St Bernards Five Rivers Medical Center

“Pharmaceutical services. CFR(s): The REH must have pharmaceutical services that meet the needs of its patients. The REH must have a pharmacy or a drug storage area that is directed by a registered pharmacist or other qualified individual in accordance with state scope of practice laws. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the REH’s registered pharmacist or other qualified individual. This Condition is not met as evidenced by: 31039 Based on observation, interview, review of facility policies, review of monthly medication inspection reports, review of United States Pharmacopeia (USP) 797 regulations and review of nurse competencies, it was determined the Pharmacy failed to have pharmaceutical services that met the needs of the patients in that the facility failed to follow acceptable standards of practice: 1. The facility failed to have a process in place to treat a Malignant Hyperthermia Emergency. 2. The facility failed to assure medication at risk for diversion was properly destroyed to decrease the risk against misuse, abuse and diversion. 3. The facility failed to inspect the Surgical Services medication areas monthly. 4. The facility failed to design, implement and maintain a formal education, training and competency assessment program, per policy, in Immediate-use Compounded Sterile Products. The failed practices had the likelihood of affecting all patients receiving pharmaceutical services in the facility. See O362 A, O362 B, O364 and O380 for details.”

“Infect prevent & control & antibiotic steward CFR(s): The REH must have active facility-wide programs for the surveillance, prevention, and control of healthcare-associated infections (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 facility-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 50014 Based on review of Policy and Procedures, Infection Prevention and Control Committee Meeting minutes, CDC (Centers for Disease and Prevention) guidelines, ADH (Arkansas Department of Health) guidelines, observations, and interviews it was determined that the facility did not ensure: 1.The Infection Control Preventionist had training or certification in infection prevention or control. 2.The Arkansas Department of Health Communicable Disease Reports were monitored by the facility. 3.Hand hygiene was being monitored in the facility. 4.Humidity levels and temperature were monitored in the Operating Room/Procedure Rooms. 5.Communication and collaboration with the Quality Assessment and Performance Improvement (QAPI) program with accurate reporting data. 6.Infection prevention and control education and training was provided to facility staff. The failed practices promoted the spread of infection and did not ensure the facility had an effective infection prevention and control program or antibiotic stewardship program in place. The failed practices had the likelihood of affecting all patients receiving care in the facility. Findings Follow: See Conditions: O-462, O-464, 46 6, O-472, and O-480”

“Pharmacy management and administration. CFR(s): (a)The pharmacy or drug storage area must be administered in accordance with accepted professional principles and in accordance with state and Federal laws. This Standard is not met as evidenced by: 31039 Based on observation and interview, it was determined the facility failed to conform to acceptable standards of practice for medication administration in that the facility failed to have a process in place to treat a Malignant Hyperthermia Emergency, and the facility had Succinylcholine and Sevoflurane available for patient use. By not adhering to the acceptable standards of practice as set forth by the Malignant Hyperthermia Association of the United States (MHAUS), the facility could not assure they were prepared for a Malignant Hyperthermia Emergency and therefore could not assure a positive patient outcome in the emergency. The failed practice had the likelihood of affecting all patients admitted for procedures. Findings follow: A. During a tour of the Surgical Services on 04/07/2025 from 2:00 PM at 3:42 PM observation showed a bottle of Sevoflurane 250 ml (milliliters) in a locked anesthesia cart. During the tour the Surgical Services Supervisor was asked if they stocked Succinylcholine, and they replied yes. Both Succinylcholine and Sevoflurane are triggering agents of Malignant Hyperthermia. B. During an interview on 04/07/2025 at 03:40 PM, the Surgical Services Supervisor was asked about a process for treating Malignant Hyperthermia, because Succinylcholine and Sevoflurane were available for patient use. They responded that the facility no longer kept the medications to treat a Malignant Hyperthermia Emergency as recommended by MHAUS. C. During an interview on 04/08/2025 at 12:45 PM, The Director of Pharmacy stated he was unaware there was Sevoflurane stored in a locked anesthesia cart, but did verify the facility did stock Succinylcholine in the Omnicell drug cabinet. The Director of Pharmacy also verified they did not stock the recommended medications to treat a Malignant Hyperthermia Emergency as recommended by MHAUS.”

“Pharmacy management and administration. CFR(s): (a)(1) A pharmacist or competent individual in accordance with state scope of practice laws must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. The pharmacist or competent individual in accordance with state law and scope of practice must be available for a sufficient time to provide oversight of the REH’s pharmacy services based on the scope and complexity of the services offered at the REH. This Standard is not met as evidenced by: 31039 Based on review of monthly medication storage area inspections, review of policy, and interview, it was determined pharmacy. By not inspecting medications in patient care areas monthly, the facility could not assure medications were properly controlled to maintain their security, proper disposal, integrity, stability, and efficacy. The failed practice had the likelihood to affect all patients who received medications from this area. Findings follow: A. Record review of facility policy titled, “Pharmacy Unit Inspections,” showed the Director of Pharmacy or qualified designee should have conducted monthly inspections of all medication areas. B. Review of monthly medication storage area inspections for April 2024 through March 2025 showed Emergency Services and Medical Surgical areas were being inspected on a monthly basis. There were no inspection reports for Surgical Services. C. During an interview on 04/07/2025 at 12:50 PM, the Director of Pharmacy verified there were no monthly medication storage inspection reports for Surgical Services. D. During tour of the GI procedure room on 04/087/2025 at 12:45 PM, the Director of Pharmacy verified the Sharps container did have syringes with Propofol in them. disoposed of in the Sharps container instead of the medication being disposed of in a designated waste container.”

“Administration of drugs. CFR(s): (c)Drugs must be prepared and administered according to established policies and acceptable standards of practice. This Standard is not met as evidenced by: 31039 Based on review of facility policy, review of United States Pharmacopeia (USP) 797 regulations, review of nurse competencies and interview, it was determined the facility failed to follow acceptable standards of practice in that they did not design, implement and maintain a formal education, training and competency assessment program, per policy, in Immediate-use Compounded Sterile Products (CSP) for 25 of 25 (#1-#25) Registered Nurses (RN) and 1 of 1 (#1) Licensed Practical Nurse (LPN) who make or have the potential to make Immediate-use CSPs. By not assuring the nurses are trained and competent, the facility could not assure the products delivered intravenously (IV) were free from inadvertent microbial contamination. The failed practice had the likelihood to affect all patients who receive Immediate-use CSPs in the facility. Findings follow: A. Record review of the facility’s policy titled “IV (Intravenous) Admixture Training & Validation Program, “effective 03/2004, showed the Director of Pharmacy was responsible to ensure compounding personnel are properly trained; and design, implement, and maintain a formal education, training, and competency-based assessment program. B. Record review of United States Pharmacopeia (USP) 797, November 1, 2023, regulations showed personnel were to be trained and demonstrate competency in aseptic processes as they related to assigned tasks and the facility’s Standard Operating Procedures (SOP). C. Record review of nurses’ competencies for 2024 did not have any training or competency requirements evaluated for 25 of 25 (#1-#25) RNs and 1 of 1 (#1) LPN. D. During an interview on 04/08/2025 at 12:40 PM, the Director of Pharmacy verified the facility failed to maintain a formal education, training and competency assessment program, per policy, in Immediate-use Compounded Sterile Products.”

“Infect prevent & control program org & policy CFR(s): (a) The REH 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, or responsible individual, 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: 50014 Based on review of CDC (Centers for Disease Control and Prevention) guidelines, policy and procedures, and an interview, it was determined that the facility failed to appoint a qualified individual to be responsible for infection control throughout the facility. By not assuring that the individual had appropriate education, training, experience, or certification in infection prevention and control, prevented the transmission of infection in the facility. Findings follow: 1. Review of “CDC’s Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings” dated 04/11/24, showed under “Leadership Support References #3. Assign one or more qualified individuals with training in infection prevention and control to manage the facility’s infection prevention program.” 2. Review of St. Bernards Five Rivers Medical Center “Infection Control Preventionist Job Description” reviewed on 04/21/25 at 10:10 AM, showed under position qualifications: “Education: Graduate of accredited Nursing School. Experience: Minimum of two years nursing experience. Self-directed, self-motivated capabilities.” 3. In an interview with the Infection Control Preventionist on 04/08/25 at 2:30 PM, she stated that, “I follow the CDC guidelines and the ADH (Arkansas Department of Health) for Infection Control. I have not been educated, trained, or certified in Infection Control. I do not do monthly or quarterly Infection Control in-services. I am not AORN (Association of perioperative Registered Nurses certified because they require a bachelor’s degree. I do not know about APIC (Association for Professionals in Infection Control and Epidemiology.” 4. Verified #1 and #2 with Infection Control Preventionist on 04/08/25 at 2:30 PM.”

“Infect prevent & control program org & policy CFR(s): (a)(2) The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the REH and between the REH and other health care settings; This Standard is not met as evidenced by: 50014 Based on review of policy and procedures, CDC (Centers for Disease and Prevention) Guidelines, Arkansas Department of Health (ADH) Mandatory Hospital Rules, and interviews, it was determined that the facility failed to follow their policy and procedures related to reportable communicable diseases. By not reporting communicable diseases, the facility had the likelihood of transmitting and spreading infectious diseases to personnel and patients in the facility. Findings follow: 1. Review of St. Bernards Five Rivers Medical Center “Infection Control Registered Nurse Position Description” reviewed on 04/21/24 at 10:10 AM, showed “Supervises all infection control activities... The infection control nurse is responsible for the identification, investigation, reporting, prevention and control of healthcare associated infections among patients and personnel. Supports and facilitates the development of the infection control programs through the implementation of infection control best practices. Supports staff with day-to-day risk infection control activities and incident management. Develops infection control processes to identify, assess, monitor, reduce and control key risks to selected St. Bernards Five Rivers Medical Center.” 2. Review of St. Bernards Five Rivers Medical Center “Employee Health Program Overview” policy with a review date of 01/14/25, showed that “All personnel with an illness should report to their supervisor and employee health nurse if indicated.” 3. Review of St. Bernards Five Rivers Medical Center Policy #27 “Communicable Disease” with a revision date of 03/1998, showed, “It is the responsibility of the Epidemiology Department to report reportable communicable diseases to the State Health Department. However, to assure that all reportable diseases are brought to her attention immediately, it is the responsibility of the health care worker who first recognizes the presence of the disease to report it to Epidemiology Department. Diseases are reported in compliance with the Instructions for Reporting Communicable Diseases to the ADH (Arkansas Department of Health).” 4. Review of CDC’s Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings” dated 04/11/24, showed a. Section 5e.1. Minimizing Potential Exposures References and resources, #1 Develop and implement systems for early detection and management (e.g., use of appropriate infection control measures, including isolation precautions, PPE (Personal Protective Equipment) of potentially infectious persons at initial points of patient encounter in outpatient settings (e.g., triage areas, emergency departments, outpatient clinics, physician offices) and at the time of admission to hospitals and long-term care facilities (LTCF).Implement processes and sick leave policies to encourage healthcare personnel to stay home when they develop signs or symptoms of acute infectious illness (e.g. fever, cough, diarrhea, vomiting, or draining skin lesions) to prevent spreading their infections to patients and other healthcare personnel. b. Section 8.2 Implement processes and sick leave policies to encourage healthcare personnel to stay home when they develop signs or symptoms of acute infectious illness (e.g. fever, cough, diarrhea, vomiting, or draining skin lesions) to prevent spreading their infections to patients and other healthcare personnel. c. Section 8.3 “Implement a system for healthcare personnel to report signs, symptoms, and diagnosed illnesses that may represent a risk to their patients and coworkers to their supervisor or healthcare facility staff who are responsible for occupational health” 5. Review of Arkansas State Board of Health Rules for Hospitals and Related Institutions in Arkansas “Infection Control” dated 06/17/24, showed a. Section 18.A.2., “There shall be a comprehensive list of communicable diseases for which patients shall be isolated and for which there are visitation restrictions. The list, and other policies and procedures for isolation, shall conform to the latest edition of the Centers for Disease Control and Prevention, Atlanta, Georgia (CDC) Guidelines.” b. Section 18.A.3. “It shall be the duty of the Administrator or his/her designee to report all infectious or communicable diseases in the facility to the Arkansas Department of Health, as required by the Rules Pertaining to Reportable Diseases in Arkansas (Ark. Code Ann. §§ 20-7-109, 110) and CMS mandatory reporting requirements for Medicare certified facilities.” c. Section 18.5.e. “There shall be policies and procedures establishing and defining the Infection Prevention and Control program to include: “Methods for obtaining reports of infections and communicable diseases in patients and health care workers in a manner and time sufficient to limit the spread of infection.” d. Section 18.A.8. “Maintain documentation of reportable diseases.” e. Section 18.C.1. “There shall be policies and procedures for screening health care workers for infectious/communicable diseases and monitoring for health care workers exposed to patients with any communicable diseases. The policies and procedures shall reflect facility-selected national guidelines. f. Section 18.C.2 “There shall be employee health policies and procedures regarding preventing the transmission of infectious diseases. The policies and procedures shall reflect facility- selected national guidelines.” g. Section 18.C.3 “There shall be policies which clearly state when health care workers shall not render direct patient care.” 6. In an interview with the Employee Health Nurse on 04/08/25 at 10:49 PM, she stated that, “I do not keep track of employee illnesses, and I do not provide educational in-services.” 7. In an interview with the Infection Control Preventionist on 04/08/25 at 11:51 PM, she stated, “I do not report mandatory reportable diseases to the ADH, our laboratory provides that information to the St. Bernards Medical Center (SBMC) in Jonesboro Reference Lab, someone at SBMC Jonesboro turns that information to the state. I do not track trends.” 8. In an interview with Laboratory manager on 04/08/25 at 12:32PM, he stated the process for positive communicable diseases, “We receive a call from St. Bernards and/or Quest. Someone contacts the provider to give them the positive results. The positive results then drop into the EMR (Electronic Medical Record). ICP then tracks and trends the information.” 9. In an interview with ED (Emergency Department) RN (Registered Nurse) on 04/09/25 at 1:05 PM, she stated that, “The Infection Control Preventionist does not share communicable diseases trends. The ED Nurse Manager shares the information. 10. In an interview with ED Nurse Manager on 04/09/25 at 1:08 PM, he stated that, “I try to watch the monthly Zoom meetings from MD (Named) Dean of New York Institute of Technology - Arkansas, he reports the communicable diseases for Craighead County. I share that information with my staff.” 11. Verified #1-10 with Infection Control Preventionist on 04/09/25 at 2:15 PM.”

“Infect prevent & control program org & policy CFR(s): (a)(3) The infection prevention and control program include surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 31039 Based on observation and interview, it was determined the facility’s infection prevention and control program’s surveillance failed to identify the unclean environment surrounding one of one (Rehabilitation) pool area. By not maintaining a clean and sanitary environment, the facility could not assure the environment was not the source and cause of transmission of infections. The failed practice had the likelihood to affect all patients that are treated in the Rehabilitation pool area. Findings follow: A. During a tour of Rehabilitation Services on 04/09/2025 from 1:00 PM to 1:50 PM, observation showed the following: 1. The pool cover is deteriorating, exposing a cloth like material, and bits of the cover were in the pool and on the loor throughout the room 2. Five floor vents with rust and dirt accumulation 3. Tour floor drains with rust and dirt accumulation 4. An inground filter that was dirty, and had a large amount of detritus accumulated on it 5. Caulking was separated or missing in multiple places around the pool and the toilet, and there was a brown black accumulation where the caulk was supposed to be 6. The floors had dirt, debris and dried fluids on them 7. A large area on the wall had chipped and peeling paint 8. A metal patient chart rack contained multiple pool chemicals on both shelves, and the shelves and the rack were heavily rusted 9. A white tissue was run against the top of the TV, thick black dirt was removed These areas indicated cannot be sanitized or have not been cleaned and therefore can harbor bacteria that could be transmitted to patients. B. During an interview on 04/09/2025 at 1:43 PM, the Administrator verified the findings at A. 46733 Based on policy and procedure review, observation, time and temperature chart review, and interview, the facility failed to follow their policy to ensure dry foods were stored at the appropriate temperature and humidity levels and failed to follow their policy to ensure hot foods were served at the appropriate temperature in one of one dry storage area and one of one kitchen. The failed practice did not ensure food products would be free of unacceptable levels of contamination and had the likelihood of affecting all patients, family members and staff who consumed food prepared in one of one kitchen. Findings follow: A. Review of Policy titled Food Production revised 03/20/24 showed, “6. Dry storage areas will be well ventilated and maintained between 40 and 75 degrees with low humidity of 30 degrees (? Percent) to 60 degrees (? Percent) degrees. F. All opened foods will be kept in sealed containers that prevent contamination and absorption (? of) humidity. The containers will be clearly labeled with the name of the food and date it was opened. 10. Patient Food Service and cafeteria staff will record temperatures three times during each meal service on the service temperature form. Catering staff will record temperatures at the time of service on the catering temperature form. Any temperatures less than 165 degrees will be reported to the production team leader for correction. Service temperatures are reported as a quality control monitor to the director.” B. Review of Time and Temperature Chart for March 1-31 of 2025 showed that on thirty-one of thirty-one days the facility recorded food temperatures at the beginning of meal service and the ending of meal service, the facility did not record temperatures a third time during each meal service per their policy. C. During a tour of the kitchen and dry storage area on 04/09/25 at 1:20 PM, the dry storage area was noted to be in a large room off of the kitchen next to the central supply area. There was no thermometer noted in the area and no process to monitor the humidity in the area per their policy. D. In an interview with the Dietary Director at the time of the findings she stated they did not monitor the temperature or humidity in the dry storage area, and they only check the food temperatures twice during each meal service. The findings in A-C were confirmed with the Dietary Director and CNO (Chief Nursing Officer) at the time of the findings. 50014 Based on review of policy and procedures, CDC (Centers for Disease and Prevention) guidelines, Arkansas Department of Health (ADH) Rules and Regulations, an interview and an observation, it was determined that the facility failed to survey hand hygiene, humidity and temperatures in the operating room/procedure rooms, and wound care procedures. By not ensuring surveillance throughout the facility, all patients that needed care from the facility could acquire an infectious disease. Finding follow: 1. Review of St. Bernards Five Rivers Medical Center Policy Infection Control Plan 2025 showed: a. “Infection Control activities to include: Monitoring and evaluation of key performance aspects of infection control surveillance, prevention and management. Hospital acquired infections. Other communicable diseases. Employee Health Trends. Public Health issues. Integrate outcomes from surveillance and control activities into Information Management Program processes throughout the facility to allow for internal comparison for trend analysis and comparison with external databases for benchmarking purposes. Interact and report to governmental agencies.” b. Performance measures were to improve the management of “comprehensive periodic surveillance outcomes ...” c. “Hand hygiene adherence will be evaluated through the infection control surveillance program.” d. Performance measures were to improve the management of “Compliance with hand hygiene, isolation precautions and standard of careReview of CDC’s Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings under 4. Performance Monitoring and Feedback.: 2. Review of St. Bernards Five Rivers “Hand Hygiene” policy with revise date of 06/21 showed: a. “ ...When hand hygiene is necessary, St. Bernards Five Rivers Medical Center personnel will follow hand hygiene practices in accordance with the following current CDC, and APIC guideline.” b. “Indications for handwashing and hand antisepsis? 1. If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands ... 2. Decontaminate hands before having direct contact with patients. 3. Decontaminate hands after contact with a patient’s intact skin (e.g., when taking a pulse or blood pressure, and lifting a patient.)” 4. Decontaminate hands after contact with body fluids or excretions, mucous membranes, nonintact skin, and wound dressing if hands are not visibly soiled. 5. Decontaminate hands if moving from a contaminated-body site to a clean -body site during patient care. 6. Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. c. Technique for Handwashing: “Avoid wearing rings in high-risk patient care areas (i.e., surgery, Intensive Care Units, as bacterial counts are increased under rings.” d. “Other aspects of hand care and protection (Glove use): 1. Gloves should be used as an adjunct, not a substitute for handwashing. 2. Gloves should be changed, and hand hygiene after using gloves for contaminated activities. 3. Hands should be washed when the integrity of the glove is in doubt, and between patients.” e. “Administrative measures: Hand hygiene adherence will be evaluated through the Infection Control Surveillance program.” 3. Review of St. Bernards Five Rivers “Hand Hygiene Tool” on 04/08/25 at 1:15 PM, showed a table with Observer, Month/Year, Hand Hygiene In/Out, Yes, No, Unknown, and Department, with 5 columns for the observer to check the appropriate box. There is a section to add comments. 4. Review of CDC’s Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings” dated 04/11/24, showed under Performance Monitoring and Feedback: 5. Review of ADH “Rules for Hospitals and Related Institutions in Arkansas Final Rules Infection Control” dated 06/17/24, showed: a. Section 18 A.4.b “The Administrator shall designate a qualified individual who shall: Direct surveillance activities;” b. Section 18 A.5.k “A plan for monitoring and evaluating all aseptic, isolation and sanitation techniques employed in the facility to ensure that approved infection prevention and control procedures are followed.” 6. Observation of wound care procedure on 04/08/25 at 1:23 PM, showed the following: a. At 1:23 PM, RN #11 did not wash or alcohol hands before putting on gloves. b. At 1:27 PM, RN Surgical Services Supervisor did not wash hands and put gloves on before touching patient #35’s wound. Once she took off the dirty bandages, she put gloves on without washing or using alcohol on her hands. c. At 1:29 PM, RN #11 With a dirty glove picked up a clean gauze and applied it to the wound. d. At 1:33, RN Surgical Services Supervisor did not wash or alcohol her hands before moving on to the next patient. 7. In an interview with Employee Health Registered Nurse on 04/08/25 at 12:15 PM, she stated, “We use what is called a “secret shopper system,” “which is a staff member picked by me to observe an employee handwashing before and after entering a patient room. The staff member is a random employee that can be anyone from the environmental services cleaner to a registered nurse. The staff member is not the manager of the employee because we wanted it to be a surprise. I do not know who the employees are being observed. I cannot track or trend that information. The numbers from the tool are reported to infection control preventionist for infection control meetings.” 8. In an interview with the Infection Control Preventionist on 04/08/25 at 2:00 PM, she stated, “I do not have a surveillance tool for Infection control, I rely on the staff to let me know if something needs to be done. 9. Verified #1-9 with Infection Control Preventionist on 04/09/25 at 2:00 PM. 10. Review of St. Bernards Five Rivers Medical Center Policy “Humidity and Temperature Levels Policy #5.5” with a review date of 11/24, showed, “The temperature, humidity, and airflow in all operating/procedure rooms shall be maintained with acceptable standards. The temperature of the operating room shall be maintained at 68 to 73 degrees Fahrenheit. The relative humidity remain at 30-60%. The operating room staff shall log operating/procedure room temperature and humidity levels daily. The operating staff will generate a work order to the Engineering Department when the temperature or humidity is out of range.” 11. Review of St. Bernards Five Rivers Medical Center Policy “Surgery Department Temperature and Humidity (Daily) Record” for January 2025 through March 2025, showed that the logs were not filled out on holidays or weekends. 12. In an interview with the surgical services manager on 04/09/25 at 8:40 AM, she stated, “I check the humidity levels daily when I am here. I contact the Engineering department if the temperature or humidity are off.” 13. In an interview with Maintenance Supervisor on 04/09/25 at 9:10 AM, he stated that, “I do not check the humidity and temperatures in the operating/procedure room because we closed surgical services.” 14. Verified #10-14 with Infection Control Preventionist on 04/09/24 at 2:10 PM.”

“Antibiotic Stewardship program organization CFR(s): (b)(2) The facility-wide antibiotic stewardship program: (i) Demonstrates coordination among all components of the REH responsible for antibiotic use and resistance, including, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, nursing services, and pharmacy services; (ii) Documents the evidence-based use of antibiotics in all departments and services of the REH; and (iii) Documents any improvements, including sustained improvements, in proper antibiotic use; This Standard is not met as evidenced by: 50014 Based on review of policy and procedures and an interview, it was determined that the governing body did not ensure a qualified individual was utilizing infection control data (i.e., surveillance and hand hygiene in the facility) to track trends in the facility. By not ensuring that information was gathered accurately and reported back to the governing board, it prevented the governing board from knowing the accuracy of the spread of infections throughout the facility. The failed practice had the likelihood of continuing to track inaccurate data, making decisions based on inaccurate data, continue to spread infectious diseases to patient care or personnel working in the facility, and to find opportunities to improve practices. Finding Follow: 1. Review of St. Bernards Five Rivers Medical Center Policy Infection Control Plan 2025 showed: a. “A commitment to reducing the risk of endemic, epidemic, and nosocomial infections in patient and healthcare workers. Each department, in partnership with the medical staff, will be responsible and held accountable for its role in the Infection Control Program. In addition to reporting isolation cases, suspected infection and positive cultures as well as providing required follow-up information, each department will be responsible for full and timely cooperation with the Infection Control Committee/Infection Control Nurse to develop and implement remedial/corrective actions. Specific assignments will be made to committees, departments, and individual personnel. These assignments are to be completed in a timely yet thorough manner. The purpose of the Infection Control Preventionist 2025 is to ensure that the organization has a functioning coordinated process in place to reduce the risk of endemic, epidemic and nosocomial infections in patients and healthcare workers and to optimize use of resources through a strong preventative program. The Infection Control Program incorporated surveillance, prevention, and control of infections throughout the organization in a continuing cycle. Surveillance will include Hospital acquired infection among patients and personnel. Targeted studies will be conducted on infections that are high risk and high volume. Surveillance by objective will be done on an as needed basis.” b. “The Infection Control Nurse also supplied the Quality Improvement Coordinator with information that be useful in identifying potential quality problems throughout the hospital. The link between assurance and infection control activities is information gathering and clinical analysis. Both are designed to identify patterns of patient care events that lead to sub-optimal outcomes, thus identifying where patient care may need improvement.” 2. Review of St. Bernards Five Rivers “Hand Hygiene Tool” form on 04/08/25 at 1:15 PM, showed a table with Observer, Month/Year, Hand Hygiene In/Out, Yes, No, Unknown, and Department, with 5 columns for the observer to check the appropriate box. There is a section to add comments. The observer is a secret shopper that is observing if the staff member washes their hands before entering a patient/procedure room and then after leaving the room. 3. In an interview with Employee Health Registered Nurse on 04/08/25 at 12:15 PM, she stated, “We use what is called a “secret shopper system,” “which is a staff member picked by me to observe an employee handwashing before and after entering a patient room. The staff member is a random employee that can be anyone from the environmental services cleaner to a registered nurse. The staff member is not the manager of the employee because we wanted it to be a surprise. I do not know who the employees are being observed. I cannot track or trend that information. The numbers from the tool are reported to infection control preventionist for infection control meetings.” 4. Verified #1-3 with Infection Control Preventionist on 04/09/24 at 2:10 PM.”

“Leadership responsibilities. CFR(s): (c)(2) The infection prevention and control professional(s) are responsible for: (i) The development and implementation of facility-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. (ii) All documentation, written or electronic, of the infection prevention and control program and its surveillance, prevention, and control activities. (iii) Communication and collaboration with the REH’s QAPI program on infection prevention and control issues. (iv) Competency-based training and education of REH personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the REH, on the practical applications of infection prevention and control guidelines, policies and procedures. (v) The prevention and control of HAIs, including auditing of adherence to infection prevention and control policies and procedures by REH personnel. (vi) Communication and collaboration with the antibiotic stewardship program. This Standard is not met as evidenced by: 50014 Based on review of policy and procedures, Infection Prevention Committee meeting minutes, and an interview, it was determined that the Infection Control Preventionist did not adhere to AORN or APIC infection control guidelines, did not present monthly or quarterly educational in-services to staff, and collected the wrong data for hand hygiene to track and trend data for quality improvement purposes. By not ensuring that the facilities infection control guidelines were developed with appropriate regulations, not educating staff routinely, and reporting data that could not provide any tracking or trending, prevented the staff from being educated, held accountable, and delayed the prevention of the spread of infectious diseases in the facility. Finding Follow: 1. Review of St. Bernards Five Rivers Infection Prevention Committee meeting notes from January 20, 2025, October 11, 2024, and April 16, 2024, showed that monthly in-services for infection control were not being given to the staff. a. Employee Health related issues will be reviewed and in-service education related to infection control practices will be provided routinely and as needed on individual basis. b. Some of the program elements were to provide “In services education related to infection control practices to ensure a safe environment for patients and personnel. Report to government agencies. f. In an interview with the Infection Control Preventionist on 04/08/24 at 2:30 PM, she stated that, “I follow the CDC guidelines and the ADH (Arkansas Department of Health) for Infection Control. I have not been educated, trained, or certified in Infection Control. I do not do monthly or quarterly Infection Control in-services. I am not AORN (Association of perioperative Registered Nurses certified because they require a bachelor’s degree. I do not know about APIC (Association for Professionals in Infection Control and Epidemiology.” 2. In an interview with the Infection Control Preventionist on 04/09/25 at 2:10 PM, she stated, “I do not have monthly or quarterly educational in services on infection control.” 3. Verified #1-3 with Infection Control Preventionist on 04/09/24 at 2:10 PM.”

“Buildings. CFR(s): (a) (3) The REH must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients. This Standard is not met as evidenced by: 31039 Based on review of Rules for Hospitals and Related Institutions, observation and interview, it was determined the facility failed to provide a safe environment in one of one Rehabilitation pool toilet and shower room in that they did not provide an emergency call system that was accessible to a collapsed patient on the floor. By not having an emergency call system that was accessible to a collapsed patient on the floor, the facility could not assure a rapid response to ensure patient safety. The deficient practice had the likelihood to affect all patients who use the pool toilet and shower room. Findings follow: A. Record review of Rules for Hospitals and Related Institutions, Section 76, F.2. showed an emergency call system shall be provided at each patient toilet, bath and shower room. An emergency call shall be accessible to a collapsed patient on the floor. Inclusion of a pull cord within four to six inches from the floor will satisfy this standard. B. During a tour of Rehabilitation Services on 04/09/2025 from 1:00 PM to 1:50 PM, observation showed a doorbell next to the commode approximately 3 feet off the ground. There was no pull chord that would be accessible to a collapsed patient on the floor. C. During an interview on 04/09/2025 at 1:15, the Administrator verified the findings at B. 46733 Based on review of AORN (Association of PeriOperative Nurses) Guidelines for Perioperative Practice: High Level Disinfection (2012-2025) and SGNA (Society for Gastroenterology Nurses and Associates) Guidelines and Standard of Infection Prevention in the Gastroenterology Setting 2015, policy and procedure review, observation, and interview, the facility failed to maintain a safe, sanitary, properly constructed, equipped, and maintained endoscopy suite, high level disinfection area, and sterile processing area. The failed practice did not ensure avoidance of sources of transmission of infection within the facility. The failed practice had the likelihood of affecting all patients having endoscopy procedures and all patients in the facility that required the use of instruments processed in the sterile processing area. Findings follow: A. Review of AORN eGuidelines for Perioperative Practice: Packaging Systems (NEW) (2012-2025) showed, “4.3 Remove supplies and equipment from external shipping containers and open-edged corrugated cardboard boxes before transfer to the sterile storage area or point of use.” B. Review of AORN eGuidelines for Perioperative Practice updated 10/01/20, showed, “When reusable blades are used, they should be cleaned and high-level disinfected or sterilized after each use according to the manufacturer’s written instructions for use (IFU). Cleaned and disinfected reusable laryngoscope blades and handles should be packaged and stored in a manner that prevents contamination. Laryngoscopes blades should be stored in individual packages.” C. Review of AORN eGuidelines for Perioperative Practice (2012-2024) 10.3.2 showed, “Storage cabinets should be situated in a secure location in the clean workroom or in a separate clean area close to, but not within the procedure room.” 13.4 showed, “Store flexible endoscopes in cabinets that are 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.” D. Review of AORN eGuidelines for Perioperative Practice: Flexible Endoscopes (2012-2025) showed, “Use a distinct visual cue to identify flexible endoscopes that are ready for use. Identifying endoscopes that are ready for use and distinguishing them from unprocessed endoscopes may help prevent the use of a contaminated scope.” 18.4 showed, “For each Automated Endoscope Reprocessor (AER) or Liquid Chemical Sterilization (LCS) processing cycle, record the following: 1. endoscope type and unique device identifier, 2. AER or LCS processing system unique device identifier, 3. date and time processing was completed, 4. processing cycle number, 5. technician processing the device, and, 6. processing results (eg, pass or fail, printout of results). Records of AER and LCS processing systems provide a source of evidence for review during an investigation of clinical issues, including infections and pseudo-infections.” E. Review of AORN eGuidelines for Perioperative Practice: High-Level Disinfection 3.3 showed, “Perform HLD (High Level Disinfection) in a designated area that is separate from the decontamination area. Separating the clean area from the area where devices are decontaminated reduces the risk of device contamination. Droplets and aerosol created during cleaning of soiled devices can cross contaminate nearby clean items on surfaces.” 3.3.1 “Separate decontamination and HLD areas by one of the following methods: 1. a wall with a built-in- automated reprocessor with the dirty side opening in the decontamination room and the clean side opening in the clean workroom, 2. a wall with a pass-through window, 3. a wall with a door, 4. a partial wall or partition that is at least 4-feet high and at least the width of the counter, or 5. a distance of at least 4 feet between the decontamination sink and the area where devices are prepared for sterilization or HLD. Although having two separate rooms is preferred, the minimum standard for design of hospitals and outpatient care facilities is a single processing room containing both decontamination and clean areas. In a one-room configuration, having a wall or physical barrier that separates the decontamination area from the clean area provides protection and minimizes the potential for contamination of processed items.” F. Review of AORN eGuidelines for Perioperative Practice: Sterilization, Sterile Processing Area (2012-2024) showed, “2.1 Perform sterilization in an area intended, designed, and equipped for sterilizations processes. 2.2 Place sterilizers in a clean work area or room with restricted access (eg, the semi-restricted area of the perioperative suite) and physical separation from high-traffic hallways or other potential sources of contamination such as scrub sinks, clinical sinks or hoppers, wash sinks, or containers for the disposal of linen and trash.” “2.3 Sterile processing areas should have 1. separate decontamination and clean work areas 2. provision for sterilization equipment and storage of related supplies in the clean area. 3. separate sinks for washing instruments and washing hands; and 4. storage space for personal protective equipment and cleaning supplies in the decontamination area. “2.3.1 The sterile processing area should be in a two-room configuration that includes a decontamination room and clean workroom that are separated by 1. a wall with a door, 2. a pass-through window that remains closed and secured when not in use, 3. a built-in washer disinfector with the dirty side opening in the decontamination room and the clean side opening in the clean workroom”. “2.4 Establish traffic patterns that define requirements for access, movement of personnel, and attire. Control of traffic patterns is intended to protect personnel, equipment, supplies, and instruments from sources of potential contamination.” “2.4.1 Establish functional workflow patterns to create and maintain physical separation between the decontamination and sterilizations areas. Establish functional workflow patterns from areas with high contamination potential to clean areas in the following order: 1. cleaning and decontamination area, 2. preparation and packaging, 3. sterilization processing, and 4. sterile storage or the point of use.” F. Review of AORN eGuidelines for Perioperative Practice: Design and Maintenance showed, “13.9 Do not use free-standing fans, portable humidifiers, air conditioners, or dehumidifiers. 13.10 Maintain the integrity of structural surfaces (eg, doors, floors, walls, ceilings, cabinets) and repair surfaces when they are damaged.” G. Review of facility policy titled: Handling and Transporting of Soiled Instruments updated 02/13/25 showed, “Instruments and endoscopes soiled with blood/body fluids should be treated with enzymatic spray to prevent drying of bio-burden. If the soiled instruments are not transported immediately to the area to be cleaned, they must be kept moist with enzymatic spray until transported. Enzymatic solution should be mixed and changed out per manufacturer’s instructions.” H. During a tour of the endoscopy suite on 4/07/25 from 2:20 PM to 3:15 PM, the following were observed: 1. In two of two supply storage cabinets there were sterile supplies, non-sterile supplies, out of package supplies, cardboard boxes, and linens. There was no separation of the supplies as they were all intermingled together, some examples included: a. Cabinet #1, top shelf-approximately twenty-five disposable lab coats (unpackaged) with two cardboard boxes of BD 20 ml (milliliter) syringes, one cardboard box of BD 10 ml syringes, one cardboard box of BD 23 G (gauge), inch-3 ml syringes b. Cabinet #1, shelf #2-PPE (Personal Protective Equipment) gowns, gloves, tongue depressors on the same shelf with one cardboard box of Sony Color Printing paper c. Cabinet #1, shelf #3-Valley Lab EKG (Electrocardiogram) electrodes, transpore tape, two boxes of Boston Scientific Steri-Flate Inflation Devices right beside the unboxed emesis basins, sterile gloves and 02 (oxygen) tubing d. Cabinet #2, right side-sterile specimen cups, more cardboard boxes, Cidex OPA cleaner, Sterile water bottles, and sterile lab specimen bottles e. Cabinet #2, left side-linen for patient use was mixed in with unused equipment parts 2. In the top drawer of the anesthesia cart there were 3 laryngoscope blades and handles not individually wrapped to ensure they had been cleaned/processed, 14 oral airways of various sizes open and not individually wrapped to ensure they were clean and unused, and one 14-French Stylet out of the package. Review of packaging for the stylets showed, “for single use only.” 3. A wire basket contained nine oral airways, not individually wrapped with two packages of capnography tubing. 4. The oxygen extension tubing was attached to the oxygen wall adapter and wrapped around the handle of the vital sign monitor. There was a note on the tubing which stated, “Do Not Throw Away.” Review of the extension tubing packaging showed, “for single use only.” 5. There was one open Yankauer and suction tubing attached to the suction canister and available for patient use. 6. There was an Endoscopy Drying/Storage Cabinet in the Endoscopy Procedure Room which contained six endoscopes, none of the endoscopes were labeled as to when they were last high level disinfected. 7. There was an Airtime Instrument Channel Dryer in the Endoscopy Room and the black metal bars on the stand which held the dryer were covered with rust. 8. The Olympus Endoscope Procedure cart was being used to store supplies such as gloves, channel buttons, bite blox, polyp traps, and an opened package of 200 count 4X4s that was about half empty. These supplies were available for patient use and inches away from where endoscopy patients have procedures. There was yellowish-brown mucous smeared on the second shelf of the cart. I. During a tour of the high-level disinfection area on 4/07/25 from 2:20 PM to 3:15 PM the following were observed 1. Dirty Side- One gallon of Prolystica Enzymatic was opened and almost empty. There was not a date or time on the container to indicate when the product was opened. There was no lid on the product. The Surgical Service Supervisor could not vocalize how long the product had been open or how long the product was good for once it was open. 2. Dirty Side-One box of fifty count Hedgehog disposable cleaning brushes, and one plastic bin that contained twenty-five individually wrapped Hedgehog disposable cleaning brushes on the rim of the cabinet which contained a sink for washing dirty scopes. There was no way to ensure the brushes were not splashed and contaminated by dirty water from the sink. 3. Clean Side-there was no scope cleaning log for the endoscopes. This Surveyor asked the Surgical Services Supervisor to provide a log or some record to verify scope cleaning and she stated that they did not have a log, the process was to keep the tapes from the scope cleaning machine itself. This Surveyor asked how quickly those tapes could be retrieved if there was ever a need to verify which scope had been used on a particular patient and when it was cleaned, and the Surgical Services Supervisor could not give a time frame or verify how long the tapes were kept by the facility. This Surveyor also asked how often the scopes were cleaned and she stated that someone comes in the day before the procedures are scheduled and cleans the scopes. She stated the facility does endoscopy procedures every other Thursday and that the scopes are not cleaned every seven days even when not used per AORN and SGNA guidelines. 4. The dirty and clean side of the high-level disinfection area was only separated by an open doorway between the areas. J. During a tour of the sterile processing area on 4/9/25 at 10:30 AM, the following were observed: 1. Dirty side-contained a hopper less than three feet from the area where 30” (inch) X (by) 30” and 54” X 54” blue wrap for sterile trays was being stored. There was also an area approximately 3 feet x 6 feet above the area of blue wrap with exposed pipes and wires coming from the ceiling. The Surgical Services Supervisor stated a dehumidifier had been removed from the area directly above the blue wrap. She could not state when the dehumidifier had been removed. 2. Dirty side-there was a dirty fan sitting on the floor just next to the area where the blue wrap was being stored. 3. Dirty side-there was an almost full, opened gallon container of Prolystica Enzymatic Cleaner on the counter. There was no date or time on the container that indicated when it had been opened. 4. Clean Side-there was an area of the wall cut out around the back of the autoclave. The area was not sealed, across the top of the autoclave there was a 4-inch opening and a 1- inch opening on each side of the autoclave, that allowed air flow from the dirty side of the sterile processing area to permeate the clean side and the clean air flow to permeate the dirty side. The back of the autoclave was not covered and was exposed to the clean side of the sterile processing area. The cut-out area of the wall was about the size of a doorway. 5. Clean Side-The cabinetry contained a one-inch strip across the front that contained raw wood which was not sealed. K. During an interview with the Surgical Services Supervisor while touring the endoscopy suite, high-level disinfection area, and sterile processing area, she confirmed the findings in A-J and confirmed the facility follows AORN and SGNA Guidelines. L. During an interview with the CNO (Chief Nursing Officer) on 4/09/25 at 10:30 AM, she confirmed the facility follows AORN and SGNA Guidelines.”

“Facilities. CFR(s): (b)(1) Diagnostic and therapeutic facilities must be located for the safety of patients. This Standard is not met as evidenced by: 48468 Based on observation of the Clean/Dirty Sterile, and interview, it was determined the facility failed to maintain the building’s physical structure, safety, environment, and equipment in a state of good repair. The failed practice promoted the spread of infection and/or placed the patients at risk of fire. The failed practice had the likelihood of affecting all patients, staff and visitors. Findings follow: A. Observation of the Steril Clean and Dirty on 04/07/25 showed the following: 1) At 2:18 PM, Ceiling tiles in Dirty Sterile had water stains 2) At 2:20 PM, Clean Sterile had rust, cracks, and mold under unlocked sink 3) At 2:22 PM, all damaged and stained tiles need to be replaced throughout the clean and dirty sterile B. The findings in A were verified by the Director of Maintenance on 04/08/25 at the time of observation.”

“Facilties. CFR(s): (b)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 31039 Based on observation and interview, it was determined the facility failed to maintain a piece of equipment in clean and working order for one of one Rehabilitation Department Cold Pack Freezer. By not maintaining the equipment, the facility could not ensure the safety and quality of care due to the state of this piece of equipment. The failed practice had the likelihood to affect all patients who receive Rehabilitation Services at the facility. Findings follow: A. During a tour of Rehabilitation Services on 04/09/2025 at 1:00 PM, observation showed the Cold Pack Machine’s door to be busted and cracked in several areas, the rubber seal not attached in areas, and the foam insulation of the door exposed. The door did not shut all the way and there was a buildup of thick ice several inches down the inside walls and creeping out onto the edge where the seal would normally sit tight. The condition of this door did not allow for a tight seal for proper functioning, nor did it allow it to be cleaned thoroughly as foam insulation cannot be sanitized. B. During an interview on 04/09/2025 at 1:30, the Administrator verified the condition of the Cold Pack Machine.”

“Safety from fire. CFR(s): (c)(1) Except as otherwise provided in this section, the REH must meet the provisions applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served, and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4). This Standard is not met as evidenced by: 48468 Based on observation, review of policy and procedure and interview, it was determined the facility failed to create, review on a biennial basis and implement policies and procedures for: 1) Installation and testing of an emergency “Stop” switch 10 to 15 feet away from generator. 2) Installation and regularly checking battery powered emergency lighting mounted on the generator for emergency and maintenance purposes. The failed practice did not ensure the facility was capable of stopping the generator in the event of an emergency and the backup generator was capable at running to meet the facility’s electrical demand. The failed practice had the likelihood to affect all patients admitted to the facility. Findings follow: A. Review of the facility’s policies on 4/7/2025 showed that the facility failed to create a policy regarding installation and testing of an emergency “Stop” switch 10 to 15 feet away from generator. Observation on 6/12/2023 showed there was no evidence of a “Stop” switch 10 to 15 feet away from the generator. B. Review of the facility’s policies on 4/7/2025 showed that the facility failed to create a policy in regards to installation and regularly checking battery powered emergency lighting mounted on the generator for emergency and maintenance purposes. D. The findings of A and B were confirmed in an interview with the Maintenance Supervisor on 4/8/2025 at 1:21 PM.”

“Building safety. CFR(s): (d)Except as otherwise provided in this section, the REH must meet the applicable provisions and must proceed in accordance with the 2012 edition of the Health Care Facilities Code (NFPA 99, and Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6). (1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to an REH. (2) If application of the Health Care Facilities Code required under paragraph (d) of this section would result in unreasonable hardship for the REH, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients. This Standard is not met as evidenced by: 48468 Based on review or facility maintenance records, review of National Fire Protection Agency (NFPA) standards, observation and interview it was determined the facility failed to: 1. Conducted ceiling tile checks monthly. 2. Ensure fire extinguishers checks were logged or checked monthly. 3. Ensure exhaust fan were checked monthly. 4. Ensure emergency exit light checks were conducted monthly. 5. Ensure emergency door checks were conducted. The failed practice did not ensure a safe environment for the patients and staff and had the likelihood to affect all patient receiving care in the facility and staff. Findings follow: A. Review of NFPA standards showed the following: 1) NFPA requirements for conducting ceiling tile checks, as outlined in NFPA 101 (Life Safety Code), stipulate that ceiling tiles must be inspected regularly to ensure they are properly secured and do not obstruct fire protection systems, such as sprinklers, or interfere with safe egress routes. 2) NFPA requirements for conducting fire extinguisher checks, as outlined in NFPA 10 (Standard for Portable Fire Extinguishers), mandate that fire extinguishers must be inspected monthly to ensure they are fully charged, properly mounted, and free of obstruction, with a thorough annual maintenance check to verify their operational readiness. 3) NFPA requirements for conducting exhaust fan checks, as outlined in NFPA 90A (Standard for the Installation of Air-Conditioning and Ventilating Systems), mandate that exhaust fans be regularly inspected and tested to ensure they are operating properly, free of obstructions, and capable of effectively ventilating smoke or fumes during an emergency. 4) NFPA requirements for conducting emergency light checks, as outlined in NFPA 101 (Life Safety Code), mandate that emergency lighting sys”