Nassau University Medical Center

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 48939 . Based on document review and interview, the Governing Body failed to maintain oversight of the infection control program to: a) ensure adequate resources for Infection Control Program activities and b) address all Surgical Site Infections (SSIs) per the facility’s Quality Assurance and Performance Improvement plan. Findings: (See Tags 0049, 0770, 0771) .”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 48939 . Based on medical record review, document review, and interview, the facility failed to utilize its Quality Assessment and Performance Improvement (QAPI) program to measure, analyze, and track data on all surgical site infections (SSIs). Findings: (See Tags 0273, 0286) .”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 48939 . Based on document review, medical record review, and interview, the facility failed to ensure that the Infection Prevention and Control (IP&C) Program was led by an infection control professional appointed by the governing body and met monthly and tracked all Surgical Site Infections (SSIs) per policy and procedure; that staff wore proper surgical attire per facility policy; that the governing body provide adequate resources to ensure the IP&C could demonstrate implementation, success, and sustainability of surveillance, prevention, and control activities; and to ensure SSIs identified by the IP&C program were adequately tracked and addressed in collaboration with hospital Quality and Performance Improvement (QAPI) leadership. Findings: (See Tags 0748, 0749, 0770, 0771) .”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 48939 . Based on document review and interview, the Governing Body failed to maintain oversight of the infection control program to (a) ensure adequate resources for Infection Control Program activities and (b) address all Surgical Site Infections (SSIs) per the facility’s Quality Assurance and Performance Improvement plan. Findings: Review of the document, “Annual Board Report - Infection Prevention and Control,” (2023 - 2024 Draft) revealed: “Drilldown: SSI Prevention ranked as the 1st priority in the 2023 Infection Prevention and Control (IP&C) Risk Assessment (RA) and will rank as the 1st priority in 2024 as SSI Rate went up by 35% in 2023 (27 SSIs) compared to SSI Rate in 2022 (20 SSIs) ...Plan of Action: SSI Prevention initiatives implemented by the Orthopedic Department in the previous years will be monitored in 2024 ... Case investigations of each SSI identified conducted with respective services.” Review of the “Isolation and Infection Prevention and Control Manual” (Revised 08/24/22) revealed: “Plan Assessment and Review: The risk assessed surveillance and organizational infection control plans are approved at least annually by the Infection Prevention and Control and Safety Committees. The Infection Prevention and Control Department reviews monthly outcome data for trends/problems and reacts accordingly ... Outcomes of both plans are evaluated by the Infection Prevention and Control and Safety Committees at least annually in the first quarter of each year ... Infection Prevention and Control Committee: ...The Committee meets at least eleven times per year and reports to the Medical Board and Performance Improvement Coordinating Group. The facility had no documented evidence that they developed an Infection Control Plan for 2024 and that the Infection Prevention and Control (IP&C) Committee met monthly as per the “Infection Prevention and Control Manual.” Per the interview on 09/04/24 at 2:00 PM, Staff H, Senior VP for Quality and Risk Management, acknowledged that the IP&C Committee should be meeting monthly per policy. Staff H stated they are unsure why meetings are quarterly rather than monthly. Staff H provided the document “February 2024 IP&C Report” (dated 03/25/24) and stated that these were the most recent minutes for the IP&C meetings. Per the interview on 09/06/24 at 2:38 PM, Staff I, Chief Medical Officer, stated, “We’ve had issues with finding a Director for the Infection Prevention and Control Program since the previous Director retired in December 2023. We had consultants come in to make the process less cumbersome ...I’ve also been overseeing the program with the assistance of [Staff D, Infectious Disease Attending] and our three (3) infection preventionists.” Staff I stated they had weekly meetings with the infection preventionists. There was no documented evidence of the weekly Infection Control meetings reported by Staff I. Review of the policy, “Committees of the Medical Board,” (Effective 11/07/2023) revealed: “Infection Prevention & Control Committee: 3.8.2 Functions: Define and develop standards and procedures for infection control ... Monitor nosocomial and other infections in an ongoing Quality Assessment and Improvement Program designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care and resolve identified problems ... Recommended resolution of identified problems in infection control and/or antibiotic usage shall be shared with all appropriate Medical Board committees and Hospital clinical, ancillary, and support services and departments. Reports will be forwarded to the Medical Board; monitoring reports and recommendations will be submitted to the Medical and Professional Affairs Committee of the Board of Directors.” Review of the SSI Report for 2024 revealed seven (7) Surgical Site Infections (SSI) from January 2024 to August 2024. There was no documented evidence that SSI data was collected for March, June, July, and August 2024. Per review of the document, six (6) of the seven (7) SSIs reported in 2024 lacked documented evidence of an investigation, and seven (7) of the seven (7) SSIs did not have evidence of implementation and monitoring of corrective actions to prevent reoccurrence. Per the interview on 09/05/24 at 2:18 PM with Staff H, Senior VP for Quality and Risk Management, only infections related to colon, spinal fusion, prosthetic hip, and hysterectomy surgeries are discussed with executive leadership. .”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 48939 Based on medical record review, document review, and interview, the facility failed to utilize its Quality Assessment and Performance Improvement (QAPI) program to measure, analyze, and track all surgical site infections (SSIs). Findings: The facility’s “2023-2024 Performance Improvement Plan and Patient Safety Plan” stated the following: Performance Measures: Surgical Site Infections: All procedure surgical site infections.” . Review of the facility’s 2023 SSI Report revealed twenty-seven SSIs. The SSI Report for 2024 revealed seven (7) SSIs from January 2024 to August 2024. There was one (1) SSI in January 2024, three (3) SSIs in February 2024, two (2) SSIs in April 2024, and one (1) SSI in May 2024. There are no documented SSIs for March, June, July, and August 2024. Review of the “Medical Dashboard 2024,” revealed zero (0) SSIs for January to March 2024 and one (1) SSI between May and June 2024. During interview on 09/05/24 at 10:05 AM with Staff E, Infection Preventionist, they stated that the infection preventionist responsible for tracking and reviewing SSIs was unavailable for interview, and the two other infection preventionists were unable to confirm if there were SSIs for March, June, July, and August 2024 . Per interview on 09/05/24 at 2:18 PM with Staff H, Senior VP for Quality and Risk Management, the Quality Department uses the Medical Dashboard to discuss only the four (4) reportable SSI categories (colon, spinal fusion, prosthetic hip, and hysterectomy) with executive leadership. Other SSIs outside of the four (4) reportable categories are not discussed. Staff H, Senior VP for Quality and Risk Management, provided emails indicating that the infection preventionist would only be tracking the four (4) reportable SSIs: colon surgery, spinal fusion, hip arthroplasty, and hysterectomy. Per the interview on 09/06/24 at 11:37 AM, Staff J, Director of Ortho Trauma and Associate Chair for the Department of Orthopedics, stated, “We have an internal review of surgical infections and complications that are self-reported.” Staff J indicated that the orthopedic surgery department has weekly meetings with approximately seven (7) attendings and 13-15 residents, but attendance and meeting minutes are not documented. There was no documentation found that indicated six (6) of the seven (7) SSIs reported for 2024 were tracked and analyzed. .”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 48939 . Based on medical record (MR) review, document review, and interview, in six (6) of seven (7) surgical site infection (SSI) reports, the facility failed to utilize its Quality Assessment and Performance Improvement Program to investigate all surgical site infection (SSI) infections, implement corrective actions and monitoring mechanisms to prevent reoccurrence. Findings: The facility’s 2023-2024 Performance Improvement Plan and Patient Safety Plan stated the following: “The Performance Improvement Coordinating Group (PICG) is charged with the following: “Investigating identified issues related to the inefficient or inappropriate delivery of care and assuring effective and sustained resolution to promote the achievement of optimal clinical outcomes...Performance Measures: Surgical Site Infections: All procedure surgical site infections.” Review of the facility’s 2024 Surgical Site Infection (SSI) Report, the Infection Prevention, Infection Control Log, and department memos revealed the following: - Patient #1 had spinal surgery on 1/11/2024 and a surgical site infection (SSI) event date of 1/19/2024. The comment section documented an interdisciplinary meeting with the surgeon, nursing director of the Operating Room (OR), infection prevention, and radiology. The following corrective actions were identified: -Hair clippers are not allowed in the OR. -Removing a disinfectant due to staff noncompliance with dry time. -Changing gloves prior to closing the incision. -C-arms (an advanced medical imaging device based on x-ray technology) are disinfected prior to entering the OR. -Adherence to skin prep prior to surgery. -OR personnel to ensure staff adherence to infection control prevention practice. -Patient #3 had spinal surgery on 1/18/2024 and a surgical site infection (SSI) event date of 2/14/2024. The comment section documented an interdisciplinary meeting with the surgeon, nursing director of the OR, and infection prevention. The following corrective actions were identified: -Diluted betadine and antibiotics are used as a means to decrease surgical site infection. -Monitor temperature and air quality during surgery. -Decrease OR traffic. -That C-arms (an advanced medical imaging device based on x-ray technology) are disinfected prior to entering the OR. Upon request, the facility could not furnish documented evidence of implementation of the corrective actions and monitoring mechanisms to prevent reoccurrence. During an interview of Staff D (Chairperson of Infection Prevention) on 9/5/2024 at 1:45 PM, Staff D confirmed these findings. - Patient #2 had a spinal surgery on 2/6/2024 and a surgical site infection (SSI) event date of 2/6/2024. An email from Staff I (Chief Medical Officer) to the Chairman of Orthopedic Surgery dated 2/26/24 documented “an increase in surgical site infections (SSI) for spine cases in the past few months” [SSIs for patients #1, #2, #3 in 20024, and #7in 2023]. An email from the Chairman of Orthopedic Surgery to Staff I (Chief Medical Officer) dated March 2, 2024, revealed that this case (Patient #2) and three other spine infection cases (Patient #1, Patient #3, and #7 were reviewed in the committee meeting, and the following corrective actions were identified: - Patient preoperative and post-operative instructions regarding changing bed linen. - Adherence to skin prep prior to surgery. - Using intraoperative antibiotic powder in surgical wounds. An email from Staff D (Chairperson of Infection Prevention) to the Chairman of Orthopedic Surgery and Staff I (Chief Medical Officer) dated March 4, 2024, documented the following additional recommendations which need consideration: - The C-arms (an advanced medical imaging device based on x-ray technology) disinfection prior to entering the OR. Are the disinfectant manufacturers’ guidelines being followed? - Pre-intra-post maintenance of blood sugar. - Compliance with changing gloves prior to closing the incision. - Adherence to skin prep prior to surgery. - Enforcing traffic control in the OR. - Temperature/humidity monitoring. - Nasal decolonization. Upon request, the facility could not furnish documented evidence of an investigation for Patient #2’s surgical site infection and evidence of that the additional corrective actions recommended by Staff D were considered, implemented, and monitored. During an interview of Staff D (Chairperson of Infection Prevention) on 9/5/2024 at 1:45 PM, Staff D confirmed these findings. -Patient #5 had spinal surgery on 4/26/2024 and a surgical site infection (SSI) event date of 5/10/2024. Upon request, the facility could not furnish documented evidence of an investigation for this potential surgical site infection (SSI). There was no documented evidence that the proposed corrective actions documented in an email on 3/2/2024 by the Chairman of Orthopedic Surgery were implemented. Per the interview of Staff H (Vice President of Quality and Risk Management) on 9/7/2024 at 10:20 AM, Staff H confirmed that the SSI for Patient #5 was not investigated. -Patient #4 had a left ankle surgery on 1/16/24 and a surgical site infection (SSI) event date of 2/14/2024. -Patient #6 had a left knee surgery on 4/11/2024, and the surgical site infection (SSI) box was marked yes. Upon request, the facility could not furnish documented evidence of investigations for these surgical site infections. Staff D (Chairperson of Infection Prevention) confirmed these findings during an interview on 9/6/2024 at 1:00 PM. .”

“INFECTION CONTROL PROFESSIONAL CFR(s): 482.42(a) Infection prevention and control program organization and policies. The hospital must demonstrate that: (1) An individual (or individuals), who is qualified through education, training, experience, or certification in infection prevention and control, is appointed by the governing body as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership; This Standard is not met as evidenced by: 48939 . Based on document review and interview, the facility failed to ensure that the Infection Prevention and Control (IP&C) Program A) was led by an infection control professional appointed by the Governing Body B) met monthly and tracked all Surgical Site Infections (SSIs) per policy and procedure. Findings: A) Review of the policy, “Committees of the Medical Board,” (Effective 11/07/2023) revealed: “Infection Prevention & Control Committee: 3.8.1) Purpose: To prevent, contain, investigate and control nosocomial infections and other infectious diseases among patients and personnel in the Hospital ... 3.8.3) Composition: 3.8.3.1) At least six (6) members of the Active Medical Staff including: Chairperson shall be a member of the division of ID [Infectious Disease], Director of Infection Control, ex-officio, Director of Employee Health Committee may also invite to its deliberations, as ex-officio members without power to vote, representatives from Nursing, Housekeeping, Food, and Nutrition, Pharmacy Services, Ambulatory Services, and Administrative Staff.” Review of the document, “Isolation and Infection Prevention and Control Manual,” (Revised 08/24/22) revealed: “Director of Infection Prevention and Control Department represents the Infection Prevention and Control Department and associated agencies. Responsible for: Developing policies governing prevention and control of infections and communicable diseases; Implementing policies governing preventing and control of infections and communicable diseases; Developing a system for identifying, reporting, investigating, and controlling infections and communicable diseases.” Per the interview on 09/05/24 at 1:15 PM, Staff D, Infectious Disease Attending and Chairperson of the IP&C Committee stated, “I give voluntary medical expertise to the Infection Control Committee. I am not the interim Director. When there is no director of Infection Control, the infection preventionists report directly to the Chief Medical Officer. I am doing my best to help Infection Control, but I am not ultimately responsible for the Department.” Per the interview on 09/06/24 at 2:38 PM, Staff I, Chief Medical Officer, stated, “We’ve had issues with finding a Director for the Infection Prevention and Control Program since the previous Director retired in December 2023. We had consultants come in to make the process less cumbersome ...I’ve also been overseeing the program with the assistance of [Staff D, Infectious Disease Attending] and our three (3) infection preventionists.” Staff I stated they had weekly meetings with the infection preventionists, but they could not provide evidence of these meetings. B) Review of the document, “Isolation and Infection Prevention and Control Manual,” (Revised 08/24/22) revealed: “Plan Assessment and Review: The risk assessed surveillance and organizational infection control plans are approved at least annually by the Infection Prevention and Control and Safety Committees. The Infection Prevention and Control Department reviews monthly outcome data for trends/problems and reacts accordingly ... Outcomes of both plans are evaluated by the Infection Prevention and Control and Safety Committees at least annually in the first quarter of each year ... Infection Prevention and Control Committee ...The Committee meets at least eleven times per year and reports to the Medical Board and Performance Improvement Coordinating Group ...Surgical Site Infections Prevention: NHCC [Nassau Health Care Corporation] provides surgical site infection rate data and prevention outcome measures to NHCC leadership, but not limited to the committees as mentioned below, licensed independent practitioners, nursing staff and other clinicians: i) Data presented monthly at the Infection Prevention and Control Committee.” Review of the document, “Annual Board Report - Infection Prevention and Control,” (2023 - 2024 Draft) revealed: “Drilldown: SSI Prevention ranked as the 1st priority in the 2023 Infection Prevention and Control (IP&C) Risk Assessment (RA) and will rank as the 1st priority in 2024 as SSI Rate went up by 35% in 2023 (27 SSIs) compared to SSI Rate in 2022 (20 SSIs) ...Plan of Action: SSI Prevention initiatives implemented by Orthopedic Department in the previous years will be monitored in 2024 ... Case investigation of each SSI identified conducted with respective services.” Staff H, Senior VP for Quality and Risk Management, provided emails indicating that the infection preventionist would only be tracking the four (4) reportable SSIs: colon surgery, spinal fusion, hip arthroplasty, and hysterectomy. Per the interview on 09/04/24 at 2:00 PM, Staff H, Senior VP for Quality and Risk Management, acknowledged that the IP&C Committee should be meeting monthly per policy. They stated that February 2024 was the most recent meeting minutes for the IP&C meetings. On 09/05/24 at 10:05 AM, Staff H stated, “The consultant was supposed to complete the 2024 IP&C risk assessment and plan. Because it was not completed, they are following the 2023 plan.” Per the interview on 09/05/24 at 10:05 AM, Staff D, Infectious Disease Attending, stated, “The consultant had us cut down to quarterly meetings because we don’t have enough staff. The Director of Infection Control is under the CMO [Chief Medical Officer] and is responsible for making sure the meeting minutes are completed and that the Department is running.” When asked how SSIs are reported, Staff D stated: “Once the issue is identified, it is only discussed with the doctor, since February ...before then, there would be interdisciplinary meetings with the surgeon, resident, OR [Operating Room] nurses, Director of Nursing, Director of Infection Control, and the infection preventionists.” Per the interview on 09/05/24 at 10:05 AM, Staff E, the Infection Preventionist, they were unable to provide a list of all SSIs for 2024. They stated that the infection preventionist responsible for SSIs was unavailable. .”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 10723 . Based on document review, observation, and interview, the facility did not ensure all generally accepted infection control measures were followed in six (6) of six (6) Operating Room (OR) observations. The facility’s policy and procedure (P&P) titled “Surgical Attire,” dated 06/04/2024, stated, “Head/ Hair Coverings: All personnel entering the semi-restricted and restricted areas of the surgical suite/operating room must don a new bouffant hat or surgical hood head covering provided by the Operating Room that completely covers and contains the head, hair, earrings and facial hair... All earrings must be confined within the surgical head cover... Personnel with facial hair will don a surgical hood head cover or beard cover that completely covers all facial hair.” Observations in the facility’s Operating Room (OR) Suite during a tour between 10:35 AM and 11:35 AM on 9/3/2024 identified the following: (1) In OR #3, the room was being set up for the next patient, and the sterile equipment was open. The anesthesiologist had their earrings uncovered and had approximately two inches of hair exposed on the top and sides of their head. The surgical resident had approximately four (4) inches of uncovered hair above their nape (area above the neck) and uncovered sideburns. The medical student had the sides of their beard uncovered. (2) In OR #4, within the sterile field, a surgeon had uncovered sideburns, and a resident had approximately two (2) inches of uncovered hair above their nape and the side of their beard. A nurse had uncovered earrings. A scrub technician at the sterile instrument table had approximately two (2) inches of hair on the sides of their face exposed. (3) In OR #6, the resident had approximately two (2) inches of uncovered hair above their nape and uncovered sideburns. (4) In OR #7, within the sterile field, a surgical resident had the sides of their beard uncovered. The scrub nurse had their sideburns uncovered. The circulating nurse had their earrings uncovered and approximately two (2) inches of exposed hair on the left side of their face. (5) In OR #10, the room was being set up for the next patient, and the sterile equipment was open. The anesthesiologist had the sides of their beard uncovered. The scrub nurse had their earrings uncovered. (6) In OR #12, within the sterile field, one surgeon had uncovered sideburns, and the other surgeon had uncovered earrings. The x-ray technician had uncovered sideburns. Per the interview of Staff A (Director of Nursing Perioperative) on 09/03/2024 at 11:35 AM, when staff is setting up a room and have the sterile equipment, the staff must have their hair and earrings covered. Staff A confirmed these findings. .”

“LEADERSHIP RESPONSIBILITIES CFR(s): Standard: Leadership responsibilities (1) The governing body must ensure all of the following: (i) Systems are in place and operational for the tracking of all infection surveillance, prevention, and control, and antibiotic use activities, in order to demonstrate the implementation, success, and sustainability of such activities. This Standard is not met as evidenced by: 48939 . Based on document review and interview, the Governing Body failed to provide adequate resources to ensure the Infection Prevention and Control (IP&C) Program could demonstrate implementation, success, and sustainability of surveillance, prevention, and control activities. Findings: Review of the document, “Annual Board Report - Infection Prevention and Control,” (2023 - 2024 Draft) revealed: “Drilldown: SSI Prevention ranked as the 1st priority in the 2023 Infection Prevention and Control (IP&C) Risk Assessment (RA) and will rank as the 1st priority in 2024 as SSI Rate went up by 35% in 2023 (27 SSIs) compared to SSI Rate in 2022 (20 SSIs) ...Plan of Action: SSI Prevention initiatives implemented by Orthopedic Department in the previous years will be monitored in 2024 ... Case investigation of each SSI identified conducted with respective services.” Per the interview on 09/04/24 at 2:00 PM, Staff H, Senior VP for Quality and Risk Management, acknowledged that the IP&C Committee should be meeting monthly per policy. They stated that February 2024 was the most recent meeting minutes for the IP&C meetings. On 09/05/24 at 10:05 AM, Staff H stated, “The consultant was supposed to complete the 2024 IP&C risk assessment and plan. Because it was not completed, they are following the 2023 plan.” Per the interview on 09/05/24 at 1:15 PM, Staff D, Infectious Disease Attending and Chairperson of the IP&C Committee stated, “I give voluntary medical expertise to the Infection Control Committee. I am not the interim Director. When there is no director of Infection Control, the infection preventionists report directly to the Chief Medical Officer. I am doing my best to help Infection Control, but I am not ultimately responsible for the department.” Per the interview on 09/06/24 at 2:38 PM, Staff I, Chief Medical Officer, stated, “We’ve had issues with finding a Director for the Infection Prevention and Control Program since the previous Director retired in December 2023. We had consultants come in to make the process less cumbersome ...I’ve also been overseeing the program with the assistance of [Staff D, Infectious Disease Attending] and our three (3) infection preventionists.” Staff I stated they had weekly meetings with the infection preventionists, but they could not provide evidence of these meetings. (See Tag 0748) .”

“HOSP ACQUIRED INFECTIONS AND QAPI CFR(s): [The governing body must ensure all of the following:] (ii) All HAIs and other infectious diseases identified by the infection prevention and control program as well as antibiotic use issues identified by the antibiotic stewardship program are addressed in collaboration with hospital QAPI leadership. This Standard is not met as evidenced by: 48939 . Based on document review and interview, the Governing Body failed to ensure Surgical Site Infections (SSIs) identified by the Infection Prevention and Control (IP&C) Program were adequately tracked and addressed in collaboration with hospital QAPI leadership. Findings: Review of the facility’s 2024 SSI Report revealed seven (7) SSIs from January 2024 to August 2024. There was one (1) SSI in January 2024, three (3) SSIs in February 2024, two (2) SSIs in April 2024, and one (1) SSI in May 2024. There are no documented SSIs for the months of March, June, July, and August 2024. The infection preventionists were unable to confirm if there were no “other” SSIs outside of the reportable category for these months. The infection preventionist responsible for reviewing SSIs was unavailable for an interview. Review of the document, “Annual Board Report - Infection Prevention and Control,” (2023 - 2024 Draft) revealed: “Drilldown: SSI Prevention ranked as the 1st priority in the 2023 Infection Prevention and Control (IP&C) Risk Assessment (RA) and will rank as the 1st priority in 2024 as SSI Rate went up by 35% in 2023 (27 SSIs) compared to SSI Rate in 2022 (20 SSIs) ...Plan of Action: SSI Prevention initiatives implemented by Orthopedic Department in the previous years will be monitored in 2024 ... Case investigation of each SSI identified conducted with respective services.” Review of the “Medical Board Minutes” from January 2024 - August 2024 revealed no evidence that SSIs identified by IP&C in 2024 were discussed. Review of Governing Body meeting minutes dated 5/22/24 revealed that one (1) reportable SSI was discussed. Per the interview on 09/05/24 at 2:18 PM with Staff H, Senior VP for Quality and Risk Management, the Quality Department uses the NUMC Medical Dashboard to discuss only the four (4) reportable SSI categories with executive leadership. The “NUMC Medical Dashboard 2024” revealed zero (0) SSIs for January to March 2024 and one (1) SSI between May and June 2024. The SSIs outside of the four (4) reportable categories are not discussed. (See Tag 0273)”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47318 Based on medical record (MR) review, document review, video surveillance review, and interview, in three (3) of five (5) MRs, the facility failed to maintain a safe environment for patients. This failure placed all patients at risk for serious harm, injury, or death. Findings: The facility failed to: - Identify patients at risk for elopement. (See Tag A-0144) - Ensure an order from a physician or licensed independent provider was obtained for behavioral restraints. (See Tag A-0168) - Document alternative or other least restrictive interventions were attempted prior to the use of restraints. (See Tag A-0186)”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 47318 Based on medical record (MR) review, document review, video surveillance review, and interview, the facility failed to identify patients at risk for elopement, in three (3) of five (5) medical records. The facility’s failure to identify elopement risk patients placed all patients at risk for serious harm, injury, or death. Findings: The facility’s policy and procedure (P&P) titled, “Patient Elopement/Wandering/Missing/Absent Patient,” last dated 7/21/2022, stated, “Patients considered to be at risk for elopement include but are not limited to...[patients with a] history of drug or alcohol abuse...history of wandering or being missing...[patients] presenting with a psychiatric complaint...” Review of Patient #1’s medical record identified that on 2/23/2024 at 2:03 PM, Patient #1 presented to the Emergency Department after ingesting 26 tablets of Klonopin [medication used to treat seizures and panic attacks] during an attempted suicide. Patient #1’s past medical history included Bipolar Disorder and polysubstance use [the use of more than one drug]. An elopement risk assessment, which consisted of a YES or NO response to the question prompt: “Is the patient considered an elopement risk?” was performed during Patient #1’s triage on 2/23/2024 at 2:03 PM. The elopement risk assessment stated, “NO,” indicating Patient #1 was not at risk. Despite Patient #1 presenting with a psychiatric complaint and a history of drug or alcohol abuse, there was no documented evidence that Patient #1 was identified as an elopement risk, nor elopement precautions implemented, as per facility policy. Review of video surveillance footage dated 2/25/2024 at 8:41 PM identified that Patient #1 eloped from the facility. Patient #1, while being followed by facility staff, exited their room, walked to the nurse’s station, down the hallway, and then exited the medical-surgical unit through the unit’s stairwell entrance. Patient #1 went missing for approximately 19 minutes and returned to the facility unaccompanied. Review of Patient #1’s medical record identified that an elopement risk assessment was performed on 2/25/2024 at 10:40PM and indicated “NO,” Patient #1 was not at risk for elopement despite “being missing,” as per facility policy. Review of Patient #2’s medical record identified that on 1/12/2024 at 4:42 AM, Patient #2 presented to the Emergency Department with a chief complaint of substance use with agitation. Patient #2’s past medical history included substance abuse. An elopement risk assessment was performed on 1/12/2024 at 5:03 AM and stated, “NO,” indicating Patient #2 was not at risk. Despite Patient #2 presenting with a psychiatric complaint and a history substance abuse, there was no documented evidence that Patient #2 was identified as an elopement risk, nor elopement precautions implemented, as per facility policy. On 1/12/2024 at 11:00 AM, a Nursing Note revealed that Patient #2 ran away from the Emergency Department with wrist restraints on both wrists. A facility Incident Report dated 1/12/2024 stated that Patient #2 was placed in two-point restraints while in the Emergency Department and then eloped with the restraints on his wrists. During interview of Staff M on 3/18/2024 at 1:37 PM, Staff M confirmed that Patient #2 had run out of the Emergency Department with restraints on his wrists. Review of Patient #2’s medical record identified that Patient #2 went missing for approximately one (1) hour and returned to the Emergency Department accompanied by police at 12:00 PM on 1/12/2024. An elopement risk assessment was performed on 1/12/2024 at 12:03 PM and stated, “NO,” indicating Patient #2 was not at risk for elopement despite “being missing,” as per facility policy. Review of Patient #3’s medical record identified that on 2/28/2024, at approximately 12:24 AM, Patient #3 presented to the Emergency Department for a mental health evaluation. Patient #3’s past medical history included poly-drug [the use of more than one drug or type of drug] and alcohol use. The Emergency Medical Services’ Pre-Hospital Record indicated that Patient #3 was uncooperative and aggressive towards officers, and that a sedative was administered to the patient at 12:00 PM. A Triage Nursing Note dated 2/28/2024 at 12:33 PM noted that Patient #3 stated they “did Fentanyl, Xanax, and alcohol today, and crack last night,” and that the patient’s mother called and stated that Patient #3 was suicidal and requesting detoxification. An elopement risk assessment was performed during triage and stated, “NO,” Patient #3 was not at risk. Despite Patient #3 presenting with a psychiatric complaint and a history of substance abuse, there was no documented evidence that Patient #3 was identified as an elopement risk, nor elopement precautions implemented, as per facility policy. A Nursing Note dated 2/28/2024 at 1:10 PM stated that while Patient #3 was in the process of undressing and changing into a hospital gown, the patient got up and ran out of the Emergency Department through the ambulance entrance doors. The patient left the emergency department with all their property before being evaluated. A Physician Note dated 2/28/2024 at 1:42 PM stated that Patient #3 ran out of the Emergency Department through the ambulance entrance doors, breaking the door in the process, and witnessed by multiple staff members. On 2/29/2024 at 12:45 AM, police and emergency medical services returned Patient #3 to the Emergency Department for a mental health and medical evaluation. An elopement risk assessment was performed and stated, “NO,” indicating Patient #3 was not at risk despite “being missing,” as per facility policy. During interview of Staff M (Registered Nurse) on 3/19/2024 at 1:37 PM, when asked how they determine which patients are considered risks for elopement, Staff M stated that they “ask the Emergency Medical Technicians and Police Officers [that accompany patients to the ED] for collateral information before indicating if the patient is an elopement risk.” During interview of Staff N (Senior Vice President Quality/Risk Management) on 3/19/2024 at 2:45 PM, Staff N confirmed these findings. Staff N stated that there was a lack of elopement risk assessment tools, and that the facility policy was not being followed. An Immediate Jeopardy (IJ) situation was identified on 3/21/2024 at 12:00 PM for the facility’s failure to identify patients at risk for elopement. The facility’s failure to identify elopement-risk patients may have contributed to patient elopements. The facility provided an IJ Removal Plan to survey staff on 3/21/2024 at 10:15 PM. The plan stated the following: Beginning 3/21/2024, all nursing staff and physicians, facility-wide and currently working, and all nursing staff and physicians prior to the start of their shift, would be educated on the following: - Revisions to the policy titled, “Patient Elopement/Wandering/Missing/Absent Patient,” dated 3/21/2024, to include an elopement screening tool based on the Waypoint Elopement Risk Scale-Stable (WERS-STABLE), categorizing patients at risk for elopement as Low, Medium, and High. A risk score will be documented in the patient’s record and interventions will be applied based on the risk score. - The use of the Waypoint Elopement Risk Scale-Stable (WERS-STABLE) tool. The education for nursing staff would be delivered by Nurse Managers and Supervisors. The education for providers would be delivered by the Chief Medical Officer (CMO) and Physician Department Chairs. Staff and providers on sick leave, Family Medical Leave Act (FMLA) or vacation, would be educated prior to the initiation of their shift. The IJ was removed on 3/25/2024 at 1:15 PM, based on the onsite verification of the IJ Removal Plan which included: (a) Interviews conducted on 3/25/2024 with senior leadership and review of education documentation and staff work schedules, confirmed that facility staff not yet in-serviced were not permitted to return to work until the in-service education was completed. (b) Review of in-service Attendance Records/Attestations verified the number of staff captured/educated. (c) Observations and interviews of staff in the patient care units, including the Emergency Department verified staff’s knowledge/education regarding the revisions to the Elopement Policy and introduction of the Waypoint Elopement Risk Scale-Stable (WERS-STABLE) tool. (d) Review of medical records verified completion of the Waypoint Elopement Risk Scale-Stable (WERS-STABLE) tool and implementation of elopement precautions. As of 1:15 PM on 3/25/2024, 83.3% of nursing staff and 74% of providers that worked since the IJ was identified on 3/21/2024 had completed their education training. A facility-wide total of 75% nursing and provider staff completed the education.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 09995 Based on medical record (MR) review, document review, and interview, in one (1) of five (5) medical records, the facility did not ensure an order from a physician or licensed independent provider (LIP) was obtained for behavioral restraints. Findings: The facility’s policy and procedure (P&P) titled, “Care of the Patient Requiring Non-Violent, Non-Self-Destructive Restraints, Violent, Self-Destructive Restraints, and Seclusion,” last revised 8/2/2023 stated, “The use of physical restraints requires authorization by the written order of the physician or practitioner.” The facility’s Incident Report dated 1/12/2024 stated that Patient #2 was placed in two-point restraints while in the emergency department, and then eloped from the emergency department with the restraints on their wrists. Review of Patient #2’s medical record identified the following: This 27-year-old was brought to the emergency department by emergency medical services on 1/12/2024 at 4:42 AM, with a chief complaint of substance abuse with agitation. At 11:00 AM, Staff M (Registered Nurse) noted that Patient #2 removed their restraint and ran from the ED. There was no documented evidence of a physician order for Patient #2’s restraints. During interview of Staff M on 3/18/2024 at 1:37 PM, Staff M confirmed that Patient #2 had restraints on their bilateral wrists when they [Patient #2] ran out of the ED. During interview of Staff N (Senior Vice President Quality and Risk Management) on 3/18/2024 at 2:45 PM, Staff N confirmed these findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(16)(iii) [there must be documentation in the patient’s medical record of] Alternatives or other less restrictive interventions attempted (as applicable); This Standard is not met as evidenced by: 09995 Based on medical record (MR) review, document review, and interview, in one (1) of five (5) medical records, the facility failed to document alternative or other least restrictive interventions were attempted prior to the use of restraints. Findings: The facility’s policy and procedure (P&P) titled, “Care of The Patient Requiring Non-Violent, Non-Self -Destructive Restraints, Violent, Self -Destructive Restraints and Seclusion,” last revised 8/2/2023, stated the following: “Each episode of use is recorded. Documentation includes information about: A description of the patient’s behavior and the intervention used. Any alternatives or other less restrictive interventions attempted. The patient’s condition or symptom(s) that warranted the use of the restraint or seclusion.” The facility’s Incident Report dated 1/12/2024 revealed that Patient #2 was placed in two-point restraints while in the Emergency Department, and then later eloped with the restraints on his wrists. Review of Patient #2’s medical record identified this 27-year-old was brought to the Emergency Department by emergency medical services on 1/12/2024 at 4:42 AM, with a chief complaint of substance abuse with agitation. On 1/12/2024 at 7:29 AM, the physician noted that Patient #2 was clinically sober, awaiting psychiatric evaluation, not suicidal or homicidal, had no auditory or visual hallucinations, and was “moving off restraint” [being taken out of restraints] while awaiting a psychiatric consultation. There was no documented evidence of alternative measures attempted prior to placing Patient #2 in physical restraints, nor a description of Patient #2’s behavior, condition, or symptoms(s) that warranted the use of restraints. During interview of Staff M (Registered Nurse) on 3/18/2024 at 1:37 PM, Staff M stated that when they received report from the night nurse on the morning of 1/12/2024, they were informed that Patient #2 had become agitated and confrontational with the staff and was placed in 2-point wrist restraints. Staff M added that when they left Patient #2’s room at approximately 11:00 AM to draw blood from another patient, they were informed by another staff member that Patient #2 had fled with their restraints still on their wrists. During interview of Staff N (Senior Vice President Quality and Risk Management) on 3/18/2024 at 2:45 PM, Staff N confirmed these findings.”