1. One expired medication was stored along with unexpired medications against the hospital's policy in one of four medication rooms; and

2. One used medication vial intended for single use was not discarded according to the manufacturer's specifications in one of four medication rooms.

These failures had the potential for exposing patients to contaminated or ineffective medications.

Findings:

During a visit to Campus 2 on 5/23/25 at 9:30 a.m., outdated or unusable medications were identified stored in two of four medication rooms as follows:

1. In the C2 Building medication room, during an observation on 5/23/25 at 10:04 a.m. with the Director of Pharmacy (DOP) and the Shift Manager at Campus 2 (SMDBH), Patient (Pt) 8's opened and expired medication inhaler (device that delivers medication directly into the lungs) albuterol (medication for lung disease) was identified. An orange sticker was observed labeled on the albuterol inhaler that indicated it had expired on 5/14/25.

During an interview on 5/23/25 at 10:05 a.m. with the SMDBH, he acknowledged the albuterol inhaler was expired on 5/14/25 and stated it should have been discarded.

2. In the Intake Building medication room, during a concurrent observation and interview on 5/23/25 at 10:25 a.m. with the DOP and the SMDBH, one opened and used preservative free Sterile Water for Injection (water that is free from germs used to dissolve medications) 10 ml (milliliter, unit of measurement) vial, intended for single use, was identified. The vial was observed to have a handwritten date that indicated an expiration date, "5/22 (2025)." The SMDBH acknowledged the vial was intended for single use and stated it should have been discarded.

During an interview on 5/23/25 at 12:11p.m. with the DOP, the DOP stated used medication vials intended for single use should not have been dated or kept and stated it should have been discarded after use. Additionally, regarding the expired albuterol inhaler, the DOP stated medications should have been reviewed for expiration date before administration and the expectation was for staff to have discarded the medication when it expired.

During a review of the hospital's policy and procedure (P&P) titled, "PHARM.1.21 Medication Storage Access and Security Policy," dated 2/27/25, indicated, "All expired, damaged, and/or contaminated medications are segregated until they are removed from the hospital.

Based on interview and record review the hospital failed to obtain and provide STAT (immediately) troponin (rapid blood test used to measure the protein (troponin) released by the heart muscle when it is damaged) results per policy of one hour when on 1/2/25, nine of 74 sampled patients (Patient (Pt) 17, Pt 18, Pt 48, Pt 49, Pt 50, Pt 51, Pt 52, Pt 53, and Pt 54) had STAT troponins ordered and not drawn for two hours after order was placed.

These failures resulted in the nine patients not having their STAT troponin checked in a timely manner and had the potential to cause delay in their treatment.

Findings:

During a review of a hospital document titled, "Lab Report for 1/2/25, Troponin," dated 1/2/25, the Lab report indicated on 1/2/25, 74 patients had a troponin level checked; of the 74 patients nine had a troponin level ordered STAT and were not drawn for greater than two hours after they were ordered.

During an interview and document review on 5/21/25, at 11:05 a.m., with Assistant Director of Laboratory (ADL), the "Laboratory TAT (Turnaround Time) STAT" details form was reviewed. The ADL stated based on this TAT STAT form on 1/2/25, the lab had not met its goal of having labs drawn and results obtained in an appropriate time frame. The ADL stated he would have expected a stat troponin lab to be drawn within 30 minutes of the order placement. The ADL stated on 1/2/25, only 31.7 percent of troponin lab draws were drawn on time. The TAT STAT form indicated the goal was to draw a troponin in less than ten minutes after ordered, receive the specimen in the lab in less than 10 minutes after lab draw and receive the result in less than 35 minutes. The TAT goal is less than 55 minutes and the hospital goal is greater than 75 percent. The ADL stated on 1/2/25 the TAT goal for Troponin was not met but that there are many contributing factors that could have affected the collection time of the troponin. The ADL stated the contributing factors included staffing levels, difficult draws, staff not escalating difficult patients, and delays due to patients being off the floor for procedures. The ADL stated waiting over two hours to have a STAT troponin lab draw was not acceptable, "but all labs face these issues".

During a review of the hospital's policy titled, "Laboratory Turnaround Times" dated 8/11/24, the policy indicated, " ... STAT: Stat orders are drawn and resulted within one (1) hour if the test methodology allows ..."

During a review of professional reference titled, "Troponin," dated 4/23/23, retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK507805/#:~:text=Diagnosing%20cardiac%20emergencies,troponins.%5B3%5D, indicated, " ... Diagnosing cardiac emergencies is one of the most crucial tasks delegated to the emergency provider. The broad differential diagnosis of chest pain must be narrowed down quickly and accurately to perform the life-saving treatments patients require.[1] Along with the history and physical examination, several important diagnostic tools are used to differentiate the different causes of chest pain.[2] One tool that has become an essential component of cardiac workups and diagnosis is the measurement of troponins.[3] ..."

Based on observation, staff interview and review of hospital documents, the hospital failed to ensure Food and Nutrition Services (FANS) was organized and managed effectively when:

1. A Registered Dietitian (RD) did not have a role in providing oversight to the food service operations or guidance to the Director of Food and Nutrition Services (DFNS) at two of two campuses (Main Hospital Campus 1 and BHC Campus 2) in accordance with professional standards of practice.

2. Professional standards of practice were not followed when the Clinical Nutrition Manager (CNM) position and Lead RD position were supervised by the DNFS who had no clinical expertise and was not qualified to evaluate the professional skills of an RD. The hospital failed to ensure the Registered Dietitian provided guidance and oversight to the DNFS.

3. The clinical nutrition screening, prioritization and assessment policy did not address the specialized nutritional needs for patients admitted with behavioral health/mental health disorders located at the BHC Campus 2 when the nutrition risk screening policy was based on patients admitted to the general acute care hospital and did not reflect the nutrition risk factors specific to a behavioral health inpatient. As a result, RDs limited assessment of the nutritional needs of behavioral health patients only following a consult from the physician or nursing staff.

4. A system was not in place to recruit and hire Registered Dietitian's in accordance with the published job description and the professional standard of practice to support face-to-face nutritional physical assessments of patients. Four of five full-time equivalent (FTE) positions for RDs were hired with the knowledge the RDs were unable to be on the hospital premises, would perform their jobs remotely and not be able to conduct nutrition-focused physical exams (NFPE) on patients.

These failures had the potential to result in inadequate oversight of the Food and Nutrition Services food safety and sanitation practices, inadequate or ineffective food service staff training and competency. Additionally, the lack of a nutrition screening specific to the needs of the behavioral health population may result in gaps in the adequacy of nutrition care provided to patients. (Cross Reference A-0023, A-0083, A-0622, A-0750)

Findings:

1. During the survey from 5/20/25 to 5/27/25, observations, interviews and document reviews indicated multiple concerns related to food production, safety and sanitation operations including: incorrect portions were served during lunch meal service at both campuses, there was no monitoring for cooling of ambient foods and facial hair was not restrained during meal service at BHC Campus 2, lack of competencies on food service staff (Cross refer A-0622, A-0750).

During an interview with the Lead RD on 5/21/25 at 2:19 p.m., Lead RD stated she has been in the position for 2 months and her job responsibilities were limited to functions in clinical nutrition. The Lead RD also stated she was based out of state and traveled to the hospital for approximately one week each month. While onsite she stated she introduced herself to others, attended ICU rounds, met with pharmacy, food service staff and the patient service manager as well as attended a director meeting with the Interim Director of Food and Nutrition Services (IDFNS). The Lead RD stated she had not closely looked at or inspected food services, observations of meal service or patient meal tray audits yet as she had other priority items to do while onsite.

During an interview with the IDFNS on 5/22/25 at 2:49 p.m., IDFNS stated they currently have a vacant Clinical Nutrition Manager (CNM) position and right now the RD oversight is done remotely by the Lead RD. The IDFNS acknowledged there was no oversight by a RD at the BHC Campus 2 at this time either.

During a review of the Clinical Dietitian position description for the Lead RD, dated 2017, indicated the clinical dietitian reported to multiple positions within the contracted vendors leadership team. It indicated no supervisory responsibilities of dietetic services and did not show any functions in food services.

During a review of the Clinical Nutrition Manager (CNM) position description, dated August 2017, indicated the supervisory responsibilities for this position were limited to clinical nutrition staff. It did not include the responsibility of providing guidance and oversight to the DFNS and dietetic services staff.

2. Dietary Services is defined as the provision of food and drink to patients in accordance with a physician's order (LawInsider, 2023). A Registered Dietitian/Nutritionist (RDN) is a health care professional educated in nutrition and foods, who is able to translate scientific information into practical solutions. An RDN has completed a bachelor's degree program, an accredited supervised practice program and has successfully completed a national exam (Academy of Nutrition and Dietetics). The RDN has a scope of practice in California law. In contrast the DFNS's qualifications were listed as a Certified Dietary Manager (CDM) whose 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.

During a review of the FANS organization chart, indicated the Lead RD was supervised by the DFNS, which would not reflect a relationship that allowed for the Lead RD to provide guidance and oversight to the DFNS as a peer.
In contrast, the position description of the Clinical Dietitian (RD), Lead RD, dated 2017, indicted this position could report to a variety of listed positions: CNM, Nutrition System Director, Assistant Director Clinical & Patient Services, Lead/Lead Specialists, or DFNS. The position description for the reporting of the RD included positions that were not shown on the departments organization structure and did not seem to be specific to the hospital. Similarly, Lead RD was supervised by the DFNS, a position with no formal training on the clinical nutrition needs of patients, and therefore unable to evaluate the skill set of a Registered Dietitian.

During a review of the currently vacant Clinical Nutrition Manager (CNM) position description, dated August 2017, showed the CNM also reported to the DFNS.

During an interview with the Chief Operating Officer (COO) on 5/27/25 at 3:34 p.m., the COO stated the IDFNS report directly to him.

3a. Patients with psychiatric illness encounter unique challenges in maintaining a healthy diet. The relationship between mental illness and nutritional status is bidirectional, shaped by both structural and illness-related barriers. Structural barriers-such as limited access to healthy foods, insufficient social support, low socioeconomic status, taste preferences, and daily habits-affect individuals with psychiatric illness and the general population alike. However, individuals with severe mental illness are at greater risk for food insecurity due to financial instability or tenuous housing. In addition to these structural barriers, patients with psychiatric illness often experience illness-related obstacles. Certain psychotropic medications can increase appetite, while cognitive impairment or reduced motivation can hinder ability to shop for and prepare healthy meals (Teasdale, et al., 2017).

Growing evidence indicates that nutritional interventions should play a central role in psychiatric care. This emerging body of research highlights the importance of improving diet quality, adopting specific dietary patterns, and incorporating supplements when appropriate to support mental health outcomes. By incorporating nutrition management into routine care using existing resources, psychiatrists can empower patients to take charge of both their mental and physical health. Looking into the future, ongoing research efforts aim to further validate and standardize these interventions in psychiatric practice (Psychiatric News, Volume 60, Number 1).

During the course of the full validation survey from 5/20/25 to 5/28/25, three patients (Patient 45, 46, 47) were reviewed for clinical nutrition care at the BHC Campus 2. None of the patients were seen by a RD for a nutrition assessment.

During a review of recommendations in Frontiers in Psychiatry, titled "Nutrition Needs in Mental Healthcare: Study of a Prospective Analytic Observational Study Assessing Nutritional Status, Eating Behavior and Barriers to Healthy Eating in Psychiatric Inpatients and Outpatients Compared to Healthy Adults", dated 6/14/22, indicated "The planning and implementation of effective nutritional interventions in mental healthcare require a valid assessment of patients' nutritional status, challenges and needs. However, to date, no validated nutritional risk screening methods that also consider overnutrition exist for people with mental disorders (9). Similar to the somatic hospital setting (10), regular nutritional risk screening should be established in mental healthcare. However, nutritional risk screening should not only focus on the identification of undernourished or malnourished patients." (Front Psychiatry. 2022 Jun 14;13: 906234. doi: 10.3389/fpsyt.2022.906234)

a1. During a review of the clinical record for Patient 47, Patient was admitted on 5/15/25 for major depressive disorder with a physician's diet order, dated 5/15/25, of a modified sodium diet.

During an interview with the Lead RD on 5/22/25 at 3:59 p.m. regarding the clinical nutrition policy, Lead RD stated they use the same screening tool as the main hospital for the DBH Campus 2 and that will capture any weight loss or decreased appetite. Lead RD stated they do not use any other specific standard of practice for the specialized nutrition needs of that patient population. The Lead RD stated she reached out to the regional RD and the policy and procedure is based on the Academy of Nutrition and Dietetics and to meet the hospital's length of stay. She stated the RDs only see patients at DBH Campus 2 for consult or a screen score of 2 or greater. The Lead RD confirmed they see patients at the Main Hospital Campus 1 for length of stay but not at the DBH Campus 2 and was unsure why it was different.

During an interview with the Director of Patient Care Services (DPCDBH) at DBH Campus 2 on 5/23/25 at 9:12 a.m., DPCDBH stated the RDs automatically receive a list of the patient diets and look at patients that have consistent carbohydrate diets or any modified diets and will see those patients. She stated nursing does an assessment on patients and if any concerns they would notify the RD or physician. DPCDBH stated there is not any type of standard of practice resource that they use to ensure the nutritional needs of patients at the DBH campus 2 are being met.

During a review from the Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), listed the nutritional indicators for Schizophrenia. It indicated "A dietary assessment indicating a probable inadequate intake of nutrients (related to inadequate intake, altered absorption, altered metabolism, or increased needs)-followed by a physical examination and observation of lesions potentially related to nutrients-are indicators of nutritional risk. These findings, followed by laboratory assessment, can validate the cause of lesions, guide treatment, and document effectiveness of treatment." It showed a "Behavioral Health Nutrition Risk Assessment Form". It indicated, "Patients with any high nutritional risk factors are highest priority for nutrition assessment and a nutrition care plan. Patients with moderate nutritional risk require in-depth nutrition assessment and a nutrition care plan. Screening programs recommend referral for weight management if a weight gain of 5% above baseline weight is observed."

Further review of the current standard of practice from AND NCM indicated nutritional indicators for Mood Disorders, Alcoholism and Drug Addiction. The Mood Disorders indicated nutritional indicators included some of the following: Depressed mood with significant change in appetite and intake, Persistent somatic complaints, taking one or more psychiatric medication and food Insecurity. These also indicated when a nutrition consultation was recommended. The hospital policy and procedure did not include any of the unique nutrition risk factors associated with caring for behavioral health inpatients.

a2. During a review of clinical records for Patient 46, Patient 46 was admitted to BHC Campus 2 on 4/23/25 with a diagnosis of chronic paranoid schizophrenia and discharged on 5/22/25. Review of the physician's orders dated 4/23/25 indicated Patient 46 was on a consistent carbohydrate diet (CCD-a diet used in the treatment of diabetes). Review of the meal intakes, dated 4/23/25 until 5/8/25, indicated there was sporadic documentation of how the patient was eating. Additionally, the location of nursing documentation of meal intake in the medical record was inconsistent. In some instances, it was listed under the "calorie count" section and in other instances it was listed in the "meal intake" section. During a concurrent interview with Shift Manager (SMDBH) DBH Campus 2 on 5/22/25 at 11:10 a.m., SMDBH stated the staff are supposed to document the intake of each meal in the "meal percentages" section of the medical record.

During an interview with the Director of Patient Care Services (DPCDBH) at DBH Campus 2 on 5/23/25 at 9:12 a.m., DPCDBH stated the RDs automatically receive a list of the patient diets and look at patients that have consistent carbohydrate diets. The hospital was unable to demonstrate Resident 46 received the benefit of a nutritional assessment.

a3. During a review of clinical record for Patient 45, Patient 45 was admitted on 5/16/25 for unspecified dependency alcohol use. History and physical dated 5/16/25, indicated history of diabetes. The patient was confined to a wheelchair. Patient 45's physician ordered diet dated 5/16/25 was a CCD- of five carbohydrates per meal and Gatorade two times a day to hydrate . There was no documentation of a nutrition assessment despite the physician's order of a carbohydrate consistent diet.

3b. During the course of the full validation survey from 5/20/25 to 5/28/25, one of five patient records (Patient 40) reviewed for clinical nutrition care at the Main Hospital Campus 1 had a delayed nutrition assessment. The hospital policy and procedures for nutrition assessment did not follow the current standard of practice.

During a review of an article from the Academy of Nutrition and Dietetics (AND) titled "Nutrition for People with Lung Cancer" published 9/18/23, indicated "About 45% to 69% of people with lung cancer experience malnutrition, which is associated with reduced quality of life, increased symptom severity and shorter survival rates." It also indicated "Weight loss is very common for these patients, and it can occur or be exacerbated by factors such as the location of the tumor, metastasis or treatments including surgery, radiation and chemotherapy and immunotherapy medications. RDNs work with these patients and their caretakers or families to mitigate the effect of malnutrition on their bodies, which can help them withstand long-term treatment and improve medical outcomes and quality of life." (https://www.eatrightpro.org/news-center/practice-trends/nutrition-for-people-with-lung-cancer)

Review of the face sheet (front page of the chart that contains a summary of basic information about the patient) for Patient 40, indicated Patient 40 was admitted on 5/14/25 to the hospital with a diagnosis of acute renal failure (sudden and rapid loss of kidney function, a decline in the kidneys' ability to filter waste and maintain fluid balance).

Review of the history and physical dated 5/14/25, indicated Patient 40 had a chief complaint of not feeling well, had a poor appetite and was undergoing chemotherapy treatment for advanced metastatic lung cancer. The Nutrition Screen dated 5/14/25 had a malnutrition screening tool (MST) score of 1. A score of two or greater creates an automatic trigger for a dietitian consult.

Review of the Nutrition Assessment dated 5/21/25, indicated Patient 40 was currently NPO (nothing by mouth). The Registered Dietitian (RD) documented Patient 40 had a nutrition diagnosis of increased nutrient needs (protein and energy) related to increased energy expenditure as evidenced by a catabolic disease state. RD documented the patient's estimated nutrition needs were as 2100 to 2520 calories per day and 101 to 126 grams of protein per day. RD documented a nutrition recommendation to resume diet when medically feasible and add strawberry nutrition supplement three times a day. Review of the meal intakes dated 5/15/25 to 5/21/25, indicated variable oral intakes from 25 to 100 percent (%), mostly 40-50%. Review of nutritional supplement intake from 5/14 to 5/21/25 revealed Patient 40 consumed 25% of the supplement once. The remaining documented offerings indicated 0% consumption.

Review of the diet orders dated 5/14/25, indicated nutrition supplement three times a day and a regular diet. There were multiple NPO orders on 5/14, 5/15 and 5/21 after midnight. Based on the documented meal intake Patient 40's meal intake met less than 50% of his estimated nutritional needs.

During a concurrent interview with the Lead RD on 5/21/25 at 11:52 a.m., Lead RD stated they rely on nursing to trigger them to see the patient or the physician according to their policy. Lead RD stated the policy and procedure for nutrition assessment is based on a patient's length of stay of greater than after seven days, the presence of wounds, a BMI (body mass index-a measure to determine whether a person has a healthy body weight for their height) of less than 18 or NPO/clear liquid greater than five days. Lead RD stated the policy and procedure references the eNCPT of 2017 (Academy of Nutrition and Dietetics electronic Nutrition Care Process Terminology). The Lead RD stated they do not see patients that have nutrition supplement orders since there are many patients that just will request them, and it is more of a preference and is not necessarily indicative of patients not eating well or needing them due to their nutritional status. The Lead RD stated she would ask her contract company for their other references for the policy and was not sure why they do not include diagnoses or therapeutic diet orders to bring the RD in earlier.

During a review of the hospital policy and procedures titled "F&N.1.79 Nutrition Screening, Prioritization and Assessment (D003A), dated approved 5/27/20 and next review date in review, indicated an initial screening assessment and prioritization process is implemented to identify patients who may require medical nutrition therapy. It indicated the RD acts on consults using the prioritization table and if a consult is received for a criterion not in the prioritization table, the RD can complete the task without completing a nutrition assessment. The policy indicated the RD evaluates information from the following sources: consults from physicians, nurses and other healthcare professionals, multidisciplinary rounds, orders for enteral or parental nutrition or nothing by mouth or clear liquids greater than five days. It indicated that within two days, the RD will assess patients from a nursing referral for MST score of two or greater, nurse request for nutrition consult, nurse/other healthcare professional referral, OB patients with certain diagnoses, education referral, pressure injury stage II or greater, calorie count, or BMI of less than 18. It also indicated that by day seven to see patients with LOS of seven or greater. The policy did not indicate any differences that pertain to the DBH Campus 2.

During a review of the Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2025, the NCM indicated to have Screening for nutrition problems other than malnutrition that included anticoagulant therapy, obesity, patients with history of heart failure, presence of edema on admission, and need for sodium-restricted diet. It also indicated, "In adults undergoing dialysis, assessments are best obtained after treatment when body fluid compartment levels are more likely to be balanced." The NCM referenced "KDOQI Clinical Practice Guideline for Nutrition in CKD (CPG)", dated 2020, the CPG indicated, ". . .percent change in usual body weight (dry weight in maintenance dialysis patients) may be a more reliable measure." The hospital policy and procedure did not reflect the current standard of practice.

4. During the course of the full validation survey from 5/20/25 to 5/28/25, eight patient records (Patient 40, 41, 42, 43, 44, 45, 46, 47) were reviewed for clinical nutrition care at both campuses.

During an interview and concurrent review of patient records on 5/21/25 starting at 10:24 a.m., the RD (RD 1) stated she started working at the hospital one month ago and she also wanted to include the Lead RD for the interview since she was newer. RD 1 stated the Lead RD lived out of state and was in Michigan. The Lead RD stated she has worked in a remote capacity at the hospital for two years and about two months ago became the interim clinical nutrition manager. The Lead RD stated since RDs are not at the hospital in person they are not able to do nutrition focused physical exams (NFPE) on the patients when conducting the nutrition assessments. RD 1 stated she does conduct NFPE when she does nutrition assessments on the patients.

During a review of the RD schedule dated May 2025, showed there were two RDs that were located in Eastern Standard Time (EST), two that were in Central Standard Time (CST), three that were in Pacific Standard Time (PST), one of which was RD 1 who was onsite.

During a review of the RD roster for the Main Hospital Campus 1, it indicated there were five RD FTEs, one of which was onsite. During a review of a document from the Interim Director of Food and Nutrition Services, it indicated 80% of the medical nutrition therapy was provided by offsite Registered Dietitians accomplished through a paper review of the electronic medical record.

During a review of the RD position description dated 2017, indicated essential functions and responsibilities included "Assesses the nutritional status of neonates/ infants, pediatric, adolescent, adult and/or geriatric patient ...Uses parameters such as ...nutrition-focused physical assessment."

During a review of the Commission on Dietetic Registration, the credentialing agency for the Academy of Nutrition and Dietetics document, titled, "Revised 2024 Scope and Standards of Practice for the Registered Dietitian Nutritionist" indicated under Standard 7, Providing Person-Population-Centered Nutrition Care, the RD conducts nutrition assessment and obtains and assesses findings from nutrition-focused physical exam (NFPE).

During an interview with the IDFNS on 5/22/25 at 2:49 p.m. IDFNS acknowledged they had mostly offsite RDs and they were trying to recruit and bring on more that were onsite. IDFNS stated they were bringing on another onsite RD soon.

Based on observation, staff interview, and review of hospital documents, the hospital failed to ensure two food service workers (FSW 1 and FSW 2) were competent in their job duties when incorrect portion sizes were used during a lunch meal observation on May 20, 2025, at the Main Hospital Campus 1 and May 22, 2025, at the BHC Campus 2. The combined census of both campuses was 370 on May 20,2025.

This failure had the potential to result in patients being served inadequate amounts of food and the menu not being followed that can result in and affect patients' nutritional and medical status.

Findings:

1. During an observation of the lunch meal service on 5/20/25 starting at 11:45 a.m. at the Main Hospital Campus 1, FSW 1 was serving the hot menu items on the lunch meal line. There was a #16 scoop (1/4 cup, 2 ounces) in the chopped meatloaf and chopped broccoli. There was no scoop in the ground meat loaf. There was #8 scoop (1/2 cup) in the mashed potatoes. Another staff would call out what diet was needed, FSW 1 used the #16 scoop for the ground and chopped diets throughout meal service.

During an observation and concurrent interview with FSW 1 on 5/20/25 at 12:27 p.m., FSW 1 stated one container was ground meatloaf, and the other was chopped meatloaf. FSW 1 confirmed she used the #16 scoop for the meatloaf on both the chopped and ground diets as well as for the chopped broccoli.

During an interview with the Interim Director of Food and Nutrition Services (IDFNS) on 5/20/25 at 12:30 p.m., IDFNS stated the portions should have been a #10 scoop (3/8 cup) for both the ground and chopped meat and a #8 scoop (1/2 cup) for the chopped vegetables.

During a review of the lunch menu for 5/20/25, indicated the portion size for the mechanical soft diets should have been 3 ounces of meatloaf, one (1) cup soft broccoli, and ½ cup mashed potatoes. For the ground diet, it showed 3 ounces chopped meatloaf, and ½ cup yellow squash.

During a review of FSW 1 personnel file, FSW 1's position description, indicated essential duties and responsibilities included serving and preparing using correct portioning. The hospital failed to provide any in-services or competencies related to the position duties for FSW 1.

2. During an observation of the lunch meal service at BHC Campus 2 on 5/22/25 starting at 11:29 a.m., FSW 2 was serving the hot lunch meal option to the patients. On the steam table, there were baby carrots with a slotted spoon, roasted potatoes with a slotted spoon, and Salisbury steak with tongs for serving. There was no measurement on the slotted spoons to indicate the serving size.

During an interview with FSW 2 on 5/22/25 at 11:50 a.m., FSW 2 stated that he would just fill up the slotted spoons and said it is the same as the four-ounce spoodle (a kitchen utensil that combines the features of a spoon and a ladle, often used for portion control) but he just uses these spoons instead.

During a review of the lunch menu for 5/22/25, indicated Salisbury steak with demi glaze, six -ounce (spatula), roasted potatoes with fresh herbs four-ounce portion, and roasted carrots ½ cup.

During a review of personnel files. No personnel file or competencies could be located for FSW 2.

During a review of the hospital policy and procedures, subject titled "Associate Competency Program Overview #E001", dated revised 1/25, indicated staff are competent to perform their responsibilities. The policy indicated that periodic assessment for evaluation of Associate Competency and ongoing training and development with in-service education.

During an interview with the IDFNS on 5/27/25 at 3:03 p.m., IDFNS stated they do monthly "CHAT" in-services at both campuses. IDFNS stated they do not necessarily have job competencies on the staff.

During the survey the hospital was unable to demonstrate evaluation of staff competencies or in-service training in relationship to staffs' position duties.

Based on observation, interview and record review, the facility failed to maintain a clean and sanitary environment in accordance with hospital's policy and procedures (P&P), and the Centers for Disease Control and Prevention (CDC) standards of practice for infection control when:

1. One of two ice machines in the Postpartum patient nutrition room had yellow and brown colored liquid build-up behind the ice chute and one of two ice machines located in the kitchen at the Behavioral Health Campus (BHC) 2 had a black substance in the water trough and on the ice machine grate and was not maintained according to the hospital's P&P titled, "Ice Machines Cleaning."

2. Ice was found in two open plastic cups in the patient nutrition freezer in the Labor and Delivery patient nutrition room and not according to the hospital's P&P titled, "Ice Handling."

3. There was no monitoring of potentially hazardous foods prepared from ingredients stored at ambient (temperature of the surrounding environment) room temperature at the BHC Campus 2.

4. Food Service Worker (FSW) 2 did not restrain facial hair when serving food for the lunch meal service on May 22, 2025, at the BHC Campus 2.

5. Raw meat was stored above ready to eat food in a reach-in refrigerator at the Main Hospital Campus 1 retail area.

These failures had the potential to place patients at risk for cross contamination (process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and the spread of infection.

6. The hospital failed to ensure that Gastroenterologist (DR 4 - medical doctor specializing in the digestive system and related organs) had eye protection during the entire colonoscopy procedure for Patient (Pt) 11.

This failure had the potential to expose DR 4 to chemical and bodily fluids and the potential for cross contamination.

7. Pt 1's open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) was performed in Operating Room (OR) 15 that had flooring with cracks.

This failure had the potential to allow bacteria to harbor in the cracked and chipped surfaces leading to an increased risk of post operative infection for Pt 1.

Findings:

1. During a concurrent observation and interview on 5/20/25 at 2:44 p.m. in the Postpartum patient nutrition room with the Director of the Neonatal Intensive Care Unit (NICU) and Pediatrics (DP), there was yellow and brown colored liquid build-up behind the ice chute. The DP took a dry paper towel and was able to wipe the liquid off. The liquid was sticky. The DP stated she was not sure what the liquid was. The DP stated it should not be there and could cause contamination if the ice touched it when dispensed and was given to patients.

During a concurrent interview and record review on 5/28/25 at 2:13 p.m. with Environmental Services (EVS-housekeeper) 1, a picture of the ice machine in the Postpartum patient nutrition room that was taken on 5/20/25 during the initial tour of this department was reviewed. EVS 1 stated her assigned area was in Postpartum. EVS 1 stated the ice machine was dirty with the yellow and brown colored liquid. EVS 1 stated patients could get sick from a dirty ice machine. EVS 1 stated she was responsible to clean the outside of the ice machine as part of her daily duties. EVS 1 stated she did not complete a daily log for cleaning the ice machine.

During an observation of the ice machine located in the kitchen at the BHC Campus 2, in the presence of the Plant Operations Technician (POT) on 5/22/25 at 10:01 a.m., there was a black substance on the side of the ice machine grate (where ice is formed) and in the water trough (where water collected and then used to make ice). The POT acknowledged the substance and stated this is cleaned by outside company and they would provide documents to show when cleaned last. No documentation was provided.

During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated environmental services should be cleaning the ice machines daily, build up can happen on the ice machines and wet areas can accumulate microorganisms and transmit bacteria to anyone using ice from these ice machines. The ICD stated the last time he did infection control rounds at the Behavioral Health Campus 2 was in August of 2024. The ICD stated he expects the staff at both campuses to report any infection control issues to management and submit any infection control problems through their reporting system. The ICD stated this is how he gets reports and addresses the issues. The ICD stated he is the only full-time infection preventionist on site and he has one part time infection preventionist who works remotely. The ICD stated he does not feel that he has enough staff for the size of the campuses he covers but that this hospital follows the corporate model so there currently is no infection prevention position open or posted.

During a review of the hospital's P&P titled, "Ice Machines Cleaning," dated 11/25/20, the P&P indicated, " ... Purpose: To remove all dust, dirt & waste ice from the surfaces of the ice machine, leaving it clean and free from odors, soil, marks or smears ... Follow regulatory and manufacturer's recommendations related to tools, logs, cleaning products & process ..."

During a review of the manufacturer's "Brand Name" instructional manual, dated 5/2001, indicated, " ... Dispense Area Sanitation ... The dispense area; spouts, sink, grill and splash
panel will need periodic cleaning and maintenance. 1. The ice chute may be pulled down to remove it from the ice dispenser. Wash and sanitize it ... Cleaning and Sanitizing ... It is the USER'S RESPONSIBILITY to see that the unit is properly maintained. It is always preferable,
and less costly in the long run, to avoid possible down time by keeping it clean; adjusting it as needed ... The following is a list of recommended maintenance that will help keep the machine running with a minimum of problems. Maintenance and Cleaning should be scheduled at a minimum of twice per year. Sanitizing of the ice storage bin should be scheduled for a minimum of 4 times a year ..."

2. During a concurrent observation and interview on 5/20/25 at 11:45 a.m. in the Labor and Delivery patient nutrition room with the DP and Registered Nurse Educator (RNE) 1, two uncovered plastic cups were filled with ice in the freezer and the ice pieces were fused together. The DP stated the plastic cups filled with ice in the freezer should not be there and could cause contamination if used for patients. The DP stated she did not know what they were doing in the freezer.

During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated ice should not be stored in open containers in the freezer. The ICD stated it puts patients at risk of cross contamination.

During a review of the hospital's P&P titled, "Ice Handling," dated 9/22/21, the P&P indicated, " ... POLICIES: ... Ice must be protected from splash, drip, and hand contamination during storage and service. In the event of a mechanical malfunction, ice will be transported in a clean, covered food-grade container from another machine in the facility/community or bought from an approved source ..."

During a professional reference tiled, "Why the ice cubes in my ice container stick together? (WIC)", dated 3/22/18, the "WIC" indicated, " ... If ice cubes have not been used for a long period of time, the cubes melt into each other during the defrost cycles and stick together ..."

During a professional reference titled, "Preventing Ice contamination with Safe Practices (PIC)", dated 4/15/20, the "PIC" indicated, " ... The FDA [Food and Drug Administration] defines ice as food ... Since ice contamination starts with the user, you need to make sure your employees are handling the ice properly ... never throw unused ice back into the ice bin. If a server accidently fills an extra glass with ice, they should toss that ice into a sink..."

3. Potentially hazardous foods (PHF) are those capable of supporting bacterial growth associated with foodborne illness. Protein based foods such as canned meat are considered to be a PHF and require time and temperature control for food safety. Similarly, PHF foods that are prepared with room temperature ingredients must also be monitored for time and temperature control (USDA Food Code, 2022).

During an observation of the initial kitchen tour at BHC Campus 2 on 5/22/25 starting at 8:59 a.m., there was a container of tuna salad dated 5/22 and the temperature was 37.4 degrees Fahrenheit (F).

During an interview with Food Service Worker (FSW) 2 on 5/22/25 at 11:27 a.m., FSW 2 stated that he made the tuna salad. FSW 2 stated he gets the tuna from the dry storage room and mayo either from refrigerator or dry storage room. FSW 2 stated he will make the tuna salad according to the recipe then put it in a container with a label and date. FSW 2 stated he does not check the temperature of the tuna before putting it in the refrigerator or monitor it for cooling.

During an interview with Executive Chef Manager (ECM) at BHC Campus 2 on 5/22/25 at 11:56 a.m., ECM confirmed they store tuna in dry storage area and the mayo could be stored in either refrigerator or dry storage area. ECM stated they do not have a log or monitor the cooling of ambient foods. ECM further indicated that was not a policy in place at the campus. During a concurrent review of the cooling log with ECM, it indicated that there was a separate place on the log to monitor the cooldown of ambient temperature foods. The log indicated food must be cooled to 41 degrees F (Fahrenheit) or below within 4 hours. ECM acknowledged there was a spot on the log for the monitoring of ambient temperature foods.

During a review of the hospital policy and procedure subject titled, "Food Handling Guidelines (HACCP)" #B007, indicated "Cooling of potentially hazardous foods prepared from room temperature ingredients: Food shall be cooled within 4 hours to 41°F if prepared from ingredients at room temperature. Use the Cooling Log form at the end of this policy to document the temperature of the food at the following times: at the end of food preparation and at 4 hours after the end of food preparation."

4. During an observation of the lunch meal service at BHC Campus 2 on 5/22/25 starting at 11:29 a.m., FSW 2 was serving the hot lunch meal option to the patients. FSW 2 had facial hair above lip that was not restrained in the beard restraint.

During an interview with the Executive Chef Manager (ECM) at BHC Campus 2 on 5/22/25 at 11:56 a.m., ECM stated the expectation is to have all facial hair covered.

During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated he does monitor staff to make sure they are wearing appropriate personal protective equipment (PPE) properly to include covering of their facial hair. The ICD stated it is the expectation that staff wear PPE properly and it is everyone's responsibility to check this is being done.

According to the 2022 Federal Food and Drug Administration (FDA) Food Code indicates, food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food; clean equipment, utensils, and Linens; and unwrapped single-service and single-use articles.

5. During an observation of the initial kitchen tour at Main Hospital Campus 1 on 5/20/25 starting at 11:10 a.m., in the retail area, in a reach-in refrigerator there was a container of raw beef on a shelf above produce. During a concurrent interview with the Interim Director of Food and Nutrition Services (IDFNS), he confirmed raw meat should be on the bottom rack and not above produce.

According to the 2022 Federal Food and Drug Administration (FDA) Food Code, indicates raw beef, poultry, and meats must be stored separately or below cooked or ready to eat foods to avoid cross contamination and potential for foodborne illness.

6. During a review of Patient (Pt) 11's "History and Physical (H&P)," dated 5/21/25, the "H&P" indicated, Pt 11 had history of colon (large intestine) polyps (abnormal tissue growths) and was planned for Coloscopy (a procedure where a flexible, lighted tube with camera called a colonoscope is inserted into the rectum to examine the entire colon).

During an observation on 5/21/25 at 10:11 a.m. in the procedure room four with the Quality Nurse (QRN) 4, Pt 11's coloscopy procedure was observed. During the entire procedure observed Gastroenterologist (DR 4 - medical doctor specializing in the digestive system and related organs) performing the procedure did not have eye protection on. QRN 4 validated the observation and stated that she also observed that DR 4 did not have eye protection. The remainder of the entire team in the procedure room had eye protection on during the procedure.

During an interview on 5/21/25 at 11:20 a.m. with the Director of surgical services (DSS) and Nursing Manager for endo (MEN) department, the DSS stated he expects everyone in the procedure assisting to have eye protection during coloscopy. The DSS stated it was normal practice to have a face shield or eye protection during coloscopy to avoid splashing into eyes.nThe DSS stated it was important to avoid risk of potential splashes or sprays of bodily fluids during the procedure. The DSS stated he was unable to comment why DR 4 did not have it during this procedure as it was a standard for her and in colonoscopy procedure.

During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated if there is risk of bodily fluids and splashing, staff should wear splash guards to include eye protection and or face shield during these high-risk splash procedures.

During a review of an article by American Society for Gastrointestinal Endoscopy (ASGE) titled "Personal protective equipment in GI endoscopy", dated 2023, published in "iGIE Volume 2, No. 2", retrieved from https://www.igiejournal.org/action/showPdf?pii=S2949-7086%2823%2900054-7 , the article indicated " ... GI endoscopic procedures place operators and personnel at risk for exposure to infectious pathogens, hazardous chemicals ... research has demonstrated that bacterial exposure can occur in individuals standing as far as 6 feet beyond the endoscope insertion site ... Eye protection ... Ocular contamination by body fluids during endoscopy presents a significant risk, because of both direct splashing of aerosolized fluids and hand to eye contamination by the endoscopist ... eye protection is a critical aspect of effective PPE. Protective eyewear consists of goggles and face shields of various designs and materials. They are also regulated by OSHA standards and must be appropriate to the specific expected hazard ..."

During review of Occupational Safety and Health Administration (OSHA - U.S. government agency within the Department of Labor with a primary mission to ensure that workers have safe and healthy working conditions by setting and enforcing standards, providing training and assistance, and conducting workplace inspections) regulations, retrieved from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.133, the OSHA regulation standards indicated, " ... 1910.133(a)(1) The employer shall ensure that each affected employee uses appropriate eye or face protection when exposed to eye or face hazards from flying particles, molten metal, liquid chemicals, acids or caustic liquids, chemical gases or vapors, or potentially injurious light radiation ..."

7. During a concurrent observation and interview on 5/22/25, at 8:55 a.m. with the Assistant Director of Nursing (ADON), in the operating room (OR 15) during Pt 1's surgical procedure, observed the operating room flooring had multiple seams running the length of the floor. The seams were split in multiple places and there were cracks in the flooring next to the seam. The ADON stated hospital was working on a plan to replace the flooring in the OR. The ADON stated it was not acceptable and agreed it could be a potential source for infection in surgical patients. The ADON stated he was aware that OR floor should not have cracks or opening where it would be hard to clean and disinfect.

During a concurrent observation and interview on 5/22/25 at 2:15 p.m. with the cardio thoracic surgeon (SUR - a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity)1 that performed procedure on Pt 1, the SUR 1 was shown the cracks in the seams in Pt 1's room. SUR 1 stated flooring was not acceptable in cardiac [heart] surgery operating room and could be source of infection in patients that are already vulnerable going through open heart surgery. SUR 1 stated Pt 1 underwent open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) in OR 15 and cracked flooring potentially could be a source of infection for any patients undergoing surgical procedures.

During an observation on 5/22/25 at 10:37 with the ADON, OR 3 flooring was also observed to have a crack in the flooring next to seams. The ADON stated he would place the work order to get in repaired as soon as possible. The ADON stated the cracked flooring was not acceptable in the OR environment and would be fixed as soon as possible.

During an interview on 5/30/25 at 8:08 a.m. with the Director of Environmental Services (DEVS), the DEVS stated his team was responsible for cleaning OR floors. The DEVS stated cracked flooring or cracked seams in the OR flooring are not acceptable and a potential source for infection. The DEVS stated there is a risk that blood and body fluids could collect in the cracks, and it would not be possible to clean and disinfect the cracked floor effectively. The DEVS stated her team had made the OR leadership team aware of the flooring condition and hospital is in the process of repairing and or replacing the flooring.

During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated floors in the OR should be continuous with no cracks or seams so they can be cleaned and disinfected easily. The ICD stated if there are cracks and open seams, staff cannot guarantee everything is removed and cleaned properly thus leaves the risk of cross contamination and can lead to infection.

During a review of the AORN publication Outpatient Surgery article, "How to Maintain a Clean OR Environment," dated 10/10/2007, the article indicated,"...To ensure a clean environment, evaluate the environment weekly or monthly for overall cleanliness as well as general condition...Are there cracks, nicks, or grooves on the floor? If so, repair them immediately to prevent bacteria from festering in the spaces..."

During a review of the Health Facilities Management article titled, "The role of maintenance in infection prevention," dated 8/16/19, the article indicated, "...Health care-associated infections (HAI) concerns to look for include: Damaged flooring in clinical areas. Damaged flooring does not provide a smooth, cleanable surface and can result in an infection prevention concern; Peeling paint or damaged wall surface. A wall surface that is not smooth is not cleanable..."

Based on observation, interview and record review, the hospital failed to delineate surgical privileges for all practitioners performing surgery in accordance with competencies of each practitioner outlined in the medical staff bylaws and failed to maintain a roster of practitioners specifying the surgical privileges of each practitioner when:

The hospital did not have surgical program prerequisites and requirements for residents (RS - physicians who have completed medical school and are undergoing postgraduate training in a specific specialty) listed, did not have a process to validate before procedures for two of two sampled residents RS 1 and RS 2 performing surgery were competent and met the credentialing and residency program requirements. The hospital did not have active standardized procedure as required by board of registered nurses to support one of one registered nurse first assistant (RNFA) 1 performing Endoscopic Vein Harvesting (EVH -is a minimally invasive technique used during open heart surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries).

These failures had the potential for increased risk of adverse events in patients requring open heart surgery as part of their physician ordered treatment plan.

Findings:

During a concurrent observation and interview on 5/22/25 at 8:55 a.m. with the Registered Nurse Quality (QRN) 3 and Assistant Director of Nursing Surgical Services (ADON) in operating room (OR) 15, Patient (Pt) 1's surgical procedure was observed. Pt 1 underwent an open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure with three separate bypass were created during the surgery. The ADON validated and verified the staffing in the room for the entire procedure included a primary cardio thoracic surgeon (SUR -a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity) 1, resident surgeon 1, Anesthesiologist (ANS - a medical doctor specializing in administering anesthesia and managing pain during medical procedures and surgeries) 1, Perfusionist (PER - healthcare professional who operates the heart-lung machine during certain surgeries, like open heart surgery, to maintain the patient's blood flow and oxygenation while the heart is stopped) 1, Registered Nurse First Assist (RNFA -is a Registered Nurse (RN) who works in an expanded role as a surgical first assistant and is responsible for working with the surgical team, in surgery, at the direction of the surgeon) 1, two RNs working as scrub nurses (work within the sterile field, directly assisting the surgeon with instruments and supplies during the procedure) and a circulating nurse (nurse who works outside the sterile field, managing patient care, coordinating with the surgical team, and ensuring a safe environment). The ADON stated that was the normal staffing for cardiovascular surgical cases at their hospital. The ADON stated that resident surgeon was the first assisting surgeon, and they typically have RNFA or Physician Assistant (PA -licensed medical professionals who work under the supervision of a licensed physician) as second assistant surgeon in the room. The ADON stated the hospital does not normally require scheduling two surgeons for the CABG procedures as the hospital has resident surgeons working with the primary surgeons. The ADON stated as far as he was aware, the resident surgeon was okay to be in the room as first assisting surgeon under the supervision of primary board-certified cardiothoracic surgeon. The ADON was unable to comment on what a resident surgeon can and cannot do at the hospital or during the surgical procedure. The ADON also was not able to comment on what year or specialty (specific area of training) residents were and stated the OR team does not have access or any way to validate, or to check program requirements for residents (define the specific types and scope of surgical procedures they are authorized to perform at a hospital and supervision requirement). The ADON stated he would have to defer to Director of Surgical Services (DSS) regarding residents and person in charge of residency program, however, his understanding was the surgeon was responsible for overseeing the residents. RNFA 1 was observed to perform the EVH part of the procedure. The ADON stated it was normal for RNFA 1 to do EVH during CABG surgeries. The ADON stated RNFA 1 has been doing EVH part of CABG surgeries for many years at the hospital and the hospital has a standardized procedure to ensure compliance as required for RNFA to perform EVH during CABG procedures. The ADON stated the RNFAs do not document the EVH procedure as being completed by them and it was documented by the surgeons in their notes.

During an interview on 5/22/25 at 10:55 a.m. with the DSS, the DSS stated he was aware of the state regulation and staffing requirement for cardiac vascular operative surgery cases. The DSS stated CABG cases must have a second physician in OR and do not require the second physician to be board certified cardiac surgeon. The DSS stated the hospital has cardiovascular surgery fifth year residents as second physician in the OR. The DSS stated the facility also has California Department of Public Health approved flex [program flexibility, which allows a hospital to temporarily deviate from specific regulatory requirements while still meeting the intent and purpose of those regulations] that allows them to staff mid-level providers [Physician assistant or RNFA] as third surgeon in cardiovascular cases requiring bypass. The DSS stated the resident surgeon's program specific requirements were with "Hospital B" and not currently listed in their system. The DSS stated medical staff, and human resources would be able to speak about the process. The DSS stated that RNFA reports to him and the hospital have policy and standardized procedures for RNFA's to work in the surgery.

During a concurrent interview and record review on 5/22/25 at 4:37 p.m. with the DSS & Manager Accreditation and regulatory (MA) 1, Title 22 of the California Code of Regulations (CCR -is a comprehensive set of rules and regulations that govern various aspects of programs in California) section 70435 Cardiovascular Surgery Service Staff was reviewed, and the program flex document was reviewed. Title 22 CCR section 70435 indicated " ... (b) Cardiovascular operative service. (1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery. He shall be responsible for: (A) Implementing established policies and procedures. (B) Training and supervising the nurses and technicians in special techniques. (C) Training and supervising the clinical perfusionists. (2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b) (1) above ...". The review of "APPROVAL OF PROGRAM FLEXIBILITY" by CDPH dated October 18, 2022, indicated, " ... This letter is in response to the request submitted by [Hospital name] for program flexibility for California Code of Regulations T22 DIV5 CH1 ART6-70435(b)(2). The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass ... The use of the PA as a second assistant is at the discretion of the primary surgeon ... The facility is required to have a 3-team cardiovascular surgical team in the OR ... The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures ..." The DSS stated he was aware of the requirements set forth in CCR and conditions in the program flex. The DSS stated he was not able to comment if the RS 1 was an independent and qualified surgeon as required per CCR and flex approval conditions for first assistant to primary surgeon for CABG procedure. The DSS stated he was in charge of the surgery scheduling team [individuals responsible for coordinating all aspects of scheduling surgical procedures] and it was not standard practice at the hospital to identify first assistant in cardiac surgery cases during scheduling process. The DSS stated he was not able to comment on what criteria was used to determine that RS 1 or surgery residents were able to be scheduled as first assistant or second surgeon in the CABG. The DSS stated he would have to defer to Medical staff office for all the surgery resident requirements and would have to look into this practice. The MA 1 stated she was aware of the program flex and CCR staffing requirements and the MA 1 stated approved flex was addressed to her name. The MA 1 stated that she posted it in the lobby upon receiving the approval of program flex and shared with leadership team. The MA 1 stated she cannot comment if the hospital was in compliance with the condition set forth in the approved flex. The MA 1 stated she does not know if it was appropriate to schedule RS 1 as first assistant to the primary surgeon and as a second surgeon in the CABG case. Both MA 1 and DSS stated they both understood and were aware of the program flex authorization was to use mid-level provider as second assistant or third surgeon but they were still required to have second qualified surgeon in the room as first assist. MA 1 stated she will provide information on the person in charge of residency program or someone that can speak to residents role.

During an interview on 5/22/25 at 5:35 p.m. with the Chief Nursing Officer (CNO), The CNO stated surgery residents need supervision but she was not aware who was responsible at the facility for the oversight of the residency program. The CNO agreed that surgical staff should know what residents can and cannot do while the residents are at their facility assisting with surgeries in the OR. The CNO stated she would need to follow up with her leadership team and do additional research prior to commenting on compliance with state regulations. The CNO stated she would need to find out from the medical staff office.

During a concurrent interview and record review with the ADON on 5/28/25 at 9:04 a.m., the hospital policy and procedures (P&P) titled "Registered Nurse First Assistant (RNFA) Standardized Procedure" with an approval date 4/24/19 was reviewed. The P&P indicated " ... To outline the nursing responsibilities for Registered Nurse First Assistants (RNFA) ... The RNFA must adhere to the policies and procedures of the surgical facility and must remain within the scope of practice as stated by the Nurse Practice Act of the State of California ... Saphenous Vein Harvesting: Open Heart ... Dissection ... Clamps tributaries ...Leaves pedicle or "neck" ... Ties without causing adventitial constriction of vein lumen ... Clip tributaries on leg side close to leg to avoid impinging on vein .... Cannulation with dilation ... Endoscopic ... Utilizes optical vessel dissector ... Utilizes bipolar cautery to dissect braches ... Utilizes retractor ... Ligates vein .... [Hospital Name] RN's currently approved to function as RNFA's under standardized procedure will be maintained by the Operating Room and on [hospital application name], the hospital intranet, which will be maintained by the Medical Staff Office. See attached list for competent operating room RNFA's ... The initial evaluation of their competency to perform the outlined functions will be performed by the sponsoring physician at the time of their training ... The standardized procedure will be reviewed annually ...." The ADON stated this is the only standardized procedure and policy they have currently that allows RNFA to do EVH, however, policy had not been reviewed for over four years since 4/24/21. The ADON validated this policy from 2019 is what OR staff and other hospital staff would see active to verify and validate RNFA performing EVH in CABG cases. The ADON stated RNFA standardized procedure policy supposed to be reviewed annually as listed in the P&P and should have been current. The ADON stated more than half of the staff members that are listed as competent are no longer working at the hospital as RNFA. The ADON stated he had been functioning as RNFA himself in surgeries before 2019 and his name was not even on that policy. The ADON stated the policy had been in review for two years and he was unable to comment why it was not completed.


During an interview on 5/28/25 at 10:38 a.m. with the RN 7, RN 7 stated she was the charge RN for heart surgeries in operating room. RN 7 stated residents works directly with the surgeon and surgeons were in charge of the resident. RN 7 stated staff in the surgery does not have access to check or review of the program requirements for residents (specific surgical procedures and conditions authorized to manage and perform at the hospital and supervision requirements). RN 7 stated as far as she was aware staff in operating room have nothing to do with residents and rely on the surgeon to supervise. RN 7 stated that surgeon was responsible to supervise and ensure that residents were doing what they were permitted to do at the hospital. RN 7 stated that RNFA privileges were not listed anywhere as well. RN 7 stated that RNFA's go to training and management tell them if they were ok to be in surgery and able to perform EVH or other procedures. RN 7 stated the hospital only had couple of RNFA's that assist with Cardiac surgeries and they have been assisting for more than five years. RN 7 staff know them well and if they encounter someone new then they would inquire with the management team to ensure that they were okay to be in the room.


During a concurrent interview and record review with the ADON on 5/28/25 at 3:20 p.m. with the Manager of Medical Staff office (MMS), the hospital policy and procedures (P&P) titled "Registered Nurse First Assistant (RNFA) Standardized Procedure" with an approval date 4/24/19 was reviewed. The P&P indicated " ... .... [Hospital Name] RN's currently approved to function as RNFA's under standardized procedure will be maintained by the Operating Room and on [hospital application name], the hospital intranet, which will be maintained by the Medical Staff Office. See attached list for competent operating room RNFA's ...". MMS stated she was not aware of this policy and Medical Staff office have nothing to do with RNFA. MMS stated currently medical staff office does not list RNFA's in their software as outline in the policy, have no oversite of the RNFA and were not involved in the process of ensuring competency, compliance or evaluation processes for RNFA. MMS stated the hospital leadership was working on identifying the person in charge of residency program and the new residents go through human resources. MMS validated that currently program requirements for residents were not listed their software for operating room staff to check and validate.


During an interview on 5/29/25 at 8:45 a.m. with MA 1, MA 1 stated she was still unable to find the person in charge of residency program at the hospital. A request was made again to provide information on the person in-charge of the residency program, requested MA 1 to provide information on last time someone from sponsoring institution attended the hospital Medical Staff meeting or if the hospital had any meeting minutes that reflects attendance as required by Medial Staff Bylaws. Training protocols approved by DMC Med staff or any record of trainee evaluations for cardiac surgery residents as required by the hospital Medial Staff Bylaws was also requested and not provided.

During a concurrent interview and record review on 5/29/25 at 3:30 p.m. with RN 5 and ADON, Pt 2's EMR was reviewed. RN 5 stated she was in the OR for Pt 2's surgery and was responsible for documenting the times staff were entering and exiting the OR during the surgery. RN 5 stated she does not recall Pt 2 specifics, but she always documented exact times. RN 5 reviewed the EMR and Pt 2's "OR Intraoperative record" and stated that Pt 2's record reflects that RS 2 was in the room from 7:45 a.m. to 8:15 a.m., surgery start time was 8:13 a.m. RN 5 validated that EMR reflects she was the one that documented times for RS 2. RN 5 stated that she was unable to comment on cardiovascular surgery staffing requirements, however, she was not aware that second surgeon [first assistant] had to be in the operating room at all times. RN 5 stated that as long as someone [another surgeon] was available she thought it was okay to proceed with the surgical procedure. RN 5 stated currently she was not aware of any way for staff to look up and check program requirements for any residents in the OR. RN 5 stated that program requirements for residents are not listed in the hospital system like surgeons. RN 5 stated currently staff were not checking what residents were allowed to do and does not verify any privileges or credentials while they were operating. RN 5 stated RNFA follows Association of Peri-Operative Registered Nurses (AORN) standards and she believes she can look up AORN standards. RN 5 stated the she was not aware if the hospital had any list of RNFAs that were deemed competent and management usually tells them what they are competent to do. RN 5 stated she does not have a way to validate their [RNFA] privileges, competency or what the RNFA were able to perform during CABG.

During a concurrent interview and record review on 5/29/25 at 3:53 p.m. with the ADON, document titled "THE RN AS FIRST ASSISTANT TO THE SURGEON" retrieved from California Board of Registered Nursing (BRN) from https://www.rn.ca.gov/pdfs/regulations/npr-b-18.pdf, indicated " ... The role of RN first assistant to the surgeon requires the performance of a combination of nursing and medical functions ... In order to perform those functions considered to be first assistant to the surgeon, the RN must adhere to standardized procedures ... STANDARDIZED PROCEDURES FOR MEDICAL FUNCTIONS ... The means designated to authorize performance of a medical function by a registered nurse is a standardized procedure developed through collaboration among registered nurses, physicians and administrator in either a licensed health facility or an organized health care system which is a licensed health facility where the standardized procedures are to be used ... GUIDELINES FOR DEVELOPING STANDARDIZED PROCEDURES ... must be developed according to the following guidelines which were jointly promulgated by the Board of Registered Nursing and the Medical Board of California. (Board of Registered Nursing, Title 16, California Code of Regulations (CCR) Section 1474; Medical Board of California, Title 16 CCR Section 1379.) ... Standardized procedures shall include a written description of the method used in developing and approving them and any revision there of ... Each standardized procedure shall ... Be in writing, dated and signed by the organized health care system personnel authorized to approve it ... Specify which standardized procedure functions registered nurses may perform and under what circumstances ... NPR-B-18 THE RN AS FIRST ASSISTANT TO THE SURGEON REV 05/1998, 06/16/2011 2 ... State any specific requirements which are to be followed by registered nurses in performing particular standardized procedure functions ... Specify any experience, training and/or education requirements for performance of standardized procedure functions ... Establish a method for initial and continuing evaluation of the competence of those registered nurses authorized to perform standardized procedure functions ... Provide for a method of maintaining a written record of those persons authorized to perform standardized procedure functions ... Specify the scope of supervision required for performance of standardized procedure functions, for example, telephone contact with the physician ... Set forth any specialized circumstances under which the registered nurse is to immediately communicate with a patient's physician concerning the patient's condition ... State the limitations on settings, if any, in which standardized procedure functions may be performed ... Specify patient record-keeping requirements ... Provide for a method of periodic review of the standardized procedures ..." The ADON stated he was aware of the BRN statement on the role of the RNFA and the hospital policy was developed to meet the requirements. The ADON stated he also understood that the hospital needs to have standardized procedures, and staff need to be able to have method of checking and validating RNFA's ability to perform EVH or other part of surgical procedure. The ADON stated currently the standardized procedure policy needed to be reviewed and updated to meet the BRN requirements. The ADON stated he still was not able to comment on the RS and was waiting to hear from leadership. The ADON stated the human resource department or medical staff was responsible for resident's requirements.

During an interview on 5/30/25 at 4:35 p.m. with the CNO, the CNO stated no one at this time can speak about the residency program. The CNO stated that they have identified the person in-charge of the residency program, however, they are waiting on confirmation from leadership team. The CNO also stated the hospital does not currently have any evaluation for surgery residents to provide and it was being conducted by "Hospital B", sponsoring hospital for the residents. The CNO stated she was unable to comment on the training protocol or provide any information on designee from the sponsoring institution that communicates or attends Medical Executive Committee [group of physicians and other key medical staff within a hospital or healthcare organization responsible for making decisions related to patient care, clinical policies, and physician performance] meeting.

During a concurrent interview and record review on 5/30/25 with the DSS & MA 1, OR case logs [systematic record of individual patient cases] for month of March 2025, April 2025 and May 2025 were reviewed for the cardiovascular surgeries. The review of OR case logs for the whole month of March 2025 indicated total of 22 open heart surgeries were done, and out of 22 cases 15 cases had resident surgeon as first assistant (second surgeon), two cases did not have any second surgeon that was a physician or resident. Out of 22 cases in March 2025 , five cases did have second surgeon that was independent and qualified surgeon, however, three of those cases second surgeon was only in the room for less than 10 minutes. A review of April 2025 case log for cardiac surgeries indicated a total of 28 open heart surgeries were done at the hospital. Out of the 28 cases, 17 cases had a resident as first assistant (second surgeon), and two cases did not have any second surgeon that was a physician or resident. Out of 28 cases, nine cases did have second independent and qualified surgeon, however, six out of eight cases, that surgeon was in the room for ten or less minutes. The DSS and MA 1 both stated that this reported data was accurate and DQ validated it by countin manually. The DSS stated the hospital team did not have a good understanding of the approved program flex and were not compliant with the conditions of approved program flex and requirement for cardiac surgery staffing under CCR. The DSS stated he now understands the CCR requirement and approved program flex. The DSS stated effective 5/23/25 changes have been put in place to ensure second independent and qualified surgeon would be present during all open -heart surgeries. The DSS stated going forward the second surgeon would be scheduled, and the OR team would be able to validate and confirm presence of independent and qualified second surgeon [first assistant] prior to patient's surgery. The DSS stated he still will be working with the division chief for expectations for residents. The DSS stated he will also be working with medical staff and hospital leadership to figure out the best way to validate what the operating room staff and residents can or cannot do.

During the review of hospital's current "MEDICAL STAFF BY LAWS" indicated, " ... ARTICLE 12: GRADUATE MEDICAL EDUCATION ... 12.1 As [Hospital name] acts as a training site for undergraduate and graduate medical education, the Medical Executive Committee shall receive input from and provide updates for representatives from the Sponsoring Institutions (SI). The Designated Institutional Official of the SI, as well as the Program Director of each residency program shall be invited to attend the Medical Executive Committee Meeting as non-voting members. 12.2 One or more members of the [Hospital name] medical staff leadership, usually the Chief of Staff or the Chief Medical Officer, shall attend the Sponsoring Institution's Graduate Medical Education Committee Meeting as the representative of [Hospital name] as training site ..."

During a review of hospital's current "MEDICAL STAFF RULES AND REGULATIONS" , the "MEDICAL STAFF RULES AND REGULATIONS" indicated " ...PHYSICIAN TRAINEES Physician trainee positions entail the provision of patient care services commensurate with the trainee's level of advancement and competence, as defined in the training program protocols approved by the Medical Executive Committee and Governing Body. The training programs shall maintain a record of trainee evaluations and shall utilize such evaluations for determining the trainee's progression within the training program. The physician trainee categories are as follows ....A Resident Physician enrolled in a residency training program approved by the Medical Executive Committee and the Governing Body may be permitted to provide patient care services at the Hospital pursuant to the conditions stated in these Bylaws, Rules and Regulations, the rules and regulations of the Department(s) to which residents are assigned, and any agreements between the Hospital and the residency training program. Resident Physicians can make medical notations in patient charts, conduct examinations, write or give verbal orders for patient care, perform procedures, under the supervision of their clinical instructor ..."

Based on observation, interview and record review, the hospital failed to ensure that operative reports included description of the significant surgical tasks that were conducted by practitioners other than the primary surgeon when:

Two of two sampled patients, Patient (Pt) 1 and Pt 2 underwent open heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure and Endoscopic Vein Harvesting ( EVH -is a minimally invasive technique used during CABG surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries) part of the procedure was completed by the assistant and their operative report did not describe the EVH portion of the procedure was completed by a practitioner other than the primary surgeon.

This failure had the potential for adverse effects in patient well-being and lack of patient's understanding of risk associated with surgery.

Findings:

During a concurrent observation and interview on 5/22/25 at 8:55 a.m. with the Registered Nurse Quality (QRN) 3 & Assistant Director of Nursing Surgical Services (ADON) in operating room (OR) 15, Patient (Pt) 1 surgical procedure was observed. Pt 1 underwent open heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure with three separate bypass were created during the surgery. The ADON validated and verified the staffing in the room for the entire procedure included primary cardio thoracic surgeon (SUR -a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity) 1, resident surgeon (RS -a physician who has completed medical school and is undergoing supervised training in a specific surgical specialty to become a board-certified surgeon ) 1, Anesthesiologist (ANS - a medical doctor specializing in administering anesthesia and managing pain during medical procedures and surgeries)1, Perfusionist (PER - healthcare professional who operates the heart-lung machine during certain surgeries, like open heart surgery, to maintain the patient's blood flow and oxygenation while the heart is stopped) 1, Registered Nurse First Assist (RNFA -is a registered nurse (RN) who works in an expanded role as a surgical first assistant and are responsible for working with the surgical team, in surgery, at the direction of the surgeon)1, two RNs working as scrub nurses (works within the sterile field, directly assisting the surgeon with instruments and supplies during the procedure) and circulating nurse (nurse works outside the sterile field, managing patient care, coordinating with the surgical team, and ensuring a safe environment). RNFA 1 was observed to perform EVH part of the procedure. The ADON stated it was normal for RNFA 1 to do EVH during CABG surgeries. The ADON stated RNFA 1 has been doing EVH part of CABG surgeries for many years and the hospital has a standardized procedure to ensure compliance as required for RNFA to perform EVH during CABG procedures. The ADON stated the RNFAs do not document the EVH procedure and it was documented by the surgeons in their notes.

During a concurrent interview and record review on 5/30/25 at 10:25 a.m. with the Manager of Accreditation and Regulatory (MA) 2, Pt 1's "Operative note" for surgery on date 5/22/25 by cardiac thoracic surgeon (SUR) 1 was reviewed. The review of the "Operative note" for surgery on 5/22/25 indicated " ... NAME OF OPERATION: Coronary artery bypass graft x 3, left internal mammary to left anterior descending artery [A blood vessel from the chest was used to bypass the blocked artery supplying the heart's front wall], saphenous vein graft ...[ veins from the leg (saphenous veins) were used as bypass grafts] ... Endoscopic venous harvesting [The veins used for the bypass grafts were taken from the legs using a minimally invasive technique with a small camera and tools] ... " The MA validated the operative report does not state specific significant surgical tasks that were conducted by practitioners other than the primary surgeon. The MA stated that the operative note does mention EVH was done but does not state it was completed by RNFA 1. The MA 2 stated she was unable to comment on the expectations or requirements for operative report and would have to defer to surgery director for any comments.

During an interview on 5/29/20 at 3:50 p.m. with the ADON, the ADON stated he had the chance to review Pt 1 and Pt 2's operative reports and reports of other cardiac surgery patients. The ADON stated none of the patients' operative notes specifically indicate that EVH was completed by RNFA. The ADON stated all of the operative reports have RNFA listed as assistant to the surgeon. The ADON also stated that the technique of EVH was mentioned in the report, however, it does not specifically state that it was completed by RNFA or any specific part of the surgical procedure was completed by the assistants to the surgeons rather than primary surgeon. The ADON stated he was not aware of any requirements for documentation for the assisting surgeon.

During a concurrent interview and record review on 6/2/25 at 10:34 a.m. with the Director of Surgical Services (DSS) state operations manual [outlines the specific requirements hospitals must meet to be eligible for Medicare and Medicaid reimbursement], "Appendix A - Survey Protocol, Regulations and Interpretive guidelines for hospital" with an issue date of 4/19/24 was reviewed. The surgical services condition of participation A-0959 was reviewed. The DSS stated he has reviewed the operative report for Pt 1 and Pt 2 and agreed that their operative report does not indicate significant surgical tasks were completed by practitioners other than primary surgeon. The DSS stated although surgical report lists the details of procedures, it does not specifically state which part was done by the assistant. The DSS stated he will inform the chief of surgery about the requirements for operative reports. The DSS stated as far he was aware currently none of the cardiac surgery operative notes indicate that EVH was done by RNFA and agreed that EVH is a significant part of the CABG surgery.

Based on interview and record review, the Medical Director of Respiratory care failed to ensure procedures performed by Respiratory Therapists (RT) and the amount of supervision required to carry out the procedures by RTs were designated in writing involving three of three Respiratory Therapists (RT 1, RT 2 and RT 3). RT 1 and RT 2 were permitted to perform Arterial line placement and RT 1 and RT 3 were permitted to perform intubation on patients without written policies and procedures and without written policies specifying how the procedures would be supervised. The Medical Director of Respiratory Services was aware of this practice and did not submit to the Medical Staff proposed policies and procedures for approval specifying the qualifications, training, experience and supervision requirements of RTs to perform A-lines and intubation on patients.

These failures had the potential for increased risk of complications in patients with insertion of A-line and intubation performed by RT.

Findings:

During an interview on 5/29/25 at 10:59 a.m. with the Manager for Respiratory Therapy (MRT), the MRT stated the respiratory therapist (RT) at the hospital insert Arterial lines in the Intensive Care Unit (ICU - specialized hospital unit for patients with life-threatening conditions that need specialized medical care and interventions) routinely. MRT stated they have a module (a structured, self-contained unit of instruction designed to help learners acquire specific competencies or skills) for A-line insertion procedure training for RTs. MRT stated RTs were required to complete the module, perform three supervised A-line insertion procedures initially and then have to insert one A-line yearly to remain competent in performing the procedure. MRT stated staff can sign each other off on performing the A-line insertion procedure. MRT stated the hospital does not have a policy or criteria that has been reviewed and approved by medical staff on the requirements for supervision, training and competency on the procedure of inserting A-line. MRT stated his medical director (DR 5) for respiratory therapy was aware of the requirements, sign offs required for RT's to insert an A-line and was ok with RT inserting A-lines in ICU. The MRT stated the hospital or the department does not have any formal A-line insertion procedure policy. MRT stated he was not aware of any adverse outcomes or complications in patients when RTs inserted A- lines. MRT stated DR 5 signs off the competency for A-line insertion but does not supervise them performing the procedure and does not evaluate their technique for performing the procedure. MRT stated the hospital use [Brand name] clinical evidence-based references for the procedure and validated that it does not list training, qualification or supervision requirement for the RT performing the procedure.

During an interview on 5/29/25 at 1:52 p.m. with the Director of Critical Care (ICUD), the ICUD stated he was in charge of ICU. ICUD stated that A-line insertion procedure was invasive and had the potential for complications. ICUD stated that he was unable to comment on the process of training and competency requirements of RT. ICUD stated that he expected the hospital to have a policy and procedure for A-line insertion and supervision requirements. ICUD stated he was unable to comment if one A-line insertion per year was sufficient to be competent.

During a phone interview on 5/30/25 at 9:54 a.m. with DR 5, DR 5 stated she was the medical director for RT team. DR 5 stated she was aware that the A-line insertion procedures were being performed by the RT team in ICU. DR 5 stated she was ok with RT performing these procedures. DR 5 stated hospital did not have any policy outlining the procedures and requirements for supervision and training for RTs performing these procedures. DR 5 stated she was made aware earlier by MRT regarding the need for A-line policy. DR 5 stated that hospital needed to work on the policy and add the requirement for more than one A-line insertion performed annually to remain competent. DR 5 stated A-line insertions had the potential to cause complication and she expected only competent RTs to perform the procedure. DR 5 stated she was not aware of any complications in patients from A- line insertion procedure performed by RTs.

During a review of document titled "DIRECTORSHIP AGREEMENT" with an effective date of 10/2/23, the "DIRECTORSHIP AGREEMENT" indicated " ... Director is a physician duly licensed to practice medicine in the State of California ("State") and is qualified in the specialty of Respiratory ("Specialty") ... Director shall perform the Services required hereunder in accordance with: (1) all applicable federal, state, and local laws, rules and regulations; (2) all applicable standards of The Joint Commission and any other relevant accrediting organizations; and (3) all applicable bylaws, rules, regulations, procedures, and policies of Hospital and its medical staff; such bylaws, rules, regulations, procedures, and policies shall include, without limitation, those relating to timely completion of medical records ... DESCRIPTION OF DUTIES AND RESPONSIBILITIES ... At least annually, review and make recommendations as necessary to revise the Unit/Service's policies and procedures ... Assist the appropriate Medical Staff Committee in reviewing and revising Medical Staff Rules and Regulations which pertain to the Unit/Service ... Respiratory Care Department ... Provide medical oversight to technical department personnel in the inpatient, ambulatory care and home care settings ... Oversee medical compliance with department policies ... Oversee monitoring and evaluation of quality, safety and propriety and follow-up services ... Assist the appropriate Medical Staff Committee in reviewing and revising Medical Staff Rules and Regulations which pertain to the
Department ..."

During a concurrent interview and record review with the MRT on 6/2/25 at 12:21 p.m. RT 1 and RT 2's competencies were reviewed. RT 1 and RT 2 both had signed competency for A-line insertion. MRT stated that he had already reached out to DR 5 and would be updating the requirement for supervising the RT for A-line competency, minimum required procedures performed annually. MRT stated the plan is to get the policy formally approved with hospital medical staff as soon as possible. MRT also stated the hospital currently have two RTs (RT 1 and RT 3) performing intubation and the hospital does not have any policy for RTs intubating adult patients. MRT stated they have policy for neonatal intubation and he would be working on intubation policy for adult patients. MRT stated he agreed that a criteria needed to be defined and approved by medical staff for RT performing invasive procedures. MRT stated that although DR 5 was aware and verbally approved the competencies, training and criteria for A-line insertion and intubation, the hospital does not have any formal policy outlining the education, training, criteria, or supervisor requirements for RTs to perform invasive procedures of A-line insertion and intubation.

During a review of statement on the Scope of Practice for respiratory therapist by Respiratory board of California, retrieved on 6/10/25 from https://www.rcb.ca.gov/licensees/scope_of_practice.shtml#:~:text=Can%20respiratory%20care%20practitioners%20place,a%20licensed%20respiratory%20care%20practitioner. The RT Scope of Practice indicated , " ... insertion of arterial lines is within the scope of practice of a licensed respiratory care practitioner. That being said, the onus is on the licensed health facility employing the respiratory care practitioner to develop appropriate training and competencies that would ensure this function is provided in a manner that would be safe when administered to the public ..."

During a review of professional reference titled " Arterial Lines", dated March 23, 2025, retrieved from "https://www.ncbi.nlm.nih.gov/books/NBK499989/", the professional reference indicated, " ... The incidence of complications in arterial catheterization among adult patients typically falls within 10% to 13%, with variations depending on the placement site ... Clinical Significance ... Arterial line placement and monitoring represent widely accepted standards of care for patients who are critically ill .... Despite these advantages, arterial catheterization has risks, including potential complications such as catheter-related infections and a chance of distal blood flow compromise. Moreover, the landscape of hemodynamic monitoring has evolved, introducing alternative techniques that have led to a decreased frequency of arterial catheterization. Consequently, the routine placement of arterial catheters in managing critically ill pediatric patients should be approached with caution and not considered standard practice ..."

During a review of professional reference titled "Tracheal intubation in the ICU: Life saving or life threatening?", dated 2011, retrieved from "https://pmc.ncbi.nlm.nih.gov/articles/PMC3237146/", the professional reference indicated " ... Tracheal intubation (TI) is a routine procedure in the intensive care unit (ICU), and is often life saving. However, life-threatening complications occur in a significant proportion of procedures, making TI perhaps one the most common but underappreciated airway emergencies in the ICU ... TI can be an acute airway emergency in itself. Unstable haemodynamics and failing oxygenation during emergency intubations can be life-threatening. Delaying securing airway or awaking the patient is not an option in case of difficulty in the ICU. Intubation failure or predicted difficulty should lead to alternatives such as NIPPV
or tracheostomy. TI performed or supervised by experienced doctors is associated with fewer complications. Familiarity with rescue airway techniques is helpful. Developing standardized evidence-based protocols is the need of the hour for airway management in the ICU environment. Hence, implementation of an intubation care bundle along with a pre-planned approach to difficult airway is essential for safe TI in the ICU ..."

Based on interviews and record review, the hospital failed to ensure procedures performed by Respiratory Therapists (RT) and the amount of supervision required to carry out the procedures by RTs were designated in writing involving three of three Respiratory Therapists (RT 1, RT 2 and RT 3). RT 1 and RT 2 were permitted to perform Arterial line placement and RT 1 and RT 3 were permitted to perform intrubaiton on patients without written policies and procedures and without written policies specifiying how the procedures would be supervised. The Medical Director of Respiratory Services was aware of this practice and did not submit to the Medical Staff proposed policies and procedures for approval specifying the qualifications, training, experience and supervision requirements of RTs to perform A-lines and intubation on patients.

RTs performing A-lines and intubations on patients. performed by Respiratory Therapists have written policies that specified qualifications, training, experience and supervision requirements for three of three Respiratory Therapists (RT 1, RT 2, and RT 3) when RT1 and RT 2 were allowed to perform Arterial line (A-line- thin, flexible tube (catheter) that is inserted into an artery and used to continuously monitor blood pressure and take blood samples) insertion procedure and RT 1 and RT 3 were allowed to perform intubation (medical procedure where a breathing tube, called an endotracheal tube, is inserted into the windpipe (trachea) to help a person breathe when they are unable to do so on their own or when it's necessary to deliver oxygen and/or medication ).

These failures had the potential for increased risk of complications in patients with insertion of A-line and intubation performed by RT.

Findings:

During an interview on 5/29/25 at 10:59 a.m. with the Manager for Respiratory Therapy (MRT), the MRT stated the respiratory therapist (RT) at the hospital insert Arterial lines in the Intensive Care Unit (ICU - specialized hospital unit for patients with life-threatening conditions that need specialized medical care and interventions) routinely. MRT stated they have a module (a structured, self-contained unit of instruction designed to help learners acquire specific competencies or skills) for A-line insertion procedure training for RTs. MRT stated RTs were required to complete the module, perform three supervised A-line insertion procedures initially and then have to insert one A-line yearly to remain competent in performing the procedure. MRT stated staff can sign each other off on performing the A-line insertion procedure. MRT stated the hospital does not have a policy or criteria that has been reviewed and approved by medical staff on the requirements for supervision, training and competency on the procedure of inserting A-line. MRT stated his medical director (DR 5) for respiratory therapy was aware of the requirements, sign offs required for RT's to insert an A-line and was ok with RT inserting A-lines in ICU. The MRT stated the hospital or the department does not have any formal A-line insertion procedure policy. MRT stated he was not aware of any adverse outcomes or complications in patients when RTs inserted A- lines. MRT stated DR 5 signs off the competency for A-line insertion but does not supervise them performing the procedure and does not evaluate their technique for performing the procedure. MRT stated the hospital use [Brand name] clinical evidence based references for the procedure and validated that it does not list training, qualification or supervision requirement for the RT performing the procedure.

During an interview on 5/29/25 at 1:52 p.m. with the Director of Critical Care (ICUD), the ICUD stated he was in charge of ICU. ICUD stated that A-line insertion procedure was invasive and had the potential for complications. ICUD stated that he was unable to comment on the process of training and competency requirements of RT. ICUD stated that he expected the hospital to have a policy and procedure for A-line insertion and supervision requirements. ICUD stated he was unable to comment if one A-line insertion per year was sufficient to be competent.

During a phone interview on 5/30/25 at 9:54 a.m. with DR 5, DR 5 stated she was the medical director for RT team. DR 5 stated she was aware that the A-line insertion procedures were being performed by the RT team in ICU. DR 5 stated she was ok with RT performing these procedures. DR 5 stated hospital did not have any policy outlining the procedures and requirements for supervision and training for RTs performing these procedures. DR 5 stated she was made aware earlier by MRT regarding the need for A-line policy. DR 5 stated that hospital needed to work on the policy and add the requirement for more than one A-line insertion performed annually to remain competent. DR 5 stated A-line insertions had the potential to cause complication and she expected only competent RTs to perform the procedure. DR 5 stated she was not aware of any complications in patients from A- line insertion procedure performed by RTs.

During a concurrent interview and record review with the MRT on 6/2/25 at 12:21 p.m. RT 1 and RT 2's competencies were reviewed. RT 1 and RT 2 both had signed competency for A-line insertion. MRT stated that he had already reached out to DR 5 and would be updating the requirement for supervising the RT for A-line competency, minimum required procedures performed annually. MRT stated the plan is to get the policy formally approved with hospital medical staff as soon as possible. MRT also stated the hospital currently have two RTs (RT 1 and RT 3) performing intubation and the hospital does not have any policy for RTs intubating adult patients. MRT stated they have policy for neonatal intubation and he would be working on intubation policy for adult patients. MRT stated he agreed that a criteria needed to be defined and approved by medical staff for RT performing invasive procedures. MRT stated that although DR 5 was aware and verbally approved the competencies, training and criteria for A-line insertion and intubation, the hospital does not have any formal policy outlining the education, training, criteria, or supervisor requirements for RTs to perform invasive procedures of A-line insertion and intubation.

During a review of statement on the Scope of Practice for respiratory therapist by Respiratory board of California, retrieved on 6/10/25 from https://www.rcb.ca.gov/licensees/scope_of_practice.shtml#:~:text=Can%20respiratory%20care%20practitioners%20place,a%20licensed%20respiratory%20care%20practitioner. The RT Scope of Practice indicated , " ... insertion of arterial lines is within the scope of practice of a licensed respiratory care practitioner. That being said, the onus is on the licensed health facility employing the respiratory care practitioner to develop appropriate training and competencies that would ensure this function is provided in a manner that would be safe when administered to the public ..."

During a review of professional reference titled " Arterial Lines", dated March 23, 2025, retrieved from https://www.ncbi.nlm.nih.gov/books/NBK499989/, the professional reference indicated, " ... The incidence of complications in arterial catheterization among adult patients typically falls within 10% to 13%, with variations depending on the placement site ... Clinical Significance ... Arterial line placement and monitoring represent widely accepted standards of care for patients who are critically ill .... Despite these advantages, arterial catheterization has risks, including potential complications such as catheter-related infections and a chance of distal blood flow compromise. Moreover, the landscape of hemodynamic monitoring has evolved, introducing alternative techniques that have led to a decreased frequency of arterial catheterization. Consequently, the routine placement of arterial catheters in managing critically ill pediatric patients should be approached with caution and not considered standard practice ..."