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Based on interview and record review, the hospital's Governing Body (GB) failed to effectively govern the hospital, provide safe and quality care to all patients, and ensure compliance with federal regulations, as evidenced by:

1. The GB failed to ensure compliance with the statutorily mandated Condition of Participation for Nursing Services when it failed to ensure the facility's nursing services were well organized to meet the needs of patients in a safe and effective manner. This included inadequate supervision of contracted staff and employees, inadequate staffing in the Medical-Surgical and Telemetry units, with the potential to result in serious patient decline and adverse events. This included an Immediate Jeopardy (IJ, immediate threat of harm to patients) which was called on 3/30/23 and the immediacy was not removed by the survey exit on 4/7/23. Refer to A 398 Findings 1 through 17 and A 392 Findings 1 a-e.

2. The GB failed to ensure compliance with the statutorily mandated Condition of Participation for Quality Assessment Performance Improvement when the hospital failed to demonstrate it had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program, despite numerous prior regulatory deficiencies having been cited. Refer to A 273 Findings 1 through 5 and A 308.

3. The GB failed to ensure compliance with the statutorily mandated Condition of Participation for Emergency Services when it failed to ensure ED staffing was adequate to implement its ED policies including the Emergency Medical Treatment and Active Labor Act policy and its reassessment policies. Refer to A 1112 Findings 1 through 4.

4. The GB failed to ensure compliance with the statutorily mandated Condition of Participation for Infection Prevention and Control when it failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control, guidelines. Refer to A 749 Findings 1 through 11, A 750 Findings 1 through 7, and A 751.

5. The GB failed to ensure compliance with the statutorily mandated Condition of Participation for Pharmaceutical Services when it failed to ensure the pharmaceutical related needs of patients were met. Refer to A 490 Findings 1 through 14, A 500 Findings 1 and 2, A 501, and A 505.

6. The GB failed to ensure compliance with the statutorily mandated Condition of Participation for Food and Dietary Services when it failed to ensure that dietary services met the needs of all patients. Refer to A 619, A 620, A 622, A 629, and A 83.

7. The GB failed to ensure compliance with the statutorily mandated Condition of Participation for Organ, Tissue, and Eye Procurement when it failed to ensure the needs of patients and wishes of patients to become donors met acceptable standards of practice and all policies, laws, and regulations relating to the determination of brain death were followed by its medical staff. Refer to A 885 Findings 1 through 3.

8. The GB failed to ensure services outlined in its contract with the food services contractor were in place. Refer to A 83.

9. The GB failed to ensure contracted hemodialysis (HD, treatment to filter waste and water from the blood) services were provided in a safe and effective manner. Refer to A 84.

10. As a result of unsafe and ineffective HD provided to patients, an IJ was called on 3/30/23 and the immediacy of the IJ had not been removed, by the time of the survey exit, on 4/7/23. There was a delay by the CEO in informing the GB members of the IJ. The hospital submitted a plan to remove the immediacy on 4/21/23 and the Immediate Jeopardy was removed during onsite verification on 4/24/23. Refer to A 57.

The cumulative effect of these systemic problems resulted in the hospital's inability to comply with the statutorily mandated Condition of Participation: Governing Body.

Based on interview, and record review, the facility's Chief Executive Officer (CEO) and Chief Nursing Officer (CNO) did not provide complete and accurate information to the facility's Governing Board (GB) regarding the provision of contracted hemodialysis (HD) services to patients within the hospital and the problems identified by the California Department of Public Health (CDPH) by this contracted service. As a result of unsafe and ineffective HD provided to patients, an Immediate Jeopardy (IJ, immediate threat of harm to patients) was called on 3/30/23 and the immediacy of the IJ had not been removed by the time of the survey exit on 4/7/23. There was a delay by the CEO in informing the GB members of the IJ. As a result the GB members failed to effectively govern the hospital, provide safe and quality care to all patients, and potentially put patients' lives at risk. Refer to A 385 and A 398 Findings 1 through 13.

Findings:

A review of the GB meeting minutes, dated 1/25/23, indicated under the Administrative report provided by the CEO, that it was required by Centers for Medicare/Medicaid Services (CMS) and CDPH that the GB shall receive additional data information going forward. The Clinical Operations report provided by the CNO, indicated a new dialysis vendor (no further details were included in the minutes) would start in March 2023 and noted it was a corporate wide contract.

A review of the GB meeting minutes, dated 3/15/23, indicated under the Administrative report provided by the CEO, that it was required by CMS and CDPH that the GB shall receive additional data information going forward. . . . "Effective immediately, the GB will receive notices as soon as possible regarding CDHP/CMS information." The Clinical Operations report provided by the Chief Nursing Officer (CNO), again indicated a new dialysis vendor (no further details were included in the minutes) would start in March 2023 and noted it was a corporate wide contract.

During an interview on 4/7/23 at 1:10 pm, the CNO said in January the GB was told about the change in the dialysis vendor, in detail, including that Registered Nurses (RN) were no longer doing the dialysis and HD techs would be doing it, with a remote Telehealth RN available, from an out of state based dialysis vendor. He said during the GB meeting on 3/15/23, they discussed again that the facility would be going with the new dialysis vendor soon. He said all this was discussed in detail and all GB members were fine with everything regarding this new contracted HD vendor.

During an interview on 4/10/23 at 7:50 am, GB member (GB 1) said they were told about a change in dialysis vendors, but learned later that dialysis RN's were no longer doing the dialysis and instead techs were doing it, who are not even licensed, with a RN remotely available. He said it was not an equivalent service and questions were raised but not answered by Administration. GB 1 also said they were told this dialysis vendor had started at another hospital within the same corporation, but later found that was not the case. He said he did not know anything about the IJ regarding issues surrounding the hemodialysis contracted vendor, that it had been called on 3/30/23 and continued without the removal of the immediacy, or that the hospital was given a 23 day termination letter on 4/7/23.

On 4/13/23 at 8:11 am, an email was sent from CDPH to the CEO and CNO asking for the names of all GB members who had been notified of the IJ on 3/30/23. A response was received at 9:23 am which included an email, dated 4/4/23, to the GB members advising them of the validation survey. There was nothing in the email that mentioned the IJ. A second email from CDPH was sent at 9:28 am, again asking for the names of the GB members who had been notified of the IJ. The CNO then responded with an email from the CEO on 4/13/23 at 10:44 am, (two weeks after the IJ was issued) which notified the voting members (did not include the non-voting) members of the GB, advising them of the IJ and details surrounding the HD issues. A third email was sent from CDPH at 4:32 pm, asking for the reason for the delay in the CEO informing the GB members of the IJ. A response was not been received.

Based on observation, interview and record review the facility failed to ensure services outlined in its contract with the food services contractor were in place when:

1. The kitchen was not sanitary and there was not a system in place to ensure kitchen sanitation (Cross Reference A620 and A750);
2. There was not an effective system in place to ensure Food and Nutrition Services staff competency;
3. Patient menus were no longer "select," and therapeutic diet menus and nutrient analysis were inadequate (Cross Reference A629);
4. Food and Nutrition Services Kitchen and Clinical Nutrition QAPI were not integrated into the hospital wide Quality Assessment and Performance Improvement (QAPI) system and processes (Cross Reference A263).

Findings:

During an interview with the Chief Operating Officer (CEO) on 4/4/23 at 1:35 pm he stated he was in charge of contracts and their review. When asked how the hospital ensured the effectiveness of the Food Services contract, the CEO stated he communicated with the Food Service Manager (FSM) regularly, met with and received and reviewed a report from the FSM every three months, and he didn't get a lot of complaints about the food. He added that employees had increased satisfaction since the salad bar and sandwich bar were added in the cafeteria, and there was a very stable staff in the Food and Nutrition Services (FANS) Department. The stated he based his evaluation on there not being any complaints, health reports, and the corporate dashboard about how much meals cost.

In continued interview, the CEO was asked how the hospital ensured food was handled safely and the kitchen was sanitary. He replied he made rounds in the kitchen a couple of times a month but did not document that. He stated he looked for clean floors, lights working, no broken equipment, and he looked at the Environment of Care (EOC) rounds reports. When asked if he had identified any areas of concern during his rounds he replied lighting, painting, had some freezer motors go out, and "Trying to get rid of the grease fires - that's the next capital expense."

Review of the facility's letters, contracts and its amendments with the food services contractor, it contained documents with dates spanning 1/24/09 through 12/6/21 and showed all Food and Nutrition Services (FANS) staff were employees of the contractor/vendor. Review of these documents defined these services:

Review of the "Management Agreement," dated 10/25/11 showed:

"4.2 Training Programs - (Vendor) shall provide in-service training to enhance development of Services Supervised Employees. (Vendor) shall maintain accurate records of said training sessions.

"4.5 Surveys - (Contractor) shall conduct weekly tray assessments, quarterly patient surveys and semi-annual employee surveys as a component of (Contractor's) self-evaluation program. Results of all surveys and action plans shall be reviewed with Client's administration."

"6.4 Condition of Premises and Equipment - The Premises and equipment provided by Client for use in the Services operation shall be in good condition and maintained by Client to ensure compliance with applicable laws concerning building conditions, sanitation, safety and health."

"Exhibit A Nutrition Services, Operating Procedures" - 1.1 (Contractor) shall manage and operate Nutrition Services for Client including Patient Services, Cafeteria Services, and Special Functions."
1.2 - (Contractor) will supply patient menus for three meals per day. Menus shall be selective and recommended by (Contractor) subject to Client's approval."
"2.1 - (Contractor) shall provide sufficient and qualified managers to supervise the Nutrition Services."
"3.2 Sanitation - Nutrition Services employees shall be responsible for cleaning areas in accordance with mutually agreed upon policies and procedures."

Review of a document provided by the CEO titled "2021-2022 Annual Contract Service Evaluation Summary" dated 8/8/22 and with the CEO listed as the responsible party, showed the CEO evaluated the contract for 10 topics including "documents records and/or other information as may be requested in furtherance of its performance improvement, utilization review and risk management? (yes);" Have all the requirements of the contract been met? (Yes). Overall staff competency assessment was rated 4 our 5 points possible.

The contract evaluation tool, and the contract evaluation conducted by the CEO did not reflect the concerns identified during survey including the lack of sanitation and systems to maintain sanitation in the kitchen, and that the emergency food plan was not fully developed or integrated into the hospital wide disaster plan (Cross Reference A620 and A750). It did not accurately reflect the lack of staff competency identified during survey regarding general sanitation, food cooling, manual warewashing, cleaning fixed equipment, labeling and dating, vegetable washing, prevention of cross contamination or sanitation of nursing unit pantry areas. It did not reflect that the patient menus were no longer "select" or that the therapeutic diet menus and nutrient analysis were inadequate (Cross Reference A629). It did not reflect that FANS was not integrated into the hospital-wide QAPI system (Cross Reference A263).

Based on observation, interview, and record review, the facility's governing body (GB) failed to ensure contracted hemodialysis (HD, treatment to filter waste and water from the blood) services were provided in a safe and effective manner when there was inadequate supervision of contracted staff, failure to follow physicians' orders, failure to have approved policies and procedures by the GB, no auditing/monitoring in place to verify the new system of care utilizing a telehealth RN (providing care for dialysis patients and oversight for Hemodialysis Technicians (HDT) performing the procedure), and failure to adhere to standards of practice for infection control.

1. Patient 1, who was in the Intensive Care Unit (ICU) had uncapped lines, and dialysis orders by the physician that specified a certain type of dialysis, were not followed.

2. Patient 27, an ICU patient, received a fluid bolus during dialysis. The ICU Registered Nurse (RN) was not told of this and the dialysis notes were not printed and placed in the record following dialysis, so there was no way for the nurse or physician to know about the amount of fluid she had received.

3. Patient 3 had dialysis and the HD notes were incomplete and did not include the physician's orders regarding the dialysate (fluid used during dialysis) and electrolytes used during the dialysis on 3/21/23. On 3/23/23, the HD notes were in conflict with what the nephrologist (physician specializing in treating kidney disorders) ordered.

4. Patient 2, an ICU patient, had an order from the nephrologist to use albumin (special intravenous fluid used to treat low blood volume) if the patient's blood pressure dropped. The HD technician used normal saline (intravenous fluids) instead of the albumin and did not tell the ICU RN prior to the administration of the normal saline.

5. Proper infection control standards were breached during the accessing of Patient 2's central venous catheter for dialysis.

6. Proper infection control standards were breached during the accessing of Patient 40's fistula for dialysis.

7. The facility continued to use their contracted vendor policies which had not been approved by the hospital governing board.

8. Patient 25, an ICU patient, was on Continuous Veno-Venous Hemofiltration (CVVH, a temporary treatment for patients with acute kidney failure who are unable to tolerate hemodialysis and are unstable. With CVVH a dialysis catheter is placed in one of the main veins of the body and dialysis is done 24 hours per day to slowly and continuously clean out waste products and fluid from the patient) for three days. There were no notes from the HD tech to indicate if the filter had been changed during this three day period.

9. The dialysis machine and treatment area was too close to a supply cart posing a potential infection control issue.

10. The HD Telehealth (remote via IPad-a small portable computer) HDRN was unable to verify treatment started within 30 minutes due to connectivity issues for Patient 29.

11. Patient 26, a dialysis patient, had a bed with a broken bed-scale resulting in inaccuracies in documented pre and post-dialysis weight measurements.

12. Patient 40 received a dialysis procedure without required assessments and verifications by the HDRN.

13. The hospital failed to audit the quality of services provided by the new Dialysis Vendor (DV) 2 contracted service (included care provided by a telehealth RN) upon implementation.

Findings:

During an interview on 3/20/23 at 2:40 pm the Chief Nursing Officer (CNO) confirmed they discontinued their old contract with their former Dialysis Vendor 1 (DV 1). DV 1 had a dialysis RN that provided all dialysis treatments to their inpatients. Their new contract, Dialysis Vendor 2 (DV 2) effective 3/20/23 had HD certified (but unlicensed) dialysis technicians (techs) provide the dialysis services to inpatients instead of RNs. The HD techs would be supervised by a Registered Nurse (RN) via telehealth. This telehealth RN would be available to view the patient via an IPad (a small portable computer) and would conduct the patient assessment this way. He confirmed there were currently no approved facility dialysis policies. He was asked why this was started before the facility had approved policies and procedures and CNO said our old contract with DV 1 ended so we went ahead with this new contracted company, even though we did not have approved policies at that time.

1. A review of Patient 1's record indicated he was admitted on 3/8/23 with chest pain and shortness of breath. During the hospitalization his condition declined and he was transferred to the ICU and started on CVVH on 3/19/23, by DV 1's RN. On 3/20/23, the DV 2's tech changed out the machine. During the new set up there were eight lines that were clamped but left uncapped. Pictures were taken of these uncapped lines and provided to the California Department of Public Health (CDPH). A note from Patient 1's nephrologist dated 3/21/23 at 3:23 pm indicated he was notified by the RN in charge of the patient about the ports of the lines not being capped and it was immediately capped by her. He notified the Vice President of Operations of the new team and brought this to his attention and had already reviewed it with the staff and CNO of the hospital.

A nurse's note dated 3/22/23 indicated the RN noticed, at 9:30 pm, the dialysis machine was actually hooked up to run CVHD (Continuous Venovenous Hemodialysis) not CVVH. The HD tech was notified.

During a concurrent interview and record review on 3/29/23 at 11:25 am, the Director of Ortho/Neuro (OND) confirmed there were no records from DV 2 regarding setting up the machine or changing filter cartridges or tubing. OND also confirmed this with the Health Information Management (HIM, medical records) department that there were no such records.

During an interview on 3/23/23 at 4:15 pm, RN 1 said Patient 1 was supposed to be set up for CVVH and that was what was ordered by the physician. Last night (night shift on 3/22/23) it was discovered that the patient was set up for CVHD and provided a picture of the incorrect set up. She said with CVHD the blood is diffusing through the filter and taking off more electrolytes than what should be. Patient 1 had an electrolyte imbalance including phosphorus levels that resulted from CVHD or CVHD at least contributed to this. She said she did not know how long the machine had been set up incorrectly and it could have been since the machines were changed on Monday morning 3/20/23 around 7 am, or when the filter was changed. She said the dialysis tech sets up the machine now, as there was no dialysis RN, with the new contract. She said the night shift nurse last night on 3/22/23 caught the mistake and it had now been corrected.

During an interview on 3/28/23 at 7:15 am, RN 2 said Patient 1 was hooked up to CVHD as opposed to CVHD, as ordered by the MD and it took three days before the mistake was discovered. She said CVHD was not as effective. The same filter and same machine were used, but during CVHD the dialysate does not touch the blood - the blood was one side of the filter and the dialysate was on the other side of the filter; CVVH blood runs through the filter and mixes in with the blood that goes back to the patient. CVVH uses convection and CVHD relies upon diffusion. She said with CVVH the filter was changed more frequently and they usually use this with a septic (infected blood) patient as it is better at getting larger particles out through the filter. CVHD was not as efficient at getting cell matter out from patients. She also said the duosol solution (solution used for dialysis) that was used in the dialysis machine used to come from their pharmacy with a bar code on it and now the new company supplies it. She said it should be stored at room temperature and there was no way for the nurses to know if that was being done since it was not coming from their pharmacy.

During an interview on 3/30/23 at 8:05 am, RN 3 said he was the ICU RN who cared for Patient 1 and found that the machine was set to CVHD as opposed to CVVH, on night shift 3/22/23 around 9:30 pm. He said he had had no dialysis experience but had worked with this machine for 8-10 years. He said he heard the filter on the machine had been changed the night shift before around 2 am on 3/22/23. When he found the error he called in the tech who came in and said he had set it up the same way as it had been originally set up. He said the CVVH was more gentle and CVHD was more aggressive and pulled off (removed) electrolytes at a more aggressive rate. He said Patient 1 had a problem with his phosphorus and they had been replacing it with every lab check, which was every six hours, and usually that only had to be done every day or every other day. He said the hospital started this new contracted service on Monday 3/20/23 and he had had a training class the Thursday and Friday before that. He said they have not had any additional training. He was asked, if there was an emergency with a patient on regular HD and the patient needed his blood returned to him emergently, if he would be able to do that and he said no he did not know anything about the regular HD machines and had had no training on that.

During an interview on 3/29/23 at 2:15 pm, the following was discussed with the CNO: no documentation of who set up the machine and who changed the filter, uncapped lines and machine set up for CVHD not CVVH as ordered by the physician. He agreed this was not acceptable and said they elevated these issue to the project lead for DV 2. He confirmed there was no Telehealth remote RN supervision of the HD tech during the set up for this patient for his CVVH which led to uncapped lines and which led to the incorrect type of dialysis being given to the patient. He said the telehealth remote RN supervision was only during the Hemodialysis process and did not include setting up the machine or changing filters.

During an interview on 3/30/23 at 10:30 am, the DV 2 hemodialysis tech (HDT 1) confirmed he set up the machine on 3/20/23 and changed the filter early in the morning around 2 am on 3/22/23 and again at 11:30 pm on 3/22/23. He said at that time he did not have access to the facility's electronic medical record (EMR). He said he looked at how the DV 1 nurse set up her machine and thought he followed her set up. He said setting up the machine was something they, the HD techs ordinarily do, and they don't contact the telehealth RN for this. The usual process was to verify the physician's order and in this case since he did not have access to the EMR, he said he should have asked the nurse to print out the physician's order for him. HDT 1 said he was not supposed to be a permanent staff at this facility so he was not given access to the EMR. He said when DV 2 opens new programs he was one of the techs that "gets things going". He said CVVH training for the other techs was given this past Monday, 3/27/23. He was asked about the uncapped lines and said he was unaware of any uncapped lines and said the only reason to remove the cap would be to connect the intravenous (IV) pump. He said he was unaware of the uncapped lines and had not seen any pictures.

During an interview on 4/6/23 at 8:30 am, the infection preventionist (IP) reviewed the pictures of Patient 1's uncapped lines. He said the uncapped lines could cause a potential infection even if clamped and agreed the clamp could come undone and staff could brush up against the uncapped lines. He said they have a policy regarding capping lines and their infection control policies were in the dialysis area with the techs who signed off that they had reviewed and understood these policies.

2. A review of Patient 27's record indicated she was admitted on 3/13/23 with nausea, vomiting, and intestinal obstruction. She had a long history of chronic renal (kidney) failure. She had surgery and was admitted to ICU following this. On 3/20/23 she was provided dialysis by the HD techs. On 3/27/23 a review of her EMR did not include the dialysis note from 3/20/23.

On 3/27/23 at 10:45 am, the ICU Director (ICUD) could not find a note for 3/20/23 and called HDT 2 who said 3/20/23 was the day their program first started and there was a glitch in their charting system. HDT 2 said she did not know this note was missing from Patient 27's chart until now and would call DV 2 to ask for them to print it out. This note was emailed on 3/28/23 at 7:06 am to CDPH. This note indicated a 250 ml bolus of normal saline was given to Patient 27 during dialysis for low blood pressure (BP).

During an interview on 4/3/23 at 2:43 pm, RN 4 said that she was not told by the HD tech and was unaware Patient 27 had been given any fluids as part of a fluid challenge during her dialysis on 3/20/23.

3. A review of Patient 3's record indicated he was admitted on 3/8/23. He had dialysis on 3/21/23. A review of the HD notes did not include the name of the dialyzer (dialysis solution) or bicarbonate (a substance called a base that helps keep a normal acid-base balance in the body).

During a concurrent interview and record review on 3/29/23 at 11:25 am, OND confirmed the dialyzer and bicarbonate were not included on the HD note from 3/21/23. He agreed there was no way to know if the physician's order was followed. The name of the HD tech and the telehealth RN was also not included on this note.

A review of the HD notes for 3/23/23 indicated the dialyser used was Revaclear 300, Concentrate Potassium was 2 and Calcium was 2.5 A review of the dialysis orders indicated the dialyser should be Elisio-15H, Potassium 3 and Calcium 2.5 The dialyser and Potassium recorded on the HD sheet did not match the physician's order.

During a concurrent interview and record review on 3/29/23 at 11:25 am, OND confirmed the 3/23/23 order indicated Elisio 15 H for the dialyser but HD note indicated Revaclear was given. The amount of the Calcium was the same on both the physician's order and the HD note but the Potassium on order was not the same as on HD note, so it looked like the physician's order was not followed on 3/23/23. He also confirmed the name of the supervising RN was simply "Tele RN" instead of the name of the RN on duty on 3/23/23.

4. A review of Patient 2's record indicated he was admitted to the Emergency Department (ED) on 3/24/23 with shortness of breath and was admitted to ICU after cardiovascular (heart) surgery. His record contained an order from his nephrologist for 100 milliliters (ml) of albumin on 3/26/23 at 9:05 am, for dialysis nurse only.

During an interview on 4/3/23 at 2:45 pm, RN 4 said she worked on 3/26/23 in ICU and was assigned to care for Patient 2. He needed dialysis and his blood pressure (BP) during dialysis was 86/50 and he had been running in the 90's. Since his systolic (highest number) BP was below 90 the HD tech called the Telehealth RN who said give 100 milliliters of normal saline (NS). RN 4 said she had already obtained an, as needed order (prn), for albumin that morning before dialysis was started. She said Patient 2 should have received the albumin not the normal saline. She said the telehealth RN did not have access to their EMR at that time and the HD tech went ahead and gave the normal saline without telling her although she was readily available in the ICU.

The above was discussed with the CEO for DV 2 during an interview on 4/5/23 at 8:45 am. He questioned if their Tele Health RN read the orders carefully. He said we want the nephrologists to write orders straight into our system but they want to continue to use the system they've been using at the hospital. He said the hospital was supposed to have provided access to the EMR at the beginning when we started. He said the Tele Health RN is supposed to log in with their specific name as the supervising RN and review the HD note.

5. During an observation of HD on 4/5/23 at 10:55 am, Patient 2 was brought up to 4th floor dialysis area in his bed. RN 29 had gloves and a mask on and was preparing to connect Patient 2 to dialysis. RN 29 picked up a trash can and placed it beside him, then before doing hand hygiene and changing gloves, used alcohol to clean the patient's central venous catheter port caps. The ICU Director (ICUD) was present and confirmed the above observation and said that RN 29 should have changed gloves and perform hand hygiene after touching the trash can. When RN 29 came out of the room this was discussed with him and he confirmed he should not have picked up the trash can or should have performed hand hygiene and changed gloves after doing so.

6. A review of Patient 40's record indicated she was admitted on 3/29/23 with altered level of consciousness. She had end stage renal disease and was on routine dialysis through a fistula (a connection that is made by joining a vein onto an artery that creates a large vessel that can be needled routinely for use during dialysis).

During an observation on 4/5/23 at 10:50 am, Patient 40 was in the dialysis area. HDT 3 cleaned the fistula with alcohol then with gloved hands, palpated (felt) ,the area cleaned it again then palpated the area again and inserted the first needle without cleaning the insertion area. The fistula was cleaned again and HDT 3 inserted the second needle. At 11:05 am there was a problem with the second needle so HDT 3 cleaned the area again, palpated it then inserted another needle without cleaning the insertion area. During an interview at 11:15 am, HDT 3 was asked about inserting the needle after palpating and before cleaning again. She said it was necessary and she had to do it that way to stabilize the fistula so she could get the needle in and this was her usual practice. ICUD was also present during these observations and interview and agreed the insertion site of the needle should have been cleaned after palpation and before the tech accessed the fistula.

DV 2's policy: Cannulation with Safety Needle Device" policy, created 4/14/21 was reviewed. It indicated under Policy: 1. Chloraprep is the preferred cleansing agent for vascular access site care. . . . Cannulate an AV Fistula: without contaminating cleaned area, stabilize access with nondominant hand. . . insert needle. . . secure access site.

7. The following three hospital policies for HD were provided by OND via email on 3/30/23 at 9:52 am,: Continuous Renal Replacement Therapy, Hemodialysis Access: Assessment for Patency & Care and Blood Sampling, and Dialysis: Peritoneal. These policies had been approved by the hospital's Medical Executive Committee and Governing Board on 3/23/23. All the remaining dialysis policies that were in use and were provided during the survey, were from DV 2 and had not been approved by the hospital's Medical Executive Committee and Governing Board.

During an interview on 4/5/23 at 8:15 am, the CNO confirmed they only have the above three hospital policies and continue to follow DV 2's policies, which have not been approved by the Executive Committee and Governing Board.

8. A review of Patient 25's record indicated she presented to the ED on 3/25/23 with abdominal pain and was admitted to the hospital. She had surgery and was admitted to ICU on 3/26/23. She was started on CVVH on 3/28/23 at 4:50 pm and this continued until 3/31/23 at 1:11 pm. No notes regarding the set up of the dialysis machine, when the filter was changed, or if the filter was changed, by the HD techs could be found in the record.

During a concurrent interview and record review on 4/5/23 at 3:45 pm, the OND confirmed there were no hemodilysis notes regarding the CVVH dialysis in this patient's record. As a result, it could not be determined if or when the machine's filter was changed by the HD tech.

9. During an observation of the HD room on the 4th floor on 4/6/23 at 10:30 am, the dialysis machine was within two feet from a large three tier medical supply cart full of supplies, some of which were opened. On 4/5/23 at 11 am, Patient 2 was observed receiving his dialysis in this spot.

During an interview on 4/6/23 at 10:30 am, HDT 5 confirmed the dialysis machine and treatment area was too close to the supply cart and was in the "splash zone" (could be splashed with blood).

10. During an observation on 4/6/23 at 10:30 am, Patient 29 was receiving dialysis in the 4th floor dialysis area. During a concurrent interview and record review at this time, HDT 5 confirmed the HD treatment started at 10:19 am. HDT 5 said the Telehealth RN checked the machine and solution prior to her connecting the patient and then verified treatment within 30 minutes. At 10:56 am teleheath RN 2 confirmed she was unable to verify treatment started within 30 minutes because she was having connection difficulty.

11. A review of Patient 26's record indicated he was admitted to the hospital on 3/24/23 with diagnoses that included chronic kidney disease and dialysis was needed. On 4/3/23, Patient 26's record indicated a dialysis procedure was performed that started at 5:13 pm and ended at 8:49 pm.

On 4/3/23 at 4 pm, during an observation and a concurrent interview with HDT 3, Patient 26 was brought to the dialysis treatment room in his bed. During discussion with HDT 3, she explained that Patient 26's bed-scale was broken, so his pre-dialysis weight would be documented using the standing scale used that morning by the hospital bedside nurse. The post-dialysis weight would be calculated based on the fluid balance from his dialysis procedure. HDT 3 explained she had been an HDT for many years and had been trained on how to accurately calculate the post weight using this method.

A review of Patient 26's hemodialysis flowsheet, dated 4/3/23, indicated a pre-dialysis weight of 92.8 kilograms and a post-dialysis weight of 90.3 kilograms. Documentation on the flowsheet was reviewed for any indication of the methods used for the pre and post weights. No such documentation was found.

On 4/4/23 at 12 pm, during an interview the Dialysis Vendor Nephrologist CEO, (DV2-CEO) stated the accuracy of pre and post dialysis weights was VERY important. He would expect that a dialysis patient in a bed with a broken bed-scale should be moved to a bed that was working. If an exception was to be made regarding calculation of a post weight instead of weighing the patient, this call should be made by the nephrologist and he would expect narrative documentation on the hemodialysis flowsheet to reflect this variance. DV2-CEO explained it would not be possible to evaluate differences in weights from procedure to procedure without taking into consideration the methods used, which was not normal procedure.

On 4/4/23 at 4:30 pm during an interview, the CNO stated a dialysis patient should aboslutely never be placed in a bed with a broken bed-scale.

12. A review of Patient 40's record indicated she was admitted to the hospital on 3/29/23 with diagnoses that included end stage renal disease. The record indicated Patient 40 had been receiving dialysis treatments for the past three weeks prior to her admission and which would be continued during her hospital stay. The records indicated Patient 40 had a dialysis procedure (approximately 4-5 hours in length) that started on 4/3/23 at 10:10 am.

On 4/3/23 at 3:30 pm during observations and concurrent interview, HDT 3 explained coordination with the telehealth HDRN for dialysis procedures.There was an IPad on a stand nearby. HDT 3 explained the IPad capabilities included video and a stethoscope accessory so the HDRN was able to hear lung sounds exactly as if she was in the room. When asked whether the nurse always used the video function and/or the stethoscope, HDT 3 replied that it depended on the nurse. Some nurses like to use the video and others do not. There was one nurse that never used it and HDT 3 didn't know what that nurse looked like as he had never seen her on the IPad screen. Regarding use of the stethoscope, HDT 3 explained it was sometimes used and sometimes not. Regarding how the HDRN completed the patient assessment without using these items, HDT explained the nurse speaks with the patient's floor nurse. HDT 3 went on to explain that the IPad had not been working today, so she and the nurse did everything by phone for her patient (Patient 40 on 4/3/23 at 10:10 am).

The Dialysis Vendor (DV 2) policy and procedure titled, Pre-Assessment and Data Collection in Acute Dialysis Services, indicated the purpose of the policy was to determine if acute patients are fit to begin dialysis treatment. Patient must have a pre-assessment by an RN and data collection by HDT before dialysis treatment is initiated to confirm that the patient's condition is not materially (substantially) different from the time when the dialysis orders were written. The pre-assessment and data collection included ambultory status, apical pulse (heart rate on the chest area), blood pressure - sitting and standing (if patient is able), breath sounds, bruising or bleeding, edema, gastrointestinal (stomach) issues, neurological issues, pain repirations, skin color, temperature, vascular access, predialysis weight. Document all assessment and data collection findings in electronic record. Bedside Pre-assessment screen. Do not initiate dialysis until a pre-dialysis assessment has been performed.

On 4/4/23 at 12 pm, the Dialysis Vendor Nephrologist CEO, (DV2-CEO) explained that the idea was that use of the video IPad and accessory stethoscope functions would mirror as close as possible to a nurse being in the room. Without this functionality, the HDRN would not be able to complete an assessment. The expectation was for the nurse to, everytime, visualize the patient, interact with the patient, observe the patient's skin tone, status of any edema, listen to lung and bowel sounds, review the vital signs, and other requirements outlined in DV 2 policies and procedures. Visualization of the machine to verify settings and other parameters was also required. DV2-CEO was not aware the video function was not being utilized as required. DV2-CEO confirmed staff should not proceed with the dialysis procedure until all required assessments and verifications had been completed.

On 4/4/23 at 4:30 pm, during an interview, CNO explained the HDRN was required to always use the video function and stethoscope attachment during patient assessments and to check all the connections and visualize the machine to ensure that all settings were correct. When asked what should happen if the IPad was not functioning properly and could not be used, CNO stated staff should not proceed with the dialysis procedure until all required assessments and verifications had been completed. The hospital nurses were not trained and cannot provide these services. The hospital nephrologists would be the only persons qualified to complete the checks normally done by the HDRN.

13. On 4/4/23 at 4:30 pm, during an interview, the CNO confirmed there was no auditing/monitoring in place to verify the new system of care utilizing a telehealth RN. Furthermore, the CNO was not aware of staff to patient ratios being maintained by DV 2 with the telehealth HDRN, nor what the requirements were. CNO was not aware whether or not the ratio was related to patient acuity, but acknowledged there would be situations where this would be important. CNO was not aware that the HDRN was overseeing patients in other facilities simultaneous with providing services in this hospital. CNO explained the HDRN had access to the hospital's electronic health records (EMRs) as read only, so they were able to review patient data. CNO was not aware of any training provided to the HDRN staff on how to navigate the hospital's EMR.

On 4/5/23 at 11:15 am, during a telephone interview, HDRN 1 was asked about the details of her current assignment for oversight of dialysis procedures. During the discussion HDRN 1 explained she was currently responsible for nine different patients (receiving dialysis at this time) located in nine different facilities located in five different states. When asked about how many patients were populated on her computer screen, HDRN 1 explained she could see one patient at a time on the screen. HDRN 1 timed how long it took switch to a different patient's information, which was approximately 20 seconds. HDRN 1 explained nurse to patient ratios were not to exceed 1 nurse to 12 patients. HDRN 1 explained she was the only nurse with patients at the time, but there was always an on call nurse for back up if needed. When asked who was the nursing manager for the company, HDRN 1 explained she had recently been appointment as the lead nurse for the west coast, but her duties had not changed yet. HDRN 1 explained the company used to have an RN in the management position which was some time ago, but the current manager had a background as a HDT. HDRN 1 had an extensive background in dialysis nursing care and explained all the nurses she worked with do as well. HDRN 1 was asked about how she learned to use so many different EMR systems, and how she is trained. HDRN 1 explained there were multiple different systems and it could be a challenge to navigate through them, adding that even when the same system was used navagation to find similar information is often very different. HDRN 1 was asked about training regarding this specific hospital policies, and she said she had not received any training from the hospital.

The DV 2 policy titled, Patient Verification and Machine Check Pre-Acute Dialysis Treatment was reviewed. The purpose of the policy was to reliably identify the patient as the person for whom the service or dialysis treatment was intended and to match the ordered service or treatment to the patient. The procedure indicated two staff members (HDRN and HRT) must verify the acute dialysis patient identity prior to each dialysis treatment and must be documented in the EMR.Two staff must verify patient treatment orders to include verifying that machine alarms test has been completed and documented, that the patient's pre-treatment vitals are complete, that fluid removal calculation for the patient was set on the machine, that the dialyzer type, manufacturer corresponds with the patient's orders, that air detector was armed and venous line ws through the blood sensor, that all lines were connected, clamps were secure, and transducers were properly seated, that patients treatment time and amount of fluid to be removed was correct, that dialysate bath corresponds with the patient's orders, that dialysis-related medications to be given were available, and verify availability of blue clamps at the machine.

The DV 2 policy titled, Post Treatment Assessment and Data Collection indicated the pupose of the policy was to provide a comparison to acute dialysis pre-assessment and an evaluation of the delivered plan of care. The policy indicated the post-assessment and data collection would be performed after treatment termination and before handing off the patient to the patient's assigned hospital nurse. The post assessment and data collection allowed the caregiver to gather data for comparison to pre-dialysis treatment. The post-assessment included ambulation status, sitting and standing blood pressure, breath sounds, bruising and bleeding, edema, gastrointestinal issues, neurological issues including mental status, respiratory rate and pattern, skin color, subjective statements, temperature, and weight. Provide the post dialysis flow sheet to the patient's hospital nurse. Confirm the patency (condition of being open/unobstructed) and general condition of vascular access and document in access screen in the EMR. Deviation of 1 kg or more from prescribed target weight should be reported to the hospital nurse, the Tele-dialysis nurse and the nephrologist. If variance is observed, re-weigh the patient.

Based on observation, interview, and record review, the hospital failed to comply with patient right requirements for one of five dialysis patients (Patient 27). Patient 27's request to have her dialysis procedure conducted in her room was not honored. This failure to honor the patient's preference deprived them of their right to participate in decision-making about their care and had the potential to cause avoidable discomfort, distrust, and anxiety for the patient.

Findings:

Review of the medical records indicated Patient 27 presented to the emergency department on 3/13/23 and was subsequently admitted to the hospital. Patient 27's diagnoses included end-stage kidney disease and a bowel obstruction. Prior to her hospital admission, Patient 27 was receiving dialysis procedures four days a week. A nephrology consult was completed, and dialysis treatments resumed during her hospital stay.

Nursing documentation, dated 3/30/23 at 6:41 am, indicated Patient 27's mother had called and stated that she did not want her daughter to go to the 4th floor for dialysis because she was not comfortable with that. The note indicated the patient was not willing to go off the floor for dialysis, and the charge nurse was notified.

On 4/3/23 at 10:50 am, the 4th floor dialysis procedure room was observed with two patients receiving dialysis (Patient's 27 and 40) and two hemodialysis technicians in attendance.

On 4/3/23 at 3:30 pm, during an interview, the Hemo-Dialysis Technician 3 (HDT 3) explained the dialysis machines were portable and the procedure was frequently done in patient rooms (indicating Patient 27's preference could have been accommodated). When asked how decisions were made about where the dialysis treatment would be performed, HDT 3 explained the preference was to have the procedure done in the dialysis procedure room.

On 4/4/23 at 3:30 pm, during an interview, Registered Nurse 32 (RN 32, Patient 27's nurse) explained that during a morning report (when she came on shift), the charge nurse told her that Patient 27 was not willing to go off the Telemetry/PCU Nursing Unit (specialized unit within a hospital that provides a higher level of care than a regular hospital unit, but a lower level of care that an intensive care unit - ICU) and would have the procedure conducted in her room. RN 32 explained this was her first experience with the new Dialysis Vendor Contracted Service (DV 2). When HDT 6 came to see Patient 27, she was expecting the procedure would be done in the room, but while she was assisting another patient, HDT 6 was seen down the hallway, transporting Patient 27's bed off the unit. RN 32 further explained she was responsible for any medical interventions that might be needed during dialysis while being conducted on a different floor of the hospital. She was uncomfortable knowing she would have to leave her other three patients and go to a different floor of the hospital if intervention was necessary. RN 32 confirmed that for the duration of the lengthy dialysis procedure, care provided to Patient 27 would not include the same level of close monitoring that was provided on the Telemetry/PCU unit. RN 32 confirmed that when Patient 27 expressed a preference to have her dialysis procedure done in her room, and this request should have been respected and accommodated for multiple reasons as described.

On 4/4/23 at 12 pm during an interview, the Nephrologist CEO of DV 2 (DV2-CEO) explained patients should only be transported to the 4th floor dialysis procedure room if the patient's room was located on the same 4th floor unit. Patient's on the Telemetry/PCU unit should always have dialysis conducted in their room (indicating compliance with DV 2 process and procedure expectations, required that Patient 27's dialysis be done in her room). DV2-CEO emphasized the importance of having the hospital bedside RN immediately available for intervention, and regular monitoring, on the unit where the dialysis was being conducted. In the rare event that a patient from the regular medical unit in the hospital needed to be transported off their own unit to the 4th floor dialysis procedure room, a hand-off of patient responsibility between nurses was required. This involved a full report from the nurse handing off care and ensured that the receiving nurse was immediately available to intervene if necessary. The DV2-CEO expected such an occurrence to be rare and not a regular practice in the facility. The CEO confirmed that it was his expectation that ICU and Telemetry/PCU patients would never be transported off their units to have dialysis. Furthermore, a patients request to have the procedure done in their room should be honored.

On 4/4/23 at 4 pm during an interview, the telemetry unit charge nurse (RN 33) confirmed Patient 27's preferences should have been honored. RN 33 explained she was not aware of expectations for Telemetry PCU patients to always have dialysis conducted in their rooms. RN 33 acknowledged nursing staff were not comfortable with being responsible for their patients while being off their unit for lengthy dialysis procedures. RN 33 explained his understanding included expectations that patients would be transported to the 4th floor for dialysis, and for the bedside nurse to have responsibility for their patient during the procedure.

On 4/4/23 at 4:20 pm during an interview, the Telemetry/PCU Manager (TUM) her understanding of how DV 2 was procedures was based on in-service training provided by DV 2 the week prior to conducting their first dialysis procedure on 3/20/23. TUM understanding of was that the regular practice would be for patient's to receive dialysis in the 4th floor procedure room unless the patient was in the ICU. TUM was not aware of the expectations as explained by DV2-CEO above. TUM acknowledged Patient 27's preference to have dialysis in her room, should have been honored.

On 4/4/23 at 2:30 pm during an interview, the newly appointed hospital Dialysis Director (responsibilities included ICU Management) explained she had no experience, training, or hospital policies and procedures related to expectations for the hospital's integration with the new contract with DV 2. The Dialysis Director was not aware of the expectations as explained by DV2-CEO above and acknowledged Patient 27 should have had dialysis in her room.

Based on staff interview and document review, the hospital's Governing Body (GB) failed to ensure the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program.

1. The quality program did not include processes of care and operations that were measured, tracked, and analyzed regarding areas where prior regulatory violations had been identified and did not include all services offered in the facility. Refer to A 273 Findings 1 - 5.

2. The QAPI program did not include indicators for areas where the facility had been issued repeated past deficiencies and resulted in nursing services that were unsafe and ineffective. Refer to A 308.

These failures put patients at risk for substandard care, adverse events, and negative outcomes. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Quality Assessment and Performance Improvement.



42448

Based on interview and record review, the hospital failed to ensure that processes of care and operations were measured, analyzed, and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practices. Documented evidence was lacking to show the following care processes were effectively evaluated and tracked for regulatory violations identified in prior surveys as well as the identification and tracking of key quality indicators and associated analysis for the pharmacy and dietary departments.

1. The number of patients left without being seen (LWBS) and without medical screening exams (MSE), reassessments and repeat vital signs in the Emergency Department (ED), although identified during the prior survey, was not tracked and analyzed and the reasons for these incidents were not included as part of their quality indicators and not tracked and analyzed.

2. Patient rapid responses (members including the Intensive Care Unit Charge nurse that assess and treat deteriorating patients to prevent further decline) and elopement, which occurred since the last survey, were not fully investigated. The facility's plan of correction from the first complaint validation survey (11/17/22) included reviewing all rapid responses and code blues and presenting findings to the resuscitation committee and reviewing all elopements. As a result, potential delays in patient care as well as lack of documentation and reassessments involving these incidents have not been tracked and analyzed.

3. The facility's Interim Operating Room (OR) Director was identified as being unqualified in the prior survey and their current OR Director is also unqualified.

4. The facility failed to identify issues regarding high percentage of medication errors of a high risk drug (insulin).

5. The facility failed to ensure its Food Services and Clinical Nutrition Programs were integrated into the hospital-wide Quality Assurance/Performance Improvement program when there was no evidence of Nutrition Services kitchen performance improvement efforts in place, no action plan response to deficiencies identified in the past two bi-annual Environment of Care (EOC) rounds in the kitchen, and no evidence that QAPI data collected by the clinical dietitians was routinely shared up through the organization or included in Governing Board Meeting Minutes or other facility wide QAPI reports.

Findings:

1. During an interview on 4/3/23 at 8:25 am, the Emergency Department Director (EDD) said their staffing had improved but was still "hit or miss" and one of the traveler nurses (nurses who take a temporary assignment) worked her last shift in the ED yesterday and had left suddenly.

During an interview on 4/7/23 at 1:10 pm, the Chief Nursing Officer (CNO) was asked why the Quality Assurance (QA) meeting minutes on 3/9/23 contained nothing regarding patients not receiving MSEs and lack of reassessments on ED patients, or if it had been discussed in the QA meeting, where was it indicated in the minutes. The CNO said we're tracking time from patient arrival to physician evaluation but it was not discussed in the QA meeting. He said it would be part of the future plan and would move up from QA to governing body.

2. During an interview on 4/7/23 at 1:10 pm, the Chief Nursing Officer said their expectation is that all rapid responses and code blues would be fully investigated and done timely so history of the telemetry monitor (remote monitoring of the patient's heart rate and rhythm) can be pulled and reviewed. He had no knowledge of the delay in care leading to a rapid response for Patient 5 who was on Telemetry or an elopement from the Telemetry floor for Patient 6 and had not identified these as concerns.

3. The issue of an unqualified Operating Room Director, which was identified on the last survey, was next discussed with the CNO on 4/7/23 at 1:10 pm. He was asked about the infection control issues identified as a result of that including improper autoclave cleaning and scope (instruments) storage which were identified on this survey. He confirmed he was unaware of these items and said their new OR Director currently needed additional training and said their plan was to bring in someone from Southern California to mentor this new employee and do an assessment to ensure her competency.

4. The high medication error rate of a high risk medication and medication error reduction program was next discussed with the CNO on 4/7/23 at 1:10 pm. A review of the QA meeting minutes included only an overall medication error rate and did not include high risk medications. He said their pharmacist was not at their last QA meeting on 3/9/23, but usually attended. He admitted the high medication error rate identified during the survey and the associated unclear physician's order had not been recognized prior to the survey. The CNO stated going forward they would focus on computerized provider order entry and medication administration.

5. The dietary issues identified during the survey which included the quality program not being included in the hospital wide quality program, sanitation and related infection control issues as well as qualification, competency and training of staff, were next discussed with the CNO on 4/7/23 at 1:10 pm. He said no one from the dietary department attended the QA meetings and there was no tracking of dietary issues. He said they have met quarterly with their contracted service and have discussed tube feeding issues. The other issues including sanitation have not been tracked or monitored.


42448


A review of a policy titled Performance Improvement (PI) Plan (Food and Nutrition Services Manual), dated 6/22 showed:

a. Purpose was "To continually improve patient care through the implementation of a systematic program that identifies, evaluates, and resolves problems related to the delivery of appropriate and high-quality nutrition services."

b. Scope included evaluation of menus, department safe and sanitary condition, patient nutrition care, and more.

c. Goal included "integrated with other areas of the hospital."

d. Objectives included systematic and relevant data collection and monitoring "for both priority issues needing improvement and as part of the continuing measurement of department activities."

e. "Systematic Monitoring Activities" listed multiple clinical nutrition topics but did not specify any kitchen food safety or sanitation topics. It further stated, "Processes are measured on a continuing basis and include those that: affect a large percentage of patients, place patients at serious risk if not performed well or in an appropriate manner and are likely to be problem-prone."

The Nutrition Services kitchen provided food to a large percentage of patients and staff in the hospital, had the potential to cause foodborne illness to susceptible populations, was complex in its responsibilities to feed people, yet did not have QAPI processes in place or that were reported up through the organization.

1.) Food and Nutrition Services/Clinical Nutrition Performance Improvement

During an interview with the Clinical Nutrition Manager (CNM) on 4/4/23 at 11:38 am, he stated the kitchen did not have any performance improvement initiatives in progress at that time. He stated data collected by the clinical nutrition team regarding timeliness of nutrition assessments and reassessments, and meal tray accuracy went to the Food Services Contractor only.

Review of clinical nutrition report titled "Performance Improvement Report" performance improvement data provided by the CNM and data from January 2022 through February 2023 showed:

a. "Patient Weight Accuracy, % (percent) Accurate Weight documentation in (medical record)" - Nurses to obtain patient Height and Weight on admission which is "missed routinely" and showed compliance scores ranged 22%-46% from January 2022 through February 2023 (higher is better). Height and weight values are important and necessary for nutrition assessment and care planning, medication dosing, identification of body fluid changes (dehydration or edema - undesirable loss or retention of fluid) and quality of care.

b. "Supplement Verification - % supplements verified (in medical record orders) by physicians" (Percentage of nutrition supplement recommendations verified in medical record orders from physicians). "Needs MD sign of in (medical record) to coincide with updated information gathered that physicians are signing off on RD ONS (oral nutrition supplement) recommendations, rather than verifying (acknowledging) the recommendations." Compliance from 1/22 to 11/22 ranged 58% to 79%, with the last value (in 11/22) at 59% (higher is better). RD recommendations for Nutrition Supplements are important interventions for patients who are not eating well or are experiencing weight loss, which inhibits healing.

c. Hospital-Acquired Malnutrition - % Malnutrition identified by RD that has been acquired in hospital." "This occurrence is typically compounded by RD recommendations either not being implemented or not implemented in a timely manner by the medical team, which leads to decline in nutritional status of the patient. Malnutrition is directly related to poorer outcomes including increased: length of stay, readmission rate, infection rate, (skin) pressure injury rate, and medication requirements." The benchmark (comparison with other hospitals) was 0-5%, and scores from May 2022 to October 2022 ranged 46% to 56%, with 13% in November 2022 (lower is better).

During a clinical chart review and concurrent interview with the Clinical Nutrition Manager (CNM) in his office on 4/5/23 at 12:45 pm, he stated the patients were supposed to be weighed on admission, and Nutrition Screening (for malnutrition risk factors) was to be done by Nursing within 48 hours of admission. Weights documented as "emergency" weights were "stated weights". "Chair" weights were done on a scale with a chair, but their "chair" had been broken for "awhile." He stated most of the facility's beds could not weigh patients in bed.

Review of the medical record for Patient 17 showed he was admitted on 3/4/23 with cellulitis, gangrene 4th toe, diabetes, alcohol abuse, and his toe was amputated during the course of his stay. He was 6'4", and "emergency" and "chair" weight were 136.6 kg/300 pounds on admission on 3/4/23, and received a Consistent Carbohydrate Diet (CCHO) order. Review of the Nutrition Assessment notes completed by the Registered Dietitian (RD), dated 3/9/, 3/14/, 3/19/, 3/25/, and 3/31/23 showed his estimated nutrition needs were 2300 - 2760 kcals (calories), and 110 - 138 grams protein, and he had an increased need for protein for wound healing. Patient 17 had variable meal intakes, with meals refused or intake less than 50% for 1 ½ days, improving to mostly 100% of meals by 3/14/23. High calorie/high protein nutrition and wound healing supplements were recommended by the Registered Dietitian (RD) on 3/9/23 but were not ordered until 3/21/23. Double protein three times daily (TID) was recommended on 3/14/23 and was provided at time of 3/19/23 nutrition assessment. The nutrition assessment dated 3/25/23 indicated the patient's intake of 100% CCHO diet plus double protein TID, plus the nutrition and wound healing supplements met his estimated needs.

Review of the facility 7-day menu's Nutrient Analysis showed on average the Consistent Carbohydrate Diet provided an average of 1,470 calories and 81 grams of protein each day, so provided Patient 17 with approximately 53 - 64% of his estimated caloric needs, and 59-74% of his estimated protein needs if he ate 100% of meals. The provision of inadequate nutrition had the potential to result in weight loss and poor or delayed wound healing. No accurate weight was recorded by Nursing during the admission for Patient 17, despite his acute care inpatient status for more than one month (at time of chart review), so it was unknown if or how much weight loss occurred, or if that had any bearing on his wound healing or length of stay.

2.) Environment of Care (EOC) Rounds

During an interview with the Interim Plant Operations Director (IPOD) on 4/3/23 at 4:00 pm he stated Environment of Care Rounds occurred in each department every six months. The EOC committee included the Environmental Services (EVS) Supervisor, Infection Control (IC) Nurse, Health Information Management (HIM) Director and himself. When asked if the Food and Nutrition Services Manager (FSM) participated, he replied "Not often."

During an interview with the Infection Prevention Director (IP) on 4/4/23 at 3:00 pm, the IP stated he participated in EOC rounds and they were scheduled in all areas of the hospital every six months. He stated he looked for cleanliness, expired products, vents, fans, and refrigerator temperature logs. He was unaware what the kitchen used to clean its equipment. When asked how he handled IP with the actual food production activities outside food storage temperatures and food rotation/dates, he stated the Executive Chef (EC) was usually with them during EOC rounds and pointed a lot of things out to them. EOC relied on the EC for expertise. EOC identified things like unclean fans, vents and floors, and the department took care of it. The IP stated findings on EOC rounds went to the Infection Prevention Committee and the EOC Committee.

During an additional interview and concurrent document review with the IP on 4/4/23 at 3:40 pm, he provided the "SRMC Environmental Surveillance Rounds, Dietary, Kitchen, Cafeteria" reports, conducted by the EOC Committee and dated 6/22 and 12/8/22:

On 6/22/22 it showed thermometers in nourishment refrigerators and daily log - Missing refrigerator and freezer temperature log entries on Monday 6/20.

On 12/18/22 it showed floors need to be re-finished in food storage room and locker area; chipped counters in dining area; chipped counter at silverware dispenser area; dirty ceiling vent in kitchen; some green chairs in dining area have torn upholstery and others are worn; dining room tables have worn edges and no longer have protective varnish coating; no dates on prepared salad dressing in salad bar; grease leak on backing behind griddle in kitchen, fans in kitchen area are dirty/dusty (Cross Reference A620 and A750).

The ICD was asked why there were no action plans for the deficiencies cited in the Dietary/ Kitchen/ Cafeteria. He replied, "Some departments just don't respond."

3.) There was no evidence that QAPI data collected by the clinical dietitians was routinely shared up through the organization's or included in Governing Board Meeting Minutes or other facility wide QAPI reports.

Review of QAPI documents on 4/4/23 at 11:55 am showed the Quality Committee Minutes dated 10/13/22, Quality/Patient Safety Committee Minutes dated 11/10/22, Quality Committee Minutes dated 12/8/22, and Governing Board Meeting Minutes dated 1/25/23 did not contain any QAPI reports related to Food and Nutrition Services or Clinical Nutrition. The Governing Board Meeting Minutes indicated CDPH investigated a reported hospital acquired, unstageable pressure ulcer, a root cause analysis completed 11/7/22 included "poor nutritional intake," yet the plan of correction cited in the report did not include any nutrition-related intervention or monitoring in their processes.

Review of the facility's Administrative Manual Provision of Patient Care Plan for Food and Nutrition Services, dated 12/20, showed the Clinical Nutrition Manager (CNM) and Executive Chef (EC) reported to the Food Service Manager (FSM), and the FSM reported to the Chief Executive Officer (CEO). In addition, the CNM reported to the CNO for feedback on clinical nutrition issues, and the FSM and CNM met with the CEO monthly.

During an interview with the Chief Nursing Officer (CNO) on 4/4/23 at 4:00 pm he stated he spoke with the CNM on a routine basis and gave him regular, undocumented feedback. The CNO stated he participated in quarterly meetings with the food services contractor where they discussed problems, best practices to try, and performance indicators. The CNO stated in his quarterly meetings with the CNM they had discussions regarding tube feeding compliance and supply chain issues and looked at performance improvement data the CNM had in progess. When asked where would one look to see how the hospital was using the QAPI data collected by the CNM, the CNO replied "I would agree with you that we don't do a good job of closing the loop. The action plans aren't in place."

During an interview with the Ortho/Neuro Director (OND) who provided interim coverage for the facility-wide QAPI, on 4/5/23 at 9:30 am, he stated he didn't know of any metrics from Dietary provided or reviewed in Quality Committee, but he was involved with the CDM in relation to the Total Joint Program committee. He had no awareness or knowledge of any clinical nutrition performance improvement activities. He was not aware of the CDM or FSM ever attending a Quality Committee meeting - he would have to look at the minutes. When asked if the Food and Nutrition Services/Clinical Nutrition should be included in hospital-wide QAPI, he replied "It's always a good idea. Nutrition is a big part of healing."

Based on interview and document review, the hospital's Governing Body (GB) failed to ensure that the Quality Assessment and Performance Improvement (QAPI) program reflected all the aspects of the hospital's services. The QAPI program did not include quality indicators for areas where the facility had been issued repeated past deficiencies and resulted in nursing services that were unsafe and ineffective.

Findings:

The minutes of the QAPI and Governing Body since the first complaint validation survey (11/17/22) were requested and provided by the Director of Performance Improvement (DPI). The QAPI committee had one meeting on 12/8/22. It mentioned the prior survey and noted the team found issues with working out of ratio (nurse to patient staffing ratio) and lacking competencies for work in high acuity areas. The recommendations/action was "continue to monitor" and the follow up date was 1/2023. The following QAPI meeting on 3/9/23 had no mention of deficiencies identified in that survey or the follow up survey on 2/28/23. The Governing Board Meeting minutes, dated 3/15/23, included staffing audits with 100% goal met in February, despite this being noted as a deficiency on the complaint survey ending on 2/27/23.

During an interview on 4/7/23 at 1:10 pm, the CNO confirmed the staffing audits show everything was "ok" because the Charge Nurses had been given patient assignments, so there were only a couple days when they were out of ratio. He said the gap was mostly on night shift where Registered Nurses were not cosigning the Licensed Vocational Nurses' assessments. He said only ratios have been looked at and they have not looked at when the Charge Nurses have patient assignments and any resulting lack of support, oversight and patient outcome associated with that. The delay in care for Patient 5 on the Telemetry unit and Patient 6's elopement from the Telemetry, on 3/12/23 unit was discussed. He said he was unaware of these incidents prior to the survey.

Based on interview and record review, the hospital failed to ensure that nursing services were consistent with nationally accepted standards of practice as evidenced by failure to provide adequate supervision and evaluation of contracted staff during the provision of hemodialysis (HD) services including failure to follow physician orders and no approved policies and procedures. This has resulted in or has the potential to result in a decline in the patients' condition.

Immediate Jeopardy was declared on 3/30/23 at 4:55 pm, as a result of the facility's failure to identify and correct practices relating to hemodialysis and the safe provision of this service to patient. Refer to Tag A 398 Findings 1 through 4. The survey exited on 4/7/23 and the facility had not implemented practices to remove the immediacy of the Immediate Jeopardy. The hospital submitted a plan to remove the immediacy on 4/21/23 and the Immediate Jeopardy was removed during onsite verification on 4/24/23.

Based on interview and record review, the hospital failed to ensure that nursing services were consistent with nationally accepted standards of practice as evidenced by:

Failure to provide adequate supervision and evaluation of contracted staff during the provision of hemodialysis (HD) services including failure to follow physician orders, failure to have policies and procedures approved by the facility's Governing Board, no auditing/monitoring in place to verify the new system of care utilizing a telehealth RN (providing care for dialysis patients and oversight for Hemodialysis Technicians (HDT) performing the procedure) and failure to adhere to accepted practices of infection control. Refer to A 398 Findings 1-13.

Failure to have adequate numbers of nurses and other staff to provide assessments, safe and effective care as needed by the patients, and implement its staffing policies to patients in the Telemetry unit (Tele, continuous remote monitoring of the patient's heart rate and rhythm) and the Orthopedic-Neuroscience Unit (O/N, medical unit) that was operating as a temporary overflow unit. Refer A 398 Findings 14-16

Failure to implement hospital policy and physicians' orders for a high risk medication. Refer A 398 Finding 17

Failure to have adequate numbers of nurses and other staff to provide assessments, safe and effective care as needed by the patients, and implement its staffing policies to patients in the Telemetry unit (Tele, continuous remote monitoring of the patient's heart rate and rhythm) and the Orthopedic-Neuroscience Unit (O/N, patient services for major joint, neck, and back surgeries and neurological disorders). Refer to A 392 Findings 1 a through 1 e.

1. Patient 1, who was in the Intensive Care Unit (ICU) had uncapped lines and dialysis orders by the physician were not followed. Refer to A 398 Finding 1.

2. Patient 27, an ICU patient, received a fluid bolus (a single dose of fluid given over a short period of time) during dialysis. The ICU Registered Nurse (RN) was not told of this and the dialysis notes were not printed and placed in the record following dialysis so there was no way for the nurse or physician to know about the amount of fluid she had received. Refer to A 398 Finding 2.

3. Patient 3 had dialysis and the HD notes were incomplete and did not include the physician's orders regarding the dialysate and electrolytes used during the dialysis on one day. On another day the HD notes were in conflict with what the nephrologist ordered . Refer to A 398 Finding 3

4. Patient 2, an ICU patient, had an order from the nephrologist to use albumin (a protein made by the liver, special fluid used to treat low blood volume) if the patient's blood pressure dropped. The tech used normal saline instead of the albumin and did not tell the ICU RN prior to the administration of the normal saline. Refer to A 398 Finding 4.

5. Proper infection control standards were breached during the accessing of Patient 2's central venous catheter for dialysis. Refer to A 398 Finding 5

6. Proper infection control standards were breached during the accessing of Patient 40's fistula for dialysis. Refer to A 398 Finding 6

7. The facility continues to use their vendor policies which have not been approved by the hospital. Refer to A 398 Finding 7

8. Patient 25, an ICU patient, was on Continuous Veno-Venous Hemofiltration (CVVH, a temporary treatment for patients with acute kidney failure who are unable to tolerate hemodialysis and are unstable. With CVVH a dialysis catheter is placed in one of the main veins of the body and dialysis is done 24 hours per day to slowly and continuously clean out waste products and fluid from the patient) for three days. There were no notes from the HD tech to indicate if the filter had been changed during this three day period. Refer to A 398 Finding 8

9. The dialysis machine and treatment area was too close to a supply cart. Refer to A 398 Finding 9

10. The HD Telehealth (remote via IPad) RN was unable to verify treatment started within 30 minutes due to connectivity issues for Patient 29. Refer to A 398 Finding 10

11. Patient 26, a dialysis patient, had a bed with a broken bed-scale resulting in inaccuracies in documented pre and post-dialysis weight measurements. Refer to A 398 Finding 11
12. Patient 40 received a dialysis procedure without required assessments and verifications by the HDRN. Refer to A 398 Finding 12.

13. The hospital failed to audit the quality of services provided by the new DV 2 contracted service (included care provided by a telehealth RN) upon implementation. Refer to A 398 Finding 13.

14. The facility did not implement its "Telemetry Monitoring: Application of and Care and Assessment of the Patient Monitor" policy when nursing staff did not respond to Patient 5's telemetry monitor alarms during 74 high priority alarm events that occurred over three consecutive hours that preceded Patient 5's rapid response code (early and rapid interventions provided to a patient to prevent serious injury, cardiac arrest, or respiratory arrest). Refer to A 398 Finding 14

15. The facility did not implement its "Telemetry Monitoring: Application of and Care and Assessment of the Patient Monitor" policy when nursing staff did not respond to Patient 6's telemetry monitor recordings that indicated Patient 5 was disconnected from their telemetry monitor and eloped (leaving the hospital without authority in an unsafe or impaired condition) from the telemetry unit undetected and unmonitored. Refer to A 398 Finding 15

16. The facility did not implement its "Provision of Patient Care, Plan for Telemetry" policy when nursing staff did not provide Patient 6 with the appropriate ongoing patient assessments, including obtaining vital signs (heart rate, blood pressure, blood oxygen saturation, and temperature), health screenings, or hourly nursing rounds (hourly screenings that include patient observation to address a patient's personal needs, positioning and turning, safety needs, and fall risk precautions). Refer to A 398 Finding 16

17. The facility failed to implement hospital policy regarding administration of medications when multiple hospital nurses administered subcutaneous regular insulin in error. Refer to A 398 Finding 17

18. The facility failed to implement its "Staffing Plan for Telemetry" policy on the Tele unit when the telemetry charge nurse (CN) assumed a patient assignment and became unavailable to provide assistance, or clinical support, to the licensed nurses on the telemetry unit. Refer to A 392 Findings 1a through 1c.

19. The facility failed to implement its "Staffing Plan for Telemetry" policy on the O/N unit, a unit that was temporarily operating as a telemetry unit, when it did not staff a charge nurse to coordinate and supervise patient care services on 3/16/23 night shift, 3/17/23 day shift, and 3/22/23 night shift and did not maintain a nurse-to-patient ratio in of 1:4 at all times on 3/19/23 night shift and 4/02/23 night shift in the Telemetry unit. Refer to A 392 Findings 1d and 1e.

The cumulative effect of these systemic problems had the potential to compromise or cause the decline in patients' health and had the potential to compromise the health and safety of patients throughout the hospital due to inadequate supervision of contracted staffing, inadequate staffing, the inability to implement nursing policies, and provide care as needed to all patients, and resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Nursing Services.

Based on interview and record review, the facility failed to have an adequate number of nurses and other staff to provide assessments, safe, and effective care as needed by the patients, in the Telemetry unit (Tele, continuous remote monitoring of the patient's heart rate and rhythm) and the Orthopedic-Neuroscience Unit (O/N, patient services for major joint, neck, and back surgeries and neurological disorders) when:

1a. On the Tele unit when the telemetry charge nurse (CN) assumed a patient assignment and became unavailable to provide assistance, or clinical support, to the licensed nurses on the telemetry unit. This failure caused, or contributed to, Patient 5 not receiving nursing services preceding a change in her condition that required a rapid medical response.

1b. On the Tele unit when the telemetry charge nurse assumed a patient assignment and became unavailable to provide assistance, or clinical support, to the licensed nurses on the telemetry unit. This failure caused, or contributed to, Patient 6 not receiving nursing services preceding his elopement (a patient voluntarily leaving a facility without giving notice to staff).

1c. On the Tele unit and the O/N unit, a unit that was temporarily operating as a telemetry unit, when the unit charge nurses assumed a patient assignment and became unavailable to supervise the Licensed Vocational Nurses (LVN) on the Tele and O/N units. This failure caused, or contributed to, an registered nurse (RN) not supervising, reviewing, or performing and independent physical health assessment on 26 of 38 patients assigned to LVNs.

1d. On the O/N unit, a unit that was temporarily operating as a telemetry unit, when it did not staff a charge nurse to coordinate and supervise patient care services on 3/16/23 night shift, 3/17/23 day shift, and 3/22/23 night shift. This failure had the potential to cause, or contribute to inadequate nursing services and patient safety issues.

1e. On the Tele unit, when it did not maintain a nurse-to-patient ratio in of 1:4 at all times on 3/19/23 night shift and 4/02/23 night shift. This failure had the potential to cause, or contribute to inadequate nursing services and patient safety issues.

Findings:

1a. A review of the facility's policy and procedure titled, "Provision of Patient Care, Plan for Telemetry", revised 12/20, indicated that the Tele unit charge nurse was accountable for the coordination and supervision of patient care activities on a daily basis. The CN duties included oversight of staffing assignments, oversight of unit patient placement, clinical leadership, and coaching. The policy further indicated that Tele RN were led by the Tele CN and Telemetry Department Director (TD).

A review of the facility's policy titled, "Staffing Plan for Telemetry, revised 9/18, indicated that indicated that the licensed nurse-to-patient ratio in Telemetry shall be no greater than 1:4 at all times (one licensed nurse to four telemetry patients) and assignments for each shift will be determined by the Tele CN. The Tele CN will not routinely assume a patient assignment, but will be available to provide assistance to and relief for the licensed nurses with patient assignments. If the Tele CN assumes a patient assignment, whenever possible, a RN who has demonstrated Tele patient care competency, will be available for break and lunch relief.

A review of Patient 5's medical record indicated that Patient 5 was a 75-year-old female who arrived by ambulance to the facility's emergency department (ED) on 3/07/23, at 10:45 pm. She was unresponsive, tachycardic (a heart rate of more than 100 beats per minute), and in severe respiratory distress (a life-threatening inability to breathe). Patient 5 was intubated (the placement of a tube through the mouth and into the airway to deliver oxygen to the lungs) and admitted to the facility's critical care unit. On 3/11/23 Patient 5 had progressed to breathing on her own and met criteria to be transferred to the Tele unit, with continuous telemetry monitoring. On 3/12/23, at 8:30 pm, Patient 5's telemetry monitor triggered 72 high-priority alarms for tachycardia and ventricular tachycardia (V-tach, a life-threatening heart rhythm where the ventricles, or lower chambers of the heart, beat rapidly and inadequately) that ranged from 140-190 beats per minute, lasting for 3.5 consecutive hours, until a rapid response code (early and rapid interventions provided to a patient to prevent serious injury, cardiac arrest, or respiratory arrest) was called on 3/13/23 at 12:08 am. A record review of nursing notes, dated 3/12/13 night shift, indicated no Tele nurses responded to Patient 5's continued heart monitor alarms, until a rapid response code was called.

A review of the facility's document titled, " Telemetry Unit Daily Assignment Sheet-Night Shift," dated 3/12/2023, indicated that the telemetry unit had one Tele CN, four Tele RNs, and one Tele LVN providing patient care. All six licensed nurses, including the Tele CN, were at a nurse to patient ratio of 1:4. The unit did not have a resource nurse (a registered nurse on staff that does not take a patient assignment so they can assist the telemetry nurses with analyzing patient data, patient assessments, and patient care priorities) or a unit floor nursing aide (NA, unlicensed personnel assistance who assist the telemetry nurses with patient care duties including: obtaining vital signs, answering patient call lights, and providing assistance during patient duress) staffed. The RN patient room assignment indicated that RN 35 was assigned to Patient 5.

During an interview on 4/04/23, at 10:02 am, RN 35 stated she has been a traveling registered nurse (a nurse that takes a temporary position in high-need areas) working in medical/surgical and telemetry units for 15 years and worked at the facility as a travel telemetry nurse for approximately five weeks. RN 35 stopped working at the facility on 3/14/23, two days after Patient 5's rapid response, because the facility was "extremely understaffed and very unsafe." RN 35 stated she observed Patient 5's telemetry monitor alarming high-priority alarms indicating V-tach at 150-170 bpm throughout the night. RN 35 stated she observed the Telemetry Technician (TT, a technician responsible for independently observing and interpreting a patient's heart rate and rhythm) yelling out from the telemetry chamber (a small room within the telemetry unit where the TT resides, that is equipped with four desktop monitors displaying live- time continuous telemetry monitoring of over 46+ patients) many times requesting that a nurse assess Patient 5 for V-tach. Since there was no resource nurse or nursing aide staffed, and every telemetry nurse, including the Tele CN, had very labor-intensive patients, no one was able to assist Patient 5's nurse or provide Patient 5 with nursing services. RN 35 stated the "entire situation was very sad" because Patient 5 was yelling all night, in obvious discomfort, until the rapid response was called.

During a telephone interview on 4/04/23, at 9:27 pm, RN 40 stated that she has been a CN on the facility's telemetry unit for approximately five years and verified she worked as a CN on 3/12/23,the night of Patient 5's rapid response. RN 40 stated that staffing was extremely tight and that every telemetry nurse, including RN 40, was assigned four "very sick" patients that required IV push medications medications (medications injected into the bloodstream through the IV tubing with a syringe rather than allowed to drip in slowly), IV titrated medications (the process of adjusting the dose of a continuous IV medication for maximum benefit), and continuous nursing assessment. During this night shift, the unit did not have a resource nurse or nursing aide staffed, so every telemetry nurse was also tasked with obtaining all patient vitals, answering call lights, and patient repositioning. Since the unit was staffed so minimally, RN 40 was unable to provide quality supervision or support to the other telemetry nurses. RN 40 stated she and TT 3 continually notified RN 36 of Patient 5's high priority alarms and requested that RN 36 assess Patient 5 and notify the MD of the severe changes in heart rate. Due to a heavy workload, and other telemetry patient emergencies, RN 40 was unable to immediately follow-up and verify that RN 36 responded to Patient 5's telemetry alarms. A few hours later, at approximately midnight, RN 40 assessed Patient 5's condition and decided to call a rapid response code blue.

During an interview on 4/6/23, at 9:15 am, Licensed Vocational Nurse (LVN) 1 stated she has been an LVN for one year and has worked at the facility's telemetry unit since becoming an LVN. LVN 1 verified that she worked the telemetry night shift on 3/12/23 and confirmed she was familiar with Patient 5. LVN 1 stated Patient 5 became very anxious and agitated a few hours into the night shift. LVN 1 reported while she was in the medication room preparing for her 9:00 pm medication pass, she heard Patient 5 yelling out from across the hall, "Help, I am dying. They are trying to kill me. They are not helping me. They are experimenting on me." LVN 1 immediately went into Patient 5's room, held her hand, and provided reassurance to calm her down. LVN 1 notified Patient 5's nurse, RN 36, of Patient 5's agitation and confusion, which continued throughout the night until a rapid response was called. LVN 1 stated she observed TT 3, and the Tele unit charge nurse, RN 40, calling to RN 36 multiple times to check on Patient 5 for extreme tachycardia alarms. LVN 1 reported that TT 3 became frustrated with RN 36's lack of response, so she called out from the Tele chamber in the general direction of the nurses station for "someone, anyone, to go check on patient 5". LVN 1 stated the unit was not sufficiently staffed for the other telemetry nurses to help RN 36. Every telemetry nurse, including the charge nurse, was assigned four very busy patients and there was not a resource nurse or a unit NA staffed to provide assistance. LVN 1 reported around the same time Patient 5 became agitated with a rapid heart rate, a disoriented and impaired telemetry patient had eloped from the unit, making the telemetry nurses and charge nurses spread thin with critical patient issues.

During a concurrent interview and record review on 4/06/23, at 12:08 pm, the Telemetry Unit Director (TD) verified that Patient 5's telemetry monitor triggered 72 separate, priority alarms, for 3.5 consecutive hours, until a rapid response was called on 3/12/23 at 12:08 am. TD stated her expectations, and the facility's policy, was for staff to immediately asses the patient, notify the doctor to discuss potential interventions, and administer hourly nursing reassessments to monitor the severe change of condition. TD verified that all Tele nurses, including the Tele CN, had assumed a patient load of 1:4 and that there was not a resource nurse or a nurse's aide staffed on the 3/12/23 night shift. TD stated this staffing arrangement was not ideal and made her very uncomfortable with compromising patient safety. TD confirmed that staffing issues may have contributed to Patient 5 not receive nursing assessments or interventions during their 3.5 hours of severe tachycardia.

1b. A review of Patient 6's medical record indicated that Patient 6 arrived to the facility ED via ambulance for acute alcohol intoxication (the quick consumption of large amounts of alcohol) and complaints of an active gastrointestinal bleed (GI bleed), coffee ground vomiting (the presence of blood in vomit), abdominal pain, and chest pain on 3/12/23 at 9:00 pm. While Patient 6 was in the ED he exhibited impulsive and dangerous behaviors and required the use of bilateral soft-wrist restraints on three occasions to remain safe and free from harm. On 3/12/23, at 9:00 pm, Patient 6 was admitted to the Tele unit for management of alcohol withdrawal, delirium tremors (a serious and potentially fatal form of alcohol withdrawal), high blood pressure, and a GI bleed. A nursing progress note entered on 3/13/23 at 9:00 am, and backdated 3/12/13 at 9:00 pm, indicated that during the 3/12/23 night shift Patient 6 had pulled out multiple IVs and attempted to elope from the Tele unit.

A review of the facility's document titled, " Telemetry Unit Daily Assignment Sheet-Night Shift," dated 3/12/2023, indicated that the telemetry unit had one Tele CN, four Tele RNs, and one Tele LVN providing patient care. All six licensed nurses, including the Tele CN, were at a 1:4. The unit did not have a resource nurse or a unit floor nursing aide. The RN patient room assignment indicated that RN 35 was assigned to Patient 6.

During an interview on 4/04/23, at 10:02 am, RN 35 confirmed she had worked the 3/12/23 night shift and was assigned to Patient 6 on the night of his elopement. RN 35 stated when Patient 6 was admitted to the Tele unit she did not immediately assess him because she wasn't notified that he was assigned to her patent load until Patient 6 had been on the Tele unit for over an hour. RN 35 stated the Tele CN was so busy with her own patient assignments and assisting the LVN, that Patient 6 was delayed getting assigned to a nurse. RN 35 reported she was unable to immediately assess Patient 6 because she had to administer a a time-sensitive IV infusion to a patient in isolation (a patient with a contagious condition requiring a single room and all hospital staff gowning, gloving, masking, and shielding when entering and exiting the single room) and all other Tele staff were busy with their patient assignments. While RN 35 was in the isolation room, Patient 6 managed to remove his telemetry monitor unit, pull out two IV catheters,access the 4th floor unit stairwell, and scoot down to the 2nd floor, without being discovered by the Tele staff. RN 35 stated the unit was staffed so tightly, without any leeway in staffing to account for patient emergencies or adverse events, that she had to call the facility's Nursing House Supervisor for assistance with managing Patient 6.

During a concurrent interview and record review on 4/04/23, at 7:45 pm, the facility's Nursing House Supervisor, RN 39, stated she had worked at the facility for 32 years, and had been in the role of Nursing House Supervisor for the past 2 years. RN 39 confirmed that she worked the night shift on 3/12/23 and assisted the telemetry staff with Patient 6's elopement. RN 39 stated the telemetry nurses were overwhelmed during this particular shift because they were severely short-staffed for the type of patients admitted to the unit. RN 35 was unable to get support admitting Patient 6 because RN 40 had to assume a four patient assignment and assist an LVN with multiple IV medications. At approximately 10:00 pm, RN 35 called RN 39 and asked for assistance getting Patient 6 set back up in his telemetry room after an attempted elopement. RN 39 stated that Patient 6 was able to disconnect from his telemetry monitor, pull out two intravenous catheters, access the facility's stairwell, and scoot on his butt to the 2nd floor until without the telemetry staff knowledge. RN 39 assisted RN 35 with changing Patient 6's bed linens, cleaning up the biohazard, placing new IV catheters, and reconnecting the telemetry monitor prior to resuming her House Supervisor duties.

During an interview on 4/07/23, at 3:30 pm, TT 3 confirmed she worked in the Tele chamber during the 3/12/23 night shift that Patient 6 eloped. TT 3 recalled yelling out of the Tele chamber for a nurse to check on Patient 6 when she identified Patient 6's Tele monitor alarming for disconnected leads. TT 3 could not recall what nurse, if any, responded to her request. This particular night shift was very short staffed. There were no available nurses aides on the unit and the Tele CN had to assume a full patient load and provide an LVN with supervision. TT 3 reported the nurses were so busy, that it was difficult to get a nurse to respond to the Tele monitor alarms. Typically when TT 3 does not get a nurse to promptly respond to a patient's Tele alarm she notifies the Tele CN that a patient assessment needs to occur STAT (a medical term for immediately).

During a concurrent interview and record review on 4/04/23, at 4:50 pm, TD stated she was not aware Patient 6 had eloped from the Tele unit. TD stated when Tele alarms indicate that leads were disconnected from a patient, it was expected that the TT immediately notify nursing staff and request a patient assessment. Tele nurses were expected to promptly assess the patient's safety and report the results to the TT. TD stated that Tele patients were placed on a Tele monitor for a reason, and they cannot be safely monitored if they were disconnected. TD confirmed that the demand on the nursing staff contributed to Patient 6's elopement. TD stated the facility asked a lot of her CNs when they were required to assume a patient assignment, and that the Tele CN cannot "be superwoman."

1c. A review of the facility's job description titled, "Job Description - LVN- Telemetry", revised 1/2014, indicated that the Tele LVN provides direct and indirect patient care services, within the scope of practice, and performs under the direction and supervision of a RN.

A review of the facility's job description titled, "Job Description - LVN- Orthopedics/Neuroscience", revised 1/2014, indicated that the Ortho/Neuro LVN provides direct and indirect patient care services, within the scope of practice, and performs under the direction and supervision of a RN.

A review of LVN physical assessments administered to patients on the Tele and O/N units, from 3/01/23 to 3/31/23, during shifts the Tele and O/N CNs were required to assume their own patient load, indicated that 26 of 38 (68%) the LVN's patient assessments did not include a CN supervising, reviewing, or performing an independent physical health assessment as required by their licensure.

During an interview on 3/30/23, at 2:56 pm, LVN 1 reported that staffing on the Tele unit had been awful. The Tele unit had been continually short-staffed, without resource nurses, or aides. LVN 1 reported she had little to no CN support because the CN's must assume a full patient load often, making them busy and unavailable. There have been several instances where LVN 1 needed to discuss critical lab values or sudden changes in a patient's condition with the CN, but the CN was unavailable because they were handling their own patient's urgent issues. Since the Tele LVN's scope of practice does not allow for LVNs to administer IV medications, they depend on the CNs to be available to administer these medications within the MD ordered times. The Tele LVNs submit a list of all their patient's IV medications with the corresponding administration time to the CN at the beginning of shift. When the CNs have their own patients, sometimes it becomes impossible for them to provide their own patient care and administer the LVN medication on time. LVN 1 stated the Tele CNs were some of the strongest clinical nurses who were not afraid of hard work, but they were asked to do something that was humanly impossible and a danger to patient safety.

During an interview on 4/03/23, at 3:45 pm. LVN 3 stated that she has worked on the facility's O/N unit for approximately one year. LVN 3 reported that the O/N CN's frequently have their own patient assignments, making it difficult for the LVNs to receive CN support. Since LVN 3 just got her licensure one year ago, she relies on the CN's to be available for consult to make sure she was not missing something critical with her patient's physical health condition. LVN stated it was very rare for a CN to have time to review the findings of an LVN patient health assessment or perform their own independent assessment. Sometimes staffing was so tight, and patient care was so busy, that it was even difficult for a CN to co-sign an LVN assessment.

During an interview on 4/05/23, at 5:10 pm, RN 41 reported he had been employed as a telemetry charge nurse at the facility for eight years. RN 41 stated there was no formal meeting or method of communication that instructed the facility's CNs on the expectations of LVN oversight. RN 41 stated that the TD briefly mentioned to him that LVNs would be working on the unit and that all CNs must co-sign LVN patient assessments and be available to administer certain IV medications. RN 41 stated this created an extra workload for CN's, particularly if they were required to assume a patient load and there was no resource RN on staff. There was a mix of quality LVNs at the facility, with some LVNs needing, or requesting, close supervision. It was unfair to both the LVN and CN to not have adequate time for supervision and support.

During concurrent interviews and record reviews on 3/30/23, at 11:54 am, 4/03/23 at 4:20 pm, 4/04/23, at 11:47 am, and 4/06/23 at 10:07 am, Ortho/Neuro Unit Director (OND) stated it was the reasonability of the unit CN to provide supervision and oversight to the facility's LVNs. When the facility began hiring LVNs to assist with staffing shortages, the facility did not disseminate any formal communications regarding LVNs joining the nursing team or provide instruction on the delegation of LVN supervision. OND had a face-to-face conversation with each CN who reported to him regarding LVN job scope and the facility's expectations of CN oversight. OND reported the facility was in the midst of updating the Provision of Care policy and procedures to include the LVN job role. OND confirmed that all patient physical assessments performed by LVN's must be co-signed by a CN who verified findings or performed a separate, independent assessment. OND confirmed that the sample of LVN physical assessments reviewed did not have any CN supervision or oversight.

During concurrent interviews and record reviews on 4/05/23, at 8:35 am, and 4/-5/23 at 4:25 pm, TD confirmed that the Tele unit CNs were expected to provide LVN oversight and supervise LVN assessments. Tele CNs entered a nursing note stating they either agreed or disagreed with an LVN assessment. If a CN disagreed with an LVN assessment the reason for disagreement should be documented with findings from the CN's independent physical assessment. TD reported she would like to have access to more clinical staff to assist Tele CNs with their job duties. When CNs work shifts where they assume patient assignments and provide LVN oversight it becomes a big workload and patient safety concern. TD reported that the facility did not roll out any formal communication to staff introducing the LVNs into the facility's nursing team. Instead, the department directors had face-to-face conversations with their CNs to explain the LVN's job scope and CNs responsibility for oversight. TD confirmed that the sample of LVN physical assessments reviewed did not have any CN supervision or oversight.

During an interview on 3/30/23, at 11:54 am, CNO stated that the facility was currently revising the Provision of Patient Care polices to include the LVN job scope and job role. It was expected that the facility's CNs supervise LVNs, review and co-sign all LVN physical assessments, and administer IV medications for patients assigned to LVNs. CNO stated the facility did not consider the LVN's patients to be a part of the CNs nurse-to-patient ratio, despite being tasked with additional patient care services for the LVNs patients. CNO agreed that when a CN assumes a 1:4 patient assignment (one licensed nurse to four telemetry patients) and was also required to conduct physical assessment reviews and administration of all IV medications to the LVNs patients, the CN was providing patient care services to a minimum of eight patients and possibly more.

1d. A review of the facility's policy and procedure titled, "Provision of Patient Care, Plan for Telemetry", revised 12/20, indicated that the Tele unit charge nurse was accountable for the coordination and supervision of patient care activities on a daily basis. The CN provides oversight of staffing assignments, oversight of unit patient placement, clinical leadership, and coaching. The policy further indicated that Tele registered nurses (RN) were led by the Tele CN and Telemetry Department Director (TD).

A review of the facility's document titled " Documentation of Nursing Assignments - Ortho 4 South", dated 3/17/23 day shift, indicated that O/N unit did not have a CN staffed for the shift. The unit had two RNs working at a 1:4 ratio to provide patient care to eight Tele patients. The unit did not have a resource nurse or nursing aide staffed.

A review of the facility's document titled " Documentation of Nursing Assignments - Ortho 4 South", dated 3/17/23 night shift, indicated that O/N unit did not have a CN staffed for the shift. The unit had two RNs working at a 4:1 ratio to provide patient care to eight Tele patients. The unit did not have a resource nurse staffed.

A review of the facility's document titled " Documentation of Nursing Assignments - Ortho 4 South", dated 3/22/23 night shift, indicated that O/N unit did not have a CN staffed for the shift. The unit had three RNs that provided patient care to 11 patients Tele patients. Two RNs were at a 4:1 ratio and one RN was at a 3:1 ratio. The unit did not have a resource nurse or unit aide staffed.

During an interview on 3/29/23, at 4:18 pm, RN 37 stated she had worked on the facility's O/N and Tele units for 6 years. RN 37 reported that the facility had been so short staffed that they resorted to unsafe patient care practices. RN 37 reported the O/N unit did not staff a CN on two night shifts. RN 37 worked alongside one other RN during a night where there was no CN and both nurses were required to assume a full patient assignment of four patients each. RN 37 reported the staffing was already spread thin by not having a NA or resource nurse scheduled. The absence of a CN resulted in the nurses not having assistance with unexpected issues for routine patient care and unexpected urgent patient care. RN 37 reported she refused to take on the legal risk of unsafe assignments.

During a concurrent interview and record review on 4/05/23, at 11:00 am, OND reported that the O/N CN's role included providing the O/N nurses with clinical leadership, clinical consulting, rapid response support, and patient care assistance. OND verified that a CN was not staffed on the O/D unit during 3/17/23 day shift and 3/19/23 night shift. OND reported that this situation was not ideal, but that was the only nursing resources he was given at the time. There were other facility units with a more critical staffing shortage than the O/N unit, so some O/N nurses were required to float off the unit. This resulted in the O/N unit not having a CN. OND stated the 4th floor ON nurses were instructed to call down to the 2nd floor Tele CN if they needed CN assistance, but he did not know if the Tele CNs had assumed their own patient load and were available to provide support.

1e. A review of the facility's policy and procedure titled, "Staffing Plan for Telemetry", revised 9/18, indicated that the licensed nurse-to-patient ratio in Telemetry shall be no greater than 1:4 at all times (one licensed nurse to four telemetry patients). Patients that required mechanical ventilation (a machine that assists with breathing), Bipap (a machine that delivers high pressurized air into the lungs through a face mask to help open the lungs), certain intravenous (IV, to provide access directly into a vein and directly into a bloodstream) medications, and hemodynamic (the measurement of blood flow through the vessels) support shall be staffed at a 1:3 nurse-to-patient ratio or higher based on acuity.

A review of the facility's document titled " Telemetry Unit Daily Assignment Sheet-Night Shift", dated 3/19/23 night shift, indicated that the Tele unit had one CN, one RN, and one LVN staffed to provide patient care to 14 Tele patients. The CN and RN were at a 1:5 ratio, a ratio that exceeded the telemetry staffing policy standards. The LVN was at a 1:4 ratio. The unit did not have a resource nurse staffed and floated (reassigned a nurse from their regular unit to a short-staffed area) four nurses out of Tele to other facility units.

A review of the facility's document titled " Telemetry Unit Daily Assignment Sheet-Night Shift", dated 4/02/23 night shift, indicated that the Tele unit had one CN and two RNs staffed to provide patient care to 15 Tele patients. The Tele CN and Tele RNs were at a 5:1 ratio, a ratio that exceeds the telemetry staffing policy standards. The unit did not have a resource nurse staffed and three nurses were floated out of Tele to other facility units.

During concurrent interviews and record reviews on 4/05/23, at 8:35 am, and 4/-5/23 at 4:25 pm, TD verified that the facility staffing policies were not followed on 3/19/23 and 4/02/23. TD reported when staffing exceeded the nurse to patient ratio, she becomes very uncomfortable with patient safety.

During a concurrent interview and record review on 3/30/23, at 11:54 am, CNO reported the facility had increased their recruiting to hire new facility nurses and they continue to utilize travel nurses for departments with staffing shortages. CNO confirmed the facility instituted a second pay reduction, mid-contract, to their current contracted travel nurses. Three of 12 travel nurses refused the facility's pay cut that was breaking contract and terminated employment at the facility. The CNO was asked to explain the process that determines the daily staffing of nurses at the facility. CNO stated that twice daily huddles (a short standup meeting) were scheduled with himself, the day shift House Nursing Supervisor, and all department directors. During the huddle they discuss the facility's current census on each unit (number of patients each unit is providing care for), the number of patient admits and discharges, the number of ED holds (patients in the ED that have been determined to need inpatient care, but are held in the ED due to a lack of hospital beds), the number of nursing staff who have called in sick, and the number of available scheduled nurses for each department. These numbers determine how many nurses will be a staffed on each unit and what nurses will be floated off of their regular unit to assist in areas with staffing shortages. CNO stated the Tele unit's nurse staffing ratios were exceeded because nurses had to be floated off the unit to assist with staffing shortages that were more critical in other departments, indicating an overall staffing shortage at the facility.

Based on observation, interview, and record review the facility failed to:
Provide adequate supervision and evaluation of contracted staff during the provision of hemodialysis (HD, treatment to filter waste and water from the blood) services including failure to follow physician orders, failure to have approved policies and procedures by the Governing Board, no auditing/monitoring in place to verify the new system of care utilizing a telehealth RN (providing care for dialysis patients and oversight for Hemodialysis Technicians (HDT) performing the procedure) and failed to adhere to standards of practice for infection control.
The facility did not provide adequate nursing services for Patient 5 and Patient 6 on the telemetry unit (a unit where patients are under constant electronic monitoring) who were receiving telemetry monitoring (a portable device connected to the patient that measures the hearts electrical activity to continuously track heart rate and rhythm) and failed to implement medication administration policies for high risk medication when:

1. Patient 1, who was in the Intensive Care Unit (ICU), had uncapped lines (tubes that connected the patient to the dialysis machine for the exchange of fluids) and physician orders for a specific type of dialysis that were not followed.

2. Patient 27, an ICU patient, received a fluid bolus (a rapid infusion of fluids over a short period of time administered through) during dialysis. The ICU Registered Nurse (RN) was not told of this, and the dialysis notes were not printed and placed in the record following dialysis, so there was no way for the nurse or physician to know about the amount of fluid Patient 27 had received.

3. Patient 3 had dialysis and the HD notes were incomplete and did not include the physician's orders regarding the dialysate and electrolytes (fluids used for dialysis) used during the dialysis on 3/21/23. On 3/23/23, the HD notes were in conflict with what the nephrologist (physician specializing in treating kidney disorders) ordered.

4. Patient 2, an ICU patient, had an order from the nephrologist to use albumin (special intravenous fluid used to treat low blood volume) if the patient's blood pressure dropped. The HD technician used normal saline (intravenous fluids) instead of the albumin and did not tell the ICU RN prior to the administration of the normal saline.

5. Proper infection control standards were breached during the accessing of Patient 2's central venous catheter (thin flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time inserted a large vein) for dialysis.

6. Proper infection control standards were breached during the accessing of Patient 40's fistula for dialysis.

7. The facility adopted the use of Dialysis Vendor's (DV) 2's policies and procedures, which had not been approved by the hospital Governing Board (a group of people legally responsible for overseeing and running an institution).

8. Patient 25, an ICU patient, was on Continuous Veno-Venous Hemofiltration (CVVH, a temporary treatment for patients with acute kidney failure who are unable to tolerate hemodialysis and are unstable. With CVVH a dialysis catheter is placed in one of the main veins of the body and dialysis is done 24 hours per day to slowly and continuously clean out waste products and fluid from the patient) for three days. There were no notes from the HD tech to indicate if the filter had been changed during this three day period.

9. The dialysis machine and treatment area was too close to a supply cart.

10. The HD Telehealth (uses remote, audio and visual communication via a wireless tablet computer) RN was unable to verify treatment started within 30 minutes due to connectivity issues for Patient 29.

11. Patient 26, a dialysis patient, had a bed with a broken bed-scale resulting in inaccuracies in documented pre and post-dialysis weight measurements.

12. Patient 40 received a dialysis procedure without required assessments and verifications by the HDRN.

13. The hospital failed to audit the quality of services provided by the new DV 2 contracted service (included care provided by a telehealth RN) upon implementation.

14. The facility did not implement its "Telemetry Monitoring: Application of and Care and Assessment of the Patient Monitor" policy when nursing staff did not respond to Patient 5's telemetry monitor alarms during 74 high priority alarm events that occurred over three consecutive hours. These alarm events indicated Patient 5 was experiencing severe changes in heart rate or heart rhythm. As a result, Patient 5 did not receive nursing assessments to identify a change in physical condition, nursing interventions, or potential emergency treatment during the three hours that preceded Patient 6's rapid response code (early and rapid interventions provided to a patient to prevent serious injury, cardiac arrest, or respiratory arrest).

15. The facility did not implement its "Telemetry Monitoring: Application of and Care and Assessment of the Patient Monitor" policy when nursing staff did not respond to Patient 6's telemetry monitor recordings that indicated Patient 6 was disconnected from their telemetry monitor and eloped (leaving the hospital without authority in an unsafe or impaired condition) from the telemetry unit undetected and unmonitored.

16. The facility did not implement its "Provision of Patient Care, Plan for Telemetry" policy when nursing staff did not provide Patient 6 with the appropriate ongoing patient assessments, including obtaining vital signs (heart rate, blood pressure, blood oxygen saturation, and temperature), health screenings, or hourly nursing rounds (hourly screenings that include patient observation to address a patient's personal needs, positioning and turning, safety needs, and fall risk precautions); and

17. The facility did not implement hospital policy regarding administration of medications when multiple hospital nurses administered subcutaneous regular insulin in error. The nurses did not administer the subcutaneous regular insulin in accordance to hospital protocol and physicians orders which resulted in eleven medication errors out of twenty six administrations of a high-alert medication-insulin.

The above failures have resulted in a decline in the patients' condition including a delay of care and delay in providing emergency medical interventions, breach of infection control practices, and high medication error rate.

Findings:

During an interview on 3/20/23 at 2:40 pm the Chief Nursing Officer (CNO) confirmed they discontinued their old contract with their former Dialysis Vendor (DV 1). DV 1 had a dialysis RN that provided all dialysis treatments to their inpatients. Their new contract, DV 2, effective 3/20/23 had HD certified (but unlicensed) dialysis technicians (techs) provide the dialysis services to inpatients instead of RNs. The HD techs would be supervised by a Registered Nurse (RN) via Telehealth. This Telehealth RN was available to view and talk to the patient via a tablet computer (a small portable computer) and would conduct the patient assessment this way. CNO confirmed there were currently no dialysis policies approved by the facility. He was asked why this new dialysis service was started before the facility had approved policies and procedures and CNO said our old contract with DV 1 ended so we went ahead with this new contracted company, even though we did not have approved policies at that time.

1. A review of Patient 1's record indicated he was admitted on 3/8/23 with chest pain and shortness of breath. During the hospitalization his condition declined and he was transferred to the ICU and started on CVVH on 3/19/23, by the DV 1's RN. On 3/20/23, the DV 2's tech changed out the machine. During the new set up there were eight lines that were clamped but left uncapped. A note from Patient 1's nephrologist dated 3/21/23 at 3:23 pm indicated he was notified by the RN in charge of the patient about the ports (connections for attaching other lines or syringes) of the lines not being capped and it was immediately capped by her. He notified the Vice President of Operations of the new team and brought this to his attention and has already reviewed it with the staff and CNO of the hospital.

A nurse's note dated 3/22/23, indicated the RN noticed, at 9:30 pm, the dialysis machine was actually hooked up to run CVHD (Continuous Veno-venous Hemodialysis) not CVVH. The HD tech was notified.

During a concurrent interview and record review on 3/29/23, at 11:25 am, the Director of Ortho/Neuro (OND) confirmed there were no records from DV 2 regarding setting up machine or changing filter cartridges or tubing. OND also confirmed this with the Health Information Management (HIM, medical records) department that there were no such records.

During an interview on 3/23/23 at 4:15 pm, RN 1 said Patient 1 was supposed to be set up for CVVH and that was what was ordered by the physician. Last night (night shift on 3/22/23) it was discovered that the patient was set up for CVHD and provided a picture of the incorrect set up. She said with CVHD the blood was diffusing through the filter and taking off more electrolytes than what should be. The patient had an electrolyte imbalance including phosphorus levels that resulted from CVHD or CVHD at least contributed to this. She said she did not know how long the machine had been set up incorrectly and it could have been since the machines were changed on Monday morning 3/20/23 around 7 am, or when the filter was changed. She said the dialysis tech sets up the machine now, as there was no dialysis RN, with the new contract. She said the night shift nurse last night on 3/22/23, caught the mistake and it has now been corrected.

During an interview on 3/28/23 at 7:15 am, RN 2 said Patient 1 was hooked up to CVHD as opposed to CVHD, as ordered by the MD and it took three days before the mistake was discovered. She said CVHD was not as effective. The same filter and same machine are used, but during CVHD the dialysate does not touch the blood - the blood is one side of the filter and the dialysate is on the other side of the filter; CVVH blood runs through the filter and mixes in with the blood that goes back to the pt. CVVH uses convection and CVHD relies upon diffusion. She said with CVVH the filter was changed more frequently and they usually used this with a septic (infected blood) patient as it was better at getting larger particles out through the filter. CVHD was not as efficient at getting cell matter out from patients. She also said the duosol solution (solution used for dialysis) that was used in the dialysis machine used to come from their pharmacy with a bar code on it and now the new company supplied it. She said it should be stored at room temperature and there was no way for the nurses to know if that was being done since it was not coming from their pharmacy.

During an interview on 3/30/23 at 8:05 am, RN 3 said he was the ICU RN who cared for Patient 1 and found that the machine was set to CVHD as opposed to CVVH, on night shift 3/22/23 around 9:30 pm. He said he has had no dialysis experience but has worked with this machine for 8-10 years. He said he heard the filter on the machine had been changed the night shift before around 2 am on 3/22/23. When he found the error he called in the tech who came in and said he had set it up the same way as it had been originally set up. He said the CVVH is more gentle and CVHD is more aggressive and pulls off electrolytes at a more aggressive rate. He said this patient had a problem with his phosphorus and they had been replacing it with every lab check, which was every six hours, and usually that only has to be done every day or every other day. He said the hospital started this new contracted service on Monday 3/20/23 and had a training class the Thursday and Friday before that. They have not had any additional training. He was asked if there was an emergency with a patient on regular HD and the patient needed his blood returned to him emergently, if he would be able to do that and he said no he does not know anything about the regular HD machines and has had no training on that.

During an interview on 3/29/23 at 2:15 pm, the following was discussed with the CNO: no documentation of who set up the machine and who changed the filter, uncapped lines and machine set up for CVHD not CVVH as ordered by the physician. He agreed this was not acceptable and said they elevated these issue to the project lead for DV 2. He confirmed there was no Telehealth remote RN supervision of the HD tech during the set up for this patient for his CVVH which led to uncapped lines and which led to the incorrect type of dialysis being given to the patient. He said the Telehealth Remote RN supervision was only during the Hemodialysis process and did not include setting up the machine or changing filters.

During an interview on 3/30/23 at 10:30 am, the DV 2 hemodialysis tech (HDT 1) confirmed he set up the machine on 3/20/23 and changed the filter early in the morning around 2 am on 3/22/23 and again at 11:30 pm on 3/22/23. He said at that time he did not have access to the facility's electronic medical record (EMR). He said he looked at how the DV 1 nurse set up her machine and thought he followed her set up. He said setting up the machine was something they, the HD techs ordinarily do, and they do not contact the Telehealth RN for this. The usual process was to verify the physician's order and in this case since he did not have access to the EMR, he said he should have asked the nurse to print out the physician's order for him. HDT 1 said he was not supposed to be a permanent staff at this facility so he was not given access to the EMR. He said when DV 2 opens new programs he was one of the techs that "gets things going." He said CVVH training for the other techs was given this past Monday, 3/27/23. He was asked about the uncapped lines and said he was unaware of any uncapped lines and said the only reason to remove the cap would be to connect the intravenous (IV) pump. He said he was unaware of the uncapped lines and had not seen any pictures.

During an interview on 4/6/23 at 8:30 am, the infection preventionist (IP) reviewed the pictures of Patient 1's uncapped lines. He said the uncapped lines could cause a potential infection even if clamped and agreed the clamp could come undone and staff could brush up against the uncapped lines. He said they have a policy regarding capping lines and their infection control policies were in the dialysis area with the techs who signed off that they had reviewed and understood these policies.

2. A review of Patient 27's record indicated she was admitted on 3/13/23 with nausea, vomiting, and intestinal obstruction. She had a long history of chronic renal failure. She had surgery and was then admitted to ICU. On 3/20/23 she was provided dialysis by the HD techs. On 3/27/23 a review of her EMR did not include the dialysis note from 3/20/23.

On 3/27/23 at 10:45 am, the ICU Director (ICUD) could not find a note for 3/20/23 and called HDT 2 who said 3/20/23 was the day their program first started and there was a glitch in their charting system. HDT 2 said she did not know this note was missing from the patient's chart until now and would call DV 2 to ask for them to print it out.

This note was reviewed on 3/28/23 at 7:06 am and indicated a 250 ml bolus of normal saline was given to Patient 27 during dialysis for low blood pressure (BP).

During an interview on 4/3/23 at 2:43 pm, RN 4 said that she was not told by the HD tech and was unaware Patient 27 had been given any fluids as part of a fluid challenge during her dialysis on 3/20/23.

3. A review of Patient 3's record indicated he was admitted on 3/8/23. He had dialysis on 3/21/23. A review of the HD notes did not include the name of the dialyzer (dialysis solution) or bicarbonate (a substance called a base that helps keep a normal acid-base balance in the body).

During a concurrent interview and record review on 3/29/23 at 11:25 am, OND confirmed the dialyzer and bicarbonate were not included on the HD note from 3/21/23. He agreed there was no way to know if the physician's order was followed. The name of the HD tech and the Telehealth RN was also not included on this note.

A review of the HD notes for 3/23/23 indicated the dialyzer used was Revaclear 300, Concentrate Potassium was 2 and Calcium was 2.5 A review of the dialysis orders indicated the dialyser should be Elisio-15H, Potassium 3 and Calcium 2.5 The dialyser and Potassium recorded on the HD sheet did not match the physician's order.

During a concurrent interview and record review on 3/29/23 at 11:25 am, OND confirmed that the 3/23/23 order said Elisio 15 H for the dialyser but HD note said Revaclear was used. The amount of the Calcium was the same on both the physician's order and the HD note but the Potassium on the order was not the same as on HD note. The physician's order was not followed on 3/23/23. He also confirmed the name of the supervising RN was simply "Tele RN" instead of the name of the RN on duty on 3/23/23.

4. A review of Patient 2's record indicated he was admitted to the Emergency Department on 3/24/23 with shortness of breath and was admitted to ICU after cardiovascular surgery. His record contained an order from his nephrologist for 100 milliliters (ml) of albumin on 3/26/23 at 9:05 am, for dialysis nurse only.

During an interview on 4/3/23 at 2:45 pm, RN 4 said she worked on 3/26/23 in ICU and was assigned to care for Patient 2. He needed dialysis and his blood pressure (BP) during dialysis was 86/50 and he had been running in the 90's. Since his systolic (highest number) BP was below 90 the HD tech called the Telehealth RN who said give 100 milliliters of normal saline (NS). RN 4 said she had already obtained an, as needed order (prn), for albumin that morning before dialysis was started. She said Patient 2 should have received the albumin not the normal saline. She said the Telehealth RN did not have access to their EMR at that time and the HD tech went ahead and gave the normal saline without telling her although she was readily available in the ICU.

The above was discussed with the CEO for DV 2 during an interview on 4/5/23 at 8:45 am. He questioned if their Tele Health RN read the orders carefully. He said we want the nephrologists to write orders straight into our system but they want to continue to use the system they've been using at the hospital. He said the hospital was supposed to have provided access to the EMR at the beginning when we started. He said the Tele Health RN was supposed to log in with their specific name as the supervising RN and review the HD note.

5. During an observation of HD on 4/5/23 at 1055 am, Patient 2 was brought up to 4th floor dialysis area in his bed. RN 29 had gloves and a mask on and was preparing to connect Patient 2 to dialysis. RN 29 picked up a trash can and placed it beside him then, before doing hand hygiene and changing gloves, used alcohol to clean the patient's central venous catheter port caps. The ICU Director (ICUD) was present and confirmed the above observation and said that RN 29 should have changed gloves and perform hand hygiene after touching the trash can. When RN 29 came out of the room this was discussed with him and he confirmed he should not have picked up the trash can or should have performed hand hygiene and changed gloves after doing so.

6. A review of Patient 40's record indicated she was admitted on 3/29/23 with altered level of consciousness. She had end stage renal disease and was on routine dialysis through a fistula (a connection that is made by joining a vein onto an artery that creates a large vessel that can be needled routinely for use during dialysis).

During an observation on 4/5/23 at 10:50 am, Patient 40 was in the dialysis area. HDT 3 cleaned the fistula with alcohol then with gloved hands, palpated (felt) ,the area cleaned it again then palpated the area again and inserted the first needle without cleaning the insertion area. The fistula was cleaned again and HDT 3 inserted the second needle. At 11:05 am there was a problem with the second needle so HDT 3 cleaned the area again, palpated it then inserted another needle without cleaning the insertion area. During an interview at 11:15 am, HDT 3 was asked about inserting the needle after palpating and before cleaning again. She said it was necessary and she had to do it that way to stabilize the fistula so she could get the needle in and this was her usual practice. ICUD was also present during these observations and interview and agreed the insertion site of the needle should have been cleaned after palpation and before the tech accessed the fistula.

DV 2's policy: Cannulation with Safety Needle Device" policy, created 4/14/21 was reviewed. It indicated under Policy: 1. Chloraprep is the preferred cleansing agent for vascular access site care. . . . Cannulate an AV Fistula: without contaminating cleaned area, stabilize access with nondominant hand. . . insert needle. . . secure access site.

7. The following three hospital policies for HD were provided by OND via email on 3/30/23 at 9:52 am,: Continuous Renal Replacement Therapy, Hemodialysis Access: Assessment for Patency & Care and Blood Sampling, and Dialysis: Peritoneal. These policies had been approved by the hospital's Medical Executive Committee and Governing Board on 3/23/23. All the remaining dialysis policies that were in use and were provided during the survey, were from DV 2 and had not been approved by the hospital's Medical Executive Committee and Governing Board.

During an interview on 4/5/23 at 8:15 am, the CNO confirmed they only have the above three hospital policies and continue to follow DV 2's policies, which have not been approved by the Executive Committee and Governing Board.

8. A review of Patient 25's record indicated she presented to the ED on 3/25/23 with abdominal pain and was admitted to the hospital. She had surgery and was admitted to ICU on 3/26/23. She was started on CVVH on 3/28/23 at 4:50 pm and this continued until 3/31/23 at 1:11 pm. No notes regarding the set up of the dialysis machine, when the filter was changed, or if the filter was changed by the HD techs could be found in the record.

During a concurrent interview and record review on 4/5/23 at 3:45 pm, the OND confirmed there were no hemodialysis notes regarding the CVVH dialysis in this patient's record. As a result, it cannot be determined if or when the machine's filter was changed by the HD tech.

9. During an observation of the HD room on the 4th floor on 4/6/23 at 10:30 am, the dialysis machine was within two feet from a large three tier medical supply cart full of supplies, some of which were opened. On 4/5/23 at 11 am, Patient 2 was observed receiving his dialysis in this spot.

During an interview on 4/6/23 at 10:30 am, HDT 5 confirmed the dialysis machine and treatment area was too close to the supply cart and was in the "splash zone" (could be splashed with blood).

10. During an observation on 4/6/23 at 10:30, Patient 29 was receiving dialysis in the 4th floor dialysis area. During a concurrent interview and record review at this time, HDT 5 confirmed the HD treatment started at 10:19 am. HDT 5 said the Telehealth RN checks the machine and solution prior to her connecting the patient and then verified treatment within 30 minutes. At 10:56 am Teleheath RN 2 confirmed she was unable to verify treatment started within 30 minutes because she was having connection difficulty.



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11. A review of Patient 26's record indicated he was admitted to the hospital on 3/24/23 with diagnoses that included chronic kidney disease and dialysis was needed. On 4/3/23, Patient 26's record indicated a dialysis procedure was performed that started at 5:13 pm and ended at 8:49 pm.

On 4/3/23 at 4 pm, during an observation and a concurrent interview with HDT 3, Patient 26 was brought to the dialysis treatment room in his bed. During discussion with HDT 3, she explained that Patient 26's bed-scale was broken, so his pre-dialysis weight would be copied from his hospital medical record reflecting a standing scale morning weight obtained on the unit. The post-dialysis weight would be calculated based on the fluid balance from his dialysis procedure. HDT 3 explained she had been an HDT for many years and had been trained on how to accurately calculate the post weight using this method.

A review of Patient 26's hemodialysis flowsheet, dated 4/3/23, indicated a pre-dialysis weight of 92.8 kilograms and a post-dialysis weight of 90.3 kilograms. Documentation on the flowsheet was reviewed for any indication of the methods used for the pre and post weights. No such documentation was found.

On 4/4/23 at 12 pm, during an interview, the Dialysis Vendor Nephrologist CEO, (DV2-CEO) stated the accuracy of pre and post dialysis weights was very important. He would expect that a dialysis patient in a bed with a broken bed-scale should be moved to a bed that was working. If an exception was to be made regarding calculation of a post weight instead of weighing the patient, this call should be made by the nephrologist and he would expect narrative documentation on the hemodialysis flowsheet to reflect this variance. DV2-CEO explained it would not be possible to evaluate differences in weights from procedure to procedure without taking into consideration the methods used, which was not normal procedure.

On 4/4/23 at 4:30 pm during an interview, the CNO stated a dialysis patient should absolutely never be placed in a bed with a broken bed-scale.

12. A review of Patient 40's record indicated she was admitted to the hospital on 3/29/23 with diagnoses that included end stage renal disease. The record indicated Patient 40 had been receiving dialysis treatments for the past three weeks prior to her admission which would be continued during her hospital stay. The records indicated Patient 40 had a lengthy dialysis procedure that started on 4/3/23 at 10:10 am.

On 4/3/23 at 3:30 pm during observations and concurrent interview, HDT 3 explained coordination with the telehealth HDRN for dialysis procedures. There was a computer tablet on a stand nearby. HDT 3 explained the computer tablet capabilities included video and a stethoscope accessory so the HDRN was able to hear lung sounds exactly as if she was in the room. When asked whether the nurse always used the video function and/or the stethoscope. HDT 3 replied that it depended on the nurse. Some nurses liked to use the video and others did not. There was one nurse that never used it and HDT 3 did not know what that nurse looked like. Regarding use of the stethoscope, HDT 3 explained it was sometimes used and sometimes not. Regarding how the HDRN completed the patient assessment without using these items; HDT explained the nurse spoke with the patient's floor nurse. HDT 3 went on to explain that the computer tablet had not been working today, so she and the nurse did everything by telephone for her patient (Patient 40 on 4/3/23 at 10:10 am).

The DV 2 policy and procedure titled, Pre-Assessment and Data Collection in Acute Dialysis Services, indicated the purpose of the policy was to determine if acute patients were fit to begin dialysis treatment. Patient must have a pre-assessment by an RN and data collection by HDT before dialysis treatment was intimated to confirm that the patient's condition was not materially different from the time when the dialysis orders were written. The pre-assessment and data collection included ambulatory status, apical pulse, blood pressure - sitting and standing (if patient was able), breath sounds, bruising or bleeding, edema, gastrointestinal issues, neurological issues, pain respirations, skin color, temperature, vascular access, pre-dialysis weight. Document all assessment and data collection findings in electronic record. Bedside Pre-assessment screen. Do not initiate dialysis until a pre-dialysis assessment has been performed.

On 4/4/23 at 12 pm, the DV2-CEO explained that the idea was that use of the video computer tablet and accessory stethoscope functions would mirror as close as possible to a nurse being in the room. Without this functionality, the HDRN would not be able to complete an assessment. The expectation was for the nurse to, every time, visualize the patient, interact with the patient, observe the patients skin tone, status of any edema, listen to lung and bowel sounds, review the vital signs, and other requirements outlined in DV 2 policies and procedures. Visualization of the machine to verify settings and other parameters was also required. DV2-CEO was not aware the video function was not being utilized as required. DV2-CEO confirmed staff should not proceed with the dialysis procedure until all required assessments and verifications had been completed.

On 4/4/23 at 4:30 pm, during an interview, CNO explained the HDRN was required to always use the video function and stethoscope attachment during patient assessments and to check all the connections and visualize the machine to ensure that all settings are correct. When asked what should happen if the computer tablet was not functioning properly and could not be used, CNO stated staff should not proceed with the dialysis procedure until all required assessments and verifications had been completed. The hospital nurses were not trained so could not provide these services. The hospital nephrologists would be the only persons qualified to complete the checks normally done by the HDRN.

13. On 4/4/23 at 4:30 pm, during an interview, the CNO confirmed there was no auditing/monitoring in place to verify the new system of care utilizing a telehealth RN (providing care for dialysis patients and oversight for HDTs performing the procedure). Furthermore, the CNO was not aware of staff to patient ratios being maintained by DV 2 with the telehealth HDRN, nor what the requirements were. CNO was not aware whether or not the ratio was related to patient acuity, but acknowledged there would be situations where that was important. CNO was not aware that the HDRN was overseeing patients in other facilities simultaneous with providing services in this hospital. CNO explained the HDRN had access to the hospital's electronic health records (EMRs) as read only, so they were able to review patient data. CNO was not aware of any training provided to the HDRN staff on how to navigate the hospital's EMR.

On 4/5/23 at 11:15 am, during a telephone interview, HDRN 1 was asked about the details of her current assignment for oversight of dialysis procedures. During the discussion HDRN 1 explained she was currently responsible for nine different patients (receiving dialysis at this time) located in nine different facilities located in five different states. When asked about how many patients were populated on her computer screen, HDRN 1 explained could see one patient at a time on the screen. HDRN 1 timed how long it took switch to a different patient's information, which was approximately 20 seconds. HDRN 1 explained nurse to patient ratios were not to exceed 1 nurse to 12 patients. HDRN 1 explained she was the only nurse with patients at the time, but there was always an on call nurse for back up if needed. When asked who was the nursing manager for the company, HDRN 1 explained she had recently been appointment as the lead nurse for the west coast, but her duties had not changed yet. HDRN 1 explained the company used to have an RN in the management position which was some time ago, but the current manager had an extensive HDT background. HDRN 1 had an extensive background in dialysis nursing care and explained all the nurses she works with did as well. HDRN 1 was asked about how she learns to use so many different EMR systems, and how she is trained. HDRN 1 explained she did not get hospital specific navigation training. There were multiple different systems and it could be a challenge to navigate throughout them. Furthermore, even when the same system was used, navigation to find similar information was often very different. HDRN 1 was asked about training on hospital policies, she had not received any training from the hospital.

The DV 2 policy titled, Patient Verification and Machine Check Pre-Acute Dialysis Treatment. The purpose of the policy was to reliably identify the patient as the person for whom the service or dialysis tr

Based on interview and record review the facility failed to ensure that Patient 6's medical record was complete, in written or electronic form, when the hospital was unable to provide the following telemetry monitoring (a portable device connected to the patient that measures the hearts electrical activity to continuously track heart rate and rhythm) records for Patient 6: A Full Disclosure Telemetry Report (a second-by-second continuous telemetry monitor report of a patient's heart rate and rhythm) and Telemetry Monitor Event Strips (a snap shot of the telemetry monitor record that captures an irregular heart rate, irregular heart rhythm, or disconnected telemetry leads related to an adverse event). This failure resulted in Patient 6's medical record having no evidence of disconnected telemetry monitoring that occurred during his elopement, thereby being incomplete and inaccurate.

Findings:

A review of the hospital's policy and procedure titled, "Telemetry Monitoring: Application of and Care and Assessment of the Patient Monitor", revised 6/22, indicated that the policy's purpose was to provide a guideline for nursing staff on the care and monitoring of the patient on a telemetry monitor. The telemetry technician's duties included, to monitor the patient's rhythm at all times and document and notify the nurse "IMMEDIATELY" of any poor quality, interrupted, or disconnected telemetry signal. The patient's primary care Registered Nurse (RN) duties included, to "assess PROMPTLY" and the integrity of the leads, wires, and battery status upon notification by the technician of any equipment dysfunction, and perform a prompt assessment of the patient at a change of condition.

During a concurrent interview and record review on 3/30/23, at 11:58 am, telemetry technician (TT, a technician responsible for independently observing and interpreting a patient's heart rate and rhythm) 2 verified that Patient 6 was assigned to Tele room #23 and placed on Tele unit #10, for continuous telemetry monitoring, on 3/12/23, at 7:59 pm. TT 2 was asked to retrieve a complete copy of Patient 6's Full Disclosure Telemetry Report and Tele Monitor Event Strips that were uploaded to Patient 6's electronic health record (EHR) from Mindray (the facility's telemetry Monitoring database). This request was made to identify the exact date and time that Patient 6 disconnected himself from the Telemetry monitor, pulled out two intravenous catheters, and eloped down the facility's 4th floor stairwell to the facility's 2nd floor. TT 2 reported there was no evidence of telemetry monitoring data or a patient history in Mindray for Patient 6. TT 2 further demonstrated that she could successfully retrieve full disclosure reports for two other patients that were connected to continuous telemetry monitoring on 3/12/23, but Patient 6's telemetry data could not be located.

On 3/30/23, at 1:58 pm, a records request was made to the facility's Ortho/Neuro Director (OND), who was filling in for the Director of Performance Improvement (DPI), for a complete copy of Patient 6's Full Disclosure Telemetry Report (a second-by-second continuous telemetry monitor report of a patient's heart rate and rhythm), and Telemetry Monitor Event Strips, dated 3/12/23, the night Patient 6 eloped from the telemetry unit. OND provided all of Patient 6's telemetry monitor strips that were uploaded to the EHR. The medical record did not contain telemetry event strips that documented Patient 6 disconnected himself from the telemetry monitor prior to eloping. OND reported that Patient 6's medical record did not have any incident reports or public safety officer reports that indicated Patient 6 eloped from the telemetry unit.

On 4/3/23, at 2:23 pm, a records request was made to the facility's HIPAA Officer (HO) for a complete legal record of Patient 6's telemetry monitor strips during his inpatient stay at the facility from 3/12/23 to 3/19/23. HO retrieved the requested records and confirmed they constituted a complete legal record that would be provided on legal subpoena. Patient 6's records consisted of 26 telemetry strips, that were routinely printed every six hours, per facility policy, to document telemetry monitoring at the time of admit, 12:00 am, 6:00 am, 12:00 pm, 6:00 pm. Patient 6's medical record did not include any telemetry strips that documented disconnection from the telemetry monitor or a change of condition during his elopement.

During a concurrent interview and record review on 4/4/23, at 2:34 pm, TT 2 stated he had worked as a certified TT at the facility for over 20 years and acted as a preceptor for new TT staff. TT 1 stated he and the facility's information technology specialist (IT) attempted to retrieve a Full Disclosure Telemetry Report but the system indicated that a complete telemetry history did not exist for Patient 6. TT 1 stated this was very unusual because he and IT were able to retrieve Full Disclosure Telemetry Reports on three randomly selected telemetry patients that were being monitored during the same time period. TT 1 verified that the only telemetry monitoring strips uploaded to Patient 6's EHR were the standard 6-hour strips (routine telemetry strips that are printed at 6:00 am, 12:00 pm, 6:00 pm, and 12:00 am). Patient 6's medical record had no evidence of telemetry strips that captured a disconnected unit during Patient 6's attempted elopement, or record of the time the telemetry unit was reconnected to Patient 6 when he returned to the unit after his elopement. TT 1 confirmed that TT's are expected to print out telemetry monitoring strips to document disconnection during an adverse event, such as elopement. These strips become part of the patients' permanent medical record.

Based on observation, interviews and document reviews the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. The hospital pharmacy failed to optimize medication therapy when multiple hospital nurses administered subcutaneous insulin in error. The nurses did not administer the subcutaneous insulin in accordance to hospital protocol and physicians orders which resulted in eleven medication errors out of twenty six administrations of a high-alert medication-insulin. (See A490)

2. The hospital did not update the content list on the outside of 30 emergency crash carts. The medications on the list did not correspond to the medications inside the cart. (See A500)

3. The hospital stored multiple medications (Iodixanol, 2% Lidocaine with Epinephrine, 1% Lidocaine with Epinephrine, Iohexol and Nitroglycerin) in direct light. The manufacturer requires that these medications be protected from light. (See A500)

4. The sterile compounding pharmacy technician failed to adhere to hospital policy for hand hygiene when the compounding pharmacy technician did not remove debris from under the fingernails, using a nail cleaner under running warm water. (See A501)

5. The hospital failed to implement hospital policy when Physician 1 conducted an Apnea Test in order to determine brain death five hours and thirteen minutes after completing intravenous (IV) continuous dose of Fentanyl and Propofol. (See A885)

6. The hospital failed to date an opened vial of Epinephrine Injection in the pharmacy. The manufacturer requires that you discard 30 days after the initial use. (See A505)

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

Based on interview and document review the hospital pharmacy failed to optimize medication therapy when multiple hospital nurses administered subcutaneous regular insulin (medication to treat diabetes) in error. The nurses did not administer the subcutaneous regular insulin in accordance to hospital protocol and physicians orders which resulted in eleven medication errors out of twenty six administrations of a high-alert medication-insulin.

Findings:

A review of the American Society of Health-System Pharmacists, national recognized pharmacy professional organization, in the entitled document ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals "Standard III. Optimizing Medication Therapy ...An important responsibility of the pharmacist is optimizing medication use. Pharmacist, in collaboration with medical and nursing staff, shall develop policies and procedures based on demonstrated best practices for ensuring the quality of medication therapy. Clinical imperatives should be primary determinants of medication -use decisions."

A review on 4/5/23 of the hospital policy dated 7/21 entitled High Alert Medications indicated "High-Alert medications bear a heightened risk for causing significant patient harm when they are used in error ...It is the responsibility of the Director of Pharmacy (DOP) to ensure compliance ...Identified high alert medications used ...include Insulin ...Insulin is to be independently double-checked by a second nurse when a dose is prepared for administration ..."

A review on 4/5/23 of Patient 21's clinical record indicated Patient 21 was 70 years old and had a diagnosis for diabetes mellitus and was on subcutaneous regular insulin in the cardiac intensive care unit (CICU). Physician 1 had written orders for subcutaneous insulin per protocol every six hours on 3/16/23/ at 7:17 pm.

During an interview Registered Nurse (RN) 19 stated that they used the Insulin Adjustment Tool when dosing for per insulin protocol. The Insulin Adjustment Tool had two sections to calculate the appropriate insulin dose. One section was for the nutritional dose which was used when a patient was eating by mouth; or calories were taken in via enteral or intravenous means. The nutritional dose was based on grams of carbohydrates consumed. The other section was a correctional dose, the correctional dose utilized the blood sugars in order to determine the dose of insulin. The nutritional dose was then added to the correctional dose and this would be the dose that was to be administered to the patient.

The following fourteen paragraphs are the errors that were identified during a review of Patient 21's record.

1. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/5/23 at 2:37 am that Patient 21 consumed 50 gm of carbohydrate and using the nutritional dose calculation from the Insulin Adjustment Tool the nutritional dose was 10 unit of Insulin. What was actually administered by RN 13 was 9 units. The 9 units was also double checked by RN 14.

2. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/5/23 at 2:37 am that Patient 21 consumed 50 gm of carbohydrate and using the nutritional dose calculation from the Insulin Adjustment Tool the nutritional dose was 10 unit of Insulin. What was actually administered by RN 10 was 9 units. The 9 units was also double checked by RN 11.

3. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/4/23 at 8:11 am that Patient 21 consumed 50 gm of carbohydrate and using the nutritional dose calculation from the Insulin Adjustment Tool the nutritional dose was 10 unit of Insulin. What was actually administered by RN 6 was 9 units. The 9 units was also double checked by RN 21. During an interview RN 6 stated that she had calculate the dose increase at 9.95 and she decided to round down to 9 units.

4. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/3/23 at 2:16 pm that Patient 21 consumed 50 gm of carbohydrate and using the nutritional dose calculation from the Insulin Adjustment Tool the nutritional dose was 10 unit of Insulin. What was actually administered by RN 6 was 9 units. The 9 units was also double checked by RN 22. During an interview RN 6 stated that she had calculate the dose increase at 9.95 and she decided to round down to 9 units.

5. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/3/23 at 8:53 am that Patient 21 consumed 50 gm of carbohydrate and using the nutritional dose calculation from the Insulin Adjustment Tool the nutritional dose was 10 unit of Insulin. What was actually administered by RN 6 was 9 units. The 9 units was also double checked by RN 22. During an interview RN 6 stated that she had calculate the dose increase at 9.95 and she decided to round down to 9 units.

6. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/2/23 at 2:45 pm that Patient 21 consumed 50 gm of carbohydrate and using the nutritional dose calculation from the Insulin Adjustment Tool the nutritional dose was 6 unit of Insulin. What was actually administered by RN 6 was 9 units. The 9 units was also double checked by RN 5.

7. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 3/31/23 at 2:23 am that Patient 21 consumed 50 gm of carbohydrate and using the nutritional dose calculation from the Insulin Adjustment Tool the nutritional dose was 0 unit of Insulin. What was actually administered by RN 8 was 5 units. The 5 units was also double checked by RN 9.

8. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 3/30/23 at 9:28 pm that Patient 21 consumed 0 gm of carbohydrate and using the nutritional dose calculation from the Insulin Adjustment Tool the nutritional dose was 0 unit of Insulin. What was actually administered by RN 8 was 6 units. The 5 units was also double checked by RN 15.

9. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 3/29/23 at 9:56 AM that Patient 21 consumed 49 gm of carbohydrate and using the nutritional dose calculation from the Insulin Adjustment Tool the nutritional dose was 5 unit of Insulin. What was actually administered by RN 10 was 3 units. The 5 units was also double checked by RN 16.

10. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/5/23 at 2:37 am a blood sugar of 141 mg/dl and using the correction dose calculation from the Insulin Adjustment Tool the correctional dose was to administer 1 unit of Insulin. What was actually administered by RN 10 was 0 units. This dose was double checked by RN 11.

11. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/3/23 at 8:53 am a blood sugar of 173 mg/dl and using the correction dose calculation from the Insulin Adjustment Tool the correctional dose was to administer 3 unit of Insulin. What was actually administered by RN 2 was 7 units. This dose was double checked by RN 22.

12. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/2/23 at 2:45 pm a blood sugar of 221 mg/dl and using the correction dose calculation from the Insulin Adjustment Tool the correctional dose was to administer 5 unit of Insulin. What was actually administered by RN 6 was 7 units. This dose was double checked by RN 5.

13. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 3/28/23 at 8:36 pm a blood sugar of 147 and using the correction dose calculation from the Insulin Adjustment Tool the correctional dose was to administer 3 unit of Insulin. What was actually administered by RN 10 was 2 units. The dose was double checked by RN 12.

14. A review on 4/5/23 of Patient 21's clinical record, via the insulin tracking log, indicated on 4/1/23 at 3:26 pm that Patient 21 was administered a total dose of 12 units of Insulin by RN 17 and the dose was double checked by RN 18. The combined calculated dose of the nutritional and correction dose was 6 units of Insulin.

The above fourteen paragraphs indicated there were multiple errors by multiple different nurses.

During an interview on 4/6/23 at 9:45 am, the Critical Care Director stated that the errors on 4/2/23 at 2:45 pm; 3/31/23 at 2:23 am; and 3/30/23 at 9:28 pm were most likely documentation errors. She also stated that they still could be medication error but most likely documentation errors. She said that she was very concerned about the remaining medication errors and the nurses needed to slow down and make sure they are making accurate calculations when dosing insulin.

During an interview on 4/6/23 at 9:45 am the DOP stated that the errors were very concerning and there were multiple opportunities for improvement. He also stated that and agreed that the calculations needed to be optimized in order to reduce calculation errors.

There were multiple registered nurses that incorrectly calculated the hospital protocol dose which resulted in eleven medication errors out of twenty six insulin administrations. 42% of the insulin administration were erroneously calculated.

Based on observation, interview, and record review the hospital failed to control medications in accordance to professional standards of practice as evidence by:

1. The hospital stored multiple medications (Iodixanol, 2% Lidocaine with Epinephrine, 1% Lidocaine with Epinephrine, Iohexol and Nitroglycerin) in direct light. The manufacturer requires that these medications be protected from light.

2. The hospital did not update the content list on the outside of the emergency crash carts. The medications on the list did not correspond to the medications inside the cart.

Findings:

1. A review on 4/3/23 of the hospital policy entitled Storage of Non-Patient Specific Medications indicated "Light sensitive preparations shall be protected from direct exposure to light. Such preparations, if not manufactured in ultraviolet inhabitant packaging, shall not be stored with direct exposure to fluorescent lighting.

During an observation on 4/3/23 at 1:59 pm, there were eight 20 ml vials of 2% Lidocaine and Epinephrine (medication used for local anesthesia) under direct light on a pharmacy shelf. The eight 20 ml vials were uncovered and were under direct light. On each labeled vial, the label indicated protect from light.

During an observation on 4/3/23 at 2:00 pm, there were fifteen 20 ml vials of 1% Lidocaine with Epinephrine under direct light on a pharmacy shelf. The fifteen 20 ml vials were uncovered and were under direct light. On each labeled vial, the label indicated protect from light.

During an observation on 4/3/23 at 2:15 pm, there were twenty 200 ml vials of Iodixanol (medication used for imaging studies) under direct light on a pharmacy shelf. The twenty 200 ml vials were uncovered and were under direct light. On each labeled vial, the label indicated protect from light.

During an observation on 4/5/23 at 8:48 am, there were three bottles of 500 ml Iohexol and one bottle of Nitroglycerin 250 ml in the emergency medication storage room that were under direct light. The three bottles of 500 ml Iohexol and one bottle of Nitroglycerin 250 ml were under direct light. On the labeling of the bottles the label indicated protect from light.
A review of the manufactures' insert for 2% Lidocaine with Epinephrine, 1% Lidocaine with Epinephrine, Iodixanol, Iohexol, and Nitroglycerin indicated that the medications should not be stored under light. All the manufactures indicated "protect from light".

During an interview on 4/3/23 at 2:15 pm the Director of Pharmacy (DOP) stated that he was not aware that the above mentioned medications were stored under direct light. He said that he would have the above mentioned medications under an amber cover which would protect the medications from light.

2. During an observation on 4/3/23 at 3:11 pm, there was an emergency crash cart in the CT 128 room and there was a content list, a list which indicated what medications were stored in the crash cart, on the outside of the cart. The following medications did not correspond with what was found inside the cart:
*2 Dextrose 50% on the list and none was found inside the cart
*2 Flumazenil 0.1 mg/ml 5 ml vial on the list and 1 found in the cart
*1 Lidocaine 2gm/250 ml on the list and none was found inside the cart
*2 Etomidate 2mg/ml 20 ml vial and 1 was found inside the cart

During an observation on 4/3/23 at 3:15 pm, there was an emergency crash cart in the CT 16 slice room and there was a content list on the outside of the cart. The following medications did not correspond with what was found inside the cart:
*2 Dextrose 50% on the list and none was found inside the cart
*2 Flumazenil 0.1 mg/ml 5 ml vial on the list and 1 found in the cart
*1 Lidocaine 2gm/250 ml on the list and none was found inside the cart
*2 Etomidate 2mg/ml 20 ml vial and 1 was found inside the cart

During an observation on 4/3/23 at 3:18 pm, there was an emergency crash cart in the Stress Cardiac Lab room and there was a content list on the outside of the cart. The following medications did not correspond with what was found inside the cart:
*2 Dextrose 50% on the list and none was found inside the cart
*2 Flumazenil 0.1 mg/ml 5 ml vial on the list and 1 found in the cart
*1 Lidocaine 2gm/250 ml on the list and none was found inside the cart
*2 Etomidate 2mg/ml 20 ml vial and 1 was found inside the cart

During an interview on 4/3/23 at 3:30 pm the DOP stated that all the carts (approximately 30 carts) did not have the correct content list on the outside of the cart. He said that the content lists would be updated and placed on the outside of the carts.

Based on observation and interview the sterile compounding pharmacy technician failed to adhere to hospital policy for hand hygiene when the compounding pharmacy technician did not remove debris from under the fingernails, using a nail cleaner under running warm water in accordance to hospital policy.

Findings:

A review on 4/3/23 of the hospital policy entitled IV (Intravenous-given directly into a vein) Admixture indicated under Personnel Cleansing and Garbing "A hand cleansing procedure shall be performed by removing debris from under the fingernails, using a nail cleaner under running warm water followed by vigorous hand washing. Hands and forearms are to be washed to the elbow for at least 30 seconds for soap (either antimicrobial or non-antimicrobial is ok) and water while in the ante room area ..."

During an observation on 4/3/23 at 1:35 pm Pharmacy Technician 1 (Tech 1) was washing his hands, prior to entering the clean room to demonstrate sterile compounding, he did not remove debris from under the fingernails using a nail cleaner under running warm water as required by hospital policy.

During an interview on 4/3/23 at 1:40 pm Tech 1 stated that he did not clean under his nails prior to entering the clean room to demonstrate sterile compounding. Tech 1 said that he did it earlier in the day but did not clean under his nails during the demonstration.

Based on observation, interview, and record review the hospital failed to date an opened vial of Epinephrine Injection in the pharmacy dispensing stock. The manufacturer requires that you discard 30 days after the initial use the vial of Epinephrine.

Findings:

During an observation on 4/3/23 at 2:05 pm, in the pharmacy there was a 30 ml vial of Epinephrine that was about ¾ empty. 75% of the medications inside the vial was gone and 25% was still available for use. The box for the 30 ml vial of Epinephrine indicated "discard 30 days after initial use" and there was an area to date when to discard, which was supposed to be written in by the individual who first opened the vial. The area to date was blank.

A review on 4/3/23 of the manufacturer insert of Epinephrine indicated that the medications was to be diluted before intravenous infusion and that the vial should be discarded 30 days after initial use. It also indicated that the vial should be dated with the new expiration date once it is opened.

During an interview on 4/3/23 at 2:10 pm the Director of Pharmacy (DOP) stated that he was not aware of the undated vial of Epinephrine and said he would have it discarded right away.

Based on observation, interview, and record review the facility failed to ensure:

1. The organizational structure of the Food and Nutrition Services was not consistent with Title 22 requirements. Refer to A 619

2. The Food Service Manager had critical systems in place when there was no system to identify food allergens, no effective system in place to maintain a sanitary kitchen and its equipment, no effective staff training program, no evidence the Food Services (kitchen/production) department participated in Quality Assurance/Performance Improvement (QAPI) activities, and the Food and Nutrition Services Emergency Food Plan was not fully developed or integrated into the hospital-wide disaster plan. Refer to A 620 Findings 1 through 5, Refer to A 750 Findings 1 through 6, and A 273 Finding 5.

3. Staff competencies for five out of five Food Service Worker (FSW) staff members. Refer to A 622

4. The menus met nutritional needs and the current standard of practice. Refer to A 629

The cumulative effect of these systemic problems resulted in failure to ensure food and dietetic services were provided in a safe and effective manner.

Based on observation, interview, and record review the organizational structure of the Food and Nutrition Services was not consistent with professional standards of practice when the Clinical Nutrition Manager (CNM) was supervised by the Certified Dietary Manager/Food Service Manager (CDM/FSM). The CDM/FSM completed performance appraisals for the CNM when he was not qualified to evaluate the professional skills of a Registered Dietitian. If the Director of the Department is not a Registered Dietitian, the Dietitian will have a peer relationship, not a subordinate relationship with the CDM/FSM. It's the responsibility of the Registered Dietitian to provide guidance and oversight to the CDM/FSM.

This failure had the potential to result in inadequate oversight of the Food and Nutrition Services food safety and sanitation practices, inadequate or ineffective staff training and competency, and gaps in the adequacy of nutrition provided to patients.

Findings:

Dietary Services is defined as the provision of food and drink to patients in accordance with a physician's order (LawInsider, 2023). A Registered Dietitian/Nutritionist (RDN) is a health care professional educated in nutrition and foods who is able to translate scientific information into practical solutions. An RDN has completed a bachelors degree program, an accredited supervised practice program and has successfully completed a national exam (Academy of Nutrition and Dietetics). The RDN has a scope of practice in California law. In contrast the CDM expertise is managing foodservice operations and ensuring food safety, usually in a healthcare facility. They are responsible for implementation of menus, foodservice purchasing, and food preparation. The CDM does not have a scope of practice in California Law.

With respect to dietary services, California Title 22 §70275 showed (a) "A registered dietitian shall be employed on a full-time, part-time or consulting basis ...services shall be provided on the premises ...(b) If a registered dietitian is not employed full time, a full-time person who meets the training requirements to be a dietetic services supervisor specified in section 1265.4 (b) of the Health and Safety Code shall be employed to be responsible for the operation of the food service." The operation of food service does not include the supervision or evaluation of a health care professional.

Review of California Health and Safety Code 1265.4 showed "(a) A licensed health facility ...shall employ a full-time, part-time or consulting dietitian. A health facility that employs a registered dietitian less than full time, shall also employ a full-time dietetic services supervisor who meets the requirements of subdivision (b) to supervise dietetic service operations. The dietetic services supervisor shall receive frequently scheduled consultation from a qualified dietitian."

Review of an untitled facility organizational chart, signed by the Chief Executive Officer (CEO) on 3/27/23 showed the Food Services Manager (FSM) reported to the CEO, and had a dotted line of responsibility to the Chief Nursing Officer (CNO). Review of an untitled, undated Food and Nutrition Services Department organizational chart showed the Clinical Nutrition Manager (CNM) reported to the FSM.

Review of the "Clinical Nutrition Manager 2 Position Profile (job description)" authored by the food service contract company, revision date 2/18, and no CNM signature, showed the CNM was to provide nutrition care for patients. Responsibilities included maintain client relationships and client satisfaction for nutrition care for patients, planning projects, communication, and execution of service quality. The responsibilities and duties of the CNM did not direct any responsibility for oversight of food services.

Review of the "GM 4, Food" Position Profile" (General manager/Food Services Manager, FSM job description), authored by the food service contract company, revision date 9/11, signed by the FSM 1/1/18, showed the position built new relationships and business opportunities to enhance profitability for the Company; upheld Company mission and values; developed business solutions for sustained growth and effective day-to-day operations. Responsibilities and duties included directing daily food service operations, maintaining sanitary and food safety conditions, adhering to regulations ...maintain kitchen and storage facilities to meet/exceed sanitary conditions, direct daily food service operations including menu evaluation and planning ...food preparation and storage ...monitor internal quality assurance and food safety audit processes.

During multiple observations, interviews and record reviews beginning 4/3/23 at 8:40 pm, concerns were identified in the Food and Nutrition Services Department with a lack of food safety and sanitation systems and practices in the kitchen (Cross Reference A620, A750); staff training and competency in crucial food safety practices such as food cooling, warewashing, cleaning fixed equipment (equipment that cannot go through a dishwasher or sink), and labeling and dating food (Cross Reference A622); An emergency food menu and plan was not in place and was not integrated into the hospital disaster plan (Cross Reference A 620); patient menus and nutrient analysis did not meet the needs of the hospital defined demographics (Cross Reference A629); Departmental QAPI (Quality Assurance Performance Improvement) was not evident for the kitchen food services, and there was no evidence either food services or clinical nutrition QAPI was integrated into the hospital wide QAPI program (Cross Reference A263).

During an interview with the Clinical Nutrition Manager (CNM) on 4/3/23 at 10:00 pm he stated he had worked at the facility for six years, as the CNM for the past 2 years, and his direct supervisor was the Food Service Manager (FSM). The FSM did his performance evaluations, and he (CNM) did the performance evaluations for the other dietitians. He stated either he or another dietitian provided in-services for the kitchen staff but there was no set schedule as to when that occurred. The CNM stated he occasionally observed patient tray line (meal tray assembly process), but there was no set schedule. He helped with policies and procedures, did occasional in-services, and ordered tube feeding products. The CNM stated he provided no oversight of the overall function of the kitchen - that was the FSM's job.

During an interview with the Chief Executive Officer (CEO) on 4/4/23 at 1:35 pm he confirmed the FSM reported to him, they met every three months, they discussed the quarterly formal reports the FSM submitted to him. He stated the FSM's boss from the contracted food services company also came quarterly to meet with him, but they did not keep records.

Review of a food service contractor company document titled "Aspire year-end reflection" with review period 9/1/21 - 8/31/22 for the CNM showed a self-evaluation and a "Reflect on the year" self- and manager- evaluation. Topics included "How often did you perform the recurrent aspects of the job competently and thoroughly with minimum supervision? How often did you develop the competencies identified for your current role? Ratings were consistently "Always" with one instance of "Always and above expectations" from the FSM. The FSM was not qualified to evaluate the CNM's performance and competency in clinical nutrition and patient care.

Based on dietary staff observations, dietary staff interview and departmental document review the hospital failed to ensure the Food Service Manager (FSM) had critical systems in place when:

1. There was no system to identify food allergens to protect patients with food allergies.

2. There was not an effective system in place to ensure the kitchen and its equipment were maintained sanitary according to professional standards of practice. (Cross Reference A-750).

3. There was not an effective staff training program which included verification of staff competency for 5 of 5 Food Service Workers (FSW) interviewed (FSW2, FSW3, FSW4, FSW5, and FSW8) (Cross Reference A622).

4. There was no evidence the Food Services (kitchen/production) department participated in Quality Assurance/Performance Improvement (QAPI) activities, or that Food Services or Clinical Nutrition Services topics were included in hospital wide QAPI processes (Cross Reference A263).

5. The Food and Nutrition Services Emergency Food Plan was not fully developed or integrated into the hospital-wide disaster plan.

These failures had the potential to compromise the medical status of patients through allergic reactions, foodborne illness or food contamination, and not meeting the needs of patients or the facility during a disaster.

Findings:

1. There was no system to identify food allergens to protect patients with food allergies.

Based on the risks inherent to the food operation, it is important that the person in charge shall demonstrate knowledge of foodborne disease prevention, application of the hazard analysis and critical control point principles, and describing foods identified as major food allergens and the symptoms that a major food allergen could cause in a sensitive individual who has an allergic reaction as well as developing a comprehensive system that can identify allergens in items offered for meal service (Food Code, 2022).

During initial tour on 4/3/23 beginning at 8:40 am, it was noted there were multiple unlabeled clear plastic bags of frozen food in the grill freezer that were opened and unlabeled. In a concurrent interview the Food Service Manager (FSM) identified the items as chicken tenders and chicken fried steak. The FSM acknowledged the items should have been labeled using the department's preparation and print machine. The Surveyor asked the FSM to describe the system for tracking allergens which may be present in these convenience items as they were removed from the cardboard box which listed ingredients. The FSM currently stated the only way to identify potential allergens was if there was backstock of the product in the main freezer. The FSM acknowledged this system was not comprehensive and was dependent on in-house product availability.

Review of the personnel file of the Certified Dietary Manager (CDM) showed a training certificate titled "Managing Food Allergens & Gluten in a Commercial Setting," with expiration date 10/12/27, yet this expertise was not being utilized by the department.

2. There was not an effective system to ensure the kitchen and its equipment were maintained sanitary according to professional standards of practice. (Cross Reference A750).

During observations in the kitchen beginning on 4/3/23 at 8:40 am, there was a buildup of grime and/or a gray substance resembling dust on many pieces of equipment including refrigerators, ovens, mixer, meat slicer, can opener, ice bucket, bulk food bins, fans, food prep counters, drawers, shelves, backsplashes, the exposed back sides of food prep counter units, and metal bake/food storage pans. Cardboard dispensers of foil and plastic wrap on the cooks' food prep counters were soiled with grease and food splatter, and plastic food storage containers were stacked wet.

During an interview on 4/3/23 beginning at 10:50 am, the FSM indicated there was a cleaning log. He also stated individual employees were responsible for cleaning their work areas, and while there was a "cleaning position," when other food service staff called in sick or were on leave the employee responsible for cleaning was pulled to cover other duties. The FSM added he had not approached the contracted Vendor or the hospital for additional staff positions to maintain the physical environment. Concurrent review of departmental document titled "Weekly Cleaning Log" revealed the daily cleaning task consisted of one piece of equipment. As an example, on Monday's the coffee machine was scheduled for cleaning. The remaining weekdays had additional pieces of equipment. There was no cleaning scheduled for weekends. It was also noted the most recent completed cleaning schedule was dated July 2021. Review of departmental schedule dated 3/24-4/6/23 revealed that except for one eight-hour stock position on Tuesdays and Fridays there was no designated cleaning position on the schedule.

During a document review and concurrent interview with the Executive Chef (EC) on 4/3/23 at 3:05 pm he also showed the last completed "Weekly Cleaning Log" dated July 2021, and stated "we just got off track with it."

During an interview with the Clinical Nutrition Manager (CNM) on 4/3/23 at 10:14 am he stated he did not provide oversight of the overall function of the kitchen, and that oversight was more the responsibility of the FSM.

Review of a policy titled Cleaning Schedules, dated 9/19 showed "Each area of Food and Nutrition Services is involved in routine cleaning and sanitation. Assignments are daily, weekly and by special request."

Review of a policy titled Sanitation Inspections, dated 9/19 showed "Sanitation inspections are an ongoing process within Food and Nutrition Services ...All utensils, counters, shelves, and equipment shall be kept clean." "a) Sanitation Inspections: Analyze departmental sanitation systems and standards; Identify areas for special cleaning; Generate topics for employee in servicing." "b) Department Inspections Evaluate: Daily cleaning assignments; Weekly cleaning assignments; Special cleaning assignments." "c) Governmental Inspections Evaluate: Compliance with federal, state and local regulations."

3. There was not an effective staff training program which included verification of staff competency for 5 of 5 Food Service Workers interviewed (FSW2, FSW3, FSW4, FSW5, and FSW8) (Cross Reference A622), and staff's lack of competency in multiple areas was noted:

3a. Manual Warewashing

On 4/3/23 beginning at 3:05 pm, FSW 8 was observed washing dishes. It was noted each section of the 3-compartment sink was filled with detergent, water, and soiled cooking equipment. In a concurrent interview FSW 8 indicated he had worked for the hospital for 2 years and was soaking the dishes prior to placing in the dishwasher. The Surveyor asked FSW 8 to describe how dishes were washed should the dishwasher be broken. FSW 8 replied "I have no idea." FSW 8 indicated he had not been trained on a manual warewashing process.

In an interview on 4/3/23 at 3:35 pm, the FSM stated training was accomplished by giving employees informational training packets with an accompanying post-test. The FSM indicated employees were instructed to read the material and return the post-test. The FSM also indicated there were in-person trainings conducted by departmental leadership staff which included himself and the Clinical Nutrition Manager.

Review of in-service documents dated 9/29/22 revealed FSW 8 attended and was deemed competent in a training titled "Walk the Talk Topic of the Month: Washing Pots and Pans." The training also guided leadership to consider including a variety of interactive activities to demonstrate competency. While FSW 8 may have completed a post-test the hospital was unable to demonstrate competency.

3b. Cleaning fixed equipment

During observations in the kitchen beginning on 4/3/23 at 8:40 am the kitchen and its equipment were not sanitary. There was a buildup of grime, food particles and splatters, and a gray substance resembling dust on floors, counters, drawers, shelves, refrigerators, freezers, pans, mixer, can opener, knife sharpener and knife rack, ice bucket and more.

During interviews between 4/3/23 at 8:00 am and 4/4/23 at 5:00 pm regarding the process for cleaning fixed equipment, three out of three staff (FSW2, FSW4, FSW5) interviewed stated they used only sanitizer solution to clean fixed equipment (equipment that cannot be washed in the dishwasher or 3-compartment sink) and confirmed they did not wash fixed equipment with soapy water and rinse prior to sanitizing.

Review of the 2022 FDA Food Code 4-603.15, 4-603.16, 4-701.10 and 4-702.11 showed: equipment that cannot be cleaned in a sink or dishwasher shall be washed using detergents, have a distinct, separate rinse after washing so that abrasives and cleaning chemicals are removed, and then shall be sanitized before use after cleaning.

Review of in-service documents titled Walk the Talk, Sanitizing Food Contact Surfaces, dated March 2022, and Annual 2023 indicated "Cleaning means removing food and other types of soil from a surface. Sanitizing means reducing the number of harmful microorganisms on that surface to a safe level. When to sanitize: Clean, rinse and sanitize after each use, when beginning to work with a different type of food, when interrupted or when equipment you have been working with may have become contaminated." All three staff (FSW2, FSW4, FSW5) who were interviewed regarding the cleaning process signed into both in-services.

3c. Food Cooling was not conducted according to professional standards of practice.

During an observation of the walk-in refrigerator and freezer on 4/3/23 at 3:05 pm, five pans of previously cooked food were either expired and/or had incomplete cooling logs. The incomplete cooling logs either did not include the time food temperatures were checked, or they did not document a final temperature and time when the food reached the required 41°F (Farenheit) or less.

The 2022 FDA Food Code 3-501.14 showed cooked time/temperature control for safety food (TCS) shall be cooled: 1) Within two hours of cooking from 135°F to 70°F; and 2) Within a total of 6 hours from 135°F to 41°F or less. TCS foods prepared from ambient temperature foods (such as tuna salad or egg salad) shall be cooled to 41°F or less within four hours.

During an interview with the EC on 4/3/23 at 3:20 pm he stated it was his and the supervisor's responsibility to check the dates and cooling logs, to toss food as needed, and he usually tried to do that daily.

3d. Staff did not label and date food accurately.

During an observation in the walk-in refrigerator/freezer on 4/3/23 at 3:20 pm, four 2 ½ pound bags of previously frozen chicken were labeled showing they were pulled from the freezer on 3/31, should be used by 4/2, and therefore were expired. In a concurrent interview, the Executive Chef (EC) explained the cook selected the wrong chicken product in the labeling machine. He should have selected frozen chicken, but he selected a fresh chicken product, resulting in the wrong dating on the label. He stated they had five days (not three) from the pull date to use frozen/thawed chicken.

In an additional, concurrent observation in the walk-in refrigerator/freezer, five-pound chubs of thawing ground beef were also labeled pulled from the freezer on 3/31, with use-by date 4/2. The EC again stated the staff had selected the wrong fresh ground beef product instead of the frozen ground beef product in the labeling machine, the dates were not correct, and the product should have five days (not three) to be used.

During an observation and concurrent interview in the cold food prep area on 4/4/23 at 10:10 am, FSW3 was chopping onions. The counter held a package of pre-sliced onions with a facility received-on date 4/4/23, and a manufacturer's use-by date 4/6/23. There was a metal pan of sliced onions and a metal pan of chopped onions with facility labels that showed "Onions, chopped or sliced, with prepared-on date 04-04-23, and use-by date 04-09-23(three days later than the manufacturer's use-by date). When asked about the label dates on her pans of onions FSW3 stated the dates were automatically programmed into and generated from the labeling machine. "I print my sticker today, and it prints out to use it in three days." She had no recognition there was a problem when the facility use-by dates exceeded vendor use-by dates by three days.

During an observation and concurrent interview in the walk-in refrigerator/freezer on 4/4/23 at 10:20 am, the EC stated the onions should be used by the manufacturer's use-by date 4/6/23, and when product had a shorter than normal use-by date they needed to be labeled with a special sticker, not the labeling machine. The EC stated he needed to do staff training on the labeling and dating machine and the use of special dating stickers.

3e. Safe and Effective Use of Vegetable Wash - One staff (FSW2) was unable to correctly state the contact time required for vegetable wash, and the facility's "Weekly Antimicrobial Produce Wash Log" did not provide comprehensive guidance for staff who tested the wash to ensure safety and effectiveness.

During an observation of the food prep area on 4/3/23 at 8:45 am, a vegetable-wash product dispenser was noted near the cook's food preparation sink. In a concurrent interview, FSW2 described the process for using the vegetable wash, including a contact time of one minute. He stated they periodically tested the vegetable wash solution and had test strips, but he didn't know where they were.

In an additional concurrent interview and record review, the EC stated he had "certain people" who tested the vegetable wash solution daily. The "Weekly Antimicrobial Produce Wash Log" dated 4/3 - 4/9 showed "Testing Dilution Ratio Pass or Fail" with checkboxes for pass or fail. When asked what pass or fail meant, the EC stated, "the test strip is simply pass or fail."

Review of the manufacturer's instructions for the "Antimicrobial Fruit and Vegetable Treatment" posted on the wall near the dispenser directed testing for correct dilution before use and to match the test strip to the Color Chart to determine concentration. It also directed a minimum of 90 seconds contact time for produce to be in the solution. The "Test Strip Color Chart" on the instructions showed eight potential color/dilution ratios and indicated 1:170 to 1:128 as acceptable dilutions. A review of the test strip container showed three possible color/dilution ratios including zero, 1:512, and 1:258. It directed staff to match the test strip color, and "See product label for recommended concentrations."

The color dilution ratios on the wall instructions and on the test strip container did not match, and there was no guidance on the log to help staff identify the correct dilution values to use. Dilutions that were too strong could contaminate produce, and dilutions that were too week could potentially not clean the produce adequately. FSW 2 used the vegetable wash in the course of his work but did not know how to check the concentration of the vegetable wash, and did not know the correct contact time for the vegetable wash to be effective.

4. There was no evidence the Food Services (kitchen/production) department participated in Quality Assurance/Performance Improvement (QAPI) activities, or that Food Services or Clinical Nutrition Services topics were included in hospital wide QAPI processes (Cross Reference A263).

Review of a policy titled Performance Improvement (PI) Plan (Food and Nutrition Services Manual), dated 6/22 showed performance improvement should be taking place "To continually improve patient care through the implementation of a systematic program that identifies, evaluates, and resolves problems related to the delivery of appropriate and high-quality nutrition services." It should include evaluation of menus, department safe and sanitary condition, patient nutrition care, and more, and it should be "integrated with other areas of the hospital." It directed inclusion of systematic and relevant data collection and monitoring "for both priority issues needing improvement and as part of the continuing measurement of department activities." The "Systematic Monitoring Activities" listed multiple clinical nutrition topics but did not specify any kitchen food safety or sanitation topics. The policy further stated, "Processes are measured on a continuing basis and include those that: affect a large percentage of patients, place patients at serious risk if not performed well or in an appropriate manner and are likely to be problem-prone." The Nutrition Services kitchen provided food to a large percentage of residents and staff in the hospital, had the potential to cause foodborne illness to susceptible populations, was complex in its responsibilities to feed people, yet did not have QAPI processes in place or that were reported up through the organization.

The FSM was unable to provide evidence of current QAPI projects in the kitchen or that anything was being done with data collected.

During an interview with the CDM on 4/4/23 at 11:38 am, he stated the kitchen did not have any performance improvement initiatives in progress at that time. He stated data collected by the Registered Dietitian (RD) team regarding timeliness of nutrition assessments and reassessments, and meal tray accuracy went to the Food Services Contractor only. The CDM shared clinical nutrition performance improvement data regarding:

a. Nurses to obtain patient Height and Weight on admission which is "missed routinely" and showed compliance scores of 39% to 46% in January and February 2023 (higher is better). Height and weight values are important and necessary for nutrition assessment and care planning, medication dosing, identification of body fluid changes (dehydration or edema - undesirable loss or retention of fluid) and quality of care.

b. Percentage of (nutrition) supplement (recommendations) verified in MediTech (orders) by physicians. Compliance from 1/22 to 11/22 ranged 58% to 79%, with the last value (in 11/22) at 59% (higher is better). RD recommendations for Nutrition Supplements are important interventions for patients who are not eating well or are experiencing weight loss, which inhibits healing.

c. Percentage of Malnutrition identified by an RD that has been acquired in the hospital. "This occurrence is typically compounded by RD recommendations either not being implemented or not implemented in a timely manner by the medical team, which leads to decline in nutritional status of the patient. Malnutrition is directly related to poorer outcomes including increased: length of stay, readmission rate, infection rate, (skin) pressure injury rate, and medication requirements." The benchmark (comparison with other hospitals) was 0-5%, and scores from May 2022 to October 2022 ranged 46% to 56%, with 13% in November 2022 (lower is better).

A review of Patient 17's medical record on 4/5/23 at 12:45 pm supported the concerns cited in the clinical nutrition QAPI data collection. It showed Patient was admitted on 3/4/23 with cellulitis, gangrene 4th toe, diabetes, alcohol abuse, and his toe was amputated during his stay. He was 6'4", with an "emergency" (emergency weight = stated weight per CDM) weight 136.6 kg/300 pounds on admission 3/4/23. At the time of the record review on 4/5/23, there was still no accurate weight recorded in the medical record despite Patient 17's health conditions and acute care inpatient status for more than one month. Review of the Nutrition Assessment notes completed by the Registered Dietitian (RD), dated 3/9, 3/14, 3/19, 3/25, and 3/31/23 showed Patient 17 had variable meal intakes that, even if he ate 100% did not meet his estimated nutrition needs. Patient 17 also had increased caloric and protein needs for wound healing. The high calorie/high protein nutrition and wound healing supplements were recommended by the Registered Dietitian (RD) on 3/9/23 to help meet Patient 17's nutrition needs were not ordered by the provider until 3/21/23. It was unknown if Patient 17's extended length of stay or his healing were related to or impacted by these deficient practices. (Cross Reference A629).

During an interview with the Interim Plant Operations Director (IPOD) on 4/3/23 at 4:00 pm he stated Environment of Care Rounds occurred in each department every six months. When asked if the Food and Nutrition Services Manager (FSM) participated, he replied "Not often."

During an interview with the Infection Prevention Director (IP) on 4/4/23 at 3:00 pm, the IP stated he participated in EOC rounds and they were scheduled in all areas of the hospital every six months. He stated he looked for cleanliness, expired products, vents, fans, and refrigerator temperature logs. He stated the Executive Chef (EC) was usually with them during EOC rounds and pointed a lot of things out to them. EOC relied on the EC for expertise, and findings on EOC rounds went to the Infection Prevention Committee and the EOC Committee.

During an additional interview and concurrent document review with the IP on 4/4/23 at 3:40 pm, he provided the "SRMC Environmental Surveillance Rounds, Dietary, Kitchen, Cafeteria" reports, dated 6/22/22 and 12/8/22. They reflected concerns such as missing refrigerator thermometers and logs, damaged/uncleanable equipment in the cafeteria, undated salad bar foods, and soiled fans. The IP was asked why the reports contained no action plans for the deficiencies cited in the Dietary/ Kitchen/ Cafeteria. He replied, "Some departments just don't respond."

Review of QAPI documents on 4/4/23 at 11:55 am showed the Quality Committee Minutes dated 10/13/22, Quality/Patient Safety Committee Minutes dated 11/10/22, Quality Committee Minutes dated 12/8/22, and Governing Board Meeting Minutes dated 1/25/23 did not contain any QAPI reports related to Food and Nutrition Services or Clinical Nutrition. The Governing Board Meeting Minutes indicated CDPH investigated a reported hospital acquired, unstageable pressure ulcer, a root cause analysis completed 11/7/22 included "poor nutritional intake," yet the plan of correction cited in the report did not include any nutrition-related intervention or monitoring in their processes.

Review of the facility's Administrative Manual Provision of Patient Care Plan for Food and Nutrition Services, dated 12/20, showed the Clinical Nutrition Manager (CNM) reported to the Chief Nursing Officer (CNO) for feedback on clinical nutrition issues, and the FSM and CNM met with the CEO monthly.

During an interview with the Chief Nursing Officer (CNO) on 4/4/23 at 4:00 pm he stated he spoke with the CNM on a routine basis and gave him regular, undocumented feedback. He stated he looked at and discussed the CNM's QAPI data collection with him during quarterly meetings. When asked where to look to see how the hospital was using the CNM's QAPI data the CNO replied "I would agree with you that we don't do a good job of closing the loop. The action plans aren't in place."

During an interview on 4/5/23 at 9:30 am, the Ortho/Neuro Director (OND) who provided interim coverage for facility wide QAPI stated he didn't know of any metrics from Dietary provided or reviewed in Quality Committee, but he was involved with the CDM in relation to the Total Joint Program committee. He had no awareness or knowledge of any clinical nutrition performance improvement activities. He was not aware of the CDM or FSM ever attending a Quality Committee meeting. When asked if the Food and Nutrition Services/Clinical Nutrition should be included in hospital wide QAPI, he replied "It's always a good idea. Nutrition is a big part of healing."

5. The Food and Nutrition Services Emergency Food Plan was not fully developed or integrated into the hospital-wide disaster plan. There was no emergency menu or nutrient analysis in place, there was no plan for allocation of water for the Food and Nutrition Services Department, there was no training for dietary or hospital-wide staff regarding emergency food, and there was not a clear delineation of duties within leadership of who was responsible for the overall coordination and implementation of the facility's Emergency Preparedness Plan.

During an observation in the emergency food storage room with the Food Service Manager (FSM) and Executive Chef (EC) on 4/3/23 at 9:25 am, the FSM explained they purchased a dehydrated food program for their emergency food supplies, and the boxes in the room provided enough food to feed 600 people three meals per day plus snacks, for four days, including staff who were working, patients, and physicians. Volunteers were not included. When asked how much water was needed and how was it calculated regarding rehydrating food, basic cleaning, and other needs in the kitchen during an emergency, the FSM stated he didn't know. He stated "the client" was responsible for any water needed and referred us to the Interim Maintenance Manager. The FSM stated he didn't know what the allocation of water was for his department during an emergency, but it was stored on the landing outside. The FSM and the facility were unable to provide information regarding emergency water allocations by the end of survey.

During further interview with the FSM and EC on 4/3/23 at 9:25 am, the FSM agreed there was no menu or instructions for implementation of the emergency food plan located with the emergency food. He stated it was in the Food and Nutrition Services (FANS) Department office somewhere. The FSM stated he did not participate in the hospital's disaster preparedness meetings. When asked if he had trained anyone in his department or in the facility regarding the emergency food plan, he responded some FANS staff had been trained on the location of the supplies but not in the execution. The FSM stated no hospital staff had been trained in the actual implementation of the plan and agreed the plan should be located with the supplies. When asked if any beverages would be available other than water, coffee and dry milk, the FSM stated they would liquidate the beverages on-hand in the kitchen and cafeteria. He agreed they had not planned for containers to rehydrate and mix the dry milk.

During an interview with the Disaster Plan Coordinator (DPC) on 4/3/23 at 1:35 pm, he was asked how the Food and Nutrition Services emergency food plan fell in with the hospital plan. He replied, "We are supposed to be able to do 96 hours." He stated they planned 1 gallon of water per person per day for 246 beds and 150 staff, with 50-gallon barrels stored in the parking structure (Plant Operations/ Engineering manages that), and five-gallon jugs in the courtyard. He was not sure how the water was allocated to the various departments. He was told "It's taken care of." "I'm the coordinator on that, but it gets delegated out and plant operations is responsible for that." He didn't know if the parking structure was seismically compliant to store emergency water. The DPC stated he answered to the Director of Plant Operations who was out sick. He further stated the HICS (Healthcare Incident Command System) logistics position made those (water) decisions.

When asked how hospital staff would know how to implement the disaster food plan the DPC replied "Dietary staff are responsible for that." A concurrent review of the "Emergency Management Policies and Procedures" including the "Emergency Operations Plan," updated December 2022 and January 2023 respectively, showed they did not include the Food and Nutrition Services emergency food plan. The DPC verified this was correct.

During an interview with the Interim Plant Operations Director (IPOD) on 4/3/23 at 4:00 pm, he stated all emergency water was stored in a locked and gated courtyard and not in the parking structure. He didn't know how the number of gallons of water were determined "I inherited it." He was unaware of a breakdown of how the water would be allocated. He stated the Plant Operations role in supporting the dietary department during a disaster would be to transport the water there, and the DPC would be the key figure to pull everything and everyone together into a cohesive plan.

Based on dietetic services observations, dietary staff interview and departmental document review the facility failed to ensure staff competency for five out of five Food Service Worker (FSW) staff members (FSW2, FSW3, FSW4, FSW5, and FSW8) when they were unable to fully verbalized competency in tasks associated with their positions for the following tasks:1. Manual Warewashing; 2. Cleaning Fixed Equipment: 3. Food Cooling; 4. Labeling and Dating; and 5. Vegetable Wash. Failure to ensure staff competency may result in poor sanitation and/or food handling practices, affecting food safety.

Findings:

1. On 4/3/23 beginning at 3:05 p.m., FSW 8 was observed washing dishes. It was noted each section of the 3-compartment sink was filled with detergent, water and soiled cooking equipment. In a concurrent interview FSW 8 indicated he had worked for the hospital for 2 years and was soaking the dishes prior to placing in the dishwasher. The Surveyor asked FSW 8 to describe how dishes were washed should the dishwasher be broken. FSW 8 replied "I have no idea." FSW 8 indicated he had not been trained on a manual warewashing process.

In an interview on 4/3/23 at 3:35 pm, the Food Service Manager (FSM) stated training was accomplished by giving employees informational training packets with an accompanying post-test. The FSM indicated employees were instructed to read the material and return the post-test. The FSM also indicated there were in-person trainings conducted by departmental leadership staff which included himself and the Clinical Nutrition Manager.

Review of in-service documents dated 9/29/22 revealed FSW 8 attended and deemed competent a training titled "Walk the Talk Topic of the Month: Washing Pots and Pans." The training reviewed the six steps of manual warewashing with specific step by step instructions and a post test. The training also guided leadership to consider including a variety of interactive activities to demonstrate competency. While FSW 8 may have completed the post-test the hospital was unable to demonstrate competency.

On 4/4/23 at 3:20 pm, the surveyor requested position specific orientation for FSW 8. On 4/5/23 at 9 am, the FSM indicated he was unable to locate the requested documents, however provided a blank document titled "New Hire Packet ..." Review of the blank document revealed orientation included working with the general manager on the job description as well as a sign off sheet titled "Employee Safety Training Checklist" and a Two Step Food Safety Training Program. The Two-Step Training Program outlined topics to be covered during the first 10 days of employment and required employee sign-off. There was no indication FSW 8 was offered or completed comprehensive training and orientation.

2. During initial kitchen tour and general kitchen observations on 4/3/23 beginning at 8:40 am, multiple kitchen areas and equipment were not clean. The areas had a combination of unidentified, dried on food particles, a buildup of grey fuzzy material resembling dust and/or a substance resembling a buildup of grease and other debris. Unsanitary equipment included floors and mops, knife sharpener and rack, interior and exterior of refrigerators and freezers, counters, drawers and shelving, pans, mixer, bulk food storage bins, ice bucket, can opener, fans, and more (Cross Reference A-620, A750).

During interviews between 4/3/23 at 8:00 am and 4/5/23 at 5:00 pm regarding the process for cleaning fixed equipment, three out of three staff (FSW2, FSW4, and FSW5) stated they used only sanitizer solution to clean fixed equipment (equipment that cannot be washed in the dishwasher or 3-compartment sink). They confirmed they did not wash equipment with soapy water and did not rinse it prior to using sanitizer. FSW 5 stated "They tell us just to wipe them down (with sanitizer) and let them dry. If there is grease, we can use soap."

Review of the 2022 FDA Food Code 4-603.15, 4-603.16, 4-701.10 and 4-702.11 showed: equipment that cannot be cleaned in a sink or dishwasher shall be washed using detergents, have a distinct, separate rinse after washing so that abrasives and cleaning chemicals are removed, and then shall be sanitized before use after cleaning.

Review of a facility policy titled Equipment Care and Cleaning, revised 2/14/11 showed inconsistent direction for staff in cleaning equipment. For example, the policy directed some equipment to be washed but not rinsed, then sanitized (pots and pans, carts). It directed other equipment to be washed but not rinsed and not sanitized (slicing machine, mixers). It directed that other equipment be cleaned with water and a brush or cloth (coffee machine, toaster, microwave oven). Still other equipment was to be washed, rinsed and sanitized (can opener). Cafeteria tables and chairs were to be wiped and sanitized with a disinfectant and dried with a towel. Steam tables "must be kept in a clean and sanitary condition through regular cleaning" but the process to clean was not described.

Review of in-service documents titled Walk the Talk, Sanitizing Food Contact Surfaces, dated March 2022, and Annual 2023 indicated "Cleaning means removing food and other types of soil from a surface. Sanitizing means reducing the number of harmful microorganisms on that surface to a safe level. When to sanitize: Clean, rinse and sanitize after each use, when beginning to work with a different type of food, when interrupted or when equipment you have been working with may have become contaminated." All three staff (FSW2, FSW4, and FSW5) who were interviewed regarding the cleaning process signed in to both in-services.

3. Review of a policy provided and identified by the FSM as the policy that addressed food cooling was titled Food Safety Standards, reviewed 9/19. It showed "All potentially hazardous foods will be identified and tracked from arrival at facility until service to ensure food is not exposed to temperature danger zone of 40°F (Fahrenheit) - 140°F for a cumulative period of more than 4 hours."

The 2022 FDA Food Code 3-501.14 showed cooked time/temperature control for safety food (TCS) shall be cooled: 1) Within two hours of cooking from 135°F to 70°F; and 2) Within a total of 6 hours from 135°F to 41°F or less. TCS foods prepared from ambient temperature foods (such as tuna salad or egg salad) shall be cooled to 41°F or less within four hours.

During an observation of the walk-in refrigerator and freezer on 4/3/23 at 3:05 pm, labels on Barbeque Beans prepared 3/6/23, and Clam Chowder prepared 3/24/23 showed they were expired. Four pans of previously cooked foods had incomplete cooling logs: Clam Chowder prepared 3/24/23, Vegan Paella prepared 4/2/23, Bacon Corn Chowder prepared 4/2/23, and Low Cal Omelet prepared 4/2/23. They did not show what time the temperatures were monitored to ensure adequate cooling in the required timeframe, and/or they were never finished to a temperature of 40°F or lower. The Bacon Corn Chowder log showed the last recorded temperature as 180°F, and the Low Cal Omelet log showed 155°F.

Review of documents provided by the FSM showed an in-service on Food Cooling administered to staff in July 2022. The curriculum was not provided by the FSM, but a five-question true/false quiz showed 13 out of 27 quizzes completed by staff included the question: "5. Because my shift ends before the four hour cooling time is up, I can't write down the final product temperature on the HACCP log. That's okay, as long as I write down that I have followed our unit's cooling procedures." Thirteen out of 13 staff answered the statement/question was true, when it was false.

4. During an observation in the walk-in refrigerator/freezer on 4/3/23 at 3:20 pm, four each 2 ½ pound bags of previously frozen chicken were in a pan on a speed rack. The label showed they were pulled from the freezer on 3/31 and should be used by 4/2. In a concurrent interview the Executive Chef (EC) explained the café cook selected the wrong chicken product in the labeling machine. He should have selected frozen chicken but selected a fresh chicken product. They had five days from the pull date to use the frozen chicken.

In an additional, concurrent observation in the walk-in refrigerator/freezer, five-pound chubs of thawing ground beef were also labeled pulled from the freezer on 3/31 and use-by 4/2. The EC again stated the staff had selected the wrong fresh ground beef product in the labeling machine instead of the frozen ground beef product, the dates were not correct, and the frozen product had 5 days to be used.

During an observation and concurrent interview in the cold food prep area on 4/4/23 at 10:10 am, FSW 3 was chopping onions. The counter held a package of pre-sliced onions with a facility received-on date 4/4/23, and a manufacturer's use-by date 4/6/23. There was a metal pan of sliced onions and a metal pan of chopped onions with facility labels that showed "Onions, chopped or sliced, with the prepared date 04-04-23 10:00 AM, and a use-by date 04-09-23 10:00 AM (three days later than the manufacturer's use-by date)." FSW 3 stated the facility purchased all pre-cut produce except for tomatoes, cucumbers, peppers and lettuce. When asked about the labels on her pans of onions she stated the dates were all automatically programmed into the labeling machine. "I print my sticker today, and it prints out to use it in three days."

During an observation in the walk-in refrigerator/freezer on 4/4/23 at 10:20 am, the EC and FSW 1 were putting away the food delivery. The EC's attention was drawn to the metal pans of onions, and the vendor's packaged pre-sliced onions with the labels described above. He stated the onions should be used by the manufacturer's use-by date 4/6/23, and when product has a shorter than normal use-by date they need to be labeled with a special sticker, not the labeling machine. He stated he just taught FSW 1 about using the special stickers, he needed to teach FSW 3 to use them too, and he needed to do general staff training on the labeling and dating machine and special dating stickers.

5. During an observation of the food prep area on 4/3/23 at 8:45 am, a vegetable-wash (product that sanitizes produce) dispenser was noted near the cook's food preparation sink. A sign above the sink indicated "Notice - Food Prep Sinks Only." In a concurrent interview, FSW 2 confirmed they used vegetable wash to clean their produce. He stated the process for using the vegetable wash was: grab a container, fill it with the vegetable wash solution, put the vegetables in. After one minute or so, drain and use the product. He stated they perform this in the 2-compartment food preparation sink. He stated they periodically tested the vegetable wash solution, and they had test strips, but he didn't know where they were.

In an additional concurrent interview, the EC stated, he had "certain people" who tested the vegetable wash solution, and the morning cold food prep staff tested it daily. A concurrent review of the "Weekly Antimicrobial Produce Wash Log" dated 4/3 - 4/9 showed "Testing Dilution Ratio Pass or Fail" with checkboxes for pass or fail. When asked what pass or fail meant, the EC stated, "the test strip is simply pass or fail."

Review of the manufacturer's instructions for the "Antimicrobial Fruit and Vegetable Treatment" posted on the wall near the vegetable wash product provided instructions in both English and Spanish. It directed: Clean and sanitize sink before use ...immerse test strip in solution sample for 1 to 2 seconds, evaluate color immediately after removing test strip from sample (not more than 15 seconds). Match the test strip to Color Chart to determine concentration ...Wash and/or brush produce for a minimum of 90 seconds contact time with the wash water. Remove produce from sink, drain and allow to air dry." The "Test Strip Color Chart" on the instructions showed eight potential color/dilution ratios, with the dilution ratios 1:170 to 1:128 as acceptable dilutions. Further review of the test strip container showed three possible color/dilution ratios including zero, 1:512, and 1:258, directed staff to match the test strip color and "See product label for recommended concentrations."

The color dilutions ratios on the wall instructions and on the test strip container did not match, and there was no guidance on the log regarding the correct dilution values to direct staff which values to choose. Staff who used the vegetable wash did not know how to check the concentration of the vegetable for safety, and did not know the correct contact time for the vegetable wash to be effective.

Based on medical record review and departmental document review the facility failed to ensure the menus met nutritional needs and the current standard of practice when the standard Carbohydrate Consistent Diet (a diet that equally distributes the amount of carbohydrate from meal to meal and from one day to the next) did not meet the needs of the hospital defined demographics.

Findings:

The Dietary Reference Intake (DRI) is a system of nutrition recommendations from the National Academy of Medicine (NAM) of the National Academies in the United States. The DRI includes Estimated Average Requirements (EAR), which is expected to satisfy the needs of 50% of the people in that age group based on a review of the scientific literature. DRIs are intended for the general public and health professionals. Applications include evaluation of the composition of diets for schools, prisons, hospitals or nursing homes (National Academy of Medicine). Nutritional needs of patients must be met through menu development in accordance with the physician's diet orders, as delineated in the facility diet manual. The analysis of the menu is the foundation of meal planning to assure that the menu meets the nutritional needs of the patient and are in accordance with the physician ordered diet. The Menu analysis includes all life stages and gender groups based on the specific population of each facility. For menus and diets that do not meet the RDAs, facilities must have an established system that addresses any nutritional inadequacies of the diet.

Hospital document titled "Nutrient/Cost Analysis Daily Averages Summary" dated 6/1/20 indicated the menu adequacy evaluation (DRI) was based on males 51-70 years of age. Review of hospital guidance titled "Evidence-based Guidelines for Nutritional Needs Related to Specific Diseases" dated 7/19 indicated, in general, the number of calories per kilogram (a metric unit of measure) of body weight would be 25-30 calories per kilogram of body weight.

1. During a general interview on 4/3/23 beginning at 9:15 am, the Food Service Manager and the Clinical Nutrition Manager (CNM) provided a general description of Food and Nutrition Services. The CNM stated at the time of admission nursing services conducted a nutrition risk assessment that evaluated recent weight changes in addition to dietary intake for the previous 7 days. Based on that information a patient was given a nutrition risk score. Patients who were at high nutritional risk were seen within 2 days of admission and patients with no nutrition risk at the time of admission were seen within 5 days.

In a follow up interview on 4/3/23 beginning at 11:45 am, the CNM indicated the hospital had one approved carbohydrate consistent diet (CCHO) which had approximately 60 grams (a metric unit of measure) of carbohydrate at each meal. The CNM confirmed this was the only approved diabetic diet.

Review of departmental document titled "Menu Nutrient Analysis Report" printed on 4/3/23 confirmed the CCHO diet consisted of a range of 55-70 grams of carbohydrate per meal. It was also noted the benchmark for the daily value of caloric content of the menu, based on the hospital's demographics of males aged 51-70, was 2000 calories per day. A summary review of the total calories offered on the 60-gram CCHO diet was listed as a range of 1479-1626, a shortfall of 521-374 calories per day based on the hospital's menu planning benchmark of 2000 calories.

Medical record review was conducted on 4/5/23 beginning at 11:30 am.

a. Patient 20 was admitted on 3/29/23. Admission diagnosis included Diabetes (a chronic health condition affecting how your body breaks down food to use as fuel). Patient 20 also underwent a coronary artery bypass surgery (heart surgery) shortly after admission.

A nursing nutrition risk screening completed on 3/29/23 noted Patient 20 did not have any nutritional risk factors. Admission diet order was a Consistent Carbohydrate Diet.

A comprehensive nutrition assessment dated 4/3/23, completed by the Registered Dietitian (RD), indicated Patient 20's estimated caloric needs were 2150-2580 calories and 103-129 grams (a metric unit of measure) of protein per day. The assessment also noted his meal consumption was 84% (percent) of the CCHO diet, which equated to an intake range of 1183-1300 calories per day, a significant daily deficit. A summary review of the amount of protein offered on the CCHO diet ranged from 68 to 98 grams of protein, a value below Patient 20's estimated needs based on the documented meal intake of 84%. The RD assessment noted the current diet and meal intake did not meet Patient 20's needs for calories or protein. As a result, rather than meeting the nutritional needs of Patient 20 through the hospital's menu, it required the addition of nutritional supplements.

b. Review of the medical record for Patient 17 showed he was admitted on 3/4/23 with cellulitis, gangrene 4th toe, diabetes, alcohol abuse, and his toe was amputated during the course of his stay. He was 6'4", 136.6 kg/300 pounds (stated) on admission 3/4/23, screened to have no nutrition risk factors, and received a Consistent Carbohydrate Diet (CCHO) order. Review of the Nutrition Assessment notes completed by the Registered Dietitian (RD), dated 3/9, 3/14, 3/19, 3/25, and 3/31/23 showed his estimated nutrition needs were 2300 - 2760 kcals (calories), and 110 - 138 grams protein, and he had an increased need for protein for wound healing. Patient 17 had variable meal intakes, with meals refused or intake less than 50% for 1 ½ days, improving to mostly 100% of meals by 3/14/23. High calorie/high protein nutrition and wound healing supplements were recommended by the Registered Dietitian (RD) on 3/9/23 but were not ordered by the provider until 3/21/23. Double protein three times daily (TID) was recommended on 3/14/23 and was provided at the time of the 3/19/23 nutrition assessment. The nutrition assessment dated 3/25/23 indicated Patient 17's 100% intake of CCHO diet plus double protein TID, plus the nutrition and wound healing supplements met his estimated nutrition needs.

Review of the Nutrient Analysis for the 7-day Consistent Carbohydrate Diet menu showed it provided an average of 1,470 calories and 81 grams of protein each day, indicating it provided Patient 17 with approximately 53 - 64% of his estimated calorie needs, and 59-74% of his estimated protein needs if he ate 100% of meals. This had the potential to result in weight loss and poor or delayed wound healing. Patient 17 was not weighed again by nursing after admission, despite his inpatient status for more than one month at the time of the chart review, so it was unknown if unplanned weight loss had occurred.

Review of hospital diet manual dated 9/27/22, the document intended to be the cornerstone of menu planning, failed to provide a description of the CCHO menu including but not limited to nutritional adequacy based on the hospital's population, rather was limited to clinical information such as the classification of diabetes and goals of medical nutrition therapy.

2. On 4/3 at 1 pm, 4/4 at 11 am, and 4/5/23 at 11 am, the hospital presented multiple documents titled "Menu Nutrient Analysis Report for the Vegetarian, Carbohydrate Controlled, Heart Healthy and Renal diets. This document was intended to provide the nutritional analysis of the hospital's therapeutic diets. It was noted the provided analysis was not complete, in accordance with the Dietary Reference Intakes, rather was limited to calories, protein, fat, carbohydrate, cholesterol, calcium, sodium and iron. In an interview on 4/5/23 at 3:15 pm, the Director of Food Service (DFS) stated he was unable to print the full nutritional analysis and acknowledged without the analysis it would not be possible for the surveyor to determine compliance with the menu planning regulatory requirements. The hospital also provided a daily analysis of the regular diet, however there was no indication the Clinical Nutrition Manager reviewed and approved the nutritional adequacy of the menus.

3. On 4/5/23 beginning at 1:45 pm, the DFS presented a nutrient analysis report for the Pureed diet. The analysis included macronutrients such as protein, fat and carbohydrate as well as a complement of vitamins and minerals. The analysis provided a daily total of the nutrients as well as a benchmark for each of the nutrients, based on the DRI for the hospital's baseline demographic of males aged 51-70. It was noted there were significant nutrient deficits for Vitamins D (at 42%), Vitamin A (at 15%), Vitamin E (at 7.5%), Vitamin K (at 26%), Thiamin (at 36%), Riboflavin (at 23%) and Niacin (at 26%). Similar deficits were seen in calcium, iron, zinc and potassium. There was no indication the hospital's CNM reviewed and approved the menus for nutritional adequacy.

Based on observation, interview and record review, the hospital failed to have an active hospital-wide Infection Control and Prevention program that demonstrated adherence to nationally recognized infection prevention and control guidelines when:

1. Three of three previously cleaned, sterilized, and ready for use surgical instrument trays (totaling 208 surgical instruments) contained 64 surgical instruments with black staining, non-manufacturer etching, unidentified markings, pitting in hinge box of scissors/clamps. Refer to A 749 Finding 1.
2. Two of two autoclaves (steam sterilizing machine) were not cleaned according to manufacturer's Instructions for Use (IFUs), or hospital policy and procedure. Autoclave 1 had heavy build-up of black staining in the chamber and Autoclave 2 had a moderate amount of orange staining in the chamber. Refer to A 749 Finding 2
3. No dedicated handwash sink in decontamination area of the Sterile Processing Department (SPD-a department used to clean soiled surgical instruments). Refer to A 749 Finding 3
4. Surgical cleaning brushes were reused and not thoroughly cleaned between cases according to manufacturer's IFUs. Refer to A 749 Finding 4.
5. Two of (2) flexible endoscope (scope - a slender, illuminated, flexible or rigid tubular instrument used for examining an inner part of the body) storage cabinets containing 25 scopes were in located in a gastrointestinal (GI - relating to the stomach and the intestine) procedure room, and not in accordance with the infection control guidelines the facility followed. Refer to A 749 Finding 5.
6. The GI scope reprocessing room (a room where scopes are cleaned with High Level Disinfectant Chemicals) did not have an eyewash station or handwash sink in accordance with the Occupational Safety Hazard Agency (OSHA), the Center for Disease Control (CDC) and the American National Standards Institute (ANSI)) guidelines. Refer to A 749 Finding 6.
7. One of two scope cabinets was not medical grade. There was no filter, and the cabinet was not in accordance with the infection control guidelines the facility followed. Refer to A 749 Finding 7.
8. Patient 1, who was in the Intensive Care Unit (ICU) had intravenous (IV) lines left uncapped during his dialysis. Refer to A 749 Finding 8.
9. Proper infection control standards were breached during the accessing of Patient 2's central venous catheter for dialysis. Refer to A 749 Finding 9
10. Proper infection control standards were breached during the accessing of Patient 40's fistula for dialysis. Refer to A 749 Finding 10.
11. Hemodialysis Technicians were not trained in the hospital-specific isolation precaution policies and procedures and contact isolation guidelines were not followed for two out of five dialysis patients when Patient 27 (who was on contact isolation precautions) was transported, in her bed, to the dialysis procedure room. During Patient 27's dialysis procedure, Patient 40 (who was not on isolation precautions) was brought in and received dialysis in the same room. Refer to A 749 Finding 11.
12. The Food Service Manager, the position responsible for the day-to-day observations, failed to effectively maintained systems to ensure food safety and the prevention of potential cross contamination. Refer to A 750 Findings 1-6.
13. The facility failed to maintain a safe environment in the soiled utility room on the medical/surgical nursing unit. Refer to A 750 Finding 7.
14. The Infection Prevention and Control department did not include oversight of the new dialysis vendor contracted service. Refer to A 751.


These failures put patients at risk for substandard care, adverse events, and negative outcomes. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Infection Prevention and Control.

Based on observation, interview, and record review, the facility failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control, guidelines, and regulations. The facility's infection control program failed to ensure:

1. Three of three previously cleaned, sterilized, and ready for use surgical instrument trays (totaling 208 surgical instruments) contained 64 surgical instruments with black staining, non-manufacturer etching, unidentified markings, pitting in hinge box of scissors/clamps.
2. Two of two autoclaves (steam sterilizing machine) were not cleaned according to manufacturer's Instructions for Use (IFUs), or hospital policy and procedure. Autoclave 1 had heavy build-up of black staining in the chamber and Autoclave 2 had a moderate amount of orange staining in the chamber.
3. No dedicated handwash sink in decontamination area of the Sterile Processing Department (SPD-a department used to clean soiled surgical instruments).
4. Surgical cleaning brushes were reused and not thoroughly cleaned between cases according to manufacturer's IFUs.
5. Two of (2) flexible endoscope (scope - a slender, illuminated, flexible or rigid tubular instrument used for examining an inner part of the body) storage cabinets containing 25 scopes were located in a gastrointestinal (GI - relating to the stomach and the intestine) procedure room, and not in accordance with the infection control guidelines the facility followed.
6. The GI scope reprocessing room (a room where scopes are cleaned with High Level Disinfectant Chemicals) did not have an eyewash station or handwash sink in accordance with the Occupational Safety Hazard Agency (OSHA), the Center for Disease Control (CDC) and the American National Standards Institute (ANSI)) guidelines.
7. One of two scope cabinets were not medical grade. There was no filter, and the cabinet was not in accordance with infection control guidelines facility followed.
8. Patient 1, who was in the Intensive Care Unit (ICU) had intravenous (IV) lines left uncapped during his dialysis.
9. Proper infection control standards were breached during the accessing of Patient 2's central venous catheter for dialysis.
10. Proper infection control standards were breached during the accessing of Patient 40's fistula for dialysis.
11. Hemodialysis Technicians were not trained in the hospital-specific isolation precaution policies and procedures and contact isolation guidelines were not followed for two out of five dialysis patients when Patient 27 (who was on contact isolation precautions) was transported, in her bed, to the dialysis procedure room. During Patient 27's dialysis procedure, Patient 40 (who was not on isolation precautions) was brought in and received dialysis in the same room.

These failures demonstrated non-compliance with infection control training and implementation of policies and procedures which resulted in cross-contamination of organisms that had the potential to cause avoidable spread of disease to patients and staff.

Findings:

On 4/5/23 at 2:30 PM, an interview was conducted with the hospital Infection Control Director (IP), who stated they followed nationally recognized infection control guidelines from:
AORN - Association of Perioperative Registered Nurses
CDC -Centers for Disease Control
SHEA- Society for Healthcare Epidemiology of America
CMS- Conditions of Participation (COP)
AAMI- American Association of Medical Instruments
APIC-American Professional in Infection Control

1. A. On April 3 2023, at 11:20 AM, a concurrent interview and inspection of two (2) previously cleaned, sterilized and ready for surgical use packed trays were opened and inspected in SPD. Present for the inspection and interview were the Central Supply Department Director (SPDD).

" 4/3/23 at 11:20 AM, a Major Tray (a large set of surgical instruments processed and sterilized, ready for surgical use) with 74 instruments was inspected. Of the 74 instruments inspected, 21 had black staining.

" 4/3/23 at 11:50 AM, a Minor Tray (a medium set of processed and sterilized surgical instruments packed in a tray, ready for surgical use) with a total of 70 instruments was examined. Fourteen (14) instruments had black stains and 3 of the 14 had grooves in the hatch box (hinge).

B. On 4/5/23 at 2:00 PM, a previously cleaned, sterilized and ready for surgical use packed Small Bone Tray (a set of sterilized instruments packed and ready for surgical use) with a total of 64 instruments, was inspected in the Sterile Processing Department. The SPDD observed the inspection.

" Three (3) instruments had black, non-raised lines on the portion of the instrument inserted into the patient during surgery that were not part of the manufacturing process.
" Twenty-two (22) instruments had dark staining, and four (4) had an orange tint on the entire instrument.

On all three inspections of surgical instruments the SPDD confirmed the findings, stating she wanted to keep the stained instruments aside to re-clean them. Upon seeing the four instruments in the bone tray with an orange tint on the entire instrument she said, "these are tarnished. I never would have packed these in a tray."
A review of the facility's policy and procedure titled, "Care and Handling of Surgical Instruments" last reviewed 5/2022, indicated the following:

" Inspect and evaluate items for,
o Cleanliness ...
o Surface integrity
o Absence of:
" Corrosion, pitting, burrs, nicks, and cracks.
" other defects
o Identify defective reusable surgical instruments and remove them from service for repair or disposal.

AORN Guidelines for Perioperative Practice (2015), Recommendation X (p629) states "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)."

2. On 4/3/23 at 10:20 AM, a tour and concurrent interview were conducted of the "Sterile Processing Prep and Pack Area" (an area within the sterile processing department where clean surgical instruments are sterilized and packaged into surgical trays in preparation for operations) accompanied by SPDD. The SPDD stated that Biomedical Engineering oversaw cleaning and maintaining the autoclaves, and the correct manufacturer's Instructions for Use (IFU-) could not be found. Inspection of the interior of autoclaves revealed:

" Autoclave 1 had orange staining in the chamber (AMSCO 400)
" Autoclave 2 had very dark black chamber staining (AMSCO EAGLE 3000)
During an interview with the Director of Biomedical Engineering (DBE) on 4/3/23 at 12:35 PM, he stated that he could not find the manufacturer's IFUs for the Autoclave 2. The DBE confirmed that the Biomedical Engineering Department nor the SPD cleaned the interior portion of the autoclaves. The DBE stated that cleaning is done annually by Nagle Medical.
On 4/4/23 at 09:30 AM, the SPDD was unable to produce a facility policy and procedure for cleaning autoclaves, but did provide the IFUs for the Amsco Eagle 3000 (Autoclave 1) dated 8/31/06, in which "Section 4.2 Recommended Periodic Maintenance:
4.2.1 Daily 1. Clean chamber as follows:
a. Wash inside of chamber and loading equipment with a mild detergent solution such as STERIS Liqui-Jet 2 Instrument Detergent, Criti-Klenz Instrument Detergent, or current STERIS equivalent (chamber must be at room temperature-off all night- before washing.
b. Rinse with tap water; dry with a lint free cloth
c. Remove chamber drain strainer ... clean out lint and sediment, reverse flush under running water
d. Place Strainer back in chamber drain."

A record review on 4/7/23 at 6:00 PM, of the CDC Guideline Factors Affecting the Efficacy of Disinfection and Sterilization', stipulates the number and location of microorganisms, the number and nature of microorganisms, innate resistance of microorganisms, concentration and potency of disinfectants, physical and chemical factors, organic and inorganic matter, duration of exposure and biofilms must all be studied and addressed to optimize disinfection and sterilization. It's important to understand the role Disinfection and Sterilization in decreasing bioburden.

A record review on 4/7/23 at 7:00 PM, of the manufacturers document "Central Sterile Services: How-to Guide to SS Corrosion Removal" explains "stainless steel corrosion, left untreated can cause product contamination, equipment downtime, and reduced equipment life."

3. On 4/4/23 a concurrent observation and interview was made at 9:45 AM of the Central Supply Decontamination room (a room used to clean and disinfect reusable surgical instruments using corrosive materials) with the Central Supply Technician (CST) and SPDD present. The CST stated, the only sinks noted were used for manual cleaning of instruments. The SPDD confirmed that the only place for handwashing after removing PPE was the hopper, which is not a sink, but a place for disposing of waste materials. The SPDD stated "There is no policy I can find on hand washing sinks in the decontamination room."
2016 AORN national guidelines followed by the facility state, "There must be separate sinks for washing instruments and for hand hygiene. Instruments should not be cleaned or decontaminated in scrub or hand sinks, because cleaning soiled instruments in a scrub or hand sink can contaminate the sink and faucet, which are intended for clean activities such as hand washing (AORN Guidelines, in section "Guideline for cleaning and care of surgical instruments"). Dedicated hygiene facilities are also required by OSHA and the CDC.

OSHA, The CDC and HICCAP (the Healthcare Infection Control Practices Advisory Committee, an advisory group within the CDC) indicated that dedicated hand hygiene facilities prevent the spread of Healthcare Acquired Infections and prevent workplace injuries.

4. On 4/4/23 an observation was made at 9:45 AM of the cleaning of dirty surgical instruments from a knee surgery by the CST, that were transported to the Central Supply Decontamination room directly from the operating room. The SPDD was in attendance, and a concurrent interview was conducted. The following concern was identified:

During cleaning of the trays of instruments while submerged in cleaner brushes are required to clean the instruments under water mixed with a detergent. The CST was using brushes soaking in a pan of green liquid the SPDD identified as Midline Enzymatic Detergent. After using the brush, it would be replaced in the green liquid. The SPDD stated the brushes were reusable, and when not in use were left soaking in the Enzymatic detergent until the end of the day, at which time they were rinsed and put through the automated washer at the end of the shift.

A facility's policy and procedure regarding the cleaning of reusable brushes was requested but not provided.

During a review of the manufacture's IFU titled "Key Surgical Cleaning Brushes," used by the facility, indicated the following, "Soak brushes in prepared enzymatic solution for two (2) minutes. Rinse brushes under cold tap water for one (1) minute. Visually inspect brushes to ensure removal of soil. Repeat process if soil is found ... Clean after each use and disinfect between cases or daily at a minimum." The maximum soak time in enzymatic solution is noted to be 2 minutes in the IFU.

A review of a document titled "The Association of Operating Registered Nurses (AORN)," dated August 29, 2019, indicated, "The SPD leaders should develop the facility's policies and procedures with input from infection preventionists using national practice guidelines (e.g., AAMI, AORN, OSHA) and should include references to the relevant standards or guidelines used in their development.

5. On 4/5/23 at 12:05 PM, a tour of the Gastrointestinal (GI) scope reprocessing room (a room where high-level-disinfection of medical scopes with cameras used to visualize structures inside the body using caustic chemicals occurs) was conducted with GI Tech (GIT). During the tour it was noted that there was only one sink in the reprocessing room, and no eyewash station. When asked where the eyewash station was, the GIT produced a squeeze bottle from a cabinet, then said there was also an eyewash sink in the nearby behavioral health overflow patient care area they could use. When asked where the sink for hand hygiene was, he replied if hands needed washing it was done in the instrument cleaning sink because the room was too small.

In a concurrent tour and interview of 4/6/23 at 10:30 AM, with the Interim Director of Perioperative Services (IDPS), of the GI scope reprocessing room, she stated, "When they built this room, we asked engineering where the sink to wash our hands was? The engineering department stated the room was too small for a hand hygiene sink."

OSHA enforces "The Code of Federal Regulations: 29 CFR 1910.151, which requires the employer to provide suitable facilities for quick drenching or flushing of the eyes and body when employees may be exposed to injurious corrosive materials. Installed and portable emergency eyewash units must be capable of delivering not less than 0.4 gallons (1.5L) of clean water per minute for at least 15 minutes. The water must be readily available to wash both eyes simultaneously. The eye wash station is also required to be handsfree."

ANSI/ISEA Z358.1 specifies that showers and eyewashes should be located within 10 seconds' travel distance from a hazard, and the victim's physical condition and potential obstacles must still be taken into consideration. The path of travel should be free from obstructions, including doors.

A review of AORN national guidelines titled, "There must be separate sinks for washing instruments and for hand hygiene," 2016, indicated the following: Instruments should not be cleaned or decontaminated in scrub or hand sinks, because cleaning soiled instruments in a scrub or hand sink can contaminate the sink and faucet, which are intended for clean activities such as hand washing (AORN Guidelines, in section "Guideline for cleaning and care of surgical instruments").

6. On 4/6/23 at 11:30 AM a concurrent tour and interview were conducted with the (IDPS) of the GI Procedure Room (a room where scopes are introduced through the anus or mouth to view conditions in patient's stomach and/or intestinal tract, and some biopsies occur). She stated the scopes have always been in the procedure room and it hasn't been a problem in the past. The facility's policy on scope storage was requested, but she replied she did not think there was such a policy. She did not provide a facility policy on endoscope storage. It was noted that Cabinet 1 had a Mass Medical plaque in the right upper corner. Cabinet 2 was located the left of the Mass Medical Cabinet did not have any identifying information. Cabinet 2 had no filter, no air circulating, and the doors did not close tightly. The doors on Cabinet 1 and Cabinet 2 were slightly ajar when we arrived. The door to the GI Procedure Room was unlocked.

On 4/6/23 at 1:30 PM, the IFUs for the Olympus scopes were reviewed with GIT and IDPS. The IFUs stipulated scopes must be stored in a clean, dry place. A one-page enclosure that came with the MASS Medical Cabinet (Cabinet 1), which stores 20 endoscopes, was produced which indicated that the filter could be removed and cleaned as needed, and the interior was to be cleaned with a lint-free cloth. No documentation was produced for Cabinet 2, which did not have a filter, and was made of particle board.

On 4/6/23 at 2:00 PM, a record review was conducted on the "2019 Guidelines of Perioperative Practice, AORN," which stipulated, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room. Storage cabinets should have doors and be located at least 3 ft (0.9 m) from any sink. Flexible endoscopes should be stored in accordance with the endoscope and storage cabinet manufacturers' IFU. Flexible endoscopes should be stored in a drying cabinet If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscope."

The CDC document of 2016 "Essential Elements of a Reprocessing Program for Flexible Endoscopes - Recommendations of the HICPAC states: ...In all practice settings where endoscopy is performed, policies related to the reprocessing of endoscopes should be developed by a multidisciplinary team that includes physicians, nurses, endoscope reprocessing personnel, infection preventionists, and other personnel who are involved in the use and reprocessing of endoscopes. For facilities with limited personnel where formation of a multidisciplinary team is not possible, consider seeking external expertise to obtain multidisciplinary input."

7. On 4/5/23 at 1:00 PM, a concurrent observation and interview was conducted with GIT in the GI Procedure Room, where 2 cabinets stored 25 endoscopes. Cabinet #1 was made by Mass Medical, with washable filters and vents, and held 20 endoscopes. Cabinet #2 had no manufacturer's name, no filters, two aftermarket vents installed on the right side of the cabinet made of particle board. It had two wood doors that open outwards and were slightly misaligned and opened during our observation. Cabinet #2 contained 5 scopes, including the facility's duodenoscopes which due to their construction are the scopes most likely to harbor infectious organisms. The facility had no IFU or care instructions for Cabinet #2 and could not identify the manufacturer.

On 4/7/23, a record review at 3 PM of APIC-AORN GUIDELINES FOR FLEXIBLE ENDSCOPES 2016 indicated:
"IX. Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage:
Cabinets used for the storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing area in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room. Storage cabinets should have doors and should be located at least 3 ft (0.9 m) from any sink. Flexible endoscopes should be stored in a drying cabinet. If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes."



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8. A review of Patient 1's record indicated he was admitted on 3/8/23 with chest pain and shortness of breath. During the hospitalization his condition declined and he was transferred to the Intensive Care Unit (ICU) and started on Continuous Veno-Venous Hemofiltration (CVVH, a temporary treatment for patients with acute kidney failure who are unable to tolerate hemodialysis (treatment to filter waste and water from the blood) and are unstable. With CVVH a dialysis catheter is placed in one of the main veins of the body and dialysis is done 24 hours per day to slowly and continuously clean out waste products and fluid from the patient) on 3/19/23, by Dialysis Vendor (DV) 1's Registered Nurse (RN). On 3/20/23, a DV 2's Technician changed out the machine. During the new set up there were eight lines that were clamped but left uncapped. Pictures were taken of these uncapped lines and provided to the California Department of Public Health (CDPH). A note from Patient 1's nephrologist dated 3/21/23 at 3:23 pm indicated he was notified by the RN in charge of the patient about the ports of the lines not capped and it was immediately capped by her. He notified the Vice President of Operations of the new team and brought this to his attention and that he has already reviewed it with the staff and Chief Nursing Officer (CNO) of the hospital.

During an interview on 3/29/23 at 2:15 pm, the lack of documentation regarding who set up the dialysis machine and left the lines uncapped was discussed with the CNO. He agreed this was not acceptable and said they elevated this issue to the project lead for DV 2. He confirmed there was no Telehealth remote RN supervision of the Hemodialysis (HD) technician (tech) during the set up for this patient for his CVVH, which led to uncapped lines. He said the Telehealth Remote RN supervision is only during the Hemodialysis process and does not include setting up the machine or changing filters.

During an interview on 4/6/23 at 8:30 am, the pictures of Patient 1's uncapped lines were reviewed with the Infection Preventionist ( IP). He said the uncapped lines could cause a potential infection even if clamped and agreed the clamp could come undone and staff could brush up against the uncapped lines. He said he found out about the change in dialysis vendors just before it happened and he did not know how system was going to work regarding techs versus RNs. He said he asked administration if he should be a part of the meetings regarding DV 2, their new dialysis vendor, but was not included in the meetings. He said he was not aware of any significant breaches like this with the uncapped lines or other infection control issues with DV 1, their prior dialysis vendor. He said the RNs from DV 1 changed the CVC dressings routinely and there have been no problems. He said he has concerns over that being done now because the current staff does not have the experience in doing this that the prior RNs had.

9. A review of Patient 2's record indicated he was admitted to the Emergency Department on 3/24/23 with shortness of breath and was admitted to ICU after cardiovascular surgery. During an observation of HD on 4/5/23 at 1055 am, Patient 2 was brought up to 4th floor dialysis area in his bed. RN 29 had gloves and a mask on and was preparing to connect Patient 2 to dialysis. RN 29 picked up a trash can and placed it beside him then, before doing hand hygiene and changing gloves, used alcohol to clean the patient's central venous catheter (CVC) port caps. The ICU Director (ICUD) was also present and confirmed the above observation. She said that RN 29 should have changed gloves and performed hand hygiene after touching the trash can. When RN 29 came out of the room this was discussed with him and he confirmed he should not have picked up the trash can or should have performed hand hygiene and changed gloves after doing so.

10. A review of Patient 40's record indicated she was admitted on 3/29/23 with altered level of consciousness. She had end stage renal disease and was on routine dialysis through a fistula (a connection that is made by joining a vein onto an artery that creates a large vessel that can be needled routinely for use during dialysis).

During an observation on 4/5/23 at 10:50 am, Patient 40 was in the dialysis area. HDT 3 cleaned the fistula with alcohol then with gloved hands, palpated (felt), the area cleaned it again, then palpated the area and inserted the first needle without cleaning the area again. The fistula was cleaned again and HDT 3 inserted the second needle. At 11:05 am there was a problem with the second needle so HDT 3 cleaned the area again, palpated it then inserted another needle without cleaning the insertion area. During an interview at 11:15 am, HDT 3 was asked about inserting the needle after palpating and before cleaning again. She said it was necessary and she had to do it that way to stabilize the fistula so she could get the needle in and this was her usual practice. ICUD was also present during these observations and interview and agreed the insertion site of the needle should have been cleaned after palpation and before the tech accessed the fistula.

DV 2's policy: Cannulation with Safety Needle Device" policy, created 4/14/21 was reviewed. It indicated under Policy: 1. Chloraprep is the preferred cleansing agent for vascular access site care. . . . Cannulate an AV Fistula: without contaminating cleaned area, stabilize access with non-dominant hand. . . insert needle. . . secure access site.

During an interview on 4/6/23 at 8:30 am, the above HD observations from yesterday were discussed with IP. He agreed that both of these did not follow policy and proper infection control practices. He said they have a policy regarding capping lines and their infection control policies are in the dialysis area with the HD techs who signed off that they had reviewed and understood these policies.


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11. The hospital's policy titled "Infection Prevention," dated 2/21, indicates that the hospital's infection control policies and procedures are consistent with the guidance from the Centers for Disease Control and Prevention (CDC) and the Association for Professionals in Infection Control and Epidemiology (APIC). The policy indicates that the department will implement and maintain the Infection Control Plan and risk assessment, provide infection surveillance to address potential hospital-acquired infections, and analyze surveillance data to determine opportunities for improvement.

The hospital's policy and procedure titled, Isolation Precautions, dated 3/23, indicate the purpose of the policy is to prevent the transmission of pathogens by using CDC recommended isolation precautions, in addition to standard precautions in all environments of patient care. The precautions apply to anyone entering the patient's room, including all healthcare workers, visitors, and family members. The policy indicates contact precaution requirements included using gloves when entering and removing them before leaving the patient's room whenever contact with blood, body fluids, non-intact skin, or contaminated environmental surfaces is anticipated. Gowns were required when entering a patient's room if there is anticipated contact with the patient's environmental surfaces or objects in the room. Remove the gown before leaving the room. The gown should be the first piece of PPE (personal protective equipment) put on. For removal, the outer (contaminated) side of the gown should be turned inward and rolled into a bundle, then discarded. Unless visibly soiled with blood or body fluids, the gown may be discarded into regular trash. Masks were not generally required for contact precautions but were appropriate for use with any patient that was coughing or sneezing. Regarding goggles and/or face shields, they were not generally required for contact precautions. The necessity depended on specific circumstances for potential exposure to eyes and should be used whenever eye protection from droplets is anticipated. The guidelines indicate hand hygiene is required before and after patient contact and/or immediately after removing PPE. Regarding Patient Placement, the policy indicates a private room should be used whenever possible. Cohorting of patients that are in isolation due to the same infection is an acceptable alternative.

The policy guidance for patient transport included: Transportation of patients in isolation precautions should be limited whenever possible. When patient transportation is necessary, precautions to minimize the risk of transmission of microorganisms to other patients, staff, and the environment are to be taken. Personnel involved in transporting a patient in isolation precautions should anticipate their exposure to the patient or the patient's environment (bed, wheelchair) and continue to wear the appropriate PPE as necessary. Gloves worn during patient transport should be considered contaminated, and care should be taken not to contaminate the hospital environment (i.e. elevators, doors, etc). The isolation status of the patient must be communicated to the receiving area, whether inside or outside of the facility. Whenever feasible, dedicated equipment should be used (stethoscopes and blood pressure cuffs). If not dedicated, disinfect following use. Patients placed on isolation precautions will have a sign placed outside of their room identifying the type of isolation and instructions specific for that isolation. For patients on C-diff [Clostridium difficile - bacterial intestinal infection that causes diarrhea to life-threatening inflammation of the large intestines] contact isolation, healthcare workers need to use soap and water for hand hygiene, and the room needs to be cleaned using a 1:10 dilution of bleach in place of the hospital-approved disinfectant. These requirements will be communicated on the isolation sign.

A review of medical records indicated that Patient 27 presented to the emergency department on 3/13/23 and was subsequently admitted to the hospital. Her diagnoses included end-stage kidney disease and a bowel obstruction. Prior to her hospital admission, she was receiving dialysis procedures four days a week. A nephrology consult was completed, and dialysis treatments resumed during her hospital stay. Patient 27's status as of 4/3/23 included contact isolation precautions for MDRO (Multidrug-Resistant Organisms, which are bacteria that have developed resistance to multiple classes of antibiotics commonly used to treat bacterial infections and can cause severe infections that are difficult to treat) and for rule out C-diff (bacteria that causes symptoms such as diarrhea, fever, abdominal pain, and nausea. It is commonly acquired in healthcare settings and can be severe and life-threatening, particularly for vulnerable individuals).

The facility provided a list of dialysis procedures performed 3/20/23 - 4/3/23. The list indicated that on 4/3/23, Patient 27's dialysis started at 9:25 am, and Patient 40's dialysis started at 10:10 am. These were the only two patients receiving dialysis at that time.

On 4/3/23, at 10:50 am, the dialysis procedure room was observed with two patients receiving dialysis (Patients 27 and 40). Personal Protective Equipment (PPE) worn by two Hemodialysis Technicians (HDT 3 and 6) in attendance included gloves. No gowns were worn.

On 4/3/23, at 3:30 pm, during observations in the dialysis procedure room and concurrent interview, HDT 3 explained that HCT orientation to the hospital was conducted by the Dialysis Vendor (DV 2) training staff. HDT 3 confirmed if a patient was on isolation precautions, dialysis should be performed in the patient's room, and isolation guidance followed. HDT 3 confirmed she and other HDTs were trained on adherance to isolation guidelines, but not specifically for this hospital. Regarding how decisions were made about where a patient would have dialysis procedure, HDT 3 stated the preference was to have it done in the procedure room, exception was intensive care patients when dialysis always done in their room.When asked how she was trained on hospital-specific policies, HDT 3 stated she received an email from DV 2 training staff that included related hospital policies on 3/20/23, which was her first she performed dialysis procedures in the hospital. HDT 3 stated no training had been provided by the hospital.

On 4/4/23, at 9:45 am, during an interview, the hospital's newly appointed Dialysis Director/Intensive Care Unit Director (DD/ICUD), confirmed that the hospital infection prevention policy and procedure requirements for contact isolation were not adhered to when Patient 27, who was on contact isolation precautions for MDRO and rule out C-diff, was transported by HCT 6 to the 4th floor dialysis procedure room. While in the room, Patient 40 (who was not on contact isolation) was brought in, and both patients received dialysis in the same room at the same time. DD/ICUD was not aware of hospital-provided education for the new Dialysis Vendor (DV 2) staff regarding infection control policies and procedure requirements. During the interview, DD/ICUD explained that she did not have the necessary experience, knowledge, training, policies, procedures, or other framework to conduct her new responsibilities. DD/ICUD stated that she was not involved in the evaluation or implementation of DV2. DD/ICUD acknowledged the contracted service was implemented by the Chief Nursing Officer (CNO) without clear process expectations, policies and procedures, or a system for oversight.

On 4/4/23, at 3:30 pm during an interview, Registered Nurse 32 (RN 32) stated she was Patient 27's bedside nurse on 4/3

Based on dietetic services observations, dietary staff interview and dietary departmental document review and observations of nursing unit trash storage areas, interviews, and document reviews, the hospital failed to effectively implement and maintain an effective infection control program to ensure systems to ensure food safety and ensure trash was stored properly. These failures had the potential for cross contamination as evidenced by lack of:

1) A comprehensive program to maintain a clean physical environment in the kitchen,

2) A system to prevent potential contamination of salad bar foods in light of the facility's current practice to reserve food from the previous day's salad bar,

3) A system to ensure nursing unit pantries for resident food are maintained clean, and a policy that clearly assigns responsibility to do that,

4) An up-to-date policy and practice regarding hair restraint in the Food and Nutrition Services Department,

5) A process and training for staff to follow manufacturer's instructions to ensure sanitation of the beverage dispensing system,

6) A system in place to ensure food equipment was air dried; and

7) A safe environment in the soiled utility room on the medical/surgical nursing unit when the trash was not properly stored, and patient supply items were stored in the cupboards and available for use. This had the potential to result in cross-contamination of germs and viruses and posed a risk to the health and safety of patients and staff.

Findings:

Hospital document titled "Provision of Patient Care, Plan for ...Infection Prevention" reviewed 12/20 noted the scope of the Infection Preventionist position was to maintain effective measures to ...identify, and to control infection acquired in the hospital ...by effective means of surveillance ...and collaboration with hospital personnel." Similarly, the plan outlines the scope for Food and Nutrition Services for the " ...safe, accurate and timely ...storage ...and distribution of food ...for all medical center patients, staff and visitors ...."

It would be the standard of practice to ensure that equipment, food-contact surfaces, nonfood-contact surfaces, and utensils remain clean to site and touch and shall be kept free of an accumulation of dust, dirt, food residue and other debris. Multi-use food-contact surfaces shall be smooth; free of breaks, open seams, cracks, chips, inclusions, pits, and similar imperfections; free of sharp internal angles, corners, and crevices; and be finished to have smooth welds and joints (Food Code, 2022). The presence of food debris or dirt on nonfood contact surfaces may provide a suitable environment for the growth of microorganisms which employees may inadvertently transfer to food. If these areas are not kept clean, they may also provide harborage for insects, rodents, and other pests (Food Code Annex, 2022).

1. During initial kitchen tour and general kitchen observations on 4/3/23 beginning at 8:40 a.m., multiple areas were not clean. The areas had a combination of unidentified, dried on food particles, a buildup of gray fuzzy material resembling dust and/or a substance resembling a buildup of grease and other debris.

1a. The floors in the dish room as well as mechanical equipment underneath the dishwasher. The mechanical equipment consisted of two cylindrical pieces of equipment, a junction box, tubing and additional stainless steel boxes square boxes each of which measured greater than 5 inches in width and greater than 12 inches in height. There was also an additional electrical junction box that was directly below the counter. All were not clean. There was a buildup of unidentified food particles, black and yellow material resembling grease and a fuzzy gray material resembling dust.

Departmental policy titled "Food and Nutrition" dated 9/19 indicated "18. The dishroom can easily become untidy and a source for potential contamination if time and effort are not provided for housekeeping ..."

1b. The floors in the general kitchen area along the cook line also had a buildup of unidentified food particles as well as a buildup of unidentifiable black debris on most of the floor ties.

1c. The hot box (a heated piece of equipment resembling a refrigerator, intended to hold foods hot) was covered with unidentified food particles, a yellow grease-like substance. The glass doors also had dried on food debris.

1d. The knife sharpener and knife rack along the back wall had a buildup of black debris as well as dried on food particles.

1e. The interior and exterior of the freezer adjacent to the grill cook had a buildup of food debris and the gasket of the refrigerator had black debris.

1f. There was a soiled mop and a floor cleaning pad wedged between the cold food preparation counter and a speed rack (a metal storage rack with the capacity to hold multiple baking sheets). In a concurrent interview the Food Service Manager (FSM) stated the mops, when not in use should be stored in the janitorial closet.

1g. The utility rack that held cleaned/sanitized meal trays for the behavioral health unit had food particles on both shelves. Similarly, shelves of the utility cart that held clear plastic containers was covered with a clear yellow substance, resembling grease as well as dried on food particles.

1h. There was a buildup of food particles underneath the rollers on the clean side of the dish machine.

1i. The wainscoting along multiple kitchen walls had yellow substance resembling grease and food debris.

1j. In the cook's refrigerator there was a buildup of food particles. A baking pan in the refrigerator also had food particles as well as buildup of a yellow substance resembling baked on grease.

1k. The cutting board affixed to the sandwich station in the kitchen had multiple, deep knife cuts.

1l. The café refrigerator door handles adjacent to the steam table had unidentified a grease-like substance. The glass doors were not clean, and the handles were not smooth, rather were in disrepair. There was also a cut out circle, measuring approximately 1 inch in the stainless-steel door frame.

1m. Throughout the kitchen, metal sheet pans used for baking, roasting, and as trays/shelving in refrigerators and speed racks had an accumulation of unidentified black/brown substance resembling baked on grease.

1n. There was tape residue on counters, shelves, and refrigerators in all production areas and tray line area. There was label residue on numerous food storage containers. These sticky residues were a potential source of cross-contamination.

1o. The single door refrigerator at the start of tray line had a thick buildup of a gray substance resembling dust across the front air-intake grate and temperature dial. The handle and other exterior areas of the refrigerator had grime and food particles.

1p. The large stand mixer had dark gray and brown sticky grime in multiple locations.

1q. The backsplash and the shelving above the cold food prep counter had dark gray accumulation of grime and a substance resembling dust. The exposed back of the cold food counter that backed up to the cook's hot food preparation area, and the pillar between the cook areas were covered in grime, food particles, a gray substance resembling dust.

1r. The white ice bucket had black grime.

1s. The ovens and wok area, and their control knobs had a buildup of grease, grime and food splatter.

1t. Three out of three white bulk dry food storage bins in the cold food prep area had grime.

1u. The food labeling machines had grime and food splatters.

1v. The cook's food preparation sinks were labeled "Notice Food Prep Sinks Only," yet soiled pans and cooking utensils were stacked on its counters on 4/3/23 from at least 9:00 am to 11:00 am.

1w. Trash cans had heavy buildup of grime and food debris.

1x. Two out of two mounted fans, one blowing over the ice machine, and one blowing over clean dishes in the dish room had a heavy buildup of grime and a gray substance resembling dust.

1y. The ice machine had a buildup of debris and a gray substance resembling dust in the motor/tubing area of the machine.

1z. The countertop can opener in the cold prep area had a black grime and food debris on and around the cutting blade.

In an interview on 4/3/23 beginning at 10:50 a.m., the FSM indicated there was a cleaning log. He also stated individual employees were responsible for cleaning their work areas. The FSM indicated there was a "cleaning position," however when other food service staff called in sick or were on leave the employee responsible for cleaning was pulled to cover other duties, however he also had not approached the contracted Vendor or the hospital for additional staff positions to maintain the physical environment. The FSM also stated there was no mechanism for deep cleaning either internally or through an outside vendor. Concurrent review of departmental document titled "Weekly Cleaning Log" revealed the daily cleaning task consisted of one piece of equipment. As an example, on Monday's the coffee machine was scheduled for cleaning. The remaining weekdays had additional pieces of equipment. There was no cleaning scheduled for weekends. It was also noted the most recent completed cleaning schedule was dated July 2021. Review of departmental schedule dated 3/24-4/6/23 revealed except for an eight-hour stock position on Tuesdays and Fridays there was no designated cleaning position on the schedule.

In an additional interview with the Executive Chef (EC) on 4/3/23 at 3:05 pm he also showed their most recently completed "Weekly Cleaning Log" dated July 2021 and stated "we just got off track with it."

In an interview on 4/3/23 at 11:05 a.m., FSW 4 indicated today was a regular day off, however he was called in to help clean the department.

In an interview on 4/4/23 beginning at 3 p.m., the Infection Preventionist (IP) described the Environment of Care (EOC) Rounds as review of refrigerator and freezer temperatures, overall kitchen cleanliness, expired food products. The IP also stated recent findings were mostly in the café with torn chairs and counters that needed repair.

Departmental policy titled "Sanitation Inspections" dated 9/19 indicated it was the expectation that sanitation inspections effectively analyze departmental sanitation systems and standards, identify areas for special cleaning and evaluate departmental cleaning assignments.

A departmental document titled "Food Safety Management System - Monthly Food Safety Audit" dated 3/8/23 as a standardized Vendor audit and completed by the FSM failed to identify any issues, scoring 100% compliance with all aspects of a food safety system. In an interview on 4/4/23 at 9:10 a.m., the FSM stated this audit was completed as a "desktop" audit. There were no direct observations or staff interviews to determine compliance. The instructions for audit completion revealed the audit was intended to be completed as observations during a walk-through.

An additional audit titled 2023 Health Safety Audit Form-Food Services developed by the Vendor and completed by the FSM on 3/3/23 failed to identify the unclean floor surfaces, rather scoring it as full compliance.

Review of hospital documents titled "SRMC Environmental Surveillance Rounds" dated 6/22 and 12/8/22 failed to recognize issues with overall kitchen cleanliness.

2. Food contamination is not just limited to foods considered risky, such as chicken or fish. Prepared fruits, vegetables, and salads can also be potentially dangerous. Pathogenic (causing disease in humans) bacteria can grow and multiply on some types of food more easily than others.

Foods that grow bacteria more easily and quickly than other foods are a higher risk and are referred to by the FDA Food Code as "Time/Temperature Control for Safety food" or "TCS food" - (formerly called "potentially hazardous food" (PHF)). Time/Temperature Control for Safety food includes: an animal food that is raw or heat-treated; a plant food that is heat-treated or cut melons, cut leafy greens, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation (Food Code, 2022).

On 4/4/23 at 2:40 p.m., food handling practices in the hospital's café were reviewed. It was noted in addition to hot foods the hospital was offering a self-serve salad bar. The salad bar contained protein items such as tuna and egg salad as well as deli meats, cut lettuce, tomatoes, milk-based products such as cottage cheese and vegetable-based protein products such as tofu and cooked beans.

In a concurrent interview FSW 7 described a process of taking food temperatures at the beginning of the lunch meal service, at approximately 10:30 a.m., and a second time at the closing of the salad bar, at approximately 3 p.m., each afternoon. FSW 7 stated once temperatures were taken leftover items would be placed in a clean stainless container, labeled, dated and held for reuse the following day. In a follow up interview on 4/5/23 at 9:20 a.m., FSW 9 confirmed this was the practice. An additional interview FSW 3 validated cold production leftovers from the salad bar were used the following day. It was also noted while the salad bar consisted of not only protein based TCS foods it also included plant-based foods that were not temperature monitored for food safety.

Hospital policy titled Food Preparation and Service reviewed 9/19 indicated " ...4. Individual portions of food once served will not be served again." Review of the most recent "Third-Party Food Safety Audit" dated 11/3/21 failed to identify the reuse of self-service foods. Similarly, the Monthly Food Safety Audit, completed by the FSM dated 3/8/23 also did not identify the reuse of salad bar items, nor did it identify that not all TCS foods were monitored for food safety.

3. Nursing unit food pantries were not clean, and it was unclear who was responsible to clean the nursing unit food areas, or when. During review of food storage practices in the Post Anesthesia Unit on 4/4/23, beginning at 10:15 a.m., it was noted the nourishment refrigerator was not clean, there was a buildup of a black material, resembling mold in refrigerator #69. In the Cardiac Intensive Care Unit nourishment refrigerator, there was patient care equipment in the freezer (#16). It was also noted there were unlabeled containers of coffee creamer and a 4-ounce unlabeled mason jar with a congealed clear yellow liquid. In a concurrent interview with Registered Nurse (RN) 44 she indicated the items in the refrigerator likely belonged to employees. She also confirmed that staff did have an employee breakroom where personal items should be stored.

Further observations of the Surgical and PCU/Telemetry nursing unit patient food storage areas beginning on 4/4/23 at 10:30 am, showed both food areas were not clean. Refrigerators showed spills and food debris. Both freezers contained either personal patient food and/or foods from Dietary that were labeled with the names of patients no longer in the hospital. Drawers showed food spills including a white powdery substance and dried brown liquid spills. On the Surgical Unit, RN 42 agreed the refrigerator and drawers were not clean, and contained food labeled for patients who had been discharged. She stated dietary staff restocked the supplies daily, and housekeeping cleaned the area. On the PCU/Tele Unit, Certified Nursing Assistant (CNA) 1 agreed the refrigerator and freezer were not clean, and contained items labeled for discharged patients. He stated dietary staff restocked the supplies daily, and nursing and EVS were responsible to clean. RN 43, stated "The refrigerator is organized but could probably use a little cleaning."

Review of a policy titled Food Safety Standards, dated 9/19 showed "Food storage in nursing units: A separate refrigerator is designated for food. Food must not be stored in refrigerator used to store medicines, chemicals, or specimens ...All containers must be labeled with patient's name and date. Such food must not be stored for more than 24 hours."

Hospital policy titled "Patient Area Nourishments" dated 8/19 indicated while it was the responsibility of Food and Nutrition Services to stock items per par levels and to discard outdated items, the policy did not identify who was responsible for cleaning. Hospital policy titled "Cleaning Schedules "dated 9/19 indicated each area of Food and Nutrition Services is involved in routine cleaning and sanitation.

4. It would be the standard of practice to ensure food employees wear hair restraints. The 2022 FDA Food Code 2-402.11(A) showed "Food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food; clean equipment, utensils, and linens; and unwrapped single service and single-use articles.

During observations in the kitchen between 4/3/23 at 8:00 am and 4/5/23 at 5:00 pm, Food Service Worker FSW 6 did not have his hair fully covered with a hair net, and five staff (FSW 2, FSW 4, FSW 7, FSW 8, and FSW 10) had facial hair including beards, mustaches and long sideburns but did not wear beard nets as they prepared and served food, and handled clean utensils and equipment.

Review of departmental policy titled "Dress Code and Personal Hygiene" dated 9/19 was not consistent with the current standard of practice and regulatory requirements, rather the policy indicated beard restraints only need to be worn if facial hair is longer than ¼ inch.

5. During general food storage observation on 4/3/23 beginning at 10:30 a.m., it was noted there was a beverage dispensing system. The dispensing system consisted of a plastic bag containing the beverage syrup in a cardboard box which was connected to water supply using a plastic connector. In a concurrent interview the surveyor asked FSW 9 to describe how the system was replaced when the plastic bag was empty. FSW 9 stated the plastic connection was taken off and placed into a new bag. FSW 9 also stated if the outside of the connector was sticky, she would wipe it down. FSW 9 confirmed the lines were not cleaned or flushed.

The operator's manual for the beverage dispenser dated 1/14/15 guided staff to flush and sanitize all syrup lines as well as the syrup connectors on a monthly basis.

6. During a general kitchen observation on 4/4/23 beginning at 10 a.m., there were multiple square plastic containers measuring approximately 10" (inches) x 10" x 12" that were inverted and stacked together wet. In a concurrent interview the Executive Chef (EC) acknowledged all items should be thoroughly dried prior to storage. Departmental policy titled Warewashing dated 9/19 noted "After disinfection the utensils shall be allowed to drain and dry ...on non-absorbent surfaces."



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7. The facility's policy and procedure for infection prevention, dated 2/21, indicated that guidance was consistent with the Centers for Disease Control (CDC) and other reputable sources.

The CDC guidance for environmental cleaning in healthcare facilities, updated 10/21, included guidance as follows. "A soiled utility room should be used to hold items that are potentially contaminated with blood or other bodily fluids until they can be transported to an appropriate are for cleaning and disinfection. The soiled utility room should be a separate area from the clean utility rooms ...." "Waste containers in the soiled utility room should be emptied regularly, and overfilled containers should be emptied immediately. Bags or other containers used for waste should be stored and transported to the disposal area to minimize contamination of the environment. Waste storage areas should be kept clean and free of debris ...." The guidance indicated clean patient care items available for use, should be stored in a clean utility room, that was in a separate location from the soiled room.

During an observation and concurrent interview on 4/3/23 at 10:15 am with the Register Nurse Ortho/Neuro Director (OND), it was determined that the facility was not maintaining a safe environment in the soiled utility room on the medical/surgical nursing unit. Observations of the soiled utility room did not meet facility guidance for infection control when the trash bin was overfilled with bags of trash extending 2-3 feet over the top of the bin, and two filled trash bags were stored on the floor. Additionally, general patient items, including 5 flower vases, three sandbags, and four call light buttons, were stored in the cupboards of the soiled utility room. OND confirmed the items should not be stored in the soiled utility room due to the potential for cross-contamination if used during patient care.

Based on observations, interviews, and document review, the hospital failed to ensure that the infection prevention and control program reflected the scope and complexity of the hospital services provided when the Infection Prevention and Control department did not include oversight of the new dialysis vendor contracted service (DV 2). This failure to involve the infection prevention and control department in the evaluation and implementation of the new dialysis vendor contract resulted in the potential for sources of germs and viruses to go unidentified, which could result in the avoidable spread of disease to patients and staff.

Findings:

During an interview on 4/4/23 at 9:45 am, the hospital's Dialysis Director/Intensive Care Director (DD/ICUD) explained that she did not have the necessary experience, knowledge, training, policies, procedures, or other framework to conduct her new responsibilities. DD/ICUD stated that she was not involved in the evaluation or implementation of DV 2. The contracted service was implemented by the Chief Nursing Officer (CNO) without clear process expectations, policies and procedures, or a system for oversight.

During an interview with the CNO on 4/4/23 at 3:30 pm, it was confirmed that the CNO was not knowledgeable regarding the delineation of hospital oversight responsibilities for DV 2. The CNO did not provide hospital policies and procedures, nor vendor policies and procedures related to coordination of DV 2 oversight with the infection prevention department in the hospital.

On 4/5/23 at 3:30 pm, during an interview with the hospital's Infection Preventionist (IP), it was confirmed that the IP department was not provided with clear process expectations or policies and procedures for DV 2. The IP was not involved in the evaluation or implementation of DV 2. It was also confirmed that there had been no communication between DV 2 and IP. The IP was not aware of the status of training for the Hemodialysis Technicians (HDTs) performing dialysis treatments in the facility. DV 2 had not provided IP with any policies and procedures regarding maintenance and cleaning of the dialysis machines. The infection prevention department did not have knowledge of DV 2's infection prevention measures, and there was no communication of how the responsibilities were to be shared. No policies and procedures were found to indicate how DV 2 would integrate with the facility's infection prevention program. The IP confirmed that the CNO had not advised the IP department about IP oversight for DV 2. The IP stated that it was important for the hospital to identify the status and necessary surveillance requirements in relation to infection prevention specific to the provision of dialysis services, including cleaning and maintenance procedures employed, hand hygiene and PPE use requirements, supplies management, policies, and procedures for the provision of dialysis services.

DV 2's policies and procedures were provided and reviewed. However, the policies regarding infection control (which included blood spills, biomedical waste, HBV, HCV, prevention of C-diff transmission, and confirmed TB disease) were not comprehensive. No evidence was found to indicate a process for monitoring and surveillance of infection control requirements. The signed contract between DV 2 and the hospital, dated 3/16/23, was reviewed, and no evidence was found to indicate a process for monitoring and surveillance of infection control requirements.

The facility's policy titled "Infection Prevention," dated 2/21, indicated that the hospital's infection control policies and procedures were consistent with the guidance from the Centers for Disease Control and Prevention (CDC) and the Association for Professionals in Infection Control and Epidemiology (APIC). The policy indicated that the department would implement and maintain the Infection Control Plan and risk assessment, provide infection surveillance to address potential hospital-acquired infections, and analyze surveillance data to determine opportunities for improvement.

The CDC guidance includes "Core Interventions for Dialysis Bloodstream Infection Prevention," updated 2019. The guidance indicated ongoing surveillance should be conducted for bloodstream infections associated with hemodialysis catheters, arteriovenous (AV) fistulas, and AV grafts. This surveillance should include tracking rates and trends over time, using standardized definitions and methods, and identifying and investigating potential outbreaks. Facilities should monitor compliance with recommended infection prevention and control practices, including hand hygiene, use of personal protective equipment (PPE), environmental cleaning, disinfection of equipment and management of supplies.

Based on interview and record review the hospital failed to ensure the needs of patients and wishes of patients to become donors met acceptable standards of practice as evidenced by:

Failure of its medical staff to adhere to and implement all aspects of its policies regarding determination and declaration of brain death. Refer to A 885

The cumulative effect of this systemic problem resulted in the hospital's inability to comply with the statutorily mandated Condition of Participation: Organ, Tissue and Eye Procurement.

Based on interview and document review the hospital failed to implement its "Determination and Declaration of Brain Death in the Adult" policy, dated 4/2021, when:

1. Medical Doctor (MD) 1 conducted an apnea (not breathing) test in order to determine brain death that was not in accordance with facility policy when he failed to preoxygenate (giving more oxygen than usual just before the test) the patient, failed to decrease the PEEP (positive end expiratory pressure, keeps small lung spaces open to allow for adequate oxygenation) on the ventilator (machine that breathes for a patient) to 5 cm (centimeters) H2O (water), failed to get ABGs (arterial blood gases, balance of oxygen and carbon dioxide in your blood to see how well your lungs are working) prior to starting the test, cut the prongs (one end of the nasal cannula is split into two prongs which are placed just inside the nose) off a nasal cannula (device used to deliver oxygen into the nose) and stuck the ends down the ET tube (tube inserted into the lungs and connected to a ventilator) instead of connecting a Tpiece (an instrument used with a ventilator during spontaneous breath trials), so the amount of oxygen delievered to the patient was unknown; and

2. Performed the test five hours and thirteen minutes after completing intravenous (IV) continuous dose of Fentanyl and Propofol (CNS - Central Nervous System depressant medications) instead of waiting five times the drug's half life.

3. The apnea test was performed when Patient 4 showed she was taking spontaneous breaths, in addition to the breaths given to her by the ventilator, and had sluggish pupillary reaction within 12 hours of the apnea test.

As a result, Patient 4's apnea test was performed earlier than it should have been, which could lead to an incorrect determination of brain death and she received less oxygen during the apnea test that she would have, had the policy been followed, possibly contributing to more oxygen deprivation and brain death.

Findings:

The facility's "Determination and Declaration of Brain Death in the Adult" policy, dated 4/2021 was reviewed. Its purpose was "according to the Uniform Determination of Death Act, an individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made in accordance with accepted medical standards."
"PROCEDURE ...legal standard for determination of death ...CLINICAL EVALUATION PREREQUISITES ...Exclude the presence of a CNS-depressant drug effect by history, drug screen, calculation of clearance using five (5) times the drug's half-life, or drug plasma levels below the therapeutic range. Prior use of hypothermia may delay drug metabolism ...
APNEA 1. Absence of a breathing drive a. Absence of a breathing drive is tested with a CO2 (carbon dioxide) challenge. b. Prerequisites i. Normotension ii. Normothermia iii Euvolemia iv. Eucapnia (PaCOs 35-45 mm Hg, normal concentration of carbon dioxide inthe blood) v. Absence of hypoxia (not enough oxygen in the tissues to sustain bodily functions) vi. No prior evidence of CO2 retention (i.e. chronic obstructive pulmonary disease, severe obesity) c. Procedure: The Critical Care Nurse, Physician, and Respiratory Therapist will be present at the patient's bedside during the apnea testing. i. Adjust vasopressors to a systolic blood pressure greater than 100 ii. Preoxygenate for at least 10 minutes with 100% oxygen to a PaO2 greater than 200 mm Hg iii. Ventilator to be adjusted to provide normocarbia (PaCO2 35-45 mm Hg) iv. Reduce positive end-expiratory pressure (PEEP) to 5 cm H2O (oxygen desaturation with decreasing PEEP may suggest difficulty with apnea testing). v. If pulse oximetry oxygen saturation remains greater than 95%, obtain a blood gas. vi. Disconnect the patient from the ventilator. vii. Connect T-piece and deliver 100% oxygen via cool aerosol (Venturi). DO NOT EXTUBATE (remove ET tube). viii. Look closely for respiratory movements for 8-10 minutes. . . . xi. If no respiratory drive is observed, repeat blood gas after approximately 10 minutes. . . .

1. A review of Patient 4's record indicated she presented to the Emergency Department via ambulance with CPR in progress on 3/18/23 at 10:18 pm. She was resuscitated, placed on a ventilator and was admitted to the Intensive Care Unit (ICU) on 3/19/23. There was a nursing note dated 3/21/23 at 11:45 am that MD 1 "was at bedside seen adjusting vent settings, placed pt (patient) on spontaneous, pt went apneic (not breathing). MD (doctor) requested nasal cannula and scissors. MD disconnected pt from vent, cut nose piece out of nasal cannula and placed end of regular cannula tubing in the end of the ETT on 15 L. When asked MD to explain what he was doing he stated he was doing an apnea test. MD informed that the protocol for apnea test is to draw ABG right before test, to preoxygenate, then to place patient on Tpiece for 8 min and draw ABGs after 8 min. MD stated he does not need to follow the protocol and continued to keep the pt off the vent at 11:57 and ordered ABG after 8 min. RT (respiratory therapist) and charge nurse also at bedside explaining the protocol. Donor network present at bedside explaining correct procedure that needs to happen for donor network requirements and MD stated he will not be doing that and instead will just order a NM (nuclear medicine) brain flow test."

During an interview on 3/30/23 at 4:15 pm, Registered Nurse (RN) RN 6 said she cared for Patient 4. She confirmed the contents in the above accurately reflected the incident. She said MD 1 cut off the nose piece of the nasal cannula stuck it down the ET tube, turned off the vent and turned the O2 to 15 liters and left her like that for 8 minutes. She said it was a regular cannula not a high flow cannula. RN 6 said she told MD 1 that was not consistent with policy as did the Charge Nurse, RT and the staff from donor network. She said she told him he needed to hyperoxygente first and get ABGs and he said she just had ABGs done but this was about 11 am and her last ABG were drawn around 4 am, and MD 1 said he did not need to follow the protocol. During the apnea test the staff from the Donor Network told MD 1 that the protocol had to be followed and the checklist all had to be done, for her to be a donor.

During an interview on 4/3/23 at 3:45 pm, RN 5 said she was the charge nurse in ICU on 3/21/23. She said Patient 4 was being worked up as a donor patient and they had contacted the donor network and someone had come in from the donor network. After morning rounds that day, RN 6, who was assigned to care for this patient and MD 1 were in the room with the patient. The Donor Network staff asked for the plan so he could coordinate the organ donations and MD 1 became very upset and said he did not need to be told what to do. RN 5 said we told Physician 1 that the brain death needed to be determined a certain way. MD 1 proceeded to cut off the nasal prong from a nasal cannula and stuck the ends down the ET tube, took the patient off the ventilator and turned the O2 to 15 L (liters) and left the patient there for 8 minutes. There was no pre-oxygenation done and no pre ABGs done. The End tidal CO2 went up to greater than 60 so MD 1 said she was brain dead. He was very angry and then ordered a nuclear medicine brain scan and insisted it must be done that day.

During an interview on 4/4/23 at 12 pm, RT 1 said she got a page to Patient 4's room and MD 1 was talking to staff from Donor Network and wanted to do an apnea test. She said MD 1 did not communicate that with anyone. The staff from Donor Network, Charge nurse and nurse caring for the patient all told MD 1 about the protocol. The charge nurse came in with a nasal cannula and MD 1 cut off the ends from the prongs and stuck the ends down the ETT, took Patient 4 off the ventilator and connected the other end of the cannula to the wall O2 and turned it to 15 Liters. RT 1 said our cannula goes up to only 6 L and we told him of the protocol but he was not receptive. She said MD 1 asked her to get ABG after 8 minutes but the patient was a hard stick and she had trouble getting those so then MD 1 said the patient was brain dead and he ordered nuclear brain flow study stat. She said prior to this, physicians have followed the protocol which includes getting ABGs and try to normalize if possible, get an oxygen Tset, and get ABG before and after the 8 minutes and compare both tests. In this case, no before and after ABGs were done and we don't know how much O2 patient was getting during this 8 minutes when she was off ventilator. Prior to the apnea test the patient had been on a ventilator with 40% FIO2 and 10 PEEP.

The nasal cannula that was used was showed to the surveyor and a picture taken.

During an interview on 4/5/23 at 9:30 am, the ICU Director said she had received two reports about the incident with the apnea test with Patient 4 and she had referred it to peer review.

During an interview on 4/6/23 at 8 am, the Chief Nursing Officer (CNO) said he spoke to MD 1 and he admitted he did not review policy and did not follow it and said this is how he has done it over the last 20 years. The CNO said he showed him the policy and reviewed it with MD 1 who admitted to cutting the nasal cannula and sticking it down the ET tube and connecting the O2 to 15 liters and was at bedside for the entire 8 minutes.



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2. A review on 4/4/23 of Patient 4's clinical record indicated Patient 4 was on the following medications:
*Fentanyl 150 mcg/hr start 3/19/23 at 4:45 am stop 3/21/23 at 5:30 am
*Propofol 27 mg/hr start 3/19/23 at 12:08 am stop 3/21/23 at 5:30 am

During an interview on 4/4/23 at 3:15 pm the Director of Respiratory Therapy stated that the Apnea test tests the breathing reflex. The Apnea test tests the lower portion of the brain called the Pons which would be responsible for the breathing reflex. If there is no breathing reflex from the Pons, that could indicate brain death, at least in the Pons area. He also said that respiratory depressive medications can affect the results of the test and you want to make sure the respiratory depressive medications do not cause a false positive response. A false positive response would be a problem because you would determine that a patient was brain dead and they may not be brain dead and just sedated due to the respiratory depressive medications. Treatment would be dramatically different.

During an interview on 4/4/23 at 4:04 pm the Director of Pharmacy (DOP) stated that Fentanyl and Propofol were medication used for reducing agitation and limiting movement for Patient 4. The DOP also stated that both Fentanyl and the Propofol could cause respiratory depression.

A review on 4/4/23 of the hospital policy entitled Determination and Declaration of Brain Death in the Adult indicated "PROCEDURE ...legal standard for determination of death ...CLINICAL EVALUATION PREREQUISITES ...Exclude the presence of a CNS-depressant drug effect by history, drug screen, calculation of clearance using five (5) times the drug's half-life, or drug plasma levels below the therapeutic range. Prior use of hypothermia may delay drug metabolism ...

A review of the Lexicomp Online, a nationally recognized drug information resource, indicated that the following drug half-life:
*Fentanyl 2 to 4 hours; when administered as a continuous infusion, the half-life prolongs
*Propofol 4 to 7 hours

A review on 4/4/23 of Patient 4's clinical record indicated Patient 4's had an Apnea Test in order to determine brain death. The test was attempted on 3/21/23 at 10:15 am. The test was not completed because the respiratory therapist could not obtain blood gases.

During an interview 4/4/23 at 1:00 pm Medical Doctor 1 (MD 1) stated that he was not aware that he had to wait five times the drug half-life when ordering the Apnea Test. He also said he wait about five hours to take the Apnea Test after stopping the Fentanyl and Propofol. He acknowledged that the Fentanyl and Propofol were stopped and in one half life the Apnea Test was attempted. He also acknowledged that he did not follow the hospital policy.


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3. On 3/18/23, Emergency Department (ED) summary chart notes indicated:
At 10:18 pm, Patient 4 arrived at ED via ambulance due to cardiac arrest (heart stopped beating). Patient 4 was found by bystanders "unresponsive with a foil of unknown substance nearby ...given Narcan ....CPR (cardiopulmonary resuscitation, chest compressions and breathing assistance)". Patient 4 was intubated (breathing tube placed in throat to provide oxygen and assist breathing). In the field, the patient had return of circulation and a pulse.

At 10:46 pm, the ED registered nurse (RN) documented "no neuro (neurological or nervous system problems) symptoms ... pupils WNL (within normal limits) ...ventilated (machine that assists breathing and oxygen via a breathing tube). After CPR in the ED, the patient, again, had return of circulation and a pulse. Patient's vital signs were temperature 95.3 F (Fahrenheit) (normal 98.6 F or 37 Celsius), heart rate 172 (HR, normal 60 to 100 beats per minute), blood pressure 218/147 (BP, average 120/80) and O2 Sat (percent of oxygen in blood, normal 100%) 88%". The chart indicated the patient's identity was unknown and was named "Jane Doe". There was no documented evidence the patient wished to be an organ donor.

At 11:00 pm, the ED vital sign sheet indicated Patient 4's BP 155/107, HR 126, respiratory rate (RR) 18 breaths per minute (normal 12 to 16), temperature 95.3 F. Patient 4 was on a ventilator.

The ED medication record indicated Patient 4 required medication for "sedation (deter patient from responding to stimuli)" started on propofol (a sedative medication that can cause relaxation to coma. It can stop breathing) (1000mg/100ml) at 2.7 ml/hr. equals 27mg/hr. (starting average sedation dose is 20 to 30 mg/hr.), and fentanyl (opioid medication that decreases pain, and can stop breathing) 50mcg/ml at 3.5 ml/hr. equals 175 mcg/hr., (starting average dose range for sedation 63 mcg/hr.)

At 11:07 pm MD (Medical Doctor) ED 3 documented Paitent 4's blood pressure and heart rate returned. Patient 4 "has been sedated and she is over breathing (spontaneous respirations, breathing on own) the vent (ventilator, machine that assist respirations and delivers oxygen) ....pupils were originally dilated, now they are midrange and reactive to light (normal eye-brain reflex response)". There was no documented evidence of bleeding, head and/or chest trauma. There was no documented evidence of imminent death, or irreversible cessation of circulatory and respiratory functions.

On 3/19/23, Discharge Summary chart notes indicated (except where noted):

At 2:15 am, the chart indicated CT scan (a machine that takes pictures of internal structures ) head results, " no evidence of acute intracranial [structures inside skull] findings".

At 2:30 am, Patient 4 arrived at the CICU (Critical Intensive Care Unit for very sick patients). The chart indicated Patient 4 received IV (medications given via a vein) fentanyl, propofol, and nicardipine (medication to lower BP). Patient 4 "observed" spontaneous respiratory rate 31 bpm (breaths per minute). Ventilator respiratory and apnea (no spontaneous breathing) rate set at 20 bpm.

At 3:49 am, IV sedation medications increased: Propofol 27 ml/hr. (270 mg/hr.) (increased from ED dose of 27 mg/hr.), and fentanyl 20 ml/hr. (1,000 mcg/hr.) (increased from ED rate of 175 mcg/hr.).

At 6:56 am, charting indicated Patient 4 breathing while on the ventilator: Observed spontaneous respiratory rate 32, "deep ...labored ... accessory muscle use (sign of difficult breathing) ...tachypnea (fast breathing)", O2 Sat 93%, heart rate 116, blood pressure 112/76. Ventilator respiratory rate set to deliver breaths and apnea trigger at 20 bpm.

At 7:03 am, charting indicated "Restraint measures taken ....clinical justifications for restraints ....unable to follow instruct ...restraints placed for safety". The charting described Patient X's observed spontaneous respiratory rate of 28, "deep ...labored) ... accessory muscle use ...tachypnea ", O2 Sat 93%, heart rate 71, blood pressure 120/74.

At 10:23 am, charting indicated, " Sedation titrates for increased RR", and Patient 4's eyes were "PERRL" (PERRL stands for pupils equal round and reactive to light, which is a normal response eye-brain reflex for brain function) react and change with light, and "sluggish". The chart indicated both eyes "pupil size 2" (pupil size in adults varies from 2 to 4 mm in diameter in bright light to 4 to 8 mm in the dark. Normal pupils are equal in size and react (get smaller) to light). The charting described Patient X's breathing: observed spontaneous respiratory rate 31, "dyspnea (difficult labored breathing) ...labored ... deep ...tachypnea", O2 Sat 91%. The ventilator respirator and apnea rate setting 20 bpm remained unchanged.

At 2:09 pm, the nursing documentation indicated Patient 4 "sedated ...occ (occasional) eye movement not follow or respond to stimuli ...remains on sedation "

At 3:56 pm, charting indicated the continuation of "restraint measures taken ....clinical justifications for restraints ....unable to follow instruct ...restraints placed for safety". Blood pressure 120/82, HR 73, breathing while on the ventilator: observed spontaneous respiratory rate 31, "deep ...labored ... accessory muscle use ...tachypnea".

At 5:39 pm, charting indicated continuation of "restraint assessment".

At 7:46 pm, charting indicated IV sedation medications continued for propofol 27 ml/hr.(270mg/hr.) and fentanyl 20 ml/hr. (1,000 mcg/hr.). Blood pressure 122/81, HR 75, breathing while on the ventilator: observed respiratory rate 21 and "normal". The chart indicated both eyes "pupil size 2 ...PERRL", react and change with light, and "sluggish".

At 9:56 pm, charting indicated Paitent 4 had "emesis (vomiting) ...coffee grounds (sign of stomach and intestine bleeding)".

At 11:00 pm, the chart indicated BP 121/88, temp 33.1, spontaneous RR 22 "normal ...accessory muscle use ....tachypnea", O2 Sat 98%. IV sedation Propofol was at 21.6 ml/hr. (216 mg/hr.) and fentanyl was at 3.5 ml/hr. (175 mcg/hr).

On 3/20/21 Discharge Summary chart notes indicated (except where noted):

At 12:33 am, the chart indicated IV sedation medications propofol and fentanyl continued.

At 1:15 am, the chart indicated Bispectral Index monitor (BIS is an external brain monitor that indicate brain wave activity, BIS range 0-100, 0 equals no brain activity to 100 equals fully awake. As effects of sedation increase, the BIS number value will decrease) was started and the reading) was placed on patient. The first documented BIS was 89 out of 100.

At 1:04 am, the chart indicated BP 114/76, HR 68, RR 20, "normal ...accessory muscle use ....tachypnea". O2 Sat 97%, temperature (temp) 33.1 C.

At 1:52 am, nursing documentation indicated Patient 4 "maintenance of hypothermia ...sedation in place ...does over breath the vent 9spontaneous respiration while on ventilator) ...vasopressors (medications to maintain blood pressure) not in need of using ... does intermittently flutter eyes with tactical (touching) stimuli"

Laboratory (lab) data on 3/20/23 at 2:00 am indicated normal labs red blood cell (HCT, blood red cells carries oxygen to the body), count white cell count (WBC, normal reflects no infection), sodium and chloride (Na CL, commonly known as salt, electrolytes that are needed for normal heart and nervous system function), potassium (electrolytes needed for normal heart and nervous system function), and kidney function (normal creatine). There was no documented evidence of an ABG, toxicology screen or alcohol levels.

At 5:14 am, the chart indicated BP 103/68, HR 76, spontaneous RR 25, "normal ...accessory muscle use ....tachypnea", O2 Sat 98%, temp 33.1 C, and BIS 90 out of 100. No changes to ventilator and apnea set rate of 20.

At 08:42 am, the chart indicated both eyes "sluggish ...pupil size 2 ...PERRL". Gastrointestinal (GI, stomach and intestines) assessment and drainage: "coffee grounds". IV sedation medications continued: Propofol at 21.6 ml/hr. (216 mg/hr) and fentanyl at 3 ml/hr. (150mcg/hr.)

At 10:06 am, the chart indicated BP 115/72, HR 91, spontaneous RR 31, "normal ...accessory muscle use ....tachypnea", O2 Sat 97%, Temp 34.6 C. BIS 83 out of 100. No changes to ventilator and apnea set rate of 20.

At 2:04 pm, MD 1 physician assessment notes indicated Patient X "code status full code (all medical life saving measures to be taken)". MD 1 documented a normal white count, red blood cell level (HCT), sodium, potassium and kidney function. MD 1 indicated "trying to find the relatives and patient's identity". The chart indicated the patient's identity was unknown. There was no documented evidence the patients wished to be an organ donor.

There was no documented evidence, MD 1 addressed and assessed Patient 4's spontaneous respiration, motor activity, response to agitation, need for restraints, brain activity on BIS, ongoing and increased medications for sedation requirements, reactive pupils or stable vital signs. There was no documented evidence, the physician assessed Patient 4 internal bleeding or continued side effects of fentanyl and propofol on breathing, brain function and body movement.

At 2:31 pm, the chart indicated BP 152/93, HR 91, spontaneous RR 31, "normal ...accessory muscle use ....tachypnea", O2 Sat 98%, BIS 82 out of 100. No changes to ventilator and apnea set rate of 20.

At 3:39 pm, nursing documentation indicated RN notified physician of patient's "increasing heart rate ... increased respiratory rate", and "MD 1 indicated the patient needs more sedation".

At 6:01 pm, the chart indicated BP 144/84, HR 117, spontaneous RR 36, "normal ...tachypnea", O2 Sat 97%, temp 36.6 C and BIS 90 out of 100. IV sedation medications increased: Propofol at 24.3 ml/hr. (243 mg/hr.) and fentanyl at 12.5 ml/hr. (625 mcg/hr.)

At 08:06 pm, the chart indicated BP 154/87, HR 121, spontaneous RR 33, "normal...tachypnea". O2 Sat 97%, Temp 36.9 C, BIS 88 out of 100.

At 11:48 pm, the chart indicated BP 136/69, HR 121, spontaneous RR 28, "normal...tachypnea", O2 Sat 97%, BIS 94 out of 100. IV sedation medications Propofol at 24.3 ml/hr. (243 mg/hr.) and fentanyl at 20 ml/hr. (1,000 mcg/hr.). The chart indicated for spontaneous breathing trial (SBT) by Repiratory therapy (RT) was not completed.

On 3/21/23 Discharge Summary notes indicated, except where indicated :

Laboratory data on 3/21/23 at 2:20 am indicated a decreased HCT 30.2 (normal 35 to 45, a drop is a sign of internal bleeding, i.e. GI bleeding, and decrease ability to deliver oxygen to vital organs), increased white count 12.2 (sign of infection), decrease in creatine (sign of kidney injury). Sodium and potassium remained normal.

At 3:07 am, the chart indicated Patient 4 "restraint Assessment".

At 5:03 am, the chart indicated BP 104/42, HR 112, RR 20, "normal...tachypnea", O2 Sat 95%, BIS 62 out of 100. IV sedation medications decreased Propofol at 8.1 ml/hr, (81 mg/hr.), and fentanyl at 10 ml/hr. (500 mcg/hr.). The chart indicated the patient's identity was unknown. There was no documented evidence the patients wished to be an organ donor.

At 7:06 am, the chart indicated "sedation vacation".

At 8:05 am, the chart indicated "SBT [spontaneous breathing trial] trial held" by respiratory therapy (RT) due to "inadequate mentation ... rewarming [bring body temperature to normal, 98.6 F or 37 C)". The chart indicated BP 113/55, HR 103, observed RR 20, "normal...tachypnea", O2 Sat 96%, temp 36.9 C, and BIS 62 out of 100. The ventilator respirator and apnea rate setting 20 bpm remain unchanged.

At 9:06 am, the chart indicated BP 112/42, HR 96, RR no patient "effort", temp 36.9 C and BIS 21. Both eyes "sluggish ...pupil size 6 ...PERRL". "Level of consciousness ...comatose". Gastrointestinal assessment and drainage: "coffee grounds".

At 11:57 am , the registered dietician (RD) assessed Patient 4 and RD documented "rewarming to finish at noon today ...visualized Propofol at 21.6 ml/hr. (216 mg/hr.)."

Sometime around 11:57 am, the nursing documentation entry recorded at 5:56 pm, indicated "MD 1 lives ID MD license in CA Idaho, and Mississippi at bedside seen adjusting vent settings ...MD disconnected patient from vent, cut nose piece out of nasal canula (small thin tubing that delivers low flow oxygen placed on the upper lip at the nostrils to a breathing patient. The tube is not used to deliver oxygen to a ventilated patient) and placed end of regular nasal canula tugging in the end of the ETT (endotracheal tube that placed inside the throat for beathing on ventilator. Placing nasal canula tubing in the ETT will occluded any air entry and breathing) ...MD 1 stated he was doing an apnea test ...MD 1 informed (by nursing) that the protocol for apnea test is to draw ABG (arterial blood gas, a test that indicates how much oxygen is in the blood and being deliver to patient) right before the test, to preoxygenate (give supplemental high flow oxygen), then to place on T-piece (large bore tube that is connected to ETT that allows the flow of air and allows one to breathe) for 8 minutes and draw ABG after 8 minutes ...MD stated that he does not need to follow the protocol and continued to keep the patient off the vent at 11:57 ...RT (respiratory therapist) and charge nurse also at bedside explaining the protocol ...Donor network present at bedside explaining correct procedures that needs to happen for donor network requirements".

There was no documented evidence, MD 1 addressed and assessed Patient 4's spontaneous respiration, motor activity, response to agitation, need for restraints, brain activity on BIS, ongoing medications for sedation requirements, reactive pupils or stable vital signs. There was no documented evidence, the physician assessed Patient 4's internal bleeding, falling HCT, decreased in kidney function, increased WBC or the side effects of fentanyl and propofol on breathing, brain function and body movement. There was no documented evidence MD 1 completed the required lab tests. For example, ABGs, drug screen and levels (test to determine what drugs are in the body), sodium, potassium, kidney function, electrolyte levels, or endocrine (hormones) disturbances. There was no documented evidence of bleeding, head and/or chest trauma. There was no documented evidence of imminent death, irreversible coma, or irreversible cessation of circulatory and respiratory functions. There was no documented evidence MD 1 discussed Patient 4's medical condition with the patient or family members.

There was no documented evidence as to why Donor Network was present at the bedside for Patient 4 who at 8:05 am, did not yet have a "SBT", and had stable vital signs and evidence of brain activity: BP 113/55, HR 103, observed RR 20, "normal...tachypnea", O2 Sat 96%, temp 36.9 C, and BIS 62 out of 100. There was no documented evidence MD 1 and hospital staff followed hospital policies for "Organ Donation and Anatomical Donations for Transplantation" or "Determination and Declaration Of Brain Death in the Adult". There is no documented evidence as required by hospital policy hospital staff and MD 1 followed national guidelines, regulatory or statutory requirements. There was no documented evidence of circulatory death, brain death or coma. "Organ Donation and Anatomical Donations for Transplantation ...Organ donation may take place when brain death has been established". There was no documented evidence the "Family Notification Form" signed by two physicians involved with confirmation of Patient 4's brain death. There was no documented evidence of donor's legal declaration of an anatomical gift. Approval for donation must be obtained either by first person authorization of the patient (Donor Registry/Advance directive/signed donor card) or next-of-kin.

At 12:04 pm, the registered dietician note indicated "patient remains intubated and no longer sedated".

At 12:18 pm "service time" and "dictated" at 3:33 pm, NM brain scan (nuclear medicine scan evaluates activity of the brain) indicated "lack of intracerebral activity consistent with brain death".

At 12:56 pm, MD 1 notes indicated Patient 4 "intubated ...off sedation ...not responding to verbal or tactile stimuli ...awaiting family". The chart indicated the patient's identity is known. There was no documented evidence the patient wished to be an organ donor.

There is no documented evidence MD 1 followed hospital protocol for Determination and Declaration of Brain Death in the Adult and completed the clinical evaluation requirements. There was no documented evidence of testing and the absence of oculocephalic testing (doll's eyes reflex), oculovestibular reflex testing (caloric stimulation), corneal reflex (blink with touching of the cornea), pharyngeal and tracheal reflexes (gag reflex), breathing drive (spontaneous breathing) or apnea test. There was no documented evidence MD 1 excluded the presence of a CNS-depressant drug effects of propofol or fentanyl, calculated of clearance drugs, or effects of hypothermia may have had on drug metabolism, lab values, and patient response. There was no documented evidence MD 1 completed the required lab tests. For example, ABGs, drug screen and levels (test to determine what drugs are in the body), sodium, potassium, kidney function, electrolyte levels, or endocrine (hormones) disturbances. There was no documented evidence MD 1 discussed Patient 4's medical condition or organ procurement with family members.

At 1:33 pm, chart indicated BP 107/45, HR 85 observed RR 16, "normal...tachypnea". O2 Sat 96%, Temp 36.8 C. The ventilator respirator and apnea rate setting at 16 bpm.

At 5:16 pm MD 1 notes indicated Patient 4's eyes "PERRL ...now breathing with the ventilator ... breathing above the ventilator [spontaneous respiration] ventilator yesterday ....urine toxicology positive for amphetamines and fentanyl ...brain flow scan today confirm brain death ...coffee ground emesis ...Donor Network has been consulted".

MD 1 indicated Patient 4's eyes "PERRL (PERRL stands for pupils equal round and reactive to light, which is a normal response eye reflex for brain function)". However, there was no documented evidence that MD 1 followed hospital protocol for Determination and Declaration of Brain Death in the Adult and completed the clinical evalautions requirements. For example, there was no documented evidence of brain: oculocephalic testing, oculovestibular reflex testing, corneal reflex, pharyngeal and tracheal reflexes (gag reflex), breathing drive, or apnea test. There was no documented evidence MD 1 excluded the presence of a CNS-depressant drug effects of propofol or fentanyl, calculated of clearance drugs, or effects of hypothermia may have had on drug metabolism, lab values, and patient response. There was no documented evidence MD 1 completed the required lab tests. There was no documented evidence of circulatory death. There was no documented evidence MD 1 discussed Patient 4's medical condition or organ procurement with family members.

At 5:45 pm, nursing documentation indicated "discussed during rounds-- patient unresponsive, no gag reflex ...no corneal reflex, pupils dilated ... donor network involved ...No family has been found yet ...MD ordered EEG (Brain scan to determine brain wave activity) ...MD 1 adjusting vent settings, placed pt on spontaneous, pt went apneic".

There was no documented evidence Patient 4 had an EEG completed. There was no documented evidence MD 1 and hospital staff followed hospital policies for "Organ Donation and Anatomical Donations for Transplantation" or "Determination and Declaration Of Brain Death in the Adult". There was no documented evidence as required by hospital policy that hospital staff and MD 1 followed national guidelines, regulatory or statutory requirements.

At 6:40 pm, MD 1 notes indicated the "'declaration of brain death' form needs to be filled out".

At 8:33 pm, the chart indicated both eyes "reaction (to light) none ...pupil size 6". BP 151/85, HR 92, RR no patient "effort". BIS no documentation. Gastrointestinal assessment and drainage: "coffee grounds".

On 3/22/23 Hospital Discharge Summary notes indicated, except where indicated

Based on interview and record review, the hospital failed to ensure that the operating room (OR) was supervised by an experienced Registered Nurse (RN) with demonstrated appropriate education, background working in surgical services, and specialized training in the provision of surgical services/management of surgical service operations. This failure had the potential for inappropriate practices to occur and result in patient infections and adverse events.

Findings:
A review of the facility's document entitled "Job Description Nursing Director Surgical Services" dated 1/2014 indicates that the "Director of Surgical Services is responsible for direction of patient care in the operative environment." Requirements for this position include "At least 2 years experience in Surgical Nursing," and "Current Certified Nurse OR (CNOR) (AORN) certificate(s) upon hire, preferred." (AORN, Association of Operating Room Nurses).

A review of the facility's job posting document entitled "Job 2023-122167 Director of Nursing-Surgical Services" indicates that the qualifications of the successful applicant include "A minimum of two years supervisory/management experience (is) necessary."

A review of a document provided by the facility on 4/3/23 at 10:00 am presented as the resume of the Operating Room Director indicates that the applicant spent 3 years (5/2014-6/2017) as "QI/QA Director Apogee Surgery Center." Job duties outlined include quality assurance activities but do not include any reference to work in the perioperative (pre-operative, intra-operative and post-operative) units. This resume contains only one reference to work in the perioperative unit, that is from 9/2009 to 8/2020 the applicant worked as a post-operative nurse in a 10 bed surgery center. The document does not indicate that the applicant has had any experience in the operative environment or any experience in a supervisory/management role in the perioperative environment.

During an interview on 4/3/23 at 10:00 am Director of Human Resources, (HRD) states that she is unable to locate any evidence in the Operating Room Director, (ORD) file that she possesses the certification of operating room nurse (CNOR).

During an interview on 4/5/23 at 10:00 am, HRD confirmed that in the job description for OR Director, when it says "At least two (2) years of experience in Surgical Nursing", that is referring to OR experience, not medical/surgical experience. The job description also indicates that "Current Certified Nurse OR (CNOR)(AORN) certificate(s) upon hire, preferred." The CNOR certificate requires "a minimum of 2 years and 2,400 hours of experience in perioperative nursing, with a minimum of 1,200 hours in the intraoperative setting." https//:aorn.org

On 4/4/23 at 2:30 pm during an interview with the Operating Room Director, (ORD) she stated that she had worked as an Licensed Vocational Nurse (LVN) instructor for Shasta College for 11 years. She had also been a Nursing House Supervisor here for 5 years. She was currently in a full time position at the facility as the DART nurse (Discharge, Admission, Resource and Training). She also worked as the Nursing House Supervisor one day per week and more as needed. She was the SART (Sexual assault response team) nurse coordinator at the facility and in that capacity was also an active SART response nurse.

ORD said that about 3-4 weeks ago the Chief Nursing Officer (CNO) approached her to offer her the position of OR Director if the current OR Director (who was on LOA at the time) did not return. She said she was interested and agreed to do that. She stated she expected to start that position on Monday 4/10/23 but had not moved into it yet.

ORD stated her background had been working in postoperative care at a small local hospital (privately owned hospital doing simpler elective procedures). She then took a position as Quality Director at an Ambulatory Surgery Center (a small physician owned surgery center doing simple elective procedures). In that role, she sometimes had an opportunity to assist in pre-op, intra-op, and post-op doing procedures she described as orthopedic, ear nose and throat and pain management procedures. The orthopedic cases were mostly carpal tunnel procedures (small incision in wrist to release tension) or arthroscopic (procedures done with assistance of a scope and without open incisions) procedures. No general surgery cases were done there. This was not a management of the operating room position. ORD acknowledged that this position was not primarily as an intraoperative nurse and was not a supervisory/management position in the perioperative arena.

About 3-4 weeks ago ORD went to the operating room at this facility and offered to assist them as she had a circulator background. She then selected the types of cases she was used to seeing at the Ambulatory Surgery Center and the surgeons she knew from there. She shadowed in those cases and then after a few times she felt she could act as circulator in those rooms. She said these cases were the ones she was familiar with, like carpal tunnels (small incisions into the wrist).

ORD had no formal orientation or training in the OR at this facility. She described her past training as self directed "online modules at the Ambulatory Surgery Center and textbooks" as well as asking an experienced nurse. She did not recall the name of the online module program she completed but it was not AORN's Perioperative 101 course. It was specific to outpatient procedures though and did not include things like prone positioning concerns for lengthy general anesthesia cases for example or more complex operating room (OR) cases. ORD had not been oriented to general acute cases or any of the larger more complex cases in this OR. She had no experience in Cardiac OR, general surgery or oversight of Sterile Processing/High Level Disinfection, (SPD/HLD).

ORD stated that her understanding of the responsibilities of this new position as Director of the OR do not include her learning to circulate or assist in all the cases. She was willing to learn and expressed hope that she will get sent to the Prime University Academy training (facility program). She understoods the magnitude of the job she was accepting and felts she had the skills to address the problems or find resources to assist her even though she did not now have that expertise. She had no training in SPD or HLD or cardiac surgery operating rooms, all areas she will be supervising. She was not able to indicate she was a certified operating room nurse. It was unclear whether she currently possessed the requirement to sit for this exam (2,000 hours in perioperative specialty with at least 1500 of that in the intraoperative arena). CC-Institute.org https://www.cc-institute.org > CNOR

ORD stated she will still be in the SART coordinator and responder role when she starts as OR Director on Monday 4/10/23, as well as still be in her college teaching role. She will quit the college teaching role in May at semester end and will quit the SART responder role when she hires and trains replacements. She stated she plans to keep the full time SART Coordinator role while she is also the full time OR Director.
She acknowledged that there was no established program for consistent onboarding of new employees into the operating room at the facility and stated she wanted to create that. She acknowledged that the way she was essentially training herself there was not optimal.

During an interview on 4/3/23 11:30 am HR Director stated she was unable to locate any unit specific skills validation checklist for Operating Room staff. The only orientation on file was online Healthstream modules. HRD stated these unit specific skills validation checklists did exist in some departments but this was not a process being done in OR.


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During an interview on 4/10/23 at 7:45 am, Medical Doctor (MD) 2, who was on the Governing Board and Medical Executive committees said the hospital just fired their old OR director who was qualified and now have a new one coming on that has only a little experience in an Ambulatory Surgery Center (focus on providing same day surgical procedures that are not so intensive as to require a hospital stay).

Based on interview and record review, the facility failed to ensure that the needs of patients seen in the Emergency Department (ED) met acceptable standards of practice as evidenced by:

Failure to provide a Medical Screening Exam (MSE) for three of six ED patients, two of which were triaged at a Level 2 (High Risk Situation such as unstable patient that is not as critical as a Level 1 patient, severe pain or distress, behavioral emergency, altered level of consciousnessand) and one who was triaged at a Level 3 (Patients require two or more resources and vital signs (VS) may or may not be in the "Danger Zone" as per Emergency Severity Index algorithm) from four and a half to seven hours, until they left the ED. No repeat assessments were done after the triage assessment for these three patients as well as a fourth patient who was triaged as a Level 4 (Patient presents with a condition that has a low potential for deterioration of complications). Refer to A 1112, Findings 1 - 4.

These failures resulted in the potential for increased adverse outcomes when emergency conditions are not promptly assessed, recognized, and treated. The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Emergency Services.

Based on interview and record review, the facility failed to have adequate numbers of nurses and other staff to provide assessments, and safe and effective care as needed by the patients, in the Emergency Department (ED).

The facility failed to implement its Emergency Medical Treatment And Active Labor Act (EMTALA) policies when three of six ED patients did not receive a Medical Screening Exam (MSE) for four and half to seven hours. The facility failed to implement its reassessment policy and patient classification policy for four out of six ED patients. The facility also failed to implement its Suicide and Psychiatric Emergency policies when no mental health referral was made and patients were not observed adequately as per their policy, for two of six ED patients. ED beds have been closed and not readily available for patients waiting in the lobby, because of lack of nurses.

These failures resulted in patients not being seen and evaluated for possible emergency medical conditions and emergency psychiatric conditions, and patients not being reassessed for possible changes during long wait times of up to several hours in the waiting room, all having the potential to result in a serious decline in the condition of these patients.

Findings:

The facility's "EMTALA - Compliance with the Emergency Medical Treatment and Active Labor Act" policy, dated 5/2021, was reviewed. It indicated, "Any individual who presents to the ED requesting examination or treatment, shall be provided with an appropriate MSE. This MSE will determine whether an individual has an actual Emergency Medical Condition (EMC). Triage is performed by qualified personnel. Triage does not take the place of an MSE. Triage prioritizes when an individual will be seen by a LIP (Licensed Independent Practitioner). A MSE is offered to any individual who presents for an examination or treatment of a medical condition. The MSE is a continuous process reflecting ongoing monitoring in accordance with an individual's needs. If an individual leaves the hospital before being seen for the MSE, the hospital is not in violation of EMTALA. The hospital needs to document the circumstances of the individual leaving as well as retain all notes pertaining to that hospital visit. As much as possible individuals should receive a full explanation of the risks and benefits of leaving the hospital. The hospital needs to be able to prove that appropriate steps were taken to discourage an individual from leaving."

The facility's "Triage" policy, dated 5/2022, indicated: "Triage involves a rapid, directed patient assessment which provides an assignment of an acuity level for each patient arriving in the unit. The goal is to quickly and efficiently determine the patient sees the correct provider and the appropriate care is provided in a timely manner. Acuity levels will be assigned to patients based on the revised Emergency Severity Index (ESI) algorithm. The triage assessment does not constitute a medical screening exam. Triage Level 1 requires immediate life-saving intervention. Triage Level 2 High Risk Situation (such as unstable patient that is not as critical as ESI 1, severe pain or distress, behavioral emergency, altered level of consciousness). Patient will be placed in the first available appropriate patient care area. The triage Registered Nurse (RN) will notify the charge nurse of these patients and document this notification. The triage RN will monitor and reassess the patient until a bed is available. Triage Level 3 Requires two or more resources and vital signs (VS) may or may not be in the "Danger Zone" as per ESI algorithm. Triage Level 4 The patient presents with a condition that has a low potential for deterioration or complications. One resource is expected to treat this patient. Triage Level 5 The patient presents with a condition that may be acute but is not urgent; the condition may be part of chronic problem with very low potential for deterioration or complications. The presenting condition is anticipated to require no resource utilization."

The facility's "Patient Classification" policy, dated 5/2021, indicated: "Patient acuity will be assigned during Triage and repeated per standard set by acuity. Level 2 requires physician evaluation and assessment within 15 minutes to stabilize. Level 3 Acute illness or injury, stable at this time, has the potential to become unstable. Should be seen by an MD/Midlevel within 60 minutes. Level 4 Patient is not in danger of losing life or limb, but is having pain or discomfort, is not three months old or younger, should be seen by an MD/Midlevel within 1-2 hours."

The facility's "Patient Assessment/Reassessment" policy, dated 5/2022, indicated: "It is the policy of the ED to assess/reassess all patients according to the following triage criteria, this includes patients that arrive via ambulance or through the lobby to the triage area. Reassessment will continue through the patient's stay in the ED based on the most recent acuity level. In the event a bed is not immediately available in the ED, the Triage Nurse will reassess as follows: Level 1 MUST go back immediately. Level 2 every 30 minutes. Level 3 every 60 minutes. Level 4 every two hours. Level 5 every four hours."

The facility's "Suicide Risk &/or Patient at Risk of Harm to Self or Others," dated 4/2019, indicated: "It is the policy of this facility to ensure patient and staff safety when patients who are deemed to be a potential risk to themselves or others while being assessed and treated in the ED or during acute hospitalization. The goal is to stabilize patients who exhibit behaviors which might cause injury to self or others, ensure psychosocial assessment, and are transferred to an appropriate inpatient/outpatient psychiatric treatment facility when determined by their attending physician that the patient is medically stable for discharge." High Risk Indicators for Self-Harm or Harming Others: "Patients exhibiting or verbalizing any of the following will be referred to the Social Services for psychosocial assessment &/or put on suicide precautions if appropriate. 9. Patients currently verbalizing suicidal-homicidal ideations."

The facility's "Safe & Supportive Observation Psychiatric Emergencies," dated 1/2022, indicated: its purpose was "To promote a safe environment clinically and for treatment purposes. 1. At triage - observation levels and suicide risk: a. Risk assessment included identification of specific factors and features that may increase or decrease risk for suicide. b. Immediate safety needs and most appropriate setting for treatment in the ED addressed. c. Documentation and reporting in electronic patient care record. 2. While awaiting mental health consultation ensure the patient is safe: a. Provide medical treatment for immediate medical problems. b. Place on appropriate level of observation. c. Patient to be held in safe area. . . . 3. Ongoing care and management of the patient in the ED. This may include: a. Ensuring safety, supervision/observation of patient, minimizing absconding risk (careful supervision and observation, no drawn curtains). b. Monitoring vital signs. . . . "

1. During an interview on 4/3/23 at 8:25 am, the Emergency Department Director (EDD) said the main ED had 16 beds and the nurses had 4 bed assignments. They don't bring patients back if there is not a nurse available for that bed and those patients wait in the lobby until a bed and nurse is available. She said one traveler RN (nurse who takes a temporary assignment) left in the middle of her contract and her last shift was yesterday.

During a concurrent interview and record review on 3/30/23, at 11:54 am, the Chief Nursing Officer (CNO) reported the facility has continued to utilize travel nurses for departments with staffing shortages. CNO confirmed the facility instituted a second pay reduction, mid-contract, to their current contracted travel nurses. Three of 12 travel nurses refused the facility's pay cut that was breaking contract, and terminated employment at the facility.

On 4/5/23 at 2:30 pm, during a phone interview, RN 28 said they had not been educated as to how to incorporate the LVNs (Licensed Vocational Nurse) into the ED other than the LVNs were to take the low acuity patients. She said sometimes the LVNs are given a four-bed assignment inside the main ED, and on some shifts, there may even be two LVNs, so that's eight patients for the Charge Nurse to oversee and directly supervise. She said Level 4 and 5 patients are often seen ahead of Level 3 patients when there are LVNs working because they can't take Level 3 patients.

A review of Patient 36's record indicated he presented to the ED on 3/15/23 at 11:11 am with chief complaint of suicidal ideation. He was triaged as a Level 2 at 11:30 am and noted to be waiting for a bed. He was noted to not be in the lobby at 6:30 pm, more than seven hours after presenting to the ED. There were no reassessments or repeat vital signs in the record and no note from a physician indicating this patient had received a medical screening exam.

During a concurrent interview and record review on 4/4/23 at 2:15 pm the EDD said Patient 36 presented to the ED on 3/15/23 at 11:10 am with a chief complaint of suicidal ideation. He was triaged at 11:30 am as a Level 2 which was typical for a suicidal patient. The first time he was noted to not be in the lobby was 6:30 pm. The triage nurse was a traveler (nurse who takes a temporary assignment) but had worked there for a while. EDD said it was noted by the nurse that this patient had no active plan to kill himself but was very depressed and thinking about suicide. She confirmed there were no repeat assessments or vital signs in the record and this patient had not been seen by a physician.

During a subsequent interview on 4/5/23 at 2:45 pm, EDD said a psychiatric patient has to be medically cleared by the physician and then the chart would be sent to county mental health, who then notifies their mental health evaluators stationed in the ED, to evaluate the patient. She said Patient 36 did not have a medical clearance from the physician so a referral to county mental health could not be done by the nurse. EDD said if we have room and believe they are a harm to self or others we try to get them to come back to a room, if a bed is available. If there is no bed we try to place them in the ED within view of the triage nurse until we find them a room, sometimes in a gurney in the hallway or a chair. She confirmed the above policies had not been followed. She reviewed their staffing sheets and said they had two beds closed down and had nine mental health patients on hold on the day Patient 36 came into the ED.

2. A review of Patient 35's record indicated she was a 13 year old patient who arrived in the ED on 3/21/23 at 6:41 pm requesting a mental health evaluation. She was triaged at 7:02 pm at a Level 2. The triage note indicated the patient's mother was present and said the patient was having extreme "rage towards members of the family." The patient had a diagnosis of Bipolar disorder. The patient's mother was concerned about the safety of the patient and family members. Tonight was the most extreme behavior the mother had witnessed and said the patient had fallen to the ground with family, hitting her right eyebrow. There was an observable goose egg lump. The patient's mother was with the patient in triage for safety. Patient 35 was first noted not in the lobby at 11:37 pm, more than four and a half hours after presenting to the ED. There were no repeat assessments or vital signs in the record and nothing to indicate that a physician had conducted a medical screening exam.

During a concurrent interview and record review on 4/4/23 at 2:15 pm the EDD said Patient 35 presented to ED 3/21/23 at 6:41 pm and was triaged as a Level 2. She was first noted not to be in the lobby at 11:37 pm. She confirmed there were no repeat assessments or vital signs and this patient had not been seen by a physician.

During a subsequent interview on 4/5/23 at 2:45 pm, EDD said this patient's mother was with her. She said if a patient had someone with them for safety, we ask that person to monitor the patient until we can get the patient back to a room. She confirmed their policies had not been followed and said a mental health referral could not be made because this patient had not been medically cleared by their physician. She reviewed their staffing sheets for this shift and said all their beds were opened and they had one Licensed Vocation Nurse (LVN) with a four bed assignment.

EDD was asked about possible reasons Patients 35 and 36 did not receive a MSE or repeat vital signs or reassessments in a timely manner. She said their staffing had improved and she wasn't sure but it could have been due to high patient volume.

3. A review of Patient 34's record indicated she was an 88 year old patient who presented to the ED on 3/8/23 at 3:18 pm with a complaint of chest pain. She was triaged at 3:30 pm as a Level 3. Repeat vital signs were done once at 4:30 pm. Patient 34 had lab tests, chest x-ray, and an electrocardiogram (EKG, electrical activity of the heart) performed. The EKG indicated there was a prior heart attack, age undetermined and other abnormalities. Patient was noted "not in lobby" at 8:28 pm, more than five hours after presentation to the ED. There was no repeat assessments during her time in the ED and no repeat vital signs after 4:30 pm, and no note from a physician indicating an exam had been done.

During a concurrent interview and record review on 4/4/23 at 2:15 pm, EDD noted Patient 34 presented to the ED on 3/8/23 at 3:18 pm. She said it looked like their standardized procedures regarding diagnostic testing had been done. She said there were no repeat assessments and vital signs were repeated once at 4:30 pm. She confirmed there was no note by a physician to show that an examination had been done.

During a subsequent interview on 4/5/23 at 2:45 pm, EDD reviewed the staffing sheets for this shift and said they had been very busy on 3/8/23 and she had been charge nurse. There was one four bed section of the ED closed due to lack of nurses due to sick calls.

4. A review of Patient 38's record indicated he presented to the ED on 3/13/23 at 11:03 am with a complaint of neck pain and was triaged as a Level 4. He was noted "not in lobby" at 3:29 pm, almost four and a half hours after presenting to the ED. There were no reassessments and no repeat vital signs in the record and no note indicating a physician had seen this patient.

During a concurrent interview and record review on 4/4/23 at 2:15 pm, EDD confirmed the above and confirmed no repeat vital signs or reassessments had been done.