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Based on observation, review of hospital documents, review of personnel records, and staff interviews, the hospital failed to comply with state regulations related to the oversight of food service operations when the requirements were not met as specified in:

1. Title 22, Division 5, Chapter 1, 70275 (b), in regard to the person responsible for the day-to-day food service operation, and State and Health and Safety Code 1265.4 statue (the Manager of Nutrition Resources, responsible for the day-to-day food service operation, was not qualified); and
2. Title 22, Section 70275(a), in regard to the person responsible for oversight of the overall food service operation (the facility did not have a Registered Dietitian to provide guidance to the food service operations manager and staff of the dietetic service at a sufficient duration and frequency.)

This failure placed patients at risk for food borne illness (illness caused by food contaminated with bacteria, viruses, parasites, or toxins) due to lack of oversight of the food service operation by qualified staff for a facility census of 52.

Findings:

During the survey from 12/7/20 to 12/23/20, observations, interviews, and document reviews indicated multiple concerns related to food safety and sanitation operations including: all foodservice refrigerators in the facility were monitored for appropriate temperatures by maintenance staff who were not trained on proper refrigerator temperatures to ensure foods were held at 41 degrees Fahrenheit (F) or below, rather had the monitoring range set up to 46 degrees F; patient food stored inside a refrigerator was above safe holding temperatures, ice machines were not clean, poultry was not thawed safely, a sink used for hand washing did not have hot water, food was not labeled and dated appropriately to show an appropriate use-by date, cooking equipment was not in good condition, staff personal belongings were not stored appropriately, drains were not clean, equipment did not have appropriate air-gaps, one freezer had a significant amount of ice build-up, and there was not a disaster plan to address the needs of patients prescribed mechanically altered diets (cross-reference A620, A724, and A749).

1. 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) states that, "if a dietitian is not employed full-time, a full-time person who has completed a supervisor's training program meeting the requirements of Essentials of an Acceptable Program of Dietetic Assistant Education, revised, June 1974, by the American Dietetic Association, 430 North Michigan Avenue, Chicago, IL 60611, shall be employed to be responsible for the operation of the food service. This program or its equivalent shall be required on and after July 1. 1977 " .

Documents provided by the facility as qualifications for the Manager of Nutrition Resources (MNR) were reviewed. The undated resume for MNR indicated he worked toward, but did not complete, a degree that was not related to nutrition or food service, and he had several years of experience in the food service industry. However, the documents did not show that MNR was qualified for his position in accordance with the Health and Safety Code 1265.4 (b) " The dietetic services supervisor shall have completed at least one of the following educational requirements:
(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.

Review of the position description titled "Nutrition Resource Manager showed the Manager of Nutrition Resources (MNR) was responsible for managing the day-to-day operation of food service as well as directing the food service operations. This document was signed and dated by MNR on 8/28/17 and read "Position summary: Plans, organizes, directs, coordinates, evaluates, daily and fiscal Nutrition Resources Department operations ..." The position description did not spell out qualifications as outlined in the California Code of Regulations, Title 22, Division 5, Chapter 1 or the Health and Safety Code 1265.4, for the person responsible for the operation of the food service. It also failed to fully reflect the regulatory qualifications for the position; rather it noted the required educational/certifications were a preference rather than a requirement. For example, it showed there was a "preference" of a Certified Dietary Manager (CDM, a Certified Food Protection Professional who has the education, training, and experience to competently perform the responsibilities of a dietary manager and has proven this by passing the nationally-recognized CDM Credentialing Exam and fulfilling the requirements needed to maintain certified status.)

On 12//7/20 during the initial tour of the kitchen that started at 2:45 p.m., MNR stated he was not a CDM. He said he was formerly a supervisor and was promoted to the manager position.

In an interview on 12/10/20 at 2:44 p.m., the Clinical Director of NR [Nutrition Resources] (DNS), who was a Registered Dietitian, stated she did not know the qualifications MNR had to qualify him for the position responsible for overseeing the day-to-day foodservice operation. She stated she was not responsible for the day-to-day management of the food service department. She indicated that most of her time was spent on clinical nutrition (management of patients in relation to analyzing a person's diet and making recommendations for optimal nutritional health) and 10 percent of her time in the kitchen. The DNS stated she did quarterly audits of the kitchen as part of her oversight but the she only provided documentation showing she did a sanitation review audit 1 day for an entire year look back (Cross-reference A-023,b)

Review of the position description titled "Clinical Director of NR [Nutrition Resources]" signed and dated by DNS on 11/4/20, showed DNS "Plans, organizes directs, coordinates, evaluates, daily the clinical Nutrition Resources Department operations. These areas include patient meal service, patient medical nutrition therapy. Also oversees Nutrition Aides, patient menu planning, menu development, and patient meals. Works in collaboration with kitchen managers. The Clinical Nutrition Resource Director participates in patient care by performing and charting nutritional assessments, diet recommendations and diet education. Discusses recommendations for medical nutrition therapy (MNT) with physicians, direct and allied patient care staff, patients and families. Relays special food requests to kitchen staff. Develops and conducts nutrition in-services to Nutrition Resource staff. Functions as preceptor to dietetic students and interns. Participates in hospital and department performance improvement studies. Attends professional meetings and conferences to maintain competency in current professional practice and trends."

While the DNS was responsible for some foodservice related activities such as supervision of the Nutrition Aides as well as menu planning and development the primary position duties were for the provision of patient medical nutrition therapy rather than the entire departmental operation, including foodservice, therefore be classified as less than full-time to Dietetic services.

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.

Review of the position description titled "Clinical Director of NR [Nutrition Resources]" showed DNS was under direct supervision of the Chief Operating officer and works in collaboration with kitchen managers. The position description did not outline all of the areas that the DNS was responsible for under Title 22.such as guidance to the supervisor and the staff of the dietetic service.

Review of the position description for MNR, titled "Nutrition Resource Manager" dated and signed by MNR on 8/28/17, showed he reported directly to the Chief operating officer. The position description did not indicate this position received guidance from a Registered Dietitian.

In an interview on 12/10/20 at 2:44 p.m., the DNS stated 10 percent of her overall time was dedicated to the kitchen and 90 percent was dedicated to clinical work. She stated before the pandemic she did audits of the kitchen on approximately a quarterly basis. She also stated she did not always do the quarterly kitchen audits herself. Instead she sent her interns (a student or trainee who works at a trade or occupation in order to gain work experience) into the kitchen to do the audits and she was not there to supervise if any potential issues were present. In addition, she said the results from last kitchen audits were done by the interns on November 19 and 20, 2020 and she did not review the results because she was too busy with clinical work. DNS had documentation for one foodservice audit review, dated 10/30/20, for a one year look back period. The DNS said this was all the documentation she had regarding monitoring the overall food service operation.

Review of resumes of the two interns (Intern 1 and Intern 2) who conducted the kitchen sanitation reviews did not show they were Registered Dietitians (RD) to be qualified to take over the duties of an RD.

Based on observation, interview, clinical record, and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. The hospital did not have an active and effective quality assurance and performance improvement (QAPI) program that analyzed data and used the data and analyses for the reduction of risk of medical errors; did not implement previously improvement actions and did not select QAPI projects for two clinical departments. (Refer to A 273 and A286)

2. The hospital did not have an effective system to protect and promote patient right's in all departments of the hospital. (refer to A144, A395 findings for Patients 18 and 34 and A466 and A808)

3. The hospital did not have an effective Medical Records Service to ensure properly executed consents and to include patient and patients' representatives were involved in discharge planning of care. (Refer to A466 and A808).

4. The hospital did not have an effective pharmaceutical services that met the needs of patients, did not have facility practices to reduce the risk of medication error and the Pharmacy Director did not have effective oversight of training and competency of staff to administer compounded drugs to patients. (refer to A491, A492, A501, A502, A505, A507)

5. The hospital did not have a Food and Dietetics Services overseen by a qualified professional and did not have an effective system to ensure safe food storage and production. (refer to A023, A749, A724 finding 5, A620).

6. The hospital did not have an effective Nursing Service to ensure accurate fall risk assessments were completed and safe care was implemented in the Emergency Department; House Supervisors were provided the training to perform their jobs competently; and nursing staff followed hospital policies and procedures to administer medications safely in all patient care areas of the hosptial. (refer to A395, A397 and A405).

7. The hospital did not have an effective Infection Control Program that ensured autoclaves and the Sterile Processing Department processed surgical instruments to the quality standards per nationally recognized standards; and did not store clean endoscopes according to nationally recognized standards; and did not track and monitor infection control practices throughout the hospital to reduce the risk of disease transmission. (refer to A749 and A750)

An Immediate Jeopardy situation was identified in the area of Infection Control for A750 42 CFR 482.42(a)(3):
Because of the serious potential harm to all surgical patients related to the inability of the hospital to ensure surgical instruments were processed according to the standards as written in Association for the Advancement of Medical Instrumentation (AAMI-an organization for advancing the development, and safe and effective use for medical technology) and AORN and the inability of the hospital to ensure endoscopes were processed and stored in a sanitary manner according to SGNA an Immediate Jeopardy (IJ) situation was called with the Chief Nursing Officer (CNO) and the Director of Quality Management Risk (DQMR) on 12/8/20 at 6:55 p.m. under A750 CFR 482.42(a)(3). The CNO and the DQMR was provided the IJ template which documented the immediate actions necessary to address the IJ situation. The CNO was provided an explanation to submit an acceptable Action Plan to address the IJ situation. Version 6.5 of the Action Plan was acceptable on 12/22/20. The following items were listed on the Action Plan and validated by the survey team: Immediately stop all surgeries utilizing surgical instruments from trays processed with the hospital autoclave. All SPD, Maintenance and OR staff completed competency of determine the steps necessary in order to utilize the autoclave without the identified black residue or obtain an autoclave that will process surgical instruments appropriately. Corrected the instrument tray to be able to be submerged prior to the autoclave process by installing appropriate size sink. In-service all SPD and OR staff to monitor surgical trays to determine if the processing of surgical instruments followed established hospital polices and standards of practice. Store scope cabinet and endoscopes in a clean area per SGNA standards. Transported and processed of endoscopes were to follow SGNA standards by using dedicated clean containers. Inservice of All OR staff to conform to SGNA standards. Provided a separate sink to be used for hand hygiene in the endoscopy storage room. Provided an eye-wash station on the same level as the endoscope cleaning room. The hospital submitted a Program Flex to suspend Surgical and Anesthesia Services to CDPH on 12/22/2020. Until the hospital's autoclaves are completely repaired and approved for use by the CDPH. Items of the Action Plan were validated through observations, interview, and record review and the IJ was removed with the CEO, the CNO, the DQMR and the DPOS in on 12/22/20 at 6:23 p.m.

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

Based on interview and record review, the facility failed to inform the governing body about two contracted services. This deficient practice resulted in the governing body being unable to evaluate whether the contracted services were provided in a safe and effective manner to patients.

Findings:

During a review of the facility's contracts list, undated, the contracts list included the ambulance contract but did not include the medical gas contract.

During a review of the facility's Quality Improvement Committee meeting minutes for 5/12/20, the contract evaluation review did not include the ambulance contract or medical gas contract.

During a review of the facility's Board of Trustees meeting minutes for 7/15/20, the annual contract review did not include the ambulance contract or medical gas contract.

During a review of the facility's ambulance contract, effective 5/1/2007, indicated automatic renewals for one year terms. During a review of the facility's medical gas contract, dated 4/2/2007, indicated automatic renewals for one year terms.

During an interview on 12/14/20 at 10:23 a.m. with the Executive Assistant to CEO (EA), the EA stated individual department directors are responsible for forwarding all contracts to the administration and for filling out annual contract evaluations. The EA stated completed contract evaluations are submitted to the Quality Improvement Committee for review and then to the Board of Trustees.

During an interview on 12/14/20 at 11:23 a.m. with the EA, the EA stated there was no contract evaluation for the ambulance contract in 2020. The EA stated the ambulance contract is a current contract.

During an interview on 12/14/20 at 12:29 p.m. with the EA, the EA stated the facility has a medical gas contract. The EA stated facility staff was instructed to add the medical gas contract to the contracts list and start evaluating the contract.

During an interview on 12/14/20 at 12:45 p.m. with the EA, the EA stated the medical gas contract was not on the facility's contracts list and the maintenance department was in charge of that contract.

During an interview on 12/16/20 at 11:53 a.m. with the Director of Plant Operations (DPOS), the DPOS stated he was probably the only person aware of the medical gas contract. The DPOS stated the medical gas contract has never been formally evaluated since he started working at the facility in 2015.

During a review of the facility's policy and procedure titled Vendor Contracts Management and Tracking, reviewed 10/19, indicated "... the hospital must maintain a list of all contracted services ..." and "... All departments shall submit contract evaluation document to Quality Improvement Committee (QIC) annually ...".

During a review of the facility's Quality Assessment Performance Improvement Plan FYE 2021, undated, indicated "...Clinical contracted patient care services will be assessed annually by the Quality Improvement Committee ... and recommendations made to the ... Board of Trustees to ensure services meet contractual, patient safety, timeliness and quality requirements ...".

Based on interview and record review, the facility failed to maintain a complete and accurate list of contracted services. This deficient practice resulted in the governing body being unaware of the medical gas contract.

Findings:

During a review of the facility's contracts list, undated, the contracts list did not include the medical gas contract.

During a review of the facility's Quality Improvement Committee meeting minutes for 5/12/20, the contract evaluation review did not include the medical gas contract.

During a review of the facility's Board of Trustees meeting minutes for 7/15/20, the annual contract review did not include the medical gas contract.

During an interview on 12/14/20 at 10:23 a.m. with the Executive Assistant to CEO (EA), the EA stated individual department directors are responsible for forwarding all contracts to the administration.

During an interview on 12/14/20 at 12:29 p.m. with the EA, the EA stated the facility has a medical gas contract. The EA stated facility staff was instructed to add the medical gas contract to the contracts list.

During an interview on 12/14/20 at 12:45 p.m. with the EA, the EA stated the medical gas contract was not on the facility's contracts list and the maintenance department was in charge of that contract.

During an interview on 12/16/20 at 11:53 a.m. with the Director of Plant Operations (DPOS), the DPOS stated he was probably the only person aware of the medical gas contract.

During a review of the facility's medical gas contract, dated 4/2/2007, the contract noted automatic renewals for one year terms.

During a review of the facility's policy and procedure titled Vendor Contracts Management and Tracking, reviewed 10/19, indicated "... the hospital must maintain a list of all contracted services ...".

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

1. The care for two of 52 Patients (Patient 18 and Patient 34) was not provided in a safe setting in the Emergency Department (refer to A144, A395 findings for Patients 18 and 34)

2. The hospital policy and procedure to obtain properly executed consent documents for patients was not followed for for eight of 13 patient charts reviewed (Pt 42, 43, 44, 45, 47, 48, 49, and 51). (refer to A466)

3. Hospital staff did not involve the patient and the patient's representative in discharge planning for care details including instructions on medications, safety protocols to prevent spread of infection following discharge, and failed to use interpretive services for non-English speaking patients for four of 13 patients (Pt 45, 47, 49, and 51). (refer to A808)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe and effective manner in accordance with the statutory-mandated Condition of Participation for Patient Rights.

Based on observation, interview and record review, the hospital failed to ensure patients in the Emergency Department (ED) received care in
a safe setting when:

1. The policy to provide one to one (1:1) continuous observation for patients identified as at risk of suicide and on 5150 hold (involuntary hold for patients who are a danger to themselves and/or others or are gravely disabled); was not implemented for 1 of 2 patients (Patient 18). Security Guard 2 provided continuous observation to Patient 18 from outside the room with the door closed, rather than as indicated on the policy " ...inside the patient 's room."

2. Patient 34 was not accurately assessed for fall risk and the need for 1:1 or 1:2 continuous observation.

These failures placed Patient 18 at increased risk for self harm and resulted in Patient 34 sustaining an unwitnessed fall.

Findings:
1. During a concurrent observation and interview on 12/7/20, at 3:30 p.m., with the Director of Emergency Services (DES), in the Emergency Department (ED), a Security Guard (SG) 2 stood outside of the closed door to room 114. The top section of the door was glass. The DES stated the patient (Pt) in room 114 (Pt 18) was there on a 5150 hold because of a suicide attempt and SG2 was assigned to provide 1:1 observation. The DES stated SG2 was not inside Pt 18 ' s room as is the hospital policy because SG2 had not been fit tested for an N95 mask (a face piece respirator used to filter airborne droplets) and the results of Pt 18 ' s COVID 19 (respiratory illness caused by the Corona virus that can be transmitted) test are pending. The DES stated the person responsible for the 1:1 observation of a suicidal patient is " supposed to be inside the room " so they are close enough to react and prevent self harm. The DES stated none of the security guards from the contracted security company have been fit tested so they won ' t go into the room of any patient who does not have a confirmed negative COVID 19 lab test result. The DES stated she does not know how many patients at risk for suicide were not provided 1:1 observation in their room due to the lack of fit tested security guards, because this had been a problem for a couple of months now with the increase in patients with positive or unknown COVID 19. The DES stated she had communicated her concerns up the chain of command.

During an interview on 12/8/20 at 4 p.m. with the Director of Plant Operations and Safety Officer (DPOS), the DPOS stated he was the person who was responsible for basic oversight of the contracted security company ' s work for the hospital. The DPOS stated he was aware that none of the guards assigned to the hospital had been fit tested for an N95 mask and that this prevented them from entering the room of any patient whose COVID 19 status was positive or unknown. The DPOS stated the CEO was aware of this and the issue was due to a dispute over who would pay for the security guards to be fit tested. The DPOS stated the CEO had the authority to make the decision, he did not. The CEO was not available for an interview.

During a concurrent interview and medical record review on 12/15/20 at 12:50 p.m., with the DES, Pt 18's "Patient Summary Report" dated 12/6/20 and 12/7/20, was reviewed. The " Patient Summary Report " indicated Pt 18 was brought in by ambulance on 12/6/20 at 4:45 p.m. after Pt 18 attempted suicide. The report indicated Pt 18 was determined to be a danger to self (DTS) and was placed on a 5150 hold. The " Patient Summary Report " indicated Patient 18 remained under a 5150 hold until 12/7/20 at 2:30 p.m. A review of the facility' s policy and procedure (P&P) titled, " 5150 Holds and Behavioral Emergencies " dated 10/20, indicated, " ...Care of patients who are at risk for suicide shall include the following procedures ... Emergency Department ...If patient is identified as a suicide risk place 1:1 observation immediately ...the 1:1 constant observer must be inside the patient' s room ... " A review of the facility' s P&P titled," Patient Rights/Responsibilities " dated 6/20, indicated," ...All patients have the right to the following: Respect and Dignity ...the right to considerate, respectful care given by competent personnel which optimizes the patient's comfort and dignity ...Quality Care Delivery ...the right to receive care in a safe and secure environment
which incorporates current standards of practice for patient environmental safety, infection control, and security ...receive high quality care based on professional standards that are continually maintained and reviewed ... "

2. During a concurrent interview and medical record review, on 12/15/20 at 2 p.m., with the DES, Patient (Pt) 34's " Patient [ED] Summary Report," dated 11/28/20 11/30/20, was reviewed. The " Patient Summary Report " indicated Pt 34 was brought in by ambulance on 11/28/20 at 10:39 a.m. to the ED with a chief complaint of worsening shortness of breath for the past two weeks. The report indicated Pt 34 was 43 years old with a history of congestive heart failure, hypertension, and polysubstance abuse. The " Patient Summary Report " indicated Patient 34 was alert, oriented, and calm upon arrival, and was receiving oxygen via nasal cannula. Pt 34 ' s initial nursing assessment indicated Pt 34 had an elevated blood pressure, heart rate, and respiratory rate, and reported pain all over body. Pt 34 ' s assessment indicated swelling of arms and legs and abdomen. Review of the document " ED Assessment " dated 11/28/20, indicated the ED physician (PHY 12) assessed Pt 34 and ordered lab tests, IV (into a vein) diuretics, medications for elevated blood pressure, and imaging studies. At 4:04 p.m. on11/28/20, PHY 12 indicated Pt 34 was to be admitted to the hospital with a diagnosis of decompensated congestive heart failure. Pt 34 remained in the ED until a bed became available on 11/30/20.

Review of the document " Fall Risk " assessment dated 11/28/20 at 10:53 a.m., indicated Pt 34 ' s Fall Risk score was zero (Low Risk), and had no risk of fall (ROF). Non skid socks were not placed on Pt 34, a ROF sign was not placed on door, and a yellow wrist band was not placed on Pt 34, as required for all patients identified as at risk for fall. The DES stated that assessment was not performed correctly since Pt 34 had multiple diagnoses and was on oxygen at that time. The DES stated even if Pt 34 did have a fall risk score of zero it would still mean she was a Low Risk for fall (not no risk) and required the basic precautions. There were no other documented fall risk assessments on 11/28/20. The DES stated the fall risk assessment should have been done each shift and when the patient ' s condition changed, and it was not. Review of the RN notes section of the " Patient Summary Report " Review of the RN notes section of the " Patient Summary Report ", indicated the following:

11/28/20 at 6:49 p.m. - Pt continuously screaming from room for nurse.
11/28/20 at 7:30 p.m. - Pt off monitor and oxygen and with gown off. Covered with a blanket. Alert and oriented; monitors and oxygen placed back on patient.
11/28/20 at 8:45 p.m. - IV Lasix given.
11/28/20 at 9:16 p.m. - Patient yelling for help. RN 16 entered room; patient was in bathroom sitting on toilet, no gown on, bed sheet had feces on it and there was
garbage on the floor.
11/28/20 at 10:13 p.m. - Patient yelling for help. Pt lying on bed with gown and blanket off. Pt belongings were on the floor, feces were on the floor. Gown placed on patient. Ativan given for anxiety.
11/29/20 at 1:53 a.m.- RN 16 called Pt 34 ' s physician (PHY 1) and left message to return call due to Pt 34 ' s oxygen saturation dropping down in the 70' s when
lying down.
11/29/20 at 2:20 a.m. - Pt restless, lethargic, hypoxic, with oxygen saturations in the 70' s and periods of apnea and bradycardia; unable to follow commands.
Worsening anasarca (severe generalized swelling all over body).
11/29/20 at 2:26 a.m.- No improvement in respiratory status. Placed on 15L oxygen via non-rebreather mask.
11/29/20 at 2:35 a.m.- RT at bedside; patient placed on BiPAP (Bilevel Positive Airway Pressure- a non-invasive method of assisted ventilation), significant
improvement in respiratory status, O2 sats improved to 99%.
11/29/20 at 6:15 a.m.- (LATE ENTRY made at 8:04 a.m.) Pt 34 kept repeating she wanted to go to the BR and was informed she had a foley catheter in now. Pt 34
got off gurney and took BiPAP off. PHY 1 at bedside and gave orders for soft restraints and Ativan 2 mg given IV. Wrist restraints placed.
11/29/20 at 8:11 a.m.- RN 17 walked into Pt 34 ' s room to find Pt on the floor next to the end of the bed, naked, one wrist restraint still attached to the right wrist,
appears asleep with snoring respirations. Patient eventually woke up enough to be assisted back to be by staff. Placed back on restraints. Report filed regarding the
fall.

Review of the medical record indicated there was not a documented head to toe assessment done after the unwitnessed fall or a fall risk reassessment done any time on 11/29/20. There was no documentation that the physician was notified about the fall. On 11/30/20 at 9 a.m., a Fall Risk assessment by RN 18 indicated Pt 34 was a Moderate risk of fall with a score of 35. RN 18 indicated inaccurately that Pt 34 did not have a history of fall, did not have multiple diagnoses, and was not receiving oxygen.

The DES stated the fall risk assessments should have been done every shift and reassessments done if there was a change in status like there was with Pt 34 when she became hypoxic and confused seven hours prior to the fall. The DES stated it is apparent staff did not understand how to complete the fall risk assessment. and had to be reeducated about the need to assess fall risk and to implement the necessary interventions for safety. The DES stated she did not have an explanation about how a patient in bed with a gown on, on BiPAP, and in wrist restraints ended up naked on the floor. The DES stated she had not done an investigation into the circumstances of the fall and had not been notified that this patient had fallen. The DES stated a patient who had a change in mental status, became hypoxic and confused and required restraints is a high risk for falls and other harm and should have had 1:1 observation at the bedside. The DES stated the RN (RN 17) taking care of Pt 34 at the time of the fall was a traveler and is no longer working there.

A review of the facility ' s P&P titled, " Patient Rights/Responsibilities " dated 6/20, indicated, " ...All patients have the right to the following: Respect and Dignity ...the right to considerate, respectful care given by competent personnel which optimizes the patient ' s comfort and dignity ...Quality Care Delivery ...the right to receive care in a safe and secure environment which incorporates current standards of practice for patient environmental safety, infection control, and security ...receive high quality care based on professional standards that are continually maintained and reviewed ... "

A review of the facility ' s P&P titled, " Fall Prevention Program and Code Star " dated 10/20, indicated, " ...Assessment is performed on admission ...reassessment is performed after any fall event, change in patient condition including altered mental status ... each shift ...and upon transfer to another unit ...The risk of fall (ROF) assessment includes an evaluation of the patient ' s history of falls, IV access, multiple diagnoses, gait, ambulatory aid used, mental status code ...The ROF score will populate based on the nurse ' s input ...Low Risk= <25; Moderate Risk= 25-45; High Risk= >45 ...[ROF] patients shall have a yellow band placed on their wrist, a ROF sign placed at the entrance to their room, yellow non-skid socks will be placed on all ROF patients ...for Moderate ROF patients supervise and assist with bedside sitting and toileting as appropriate ...use a bedside commode if appropriate ...for High ROF patient, remain with patient while toileting ...activate bed alarm immediately ...24-hour 1:1 or 1:2 observation, document 15-minute observation form ... reassessment is performed after any fall event using the ROF assessment tool ...a head to toe assessment is also completed and documented ... "

Based on observation, interview and record review, the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program when:

1. No annual quality assessment projects were selected for one clinical department and data for selected quality assessment projects in two clinical departments was not tracked and monitored. (refer to A273)

2. Previously identified performance improvement actions were not implemented when the security guard acting as a constant observer for Patient 18 was located outside the room in the Emergency Department. (refer to A286)

The cumulative effects of these systemic problems resulted in the hospital's inability to patient care in a safe and effective manner in accordance with the statutory-mandated Condition of Participation for QAPI.

Based on interview and record review, the facility failed to select annual quality assessment projects for one clinical department and to track data for selected quality assessment projects in two clinical departments. This deficient practice had the potential for the facility to be unaware of its performance in providing quality patient care.

Findings:

During a review of the facility's Quality Assessment and Performance Improvement (QAPI) program for fiscal year 2020-2021, no Annual Plan or quarterly data was available for Respiratory Therapy.

During an interview on 12/16/20 at 4:00 p.m. with the Director of Quality Management and Risk (DQMR), the DQMR stated she could not find any data for the Respiratory Therapy QAPI program for 2020-2021. When asked if Respiratory Therapy was supposed to have its own QAPI plan, the DQMR stated yes.

During a review of the Respiratory Therapy Annual Plan July 1, 2019 - June 30, 2020, approved 1/11/2020, indicated six planned performance improvement projects: Multi-Disciplinary Rounds held every weekday, Ventilator Associated Pneumonia, Both Spontaneous Awakening Trials (SAT) and Spontaneous Breathing Trials (SBT), Safety Checks completed, Reported ABG's, and Family Engagement and Empowerment. During a review of the Respiratory Therapy quarterly data for January - March 2020; quarterly data for April - June 2020; and Annual Evaluation for July 1, 2019 - June 30, 2020, data was collected and analyzed for four performance improvement projects: CTS Proficiency Testing, Re-Intubation within 24 hours of extubation, Spontaneous Breathing Trial Performed daily on eligible ventilated patients, and Number of patients on Oxygen delivery device who had a skin check done on each shift.

During an interview on 12/16/20 at 4:00 p.m. with the DQMR, the DQMR stated the quality indicators in the Annual Plan are supposed to match the quality indicators with collected data. When asked why data was collected for different quality indicators than the ones chosen in the Annual Plan, the DQMR stated the previous ICU (intensive care unit) director did not inform the respiratory therapists of the selected quality indicators, so the respiratory therapists were collecting data on different quality indicators.

During a review of the Critical Care Services Annual Plan July 1, 2019 - June 30, 2020, approved 1/11/2020, Delirium and Early Mobility and Exercise were included as two planned performance improvement projects. During a review of the Critical Care Performance Measurement Report (PMR) 2019-2020, undated, indicated no data for Delirium or for Early Mobility and Exercise. During a review of the Critical Care Unit Annual Evaluation for July 1, 2019 - June 30, 2020, approved 10/27/20, indicated no data was collected or analyzed for Delirium or for Early Mobility and Exercise.

During an interview on 12/15/20 at 9:47 a.m. with the DQMR, the DQMR stated the Annual Plan is a guide for each department director for which quality indicators to collect data. The DQMR stated the department director is expected to collect data for each quality indicator on the department's Annual Plan.

During an interview on 12/16/20 at 4:00 p.m. with the DQMR, the DQMR stated she was unable to find any data on Delirium or Early Mobility and Exercise.

During a review of the facility's Quality Assessment Performance Improvement Plan FYE 2021, undated, indicated "... Each Service Director develops a unit specific plan ... which describes the goals, standards of practice, standards of care and measurements to be utilized in performance improvement ..." and "... Data is collected monthly and reported quarterly ...".

Based on observation, interview, and record review, the facility failed to implement performance improvement actions when the security guard acting as a constant observer for Patient 18 was not located inside the patient's room. This deficient practice had the potential to jeopardize the health and safety of suicidal patients.

Findings:

During an interview and concurrent record review on 12/15/20 at 12:50 p.m. with the Director of Quality Management and Risk (DQMR), the DQMR presented the root cause analysis (RCA) for an October 2020 patient adverse event in the Emergency Department. The DQMR stated the RCA was completed in November 2020. The RCA noted a suicidal patient under a 5150 hold (a hold placed when a patient is a danger to self, others, or gravely disabled) harmed himself with an object located inside his room. The DQMR stated the security guard, who was acting as a constant observer, stepped outside of the patient's room and the patient harmed himself with the object. The RCA revealed problems with unsafe objects in suicidal patients' rooms, with the security guard not being in the patient's room at all times, and with inadequate medication dosage.

The RCA noted a root cause was the security guard not being in the patient's room because he felt uncomfortable, and there was no statement of duties for the security guards. The RCA noted constant observers or security guards need to follow the requirements of 1:1 observation and to understand the importance of keeping eyes on the patient at all times. The RCA indicated this was to be enforced by nursing leadership daily while rounding in the Emergency Department when suicidal patients were present.

During a review of the facility's policy and procedure titled 5150 Holds and Behavioral Emergencies, revised 10/20, it indicated "... if patient is identified to be a suicide risk the charge nurse must be notified and place 1:1 observation immediately. The 1:1 constant observer must be inside the patient's room ..." and "... Guards/constant observers must be inside patients room at all times if the patient is deemed a suicidal/ danger to self ...".

During a continued review of the RCA for the October 2020 Emergency Department patient adverse event, the corrective action plan, with a completion deadline of 11/12/2020, noted the facility would create and implement a statement of duties for the security guards. The plan was to be monitored for success through the Emergency Department Quality Assessment Performance Improvement program, by monitoring the number of constant observers visualized sitting inside a suicidal patient's room for 30 random direct observations.

During a concurrent observation and interview on 12/7/20 at 3:30 p.m. with the Director of Emergency Services (DES) in the Emergency Department, Security Guard 2 was observed outside Patient 18's room. The DES stated Patient 18 was a suicidal patient on a 5150 hold and Security Guard 2 was assigned to provide 1:1 observation for Patient 18. The DES stated the person responsible for providing 1:1 observation for a suicidal patient is supposed to be inside the patient's room.

During an interview on 12/15/20 at 2:05 p.m. with the DQMR and the DES, the DES stated Security Guard 2 was outside the patient's room because Patient 18 had not yet been ruled out for COVID-19 (a viral illness spread mainly through droplets produced during coughing or sneezing). The DES stated the administration decided not to fit-test (a process that checks whether a respirator, such as an N95 facemask, fits a person's face and protects them) the security guards.

During an interview on 12/15/20 at 2:58 p.m. with the DES, the DES stated the security guards have not had personal protective equipment since the start of COVID-19. When asked if nursing leadership should have enforced the security guard being inside Patient 18's room on 12/7/20, the DES stated she could not force security guards to enter patient rooms without proper fit-testing. The DES stated nursing leadership included house supervisors and Emergency Department charge nurses.

During an interview on 12/17/20 at 11:29 a.m. with the Medical Director of Emergency Department (MDED), the MDED stated he was not aware the security guards had not been fit-tested for N95 facemasks and thus were unable to enter rooms with possible or confirmed COVID-19 patients.

During an interview on 12/18/20 at 10:07 a.m. with the DQMR and DES, the DES stated the facility started fit-testing the security guards and providing personal protective equipment on 12/8/20. When asked why the security guards had not been fit-tested previously, the DES stated the administration decided the facility was not going to fit-test them. The DQMR stated the facility still has an obligation to provide a safe patient environment. The DES stated, if there was not a shortage of fit-tested staff, then it was probably oversight on the facility's part that Patient 18 had not been ruled out for COVID-19 and thus required a fit-tested constant observer.

Based on interview and record review, the facility failed to update clinical privileges for two of 12 sampled physicians (Physicians 1 and 2). The approved privilege list included procedures for which Physicians 1 and 2 had no documented clinical activity for the past several years.

This deficient practice had the potential for physicians to be performing procedures without demonstrating continued competency and for placing patients at risk.

Findings:

During a review of the facility's Medical Staff Bylaws, approved 2/20/2020, Article 5.10 revealed "A. The credentialing and privileging processes described in these bylaws, and medical staff policies require that the Medical Staff develop performance and monitoring activities to ensure that decisions regarding ... granting or renewing of privileges are, among other things, detailed, current, accurate, objective and evidence-based."

During a concurrent interview and record review on 12/11/20 at 12:11 p.m. with the Director of Medical Staff (DMS), the credentialing file of Physician 2 (PHY2) was reviewed. The DMS stated the Health Information Management (HIM) department runs a clinical activity report by patient diagnosis and by procedure for physicians applying for reappointment.

PHY2 was reappointed to the facility's medical staff in November 2019. A review of PHY2's requested and granted clinical privileges (a list of specific services and procedures a physician is deemed qualified to provide or perform) from September 2019 included: paracentesis (a procedure in which a needle or tube is placed into the abdomen to remove fluid for diagnostic or therapeutic purposes), thoracentesis (a procedure in which a needle is inserted between the lung and chest wall to remove fluid for diagnostic or therapeutic purposes), and lumbar puncture (a procedure in which a needle is inserted into the space surrounding the spinal column to remove fluid for testing). On PHY2's log titled Clinical Activity by Procedure 09/01/2017 - 09/01/2019, there was no documentation of paracentesis, thoracentesis, or lumbar puncture.

A review of PHY2's requested and granted clinical privileges from September 2017 included paracentesis and thoracentesis. On PHY2's log titled Clinical Activity by Procedure 09/01/2015 - 09/01/2017, there was no documentation of paracentesis or thoracentesis.

The DMS stated the expectation is physicians should not be given privileges if there is no activity to support the request. When asked what current in Medical Staff Bylaws Article 5.10 meant, the DMS stated current is interpreted as the past 24 months.

During a concurrent interview and record review on 12/14/20 at 1:45 p.m. with the Director of Medical Staff (DMS), the credentialing file of Physician 1 (PHY1) was reviewed. PHY1 was reappointed to the facility's medical staff in July 2020. A review of PHY1's requested and granted clinical privileges from May 2020 included paracentesis, thoracentesis, and lumbar puncture. On PHY1's log titled Clinical Activity by Procedure 05/01/2018 - 05/01/2020, there was no documentation of paracentesis, thoracentesis, or lumbar puncture.

During an interview on 12/16/20 at 12:26 p.m. with the Chair of Medicine (CHMD), the CHMD stated, in the Medical Staff Bylaws, current meant either performing the procedure in the two years prior to reappointment or completing a training or refresher course. When asked about PHY1 and PHY2 being granted privileges to perform paracentesis, thoracentesis, and lumbar puncture with no documented performance in the two years before their reappointment dates, the CHMD stated they should have looked at clinical activity logs from other facilities.

Based on interview and record review, the facility failed to enforce its Medical Staff Bylaws when

1. Four of 15 sampled medical staff members or allied health practitioners did not have documented baseline tuberculosis (TB, a highly contagious disease spread through tiny droplets released during coughing or sneezing) testing or annual TB education.
2. Privileges for one of three sampled allied health practitioners did not reflect the required level of supervision.

This deficient practice had the potential to result in providers being unaware of their tuberculosis status and risking the health of others, and the potential for facility staff to be unaware of supervision requirements for providers and risking unsafe patient care.

Findings:

1. During an interview on 12/10/20 at 1:08 p.m. with the Director of Medical Staff (DMS), the DMS stated the facility does not require physicians to submit their tuberculosis status.

During a concurrent interview and record review on 12/14/20 at 1:45 p.m. with the DMS, the DMS stated the facility does not collect TB status when medical staff members or allied health providers apply. The DMS stated there was no documented baseline TB status for Allied Health Provider 2, Allied Health Provider 3, Physician 3, and Physician 4 in their credentialing files. When asked if medical staff members or allied health practitioners received annual tuberculosis education, the DMS stated the Medical Staff Department did not provide TB education but perhaps the Infection Control Coordinator had more information.

During an interview on 12/14/20 at 11:31 a.m. with the Infection Control Coordinator (ICC), the ICC stated the county-level risk for TB was intermediate. The ICC stated her expectation is that medical staff members undergo the same annual TB testing as employees do. The ICC stated, for TB, she follows the Centers for Disease Control and Prevention guidelines and the California Department of Public Health Aerosol Transmissible Disease guidelines.

During a review of the Centers for Disease Control and Prevention (CDC) 2019 guidelines (Sosa LE, Njie GJ, Lobato MN, et al. Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019. MMWR Morb Mortal Wkly Rep 2019;68:439-443.), the guidelines recommended that all United States health care personnel undergo baseline or preplacement TB screening and individual risk assessment. The CDC guidelines noted that baseline testing enabled the comparison of test results during potential exposure to TB, the detection and treatment of TB disease or latent TB infection (a state in which the bacteria causing TB is present in the body but inactive), and the reduction of risk to patients and other health care personnel. The CDC guidelines recommended health care facilities educate all health care personnel annually about TB, including risk factors and signs and symptoms. The CDC guidelines noted health care personnel may experience and transmit TB to patients or other contacts, if their risks for TB exposure or TB progression go unrecognized.

During an interview on 12/16/20 at 1:50 p.m. with the ICC, the ICC stated medical staff members should receive annual TB education but she did not know who was responsible for medical staff education.

During an interview on 12/16/20 at 2:13 p.m. with the Director of Clinics and Employee Health (DCEH) and the LVN Clinic Manager (LVNCM), the DCEH and LVNCM stated they were not aware if any TB education was provided annually to medical staff members.

During a review of the facility's Medical Staff Bylaws, approved 2/20/2020, Article 2.2-1 revealed "A practitioner must demonstrate compliance with all the basic standards set forth in this section ... document their ... Current adequate physical and mental health status ... so as to demonstrate to the satisfaction of the Medical Staff that they are sufficiently healthy ... and that patients treated by them can reasonably expect to receive quality medical care ..." and "... with respect to communicable diseases and other conditions that could affect ability to provide safe and quality care, practitioners are expected to know their own health status ...".

2. During a review of the facility's Medical Staff Bylaws, approved 2/20/2020, Article 2.8-7 revealed "Allied Health practitioners may only provide clinical services to a patient under supervision of a Medical Staff member ... The supervising/collaborating physician must provide supervision as designated in the privileges in at least one of the following definitions: Direct (D) ... Indirect (I) ... Available (A) ...".

During a concurrent interview and record review on 12/14/20 at 1:45 p.m. with the Director of Medical Staff (DMS), the credentialing file for Allied Health Provider 1 (AHP1) was reviewed. The privilege list for AHP1 from March 2020 did not indicate the required level of physician supervision. When asked how facility staff would know what level of supervision was required for AHP1, the DMS stated the staff would not know.

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

1. Fall risk was not accurately assessed and/or safety measures were not implemented for the prevention of falls for six of eight sampled ED patients (Patient [Pt] 17, Pt 18, Pt 28, Pt 29, Pt 34, and Pt 38); the unwitnessed fall of a restrained patient (Patient 34) was not investigated. (Refer to A395)

2. Registered Nurses (RNs) responsible for supervision of the hospital and RN Travelers (RNTs) (temporary nurses contracted with the hospital for a short time, approximately 13 week assignments) did not receive the appropriate training, education, supervision, and had the specialized qualification and competence to meet the needs of patients. (refer to A397, findings 1 and 2).

3. Medications were not administered as per the hospital's protocol and manufacturer's specifications for four of 52 sampled patients (Patients 20, 26, 44, and 53). (Refer to A405, findings 1, 2, 3 and 4)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide nursing services in a safe and effective manner in accordance with the statutory-mandated Conditions of Participation for Nursing Services.

Based on interview and record review, the hospital failed to evaluate and supervise the nursing care of patients in the ED when:
1. Fall risk was not accurately assessed and/or safety measures were not implemented for the prevention of falls for six of eight sampled ED patients (Patient [Pt] 17, Pt 18, Pt 28, Pt 29, Pt 34, and Pt 38); the unwitnessed fall of a restrained patient (Patient 34) was not investigated.

These failures placed patients in the ED at increased risk for falls and resulted in Patient 34 ' s unwitnessed fall. The failure to investigate Pt 34 ' s fall resulted in a missed opportunity to identify and address risks to patient safety.

Findings:

1. During a concurrent interview and medical record review, on 12/15/20 at 12:50 p.m., with the Director of Emergency Services (DES), Patient 18 ' s " Patient Summary Report, " dated 12/6/20 and 12/7/20, was reviewed. The " Patient Summary Report " indicated Pt 18, a 72-year-old, was brought in by ambulance on 12/6/20 at 4:45 p.m. after Pt 18 attempted suicide and was in a motor vehicle accident. Pt 18 was determined to be a danger to self (DTS) by law enforcement prior to arrival at the hospital and was placed on a 5150 hold (involuntary hold for patients who are a danger to themselves and/or others or are gravely disabled). Patient 18 remained under a 5150 hold until 12/7/20 at 2:30 p.m. and was discharged on 12/7/20 at 4:35 p.m. Review of the record indicated a fall risk assessment was completed on 12/6/20 at 5:39 p.m. by the ED nurse (RN 16). The fall risk assessment consisted of a series of questions answered by the nurse, related to a patient ' s physical and mental condition in order to determine the potential for a fall (the Risk of Fall-ROF). The response to each question was entered into the electronic health record (EHR) and had a numeric value assigned to it. The sum of these numbers (totaled electronically) were reflected as the ROF Score. The ROF score corresponded to a defined numeric range and indicated a risk level (low, moderate, high), with fall prevention measures to be implemented depending on the level of risk. The nurse also answers the question, Risk of Fall? YES or NO. Pt 18 was identified (by the point total) as a Moderate fall risk with a ROF score of 30 (Moderate range= 25-45) due to a weak gait and an IV (intravenous- into a vein) line in place. The RN who completed the assessment (RN 16) answered NO to the ROF question, which indicated Pt 18 was not a fall risk and did not implement fall prevention measures per policy. There were no additional fall risk assessments documented during Pt 18 ' s stay. The DES stated RN 16 should have answered YES to the question about Pt 18 ' s risk of fall. The DES stated fall risk assessments are supposed to be done each shift.

During a concurrent interview and medical record review, on 12/15/20 at 1:15 p.m., with the DES, Patient 17 ' s " Patient Summary Report " , dated 12/6/20 through 12/8/20, was reviewed. The report indicated Pt 17, a 70-year-old, was brought in by ambulance on 12/6/20 at 2:29 p.m. with respiratory distress. Pt 17 was evaluated and determined to have a NSTEMI (non-ST elevation myocardial infarction [heart attack]) and the plan was to transfer to a hospital with a cardiac catheterization lab (a room where cardiac catheterizations [a procedure where a small tube is inserted into a vein or artery and guided to the heart to diagnose and treat heart problems] are performed). The report indicated Pt 17 remained in ED until 12/8/20 at 1:45 p.m. when he was transferred to another hospital. Review of the record indicated a fall risk assessment was completed on 12/6/20 at 2:30 p.m. and Pt 17 was identified as High fall risk per the Morse Fall Risk score. There were no additional fall risk assessments documented during Pt 17 ' s stay. The DES stated the fall risk assessment should have been done each shift and when the patient ' s condition changed, and it was not.

During a concurrent interview and record review on 12/15/20 at 1:35 p.m., with the DES, Pt 29 ' s medical record was reviewed. The document " Patient Summary Report " , dated 12/7/20, indicated Pt 29 came to the ED on 12/7/20 at 1:48 p.m. for chest pain and cough for three days with exposure to COVID-19. Pt 29 ' s medical history included lupus (an autoimmune disease), hypertension (high blood pressure), a blood clotting disorder (condition which causes the blood to be either too thin or not thin enough). On 12/7/20 at 2:24 p.m. a fall risk assessment was documented by RN 17. The fall risk assessment indicated Pt 29 ' s fall risk score was zero (Low Risk). RN 17 responded NO to the risk of fall question. There was no documentation regarding fall prevention measures implemented. The DES stated Pt 29 should have had a score of 15 (not zero) because of multiple diagnoses and the RN should of responded YES to the question about risk of fall.

During a concurrent interview and record review on 12/15/20 at 1:50 p.m., with the DES, Pt 28 ' s medical record was reviewed. The document " Patient Summary Report, " dated 12/6/20-12/8/20, indicated Pt 28 came to the ED on 12/6/20 at 10:54 p.m. and was transferred to another facility on 12/8/20 at 9:38 p.m. On 12/6/20 at 11:47 p.m. a fall risk assessment was documented. The fall risk assessment indicated Pt 28 was identified as Low Risk. There was no documentation regarding fall prevention measures implemented as required per policy. There were no additional fall risk assessments documented during Pt 28 ' s stay. The DES stated the fall risk assessment should have been done each shift and when the patient ' s condition changed, and it was not.

During a concurrent interview and medical record review, on 12/15/20 at 2 p.m., with the DES, Patient 34 ' s " Patient Summary Report " , dated 11/28/20-11/30/20, was reviewed. The " Patient Summary Report " indicated Pt 34 was brought in by ambulance on 11/28/20 at 10:39 a.m. to the ED with a chief complaint of worsening shortness of breath for past two weeks. The report indicated Pt 34 was 43 years old with a history of congestive heart failure (CHF-a condition where the heart isn ' t pumping as well as it should be, leading to edema [swelling] in the legs, abdomen, lungs), hypertension (high blood pressure), and polysubstance (more than one drug) abuse. The " Patient Summary Report " indicated Patient 34 was alert, oriented, and calm upon arrival, and was receiving oxygen via nasal cannula (a flexible tube with two open prongs which sit inside the nostrils; tubing is attached to an oxygen source)... Pt 34 ' s initial nursing assessment indicated Pt 34 had increased blood pressure, heart rate, and respiratory rate, and reported pain all over body. Pt 34 ' s assessment indicated swelling of arms and legs and abdomen. Review of the document " ED Assessment " dated 11/28/20, indicated the ED physician (PHY 12) assessed Pt 34 and ordered lab tests, IV (into a vein) diuretics (medication to help the body get rid of excess fluid), medications for elevated blood pressure, and imaging studies. At 4:04 p.m. on 11/28/20, PHY 12 indicated Pt 34 was to be admitted to the hospital with a diagnosis of decompensated congestive heart failure (worsening symptoms of CHF). Pt 34 remained in the ED until a bed became available on 11/30/20.

Review of the document " Fall Risk " assessment dated 11/28/20 at 10:53 a.m., indicated Pt 34 ' s Fall Risk score was zero (Low Risk), and had no risk of fall (ROF). Non-skid socks were not placed on Pt 34, a ROF sign was not placed on door, and a yellow wrist band was not placed on Pt 34, as required for all patients identified as at risk for fall. The DES stated that assessment was not performed accurately since Pt 34 had multiple diagnoses and was on oxygen at that time. The DES stated even if Pt 34 did have a fall risk score of zero it would still mean she was a Low Risk for fall (not no risk) and required the basic precautions (fall prevention measures implemented for all patients identified as at risk for falls such as non-skid socks, yellow wrist band, signage on door). There were no other documented fall risk assessments on 11/28/20. The DES stated the fall risk assessment should have been done each shift and when the patient ' s condition changed, and it was not.

Review of the RN notes section of the " Patient Summary Report " , indicated the following:

11/28/20 at 8:45 p.m.- IV Lasix (a diuretic medication) given.
11/28/20 at 9:16 p.m.- Patient yelling for help. RN 16 entered room; patient was in bathroom sitting on toilet, no gown on, bed sheet had feces on it and there was garbage on the floor.
11/28/20 at 10:13 p.m.- Patient yelling for help. Pt lying on bed with gown and blanket off. Pt belongings were on the floor, feces were on the floor. Gown placed on patient. Ativan given for anxiety.
11/29/20 at 1:53 a.m.- RN 16 called Pt 34 ' s physician (PHY 1) and left message to return call due to Pt 34 ' s oxygen saturation (O2 sats- the extent to which hemoglobin [element in blood that binds with oxygen to carry it through the bloodstream] is saturated with oxygen) dropping down in the 70 ' s (normal range 95-100%) when lying down.
11/29/20 at 2:20 -2:26 a.m.- Pt restless, lethargic, hypoxic, with oxygen saturations in the 70 ' s and periods of apnea (breathing stopped) and bradycardia (slow heart rate); unable to follow commands. Worsening anasarca (severe generalized swelling all over body). Placed on 15 L (liters-unit of measurement) oxygen via non-rebreather mask (a face mask covering nose and mouth, connected to bag filled with a high concentration of oxygen. One-way valves prevent exhaled air from reentering the oxygen bag).
11/29/20 at 2:35 a.m.- Respiratory therapist (RT) at bedside; patient placed on BiPAP (Bilevel Positive Airway Pressure- a non-invasive method of assisted breathing), significant improvement in respiratory status, O2 sats improved to 99%.
11/29/20 at 6:15 a.m.- (LATE ENTRY made at 8:04 a.m.) Pt 34 kept repeating she wanted to go to the BR [bathroom] and was informed she had a foley catheter (a tube inserted into the bladder connected to a urine drainage bag) in now. Pt 34 got off gurney and took BiPAP off. PHY 1 at bedside and gave orders for soft restraints and Ativan 2 mg given IV. Wrist restraints placed.
11/29/20 at 8:11 a.m.- RN 17 " walked into Pt [34 ' s] room to find Pt on the floor next to the end of the bed, naked, one wrist restraint still attached to the right wrist, appears asleep with snoring respirations. Patient eventually woke up enough to be assisted back to be by staff. Placed back on restraints. Report filed regarding the fall. "

Review of the medical record indicated there was not a documented head to toe assessment done after the unwitnessed fall or a fall risk reassessment done any time on 11/29/20. There was no documentation that the physician was notified about the fall. On 11/30/20 at 9 a.m. a Fall Risk assessment by RN 18 indicated Pt 34 was a Moderate risk of fall with a score of 35. RN 18 indicated inaccurately that Pt 34 did not have a history of fall, did not have multiple diagnoses, and was not receiving oxygen. The DES validated the fall risk assessment was not accurate as completed by RN 18. The DES stated the fall risk assessments should have been done every shift and reassessments done if there was a change in status like there was with Pt 34 when she became hypoxic and confused seven hours prior to the fall. The DES stated she could not explain the circumstances of the fall; stated she did not understand how a patient in bed with a gown on, on BiPAP, and in wrist restraints ended up naked on the floor. The DES stated she was not notified of the fall and had not done an investigation into the circumstances of the fall. The DES stated a patient who came into the ED alert and oriented and then later became confused, had a decrease in oxygen levels, and required restraints was a high risk for falls and other injuries and should have had 1:1 observation at the bedside. The DES stated the RN (RN 17) taking care of Pt 34 at the time of the fall was not available for interview.

During a concurrent interview and medical record review, on 12/16/20 at 2:30 p.m., with the DES, Patient 38 ' s " Patient Summary Report " , dated 12/1/20 through 12/4/20, was reviewed. The report indicated Pt 38, a 91-year-old, was brought in by ambulance on 12/1/20 at 2:20 p.m. Pt 38 had symptoms of a stroke and a seizure. The report indicated on 12/1/20 at 4:06 p.m. there was a decision to admit Pt 38, however Pt 38 remained in the ED until 12/4/20 at 9:53 p.m. due to lack of intensive care unit beds. Review of the record indicated a fall risk assessment was completed on 12/1/20 at 2:44 p.m. and Pt 38 was identified as High fall risk per the Morse Fall Risk score. The RN (RN 17) who completed the assessment indicated Pt 38 was not a fall risk and did not implement fall prevention measures. There were no additional fall risk assessments documented during Pt 38 ' s stay. The DES stated the fall risk assessment should have been done each shift and when the patient ' s condition changed, and it was not.

The DES stated it is apparent after reviewing the assessments with incorrect entries that staff needed to be reeducated on how and when to complete fall risk assessments and the interventions for safety (such as assigning 1:1 observation, placing signage on the door, use of the yellow wristband) which should have been implemented.

A review of the facility ' s P&P titled, " Patient Rights/Responsibilities " dated 6/20, indicated, " ...All patients have the right to the following: Respect and Dignity ...the right to considerate, respectful care given by competent personnel which optimizes the patient ' s comfort and dignity ...Quality Care Delivery ...the right to receive care in a safe and secure environment which incorporates current standards of practice for patient environmental safety, infection control, and security ...receive high quality care based on professional standards that are continually maintained and reviewed ... "

A review of the facility ' s P&P titled, " Fall Prevention Program and Code Star " dated 10/20, indicated, " ...Assessment is performed on admission ... reassessment is performed after any fall event, change in patient condition including altered mental status ... each shift ...and upon transfer to another unit ...The risk of fall (ROF) assessment includes an evaluation of the patient ' s history of falls, IV access, multiple diagnoses, gait, ambulatory aid used, mental status code ...The ROF score will populate based on the nurse ' s input ...Low Risk= <25; Moderate Risk= 25-45; High Risk= >45 ...[ROF] patients shall have a yellow band placed on their wrist, a ROF sign placed at the entrance to their room, yellow non-skid socks will be placed on all ROF patients ...for Moderate ROF patients supervise and assist with bedside sitting and toileting as appropriate ...use a bedside commode if appropriate ...for High ROF patient, remain with patient while toileting ...activate bed alarm immediately ...24-hour 1:1 or 1:2 observation, document 15-minute observation form ... reassessment is performed after any fall event using the ROF assessment tool ...a head to toe assessment is also completed and documented ...All patient falls shall be documented as unusual occurrence in [software name- an electronic incident reporting system] ... "

Based on interview and record review, the hospital failed to ensure Registered Nurses (RNs) responsible for supervision of the hospital and RN Travelers (RNTs) (temporary nurses contracted with the hospital for a short time, approximately 13 week assignments) received the appropriate training, education, supervision, and had the specialized qualification and competence to meet the needs of patients when:

1. The Chief Nursing Officer (CNO) did not ensure Nursing House Supervisors (NHS) 1 and 2 and Clinical Coordinator (CC) RNs 2 and 3 received the proper orientation, training, and demonstrated competence to perform the functions and carry out the Nursing House Supervisor (NHS) responsibilities.

2. The Director of Intensive Care Services (DICU) did not ensure RNT 1 and RNT 2 were oriented to the intensive care unit (ICU) prior to being assigned patient care tasks.
These failures had the potential for patients' care needs to be unmet and to compromise the health and well-being of all patients in the facility from care provided by staff who were not well trained and well qualified.

Findings:

1. During a concurrent interview and record review on 12/11/20 at 12:45 p.m., with the Director of Human Resources (DHR), employee files for NHS 1, NHS 2, CC 2, and CC 3 were reviewed. The DHR validated the following: NHS 1 did not have a NHS competency skills checklist in their employee file; NHS 2's NHS competency skills checklist dated 1/5/13 needed to be updated with the current form; CC 2 sometimes performed NHS functions and did not have a NHS competency skills checklist; and CC 3's NHS skills competency checklist dated 8/18/07 needed to be updated with the current form; they no longer used that NHS competency skills checklist in NHS 1's and NHS 3's employee files. The DHR stated competency skills checklists were generally completed initially one time when the nurse was assigned to perform NHS responsibilities. The DHR stated all staff who perform NHS functions should complete a NHS competency skills checklist or they may not know what they were supposed to do as a NHS.

During a concurrent interview and record review on 12/17/20 at 2:50 p.m. with the DHR, CC's 4, 5, 6, 7, 8, 9, 10, and 11 employee files were reviewed. The DHR stated CC's 4, 5, 6, 7, 8, 9, 10, and 11 primary job was as a clinical coordinator (charge nurse responsible for a unit during an assigned shift), they sometimes performed NHS (nurse in charge of all the administrative and hospital responsibilities when key leaders are not present) functions and they did not have a NHS competency skills checklist in their employee files.

During an interview on 12/21/20 at 9:15 a.m. with CNO 1, CNO 1 stated she was interim CNO and was made aware that NHSs were compounding medications because the pharmacists were only on call and there were no in-house pharmacists in the hospital at night. CNO 1 stated NHS's should not be mixing (compounding) medications if they were not authorized or competent. CNO 1 stated she was not aware of the missing and outdated NHS competency skills checklists and in the past, the NHS reported directly to the former CNO who had responsibility for oversight of all staff acting in the NHS role. CNO 1 stated it was important for patient safety and staff could make a mistake if they were not trained, oriented, and demonstrated competence in their assigned areas and in their assigned roles.

During an interview on 12/21/20 at 9:25 a.m., with the Director of Medical and Surgical Services (DMSS), the DMSS stated she has RN staff who function in the NHS role, but she was not responsible for oversight and supervision of NHS's. The DMSS stated she discussed with a former Chief Nursing Officer (CNO) the need for CC's to complete the NHS competency skills checklist before they are assigned the NHS role. The DMSS stated, nothing was done [to address the need for CCs to complete the NHS competency skills checklist] and it was important for staff to complete and demonstrate competence in the areas and roles they are assigned.

During a review of the hospital document titled, "Job Description Position Title: House Supervisor," dated 9/07, the Job Description document indicated, " ...Scope of Care: Based on Scope of Service To Be Completed With Employee ...Neonatal ...Infant ...Child ...Adolescent ...Adult ...Geriatric ...Medical Staff/Medical Office Staff ...Employees (Staff and Management) ...Patient's Family/Visitors ...Other Community Resources Representatives ...All job requirements listed indicate the minimum level of knowledge, skills, and/or ability deemed necessary to perform this job proficiently ...Reports To: Vice Patient [President] Patient Care Services [CNO]. In the VP's absence, report to a designated director and CEO [Chief Executive Officer] ...Position Summary: The House Supervisor ...manages all administrative and nursing activities, directly and indirectly related to patient care services to all patient populations throughout the Hospital ...responsible for the management of department resources and staff adjustments ...Supervisor demonstrates an understanding of the functional and or development age of the individuals served ...is responsible for performing all administrative functions which are delegated by the Vice President, Patient Care Services and CEO. During this time assumes decision making in authorized and delegated responsibilities and follows the [hospital] chain of command for reporting..."

During review of the hospital policy and procedure titled, "Orientation, Performance Appraisal & Competency Program," dated 10/19, , the Orientation and Performance Appraisal policy and procedure indicated, " ...Purpose: Assure hospital employees or contractors providing services in lieu of an employee are performing their defined job duties according to each designated job description to assure incumbent meets performance and personal objectives ...E. Skill Competency Documentation 1. Designation of annual Competency Requirements Department Director or designee will select on an annual basis competencies to be demonstrated by each staff member. These competencies shall be selected as appropriate to the staff member's job/position description, duty requirments, skills and knowledge ...3 ...c) Documentation of competency will be filed in the department director's personnel file. Documenation of completed competencies ...will be verified on Annual Competency Evaluation Form and forwarded to the Human Resources ..."

During a review of professional reference, Business and Professions Code Division 2. Healing Arts, Chapter 9. Pharmacy, Article 3. Scope of Practice and Exemptions; 4051, the professional reference indicated, "(a) Except as otherwise provided in this chapter, it is unlawful for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription pursuant to Section 4040 of a prescriber unless he or she is a pharmacist under this chapter ..." https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=BPC§ionNum=4051.

2. During a review of the hospital document titled, "Intensive Care Unit [ICU] Daily Assignment Sheet," dated 12/9/20, the ICU Daily Assignment Sheet indicated "Day [7 a.m. to 7 p.m.]," CC 6 was assigned to provide orientation to RNT 1. CC 6 and RNT 1 were assigned to care for Pt 53 in room (Rm) 301 and Rm 303. RN 6 was assigned to provide orientation to RNT 2 and assigned to provide care to patients in Rm 302 and Rm 304.

During a review of Pt 53's demographic face sheet (document in the Pt's clinical record that indicates important information about the patient such as address, emergency notification, date of birth, date of hospital admission and other important information) with the admission date 11/13/20 at 7:31 p.m., indicated Pt 53 was assigned to Rm 301.

During an interview on 12/16/20 at 2:05 p.m., with RNT 2, RNT 2 stated she was at the hospital for only two days, she received her badge from the HR department and was advised she would be assigned to orient with another nurse. RNT 2 stated she did not know who that nurse was and she did not receive any orientation to the ICU except for the glucometer (an instrument used to measure the concentration of sugar in the blood stream). RNT 2 stated she requested but was not transferred to another unit. RNT 2 stated she did not get her meal break at the appropriate time and when she did, she was told to just tell one of the other nurses she was going on break and that nurse would watch her assigned patient. RNT 2 stated the DICRS was periodically in and out of the ICU and she barely saw the DICRS the whole day.

During an interview on 12/16/20 at 2:55 p.m., with RNT 1, RNT 1 stated on 12/9/20 she was assigned to shadow another nurse and also assigned to simultaneously care for a patient in Rm 301. RNT 1 stated she was oriented to the use of the glucometer only and received no additional orientation to the ICU. RNT 1 stated she did not get her meal break at the appropriate time; there was not break nurse to relieve her of her duties. RNT 1 stated the DICRS was unavailable to respond to orientation questions and she saw the DICRS on the ICU one time about two hours into the shift.

During an interview and record review on 12/17/20 at 2:45 p.m., with Registered Pharmacist (RPH) 3, an electronically generated audit log was reviewed. RPH 3 validated the electronic audit log indicated on 12/9/20, the medication Meropenem (antibiotic [medication used to prevent or eliminate infection]) 1 GM (gram [unit of measure]) was scheduled to be administered to Pt 53 at 10:30 a.m and 6:30 p.m. (8 hours between doses) and RNT 1 had administered the Meropenen to Pt 53 at 3:04 p.m. and 5:43 p.m. (2 hours and 39 minutes between doses). RPH 3 stated RNT 1 had made a medication error by administering two doses with only 2 hours and 39 minutes between doses; the doses were administered too close together. RPH 3 stated he knew RNT 1 had made the error because RNT 1 had called and notified him about the error.

During an interview on 12/17/20 at 2:50 p.m. with the DHR, RNT 1's, 2's and 3's hospital and unit orientation checklists were requested. The DHR stated hospital orientation was not completed for RNT 1 and RNT 2. RNT 1 did not have a unit orientation checklist and RNT 2's unit orientation checklist was completed and signed by only the Director of Intensive Care and Respiratory Services (DICRS) and not RNT 2. The DHR stated she was informed by someone at the State Department managing the Travel Nurses that the travel nurses could hit the ground running and did not need orientation.

During an interview and record review on 12/18/20 at 10:55 a.m. with the DICRS, the DICRS stated on 12/9/20 she met RNT 1 and RNT 2 when they arrived to the ICU; she was not sure what time. The DICS stated she did give RNT 1 and RNT 2 a patient care assignment. The DICS stated, "I'm not worried about patient care, I'm worried about them getting [understanding] Meditech [the hospital's electronic medical record system]." The DICRS stated unit orientation generally lasted the first four hours of a nurses arrival to the ICU and sometimes could last the entire day. The DICRS stated even though she was informed that RNT 1 and RNT 2 did not need orientation, on 12/9/20, she assigned CC 6 to provide orientation to RNT 1 and RN 6 to provide orientation to RNT 2. The DICRS validated that RNT 1 did not have a unit orientation checklist and had a medication administration error. DICRS stated, "she [referring to RNT 1] seemed overwhelmed, that's why I let her go, I wouldn't have her back because of the medication error." A document titled, "Department Orientation For Nursing Employee Float," dated 12/9/20 indicated, " ...Department: ICU Name of Employee [RNT 2] ..." and the space to indicate the Job Description was blank and all items were checked off. The first initial and last name of the DICRS was hand written at the bottom and the space for indicating Employee Signature was blank. The DICRS stated, "I can't make her [RNT 2] sign it, I can't be responsible for making her sign it." The DICRS stated she interviews travel nurses to determine their competence to care for ICU patients.

During review of the hospital document titled, "[hospital name] Traveler/Registry Staff Nursing Orientation," undated, indicated, " ...Objectives Explain the process for accessing policies and procedures, Verbalize policy and procedures for the following: Restraints, Abuse Reporting, Behavioral Emergencies, Medication Administration/Narcotic Wasting, IV Therapy, Organ and Tissue Donation. Define Infection Control Practices at [the hospital] ...Standards of Nursing Care Department specific located in [hospital] Policies ...Adopted and followed by all licensed nursing staff. Defines expected nursing actions and behaviors. Used to measure level of competency ...Medication Safety 6 Rights of Medication administration. Right patient, Right medication, Right routs, Right dose, Right time, Right to refuse ..."

During review of the hospital policy and procedure titled, "Orientation, Performance Appraisal & Competency Program," dated 10/19, the Orientation and Performance Appraisal policy and procedure indicated, " ...Purpose: Assure hospital employees or contractors providing services in lieu of an employee are performing their defined job duties according to each designated job description to assure incumbent meets performance and personal objectives ...New Hire Department Specific Orientation Program 1. Developed by the Department Director ...4. Orientation includes training program designed to ensure employee understanding and successful performance of position duties. 5. Document orientation on check off list to include skills, and knowledge requirements. Documentation will provide format to review competency prior to completion of introductory period. 6. Director to assure documentation is filed in department personnel file ..."

During a review of professional reference, Barclays Official California Code of Regulations, 22 CA ADC; 70214. Nursing Staff Development, the professional reference indicated, " ...(a) There shall be a written, organized in-service education program for all patient care personnel, including temporary staff as described in subsection 70217(m). The program shall include, but shall not be limited to, orientation and the process of competency validation as described in subsection 70213(c). (1) All patient care personnel, including temporary staff as indicated in subsection 70217(m), shall receive and complete orientation to the hospital and their assigned patient care unit before receiving patient care assignments...(A) Assignments shall include only those duties and responsibilities for which competency has been validated. (B) A registered nurse who has demonstrated competency for the patient care unit shall be responsible for nursing care as described in subsections 70215(a) and 70217(h)(3), and shall be assigned as a resource nurse for those registered nurses and licensed vocational nurses who have not completed competency validation for that unit. (C) Registered nurses shall not be assigned total responsibility for patient care, including the duties and responsibilities described in subsections 70215(a) and 70217(h)(3), until all the standards of competency for that unit have been validated. (4) Orientation and competency validation shall be documented in the employee's file and shall be retained for the duration of the individual's employment ...(c) The administrator of nursing services shall be responsible for seeing that all nursing staff receive mandated education as specified in subsection (a) of this Section ..." https://govt.westlaw.com/calregs/Document/IE9E78290D4BB11DE8879F88E8B0DAAAE?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&contextData=(sc.Default).

Based on observation, interview, and record review, the hospital failed to ensure medications were administered as per the hospital's protocol and manufacturer's specifications for four of 52 sampled patients (Patients 20, 26, 44, and 53) as evidenced by:

1. The nursing staff failed to implement their heparin (medication to prevent blood clotting) infusion protocol (formal set of rules and procedures to be followed during a particular course of treatment) for the safe and effective use of heparin for Patient 26 and 44.

a. The nursing staff failed to ensure the PTT (Partial Thromboplastin Time- the blood test that measures how long it takes for the blood to clot) result was available in a timely manner after the dosage changes of the heparin infusion.

b. The nursing staff did not adjust the heparin infusion rate in a timely manner after obtaining PTT lab result.

c. The nursing staff failed to administer heparin bolus dose in accordance with the hospital's heparin infusion protocol.

2. The nursing staff failed to administer Protonix (medication to prevent or treat stomach ulcer) in accordance with the manufacturer's specifications for Patient 20 when Protonix was administered intravenously at a faster rate than specified by the manufacturer.

3. Registered Nurse Traveler (RNT) 1 administered two doses of antibiotic medication separated by two hours and 39 minutes to Pt 53 when the doses should have been administered 8 hours apart.

4. Nursing staff did not follow professional standards of practice and the hospital policy and procedure when Nursing Supervisors compounded or mixed medications when pharmacists were unavailable.

These failures had the potential to result in unsafe or ineffective treatment of the patient's clinical conditions.

Findings:

1. During a concurrent interview and record review on 12/10/20, at 10:30 a.m., with the Director of Pharmacy (DP), Registered Pharmacist (RPH) 4, and Registered Nurse (RN) 4, Pt 26's electronic medical records (EMR) for their admission on 12/1/20, was reviewed. The DP, RPH, and RN 4 confirmed Pt 26's weight on 12/1/20 was 216.5 kg, and per the Emergency Department (ED) assessment on 12/1/20 Pt 26 was diagnosed with a Deep Vein Thrombosis [DVT- clot forms in a deep vein (a type of blood vessel) in the body] of the upper right extremity. The DP, RPH, and RN 4 confirmed the PHA (pharmacy) Order for heparin PE (Pulmonary Embolism-the blood clots in one of the blood vessels of the lungs)/DVT protocol to start on 12/1/20 at 4 p.m.

During a review of the hospital's protocol titled, "HEPARIN ORDERS FOR PE/DVT," (undated), the hospital's heparin infusion protocol indicated the following:

1. When PTT level is less than 50 seconds, give heparin bolus of 40 units/kg (kilogram), increase heparin infusion rate by 100 units/hr (hour) [or 1 ml (milliliter)/hr], and obtain the next PTT level in 6 hours.

2. When PTT level is between 50 to 59 seconds, increase heparin infusion rate by 50 units/hr (or 0.5 ml/hr) and obtain the next PTT level in 6 hours.

3. The PTT goal is between 60 to 85 seconds.

a. During a concurrent interview and record review on 12/10/20, at 10:40 a.m., with DP, RPH, and RN 4, Patient 26's EMR was reviewed and showed the following:

The nursing staff initiated the heparin IV (intravenous) infusion protocol on 12/01/20 at 6:44 p.m., as per ordered.

The clinical record indicated on 12/3/20 at 00:16 a.m., the PTT result was 22 seconds. Heparin bolus of 8,000 units was administered at 01:49 a.m. and heparin infusion rate increased to 2,000 units/hr (or 20 mls/hr) at 01:40 a.m., according to the protocol.

The clinical record indicated on 12/3/20 at 9:46 a.m. (or approximately about 8 hours after the adjustment of heparin dose), the PTT result was 28 seconds.

According to the heparin protocol the PTT should be available 6 hours after the heparin bolus dose at 1:49 a.m. but the PTT was not available until 9:46 a.m. (about 2 hours late). RPH 4 and RN 4 confirmed the PTT result were not available in a timely manner (about 8 hours after the adjustment of heparin dose on 12/3/20 at 1:49 a.m.). RN 4 stated the PTT results should be available sooner.

b. During a concurrent interview and record review on 12/10/20, at 10:55 a.m., with DP, RPH, and RN 4, Patient 26's EMR was reviewed and showed the following:

The clinical record indicated on 12/3/20 at 3:31p.m., the PTT result was 51 seconds. Heparin infusion rate was increased to 2,150 units/hr (or 21.5 mls/hr) at 7:37 p.m. (or more than 4 hours after the PTT result).

The clinical record indicated on 12/4/20 at 9:38 a.m., the PTT result was 41 seconds. Heparin bolus of 8,000 units was administered at 11:11 a.m. (or more than 1.5 hours after the PTT result).

RPH 4 and RN 4 confirmed the heparin infusion rate was not adjusted in a timely manner (more than 4 hours after the PTT result on 12/3/20 at 3:31 p.m.), and the heparin bolus was administered late (more than 1.5 hours after the PTT result on 12/4/20 at 9:38 a.m.)

During a concurrent interview and record review, on 12/22/20, at 10:15 a.m., with RN 6, Pt 44's medical records for 9/8/20 were reviewed. RN 6 confirmed that she took care of Pt 44 on 9/8/20 and that this patient was on a heparin drip for an Acute MI (myocardial infarction- heart attack). RN 6 confirmed that a PTT was drawn on Pt 44 on 9/8/20 at 4:25 a.m., and she changed the heparin drip dosage at 10:50 a.m. based on the results from 4:25 a.m. RN 6 stated the expectation is that the heparin dose is changed as soon as possible or within an hour of receiving the last PTT results.

During an interview on 12/22/20, at 9:50 a.m., with the Director of Quality Management and Risk (DQMR), the DQMR stated the Director of Intensive Care and Respiratory Services last day working for this facility was on 12/21/20. The DQMR stated the New Chief Nursing Officer (NCNO ) was in charge of the Intensive Care and Respiratory Services at this time until they hire a new director.

During a concurrent interview and record review, on 12/22/20, at 10:30 a.m., with the NCNO, Pt 44's Heparin Flowsheet for Acute MI and Pt 44's PTT results, were reviewed. The NCNO confirmed on 9/8/20 at 4:25 a.m. Pt 44's PTT results were 34. The NCNO confirmed on 9/8/20 at 10:50 a.m. the 4:25 a.m. PTT results were used to adjust Pt 44's heparin drip. The NCNO stated the expectation is the heparin drip will be adjusted as soon as possible after receiving the PTT results, six hours later is not acceptable. The NCNO stated the PTT results were probably inaccurate since it was done 6 hrs earlier. The NCNO stated the risks of having Pt 44's PTT at 34 while they were having an MI were increased muscle damage, decreased perfusion, and a higher risk of clotting.

During a concurrent interview and record review on 12/22/20, at 12:50 p.m., with the Director of Pharmacy (DP), Pt 44's Heparin Flowsheet for Acute MI and Pt 44's PTT results, were reviewed. The DP confirmed Pt 44's PTT results on 9/8/20 at 4:25 a.m. were used for the heparin rate change at 10:50 a.m. The DP stated these results should not have been used for this rate change. The DP stated the PTT results would most likely be lower since it was six hours before they adjusted the heparin drip rate, "this puts the patient at higher risk of clotting since the PTT wasn't in optimal range."

c. During a concurrent interview and record review on 12/10/20, at 11 a.m., with DP, RPH, and RN 4, Patient 26's EMR was reviewed and showed the following: * On 12/5/20 at 2:00 p.m., the PTT result was 36 seconds. The heparin protocol indicated to give heparin bolus of 40 units/kg when PTT level was less than 50 seconds. However, there was no heparin bolus was administered to Patient 26 at that time. RPH 4 and RN 4 confirmed the heparin bolus was not administered to Patient 26. RN 4 stated the nurse should administer the heparin bolus dose to the patient as per the heparin protocol.

During a review of the hospital's policy and procedure (P&P) titled, "High Risk & High Alert Medications" dated 9/2019, the P&P indicated, heparin was one of the high-risk medications.

During an interview on 12/11/20 at 10:05 a.m., with the DP, Director of Medical Surgical Services (DMSS), and RPH 4, they acknowledged that the nurse did not follow the heparin infusion protocol, and Patient 26's therapeutic goal of PTT level was not achieved after three days. The DP stated the pharmacy reviewed the heparin order and protocol but the pharmacy did not monitor every 6 hours titration of the heparin protocol with the nurse. The DP and RPH 4 confirmed that heparin was a high-risk medication.

2. During a concurrent observation and interview on 12/8/20, at 10:45 a.m., RN 5 was observed administering Protonix 40 mg (milligram) via IVP (Intravenous push - manually administer medication by using a syringe) for Patient 20 in approximately 52 seconds. When asked how long she should administer Protonix 40 mg IVP, RN 5 stated she had to look it up. She checked the hospital's drug reference and stated Protonix 40 mg IVP should be given over at least 2 minutes.

During an interview on 12/8/20, at 10:50 a.m., with the DP and RN 5, the DP checked the hospital's drug reference and stated Protonix 40 mg IVP should be given over at least 2 minutes.

During a review of the hospital's P&P titled, "Medication Orders, Administration and Documentation" dated 6/18, the P&P indicated, "All licensed nursing personnel are expected to know the purpose of the medications they are administering, the recommended dosage, route of administration and contraindications before administering any drug to a patient. If the nurse is unfamiliar with the ordered drug, he/she must review the package insert (a document included in the package of a medication that provides information about that drug and its use) ...whichever is applicable, prior to the administration of the drug"

During a review of the "Full Prescribing Information" for Protonix IV provided by the hospital, the "Full Prescribing Information" for Protonix IV indicated, "Administer intravenously over a period of at least 2 minutes."

3. During a review of the hospital document titled, "Intensive Care Unit [ICU] Daily Assignment Sheet," dated 12/9/20, the ICU Daily Assignment Sheet indicated "Day [7 a.m. to 7 p.m.]," CC 6 was assigned to provide orientation to RNT 1. CC 6 and RNT 1 were assigned to care for Pt 53 in room (Rm) 301.

During a review of Pt 53's demographic face sheet (document in the Pt's clinical record that indicates important information about the patient such as address, emergency notification, date of birth, date of hospital admission and other important information) with the admission date 11/13/20 at 7:31 p.m., indicated Pt 53 was assigned to Rm 301.

During an interview and record review on 12/17/20 at 2:45 p.m., with Registered Pharmacist (RPH) 3, an electronically generated audit log was reviewed. RPH 3 validated the electronic audit log indicated on 12/9/20, the medication Meropenem (antibiotic [medication used to prevent or eliminate infection]) 1 GM (gram [unit of measure]) was scheduled to be administered to Pt 53 at 10:30 a.m. and 6:30 p.m. (8 hours between doses) and RNT 1 had administered the Meropenem to Pt 53 at 3:04 p.m. and 5:43 p.m. (2 hours and 39 minutes between doses). RPH 3 stated RNT 1 had made a medication error by administering two doses with only 2 hours and 39 minutes between doses; the doses were administered too close together. RPH 3 stated he knew RNT 1 had made the error because RNT 1 had called and notified him about the error.

During an interview on 12/17/20 at 9:15 a.m. with Chief Nursing Officer (CNO) 1, CNO 1 stated RNT 1 hung a bag of antibiotic medication and administered it to Pt 53, administered another dose of antibiotics a couple hours later and because of the medication error, they had to let RNT 1 go [terminated employment] on RNT 1's second day at the hospital.

During an interview on 12/18/20 at 10:55 a.m. with the DICRS, the DICRS stated, "she [referring to RNT 1] seemed overwhelmed, that's why I let her go, I wouldn't have her back because of the medication error."

During review of the hospital document titled, "[hospital name] Traveler/Registry Staff Nursing Orientation," undated, indicated, " ...Objectives Explain the process for accessing policies and procedures, Verbalize policy and procedures for ...Medication Administration/Narcotic Wasting, IV Therapy ...Standards of Nursing Care Department specific located in [hospital] Policies ...Adopted and followed by all licensed nursing staff. Defines expected nursing actions and behaviors. Used to measure level of competency ...Medication Safety 6 Rights of Medication administration. Right patient, Right medication, Right routs, Right dose, Right time, Right to refuse ..."

During a review of the Centers for Disease Control (CDC) professional reference titled, " Antibiotic Do's & Don'ts," dated 1/31/20, the CDC professional reference indicated, " ...Smart use of antibiotics is the best care ...steps you can take to use antibiotics appropriately so you can get the best treatment ...protect yourself from harms caused by unnecessary antibiotic use, and combat antibiotic resistance. Take antibiotics ONLY if you need them ...Taking antibiotics when they're not needed won't help you, and their side effects can still cause harm ...Take antibiotics exactly as prescribed if you need them ..." https://www.cdc.gov/antibiotic-use/community/about/can-do.html.

4. During a concurrent interview and record review on 12/9/20, at 1:55 p.m., with the Director of Pharmacy (DP), the Inservice & Education Coordinator (IEC), and Registered Pharmacist (RPH) 4. The house supervisors took the medications [Bumex (medication use to treat fluid retention and high blood pressure) 2.5 mg (milligram)/10 ml (milliliter) and sodium bicarbonate (medication use to neutralize excess acid levels in the blood) 50 mEq (milliequivalent)] from the Pyxis night locker (an automated dispensing cabinet of medications access by designated personnel when the pharmacy is closed). The house supervisors prepared the medium risk level (compounding process includes complex aseptic manipulations other than the single-volume transfer) compounded sterile preparations (CSPs) (Bumex 24 mg in 240 ml dextrose 5% and sodium bicarbonate 150 mEq in1000 ml dextrose 5%) in the Intensive Care Unit (ICU) storage room without IV hood (a work area where intravenous products are compounded). The DP stated the pharmacy did not train or evaluate the house supervisors for the competency in IV compounding. The IEC stated she did not conduct training on IV compounding for the house supervisors.

During an interview on 12/14/20, at 4:55 p.m., with Nursing House Supervisor (NHS) 1, NHS 1 stated one of her responsibilities as a NHS was permitted to access and mix [compound] all medications from the pharmacy night locker including antibiotics, amiodarone, sodium phosphate, bumex, sodium bicarbonate, and protonix and the medications were mixed in the medication room near the night locker. NHS 1 stated, "We have to make it if it's not available." NHS 1 stated the Director of Pharmacy Services (DPS) and the former Chief Nursing Officer (CNO) had instructed her to do it that way [mix medications] regardless of the level of risk for the medication. NHS 1 stated she had been following this practice for approximately seven years and she had not received any specialized training or education related to mixing medications except from another house supervisor. NHS 1 could not recall the name of the other house supervisor. NHS 1 stated she does not know what qualifications or competencies are necessary to allow her to mix medications, she was unsure which medications were medium or high risk, and she just mixes the medications because they were ordered after the pharmacist has left the hospital.

During a interview on 12/15/20, at 9:18 a.m., with NHS 2, NHS 2 stated he has been acting in NHS role since 2012 and he has access to all the medications in the night locker including antibiotics, all types of insulin, sodium bicarbonate, bumex, rocephen, unison, and other medications and he mixes medications in the medication room near the night locker. NHS 2 stated He has been mixing medication since 2014, the DPS and the former CNO advised him that he could mix three separate medications or more; that was part of the NHS job description. NHS 2 stated on multiple occasions he contacted the on-call pharmacist, but they would not come into the hospital. NHS 2 stated he had received instruction from a former NHS, the DPS and NHS's were not required to complete any medication compounding competency, and the former CNO had instructed them to perform medication compounding processes.

During a review of the hospital's policy and procedure (P&P) titled, "Sterile Compounding: Training, Competency, Quality Assurance Process Validation, and Recordkeeping" dated 6/20, the P&P indicated, "[hospital's name] pharmacy shall maintain documentation, demonstrating that personnel involved in compounding have the skills and training required to properly and accurately perform their assigned responsibilities and documentation demonstrating that all personnel involved in compounding are trained in all aspects of policies and procedures. This training shall include but is not limited to support personnel (e.g. institutional environmental services, housekeeping), maintenance staff, supervising pharmacist and all others whose jobs are related to the compounding process ...Each person engaged in sterile compounding must successfully complete practical skills training in aseptic technique and aseptic area practices ...Each pharmacist responsible for, or directly supervising and controlling, aseptic techniques or practices, must demonstrate the skills needed to ensure the sterility of compounded drug preparations ...Each person's proficiency and continuing training needs must be reassessed at least every 12 months. Results of these assessments must be documented and retained in the pharmacy for three years." USP Chapter 797 was one of the references of this hospital's P&P.

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations revised 2012 in the section Personal Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures showed, "Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel and through multimedia instructional sources and professional publications in the theoretical principles and practical skills of garbing procedures, aseptic work practices, achieving and maintaining ISO (International Organization for Standardization) Class 5 ...environmental conditions, and cleaning and disinfection procedures."

During a review of professional reference, Business and Professions Code Division 2. Healing Arts, Chapter 9. Pharmacy, Article 3. Scope of Practice and Exemptions; 4051, the professional reference indicated, "(a) Except as otherwise provided in this chapter, it is unlawful for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription pursuant to Section 4040 of a prescriber unless he or she is a pharmacist under this chapter ..." https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=BPC§ionNum=4051.

Based on interview and record review, the hospital failed to have an effective system to maintain the medical record for each patient treated in the hospital when:

1. Properly executed (legally and properly signed with explanation) informed consent documents (record of communication between provider and patient to authorize a specific medical care) were not completed per the hospital Policy and Procedures for eight of 13 patient charts reviewed (Pt 42, 43, 44, 45, 47, 48, 49, and 51). (Refer to A466).

2. Patient and the patients' representative's involvement was not fully documented in discharge planning care details for four of 13 patients (Pt 45,47,49,51) for:
a. instructions on all medications at discharge explained to the patient and patient representative (Pt 49 and 51) and
b. safety protocols to prevent spread of infection following discharge not provided to Pt 43 and 45 or their representatives and
c. failed to use interpretive services for non-English speaking patients for four of 13 patients (Pt 45, 47, 49, and 51). (Refer to A808)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide Medical Record Services in an effective manner with documented informed consent that was legally secured as required for patient rights. Patient and representative were not informed of discharge plans and post-hospital care instructions in accordance with the statutory mandated Conditions of Participation for Medical Record Services.

Based on interview and record review, the facility failed to obtain properly executed (legally and properly signed with explanation) informed consent documents (record of communication between provider and patient to authorize a specific medical care) per their Policy and Procedures for eight of 13 patient charts reviewed (Pt 42, 43, 44, 45, 47, 48, 49, and 51). These failures had the potential to result in treatment and procedures performed that violated patients' right to consent and to have treatment explained, without full disclosure of medical information to the patient or their designated representative.

Findings:

1. During a concurrent interview and record review, on 12/8/20, at 2:43 p.m., with the Director of Health Information (DHI) and Registered Nurse Informaticist (RNI), Pt 42's electronic medical records (EMR) admission dated 9/30/20 were reviewed. The DHI and RNI both stated that Pt 42 was a 94-year-old admitted with left hip fracture (break in the bone) and a diagnosis of dementia (a brain disorder that causes memory issues, personality changes, and impaired reasoning). DHI and RNI stated Pt 42's face sheet showed the patients primary language was English. DHI and RNI stated the Emergency Department (ED) Assessment dated 9/30/20 stated, "Patient is Mandarin speaking (mandarin is the most widely spoken form of Chinese language) and limited history was obtained." DHI and RNI also stated that Pt 42's History & Physical dated 9/30/20, stated, "History limited 2/2 [secondary to] language barrier". The DHI and the RNI both stated during a concurrent record review of Pt's 42's EMR two Conditions of Admission on 9/30/20 [one in the ED and one on the Medical unit]; record review for Pt 42's Consent for Surgery on 10/2/20; and the Patient Signature Page for discharge instructions dated 10/2/20 were reviewed and all stamped "PATIENT UNABLE TO SIGN." Both the DHI and the RNI stated that the facility should have contacted the patients designated representative if they were unable to get the patient's signature. The DHI and the RNI stated that all consents for admission and authorization for treatment, for surgery and for discharge arrangements, for Pt 42 were in English and none were done in Mandarin which was Pt 42's primary language. The DHI and the RNI both stated consents should be in the patient's primary language and an interpreter should have been used. The DHI and the RNI both stated interpreter services were not used for any of Pt 42's consents.

2. During a concurrent interview and record review, on 12/8/20, at 3:44 p.m., with the DHI and RNI, Pt 43's EMR admission dated 7/30/20, was reviewed. The DHI and the RNI stated that Pt 43 was a 71-year old patient admitted with Acute Respiratory Failure (condition in which lungs have a hard time loading blood oxygen), pneumonia due to COVID-19 virus (Lung infection caused by COVID-19 virus- Coronavirus disease 2019- respiratory illness), and septic shock (infection in the blood that can cause shock symptoms include fever, chills, tachycardia, and increased respiratory rate; medical emergency that requires urgent medical attention). The DHI and the RNI stated Pt 43 had a central line (tube placed in a vein for long-term drug therapy) placed and was intubated (tube placed to help one breathe) while in the emergency room on 7/30/20. The DHI and the RNI stated Pt 43's face sheet had Pt 43's wife as his emergency contact. The DHI and the RNI stated that the patient and the patient's personal representative did not sign either of the Conditions of Admission (COA) dated 7/30/20. The DHI and the RNI stated both COA's were stamped "PATIENT UNABLE TO SIGN," with no indication why the patient was not able to sign.

3. During a concurrent interview and record review, on 12/9/20, at 2 p.m., with the DHI and RNI, Pt 44's EMR admission dated 9/5/20 was reviewed. The DHI and the RNI stated PT 44 was admitted to the hospital for altered mental status, end stage renal disease (ESRD, a chronic loss of kidney function) and sepsis (a potential life-threatening infection). The DHI and the RNI stated that Pt 44's face sheet dated 9/5/20, indicated his primary language was Spanish. During a concurrent interview and record review on 12/9/20 at 2 p.m., with the DHI and the RNI, Pt 44's Transfer to an Outside Facility document dated 9/17/20 was marked as "Telephone Consent," but not signed by Pt 44's spouse and only cosigned by one witness.

4a. During a concurrent interview and record review, on 12/9/20, at 3 p.m., with the DHI and the RNI, Pt 45's EMR was reviewed for her admission date 9/22/20. The DHI and the RNI stated Pt 45 was admitted for congestive heart failure (CHF-heart does not pump effectively causing back up of fluids), positive corona virus test (COVID-19), with history of coronary artery disease (CAD- fatty deposits in the arterial walls thus narrowing the arteries), and right sided chest pain. The DHI and the RNI stated Pt 45's face sheet indicated Pt 45 was Spanish speaking and had designated a daughter for their emergency contact. The DHI and the RNI stated Pt 45's Patient Signature Page on 9/28/20 for discharge was not in Spanish and indicated a handwritten notation of "Gave telephone instructions to [daughter's name]" in signature space. The DHI and the RNI reviewed Pt 45's test results for COVID-19 dated 9/23/20 at 1527 p.m., the DHI and RNI stated Pt 45 results indicated "abnormal: Detected". The DHI and the RNI reviewed Case Management notes for 9/23/20 and 9/26/20 and stated that neither provided the family with the COVID-19 diagnosis or education on quarantine/isolation for the patient and family members since the patient would be returning home. The DHI and RNI stated that during the concurrent interview and record review of Pt 45's discharge instructions dated 9/28/20, it did not include education for patient or family on COVID-19.

4b. During a concurrent interview and record review, on 12/9/20, at 3:30 p.m., with the DHI and the RNI, Pt 45's EMR was reviewed for her admission date of 10/11/20. The DHI and RNI stated that Pt 45's was a re-admission from her previous admit on 9/22/20. The DHI and RNI stated Pt 45's diagnosis for this admission (10/11/20) was fall with injury (hematoma {bruise}) to the left forehead, cerebral vascular accident (stroke- blood flow to a part of the brain is stopped either by a blockage or rupture of a blood vessel), chronic renal failure (kidneys do not function properly) and past history of COVID-19. The DHI and the RNI stated the following consent documents for Pt 45 were not signed by the patient or personal representative or in the patient's primary language:
- The COA (Spanish Version) for 10/11/20, showed a handwritten entry of "Patient unable to sign" and "Patient came in altered mental status. Unable to sign due to being unresponsive"
- The Patient Transfer Acknowledgement was unsigned by patient or patient representative on the transfer date of 10/16/20.
- The Patient Signature Page for discharge instructions was signed on 10/16/20 by Pt 45 however it was in English and not in Spanish and there was no mention of interpreter services used.

5. During a concurrent interview and record review, on 12/9/20, at 3:45 p.m., with the DHI and the RNI, Pt 47's EMR for his admission on 6/16/20 was reviewed. The DHI and the RNI stated Pt 47 was admitted with diagnosis of CHF, chronic kidney disease (kidneys do not filter properly) and experienced a cardiac arrest (heart stops functioning) while in the emergency room. The DHI and the RNI stated Pt 47's face sheet indicated Pt 47 was Spanish speaking. The DHI and the RNI stated the following consent documents were not signed by Pt 47 nor the patient's representative:
- The COA for 6/16/20 was stamped, "PATIENT UNABLE TO SIGN."
- Patient Signature Page for Discharge Instructions on 7/1/20 were in English and stamped, "PATIENT UNABLE TO SIGN."
- The Consent for Surgery for a thoracentesis (removal of fluid by a needle placed in the chest cavity) procedure dated 6/18/20 and 6/21/20 both indicated "PATIENT UNABLE TO SIGN."

6. During a concurrent interview and record review, on 12/10/20, at 2 p.m., with the DHI and the RNI, Pt 48's EMR for her admission on 1/21/20 was reviewed. The DHI and the RNI stated Pt 48 was admitted on 1/21/20 for altered mental status and diabetes mellitus (disease in which the body's ability to produce or respond to the hormone insulin is impaired) and discharged on 2/20/20. The DHI and the RNI stated the following consent documents were not signed by Pt 48 nor the patient's representative:
- The COA for 1/21/20 was stamped, "PATIENT UNABLE TO SIGN," and there was no indication that patient's representative was contacted for consent.

7. During a concurrent interview and record review, on 12/10/20, at 2:30 p.m., with the DHI and the RNI, Pt 49's EMR for his admission on 4/23/20 was reviewed. The DHI and the RNI stated Pt 49 was admitted on 4/23/20 and discharged on 5/3/20. Pt 49's face sheet indicated Spanish was Pt 49's primary language. The DHI and the RNI stated the following consent documents were not signed by Pt 49 nor the patient's representative:
- The COA (Spanish Version) for 4/23/20 was stamped, "PATIENT UNABLE TO SIGN," with no indication why patient was not able to sign.
- Patient Signature Page for discharge instructions dated 5/3/20 had handwritten comment, "Patient unable to sign." The 61- pages of discharge instructions were in English only.

8. During a concurrent interview and record review, on 12/10/20, at 2:45 p.m., with the DHI and the RNI, Pt 51's EMR for his admission on 10/17/20 was reviewed. The DHI and the RNI stated Pt 51 was admitted for acute kidney injury and acute urinary tract infection on 10/17/20. Pt 51's face sheet indicated Pt 51's primary language was Spanish. The DHI and the RNI stated the following consent documents were either not signed or dated and timed by Pt 51 nor the patient's representative or in the patient's primary language:
- The COA on 10/17/20 was stamped, "PATIENT UNABLE TO SIGN."
- Pt 51 was discharged on 10/23/2020 per the Discharge Summary. The Patient Signature Page for discharge instructions was signed by the patient but was not dated nor timed and was in English only.

During a concurrent interview and Policy and Procedure (P&P) review, on 12/10/20, at 3 p.m., with DHI, the P&P titled, "Chart Assembly/Scanning," dated 2/20/20, was reviewed. The DHI stated that the P&P indicated, " ... The Legal Medical Record is stored in the EMR [Electronic Medical Record, same as the E.H.R] within [Vendors name], and at a minimum consists of the following documents: 1. Patient's Demographic Face Sheet ... 16. Miscellaneous to include Consent forms, Conditions of Admission ... and other outside or miscellaneous documents ..."

A review of the facility's P&P titled, "Registration Forms Requiring Patient Signature," dated 2/96 (last revised 10/20), was reviewed. The P&P indicated, " ... POLICY: Admissions specialist to ensure patients are registered appropriately, ensure all paperwork and forms are explained to the patient or responsible party, and ensure all required forms are signed by the patient or responsible party. RESPONSIBILITY: 1. All patient's or responsible party must sign the Conditions of Admission (C of A) and Authorization for Treatment form ... 3. A responsible party includes but is not limited to a spouse, parent, adult child, adult sibling, or next of kin. 4. All forms must be signed by the patient or responsible party and witnessed by one employee. If a patient is unable to sign but is able to give verbal consent, the forms must be witnessed by two employees. A consent received over the telephone by a responsible party shall require two witnesses ... All signatures must be in legible handwriting. 5. In the event that a patient cannot give written or verbal consent, the reason why must be stated on the form and witnessed by two employees ... the admission staff will follow up with the patient to receive a signature once patient is within capacity to sign or contact responsible party. All forms are required to be signed before the patient is discharged ..."

Based on observations, interviews, and record reviews, the hospital failed to ensure the provision of pharmaceutical services met the needs of patients as evidenced by:

1. The pharmacy staff failed to post the correct medication name of the first medication to be expired within one of one malignant hyperthermia [MH, a rare but potentially fatal syndrome triggered by an anesthetic (numbing) agent] cart. (refer to A0491, # 1)

2. The pharmacy staff failed to ensure the medication in one of one MH cart matched the medication content list. One bag of 3,000 ml (milliliter) 0.9% sodium chloride irrigation (use for washing, irrigation and rinsing purposes) was stored in the refrigerator instead of three bags of 1,000 ml refrigerated cold saline (0.9% sodium chloride) solution for IV (intravenous) cooling. (refer to A0491, # 2)

3. The hospital failed to ensure the pharmacist was involved in the training and competency evaluation for two of two house supervisors who were performing sterile (germ-free) IV compounding (mixing medications). (refer to A0492)

4. The pharmacy did not take further corrective actions to identify a highly pathogenic (capable of causing disease) microorganism (yeast) in the segregated compounding room (a designated space for sterile-to-sterile compounding) one of one air sampling with positive yeast result to the genus level (rank to classify organisms). (refer to A0501, # 1)

5. The pharmacy did not investigate into the source of the highly pathogenic microorganisms with the assistance of a competent microbiologist (a scientist who studies microorganisms including bacteria, fungi or yeast), infection control professional, or industrial hygienist. (refer to A0501, # 2)

6. The top surfaces of one of one CAI [Compounding Aseptic Isolator, a form of IV hood (a work area where IV products are compounded)] and one of one LAFH (Laminar Air Flow Hood, a form of IV hood) were not clean. Also, Environmental Assistant-Housekeeper (EAH) 2 was unable to clean the entire area behind the LAFH and back wall. (refer to A0501, # 3)

7. EAH 2's competency assessment was not completed in the year of 2019 and 2020. (refer to A0501, # 4)

8. Review of the Pyxis night locker (an automated dispensing cabinet of medications access by designated personnel when the pharmacy is closed) report for one month showed two nursing staff prepared the medium-risk (multiple individual or small doses of sterile products are combined or pooled to prepare a mixed product) compounded sterile preparations (CSPs) in Intensive Care Unit (ICU) storage room without the IV hood. (refer to A0501, # 5)

9. Two of two nursing staff had not been reassessed every 12 months for preparing IV compounding. (refer to A0501, #6)

10. The hospital failed to ensure the medications were stored securely and safely in outpatient radiology building and the West Medical Surgical floor of the main hospital. (refer to A0502, # 1 and 2)

11. Two outdated (no longer useful) medications were found in the pharmacy's refrigerator and the West patient medication cubbies (small boxlike enclosures for patient's medications). (refer to A0505, # 1)

12. The pharmacy staff labeled one of one opened Adrenalin (medication for blood pressure control) vial with 30 days Beyond Use Date (BUD, the date or time after which a medication shall not be stored). (refer to A0505, # 2)

13. An expired bag of Lactated Ringer's (medication to replace fluids and electrolytes) was found in the West clean utility supplies room. (refer to A0505, # 3)

14. One of one each of the pre-mixed (mixed in advance) levofloxacin (an antibiotic medication) 250 mg (milligram) and 500 mg without a foil overwrap were not protected from light on the pharmacy's medication shelf. (refer to A0505, # 4)

15. The hospital failed to develop and implement their policy and procedure (P&P) for the safe use of ketorolac (an anti-inflammatory medication) when the hospital's P&P for Medication Automatic Stop Orders did not limit the duration of ketorolac therapy to five days in accordance with the manufacturer's specifications. (refer to A0507)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide pharmaceutical services in a safe and effective manner in accordance with the statutory-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interview, and record review, the hospital failed to implement the hospital's policy and procedure (P&P) for the safe and effective storage of the emergency medications in one of one malignant hyperthermia [MH, a rare but potentially fatal syndrome triggered by an anesthetic (numbing) agent] cart as evidenced by:

1. The pharmacy staff failed to post the correct medication name of the first medication to be expired within the MH cart.

2. The pharmacy staff failed to ensure the medication in the MH cart matched the medication content list. One bag of 3,000 ml (milliliters) 0.9% sodium chloride irrigation (use for washing, irrigation and rinsing purposes) was stored in the refrigerator instead of three bags of 1,000 ml refrigerated cold saline (0.9% sodium chloride) solution for IV (intravenous) cooling.

These failures had the potential to delay in treatment to patients with malignant hyperthermia which was an emergent, potentially fatal syndrome.

Findings:

1. During a concurrent observation and interview on 12/8/20 at 3:55 p.m., with the Director of Pharmacy (DP), in the hospital's Preoperative room, the MH cart was inspected. The orange label that was posted on the outside of the MH cart, showed "Crash Cart Check", "First Drug to Exp.(expire)" on 6/1/21, and "Name of Drug" "Bicarb (bicarbonate, medication use to neutralize excess acid levels in the blood) vial." However, an inspection of the medication tray of the MH cart at that time showed there were 24 vials of sterile water for injection 50 ml with the expiration date of 5/1/21. The DP confirmed the orange label on the outside of the MH cart was incorrect. The DP stated the orange label should show the sterile water for injection with the expiration date of 5/1/21.

2. During a concurrent observation and interview on 12/8/20 at 3:55 p.m., with DP, in the hospital's Preoperative room, an inspection of the refrigerator next to the MH cart showed there was one bag of 3,000 ml 0.9 % sodium chloride irrigation stored in the refrigerator. The DP stated there should be three bags of 1,000 ml refrigerated cold saline solution for IV cooling in the MH cart. The DP stated one bag of 3,000 ml 0.9% sodium chloride irrigation was not the same as three bags of 1,000 ml refrigerated cold saline solution for IV cooling in the MH cart.

During a review of the hospital's P&P titled, "Malignant Hyperthermia" dated 12/19, the P&P indicated, "The Malignant Hyperthermia/Crisis Cart will remain locked and ready for emergency use. The pharmacy checks the drugs for outdates on a monthly basis. The Surgical Services staff will inventory the cart on a monthly basis, and the cart will be locked by pharmacy after the contents are verified ... Cool the patient with core temperature > (greater than) 39°C (Celsius), lavage (washing out) open body cavities, stomach, bladder, or rectum ... Infuse cold saline intravenously ... Malignant Hyperthermia and Crisis Cart Contents ... MH (malignant hyperthermia) Refrigerator ...3 ea (each) - 1000 ml refrigerated cold saline solution for IV cooling."

Based on interview and record review, the hospital failed to ensure the pharmacist was involved in the training and competency evaluation for two of two house supervisors who were performing sterile (germ-free) intravenous (IV) compounding (mixing medications). This failure had the potential to increase the risk of medication errors and contaminations of the sterile compounding products, which would be harmful for patients.

Findings:

On 12/9/20 at 1:55 p.m., a concurrent interview and record review was conducted with the Director of Pharmacy (DP), the Inservice & Education Coordinator (IEC), and Registered Pharmacist (RPH) 4. Review of the Pyxis night locker (an automated dispensing cabinet of medications access by designated personnel when the pharmacy is closed) record showed Nurse House Supervisor (NHS) 3 took 10 vials of Bumex (medication use to treat fluid retention and high blood pressure) 2.5 mg (milligram)/10 ml (milliliter) and NHS 2 took three vials of sodium bicarbonate (medication use to neutralize excess acid levels in the blood) 50 mEq (milliequivalent) from the Pyxis night locker. NHS 3 and NHS 2 prepared the medium risk level (multiple individual or small doses of sterile products are combined or pooled to prepare a mixed product) compounded sterile preparations (CSPs) [Bumex 24 mg in 240 ml dextrose 5% (an IV solution) and sodium bicarbonate 150 mEq in 1,000 ml dextrose 5%] in the Intensive Care Unit (ICU) storage room without IV hood (a work area where intravenous products are compounded). The DP stated the pharmacy did not train or evaluate the house supervisors for the competency in IV compounding. The IEC stated she did not conduct training on IV compounding for the house supervisors.

During an interview on 12/9/20 at 6:50 p.m., with NHS 1, NHS 1 stated she had been the house supervisor for seven years and the previous house supervisor showed her how to mix the intravenous medications seven years ago. NHS 1 further stated she had not been trained by a pharmacist or pharmacy staff on the IV compounding. NHS 1 stated she was not aware of USP <797> [United States Pharmacopoeia (a book contains a list of drugs) chapter describing conditions and practices for compounding sterile drugs] and she should have training on the IV compounding.

During an interview on 12/10/20 at 9:00 a.m., with the DP, the DP stated he was not aware that medium risk level CSPs (Bumex 24 mg in 240 ml dextrose 5% and sodium bicarbonate 150 mEq in 1,000 ml dextrose 5%) were compounded in the ICU storage room. The DP further stated the house supervisor should be trained and should have competency assessment for sterile IV compounding. When asked who was responsible for sterile IV compounding in the hospital, the DP stated pharmacy was responsible for sterile IV compounding in the hospital. The DP further stated pharmacy should be responsible to train hospital's staff who engaged in the IV compounding. The DP confirmed pharmacy should be responsible to train the house supervisor on sterile IV compounding.

During an interview on 12/10/20 at 6:40 p.m., with NHS 2, NHS 2 stated two house supervisors trained him on mixing medications on 2014. NHS 2 further stated he had not had any annual training or competency assessment since 2014. NHS 2 stated it would be nice to have yearly competency assessment.

During a follow up interview on 12/11/20 at 9:04 a.m., with the DP, the DP confirmed the house supervisor should not prepare the medium risk CSPs with three or more entries into an IV solution bag (container, such as: using 10 vials of Bumex to mix Bumex 24 mg in 240 ml dextrose 5% or using three vials of sodium bicarbonate to mix sodium bicarbonate 150 mEq in 1000 ml dextrose 5%). The DP further stated the house supervisor should call the on-call pharmacist to prepare the medium risk CSPs.

On 12/11/20 at 9:45 a.m., the DP stated the pharmacist was the expert personnel of sterile IV compounding in the hospital and pharmacist should be responsible for training hospital's staff on the sterile IV compounding.

During a review of the hospital's P&P titled, "Sterile Compounding: Training, Competency, Quality Assurance Process Validation, and Recordkeeping" dated 6/20, the P&P indicated, "[hospital's name] pharmacy shall maintain documentation, demonstrating that personnel involved in compounding have the skills and training required to properly and accurately perform their assigned responsibilities and documentation demonstrating that all personnel involved in compounding are trained in all aspects of policies and procedures. This training shall include but is not limited to support personnel (e.g. institutional environmental services, housekeeping), maintenance staff, supervising pharmacist and all others whose jobs are related to the compounding process...Each person engaged in sterile compounding must successfully complete practical skills training in aseptic [free from contamination] technique and aseptic area practices...Each pharmacist responsible for, or directly supervising and controlling, aseptic techniques or practices, must demonstrate the skills need to ensure the sterility of compounded drug preparations...Each person's proficiency and continuing training needs must be reassessed at least every 12 months. Results of these assessments must be documented and retained in the pharmacy for three years." USP Chapter <797> was one of the references of this hospital's P&P.

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations revised 2012 in the section Personal Training and Competency Evaluation of Garbing [gowning], Aseptic Work Practices, and Cleaning/Disinfection Procedures showed, "Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel and through multimedia instructional sources and professional publications in the theoretical principles and practical skills of garbing procedures, aseptic work practices, achieving and maintaining ISO (International Organization for Standardization) Class 5 ...environmental conditions, and cleaning and disinfection procedures."

Based on observation, interview, and record review, the hospital failed to develop and implement the hospital's policy and procedure (P&P) for the safe sterile (germ-free) compounding (mixing medications) in accordance with the USP <797> [United States Pharmacopoeia (a book contains a list of drugs) chapter describing conditions and practices for compounding sterile drugs] as evidenced by:

1. The pharmacy did not take further corrective actions to identify a highly pathogenic (capable of causing disease) microorganism (yeast) in the segregated compounding room (a designated space for sterile-to-sterile compounding) one of one air sampling with positive yeast result to the genus level (rank to classify organisms).

2. The pharmacy did not investigate into the source of a highly pathogenic microorganism (yeast) with the assistance of a competent microbiologist (a scientist who studies microorganisms including bacteria, fungi or yeast), infection control professional, or industrial hygienist.

3. The top surfaces of one of one CAI [Compounding Aseptic Isolator, a form of IV (intravenous) hood (a work area where IV products are compounded)] and one of one LAFH (Laminar Air Flow Hood, a form of IV hood) were not clean. Also, Environmental Assistant-Housekeeper (EAH) 2 was unable to clean the entire area behind the LAFH and back wall.

4. EAH 2's competency assessment was not completed in the year of 2019 and 2020.

5. Review of the Pyxis night locker (an automated dispensing cabinet of medications access by designated personnel when the pharmacy is closed) report for one month showed two nursing staff prepared the medium-risk (multiple individual or small doses of sterile products are combined or pooled to prepare a mixed product) compounded sterile preparations (CSPs) in Intensive Care Unit (ICU) storage room without the IV hood.

6. Two of two nursing staff had not been reassessed every 12 months for preparing IV compounding.

These failures had the potential to increase the risk of contamination of the sterile compounding products.

Findings:

1. During an interview with the Director of Pharmacy (DP) on 12/7/20 at 3:00 p.m., the DP stated the hospital followed the USP Chapter <797> as the hospital's standards for the compounding of CSPs.

During a review of the hospital's P&P titled, "Sterile Compounding: Facility and Equipment Certification, and Quality Control Standards" dated 6/2020, the P&P indicated, "If viable [capable of living or growing] air sampling does not meet requirements, action may include investigating failures in equipment, cleaning, disinfecting, and/or policies and procedures." USP Chapter <797> was one of the references of this hospital's P&P.

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations revised 2012 in the section Environmental Viable Airborne Particle Testing Program showed, "Action Levels, Documentation, and Data Evaluation...Sampling data shall be collected and reviewed on a periodic basis as a means of evaluating the overall control of the compounding environment... An investigation into the source of the contamination shall be conducted. Sources could include HVAC [Heating, Ventilation, and Air Conditioning] systems, damaged HEPA [High Efficiency Particulate Air] filters, and changes in personnel garbing [gowning] or work practices. The source of the problem shall be eliminated, the affected area cleaned, and resampling performed ... Regardless of the number of cfu [colony-forming unit, growth on culture plate] identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered (at least the genus level) by an appropriate credentialed laboratory of any microbial bioburden [number of bacteria living on a surface] captured as a cfu using an impaction air sampler. Highly pathogenic microorganisms (e.g.,...molds and yeasts) can be potentially fatal to patients receiving CSPs and must be immediately remedied, regardless of cfu count..."

Review of the Biological Sampling Report for the test date 11/3/20, showed the following:

* "USP <797> Viable Sample Report" of the center of the segregated compounding room with the test method of "FUNGAL - AIR USP" resulted with "1 CFU/m³ (colony-forming units per cubic meter)."

* "Samples with microorganisms above the recommended action levels per USP <797> or deemed highly pathogenic. Refer to sample page below for detailed results."

* Further review of the Viable Sample Report showed "Yeast (yeast)" was reported with 1 CFU/m³ in the center of the segregated compounding room ISO (International Organization for Standardization - measurement of air cleanliness) 7 on 11/12/20.

During a concurrent interview and record review on 12/9/20 at 10:10 a.m., with DP and Registered Pharmacist (RPH) 1, the DP confirmed yeast was identified in the center of the segregated compounding room. When asked about the source of contamination, the DP stated he could not identify the source of contamination so he retrained the pharmacy staff, cleaned the room, and changed the HEPA filter. When asked whether the yeast had been identified to the genus level, the DP stated the yeast had not been identified to the genus level. The DP further stated the yeast in the segregated compounding room should be identified to genus level.

During an interview on 12/10/20 at 3:00 p.m., with the DP and the Microbiologist (MB), the MB stated the pharmacy should identify the yeast in the segregated compounding room to the genus level to help finding out the source of contamination.

2. Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations revised 2012 in the section Environmental Viable Airborne Particle Testing Program showed, "Action Levels, Documentation, and Data Evaluation...Sampling data shall be collected and reviewed on a periodic basis as a means of evaluating the overall control of the compounding environment... An investigation into the source of the contamination shall be conducted. Sources could include HVAC systems, damaged HEPA filters, and changes in personnel garbing or work practices. The source of the problem shall be eliminated, the affected area cleaned, and resampling performed ...Highly pathogenic microorganisms (e.g.,...molds and yeasts) can be potentially fatal to patients receiving CSPs and must be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist."

During a concurrent interview and record review on 12/9/20 at 10:10 a.m., with DP and RPH 1, the DP confirmed yeast was identified in the center of the segregated compounding room. When asked about the source of contamination, the DP stated he could not identify the source of contamination so he retrained the pharmacy staff, cleaned the room, and changed the HEPA filter. When asked whether the microbiologist and infection control professional were aware of the yeast in the segregated compounding room, the DP stated they were not aware of the positive yeast in the segregated compounding room. The DP further stated he should involve the microbiologist and infection control professional to find out the possible sources of yeast in the segregated compounding room.

During an interview on 12/10/20 at 3:00 p.m., with the DP and the MB, the MB stated he was not aware of the yeast in the segregated compounding room from the Biological Sampling Report on 11/3/20. The DP stated he should consult with the microbiologist to find out the possible sources of contamination and the corrective actions.

3. During a tour of the sterile compounding room on 12/8/20 from 2:00 p.m. to 2:55 p.m., with RPH 3 and RPH 1, in the main pharmacy, inspection of the segregated compounding room showed it contained a CAI on the right side and a LAFH on the left side with a small gap between the CAI and the LAFH. The LAFH was observed bolted to the wall behind the LAFH to prevent it from moving. There was a wall on the right side of the CAI with a small gap between the wall and the CAI. There was a workstation on the left side of the LAFH with a small gap between the LAFH and the counter of the workstation. The surveyor used the lint-free wipe to wipe the top of the CAI and another lint-free wipe to wipe the top of the LAFH. There was a layer of dust on the wipes after wiping the CAI and the LAFH. RPH 3 confirmed the finding. When asked about the area behind the LAFH, RPH 3 stated the gap was about 3 inches between the LAFH and the wall; and there was no way that the environmental service staff could clean the areas behind the LAFH and the wall behind it. Then, RPH 1 came into the sterile compounding room to replace RPH 3. RPH 1 saw the wipes and confirmed the findings.

During an interview on 12/8/20 at 2:55 p.m., with EAH 2 and RPH 1, in the main pharmacy, EAH 2 stated he had been cleaning the IV hoods for about six years. When asked about the top of the LAFH and CAI, EAH 2 stated he tried to clean, but not the entire top of the hood. EAH 2 acknowledged the layer of dust on the lint-free wipe for both of the LAFH and CAI. When asked about the area behind the LAFH, EAH 2 stated he could not clean behind the LAFH and could not clean the entire wall behind the LAFH. EAH 2 further stated he could not clean behind both of the hoods and the entire wall. RPH 1 stated the entire area behind the LAFH, CAI, and the wall should be cleaned.

During an interview on 12/9/20 at 9:30 a.m., with the DP and RPH 1, RPH 1 confirmed the gap between the CAI and the wall was about 3 inches; and the gap between the counter of the workstation and the LAFH was about 4 - 5 inches. RPH 1 stated she thought the environmental service staff could clean the areas behind the hoods and the wall. RPH 1 further stated the top of the hood, the area behind the hood, and the wall were the missing spots. The DP and RPH 1 confirmed environmental service staff should clean the top of the hood, area behind the hood, and the wall monthly.

During a review of the hospital's P&P titled, "Sterile Compounding: Facility and Equipment Cleaning and Disinfecting Standards" dated 6/2020, the P&P indicated, "Purpose: to provide an environment for the safe compounding of sterile drug preparations...Cleaning and disinfection shall be completed as described in this policy and procedure...A sporicidal [tending to kill spores (cells produced by bacteria or fungi)] agent shall be use monthly...Monthly Cleaning: Walls, ceilings, storage shelving, stools and all other items in the segregated compounding area will be cleaned with a germicidal [destroying germs] detergent and sterile water monthly."

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations revised 2012 in the section Cleaning and Disinfecting the Compounding Area showed, "Environmental contact is a major source of microbial contamination of CSPs. Consequently, scrupulous attention to cleaning and disinfecting the sterile compounding areas is required to minimize this as a source of CSP contamination."

4. During an interview on 12/8/20 at 2:55 p.m., with EAH 2 and RPH 1, in the main pharmacy. EAH 2 stated he could not clean the entire top of the hoods, behind the hoods, and the wall behind the IV hoods. When asked about the competency assessment for the environmental service staff, RPH 1 stated she did yearly competency assessment for environmental service staff.

During a review of the "[hospital's name] Sterile Compounding Facility and Equipment Standards. Cleaning, Disinfecting, Certification, and Quality control - Environmental Services" on 12/9/20 at 9:30 a.m. with the DP and RPH 1, EAH 2's form was observed signed by EAH 2 dated 9/21/20. However, the section of "Part II of competency to be completed with pharmacy staff" was not completed. The section of "Competency Assessed by" and "date" were left blank. RPH 1 confirmed the finding and stated she thought she did but she did not document on the form.

During a concurrent interview and record review on 12/10/20 at 3:40 p.m., with the DP, the DP confirmed there was no "[hospital's name] Sterile Compounding Facility and Equipment Standards. Cleaning, Disinfecting, Certification, and Quality control - Environmental Services" for EAH 2 in the year of 2019. The DP stated the competency assessment for EAH 2 should be completed in the year of 2019 and should be validated by the pharmacist in the year of 2020.

During a review of the hospital's P&P titled, "Sterile Compounding: Training, Competency, Quality Assurance Process Validation, and Recordkeeping" dated 6/2020, the P&P indicated, "This training shall include but is not limited to support personnel (e.g. institutional environmental services, housekeeping)... Each person's proficiency and continuing training needs must be reassessed at least every 12 months. Results of these assessments must be documented and retained in the pharmacy for three years... All environmental services staff must be trained in cleaning and disinfecting in accordance to Policies and Procedures: Facility and Equipment Cleaning and Disinfecting Standards."

5. On 12/9/20 at 1:55 p.m., a concurrent interview and record review was conducted with the DP, the Inservice & Education Coordinator (IEC), and RPH 4.

Reviewed of the Pyxis night locker "All Transaction Activity Detail Report Period: 11/9/2020 - 12/9/2020" and the medical records for Patients 22 and 23 showed the following:

* On 11/25/20 at 00:04 a.m., Nursing House Supervisor (NHS) 3 took 10 vials of bumetanide (medication use to treat fluid retention and high blood pressure) from the Pyxis night locker for Patient 23.

Patient 23's medical record showed 10 vials of Bumex (or bumetanide) 2.5 mg (milligram)/10ml (milliliter) were used to prepare a bag of Bumex 24 mg in 240 ml dextrose 5% (an IV solution). The Bumex bag was administered to Patient 23 on 11/25/20 at 00:35 a.m.

* On 11/28/20 at 7:54 p.m., NHS 2 took three vials of sodium bicarbonate (medication use to neutralize excess acid levels in the blood) 8.4% from the Pyxis night locker for Patient 22.

Patients 22's medical record showed three vials of sodium bicarbonate 8.4% 50 mEq (milliequivalent) were used to prepare a bag of sodium bicarbonate 8.4% 150 mEq in 1,000ml dextrose 5%. The sodium bicarbonate bag was administered to Patient 22 on 11/28/20 at 8:22 p.m.

The DP, the IEC, and RPH 4 acknowledged there would be three or more entries into each of these above bags when preparing Bumex 24 mg in 240 ml dextrose 5% for Patient 23 and sodium bicarbonate 8.4% 150 mEq in 1,000 ml dextrose 5% for Patient 22. The DP stated preparing Bumex 24 mg in 240 ml dextrose 5% and sodium bicarbonate 8.4% 150 mEq in 1,000 ml dextrose 5% were the medium-risk level CSPs. The DP confirmed Bumex 24 mg in 240 ml dextrose 5% was administered to Patient 23 on 11/25/20; and sodium bicarbonate 8.4% 150 mEq in 1,000ml dextrose 5% was administered to Patient 22 on 11/28/20. The DP stated there was no IV hood in the night locker or ICU; the house supervisor should not prepare the medium-risk level CSPs in the night locker or ICU.

During an interview on 12/9/20 at 6:50 p.m., with NHS 1, NHS 1 stated she took the medications from the Pyxis night locker and compounded on the counter in the ICU storage room. NHS 1 confirmed there was no IV hood, no IV compounding room in the ICU storage room. NHS 1 stated she took 10 vials of Bumex 2.5 mg/10 ml from the Pyxis night locker; there were approximately 11 entries into the 250 ml dextrose 5% bag to prepare Bumex 24 mg in 240 ml dextrose 5%. NHS 1 further stated she took three vials of sodium bicarbonate 8.4% 50 mEq from the Pyxis night locker; and there were approximately six entries into the dextrose 5% bag to prepare sodium bicarbonate 8.4% 150 mEq in 1,000 ml dextrose 5%. NHS 1 stated she took the medications from the Pyxis night locker, compounded and gave the bags to the nurse, and there was no compounding log.

During an interview on 12/10/20 at 6:40 p.m., with NHS 2, NHS 2 stated he took the medications from the Pyxis night locker and compounded on the counter in the ICU storage room. NHS 2 stated he took three vials of sodium bicarbonate 8.4% 50 mEq from the Pyxis night locker; and there were approximately three entries into the dextrose 5% to prepare sodium bicarbonate 8.4% 150 mEq in 1,000 ml dextrose 5%. NHS 2 further stated he took 10 vials of Bumex 2.5 mg/10 ml from the Pyxis night locker and there were approximately 12 entries into the 250 ml dextrose 5% bag to prepare Bumex 24 mg in 240 ml dextrose 5%. NHS 2 confirmed that he prepared sodium bicarbonate 8.4% 150 mEq in 1,000 ml dextrose 5% for Patient 22 on 11/28/20.

During an interview on 12/10/20 at 3:15 p.m., with the DP, the DP stated the house supervisor should not prepare the medium-risk level CSPs unless there was an emergent or immediate patient care need. He stated the hospital had the P&P for immediate use.

During a review of the hospital's P&P titled, "Sterile Compounding for Immediate Use" dated 6/2020, the P&P indicated, "Immediate use sterile compounding may be completed outside the pharmacy when there is an emergent or immediate patient care need such as CPR [cardiopulmonary resuscitation], emergency room treatment, diagnostic agents or any time a delay in therapy may put the patient risk...Any sterile compounded drug preparation compounded outside the pharmacy laminar air flow hood (LAFH) shall be meet the following criteria and be prepared as follows:...only nonhazardous or diagnostic products...The compounding process shall not exceed 1 hour unless required...Aseptic [free from contamination] technique...labeled "for immediate use only"...Administration shall begin no later than one hour following the start of the compounding process." The P&P did not specify the risk level of the CSPs for immediate use sterile compounding.

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations revised 2012 in the section Immediate-use CSPs showed, "The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. Such situations may include cardiopulmonary resuscitation, emergency room treatment, preparation of diagnostic agents, or critical therapy where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due to delays in therapy...Preparations that are medium-risk level and high-risk level CSPs shall not be prepared as immediate-use CSPs...Immediate-use CSPs are exempt from the requirements described for Low-Risk Level CSPs only when all of the following criteria are met:...1. The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products...from the manufacturers' original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device."

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations revised 2012 in the section Medium-Risk Level CSPs showed, "Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP...The compounding process includes complex aseptic manipulations other than the single-volume transfer."

During a follow up interview on 12/11/20 at 9:04 a.m., with the DP, the DP reviewed USP <797> and stated the hospital needed to reconcile to USP <797>. The DP confirmed the house supervisor should not prepare the medium-risk CSPs with three or more entries into an IV solution bag (container). The DP further stated the house supervisor should call the on-call pharmacist to prepare the medium-risk CSPs.

6. On 12/9/20 at 1:55 p.m., an interview was conducted with the DP, the IEC, and RPH 4. The DP stated the pharmacy did not train or evaluate the house supervisors for the competency in IV compounding. The IEC stated she did not conduct training on IV compounding for the house supervisors.

During an interview on 12/9/20 at 6:50 p.m., with NHS 1, NHS 1 stated she had been the house supervisor for seven years and the previous house supervisor showed her how to mix the intravenous medications seven years ago. There was no training or competency assessment on IV compounding from anyone in the last seven years including pharmacist or pharmacy staff. NHS 1 stated she was not aware of USP <797> standards, and she should have a training on the IV compounding.

During an interview on 12/10/20 at 6:40 p.m., with NHS 2, NHS 2 stated two house supervisors trained him on mixing medications in 2014. NHS 2 further stated he had not had any annual training or competency assessment since 2014. NHS 2 stated it would be nice to have yearly competency assessment.

During an interview on 12/10/20 at 9:00 a.m., with the DP, the DP stated he was not aware that medium-risk level CSPs (Bumex 24 mg in 240 ml dextrose 5% and sodium bicarbonate 150 mEq in 1,000 ml dextrose 5%) were compounded in the ICU storage room. The DP further stated the house supervisor should be trained and should have the competency assessment for sterile IV compounding.

During a review of the hospital's P&P titled, "Sterile Compounding: Training, Competency, Quality Assurance Process Validation, and Recordkeeping" dated 6/20, the P&P indicated, "[hospital's name] pharmacy shall maintain documentation, demonstrating that personnel involved in compounding have the skills and training required to properly and accurately perform their assigned responsibilities and documentation demonstrating that all personnel involved in compounding are trained in all aspects of policies and procedures. This training shall include but is not limited to support personnel (e.g. institutional environmental services, housekeeping), maintenance staff, supervising pharmacist and all others whose jobs are related to the compounding process...Each person engaged in sterile compounding must successfully complete practical skills training in aseptic technique and aseptic area practices...Evaluation must include written testing and a written protocol of periodic routine performance checks involving adherence to aseptic area policies and procedures. Each person's proficiency and continuing training needs must be reassessed at least every 12 months. Results of these assessments must be documented and retained in the pharmacy for three years." USP Chapter <797> was one of the references of this hospital's P&P.

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations revised 2012 in the section Personal Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures showed, "Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel and through multimedia instructional sources and professional publications in the theoretical principles and practical skills of garbing procedures, aseptic work practices, achieving and maintaining ISO Class 5...environmental conditions, and cleaning and disinfection procedures."

Based on observation, interview, and record review, the hospital failed to store drugs securely when:

1. In an outpatient radiology building one out of one cabinet containing vials of Gadolinium (an intravenous drug used to enhance the quality of magnetic resonance imaging (MRI - a machine using powerful magnets and radio waves to create detailed pictures of the body) was unlocked and medications were stored in an unsecured area. A cart containing medications and supplies was in a room with an unlocked door, and the medication drawer in the cart had a plastic break-away lock (a thin plastic strap that is easily broken for emergency access.)

2. On the West Medical Surgical floor of the main hospital, three keys to the medication cabinet, the medication refrigerator and the patient medication cubbies (small boxlike enclosures for patient's medications) were stored in an unlocked drawer.

These failures had the potential for medications to be accessible to unauthorized persons and possible misuse of the potentially lethal (deadly) drugs.

Findings:

1. During a concurrent observation and interview on 12/7/20 at 3:45 p.m. with the Radiology Supervisor (RS) in the outpatient radiology building, a cabinet containing vials of Gadolinium was unlocked. No staff was present in the MRI room. The RS stated the cabinet was probably always unlocked and maintenance staff had a key to the room.

During an interview on 12/8/20 at 9:17 a.m. with the RS, the RS stated the pharmacy department manages the Gadolinium, and the MRI technologists alert the pharmacy when the radiology department runs low on Gadolinium vials.

During an interview on 12/11/20 at 10:27 a.m. with the RS, Director of Pharmacy (DP) and MRI technician (MRIT), the DP stated the MRI room was not known to the pharmacy department as a drug storage location. The DP stated the cabinet containing Gadolinium vials was a drug storage area, and the pharmacy department would need to put it on the schedule for monthly drug storage monitoring. The MRIT stated she previously had not been locking the Gadolinium cabinet when leaving the MRI room.

During a concurrent observation and interview on 12/11/20 at 10:15 a.m. with the RS and the DP in the outpatient radiology building, a cart containing medications and supplies was in a room with an unlocked door, and the medication drawer in the cart had a plastic break-away lock (a thin plastic strap that is easily broken for emergency access.) The medication drawer contained a tray with the following contents:

Adenosine (a medication used in cardiac emergencies) 6 mg (milligrams) / 2 ml (milliliters) - 3 vials (small bottles)
Calcium Chloride (a medication used in cardiac emergencies) 10% (1 gram/10 ml) - 2 syringes
Dextrose (medication used to treat low blood sugar) 50% (50 ml) - 1 syringe
Epinephrine (a medication used in cardiac emergencies) 1mg/1ml, 30 ml - 1 vial
Magnesium Sulphate (a medication used in cardiac emergencies) 1 gram/2ml - 2 vials
Naloxone (a medication used in cardiac emergencies) 0.4 mg/1 ml - 3 vials
Norepinephrine (a medication used in cardiac emergencies) 4 mg/4ml - 1 vial
Phenylephrine (a medication used in cardiac emergencies) 10 mg/1 ml - 1 vial
Procainamide (a medication used in cardiac emergencies) 1 gram/10 ml - 1 vial
Verapamil (a medication used in cardiac emergencies) 5 mg/2ml - 2 vials
Normal Saline flushes (salt water) - 3 syringes
Benadryl (a medication used for allergic reactions) 50 mg/1ml - 1 vial
Solu-Medrol (a medication to reduce swelling in emergencies) 125mg/2 ml - 1 vial
Vecuronium (medication that paralyzes a person so that an artificial airway can be placed) 10mg - 1 vial (marked "high risk drug")
Midazolam (a sedative medication) 2mg/2ml - 3 vials (marked "high risk drug")

The RS stated the building was occupied by 3-4 registration staff, 3-4 ultrasound technicians, and centralized scheduling staff (clerical staff.) The RS stated none of the staff working in the building were licensed to use any of the medications in the drawer and there are no physicians or nurses who work in the radiology area who would need access to any of the medications. The RS stated, "If we have an emergency in this building we call 911."

The DP stated there was no reason for these medications to be in the building, and he will have them removed. The DP stated there is a risk of misuse from having medications in an area that is unsecured, and that some of the medications are "high risk" and potentially lethal.

During a review of the facility's policy and procedure titled Medication Storage and Unit Inspections, revised 5/20, indicated "... All drugs and drug storage areas within the hospital shall be inspected at least monthly ..." and "... Inspections shall address ... medication carts, and cabinets are locked and working properly ...".

2. During a concurrent observation and interview on 12/8/20 at 11:30 a.m., with the DP, Director of Medical Surgical Services (DMSS), and Registered Nurse (RN) 1, in the West Medical Surgical floor, RN 1 took one of the keys from the unlocked drawer next to the nursing station to open the medication refrigerator. There were several medications including Zosyn (an antibiotic) in the refrigerator. RN 1 stated the drawer was not locked, and any of the staff members including the registered nurses, unit clerk, and certified nursing assistants (CNAs) could access these keys. When asked about other keys, RN 1 stated these keys were for the West medication cabinet (for non-refrigerated medications) and the West patient medication cubbies. RN 1 further stated the drawer should be locked. Inspection of the West medication cabinet and the West patient medication cubbies showed several medications including metronidazole (an antibiotic) in the medication cabinet and regular insulin (medication to lower blood sugar) in the patient medication cubbies.

During an interview on 12/8/20 at 1:15 p.m., with the DP, the DP stated medications in the West Medical Surgical floor were not secured but they should be. CNAs and the unit clerk should not have access to the medications.

During an interview on 12/9/20 at 9:50 a.m., with the DMSS, the DMSS stated the keys should only be accessible to the nurses and the clinical coordinators. CNAs and unit clerk who were the unauthorized personnel and should not have access to the keys.

During another visit on 12/9/20 at 11:20 a.m., with the DP, in the West Medical Surgical floor, the same drawer (as mentioned above) was again observed unlocked with the keys to the medication refrigerator, medication cabinet, and patient medication cubbies in the unlocked drawer. There was a patient care technician (non-medical staff) nearby the drawer.

During an interview on 12/9/20 at 1:45 p.m., with the DP, the DP confirmed the finding and stated the patient care technician should not have access to the keys.

During a review of the hospital's policy & procedure (P&P) titled, "Medication Security" dated 5/2019, the P&P indicated, "All drugs store in [hospital's name] shall be accessible only to authorized personnel...All drugs...will be stored in lockable storage or secured areas such as...cabinets...All medications on nursing stations shall be in lockable storage at all times. Authorized personnel include Registered Nurses (RN), Licensed Vocational Nurses (LVN), Respiratory Therapist (RT), Pharmacist, Pharmacy Technicians, and Pharmacy students/interns."

Based on observation, interview, and record review, the hospital failed to ensure outdated (no longer useful), mislabeled, expired, or deteriorated (reduced quality) medications were not available for patient use as evidenced by:

1. Two outdated medications were found in the pharmacy's refrigerator and the West patient medication cubbies (small boxlike enclosures for patient's medications).

2. The pharmacy staff labeled one of one opened Adrenalin (medication for blood pressure control) vial with 30 days Beyond Use Date (BUD, the date or time after which a medication shall not be stored).

3. An expired bag of Lactated Ringer's (medication to replace fluids and electrolytes) was found in the West clean utility supplies room.

4. One of one each of the pre-mixed (mixed in advance) levofloxacin (an antibiotic medication) 250 mg (milligram) and 500 mg without a foil overwrap were not protected from light on the pharmacy's medication shelf.

These failures had the potential of exposing patients to expired or deteriorated medications that could lead to ineffective treatment (such as longer hospitalization or condition deterioration) for the patients.

Findings:

1a. During a concurrent observation and interview on 12/7/20 at 3:40 p.m., with the Director of Pharmacy (DP) and Registered Pharmacist (RPH) 1, in the hospital's pharmacy, a bag of cisatracurium (a paralyzing agent - medication to relax skeletal muscle during surgery) was observed in the same bin with other antibiotic bags in the refrigerator. The cisatracurium bag was labeled with high alert (heightened risk of causing significant patient harm when used in error) sticker and "BEYOND USE DATE, (EXP DATE): 12/05/20". The DP and RPH 1 confirmed the observation. They stated the cisatracurium bag should not be stored in the refrigerator and should be discarded.

b. During a concurrent observation and interview on 12/8/20 at 11:30 a.m., with the DP, Director of Medical Surgical Services (DMSS), Registered Nurse (RN) 1 and RN 2, in the West Medical Surgical floor, the West patient medication cubbies were inspected. An opened vial of regular insulin (medication to lower blood sugar) with the label of "Beyond-Use Date 12/03/20" was observed in Patient 21's cubby. The DMSS, the DP, RN 1, and RN 2 confirmed the observation. RN 1 stated the nurse should check the BUD. The DP stated the insulin vial should be discarded.

During a review of the hospital's policy and procedure (P&P) titled, "Multidose (contains more than one dose of medication) Medications" dated 10/2018, the P&P indicated, "The BUD is the date and time beyond which the medication should not be used."

During a review of the hospital's P&P titled, "Medication Storage and Unit Inspections" dated 5/2020, the P&P indicated, "Expired, contaminated, deteriorated, or unusable drugs are not available for use ...Multidose medications are dated and initiated and not expired"

2. During a concurrent observation and interview on 12/7/20 at 3:40 p.m., with the DP and RPH 1, in the hospital's pharmacy, an opened vial of Adrenalin 30 mg / 30 ml (milliliter) with the BUD of 1/5/21 (29 days from 12/7/20) was observed in the refrigerator. RPH 1 stated the Adrenalin vial was opened yesterday (12/6/20) and the pharmacy technician labeled it with 30-day BUD. After reviewed the hospital's P&P, RPH 1 stated the Adrenalin vial should have 28 days BUD. The DP confirmed the BUD should be 28 days from 12/6/20 (or 1/3/21).

During a review of the hospital's P&P titled, "Multidose Medications" dated 10/2018, the P&P indicated, "The BUD is the date and time beyond which the medication should not be used ... Multi-dose sterile medications have a BUD within 28 days."

3. During a concurrent observation and interview on 12/8/20 at 10:15 a.m., with Clinical Coordinator (CC) 1 and RN 3, in the West clean utility supplies room, a bag of Lactated Ringer's 500 ml was identified on the shelf with the expiration date of 11/2020. CC 1 stated the bag should be discarded.

During a review of the hospital's P&P titled, "Medication Storage and Unit Inspections" dated 5/2020, the P&P indicated, "Expired, contaminated, deteriorated, or unusable drugs are not available for use."

4. During a concurrent observation and interview on 12/7/20 at 4:00 p.m., with the DP and RPH 1, in the hospital's pharmacy, two pre-mixed levofloxacin 500 mg and 250 mg bags were observed without the foil overwrap in the bins on the pharmacy shelf. The levofloxacin bags were observed exposed to the light from the ceiling. RPH 1 stated these levofloxacin bags were not covered in amber bags to protect from light, and should be destroyed.

During an interview on 12/8/20 at 1:30 p.m., with the DP, the DP stated levofloxacin bags should be placed in an amber bag once the levofloxacin bags were removed from their foil overwrap because levofloxacin bags should be protected from light.

During a review of the hospital's P&P titled, "Medication Storage and Unit Inspections" dated 5/2020, the P&P indicated, "Medications shall be stored according to the manufacturer recommendations...Light sensitive drugs should be stored in the original container if possible. If removed from the original container, the medications shall be placed in an amber bag or other container protecting the drug from light...Expired, contaminated, deteriorated, or unusable drugs are not available for use...Remove any light sensitive drugs not stored appropriately."

During a review of the "Full Prescribing Information" of levofloxacin injection in 5% dextrose (an IV solution) provided by the hospital, it indicated, "...Avoid excessive heat and protect from freezing and light."

Based on interview, and record review, the hospital failed to develop and implement their policy and procedure (P&P) for the safe use of ketorolac (an anti-inflammatory medication) when the hospital's P&P for Medication Automatic Stop Orders did not limit the duration of ketorolac therapy to five days in accordance with the manufacturer's specifications. This failure had the potential to increase the risk of bleeding or kidney failure for patients with prolonged use of ketorolac.

Findings:

During a review of the hospital's P&P titled, "MEDICATION AUTOMATIC STOP ORDERS" dated 11/2018, the P&P indicated, "...to ensure the safe administration of medications and IV (intravenous) therapy...Automatic Stop Interval(s) shall be developed and approved the medical staff..." However, the P&P did not specify the duration of ketorolac therapy.

During a review of the package insert (a document included in the package of a medication that provides information about that drug and its use) for ketorolac provided by the hospital, the package insert indicated, "...Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for short-term (up to 5 days in adults) management of moderately severe acute pain...the combined duration of use of ketorolac tromethamine injection and ketorolac tromethamine tablets is not to exceed 5 (five) days, because of the increased risk of serious adverse events..."

During a concurrent interview, and record review on 12/9/20 at 10:45 a.m., with the Director of Pharmacy (DP) and Registered Pharmacist (RPH) 1, RPH 1 was asked to enter the order of ketorolac in the pharmacy computer system. RPH 1 stated the order had no stop date, and ketorolac could be used for longer than 5 days. RPH 1 stated there were many patients who were on ketorolac in the hospital. The DP and RPH 1 stated the order for ketorolac should be stopped after 5 days. The DP confirmed the hospital's P&P did not have the limit of 5 days duration of therapy for ketorolac. When asked about the potential risk for prolonged use of ketorolac, RPH 1 stated prolonged use of ketorolac could potentially cause kidney issues. The DP stated prolonged use of ketorolac could potentially cause gastrointestinal bleeding.

During a review of the hospital's P&P titled, "Black Box Warning [the strongest warning that the FDA (Food and Drug Administration) requires] Medications" dated 9/2019, the P&P indicated, "Purpose: to ensure patient safety with respect to "black boxed warning" medication...Ketorolac injection..." The warning summary for ketorolac injection was "associated with GI [gastrointestinal] bleed, renal [kidney] failure..."

Based on observation, review of hospital documents, and staff interviews, the hospital failed to ensure:

1. The staff responsible for daily management of the dietary services was qualified for the position and a qualified staff served as the director of the food and dietetic services in a full time capacity (refer to A620);
2. Safe and effective food storage/production practices (refer to A620);

3. Comprehensive disaster planning (refer to A620).

The cumulative effect of these systemic problems resulted in the inability of the facility's food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with acceptable standards of practice. The system problems resulted in the facility's inability to meet the Condition of Participation for Food and Dietetic Services.

Based on observation, interview, and facility document review, the facility failed to have a director of the food and dietetic services responsible for the daily management of the dietary services when:

1. The staff responsible for daily management of the dietary services was not qualified for the position;
2. The facility did not have a staff serving as the director of the food and dietetic services in a full-time capacity;
3. Safe and sanitary practices were not followed for preparing and storing food;
4. The disaster plan did not address the needs of patients prescribed mechanically altered diets (diets containing foods altered to prevent choking hazards for patients with dysphagia, a swallowing disorder, and chewing difficulties).

This failure placed patients at risk for food borne illness (illness caused by food contaminated with bacteria, viruses, parasites, or toxins), nutritional risk, and choking risk due to lack of oversight of the food service operation by qualified staff for a facility census of 52.

Findings:

1. 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) states that, "if a dietitian is not employed full-time, a full-time person who has completed a supervisor's training program meeting the requirements of Essentials of an Acceptable Program of Dietetic Assistant Education, revised, June 1974, by the American Dietetic Association, 430 North Michigan Avenue, Chicago, IL 60611, shall be employed to be responsible for the operation of the food service. This program or its equivalent shall be required on and after July 1. 1977 " .

Documents provided by the facility as qualifications for the Manager of Nutrition Resources (MNR) were reviewed. The undated resume for MNR indicated he worked toward, but did not complete, a degree that was not related to nutrition or food service, and he had several years of experience in the food service industry. However, the documents did not show that MNR was qualified for his position in accordance with the Health and Safety Code 1265.4 (b) " The dietetic services supervisor shall have completed at least one of the following educational requirements:
(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.

Review of the position description titled "Nutrition Resource Manager showed the Manager of Nutrition Resources (MNR) was responsible for managing the day-to-day operation of food service as well as directing the food service operations. This document was signed and dated by MNR on 8/28/17 and read "Position summary: Plans, organizes, directs, coordinates, evaluates, daily and fiscal Nutrition Resources Department operations ..." The position description did not spell out qualifications as outlined in the California Code of Regulations, Title 22, Division 5, Chapter 1 or the Health and Safety Code 1265.4, for the person responsible for the operation of the food service. It also failed to fully reflect the regulatory qualifications for the position; rather it noted the required educational/certifications were a preference rather than a requirement. For example, it showed there was a "preference" of a Certified Dietary Manager (CDM, a Certified Food Protection Professional who has the education, training, and experience to competently perform the responsibilities of a dietary manager and has proven this by passing the nationally-recognized CDM Credentialing Exam and fulfilling the requirements needed to maintain certified status.)

On 12//7/20 during the initial tour of the kitchen that started at 2:45 p.m., MNR stated he was not a CDM. He said he was formerly a supervisor and was promoted to the manager position.

In an interview on 12/10/20 at 2:44 p.m., the Clinical Director of NR [Nutrition Resources] (DNS), who was a Registered Dietitian, stated she did not know the qualifications MNR had to qualify him for the position responsible for overseeing the day-to-day foodservice operation. She stated she was not responsible for the day-to-day management of the food service department. She indicated that most of her time was spent on clinical nutrition (management of patients in relation to analyzing a person's diet and making recommendations for optimal nutritional health) and 10 percent of her time in the kitchen. The DNS stated she did quarterly audits of the kitchen as part of her oversight but the she only provided documentation showing she did a sanitation review audit 1 day for an entire year look back (Cross-reference A-023,b)

Review of the position description titled "Clinical Director of NR [Nutrition Resources]" signed and dated by DNS on 11/4/20, showed DNS "Plans, organizes directs, coordinates, evaluates, daily the clinical Nutrition Resources Department operations. These areas include patient meal service, patient medical nutrition therapy. Also oversees Nutrition Aides, patient menu planning, menu development, and patient meals. Works in collaboration with kitchen managers. The Clinical Nutrition Resource Director participates in patient care by performing and charting nutritional assessments, diet recommendations and diet education. Discusses recommendations for medical nutrition therapy (MNT) with physicians, direct and allied patient care staff, patients and families. Relays special food requests to kitchen staff. Develops and conducts nutrition in-services to Nutrition Resource staff. Functions as preceptor to dietetic students and interns. Participates in hospital and department performance improvement studies. Attends professional meetings and conferences to maintain competency in current professional practice and trends."

While the DNS was responsible for some foodservice related activities such as supervision of the Nutrition Aides as well as menu planning and development the primary position duties were for the provision of patient medical nutrition therapy rather than the entire departmental operation, including foodservice, therefore be classified as less than full-time to Dietetic services.

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.

Review of the position description titled "Clinical Director of NR [Nutrition Resources]" showed DNS was under direct supervision of the Chief Operating officer and works in collaboration with kitchen managers. The position description did not outline all of the areas that the DNS was responsible for under Title 22.such as guidance to the supervisor and the staff of the dietetic service.

Review of the position description for MNR, titled "Nutrition Resource Manager" dated and signed by MNR on 8/28/17, showed he reported directly to the Chief operating officer. The position description did not indicate this position received guidance from a Registered Dietitian.

In an interview on 12/10/20 at 2:44 p.m., the DNS stated 10 percent of her overall time was dedicated to the kitchen and 90 percent was dedicated to clinical work. She stated before the pandemic she did audits of the kitchen on approximately a quarterly basis. She also stated she did not always do the quarterly kitchen audits herself. Instead she sent her interns (a student or trainee who works at a trade or occupation in order to gain work experience) into the kitchen to do the audits and she was not there to supervise if any potential issues were present. In addition, she said the results from last kitchen audits were done by the interns on November 19 and 20, 2020 and she did not review the results because she was too busy with clinical work. DNS had documentation for one foodservice audit review, dated 10/30/20, for a one year look back period. The DNS said this was all the documentation she had regarding monitoring the overall food service operation.

Review of resumes of the two interns (Intern 1 and Intern 2) who conducted the kitchen sanitation reviews did not show they were Registered Dietitians (RD) to be qualified to take over the duties of an RD.

3a. Review of the document titled "Food Storage, Handling and Preparation" revised and reviewed on 1/20, showed the following:

"Nutrition Resources will have an effective program utilizing ServeSafe [certification for food and alcohol safety training] standards to monitor and document food handling and preparation which will optimize safety and nutritive value.
Definition: The Department of Nutrition Resources operates under guidelines established by Hazard Analysis Critical Control Points (HACCP), a food safety system which focus is on identifying hazards, controlling points during handling and preparation, and monitoring to evaluate the effectiveness of the control measures in preventing food borne illnesses A critical control point is an operation (practice, preparation step, procedure), by which a preventive or control measure can be applied that would eliminate, prevent, or minimize a hazard or hazards.
General information:
1. Food storage and preparation areas, including unit pantries, will be maintained in a clean, sanitary, and orderly manner at all times ...
4. To minimize risks from biological contamination [when food becomes contaminated with living organisms or substances they produce. This includes biological matter produced by humans, rodents, insects and microorganisms], all readily perishable foods or beverages (Potentially Hazardous Foods [foods that require time-temperature control to keep them safe for human consumption]) capable of supporting rapid and progressive growth of microorganisms, which can cause food infection [illness caused by food contaminated with bacteria, viruses, or toxins] or food intoxication [infectious organisms or their toxins are the most common causes of food poisoning], will be maintained at temperatures of 40 degrees F [Fahrenheit] or below, or at 140 degrees F or above , at all times except during necessary periods of preparation and service ...
Procedure:
1. All Potentially Hazardous Foods will be stored under the following conditions:
a. Refrigerated food will be stored at:
i. Refrigerated foods: 32degrees - 40 degrees F ...

3. All Potentially Hazardous Foods will be held under the following conditions:
b. ..
c. ..
i. All cold storage/holding units will be maintained and documented in accordance with policy at 40 degrees F or below."
Review of the Policy and Procedure titled "Refrigerator/Freezer Temperature Log" revised and reviewed on 1/20, showed the Maintenance staff was responsible for monitoring all of the facility refrigerator temperatures. It also showed the temperature range for refrigerators should be between 35 degrees and 46 degrees. It was noted this policy contradicted the policy above titled "Food Storage, Handling, and Preparation" for the temperature range required for food storage in refrigerators.

According to the 2017 Federal Food Code, the standard of practice for the safe storage of Time/Temperature Control for Safety Food (TCS Food, food that grows bacteria more easily and quickly that other foods and require time and temperature controls to prevent unsafe bacteria growth) is 41 degrees F or less.

On 12/8/20 at 10:30 a.m., in an interview with the DPOS and the Maintenance Lead (MS), DPOS stated the Central Utility Plant tracks refrigerator temperatures on a computer. If a temperature went out of range, an alarm is sounded, and an alert was sent to his phone. MS stated all of the refrigerators and freezers in the facility were on this system.

On 12/8/20 at 11:01 a.m., an interview with Maintenance Worker 2 (MW 2), Maintenance Worker 5 (MW 5), and DNS and a concurrent observation of the patient nourishment refrigerator located in the pantry room on the Maternity unit showed an external thermometer attached to the side of the refrigerator. The thermometer had wires attached that led to the inside of the refrigerator. MW2 stated the thermometer showed the inside temperature of the refrigerator and an alarm went off to notify maintenance if the refrigerator temperature went too high. The outside thermometer read 43.4 degrees Fahrenheit (F). The temperature of food stored inside the refrigerator was measured with a digital thermometer. A carton of milk was 49.8 degrees F and a container of diet chocolate pudding was 45.8 degrees F. MW5, entered the pantry room and wrote down the reading of the external thermometer on a piece of paper. He stated he was doing his daily rounds to check the refrigerator temperatures to make sure they were an appropriate temperature. He also looked inside the refrigerator for an internal thermometer and stated he usually checked the internal thermometer to make sure it was the same as the external thermometer. He said there was not an internal thermometer in the refrigerator so he could not compare the thermometers. He also stated the appropriate range for the refrigerator was 36 degrees F to 46 degrees F. The temperatures of additional food items were measured with a digital thermometer. The temperature of sliced turkey meat for a turkey sandwich was 51.3 degrees F. DNS measured the temperature of the sliced turkey for another turkey sandwich and the temperature was 57 degrees F. She said the temperature was too high. She explained that maintenance was responsible for monitoring these refrigerators. She also stated Nutrition Resource staff did not document refrigerator temperatures.

In an interview on 12/8/20 at 2:20 p.m., the DPOS stated maintenance was responsible for monitoring the nourishment refrigerator temperatures. He confirmed there was a total of 7 nourishment refrigerators on units. He stated the appropriate temperature for the food refrigerators was 36 degrees F to 46 degrees F. He said if the refrigerator temperatures went above this range maintenance was alerted with an alarm and the refrigerator was checked. He also stated he was not sure if there were internal thermometers located inside the refrigerators.

In an interview on 12/8/20 at 2:45 p.m., Nutrition Aide 2 (NA2) stated she was responsible for stocking the nourishment refrigerators daily and confirmed she stocked the refrigerator on 12/8/20 and she did not stock the refrigerators on 12/8/20 until 12 p.m., and she confirmed any food that was in the refrigerator from the kitchen at 11 a.m. on 12/8/20 was placed there the prior day on 12/7/20.

In an interview on 12/9/20 at 11:11 a.m., the ICC stated it was her roll to conduct infection control audits for the kitchen. She stated she did not check the nourishment refrigerators in the pantries on the units, but she probably should.

In an interview on 12/10/20 at 2:44 p.m., DNS stated she did not train maintenance on appropriate temperatures for food refrigerators because she was not invited to do a training.

In an interview on 12/11/20 at 9:50 a.m., NA2 stated she regularly stocked the patient refrigerators on 8 stations. She said if she noticed a refrigerator temperature was above 40 degrees F, she called DNS. She said in the past month she regularly observed high refrigerator temperatures. She stated she called DNS each week and reported high refrigerator temperatures. She said it was verbal and she did not have documentation.

In an interview on 10/11/20 at 10:04 a.m., DNS stated she expected Nutrition Resources staff to contact her if high refrigerator temperatures were identified. She stated she did not receive any notification from any staff that the nourishment refrigerators were high in quarter 1 or quarter 2. She said they were currently in quarter 2 which included October, November, and December and the first quarter included July, August, September. She said she was not able to recall any information about refrigerator temperatures prior to quarter 1. She stated she was not sure Nutrition Resources staff had training on monitoring refrigerator temperatures. The DNS was not able to provide documentation to show staff was trained on appropriate refrigerator temperatures.

Review of external thermometer temperature data logs for the pantry refrigerators, tracked by the maintenance department from 12/8/20 to 12/10/20, showed the ICU (Intensive Care Unit) refrigerator temperature range was consistently between 42.5 degrees F - 43 degrees F, the Pre Operation pantry refrigerator was consistently between 42 degrees F and 45 degrees F, and all of the other pantry refrigerators including the Emergency Room (2 refrigerators), NW (West), Maternity, and Labor and Delivery all had a significant amount of temperature fluctuation above and below 41 degrees F.

3b. According to the standards of practice described in the 2017 Federal Food Code, food-contact surfaces and utensils shall be clean to sight and touch.

On 12/8/20 at 3:54 p.m., an observation of the internal components of the ice machine located in the kitchen and a concurrent interview with Maintenance Worker 1 (MW 1), showed a brown and pink residue along the entire upper edge of the evaporator plate (the component where water flows over and ice is formed) and on the plastic edge directly above the evaporator plate. When wiped with a paper towel, the residue came off easily. MW1 confirmed there was residue inside the ice machine.

On 12/9/20 at 10:03 a.m., an observation of the internal components of the ice machine located in the West unit and concurrent interview with MW2, showed pink residue around the end of the tube where formed ice came into contact when dispersed into the ice bin. The pink residue was removed when wiped with a paper towel. MW2 confirmed residue was present.

On 12/9/20 at 10:25 a.m., an observation of the internal components of the ice machine located in the Intensive Care Unit (ICU) and a concurrent interview with MW2, showed pink residue around the tube where formed ice was dispensed into the ice bin. There was also black residue on the plastic just under the tube on the inside surface of the ice bin where ice was stored. MW2 confirmed the pink and black residue was present.

Review of the e-mail document titled "Subject: Kitchen Sanitation Review Findings" dated 10/30/20, showed "mold inside the ice machine." The e-mail was from the DNS and addressed to the MNR and other kitchen staff. The DNS also stated in the e-mail, "If you need any clarification or have any questions on what I found, please let me know. All of this needs to be fixed ASAP [As soon as possible.]"

Review of the Maintenance Work Order # 11150 showed the ice machine was cleaned and sanitized on 10/28/20.

In an interview on 12/22/20 at 4:44 p.m., DNS stated she checked the kitchen ice machine for cleanliness on 10/30/20 by wiping the inside of the ice dispenser from which ice was dropped into the bin, with a towel. She stated she notified maintenance. DNS provided a screen shot of a text message she sent from her phone to the DPOS on 10/30/20. The message read "I found mold inside the ice machine in the kitchen that was supposed to have been cleaned on Wednesday." She also attached a photo in the text that showed a white towel with pink residue on the towel. The DPOS's reply in the text showed "We are on it thanks."

The DNS provided a Maintenance work order as evidence of the next time the ice machine was cleaned after she sent DPOS the text message about mold in the ice machine. Review of the Maintenance Work Order #11555 showed the ice machine in the kitchen was assigned to maintenance staff of 11/1/20 but was not cleaned until 11/28/20.

3c. According to the USFDA (US Food and Drug Administration), Refrigerator and Freezer Storage Chart, March 2018, the safe time limit to prevent spoilage of refrigerated fresh poultry was 1-2 days.

During a review of the facility's document titled, "Refrigerated Storage Life of Food," (undated), indicated, raw meat (frozen) maximum storage period is three days to thaw; one day to use for a total of four days. Raw meat (refrigerated) maximum storage period is four days.

During a concurrent observation and interview on 12/7/20, at 3:30 p.m., with the Executive Chef (EC), in the walk-in refrigerator, two 40 pound boxes of raw chicken dated November 27 were observed. Upon questioning regarding the chicken, the EC stated the chicken was likely pulled from the freezer, but the employee failed to date it. The EC stated food pulled from the freezer must have a date indicating when the food started the thawing process.

During an interview on 12/9/20, at 11:15 a.m., with the Infection Control Coordinator (ICC), the ICC stated she had a concern with the time frame of the raw chicken in the refrigerator dated November 27, 2020.

During an interview on 12/11/20, at 8:51 a.m., with the Director of Nutrition Services (DNS), the DNS stated she was not sure how long raw chicken could be safely stored in the refrigerator.

3d. According to the USFDA 2017 Food Code, 5 205.11 Using a Handwashing Sink: (B) A HANDWASHING SINK may not be used for purposes other than handwashing.

Water temperature of a handwashing sink much be 100 to 108°F. (USFDA Food Code 2017, Annex 3).

During a review of the facility's policy and procedure titled, "Food Storage, Handling and Preparation," revised and reviewed on 1/20, showed, each handwashing station will be maintained with hot and cold running water, soap, and disposable paper towels.

During a concurrent observation and interview on 12/7/20, at 3:15 p.m., with Nutrition Aide (NA) 1 and the EC, in the food service area of the facility cafeteria, a sink with a wall mounted paper towel dispenser and hand soap were observed. The water temperature of the sink was 74.7 degrees Fahrenheit (F). The NA 1 stated she used the sink for hand washing. The EC stated he was not sure what the sink was used for and confirmed the water temperature was not appropriate for handwashing. The EC stated Plant Operations was responsible for the sink.

During a concurrent observation and interview on 12/8/20, at 11:15 a.m., with the Director of Plant Operations and Safety Officer (DPOS), in the food service area of the facility cafeteria, food remnants were observed in the handwashing sink. The DPOS stated the sink in the food service area of the facility cafeteria was used for handwashing. The DPOS was not aware the of the cafeteria sink water temperature.

During an interview on 12/8/20, at 3:30 p.m., with the DNS, a picture of the food remnants found in the facility cafeteria sink was shared with the DNS. The DNS stated she was not sure what the cafeteria sink was used for. The DNS confirmed water temperature of 74.7 degrees F was not appropriate for handwashing.

During an interview on 12/9/20, at 11:15 a.m., with the ICC, the ICC stated handwashing sinks must not be used for purposes other than handwashing and the temperature must be 100 degrees F for handwashing.

During an interview on 12/11/20, at 9:50 a.m., with the Manager of Nutrition Resources (MNR), the MNR stated the cafeteria sink was used to clean the smoothie cups and was not a handwashing sink. The MNR stated he was not aware the cafeteria sink was being used for handwashing.

During an interview on 12/11/20, at 12:37 p.m., with the DPOS, the DPOS stated he had never received a work order for the water temperature of the sink in the food service area of the facility cafeteria.

3e. According to the USFDA 2017 Food Code, 5-501.113 Covering Receptacles: receptacles and waste handling units for refuse, recyclables, and returnables shall be kept covered: (B) With tight-fitting lids or doors if kept outside the food establishment.

According to the USFDA 2017 Food Code, 5-501.116 Cleaning Receptacles: (B) Soiled receptacles and waste handling units for refuse, recyclables, and returnables shall be cleaned at a frequency necessary to prevent them from developing a buildup of soil or becoming attractants for insects and rodents.

According to the USFDA 2017 Food Code, 5-502.11 Frequency: refuse, recyclables, and returnables shall be removed from the premises at a frequency that will minimize the development of objectionable odors and other conditions that attract or harbor insects and rodents.

During a concurrent observation and interview on 12/8/20, at 10:40 a.m., with the DPOS and the Manager of Environmental Services (MEVS), in the trash storage area located in the rear of the facility, the following were observed: a large pile of cardboard boxes with other types of trash intermingled, two uncovered metal garbage storage bins, overflowing with garbage, and two feral cats; one of which was trying to eat dried garbage stuck to the trash compactor.

The DPOS stated the environmental services department notified plant operations when the garbage storage bins were full. Plant operations used a fork- lift to empty the garbage storage bins into the trash compactor. The DPOS confirmed the garbage storage bins were overflowing with garbage and did not have lids. The DPOS stated the facility had a problem with feral cats in the area. The MEVS stated the facility previously had a program that was responsible for emptying the trash and breaking down the cardboard boxes, but due to the COVID-19 pandemic, the program had been canceled in April 2020. The MEVS stated the facility did not have the staff to empty the garbage in a timely manner.

During an interview on 12/9/20, at 11:15 a.m., with the ICC, the ICC stated she had a concern with the facility's trash storage.

3f. Review of the undated document titled "Refrigerated Storage Life of Foods" showed salad dressing cups had a maximum storage period of 5 days. The document also provided instructions on how to determine the expiration date and showed "Day 1 is the date received or produced ..."

On 12/7/20 at 2:45 p.m. during the initial tour of the kitchen, an interview with MNR and a concurrent observation, showed 7 trays of salad dressing in individual plastic containers located in a reach-in refrigerator. Each tray contained more than 30 individual containers. Each tray also had a label that read use by "5 days." Each label also had dates, which MNR stated were the dates the salad dressing was removed from a large container of salad dressing and placed in the individual cups, and the date the salad dressing was to be used or discarded. He confirmed all of the salad dressings were to be used within 5 days of placing in the individual cups. The tray labeled Caesar salad dressing was dated 11/6/20, use by 5 days, 12/12/20. The tray labeled 1000 island dressing was dated 10/26/20 and use by 5 days, 12/12/20. The tray labeled Asian dressing was dated 11/29/20, use by 5 days, 12/12/20. 4 trays were labeled Ranch dressing. Two trays of Ranch were dated 12/6/20 , use by 5 days, 12/12/20. 1 tray of Ranch was dated 12/6/20, use by 5 days, 12/11/20. The next tray of Ranch had a use by day of 12/11/20 but did not have the date the dressing was placed in the containers. MNR said that any of the dressings dated 12/6/20 should be used by 12/11/20. He confirmed the tray of Caesar dressing, 1000 island dressing, Asian dressing, and 3 trays of Ranch dressing were all dated incorrectly. MNR also stated he did not understand why the dates were incorrect because a machine was used to print out labels with dates depending on the food the staff entered into the system. He said the machine calculated the dates and the staff did not have to determine the dates.

The DNS provided a Nutrition Resources staff in-service titled "Infection Control and Personal Hygiene" as evidence staff was trained on labeling and dating. Review of the document showed the in-service was conducted on 11/20/20. The slides used for the in-service showed "label and date all foods". It did not show that staff were trained on how to label and date foods. In addition, a review of the "Infection Control and Personal Hygiene Quiz" dated 11/20/20 had 5 questions and did not have any questions to assess competency of labeling and dating. This was the only in-service provided by the facility to show training was conducted on labeling and dating.

In an interview on 12/9/20 at 11:11 a.m., the ICC stated multiple different dates on the salad dressing was a concern.

3g. According to the USFDA Food Code cutting surfaces such as cutting boards and blocks that become scratched and scored may be difficult to clean and sanitize. As a result, pathogenic microorganisms transmissible through food may build up or accumulate. These microorganisms may be transferred to foods that are prepared on such surfaces. (USFDA Food Code Annex, 2017).

According to the USFDA 2017 Food Code, Section 4-501.11 Good Repair and Proper Adjustment: (C) cutting or piercing parts of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is opened.

During a review of the facility's policy and procedure titled, "Food Storage, Handling and Preparation," revised and reviewed on 1/20, indicated, all utensils ...will be kept clean, sanitary, maintained in good repair and will be free of breaks, corrosion, open seams, cracks and chipped areas. Any cookware with excess carbon build-up will be cleaned and sanitized with the appropriate and approved cleaning agents.

During a concurrent observation and interview on December 7, 2020, between 2:40 PM and 3:30 PM, with the MNR, the EC and the DNS, in the kitchen,
1. two green cutting boards were heavily marred with knife marks,
2. the can opener blade was rough and worn,
3. wood handles on ten metal spatulas were cracked and worn,
4. eight stock pots had heavy black residue on the outside of the pots,
5. seventeen large muffin pans had heavy black residue on the top surface of the pans,
6. 3 frying pans had a heavy black residue on the inside surface,
7. 3 large roast pans had a heavy black residue on the inside surface,
8. 5 non-stick frying pans had scratches covering the inside non-stick cooking surface, and
9. four rubber spatulas were cracked and chipped.

The EC confirmed the cutting boards should be replaced. The DNS stated she tries to do a monthly kitchen sanitation audit but had not noticed the cutting boards. The EC was not aware the can opener blade needed replacement. The EC confirmed the ten metal spatulas, the eight stock pots, and the four rubber spatulas needed replacement. The MNR confirmed there was black build up on the frying pans, roast pans, and large muffin pans. He also confirmed the non-stick frying pans were scratched. The MNR stated the expectation

Based on observation, interview, and record review, the facility failed to maintain patient care and kitchen equipment when:

1. One electroencephalogram machine (EEG machine - a machine that detects electrical activity in the brain) located in the main hospital laboratory had an outdated preventative maintenance sticker.
2. Three machines located in operating room storage rooms had outdated safety inspection stickers.
3. One ultrasound machine located in an operating room storage room had no preventative maintenance label.
4. One disinfection machine located in the outpatient radiology building had an outdated preventative maintenance sticker.
5. The inside of a reach-in freezer had a significant amount of ice build-up.

These deficient practices had the potential to result in unsafe patient care and affect the quality and safety of food.

Findings:

1. During a concurrent observation and interview on 12/7/20 at 4:00 p.m. with the Radiology Supervisor (RS) in the main hospital laboratory, an EEG machine was observed with a clinical engineering sticker noting preventative maintenance was performed in May 2018 and the next preventative maintenance was due in May 2019. The RS confirmed the preventative maintenance was overdue.

During an interview on 12/8/20 at 1:48 p.m. with the Director of Biomedical Services (DBS), the DBS confirmed the biomedical staff was informed on 12/8/20 that the EEG machine was located in the main hospital laboratory. The Director of Biomedical Services stated the EEG machine was previously marked as not located, but "now we've got it accounted for."

During an interview on 12/16/20 at 11:21 a.m. with the Director of Plant Operations (DPOS), the DPOS stated the expectation is preventative maintenance for equipment is done by the due date.

2. During a concurrent observation and interview on 12/8/20 at 1:48 p.m. with the Director of Biomedical Services (DBS) in an operating room storage room, a Novasure machine was observed with a safety inspection sticker dated 8/13/18 and noting the next due date was 8/2019. The DBS stated the Novasure machine was not familiar to him and he was going to check if the machine was in his inventory. A Fluent fluid management machine was observed with a pink electrical safety check sticker dated 10/28/20 and expiring on 11/30/20. The DBS confirmed the Fluent machine's safety check was outdated.

During a concurrent observation and interview on 12/8/20 at 2:21 p.m. with the DBS and the Director of Surgical Services (DSS) in an operating room storage room, the DSS stated the Fluent machine was not being used. The DBS stated the Fluent machine was not picked up by the company's representative as planned. The DSS stated the Novasure machine was used by a physician who retired several months ago, and that Biomedical Services had been tracking the machine. The DBS stated his staff could start tracking the machine today.

During a concurrent observation and interview on 12/8/20 at 2:28 p.m. with the DBS and the DSS in an operating room storage room, an Erbe endocautery machine (a machine using heat to treat body tissues) was observed with a sticker noting the machine was tested on 5/16/13. The DSS stated the machine was not being used. The DBS stated the Erbe machine should be removed if it is not being used.

During an interview on 12/16/20 at 11:21 a.m. with the Director of Plant Operations (DPOS), the DPOS stated the expectation is preventative maintenance for equipment is done by the due date.

3. During a concurrent observation and interview on 12/8/20 at 2:28 p.m. with the Director of Biomedical Services (DBS) and the Director of Surgical Services (DSS) in an operating room storage room, an ultrasound machine (a machine that uses high-frequency sound waves to view inside the body) was observed with no preventative maintenance label. The DSS stated the ultrasound machine was not being used. The DBS stated the preventative maintenance sticker had been removed. The DBS stated the protocol is if equipment is removed from service, Biomedical Services is notified and his staff takes off the sticker and disposes of the equipment. The DBS stated the ultrasound should have either been pulled and placed in the Biomedical Services room, or a sign should have been placed on it to not use it.

During a review of the facility's policy and procedure titled Equipment Labeling, reviewed 01/20, indicated "Equipment included in the Clinical Engineering Medical Equipment Planned Maintenance Program will be labeled as follows ... Equipment will have a "serviced" or "inspected" label indicating the date and technician's initials ...".

4. During a concurrent observation and interview on 12/11/20 at 10:27 a.m. with the Radiology Supervisor (RS) in the outpatient radiology building, a Cidex disinfection machine was observed with a preventative maintenance sticker dated 12/18 and noting the next maintenance was due 12/19. The RS stated the preventative maintenance was overdue, and that the maintenance department was in charge of it.

During an interview on 12/16/20 at 11:21 a.m. with the Director of Plant Operations (DPOS), the DPOS stated the expectation is preventative maintenance for equipment is done by the due date. The DPOS stated the biomedical staff was responsible for ensuring preventative maintenance was performed on the Cidex disinfection machine.

During an interview on 12/16/20 at 11:32 a.m. with the Director of Biomedical Services (DBS), the DPOS, and RS, the DBS stated the Cidex disinfection machine requires an annual safety check and filter replacements every six months. The DBS stated his staff previously was unable to find the Cidex disinfection machine located in the outpatient radiology building. The Radiology Supervisor stated the Cidex disinfection machine was currently being used, perhaps several times a week.

5. On 12/7/20 during the initial tour of the kitchen at 2:45 p.m., an observation and concurrent interview with the Manager of Nutrition Resources (MNR) showed a reach-in freezer located in the dry storeroom with ice build-up along the intire length of the freezer door rubber gasket at the hinge side of the door, and the inside surface of the freezer ceiling. The freezer held a variety of food such as ice cream, pastries, and cookies. MNR confirmed the ice build-up and stated he put in a work order to fix it.

Review of the e-mail work order request that MNR provided as the work order he put in for the ice buld-up in the freezer, titled "Subject: TheWorxHub Maintenance Request #7522: Dry Food Storage" dated 3/9/20 showed a work order request for ice build-up in the freezer in the dry storeroom.

An invoice from an outside company showed the freezer was serviced on 3/18/20 and 3/24/20.

Review of the manufacturer's manual for the freezer dated 10/06, showed under the Care and Maintenance section, the most important thing to ensure long, reliable service is to regularly clean the condenser coil and the condensing unit requires regularly scheduled cleaning ..."

In an interview on 12/11/20, the Director of Plant Operations and Safety Officer (DPOS) stated there was no regular maintenance for the freezer. He also stated during the bi-yearly Physical Environment Patient Safety Team (PEPST) rounds, he only looked at the outside thermometer on the freezers and he did not check the condition of the inside.

Review of the document titled "Physical Environment Patient Safety Team (PEPST) HFAP 11.01.01:Once Every 12 Months Non-Patient Care Safety Survey" dated 10/13/20, showed to inspect the cleanliness of the inside and outside of the refrigerators. There was not a section on this document that included freezers.

Based on observation, interview and record review, the hospital failed to have an infection control program with demonstrated adherence to nationally recognized infection prevention and control guidelines when:

1. Temperatures in the clean and the decontamination area of the Sterile Processing Department (SPD-performs sterilization and other actions on medical devices and equipment) were out of range for multiple days in December 2020. The Maintenance Department did not have documented evidence this occurrence was reported and resolved. (refer to A750, finding 1)

2a. Two of three autoclaves (used in medical and laboratory setting to sterilize instruments) were not cleaned and maintained daily and weekly per manufacturer's instructions for use (IFUs). Autoclave 1 was observed to have light blue and grey fuzzy matter on the outside hood, black residue within the sanitizing compartment and rust colored stain above the gasket (seal to keep moisture from escaping). As of, 11/12/2020 Autoclave 2 was out of order and not sterilizing instruments. Autoclave 3 was observed to have dark gray dust-like residue within the sanitizing compartment. Autoclave 1 and 2 were located in SPD and Autoclave 3 was in the Operating Room (OR). (refer to A750, finding 2)

2b.The manufacturer's recommended cleaning product to clean two of three autoclaves (Autoclave 1 and 3) per manufacturer's IFU's was not used and no documented evidence of daily cleaning was provided. (refer to A750, finding 2)

2c.Three of three autoclaves were not maintained according to acceptable standards of practice per the Association of Perioperative Registered Nurses (AORN). (refer to A750, finding 2)

3a.Two of two inspected surgical trays, multiple surgical instruments that were previously processed were stained and discolored and did not meet acceptable standards of practice for quality. (refer to A750, finding 3)

3b. Surgical Scrub Technician (SST) did not check for sharpness of scissors when inspecting surgical instruments according to the AORN. (refer to A750, finding 3)

4. In the SPD pre pack area (clean area), the autoclave loading cart had brown stains. In the SPD decontamination area (disinfection, cleaning and decontamination room) the Environmental Assistant Housekeeper I (EAH I) did not follow manufacturer's IFUs for the contact time for the disinfectant product used. Two of three ceiling vents had gray color fuzzy matter. The tile flooring had rust color and grey stains. The loading cart had rust colored stains on the loading cart. The Sterile Processing Technician (SPT) did not follow proper technique by not completely submerging an instrument tray in enzymatic detergent (use to remove stubborn organic debris such as stains, blood, mucus and stains) which was mixed with water on a three division sink. A second large surgical instrument tray was larger than the sink and was not completely submerged in the water on the three division sink. The Central Supply Technician (CST) did not pre-soak and clean the non-used surgical instruments prior to placing the surgical instruments in the washer. The CST did not use the recommended cleaning product to clean the washer per manufacturer's IFU's and no documented evidence of cleaning was provided. The SPD department staff used unapproved cleaning products to clean sinks and surfaces in the decontamination area. (refer to A750, finding 4)

5. The storage cabinet for clean scopes (a reusable patient instrument, used to visualize an interior organ) was located next to a hopper (a device where liquid and solid excretion are dumped, flushed and washed out) and in a soiled utility room used for dirty endoscopes and did not follow the standards as indicated by Society of Gastroenterology Nurses and Association (SGNA). (refer to A750, finding 5)

6. Clean endoscopes were transported from a soiled utility room without the use of a transport container in accordance with SGNA standards. (refer to A750, finding 6)

7. There was no eye wash station located in the GI processing room per AORN, SGNA, Healthcare Infection Control Practice Advisory Committee (HICPAC), and Occupational Safety and Health Administration (OSHA) standards. (refer to A750, finding 7)

8. Staff in the GI processing room used the sink for cleaning contaminated scopes for hand washing and not in accordance with AORN. (refer to A750, finding 8)

9. The hospital did not have a method of determining humidity levels in the sterile (free from bacteria) supply area in the perioperative department and the GI processing room per AORN or SGNA or CDC (national health protection agency). (refer to A750, finding 9)

10. The GI processing room staff did not provide documented evidence of cleaning of the GI scope cabinet per AORN. (refer to A750, finding 10)

11. Hospital staff did not provide evidence of terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) of the hospital GI processing room, OR sterile items in the storage area, SPD sterile processing rooms, and decontamination rooms (a workspace room used to process and clean equipment/instruments which contain contaminants such as micro-organisms or hazardous materials, including chemicals, radioactive substances, and infectious diseases) per AORN. (refer to A750, finding 11)

12. Hospital staff did not follow CDC standards for the storage of Personal Protective Equipment (PPE) and was not stored per policy in the radiology and laboratory department. (refer to A750, finding 12)

13. Hospital staff did not follow CDC standards for the storage of Personal Protective Equipment in the medical surgical unit and Emergency Department (ED). (refer to A750, finding 13)

14. In the Emergency Department (ED), the steps for processing and disinfecting ultrasound vaginal probes did not follow the hospitals Policies and Procedures (P&P) and national standards. (refer to A750, finding 14)

15. The infection control officer failed to develop and implement an effective system for monitoring, investigating and controlling infections in the Nutrition Resources department.
(refer to A749)

Because of the serious potential harm to all surgical patients related to the inability of the hospital to ensure surgical instruments were processed according to the standards as written in Association for the Advancement of Medical Instrumentation (AAMI-an organization for advancing the development, and safe and effective use for medical technology) and AORN and the inability of the hospital to ensure endoscopes were processed and stored in a sanitary manner according to SGNA an Immediate Jeopardy (IJ) situation was called with the Chief Nursing Officer (CNO) and the Director of Quality Management Risk (DQMR) on 12/8/20 at 6:55 p.m. under A750 CFR 482.42(a)(3). The CNO and the DQMR was provided the IJ template which documented the immediate actions necessary to address the IJ situation. The CNO was provided an explanation to submit an acceptable Action Plan to address the IJ situation. Version 6.5 of the Action Plan was acceptable on 12/22/20. The following items were listed on the Action Plan and validated by the survey team: Immediately stop all surgeries utilizing surgical instruments from trays processed with the hospital autoclave. All SPD, Maintenance and OR staff completed competency of determine the steps necessary in order to utilize the autoclave without the identified black residue or obtain an autoclave that will process surgical instruments appropriately. Corrected the instrument tray to be able to be submerged prior to the autoclave process by installing appropriate size sink. In-service all SPD and OR staff to monitor surgical trays to determine if the processing of surgical instruments followed established hospital polices and standards of practice. Store scope cabinet and endoscopes in a clean area per SGNA standards. Transported and processed of endoscopes were to follow SGNA standards by using dedicated clean containers. Inservice of All OR staff to conform to SGNA standards. Provided a separate sink to be used for hand hygiene in the endoscopy storage room. Provided an eye-wash station on the same level as the endoscope cleaning room. The hospital submitted a Program Flex to suspend Surgical and Anesthesia Services to CDPH on 12/22/2020. Until the hospital's autoclaves are completely repaired and approved for use by the CDPH. Items of the Action Plan were validated through observations, interview, and record review and the IJ was removed with the CEO, the CNO, the DQMR and the DPOS in on 12/22/20 at 6:23 p.m.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide Infection Control services in a safe and effective manner in accordance with the statutory-mandated Conditions of Participation for Infection Prevention and Control and Antibiotic Stewardship Program.

Based on observation, interview and record review, the facility failed to ensure the infection control officer developed and implemented an effective system for monitoring, investigating and controlling infections in the Nutrition Resources Department (the term the facility uses to refer to Food and Nutrition Services) when:
1. Food stored in one of eight pantry refrigerators was not stored at a safe temperature; and all food service refrigerators in the facility were not monitored at a safe temperature;
2. Three of eight ice machines were not clean;
3. Poultry was not thawed safely;
4. Water for a sink used for handwashing was not at an appropriate temperature;
5. Trash was not stored appropriately;
6. Salad dressing was not dated with apprpriate use-by dates;
7. Cooking utensils and equipment were not in good condition;
8. Staff personal belongings were not stored appropriately;
9. A floor drain was not clean; and
10. Equipment did not have appropriate air-gaps

These failures had the potential to spread infections to patients, staff and visitors for a facility census of 52.

Findings:

Review of the position description titled "Infection Control Coordinator" revised 7/20, unsigned, showed under Position Roles and Responsibilities: "the Infection Control Coordinator collaborates with department directors ....on infection control related issues ..."

In an interview on 12/9/20 at 11:11 a.m., the Infection Control Coordinator (ICC) stated she was the infection preventionist at the facility for 3 months and did quarterly infection control tours of all areas in the kitchen. She said she looked at all potential infection control issues and gave examples of areas she looked at, such as food and produce storage, freezers, food received dates to ensure food was not expired, tray-line food service. She said she did not conduct any in-services regarding infection control for kitchen staff. She stated she did one infection control tour of the kitchen so far.

In an interview on 12/10/20 at 10:15 a.m., the ICC gave the surveyors an undated document titled "[name of facility] Retail Kitchen & Cafeteria Quarterly Sanitation and Food." Review of the 7-page document showed a list of infection control items. Next to each item was a box to mark yes, no or not applicable. None of the boxes were checked to show that infection issues were reviewed. She stated she did not complete the document and instead she took notes on another piece of paper and had not transferred them to the report.

In an interview on 12/10/20 at 2:20 p.m., the ICC provided notes typed on a piece of paper titled "Kitchen Review on 10/3/19 by Infection Control." Review of the document showed issues were mainly related to incorrect labeling and dating of food items and food items stored past their expiration date. It was noted the document was dated prior to the ICC's start date at the facility. When she was questioned about the date, she stated she mistakenly documented the wrong year. She said she took these notes during the Physical Environment Patient Safety Team (PEPST) rounds in the kitchen in October. She stated since she was in the kitchen for the PEPST rounds she took notes for the infection control audit at the same time. She explained the PEPST rounds were different from her infection control audit. She stated her infection control findings were not included in the PEPST report done by the Director of Plant Operations and Safety Officer (DPOS),

In an interview on 12/10/20 at 2:44 p.m., The Director of Nutrition Resources (DNS) stated the ICC just gave her a copy of an infection control audit this week and did not recall any information from her regarding infection control in the kitchen prior to this week.

In an interview on 12/11/20 at 9:50 a.m., the Manager of Nutrition Resources (MNR) stated he did not receive any information from the ICC regarding findings during an infection control audit. He stated he did not have any communication with the ICC. The surveyor reviewed the items listed on the document titled "Kitchen Review on 10/3/19 by Infection Control" and he stated he was not aware of any of the issues listed.

In an interview on 12/11/20 at 11:08 a.m., the Chief Nursing Officer (Interim; CNO) stated she did not have any other infection control audits of the kitchen, other than what was already provided, within a 12 month look back period from a facility Infection Preventionist.

In an interview on 12/11/20 at 11:32 a.m., the DPOS stated PEPST did rounds in the kitchen twice a year which mainly involved looking at the environment and equipment such as freezers and refrigerators to make sure they were operating appropriately. He gave an example of outside thermometers of the freezers were observed but freezer doors were not opened to look at the food inside.

Review of the document titled "Physical Environment Patient Safety Team (PEPST) HFAP 11.01.01:Once Every 12 Months Non-Patient Care Safety Survey" dated 10/13/20, showed a PEPST audit was done in the kitchen and it consisted of potential environmental safety issues not potential infection control issues.

In an interview on 12/11/20 at 12:53 p.m., the ICC stated the results of the quarterly infection control audit went directly to the DNS via e-mail. She stated she was hired on 8/17/20 and did not do a quarterly kitchen audit yet.

During the survey, from 12/7/20 -12/23/20 , the following infection control issues related to Nutrition Resources were found:

1. Review of the document titled "Food Storage, Handling and Preparation" revised and reviewed on 1/20, showed the following:

"Nutrition Resources will have an effective program utilizing ServeSafe [certification for food and alcohol safety training] standards to monitor and document food handling and preparation which will optimize safety and nutritive value.
Definition: The Department of Nutrition Resources operates under guidelines established by Hazard Analysis Critical Control Points (HACCP), a food safety system which focus is on identifying hazards, controlling points during handling and preparation, and monitoring to evaluate the effectiveness of the control measures in preventing food borne illnesses A critical control point is an operation (practice, preparation step, procedure), by which a preventive or control measure can be applied that would eliminate, prevent, or minimize a hazard or hazards.
General information:
1. Food storage and preparation areas, including unit pantries, will be maintained in a clean, sanitary, and orderly manner at all times ...
4. To minimize risks from biological contamination [when food becomes contaminated with living organisms or substances they produce. This includes biological matter produced by humans, rodents, insects and microorganisms], all readily perishable foods or beverages (Potentially Hazardous Foods [foods that require time-temperature control to keep them safe for human consumption]) capable of supporting rapid and progressive growth of microorganisms, which can cause food infection [illness caused by food contaminated with bacteria, viruses, or toxins] or food intoxication [infectious organisms or their toxins are the most common causes of food poisoning], will be maintained at temperatures of 40 degrees F [Fahrenheit] or below, or at 140 degrees F or above , at all times except during necessary periods of preparation and service ...
Procedure:
1. All Potentially Hazardous Foods will be stored under the following conditions:
a. Refrigerated food will be stored at:
i. Refrigerated foods: 32degrees - 40 degrees F ...

3. All Potentially Hazardous Foods will be held under the following conditions:
b. ..
c. ..
i. All cold storage/holding units will be maintained and documented in accordance with policy at 40 degrees F or below."
Review of the Policy and Procedure titled "Refrigerator/Freezer Temperature Log" revised and reviewed on 1/20, showed the Maintenance staff was responsible for monitoring all of the facility refrigerator temperatures. It also showed the temperature range for refrigerators should be between 35 degrees and 46 degrees. It was noted this policy contradicted the policy above titled "Food Storage, Handling, and Preparation" for the temperature range required for food storage in refrigerators.

According to the 2017 Federal Food Code, the standard of practice for the safe storage of Time/Temperature Control for Safety Food (TCS Food, food that grows bacteria more easily and quickly that other foods and require time and temperature controls to prevent unsafe bacteria growth) is 41 degrees F or less.

On 12/8/20 at 10:30 a.m., in an interview with the DPOS and the Maintenance Lead (MS), DPOS stated the Central Utility Plant tracks refrigerator temperatures on a computer. If a temperature went out of range, an alarm is sounded, and an alert was sent to his phone. MS stated all of the refrigerators and freezers in the facility were on this system.

On 12/8/20 at 11:01 a.m., an interview with Maintenance Worker 2 (MW 2), Maintenance Worker 5 (MW 5), and DNS and a concurrent observation of the patient nourishment refrigerator located in the pantry room on the Maternity unit showed an external thermometer attached to the side of the refrigerator. The thermometer had wires attached that led to the inside of the refrigerator. MW2 stated the thermometer showed the inside temperature of the refrigerator and an alarm went off to notify maintenance if the refrigerator temperature went too high. The outside thermometer read 43.4 degrees Fahrenheit (F). The temperature of food stored inside the refrigerator was measured with a digital thermometer. A carton of milk was 49.8 degrees F and a container of diet chocolate pudding was 45.8 degrees F. MW5, entered the pantry room and wrote down the reading of the external thermometer on a piece of paper. He stated he was doing his daily rounds to check the refrigerator temperatures to make sure they were an appropriate temperature. He also looked inside the refrigerator for an internal thermometer and stated he usually checked the internal thermometer to make sure it was the same as the external thermometer. He said there was not an internal thermometer in the refrigerator so he could not compare the thermometers. He also stated the appropriate range for the refrigerator was 36 degrees F to 46 degrees F. The temperatures of additional food items were measured with a digital thermometer. The temperature of sliced turkey meat for a turkey sandwich was 51.3 degrees F. DNS measured the temperature of the sliced turkey for another turkey sandwich and the temperature was 57 degrees F. She said the temperature was too high. She explained that maintenance was responsible for monitoring these refrigerators. She also stated Nutrition Resource staff did not document refrigerator temperatures.
In an interview on 12/8/20 at 2:20 p.m., the DPOS stated maintenance was responsible for monitoring the nourishment refrigerator temperatures. He confirmed there was a total of 7 nourishment refrigerators on units. He stated the appropriate temperature for the food refrigerators was 36 degrees F to 46 degrees F. He said if the refrigerator temperatures went above this range maintenance was alerted with an alarm and the refrigerator was checked. He also stated he was not sure if there were internal thermometers located inside the refrigerators.

In an interview on 12/8/20 at 2:45 p.m., Nutrition Aide 2 (NA2) stated she was responsible for stocking the nourishment refrigerators daily and confirmed she stocked the refrigerator on 12/8/20 and she did not stock the refrigerators on 12/8/20 until 12 p.m., and she confirmed any food that was in the refrigerator from the kitchen at 11 a.m. on 12/8/20 was placed there the prior day on 12/7/20.

In an interview on 12/9/20 at 11:11 a.m., the ICC stated it was her roll to conduct infection control audits for the kitchen. She stated she did not check the nourishment refrigerators in the pantries on the units, but she probably should.

In an interview on 12/10/20 at 2:44 p.m., DNS stated she did not train maintenance on appropriate temperatures for food refrigerators because she was not invited to do a training.

In an interview on 12/11/20 at 9:50 a.m., NA2 stated she regularly stocked the patient refrigerators on 8 stations. She said if she noticed a refrigerator temperature was above 40 degrees F, she called DNS. She said in the past month she regularly observed high refrigerator temperatures. She stated she called DNS each week and reported high refrigerator temperatures. She said it was verbal and she did not have documentation.

In an interview on 10/11/20 at 10:04 a.m., DNS stated she expected Nutrition Resources staff to contact her if high refrigerator temperatures were identified. She stated she did not receive any notification from any staff that the nourishment refrigerators were high in quarter 1 or quarter 2. She said they were currently in quarter 2 which included October, November, and December and the first quarter included July, August, September. She said she was not able to recall any information about refrigerator temperatures prior to quarter 1. She stated she was not sure Nutrition Resources staff had training on monitoring refrigerator temperatures. The DNS was not able to provide documentation to show staff was trained on appropriate refrigerator temperatures.

Review of external thermometer temperature data logs for the pantry refrigerators, tracked by the maintenance department from 12/8/20 to 12/10/20, showed the ICU (Intensive Care Unit) refrigerator temperature range was consistently between 42.5 degrees F - 43 degrees F, the Pre Operation pantry refrigerator was consistently between 42 degrees F and 45 degrees F, and all of the other pantry refrigerators including the Emergency Room (2 refrigerators), NW (West), Maternity, and Labor and Delivery all had a significant amount of temperature fluctuation above and below 41 degrees F.

2. According to the standards of practice described in the 2017 Federal Food Code, food-contact surfaces and utensils shall be clean to sight and touch.

On 12/8/20 at 3:54 p.m., an observation of the internal components of the ice machine located in the kitchen and a concurrent interview with Maintenance Worker 1 (MW 1), showed a brown and pink residue along the entire upper edge of the evaporator plate (the component where water flows over and ice is formed) and on the plastic edge directly above the evaporator plate. When wiped with a paper towel, the residue came off easily. MW1 confirmed there was residue inside the ice machine.

On 12/9/20 at 10:03 a.m., an observation of the internal components of the ice machine located in the West unit and concurrent interview with MW2, showed pink residue around the end of the tube where formed ice came into contact when dispersed into the ice bin. The pink residue was removed when wiped with a paper towel. MW2 confirmed residue was present.

On 12/9/20 at 10:25 a.m., an observation of the internal components of the ice machine located in the Intensive Care Unit (ICU) and a concurrent interview with MW2, showed pink residue around the tube where formed ice was dispensed into the ice bin. There was also black residue on the plastic just under the tube on the inside surface of the ice bin where ice was stored. MW2 confirmed the pink and black residue was present.

Review of the e-mail document titled "Subject: Kitchen Sanitation Review Findings" dated 10/30/20, showed "mold inside the ice machine." The e-mail was from the DNS and addressed to the MNR and other kitchen staff. The DNS also stated in the e-mail, "If you need any clarification or have any questions on what I found, please let me know. All of this needs to be fixed ASAP [As soon as possible.]"

Review of the Maintenance Work Order # 11150 showed the ice machine was cleaned and sanitized on 10/28/20.

In an interview on 12/22/20 at 4:44 p.m., DNS stated she checked the kitchen ice machine for cleanliness on 10/30/20 by wiping the inside of the ice dispenser from which ice was dropped into the bin, with a towel. She stated she notified maintenance. DNS provided a screen shot of a text message she sent from her phone to the DPOS on 10/30/20. The message read "I found mold inside the ice machine in the kitchen that was supposed to have been cleaned on Wednesday." She also attached a photo in the text that showed a white towel with pink residue on the towel. The DPOS's reply in the text showed "We are on it thanks."

The DNS provided a Maintenance work order as evidence of the next time the ice machine was cleaned after she sent DPOS the text message about mold in the ice machine. Review of the Maintenance Work Order #11555 showed the ice machine in the kitchen was assigned to maintenance staff of 11/1/20 but was not cleaned until 11/28/20.

3. According to the USFDA (US Food and Drug Administration), Refrigerator and Freezer Storage Chart, March 2018, the safe time limit to prevent spoilage of refrigerated fresh poultry was 1-2 days.

During a review of the facility's document titled, "Refrigerated Storage Life of Food," (undated), indicated, raw meat (frozen) maximum storage period is three days to thaw; one day to use for a total of four days. Raw meat (refrigerated) maximum storage period is four days.

During a concurrent observation and interview on 12/7/20, at 3:30 p.m., with the Executive Chef (EC), in the walk-in refrigerator, two 40 pound boxes of raw chicken dated November 27 were observed. Upon questioning regarding the chicken, the EC stated the chicken was likely pulled from the freezer, but the employee failed to date it. The EC stated food pulled from the freezer must have a date indicating when the food started the thawing process.

During an interview on 12/9/20, at 11:15 a.m., with the Infection Control Coordinator (ICC), the ICC stated she had a concern with the time frame of the raw chicken in the refrigerator dated November 27, 2020.

During an interview on 12/11/20, at 8:51 a.m., with the Director of Nutrition Services (DNS), the DNS stated she was not sure how long raw chicken could be safely stored in the refrigerator.

4. According to the USFDA 2017 Food Code, 5 205.11 Using a Handwashing Sink: (B) A HANDWASHING SINK may not be used for purposes other than handwashing.

Water temperature of a handwashing sink much be 100 to 108°F. (USFDA Food Code 2017, Annex 3).

During a review of the facility's policy and procedure titled, "Food Storage, Handling and Preparation," revised and reviewed on 1/20, showed, each handwashing station will be maintained with hot and cold running water, soap, and disposable paper towels.

During a concurrent observation and interview on 12/7/20, at 3:15 p.m., with Nutrition Aide (NA) 1 and the EC, in the food service area of the facility cafeteria, a sink with a wall mounted paper towel dispenser and hand soap were observed. The water temperature of the sink was 74.7 degrees Fahrenheit (F). The NA 1 stated she used the sink for hand washing. The EC stated he was not sure what the sink was used for and confirmed the water temperature was not appropriate for handwashing. The EC stated Plant Operations was responsible for the sink.

During a concurrent observation and interview on 12/8/20, at 11:15 a.m., with the Director of Plant Operations and Safety Officer (DPOS), in the food service area of the facility cafeteria, food remnants were observed in the handwashing sink. The DPOS stated the sink in the food service area of the facility cafeteria was used for handwashing. The DPOS was not aware the of the cafeteria sink water temperature.

During an interview on 12/8/20, at 3:30 p.m., with the DNS, a picture of the food remnants found in the facility cafeteria sink was shared with the DNS. The DNS stated she was not sure what the cafeteria sink was used for. The DNS confirmed water temperature of 74.7 degrees F was not appropriate for handwashing.

During an interview on 12/9/20, at 11:15 a.m., with the ICC, the ICC stated handwashing sinks must not be used for purposes other than handwashing and the temperature must be 100 degrees F for handwashing.

During an interview on 12/11/20, at 9:50 a.m., with the Manager of Nutrition Resources (MNR), the MNR stated the cafeteria sink was used to clean the smoothie cups and was not a handwashing sink. The MNR stated he was not aware the cafeteria sink was being used for handwashing.

During an interview on 12/11/20, at 12:37 p.m., with the DPOS, the DPOS stated he had never received a work order for the water temperature of the sink in the food service area of the facility cafeteria.

5. According to the USFDA 2017 Food Code, 5-501.113 Covering Receptacles: receptacles and waste handling units for refuse, recyclables, and returnables shall be kept covered: (B) With tight-fitting lids or doors if kept outside the food establishment.

According to the USFDA 2017 Food Code, 5-501.116 Cleaning Receptacles: (B) Soiled receptacles and waste handling units for refuse, recyclables, and returnables shall be cleaned at a frequency necessary to prevent them from developing a buildup of soil or becoming attractants for insects and rodents.

According to the USFDA 2017 Food Code, 5-502.11 Frequency: refuse, recyclables, and returnables shall be removed from the premises at a frequency that will minimize the development of objectionable odors and other conditions that attract or harbor insects and rodents.

During a concurrent observation and interview on 12/8/20, at 10:40 a.m., with the DPOS and the Manager of Environmental Services (MEVS), in the trash storage area located in the rear of the facility, the following were observed: a large pile of cardboard boxes with other types of trash intermingled, two uncovered metal garbage storage bins, overflowing with garbage, and two feral cats; one of which was trying to eat dried garbage stuck to the trash compactor.

The DPOS stated the environmental services department notified plant operations when the garbage storage bins were full. Plant operations used a fork- lift to empty the garbage storage bins into the trash compactor. The DPOS confirmed the garbage storage bins were overflowing with garbage and did not have lids. The DPOS stated the facility had a problem with feral cats in the area. The MEVS stated the facility previously had a program that was responsible for emptying the trash and breaking down the cardboard boxes, but due to the COVID-19 pandemic, the program had been canceled in April 2020. The MEVS stated the facility did not have the staff to empty the garbage in a timely manner.

During an interview on 12/9/20, at 11:15 a.m., with the ICC, the ICC stated she had a concern with the facility's trash storage.

6. Review of the undated document titled "Refrigerated Storage Life of Foods" showed salad dressing cups had a maximum storage period of 5 days. The document also provided instructions on how to determine the expiration date and showed "Day 1 is the date received or produced ..."

On 12/7/20 at 2:45 p.m. during the initial tour of the kitchen, an interview with MNR and a concurrent observation, showed 7 trays of salad dressing in individual plastic containers located in a reach-in refrigerator. Each tray contained more than 30 individual containers. Each tray also had a label that read use by "5 days." Each label also had dates, which MNR stated were the dates the salad dressing was removed from a large container of salad dressing and placed in the individual cups, and the date the salad dressing was to be used or discarded. He confirmed all of the salad dressings were to be used within 5 days of placing in the individual cups. The tray labeled Caesar salad dressing was dated 11/6/20, use by 5 days, 12/12/20. The tray labeled 1000 island dressing was dated 10/26/20 and use by 5 days, 12/12/20. The tray labeled Asian dressing was dated 11/29/20, use by 5 days, 12/12/20. 4 trays were labeled Ranch dressing. Two trays of Ranch were dated 12/6/20 , use by 5 days, 12/12/20. 1 tray of Ranch was dated 12/6/20, use by 5 days, 12/11/20. The next tray of Ranch had a use by day of 12/11/20 but did not have the date the dressing was placed in the containers. MNR said that any of the dressings dated 12/6/20 should be used by 12/11/20. He confirmed the tray of Caesar dressing, 1000 island dressing, Asian dressing, and 3 trays of Ranch dressing were all dated incorrectly. MNR also stated he did not understand why the dates were incorrect because a machine was used to print out labels with dates depending on the food the staff entered into the system. He said the machine calculated the dates and the staff did not have to determine the dates.

The DNS provided a Nutrition Resources staff in-service titled "Infection Control and Personal Hygiene" as evidence staff was trained on labeling and dating. Review of the document showed the in-service was conducted on 11/20/20. The slides used for the in-service showed "label and date all foods". It did not show that staff were trained on how to label and date foods. In addition, a review of the "Infection Control and Personal Hygiene Quiz" dated 11/20/20 had 5 questions and did not have any questions to assess competency of labeling and dating. This was the only in-service provided by the facility to show training was conducted on labeling and dating.

In an interview on 12/9/20 at 11:11 a.m., the ICC stated multiple different dates on the salad dressing was a concern.

7. According to the USFDA Food Code cutting surfaces such as cutting boards and blocks that become scratched and scored may be difficult to clean and sanitize. As a result, pathogenic microorganisms transmissible through food may build up or accumulate. These microorganisms may be transferred to foods that are prepared on such surfaces. (USFDA Food Code Annex, 2017).

According to the USFDA 2017 Food Code, Section 4-501.11 Good Repair and Proper Adjustment: (C) cutting or piercing parts of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is opened.

During a review of the facility's policy and procedure titled, "Food Storage, Handling and Preparation," revised and reviewed on 1/20, indicated, all utensils ...will be kept clean, sanitary, maintained in good repair and will be free of breaks, corrosion, open seams, cracks and chipped areas. Any cookware with excess carbon build-up will be cleaned and sanitized with the appropriate and approved cleaning agents.

During a concurrent observation and interview on December 7, 2020, between 2:40 PM and 3:30 PM, with the MNR, the EC and the DNS, in the kitchen,
1. two green cutting boards were heavily marred with knife marks,
2. the can opener blade was rough and worn,
3. wood handles on ten metal spatulas were cracked and worn,
4. eight stock pots had heavy black residue on the outside of the pots,
5. seventeen large muffin pans had heavy black residue on the top surface of the pans,
6. 3 frying pans had a heavy black residue on the inside surface,
7. 3 large roast pans had a heavy black residue on the inside surface,
8. 5 non-stick frying pans had scratches covering the inside non-stick cooking surface, and
9. four rubber spatulas were cracked and chipped.

The EC confirmed the cutting boards should be replaced. The DNS stated she tries to do a monthly kitchen sanitation audit but had not noticed the cutting boards. The EC was not aware the can opener blade needed replacement. The EC confirmed the ten metal spatulas, the eight stock pots, and the four rubber spatulas needed replacement. The MNR confirmed there was black build up on the frying pans, roast pans, and large muffin pans. He also confirmed the non-stick frying pans were scratched. The MNR stated the expectation was for pans and utensils to be replaced when residue build up could not be removed or were in poor condition. He said he did not request a replacement for the items observed that were scratched and/or had residue build-up.

8. According to the standard of practice described in the 2017 Federal Food Code, lockers or suitable facilities shall be provided for the orderly storage of employee's clothing and other possessions. Lockers or other suitable facilities are to be located in a designated room or area where contamination of food, equipment, utensils, linens, and single-service items cannot occur.

On 12/7/20 at 2:45 p.m., during the initial tour of the kitchen, an interview with MNR and a concurrent observation, showed a rack holding white chef coats and 7 other coats and sweaters mixed in with the white chef coats. MNR stated the chef coats were clean and one of the other coats was for staff to wear in the freezer. The other 6 coats and sweaters were staff personal items brought from home. MNR stated the white chef coats were clean and employee personal clothing from home should not be mixed with the clean coats. He said the personal items from home could contaminate the clean chef coats. In addition, the rack holding the coats was stored next to a tall rack holding bread. The freezer coat hanging on the clothing rack came into contact with the rack of bread. MNR stated this was where the bread rack and clothing rack were usually stored and the clothing on the coat rack should not come into contact with the bread rack.

Review of an e-mail document titled "Subject: Kitchen Sanitation Review Findings" dated 10/30/20, showed a list of items DNS observed when she did a sanitation inspection in the kitchen. The e-mail was from DNS and addressed to MNR. One item identified by DNS, was "Clothing touching the bread rack." DNS also stated in the e-mail, "If you need any clarification or have any questions on what I found, please let me know. All of this needs to be fixed ASAP [As soon as possible.]" No documentation was provided, upon the surveyor's request, to show corrective action for this issue.

In an interview on 12/9/20 at 11:11 a.m., the ICC stated she looked at storage of employee clothing but was not sure it was on her checklist. She said employee clothing mixed with the clean chef coats was a problem.

9. According to the USFDA 2017 Food Code, 4-602.13 Nonfood-Contact Surfaces: nonfood-contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil residues.

During a concurrent observation and interview on 12/7/20, at 3:05 p.m., with the EC and the DNS, in the dish room, a floor drain under the dish machine was observed with a black residue. The black residue could be removed with a paper towel. The EC stated housekeeping was responsible for cleaning the floor drains and confirmed the drain needed cleaning.

During an interview on 12/9/20, at 11:15 a.m., with the ICC, the ICC confirmed she had a problem with the dirty drain in the dish room.

During an interview on 12/12/20, at 11:14 AM, with the MEVS, the MEVS stated environmental services is responsible for mopping the kitchen floors, cleaning the ceiling vents and fans but is not responsible for cleaning the floor drains in the kitchen.

10. According to the 2017 Federal Food Code, "an air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment, or nonfood equipment shall be at least twice the diameter of the water supply inlet and may not be less than 25 mm (1 inch)."

On 12/7/20 at 2:45 p.m., during the initial tour of the kitchen with MNR, an observation showed 3 pieces of equipment that were used for food and did not have adequate or visible air gaps for the equipment drainpipes. The first piece of equipment observed was a standing steamer. The drainpipe that from the steamer was less that a half inch from the floor sink. The diameter of the drainpipe was more that 1.5 inches. The end of the drainpipe had a build- up of black and thick white residue. The next two pieces of equipment were two food preparation sinks. The drainpipes from each sink were plumbed into the wall and there were no visible air gaps in the drainpipes. MNR confirmed he did not see visible air gaps for the sinks.

In an interview with the ICC on 12/9/20 at 11:11 a.m., the ICC stated she did not look for air-gaps on kitchen equipment.

Based on observations, interviews, and record reviews, the hospital failed to implement an effective infection control program to avoid sources and transmission of infection when:

1. Temperatures in the clean and the decontamination area of the Sterile Processing Department (SPD-performs sterilization and other actions on medical devices and equipment) were out of range for five of seven days in December 2020.

2a. Two of three autoclaves (used in medical and laboratory setting to sterilize instruments) were not cleaned and maintained daily and weekly per manufacturer's instructions for use (IFUs). Autoclave 1 was observed to have light blue and gray fuzzy matter on the outside hood, black residue within the sanitizing compartment and rust colored stain above the gasket (seal to keep moisture from escaping). As of 11/12/2020, Autoclave 2 was out of order and not sterilizing instruments. Autoclave 3 was observed to have dark gray dust-like residue within the sanitizing compartment. Autoclave 1 and 2 were located in SPD and Autoclave 3 was in the Operating Room (OR).

2b. The manufacturer's recommended cleaning product to clean two of three autoclaves (Autoclave 1 and 3) per manufacturer's IFU's was not used.

2c. Three of three autoclaves were not maintained according to acceptable standards of practice per the Association of Perioperative (around the time of surgery) Registered Nurses (AORN).

3a. Two of two inspected surgical trays, 75 surgical instruments that were previously processed were stained and discolored and did not meet acceptable standards of practice for quality.

3b. Surgical Scrub Technician (SST) did not check for sharpness of scissors when inspecting surgical instruments according to the AORN.

4a. In the SPD pre pack (clean room) and decontamination room [disinfection and cleaning room]: a) The autoclave loading cart in the pre pack room had multiple brown stains, b) Two of three ceiling vents had of gray fuzzy matter, d) The tile flooring had rust color and gray stains, e) The loading cart had rust colored stains on the bottom part of the loading cart, and f) A second large surgical instrument tray which was larger than the sink was not completely submerged in the water on the three division sink.

4b. The Environmental Assistant Housekeeper I (EAH I) did not follow manufacturer's IFUs for the contact time for the disinfectant product used. The Sterile Processing Technician (SPT) did not follow proper technique by not completely submerging an instrument tray in enzymatic detergent (use to remove stubborn organic debris such as stains, blood, mucus and stains) which was mixed with water on a three division sink. The Central Supply Technician (CST) did not pre-soak and clean the non-used surgical instruments prior to placing the surgical instruments in the washer. The CST did not use the recommended cleaning product to clean the washer per manufacturer's IFU's and no documented evidence of cleaning was provided. The SPD department staff used unapproved cleaning products to clean sinks and surfaces in the decontamination area.

5. The storage cabinet for clean scopes (a reusable patient instrument, used to visualize an interior organ) was located next to a hopper (a device where liquid and solid excretion are dumped, flushed and washed out) and in a soiled utility room used for dirty endoscopes and did not follow the standards as indicated by Society of Gastroenterology [branch of medicine which deals with the disorder of the stomach and intestines] Nurses and Association (SGNA).

6. Clean endoscopes were transported from a soiled utility room without the use of a transport container in accordance with SGNA standards.

7. There was no eye wash station located in the GI processing room per AORN, SGNA, Healthcare Infection Control Practice Advisory Committee (HICPAC), and Occupational Safety and Health Administration (OSHA) standards.

8. One of one staff in the GI (Gastrointestinal - stomach and small intestine) processing room used the sink for cleaning contaminated scopes for hand washing and not in accordance with AORN.

9. The hospital did not have a method of determining humidity levels in the sterile (free from bacteria) supply area in the perioperative department and the GI processing room per AORN or SGNA or CDC (Center for Disease Control and Prevention - national health protection agency).

10. The GI processing room staff did not provide documented evidence of cleaning of the GI scope cabinet per AORN.

11. Hospital staff did not provide evidence of terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) of the hospital GI processing room, OR sterile items in the storage area, SPD sterile processing rooms, and decontamination rooms (a workspace room used to process and clean equipment/instruments which contain contaminants such as micro-organisms or hazardous materials, including chemicals, radioactive substances, and infectious diseases) per AORN.

12. Hospital staff did not follow CDC standards for the storage of Personal Protective Equipment (PPE- example mask, gown and goggles protective clothing to protect wearer's body from injury or infection) and was not stored per policy in the radiology and laboratory department

13. Hospital staff did not follow CDC standards for the storage of Personal Protective Equipment in the medical surgical unit and Emergency Department (ED).

14. In the Emergency Department (ED), the steps for processing and disinfecting ultrasound vaginal probes did not follow the hospitals Policies and Procedures (P&P) and national standards.

These failures resulted in the potential for transmission of infections for patients undergoing surgical procedures in the OR, endoscopic procedures in the Endoscopy Room, and emergency procedures in the ED.

Because of the serious potential harm to all surgical patients related to the inability of the hospital to ensure surgical instruments were processed according to the standards as written in Association for the Advancement of Medical Instrumentation (AAMI an organization for advancing the development, and safe and effective use for medical technology) and AORN and the inability of the hospital to ensure endoscopes were processed and stored in a sanitary manner according to SGNA, an Immediate Jeopardy (IJ) situation was called with the Chief Nursing Officer (CNO) and the Director of Quality Management Risk (DQMR) on 12/8/20 at 6:55 p.m. under A750 CFR 482.42(a)(3). The CNO and the DQMR were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The CNO was provided an explanation to submit an acceptable Action Plan to address the IJ situation. Version 6.5 of the Action Plan was acceptable on 12/22/20. The following items were listed on the Action Plan and validated by the survey team: Immediately stop all surgeries
utilizing surgical instruments from trays processed with the hospital autoclave. All SPD, Maintenance and OR staff completed competency of determine the steps necessary in order to utilize the autoclave without the identified black residue or obtain an autoclave that will process surgical instruments appropriately. Corrected the instrument tray to be able to be submerged prior to the autoclave process by installing appropriate size sink. In service all SPD and OR staff to monitor surgical trays to determine if the processing of surgical instruments followed established hospital polices and standards of practice. Store scope cabinet and endoscopes in a clean area per SGNA standards. Transported and processed of endoscopes were to follow SGNA standards by using dedicated clean containers. Inservice of All OR staff to conform to SGNA standards. Provided a separate sink to be used for hand hygiene in the endoscopy storage room. Provided an eye wash station on the same level as the endoscope cleaning room. The hospital submitted a Program Flex to suspend Surgical and Anesthesia Services to CDPH on 12/22/2020. Until the hospital's autoclaves are completely repaired and approved for use by the CDPH. Items of the Action Plan were validated through observations, interview, and record review and the IJ was removed with the CEO, the CNO, the DQMR and the DPOS in on 12/22/20 at 6:23 p.m.

Findings:

1. During a concurrent observation and interview on 12/7/20, at 2:54 p.m., with the Central Supply Technician (CST), in the clean area of the SPD, the digital temperature monitoring device was observed at 64.8 degrees (F -Fahrenheit).

During a concurrent interview and record review on 12/7/20, at 2:58 p.m. with the CST, the "Central Supply Daily Temperature and Humidity Checks (CSDTHC)" dated 12/2020 was reviewed. The CSDTHC indicated, "SPD Clean area Temperature Range maintain at (68-73 F) December 2, 2020 - 67.1 (F), December 3,2020 - 67.1 (F), December 4, 2020 - 63.5 degrees (F), SPD Decontamination area Temperature Range maintain at (60-65 F), December 1, 2020 - 71.1 (F), December 2, 2020 - 70.3 (F), December 3, 2020 - 70.1 (F). The CST stated the temperature range for the clean SPD area should be between 68-73 degrees (F) and the decontamination SPD area should be between 60 and 65 degrees (F). The CST stated she called the maintenance department to fix the temperature on 12/7/20. The CST stated she was not able to provide documentation or evidence this occurrence was reported to the maintenance department and resolved.

During a concurrent observation and interview on 12/7/20, at 3:39 p.m., with CST, in the clean area of the SPD, the digital temperature monitoring device was observed at 63.5 degrees (F). The CST validated the digital temperature monitoring device was 63.5 degrees (F).

During an interview on 12/8/20, at 10:37 a.m., with the Infection Control Coordinator (ICC), the ICC stated the hospital followed nationally recognized infection control guidelines from AORN, AAMI, and CDC.

During a concurrent observation and interview on 12/8/20, at 10:40 a.m., with Infection Control Coordinator (ICC), in the clean area of the SPD, digital temperature monitoring device was observed at 65.3 (F). ICC stated temperature range for clean SPD area should be between (68-73) (F) and decontamination SPD area should be between (60-65) (F). ICC stated proper temperature should be maintained to prevent compromising sterile surgical instrument and to prevent infection.

During a review of the facility's policy and procedure (P&P) titled, "Infection Control for Sterile Processing" dated January 2020, the P&P indicated "Purpose: To provide infection control procedures in Central service area ... Air Temperature and humidity will be monitored daily." There was no reference to the temperature range to be maintained and monitored in the clean area and decontamination area listed in this P&P.

During a professional reference review retrieved from the AAMI, titled Sterility Update 2010, " ...relative humidity should be maintained between 30% and 60% in all work areas. "Because of the need to wear PPE, temperature in the decontamination area should be between 60 degrees Fahrenheit and 65 degrees Fahrenheit ..."

2. During a concurrent observation and interview on 12/7/20, at 3:35 p.m., with CST, in the clean area of the SPD, Autoclave 1 was observed to have light blue and gray particles on the outside surface of the autoclave. The CST stated Autoclave 1 should not have blue and gray particles on the outside surface. The CST stated there was no daily cleaning log for the Autoclave 1 because the autoclaves did not need to be cleaned daily. The CST stated the autoclaves were cleaned weekly by the maintenance department. The CST stated Autoclave 1 was the only autoclave used to process surgical instruments and Autoclave 2 was out of order as of 11/12/20 and had not been fixed. The CST stated Autoclave 1 was the only autoclave that processed all instruments delivered the OR to the SPD.

During a review of the facility document titled, "OPERATION LIST (OL)" dated 12/7/20, the "OL" indicated 21 operations were scheduled for 12/7/20.

During a review of the facility document titled, "OL" dated 12/8/20, the "OL" indicated 13 operations were scheduled for 12/8/20.

During a concurrent observation and interview on 12/8/20, at 10:40 a.m., with the ICC, in the clean area of the SPD, Autoclave 1 had an area with large black residue within the sanitizing compartment and rust color stain above the gasket. Autoclave 1 had a sticker which indicated preventative maintenance] due on 9/2020. The ICC stated Autoclave 1 should be cleaned both inside and outside. ICC stated maintenance and routine cleaning and disinfection of the autoclave should have been done and Maintenance Worker II (MWII) should follow the manufacturer's IFU's of the autoclave to prevent the risk of compromising surgical instruments and to prevent infection.

During a concurrent interview and record review on 12/9/20, at 10:45 a.m., with MWII, the "Manufacturer's IFU for autoclave [brand name]", dated 7/22/1980 was reviewed. MWII stated he cleaned and sanitized the autoclaves every week. MWII stated autoclaves should be free from black residue within the sanitizing compartment and rust color stain above the gasket. MWII stated he used [brand name] to clean the inside chamber of the autoclave and [brand name] for the drain of the autoclave. MWII stated he should not be using the [brand name] to clean the inside chamber of the autoclave and [brand name] for the drain of the autoclave because they are not approved by the hospital for used. MWII stated he was not aware of the manufacturer's IFU for the autoclave and did not receive training on cleaning and maintenance of the autoclave. MWII stated he was unaware and had not read the manual or the manufacturer's IFU for the autoclave. MWII stated he should follow the daily and weekly cleaning of the autoclave and use the recommended cleaning product per manufacturer's IFU. MWII stated he should be following the manufacturer's IFU for the autoclave for safety of patients and did not. MWII stated he should have followed proper conditioning of the autoclave and to make sure the autoclave was properly cleaned.

During a concurrent observation and interview on 12/10/20, at 5:27 p.m., with the [brandname] Chamber Cleaner (SCC), in the SPD, Autoclave 1 and Autoclave 2 was observed clean. The SCC stated, he finished professionally cleaning the autoclaves.

During an observation, interview, and record review on 12/13/20, at 11 a.m., with the Director of Surgical Services (DSS), the flash autoclave (Autoclave 3-a machine that has a heated chamber used for sterilizing equipment and surgical instruments using chemical reactions, high pressures, high temperatures, and steam), in the utility room across from surgical suite 2 was observed and had dark gray residue around the door seal and on the door hinges. The DSS stated surgical staff seldom use the flash autoclave and put her hand in the flash autoclave; rubbed around the chamber area and had dark gray dust-like residue on her hand. The DSS stated the autoclave should not be like that [dirty] and the flash autoclave should be clean.

During an interview on 12/13/20, at 11:20 p.m., with the Director of Plant Operations & Safety Officer (DPOS), the DPOS stated the flash autoclave should not be dirty. The DPOS stated the hospital had a company come to professionally clean the autoclave, and the company manually wiped down the flash autoclave, but did not use the machine because it would not fit in the room.

During a concurrent observation and interview on 12/15/20, at 11:39 a.m., with the CST, in the clean area of the SPD, CST inspected newly processed surgical instrument sets. CST stated, there were 19 of the 102 surgical instruments have discoloration and stain. CST stated having 19 surgical instruments stained and discolored is not acceptable set of instruments for used.

During a concurrent interview and record review on 12/15/20, at 12:45 p.m., with the DSS, the document titled, "Steam Sterilizer Log #4," dated 11/20 was reviewed. The DSS validated the Steam Sterilizer Log #4 was the log for the flash autoclave, the log indicated tests were performed on the flash autoclave on 11/3/20, 11/4/20, 11/5/20, 11/12/20, 11/17/20, and 11/18/20 and the flash autoclave was used on 11/5/20 to sterilize surgical equipment; leg holder and a cannulated instrument on 11/11/20. The DSS stated she was unaware of how often the flash autoclave was cleaned, she did not keep track of the cleaning logs except maintenance would manually clean the flash autoclave by wiping it down once a week.

During a concurrent observation and interview on 12/16/20, at 10:35 a.m., with the CST, in the clean area of the SPD, CST inspected newly processed surgical instrument sets. CST stated, there were 67 of the 102 surgical instruments have discoloration and stain. CST stated having 67 surgical instruments stained and discolored is not acceptable set of instruments for used.

During an interview on 12/17/20, at 12:50 p.m., with DPOS, the DPOS stated autoclave 1 was the only autoclave working and was used to process all surgical instruments and was due for Preventive maintenance (PM) on September 2020. The DPOS stated Biomed (department to ensure that medical equipment used in patient care is properly configured and functioning safely) should have contacted [brand name] -a company who specializes in autoclaves) to service the autoclave for annual PM. The DPOS stated the hospital did not have a process of monitoring the PM of autoclaves. The DPOS stated the CST should have reported when autoclaves were due for PM to the Maintenance Department and Biomed. The DPOS stated MWII should have been formally trained with competencies in order to evaluate the quality of the cleaning the autoclave per manufacturer's IFU. DPOS stated manufacturer's IFU should be followed to make sure staff are fully aware of the correct process, to know what is appropriate for the autoclave and to understand the scope of work for safety of staff.

During a concurrent observation and interview on 12/21/20, at 12:54 p.m., with the CST, in the clean area of the SPD, CST inspected newly processed surgical instrument sets. CST stated, One surgical instrument set there were 62 of the 66 surgical instruments have discoloration and stain. CST stated having 62 surgical instruments stained and discolored is not acceptable set of instruments for used. CST inspected second surgical instrument set there were 51/53 surgical instruments have discoloration and stain. CST stated having 51 surgical instruments stained and discolored is not acceptable set of instruments for used.

During an interview on 12/21/20, at 11:30 a.m., with the DPOS, the DPOS he had never received training and was unaware of the frequency for cleaning autoclaves.

During a review of the "Manufacturer's IFU for autoclave [brand name]", dated 7/22/1980, the IFU indicated, " ... 5 Routine Maintenance ... Daily .... Clean chamber and loading equipment as follows: a. Wash inside of sterilizing chamber and loading equipment with mild detergent solution such as [brand name] ...Rinse with tap water; dry with lint free cloth ... Remove chamber drain strainer. Clean out lint and sediments; reverse flush under running water ... Flush drain weekly ... also flush drain whenever line comes clogged or spillage occur during a liquid processing cycle ... Weekly ... Flush chamber drain as follows: ... Rinse drain with hot solution of trisodium phosphate (cleaning agent stain remover and degreaser ]-two tablespoon to one quart of water) ... the flush drain with one quart of hot water ... Monthly ... Place a few drops of a heavy machine oil on the chamber door hinge by opening and closing the door several times ..."

During a review of the facility's P&P titled, "Sterilization Steam" dated 12/19, the P&P indicated, "Purpose: Provide steam sterilization guidelines for reusable items that can with stand high temperature ... Special Instructions: Report any suspected malfunctions to the supervisor immediately ... A preventive maintenance contract maintained for all sterilizing equipment. They are responsible for all repairs and bimonthly checks ... Regular cleaning is performed by the maintenance department staff ... Monitoring of the sterilizers is the responsibility of Surgical Services."

During a professional reference review retrieved from https://www.cdc.gov/coronavirus/2019-ncov/community/disinfecting-building-facility.html on 11/21/20, titled, "Disinfecting Your Facility" dated July 28, 2020, the professional reference indicated, " ...Disinfect ...Follow the instructions on the label to ensure safe and effective use of the product ...Always read and follow the directions on the label to ensure safe and effective use ..."

3. During a concurrent observation and interview on 12/7/20, at 4:14 p.m., with CST, in the SPD, one minor (set of instruments used for short surgical procedure) sterilization container filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of CST. The following concerns were identified upon observation of the surgical instruments: in the minor tray 13 of 78 instruments contained the following: 11 instruments were stained and two instruments were discolored. The CST stated the previously cleaned and sterilized surgical instruments should be free from stains and discoloration. The CST stated the instruments should have been pulled and sent out for replacement to prevent compromising the sterility of the surgical tray and to prevent infection.

During a concurrent observation and interview on 12/8/20, at 10:02 a.m., with the SST in the pre and pack (clean area where surgical instruments are inspected prior to autoclave) area of SPD, SST was observed inspecting surgical instruments without checking for sharpness of cutting edge of scissors. The SST stated she should have checked the sharpness of the scissors to make sure they were working as intended.

During a concurrent observation and interview on 12/8/20, at 10:35 a.m., with the CST, in the pre and pack area of SPD, SST was observed inspecting surgical instruments without checking for sharpness of cutting edge of scissors. The CST validated and stated the SST should have checked the scissors for sharpness and replace if the scissors were not sharp.

During a concurrent observation and interview on 12/8/20, at 1:10 p.m., with the CST, in the SPD, one major sterilization tray (collection of reusable surgical instrument created to which are used during complex surgery) filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of CST. The following concerns were identified upon observation of the surgical instruments: in the major tray 62 of 102 instruments contained the following: 60 instruments were stained and two instruments were discolored. The CST stated the previously cleaned and sterilized surgical instruments should be free from stain and discoloration and the instruments should have been pulled and sent out for replacement to prevent compromising the sterility of the surgical tray and to prevent infection.

During an interview on 12/9/20, at 1:22 p.m., with the ICC, the ICC stated, the previously processed surgical instruments should be free from stain and discoloration and no markings that could cause infection and harbor bacteria. The ICC stated SPD staff should check the scissors for sharpness and instruments proper function to get a clean cut to prevent infection.

During a review of the facility's P&P titled, "Instrument Care and Cleaning," dated 1/20, the P&P indicated, "Purpose: To provide a standard for care and cleaning of instruments .... Policy Instruments ....trays and other precision items are to be cleaned manually, as per described procedure in the decontamination section ... Cleaning procedure: Inspection and Sorting: Inspects instruments for defects. Dull or defective instruments shall be removed from use and inspected by the supervisor for final decision about their future use ... scissors and other cutting instruments for sharpness and absence of nicks ..."

During a professional reference review from AAMI titled, "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC Guidelines, and AORN guidelines, their recommendations, stipulated the following: "Instruments should undergo an inspection for proper function and cleanliness ...1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects. 2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."

During a professional reference review from AORN Guidelines for "Perioperative Practice (2015), Recommendation X (p629) dated indicated, "Surgical instruments should be inspected and correct working order after decontamination and if soiled or defective, should be removed from service until they are cleaned or repaired. Items that are not clean or do not function correctly put a patient at risk for Injury or SSI (surgical site infection)."

4. During a concurrent observation and interview on 12/8/20, at 9:47 a.m., with the CST, in the SPD pre pack area, the autoclave loading cart had rust color stains. The CST validated the autoclave loading cart had rust color stains and stated maintenance staff would oversee the cleaning and maintenance of loading carts. The CST stated she was unaware and did not have access to the manufacturer's IFU for cleaning and disinfection of the loading carts.

During a concurrent interview and record review on 12/9/20, at 10:45 a.m., with the MWII, MWII stated he cleaned and sanitized the loading cart every week. MWII stated the loading cart should be free of rust color stain. MWII stated he used [brand name, which he was not aware if hospital approved the use of chemical to be used] to clean the cart. MWII stated he did not receive formal training on cleaning and maintenance of the loading cart. MWII stated he did not have access to the manual or the manufacturer's IFU for the cart. MWII stated he should follow the recommended cleaning product per manufacturer's IFU. MWII stated he should have followed the manufacturer's IFU for the cart to ensure safety of patients and employees.

A request was made for the loading cart's IFU on 12/7/20 to 12/22/20 from the CST, MWII, DPOS, DSS. The hospital was unable to provide the IFU prior to the exit of the survey on 12/23/20.

During a concurrent observation and interview on 12/8/20, at 2:10 p.m., with EAH I, in the SPD decontamination area, EAH I was observed cleaning. EAH I wiped the table and cart with disinfectant [brand name] and let it dry for two minutes. EAH I then mopped the floor with [brand name] and let it dry for five minutes. EAH I stated [brand name] dries fast. EAH I stated [brand name] direction for use contact time indicated 10 minutes. EAH I stated the contact time indicated the time needed to remain wet for 10 minutes to prevent infection.

During a concurrent observation and interview on 12/8/20, at 2:41 p.m., with the CST, in the SPD decontamination the following was observed, two of three ceiling vents were covered with gray, fuzzy matter. The handle to one of two carts had a large area of metal peeled off and with large amounts of rust colored stain. Floor tiles were covered with gray particles and rust colored stain. The CST cleaned a large surgical instrument tray that was not fully submerged under enzymatic and water solution three division sink; and a second large surgical instrument tray larger than the sink was not fully submerged in water sitting partially in another sink. The CST did not pre-soak non-used surgical instruments delivered from the OR with enzymatic cleanser and did not individually and manually clean the surgical instruments prior to placing in the washer. The recommended cleaning product to clean washers per manufacturer's IFU's was not used and no documented evidence of cleaning was provided. The CST used a cleaning product that was not listed as approved and was a product intended to clean sinks and surfaces. The CST validated the observations. The CST stated EVS staff would oversee the cleaning of SPD decontamination area every day and was unaware if EVS staff performed terminal cleaning. The CST stated the cart handle should be free from metal peeling and rust colored stain. The CST stated surgical instrument trays should be fully submerged in enzymatic cleaner and water. The CST stated due to the size of the sink the surgical instrument tray could not be fully submerged. The CST stated for non-used surgical instruments delivered from the OR there was no need to pre-soak in enzymatic cleaner and clean individually and the instruments could go directly to the washer (automated cleaning and disinfect of surgical instruments). The CST stated she used [brand name] to clean and disinfect the washer and the contact time for the [brand name] was three minutes. The CST was not able to provide the manufacturer's IFU and evidence of daily cleaning for the washer. The CST stated she used alcohol for cleaning and disinfecting the wet sink and surfaces in SPD decontamination room.

During an interview on 12/8/20, at 3:15 p.m., with the ICC, she stated SPD decontamination area should not have gray particles on the vents and the tile flooring should be free from any stains or discoloration. The ICC stated the cart with peeling metal and rust colored stain should not be used and surgical instrument trays should be fully submerged in the sink. The ICC stated all surgical instruments delivered from the OR should follow the same process in the decontamination area including presoaking in enzymatic cleaner and manually cleaning each surgical instrument. The ICC stated manufacturer's IFU should be followed for the washer. The ICC stated the CST should not use [brand name used by CST] and CST should use [appropriate brand name] and routine cleaning should be done and documented by CST. The ICC stated the CST should not use alcohol in cleaning the wet sink and surfaces. The ICC stated the CST should have dried the sink and used the recommended disinfectant by the hospital [brand name] and followed the hospitals P&P in infection control and SPD to prevent cross contamination and infection.

During an interview on 12/9/20, at 1:22 p.m., with the ICC, the ICC stated the disinfectant used by EAH I in SPD [brand name], the ten minute contact time should be followed. The ICC stated the contact time indicated the amount of time surfaces needed to stay wet in order to kill organisms. The ICC stated when staff did not follow the 10 minute contact time that would compromise the effectiveness of the disinfectant. The ICC stated staff should follow the manufacturer's IFU to prevent infection.

During an interview on 12/9/20, at 3:14 p.m., with the Manager Environmental Services (MEVS), MEVS stated EAH I should follow the manufacturer's IFU for [brand name] disinfectant. The MEVS stated [brand name] disinfectant had a contact time of 10 minutes which indicated the surface should remain wet with the solution for 10 minutes to be effective in preventing infections.

During a review of the manufacturer's IFU for washer [brand name], dated 5/15/07, the IFU indicated, "Washer/Disinfector ... Cleaning Procedures .... 1. Required materials: Synthetic sponge ... touch screen cleaner: Non-ammonia based glass cleaner .... 2. Washer/Disinfector Cleaning procedure and maintenance Chores .... 2.2 Maintenance chores: 2.2.1 Only a machine that receives daily cleaning and preventive maintenance can operate properly ... 2.2.4 The customer (normally the technical service of the hospital) is responsible for routine cleaning and maintenance work ... 2.2.5 Completed maintenance work must be carried out according to documented protocol ... 4. Stainless steel front panel cleaning procedure for sterilizer and washer/disinfector. 4.2 Possible cleaning agents depending on residue build up severity ... 4.2.2. Mild dirt build up [equals] water and alkaline (base dissolved in water) soap/detergent wipe with soft towel ... 4.2.3. Moderate dirt build up [equals] water and stainless steel cleanser [brand name] wipe with soft cloth and synthetic sponge .... 4.4 Wipe silicone door seals clean to minimize chemical and mechanical deterioration of seal ..."

Based on interview and record review, the facility failed to involve the patient and the patients' representatives in discharge planning for care five of 13 patients (Pt 43,45,47,49, and 51) when:
a. instructions on all medications at discharge were not explained to the patient and patient representative (Pt 49 and 51) and
b. safety protocols to prevent spread of infection following discharge not provided to Pt 43 and 45 or their representatives and
c. failed to use interpretive services for non-English speaking patients for four of 13 patients (Pts 45, 47, 49, and 51).

These failures had the potential to cause harm to these patients following discharge (example of harm: not understanding discharge medications or instructions because they were not explained in their primary language, possibly taking the wrong dose or not stopping a medication that should be stopped causing the patient to get dehydrated; for Pts 45,47, and 49) and had the potential to spread the COVID-19 virus (Coronavirus disease 2019- respiratory illness that is spread easily from person to person; for Pts 43 and 45).

Findings:

During a concurrent interview and record review on 12/9/20 at 2:45 p.m. with the Director of Health Information (DHI) and the Registered Nurse Informaticist (RNI), Pt 43's electronic medical record (EMR) was reviewed for the admission date 7/30/20 from a skilled nursing facility. Pt 43 was admitted from the emergency room with septic shock (infection in the blood that can cause shock symptoms include fever, chills, tachycardia, and increased respiratory rate; medical emergency that requires urgent medical attention), pneumonia (lung infection) due to COVID-19 virus; and acute respiratory failure. Pt 45 is quadriplegic (paralysis of all four limbs) and has diagnosis of dementia (impaired ability to remember, think, or make decisions that interferes with doing everyday activities) and he was intubated (had a tube inserted in the windpipe to allow for flow of oxygen) in the emergency room on 7/30/20, until 8/2/20.

During a record review of Pt 43's medical record on 12/22/20 of a COVID-19 Screening Assessment on 8/2/20 indicated "COVID-19 Risk Level: Positive for COVID-19". The Discharge Summary dated 8/5/20 lists the Primary Diagnosis of "(1) COVID-19, Status Acute". The Case Management notes on 8/6/20 include documentation specific to the ambulance transportation arrangements back to the skilled nursing facility but no documentation about infection isolation precautions.

During a concurrent interview and record review, on 12/9/20, at 3 p.m., with the Director of Health Informatics (DHI) and the Registered Nurse Informaticist (RNI), Pt 45's electronic medical records (EMR) was reviewed for her admission date 9/22/20. The DHI and the RNI stated Pt 45 was admitted for congestive heart failure (CHF-heart does not pump effectively causing back up of fluids), positive corona virus test (COVID-19), with history of coronary artery disease (CAD- fatty deposits in the arterial walls thus narrowing the arteries), and right sided chest pain. The DHI and the RNI stated Pt 45's face sheet indicated Pt 45 was Spanish speaking and had designated a daughter for their emergency contact. The DHI and the RNI stated Pt 45's Patient Signature Page 9/28/20 for discharge was not in Spanish and indicated a handwritten notation of "Gave telephone instructions to [daughter's name]" in signature space. The DHI and the RNI reviewed Pt 45's test results for COVID-19 dated 9/23/20 at 1527 p.m., the DHI and RNI stated Pt 45 results indicated "abnormal: Detected". The DHI and the RNI reviewed Case Management notes for 9/23/20 and 9/26/20 and stated that neither provided the family with the COVID-19 diagnosis or education on quarantine/isolation for the patient and family members since the patient would be returning home. The DHI and RNI stated that during a record review of Pt 45's discharge instructions dated 9/28/20, it did not include education for patient or family on COVID-19.

During a concurrent interview and record review, on 12/9/20, at 3:30 p.m., with the DHI and the RNI, Pt 45's EMR was reviewed for her admission date 10/11/20. The DHI and RNI stated that Pt 45's was a re-admission from her previous admit on 9/22/20, they stated her diagnosis for this admission was fall with injury of a hematoma (bruise) to the left forehead, cerebral vascular accident (stroke- blood flow to a part of the brain is stopped either by a blockage or rupture of a blood vessel), CAD, chronic renal failure (kidneys do not function properly) and past history of COVID-19. The DHI and the RNI stated the following consent documents for Pt 45 were either not signed by the patient or personal representative or provided in the patient's primary language:
- The Patient Transfer Acknowledgement is unsigned by patient or patient representative on 10/16/20.
- The Patient Signature Page for discharge instructions was signed on 10/16/20 by the Pt 45 but it was in English and not in Spanish and there was no mention of interpreter services used.

During a record review on 12/23/20 of Pt 45's medical record when discharged on 10/16/20 showed that the Patient Signature Page for receipt of discharge instructions lists the Drugs and Patient Instructions: "Aspirin ..., Hydralazine Tablets, Isosorbide Mononitrate Extended, Atorvastatin, Clopidogrel, Pantoprazole Delayed-Release T". The instructions given to the patient omitted medications listed by the attending physician in the Discharge Summary of 10/16/20 for Discharge Medications and did not include "Dronabinol..., Bumetanide... and Levocarnitine".

During a concurrent interview and record review, on 12/9/20, at 3:45 p.m., with the DHI and the RNI, Pt 47's EMR for his admission on 6/16/20, was reviewed. The DHI and the RNI stated Pt 47 was admitted with diagnosis of CHF, chronic kidney disease (kidneys do not filter properly) and experienced a cardiac arrest (heart stops functioning) while in the emergency room. The DHI and the RNI stated Pt 47's face sheet indicated Pt 47 was Spanish speaking. The DHI and the RNI stated the following consent document was not signed Pt 47 nor the patient's representative: Patient Signature Page for Discharge Instructions on 7/1/20 were in English and stamped, "PATIENT UNABLE TO SIGN," with no indication that the patient's representative was contacted, requested a printed copy of form, facility did not provide.

During a concurrent interview and record review, on 12/10/20, at 2:30 p.m., with the DHI and the RNI, Pt 49's EMR for his admission on 4/23/20, was reviewed. The DHI and the RNI stated Pt 49 was admitted on 4/23/20, discharged on 5/3/20, and the face sheet indicated Spanish is Pt 49's primary language. The DHI and the RNI stated the following consent document for discharge was not signed by Pt 49 nor by the patient's representative: Patient Signature Page for discharge instructions had handwritten comment, "Patient unable to sign," on 5/3/20. The 61 pages of discharge instructions were in English only and list of discharge medications included " ...Finasteride (by mouth) and Clopidogrel (by mouth). The discharge instructions omitted the following medications listed in the discharge summary by the attending physician on 5/3/20:
o Guaifenesin/Dextromethorphan
o Omeprazole
o Furosemide
o Atorvastatin Calcium
o Metolazone
o Furosemide
o Calcium + D
o Aspirin...
o Glimepiride
o Allopurinol
o Gabapentin
o Vitamin D3
o Ergocalciferol

During a concurrent interview and record review, on 12/10/20, at 2:45 p.m., with the DHI and the RNI, Pt 51's EMR for her admission on 10/17/20, was reviewed. The DHI and the RNI stated Pt 51 was admitted for acute kidney injury (abrupt decrease in kidney function) and acute urinary tract infection (infection in any part of the urinary system) on 10/17/20 and stated the face sheet indicated Pt 51's primary language was Spanish. The DHI and the RNI stated the following consent documents were either not signed or dated and timed by Pt 51 nor the patient's representative or in the patient's primary language:
- The COA on 10/17/20 was stamped, "PATIENT UNABLE TO SIGN."
- Pt 51's was discharged on 10/23/20 per the Discharge Summary. The Patient Signature Page for discharge instructions was signed by the patient but was not dated nor timed and was in English only. Additionally, the discharge form was not signed by a hospital caregiver, RN, nor doctor.

On 12/23/20, the policy and procedure for COVID-19 documentation in the EMR was requested of DHI. The DHI stated "I do not have one policy that speaks to COVID documentation."

During a review of the facility's policy and procedure titled, Patient's Rights/Responsibilities, dated 9/23/77 (updated last 6/20), indicated, " ... Communication The right to: ... Be communicated with in a manner that is clear, concise and understandable. Information provided will be appropriate to the age and cognition of the patient. Be provided with a qualified interpreter free of charge; either in person or on the phone as deemed appropriate if the patient has limited English proficiency ... Participation in Care The right to: Participate with the providers in the development, implementation and revision of the patient plan of care - both inpatient and outpatient, including the discharge plan ... Receive information upon discharge of continuing healthcare requirements and follow-up care ..."

During a review of the facility's policy and procedure titled, Interpreter Program Services, dated 3/22/93 (updated last 6/19), indicated, " ... PURPOSE: [Name of Hospital] desires to assure all patients, visitors requiring services at the Hospital and its out-of-hospital locations have available interpretive services 24 hours, seven days a week, for those with language or communication barriers ... PROCEDURE: ... A Hospital interpreter must be used for legal/ technical/ medical terminology discussions ... FORMS WRITTEN IN LANGUAGES OTHER THAN ENGLISH- Forms commonly read and signed by patients, family members, visitors shall be provided in a language commonly spoken by 5 percent of the county/community population. Such forms would include those commonly used and to be placed in Medical Record Chart ..."

Based on observation, interview, and record review, the facility failed to remove expired surgical procedure supplies from availability. This deficient practice had the potential to result in unsafe patient care.

Findings:

During a concurrent observation and interview on 12/8/20 at 9:17 a.m. with the Radiology Supervisor (RS) in the radiology department ultrasound room, an incision and drainage (a procedure to release fluid from under the skin) tray was observed with an expiration date of 12/31/19. The RS confirmed the tray was expired. The RS stated staff should be monitoring stock.

During a concurrent observation and interview on 12/8/20 at 10:43 a.m. with the RS in an operating room storage room, one bone marrow biopsy (a procedure that removes a sample of bone and bone marrow, the soft tissue inside bones) tray with expiration date 10/31/20, one percutaneous (through the skin) entry thinwall needle with expiration date 10/2020, two gastrostomy balloon retention feeding tube (a feeding tube inserted through the abdominal wall into the stomach) trays with expiration date 7/3/2020, and two gastrostomy balloon retention feeding tube trays with expiration date 8/15/2020 were observed. The RS confirmed the procedure supplies were expired.

During a review of the facility's policy and procedure titled SUPPLIES - EXPIRATION DATE, reviewed 02/20, indicated "... Discard any supplies that expire while on inventory shelf ..." and "... Expiration dates are to be checked daily. Remove any supplies from the shelf with an expiration date and discard ...".