Honorhealth Four Peaks 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: 43788 Based on review of documents, observations and interviews, it was determined the hospital failed to ensure the Governing Body evaluated hospital services related to Licensing Standards, QAPI, Nursing Services, Physical Environment, and Infection Prevention and Control. This deficient practice poses the risk of the Governing Body being unaware of the overall function and management of the hospital and the inability to improve patient care services. Findings include: A0022: The Governing Body and Hospital failed to meet the standards for licensing established by the state licensing agency as demonstrated by: 1. Failure to ensure the facility did not repeatedly admit patients in excess of the licensed capacity which poses a potential risk of impacting the quality of care provided. 2. Failure to ensure a request for approval to increase the facility’s licensed capacity was submitted to the state licensing agency which has the potential risk of inadequate oversight of the facility by the state licensing agency. 3. Failure to notify the state licensing agency of a removal of surgical services which has the potential risk of inadequate oversight of the hospital by the state licensing agency. 4. Failure to establish in writing, the hospital’s scope of services which has the potential risk of inadequate oversight if the administration has not reviewed and evaluated all services available at the facility. 5. Failure to establish in writing, a policy establishing the roles and responsibilities for staff with water testing and analysis for dialysis machines which poses a potential risk of impacting safe, quality of care provided. A0057: The Governing Body failed to ensure the Chief Executive Officer was responsible for the daily operation and management of the hospital. A0263: The Governing Body failed to ensure to have a quality assessment and performance improvement program that reflected the complexity of the hospital’s organization and services involving all hospital departments. A0273: The Governing Body failed to ensure the quality committee gathered and analyzed data related to the provision on “in-house” dialysis services since terminating contracted services through a dialysis vendor . A0286: The Governing Body failed to ensure the quality program defined its scope, activities, and executive responsibilities related to the provision of “in-house” dialysis services when the facility stopped providing the service through a contracted vendor. A0308: The Governing Body failed to ensure the quality program reflected the evaluation of the provision of dialysis services. A0309: The Governing Body failed to provide evaluation and oversight to the Quality Assurance and Performance Improvement (QAPI) program related to “in-house” dialysis services. A0385: The Governing Body failed to ensure the Chief Executive Officer was responsible for the daily operation and management of nursing services. A0386: The Governing Body failed to ensure the nurse executive managed the overall nursing services of the facility. A0398: The Governing Body failed to ensure the nurse executive ensured nursing staff complied with hospital policy and procedures regarding dialysis services. A0700: The Governing Body failed to ensure the hospital premises and equipment were maintained to prevent patient harm. A0701: The Governing Body and Hospital failed to ensure the facility was adequately maintained by: 1. failing to ensure the designated, licensed surgical area was maintained and operational. 2. failing to ensure water damaged areas in the hospital were repaired. 3. failing to ensure that hallways/egresses in the Emergency Department were free of obstructions. 4. failing to ensure vacuum pumps (primary and backup) were functioning properly. 5. failing to ensure runoff water from the Magnetic Resonance Imaging (MRI) scanner was draining properly into the sewer and not pooling in a drainage ditch. 6. failing to ensure weeds and dead shrubbery were removed and kept under control. 7. failing to ensure possible ligature points in the ED seclusion room were eliminated. 8. failing to ensure Biohazard Hazard signs were posted on storage areas and the storage area secured. 9. failing to ensure the eyewash station next to the nurse’s station in the Emergency Department was functioning. 10. failing to ensure oxygen tanks were in a secured location and proper signs were posted on storage rooms with oxygen. A0724: The Governing Body failed to ensure facilities, supplies, and equipment were maintained to ensure an acceptable level of safety and quality. A0747: The Governing Body failed to ensure the facility adhered to nationally recognized infection prevention and control guidelines regarding dialysis services. A0750: The Governing Body failed to ensure the facility was performing required/recommended water analysis and cultures on dialysis equipment. A0772: The Governing Body failed to ensure the facility had policy and procedures in place that address who is responsible for obtaining/processing AAMI analysis water, and microbiological monitoring samples and address actions to be taken for out or range results. A0774: The Governing Body failed to ensure an infection preventionist collaborated with the quality committee on infection prevention and control issues as related to following standards for microbiological monitoring of water and dialysate from dialysis machines used to provide hemodialysis treatment to patients in the facility. A0941: The Governing Body failed to ensure that the hospital is providing surgical services. The cumulative effect of these systemic deficient practices resulted in the facility’s failure to meet the requirement for the Condition of Participation for Governing Body.”

“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: 43788 Based on the record review and interviews, it was determined the hospital failed to have a quality assessment and performance improvement program that reflected the complexity of the hospital’s organization and services involving all hospital departments as evidenced by: A0273: Failure to ensure the quality committee gathered and analyzed data related to the provision on “in-house” dialysis services since terminating contracted services through a dialysis vendor . A0286: Failure to ensure the quality program defined its scope, activities, and executive responsibilities related to the provision of “in-house” dialysis services when the facility stopped providing the service through a contracted vendor. A0308: Failure to ensure the quality program reflected the evaluation of the provision of dialysis services. A0309: Failure to provide evaluation and oversight to the Quality Assurance and Performance Improvement (QAPI) program related to “in-house” dialysis services. The cumulative effect of these systemic deficient practices resulted in the facility’s failure to meet the requirement for Condition of Participation for Quality Assessment and Performance Improvement.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 43788 Based on the review of documents,observations, and interviews, it was determined that the Hospital failed to meet the requirement of the Conditions of Participation for Nursing Services as evidenced by the following references to standard-level deficiencies: A0386: The nurse executive failed to manage the overall nursing services of the facility. A0398: The nurse executive failed to ensure nursing staff complied with hospital policy and procedures regarding dialysis services. A0724: Failure to ensure facilities, supplies, and equipment were maintained to ensure an acceptable level of safety and quality. A0747: Failure to ensure the facility adhered to nationally recognized infection prevention and control guidelines regarding dialysis services. A0750: Failure to ensure the facility was performing required/recommended water analysis and cultures on dialysis equipment. A0772: Failure to ensure the facility had policy and procedures in place that address who is responsible for obtaining/processing AAMI analysis water, and microbiological monitoring samples and address actions to be taken for out or range results.. A0774: Failure to ensure an infection preventionist collaborated with the quality committee on infection prevention and control issues as related to following standards for microbiological monitoring of water and dialysate from dialysis machines used to provide hemodialysis treatment to patients in the facility. The cumulative effect of these systemic deficient practices resulted in the facility’s failure to meet the requirement for Condition of Participation for Nursing Services.”

“PHYSICAL ENVIRONMENT CFR(s): 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. This Condition is not met as evidenced by: 43788 Based on review of documents, observations, and interviews, it was determined that the Hospital failed to meet the requirement of the Condition of Participation for Physical Environment as evidenced by the following references to standard level deficiencies: A0701: The Governing Body and the Hospital failed to ensure the facility was adequately maintained by: 1. failing to ensure the designated, licensed surgical area was maintained and operational. 2. failing to ensure water damaged areas in the hospital were repaired. 3. failing to ensure that hallways/egresses in the Emergency Department were free of obstructions. 4. failing to ensure vacuum pumps (primary and backup) were functioning properly. 5. failing to ensure runoff water from the Magnetic Resonance Imaging (MRI) scanner was draining properly into the sewer and not pooling in a drainage ditch. 6. failing to ensure weeds and dead shrubbery were removed and kept under control. 7. failing to ensure possible ligature points in the ED seclusion room were eliminated. 8. failing to ensure Biohazard Hazard signs were posted on storage areas and the storage area secured. 9. failing to ensure the eyewash station next to the nurse’s station in the Emergency Department was functioning. 10. failing to ensure oxygen tanks were in a secured location and proper signs were posted on storage rooms with oxygen. A0724: The Governing Body failed to ensure facilities, supplies, and equipment were maintained to ensure an acceptable level of safety and quality. The cumulative effects of these systemic practices resulted in the failure of the hospital to deliver statutorily mandated compliance with Federal regulations for Physical Environment.”

“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: 43788 Based on review of documents, observations, and interviews, it was determined that the Governing Body failed to meet the requirement of the Condition of Participation for Infection Prevention and Control as evidenced by the following references to standard level deficiencies: A0750: The Governing Body failed to ensure the facility was performing required/recommended water and dialysate cultures and entdotoxin testing on dialysis equipment. A0772: The Governing Body failed to ensure the facility had policy and procedures in place that address who is responsible for obtaining/processing AAMI analysis water, and microbiological monitoring samples and address actions to be taken for out or range results. A0774: The Governing Body failed to ensure the facility communicated to the QAPI program regarding tracking and quality for AAMI analysis or feed/source water and product water, microbiological culture and endotoxin, and chlorine testing. The cumulative effect of these systemic deficient practices resulted in the facility’s failure to meet the requirement for the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship and provide a safe environment for patients to protect them from harm.”

“LICENSURE OF HOSPITAL CFR(s): 482.11(b) The hospital must be - o Licensed; or o Approved as meeting standards for licensing established by the agency of the State or locality responsible for licensing hospitals. This Standard is not met as evidenced by: 43788 Based on review of documents, Hospital Website, Arizona Department of Health Services (ADHS) licensing file, observations, and staff interviews, it was determined the Governing Body and Hospital failed to meet the standards for licensing established by the state licensing agency as demonstrated by: 1. Failure to ensure the facility did not repeatedly admit patients in excess of the licensed capacity which poses a potential risk of impacting the quality of care provided. 2. Failure to ensure a request for approval to increase the facility’s licensed capacity was submitted to the state licensing agency which has the potential risk of inadequate oversight of the facility by the state licensing agency. 3. Failure to notify the state licensing agency of a removal of surgical services which has the potential risk of inadequate oversight of the hospital by the state licensing agency. 4. Failure to established in writing, the hospital’s scope of services which has the potential risk of inadequate oversight if the administration has not reviewed and evaluated all services available at the facility. 5. Failure to have in writing, a policy and procedure establishing the roles and responsibilities for staff for obtaining/processing AAMI analysis water, and microbiological monitoring samples and address actions to be taken for out of range results for dialysis machines which poses a potential risk of impacting safe, quality of care provided. Cross reference: A0043, A0057, A0263, A0398, A0941 Findings include: 1. and 2. Review of hospital website revealed: “...Florence Hospital, a campus of Mountain Vista Medical Center, is a 36-bed hospital offering emergency care, as well as surgical, imaging, and laboratory services....” Review of current hospital license posted in the hospital lobby revealed: “...This facility is licensed to operate as a(n) General Hospital... Licensed Beds MOSU - Adult ICU/Med/Surg =36...Total Capacity: 36...Effective: August 1, 2020....” Review of the Arizona Department of Health Licensing File for the hospital revealed an initial licensing approval letter dated 05/04/2020 which revealed: “...If no deficiencies have been cited and all fees are paid, you may begin providing services today, 05/01/2020, which will be the effective date of the license. The approval is for the added Correctional Medicine Unit: sixteen (16) MOSU adult ICU/Medical/surgical patient rooms. The addition of this Correctional Medicine Unit of sixteen (16) MOSU patient rooms, will be added to the already approved, and existing Nursing Unit of twenty (20) MOSU patient rooms for a total capacity of thirty-six (36) patient beds/rooms...Further review of the licensing file revealed no documented communication from the hospital to the Department notifying when the hospital’s CMU was over the licensed bed capacity. Review of the hospital census for 03/28/2024 revealed the census in the Correctional Medicine Unit (CMU) was 20 patients. Review of the census for the CMU from 01/01/2024 to 03/28/2024 revealed the following months were the census was over the 16 bed capacity for the CMU: 01/01/2024 through 01/31/2024 census was 20-21 patients daily 02/01/2024 through 02/29/2024 census was 18-21 patients daily 03/01/2024 through 03/28/2024 census was 18-21 patients daily Observation on tour of the CMU on 03/28/2024 revealed 16 individual patient rooms and 5 individual triage bay rooms on the unit. Further observation revealed 16 patient rooms were occupied and 4 of the triage bays were occupied with patients. Employee #1 confirmed during an interview on 03/28/2024 that the hospital was licensed for 36 beds with 20 beds in the Multi-Organizational Specialty Unit (MOSU) and 16 beds on the CMU. Employee #1 confirmed the 5 triage bays in the CMU were not a part of the licensed bed capacity. Employee #1 confirmed that the hospital was using the 5 triage bays as patient rooms and the capacity was 21 beds instead of 16 beds. Employee #1 confirmed that the Department had not been notified or approved the increase in licensed beds for the CMU. 3. Hospital website revealed the following service provided: “...Our surgical team at Florence Hospital consists of board-certified general and specialty surgeons, anesthesiologists, highly trained nurses, technologists, and other support staff. Surgeries are performed on-site in one of our state-of-the-art surgical suites...We offer the convenience of same-day outpatient surgery, as well as traditional inpatient surgical services. Our services include: General Surgery, Orthopedic Surgery, and Urological Surgery....” Arizona Department of Health Licensing file dated 08/29/2019 revealed the hospital was approved for: “...Surgery Department: one (1) Operating Room, two (2) Pre-Op stations, tow (2) PACU stations, one (1) PACU all room, instrument processing, and sterilization room....” Further review of the Department licensing file revealed no communication from the hospital requesting removal of surgical services from the current license. Observation while on tour of the facility on 03/27/2024 revealed the Operating Room (OR) was closed and non-operational. Employee #1 confirmed that the hospital had stopped providing surgical services ‘over a year ago’. Employee #2 confirmed that the hospital had failed to notify the Department that the hospital had stopped providing surgical services. Employee #2 confirmed in an interview on 03/27/2024 the Operating Room (OR) was used for one surgery since the facility had opened in 2019 and has remained closed for at least 2-3 years from present date. Employee #2 stated, “We can’t get any surgeons here”. 4. Request for the hospital’s Scope of Services was requested on 03/27/2024. A site specific Scope of Services documentation was not provided. The Scope of Services provided encompassed Mountain Vista Medical Center with Florence Hospital listed as part of the Mountain Vista Campus. Review of the document revealed no specific listings of Florence Hospital Scope of Services. Employee #1 confirmed in an interview on 03/28/2024 that the facility did not have a Scope of Services specific to Hospital #1 available for review. 5. The facility policy titled “Water Testing Guidelines for the Tablo Dialysis System” revealed: “...This policy provides guidelines for routine water culture testing for contaminants, for residual chlorine/chloramine levels, pH testing (when applicable), and monthly and bi-annually (AAMI) water analysis....” The policy did not address who is responsible to collect, process, maintain, and report on AAMI analysis of water, and for water and dialysate culture and endotoxin testing for the dialysis equipment in the facility. Employees #8 and 9 confirmed on 03/27/2024 that they were unsure who had responsibility of collecting and gathering/disseminating water analysis and water/dialysate microbiological testing for dialysis equipment at the facility and each stated they were not responsible for the collection, maintenance, and reporting of data.”

“CHIEF EXECUTIVE OFFICER CFR(s): 482.12(b) The governing body must appoint a chief executive officer who is responsible for managing the hospital. This Standard is not met as evidenced by: 43788 Based on review of documents, observations, and interviews, it was determined the Chief Executive Officer (CEO) failed to manage the daily operation of the hospital. This deficient practice poses a risk to the health and safety of patients when leadership does not provide proper guidance, enforcement of policies and procedures and provide resources to provide care to meet the needs of patients. Findings include: It was determined the CEO failed to manage to manage the day-to-day operations of the hospital as demonstrated by the following: A0022: Failure to meet the standards for licensing established by the state licensing agency as demonstrated by: 1. Failure to ensure the facility did not repeatedly admit patients in excess of the licensed capacity which poses a potential risk of impacting the quality of care provided. 2. Failure to ensure a request for approval to increase the facility’s licensed capacity was submitted to the state licensing agency which has the potential risk of inadequate oversight of the facility by the state licensing agency. 3. Failure to notify the state licensing agency of a removal of surgical services which has the potential risk of inadequate oversight of the hospital by the state licensing agency. 4. Failure to established in writing, the hospital’s scope of services which has the potential risk of inadequate oversight if the administration has not reviewed and evaluated all services available at the facility. 5. Failure to have in writing, a policy and procedure establishing the roles and responsibilities for staff for obtaining/processing AAMI analysis water, and microbiological monitoring samples and address actions to be taken for out of range results for dialysis machines which poses a potential risk of impacting safe, quality of care provided. A0263: Failure to ensure to have a quality assessment and performance improvement program that reflected the complexity of the hospital’s organization and services involving all hospital departments. A0273: Failure to ensure the quality committee gathered and analyzed data related to the provision on “in-house” dialysis services since terminating contracted services through a dialysis vendor . A0286: Failure to ensure the quality program defined its scope, activities, and executive responsibilities related to the provision of “in-house” dialysis services when the facility stopped providing the service through a contracted vendor. A0308: Failure to ensure the quality program reflected the evaluation of the provision of dialysis services. A0385: Failure to ensure the Nurse Executive was responsible for the daily operation and management of nursing services. A0386: Failure to ensure the nurse executive managed the overall nursing services of the facility. A0398: Failure to ensure the nurse executive ensured nursing staff complied with hospital policy and procedures regarding dialysis services. A0700: Failure to ensure the hospital premises and equipment were maintained to prevent patient harm. A0701: Failure to ensure the facility was adequately maintained by: 1. failing to ensure the designated, licensed surgical area was maintained and operational. 2. failing to ensure water damaged areas in the hospital were repaired. 3. failing to ensure that hallways/egresses in the Emergency Department were free of obstructions. 4. failing to ensure vacuum pumps (primary and backup) were functioning properly. 5. failing to ensure runoff water from the Magnetic Resonance Imaging (MRI) scanner was draining properly into the sewer and not pooling in a drainage ditch. 6. failing to ensure weeds and dead shrubbery were removed and kept under control. 7. failing to ensure possible ligature points in the ED seclusion room were eliminated. 8. failing to ensure Biohazard Hazard signs were posted on storage areas and the storage area secured. 9. failing to ensure the eyewash station next to the nurse’s station in the Emergency Department was functioning. 10. failing to ensure oxygen tanks were in a secured location and proper signs were posted on storage rooms with oxygen. A0724: Failure to ensure facilities, supplies, and equipment were maintained to ensure an acceptable level of safety and quality. A0747: Failure to ensure the facility adhered to nationally recognized infection prevention and control guidelines regarding dialysis services. A0750: Failure to ensure the facility was performing required/recommended water analysis and cultures on dialysis equipment. A0772: Failure to ensure the facility had policy and procedures in place that address who is responsible for obtaining/processing AAMI analysis water, and microbiological monitoring samples and address actions to be taken for out or range results.. A0774: Failure to ensure an infection preventionist collaborated with the quality committee on infection prevention and control issues as related to following standards for microbiological monitoring of water and dialysate from dialysis machines used to provide hemodialysis treatment to patients in the facility. A0941: Failure to ensure that the hospital is providing surgical services. Employee#3 confirmed during an interview on 03/27/2024 that s/he was the President of the Arizona Region and was responsible for the management of the facility.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure (3) of (3) patients receiving dialysis treatment at the facility were dialyzed with machines that had appropriate initial and ongoing validation testing for AAMI quality water including microbiological testing to ensure the patient was not at risk for chemical contaminant toxicity, pyrogenic reactions, bacteremia, and/or sepsis. Cross reference tag 0724 Findings include: The policy titled “Routine Water Testing Guidelines for the Tablo Dialysis System” requires: “...Association for the Advancement of Medial Instruments (AAMI): provides guideline for water treatment equipment and quality of dialysis fluids for hemodialysis and other therapies...AAMI Water Analysis Testing...Water analysis testing will be conducted after new installation and at a minimum annually...Dialysis water analysis log...All sampling should be documented using the log (Refer to Attachment A: Water and Dialysate Testing Log)...Log shall be maintained for a period of 3 years...Documentation will be managed through the Water Management Program...AAMI testing as identified by water management will be performed bi-annually...Validation procedure shall require initial AAMI water analysis on tap (source/feed) water and device product water...Documentation will be managed through the Water Management Program...Initial water (water and dialysate culture) testing is weekly, times 4 weeks, then will occur monthly...Water and Dialysate Microbiological Testing for Bacteria and Endotoxins...Testing will be completed monthly...When the Tablo System is initially installed or when the system is modified, initial testing and validation should be completed before use...Validation procedure shall require initial AAMI water analysis on tap water and device product water, colony count and LAL ’ s on water and dialysate of each device weekly and repeated for 3 weeks. Patient treatments may be performed if the first 2 weeks of testing are within acceptable limits and completed, reviewed, and approved by the Nephrologist/Designee...Recommended Microbiology and Endotoxin Results Log (Refer to Attachment A: Water and Dialysate Testing Log)...All sampling should be documented using the log...Each machine shall have one log and the log should be maintained for 3 years....” The document titled “ANSI/AAMI RD52:2004” requires: “...4.1.1 Water...4.1.1 Maximum level of chemical contaminants in water: chem analysis...Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall not contain chemical contaminants at concentrations in excess of those listed in ANSI/AAMI RD62....” The “Tablo Hemodialysis System” user manual for professional users requires: “...Warning: Water samples should be periodically tested per your sites policies to ensure they continue to meet ANSI/AAMI/ISO 23500 or other appropriate quality standards. Failure to periodically test water samples to quality standards may result in serious injury or patient harm....” The facility did not provide documentation that initial AAMI water analysis testing for chemical contaminants and routine follow up testing. Additionally, the facility did not conduct initial weekly and subsequent monthly microbiological testing on all three dialysis machines that were used to provide chronic dialysis treatment to correctional inmates admitted to the correctional unit of the facility. Review of the “Registration Census” revealed Patient #1 , 2, and 3 were admitted to the facility correctional medical unit for dialysis treatment. Observation on 03/27/2024 revealed Patients #1 - 3 receiving dialysis treatment in the correctional medical unit at the facility. Employee #8 confirmed on 03/27/2024 that s/he was unaware that the facility dialysis equipment t used to provide dialysis treatment for Patients #1, 2, and 3 had not had appropriate AAMI water analysis testing and water and dialysate microbiological testing as required.”

“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: 43788 Based on document review and interview, it was determined that the facility failed to ensure the quality committee gathered and analyzed data related to the provision on “in-house” dialysis services since terminating contracted services through a dialysis vendor which has the potential risk of patient harm if the facility isn’t measuring, analyzing, and tracking data to assess performance and process of care. Findings include: The facility document titled “Quality and Patient Safety Plan” did not include dialysis services in its program scope and data collection to monitor and assure that the facility was monitoring performance, effectiveness, and safety of the dialysis services provided at the facility. Quality committee reports were reviewed dated August, September, October, November 2023, and January 2024. No scope and data for dialysis services and required machine maintenance were included in the reports. Employee #1 confirmed on 03/28/2024 that there were no additional reports to provide that covered data collection and monitoring in the quality program for dialysis services.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: 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 ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 43788 Based on document review and interview, it was determined that the facility failed to ensure the quality program defined its scope, activities, and executive responsibilities related to the provision of “in-house” dialysis services when the facility stopped providing the service through a contracted vendor which has the potential risk of patient harm through lack of oversight for services provided in the facility. Findings include: The facility “Quality and Patient Safety Plan” updated December 2022 for the 2023-2024 calendar year did not address patient safety for the provision of “in-house” dialysis services as it related to scope, activities, and executive responsibilities in the quality management plan. Quality committee reports dated August, September, October, November 2023, and January 2024 did not reveal evidence that the program scope, activities, and responsibilities for ‘in-house” dialysis services were incorporated into the quality plan and/or report. The facility policy titled “Routine Water Testing Guidelines for the Tablo Dialysis System” requires: “...The Medical Director or designee should review and sign off all water analysis (AAMI) results, abnormal results, and associated plan of correction. The results and action plan should be shared with infection control....” Evidence of Medical Director/designee review and sign off for all water analysis on the “in-house” dialysis machines was requested. None was provided. Employee #1 confirmed on 03/28/2024 that the required oversight by the medical director/designee was not conducted as required by policy and that the quality program didn’t include in its scope, activities, and executive responsibilities the provision of dialysis services once the facility terminated its vendor contract with an outside dialysis provider and began providing “in-house” dialysis treatments.”

“QAPI GOVERNING BODY, STANDARD TAG CFR(s): 482.21 ... 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) ... The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Standard is not met as evidenced by: 43788 Based on document review and interview, it was determined the governing body failed to ensure the quality program reflected the evaluation of the provision of dialysis services. This failure of the hospital to address the evaluation of services has a high potential risk of deteriorating quality of care to patients if deficiencies in services are not identified and addressed. Findings include: The policy titled “Outset Tablo Inpatient Dialysis System Chapter/Department: Provision of Care/Tablo Hemodialysis” covered the procedure for performing dialysis treatment using the Tablo Dialysis Machine. The document titled “Plan for the Provision of Patient Care” was provided upon request of a scope of services. The plan was specific to Mountain Vista Medical Center and not Florence Hospital. The plan did not outline the provision of dialysis services. The facility “Quality and Patient Safety Plan” updated December 2022 for the 2023-2024 calendar year did not reflect the organization and provision of dialysis services provided at the facility nor the accompanying requirements to evaluate and ensure appropriate safety measures for the provision of dialysis services. Employee #1 confirmed on 03/28/2024 that the quality program did not reflect the complexity of the hospital’s services to include the provision of dialysis services.”

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This Standard is not met as evidenced by: 43788 Based on review of hospital policies and procedures, hospital documents, and staff interviews, it was determined that the Governing Body failed to provide evaluation and oversight to the Quality Assurance and Performance Improvement (QAPI) program related to “in-house” dialysis services. This deficient practice poses a significant risk for patient’s health and safety, when the hospital’s Governing Body and CQI Committees fail to ensure that quality improvement, quality assessment, quality of care and performance improvement projects are evaluated. Findings include: The facility “Quality and Patient Safety Plan” updated December 2022 for the 2023-2024 calendar year did not address patient safety for the provision of “in-house” dialysis services as it related to scope, activities, and executive responsibilities in the quality management plan. The facility did not provide documentation that the infection preventionist/infection control committee communicated and collaborated with the quality program related to water analysis and microbiological testing for cultures and endotoxins of dialysis machines used in the facility. Quality committee reports dated August, September, October, November 2023, and January 2024 did not reveal evidence that the program scope, activities, and responsibilities for ‘in-house” dialysis services were incorporated into the quality plan and/or report. The Governing Board meeting minutes dated June 2023 through February 2024 did not contain any quality data that included tracking and/or monitoring of microbial testing for in-house dialysis treatments and equipment overseen by the Infection Control committee. Employee #1 confirmed on 03/28/2024 that there were no additional reports to provide that covered data collection and monitoring in the quality program for dialysis services. Employee #1 confirmed that there was no documentation of collaboration between the infection control committee and the hospital quality program on microbiological culture and endotoxin testing and subsequent monthly testing for dialysis machines used to provide treatment at the facility.”

“ORGANIZATION OF NURSING SERVICES CFR(s): 482.23(a) The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. This Standard is not met as evidenced by: 43788 Based on review of documents, observation and interviews, it was determined the Chief Nursing Officer failed to manage the overall nursing services of the facility. This deficient practice poses a risk to the health and safety of patients if there is a lack of continuous nursing supervision in the provision of quality patient care to meet the needs of patients. Findings include: Review of facility organizational chart revealed the Chief Nursing Officer oversees four (4) facilities within the organization including Mountain Vista Medical Center and Florence Hospital. Further review of the organizational chart revealed a Director of Nursing (DON) assigned to the Florence Hospital. Upon arrival to facility on 03/27/2024, surveyors were informed that the Chief Nursing Officer and Director of Nursing were not on the premises. The surveyors were informed the Director of Nursing was on vacation and the Chief Nursing Officer was at another facility. During the survey it was determined the Chief Nursing Officer failed to perform the core functions of the position as demonstrated by the following: A0263: Failure to ensure to have a quality assessment and performance improvement program that reflected the complexity of the hospital’s organization and services involving all hospital departments. A0273: Failure to ensure the quality committee gathered and analyzed data related to the provision on “in-house” dialysis services since terminating contracted services through a dialysis vendor . A0286: Failure to ensure the quality program defined its scope, activities, and executive responsibilities related to the provision of “in-house” dialysis services when the facility stopped providing the service through a contracted vendor. A0308: Failure to ensure the quality program reflected the evaluation of the provision of dialysis services. A0398: Failure to ensure nursing staff complied with hospital policy and procedures regarding dialysis services. A0700: Failure to ensure the hospital premises and equipment were maintained to prevent patient harm. A0701: Failure to ensure the facility was adequately maintained by: 1. failing to ensure the designated, licensed surgical area was maintained and operational. 2. failing to ensure water damaged areas in the hospital were repaired. 3. failing to ensure that hallways/egresses in the Emergency Department were free of obstructions. 4. failing to ensure vacuum pumps (primary and backup) were functioning properly. 5. failing to ensure runoff water from the Magnetic Resonance Imaging (MRI) scanner was draining properly into the sewer and not pooling in a drainage ditch. 6. failing to ensure weeds and dead shrubbery were removed and kept under control. 7. failing to ensure possible ligature points in the ED seclusion room were eliminated. 8. failing to ensure Biohazard Hazard signs were posted on storage areas and the storage area secured. 9. failing to ensure the eyewash station next to the nurse’s station in the Emergency Department was functioning. 10. failing to ensure oxygen tanks were in a secured location and proper signs were posted on storage rooms with oxygen. A0724: Failure to ensure facilities, supplies, and equipment were maintained to ensure an acceptable level of safety and quality. A0747: Failure to ensure the facility adhered to nationally recognized infection prevention and control guidelines regarding dialysis services. A0750: Failure to ensure the facility was performing required/recommended water analysis and cultures on dialysis equipment. A0772: Failure to ensure the facility had policy and procedures in place that address who is responsible for obtaining/processing AAMI analysis water, and microbiological monitoring samples and address actions to be taken for out or range results.. A0774: Failure to ensure an infection preventionist collaborated with the quality committee on infection prevention and control issues as related to following standards for microbiological monitoring of water and dialysate from dialysis machines used to provide hemodialysis treatment to patients in the facility. Employee #1 confirmed in an interview on 03/27/2024 that s/he was the Chief Nursing Officer (CNO) for facility and that when s/he was not on the premises, the Director of Nursing (DON) was in charge of nursing services. Employee #1 confirmed that if the Director of Nursing was not on the premises, then s/he was in charge but s/he was only on the premises on Fridays. Employee #1 confirmed that there is no other nursing staff designated as in charge when the CNO or DON are not on the premises.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 43788 Based on a review of documents, observations, and interviews, it was determined the nurse executive failed to ensure hospital staff followed policies and procedures while providing nursing care to patients receiving dialysis procedures at the hospital. This deficient practice poses a risk to the health and safety of patients if staff do not follow guidelines on performing proper dialysis procedures. Cross reference: A0043, A0057, A0385, A0386, A0724, A0747, A0750, A0772, A0774 Findings include: The policy titled “Routine Water Testing Guidelines for the Tablo Dialysis System” requires: “...Dialysis water analysis log...Abnormal results and plan of correction should be documented using the log...Abnormal results and plan of correction should be discussed in Quality Committee, Medical Executive Committee, and Infection Control Committee...The Medical Director or designee should review and sign off all water analysis (AAMI) results, abnormal results, and associated plan of correction. The results and action plan should be shared with infection control....Documentation will be managed through the Water Management Program...Initial water (water and dialysate culture) testing is weekly, times 4 weeks, then will occur monthly...Water and Dialysate Microbiological Testing for Bacteria and Endotoxins...Testing will be completed monthly...When the Tablo System is initially installed or when the system is modified, initial testing and validation should be completed before use...Validation procedure shall require initial AAMI water analysis on tap water and device product water, colony count and LAL ’ s on water and dialysate of each device weekly and repeated for 3 weeks. Patient treatments may be performed if the first 2 weeks of testing are within acceptable limits and completed, reviewed, and approved by the Nephrologist/Designee...Recommended Microbiology and Endotoxin Results Log (Refer to Attachment A: Water and Dialysate Testing Log)...All sampling should be documented using the log...Each machine shall have one log and the log should be maintained for 3 years....” The document titled “ANSI/AAMI RD52:2004” requires: “...7.2 Microbial monitoring methods...7.2.1 General: samples before disinfect...Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines....” The “Tablo Hemodialysis System” user manual for professional users requires: “...Warning: Water samples should be periodically tested per your sites policies to ensure they continue to meet ANSI/AAMI/ISO 23500 or other appropriate quality standards. Failure to periodically test water samples to quality standards may result in serious injury or patient harm....” Observation on 03/27/2024 and 03/28/2024 revealed the following dialysis machines with the corresponding serial numbers listed below were found at Florence Hospital. Outset SN-603630 Outset SN-603631 Outset SN-603634 Observation on 04/01/2024 revealed the following dialysis machines with the corresponding serial numbers listed below were found in the Mountain Vista facility. SN-603620 SN-603623 SN-603624 SN-603627 SN-603628 SN-603629 A copy of the “Water and Dialysate Testing Log” with results of microbiological testing for each machine in the facility was requested. None was provided for review. Documents titled “Microbiology (Colony Count/LAL) were provided for machine 603630 and machine 603631. The microbiology report for machine 603630 and machine 603631 revealed testing conducted and reported on the following dates. 08/04/2023 08/08/2023 08/15/2023 08/22/2023 11/21/2023 There were only four days between the first and second weekly validations for machine 603630 and machine 603631. Only one month of microbiology culture and endotoxin testing was completed in November 2023 for machine 603630 and machine 603631. No initial weekly validation testing or subsequent monthly microbiological testing of water and dialysate were provided for machine 603634. Machine 603631 and machine 603634 were observed in service providing dialysis treatment on 03/27/2024. Neither machine had appropriate initial validation testing weekly for four weeks and did not have subsequent monthly microbiological testing at the time of the survey/observation on 03/27/2024. There were no microbiology cultures and endotoxin testing performed for the month of October 2023, on the six machines at Mountain Vista Medical Center. Employee #8 confirmed that the logs referenced in the policy were not being utilized. Employee #8 confirmed that the log that s/he uses s/he had brought in from another dialysis facility not associated with the hospital. Employee #8 confirmed that the logs are not maintained and any documentation regarding chlorine/chloramine testing is documented in the patient’s medical record, and there is no central log for tracking or record keeping use. Employees #8 and 9 confirmed on 03/27/2024 that they were unsure who had responsibility of collecting and gathering/disseminating water analysis and water/dialysate microbiological testing for dialysis equipment at the facility and each stated they were not responsible for the collection, maintenance, and reporting of data.”

“MAINTENANCE OF PHYSICAL PLANT CFR(s): 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. This Standard is not met as evidenced by: 43788 Based on review of documents, observations and staff interviews, it was determined the Governing Body and Hospital failed to ensure the facility was adequately maintained by: 1. failing to ensure the designated, licensed surgical area was maintained and operational. 2. failing to ensure water damaged areas in the hospital were repaired. 3. failing to ensure that hallways/egresses in the Emergency Department were free of obstructions. 4. failing to ensure vacuum pumps (primary and backup) were functioning properly. 5. failing to ensure runoff water from the Magnetic Resonance Imaging (MRI) scanner was draining properly into the sewer and not pooling in a drainage ditch. 6. failing to ensure weeds and dead shrubbery were removed and kept under control. 7. failing to ensure possible ligature points in the ED seclusion room were eliminated. 8. failing to ensure Biohazard Hazard signs were posted on storage areas and the storage area secured. 9. failing to ensure the eyewash station next to the nurse’s station in the Emergency Department was functioning. 10. failing to ensure oxygen tanks were in a secured location and proper signs were posted on storage rooms with oxygen. These deficient practices pose a risk to the health and safety of patients by being potential sources of infections, breeding grounds for insects and vermin, potential damage to community water systems,potential fire hazard and potential risk for injury or death if not corrected. Cross reference: A0043, A0057, A0386, A0700 Findings include: Request was made for a environmental maintenance policy, one was not provided. 1. Observation while on tour of the facility on 03/27/2024 revealed the Operating Room (OR) was closed and non-operational. Further observation on tour of hospital on 03/27/2024 and 03/28/2024 revealed Operating Room (OR) medical equipment and wooden pallets of supplies were in hallways and rooms in the operating rooms, pre-op and PACU. Further observation revealed water stained ceiling tiles present in the OR nurse’s station. Further observation revealed stainless steel sinks with corroded rust covering approximately 1/3 to 1/2 of the sink basins. Further observation revealed the door to the negative pressure room in the Preop/PACU area propped open with a trash can; when the door was closed the low pressure air alarm would alarm. Further observation revealed white calcium buildup covering the dispenser and overflow tray of the ice machines in the surgical area. Employee #1 confirmed in an interview on 03/28/2024 that the surgical area is non-operational and is being used for storage of hospital equipment. Employee #2 confirmed in an interview on 03/27/2024 the Operating Room (OR) was used for one surgery since the facility had opened in 2019 and has remained closed for at least 2-3 years from present date. 2. Upon arrival to the hospital on 03/27/2024 and 03/28/2024 revealed the front entrance to the hospital was locked with yellow caution tape across the door. Observation while on tour of the hospital on 03/28/2024 revealed the front lobby area to be closed with the walls encased in plastic tarplins and ceiling tiles present with water staining. Further observations while on tour revealed water damaged ceiling tiles in the Emergency Department and Surgical Services area. Further observation revealed peeling paint from the ceiling in the seclusion room in the Emergency Department as well as an active water leak in the seclusion room bathroom. Further observation revealed stainless steel sinks in the surgical services area with calcium build up around the faucets and corroded rust covering approximately 1/2 to 1/2 of the sinks basins. Employee #1 confirmed in an interview on 03/28/2024 that the water damage was from multiple water leaks. Employee #1 confirmed the doors to the main entrance of the hospital were locked and inaccessible. 3. NFPA 101 Life Safety Code, 2012, Chapter 19, Section 19.2.3.4 “Any required aisle, corridor, or ramp shall not be less than 48 in. (1220 mm) in clear width where serving as means of egress from patient sleeping rooms, unless otherwise permitted by one of the following: (5) Where the corridor width is at least 8 ft (2440 mm), projections into the required width shall be permitted for fixed furniture, provided that all of the following conditions are met: (a) The fixed furniture is securely attached to the floor or to the wall. (b) The fixed furniture does not reduce the clear unobstructed corridor width to less than 6 ft (1830mm), except as permitted by 19.2.3.4(2). (c) The fixed furniture is located only on one side of the corridor. (d) The fixed furniture is grouped such that each grouping is not does not exceed an area of 50 ft* (4.6 m*). (e) The fixed furniture groupings addressed in 19.2.3.4(5)(d) are separated from each other by by a distance of at least 10 ft (3050 mm). (f) The fixed furniture is located so as to not obstruct access to building service and fire protection equipment....” Observation while on tour of Emergency Department on 03/28/2024 revealed the hallways of the ED were not free of obstructions. Observed in the hallways making the egress less than 5 feet were computer monitors on moveable stations, vital signs machines on wheels, video conferencing monitor on moveable station, and a patient scale. Employee #4 confirmed during an interview on 03/28/2024 that the ED hallway egress was less than 5 feet and the equipment should be placed elsewhere. 4. Maintenance Logs were requested, none were provided. 99: Health Care Facilities Code, 2012 Edition - Chapter 5 Gas and Vacuum Systems 5.1.3.6 * Category 1 Medical Air Supply Systems. 5.1.3.6.3.13 Operating Alarms and Local Signals. Medical air systems shall be monitored for conditions that can affect air quality during use or in the event of failure, based on the type of compressor(s) used in the system. When the backup or lag compressor is running, a local alarm shall activate [see 5.1.9.5.4(1)]. This signal shall be manually reset. 5.1.3.6.3.14 Medical Air Quality Monitoring. Medical air quality shall be monitored downstream of the medical air regulators and upstream of the piping system as follows: 1. Dew point shall be monitored and shall activate a local alarm and all master alarms when the dew point at system delivery pressure exceeds +2°C (+35°F). 2. Carbon monoxide shall be monitored and shall activate a local alarm when the CO level exceeds 10 ppm. [See 5.1.9.5.4(2). 3. Dew point and carbon monoxide monitors shall activate their individual monitor’s signal at the alarm panels where their signals are required when their power is lost. Observation while on tour on 03/28/2024 revealed the AIR display on the medical gas alarm system displays were red indicating LOW air. Observation of the air flow dispenser in Room 105 on the MOSU revealed no air was being released from the air flow dispenser. Employee #4 confirmed in an interview on 03/28/2024 that the hospital has two vacuum pumps, one is the primary and the other is the back up in case the primary fails. Employee #4 confirmed that the LOW air alarm on the medical gas alarm display is from the back up vacuum pump which is not functioning. Employee #4 confirmed that both the primary pump and back up pump were not functioning and parts were taken off the back up pump to repair the primary pump. Employee #4 stated that the vacuum pumps have a contracted vendor for maintenance and the contracted company has not replaced the part that needs to be repaired on the back up pump. 5. Observation while at the hospital on 03/27/2024 and 03/28/2024 revealed a water runoff area along the southside of the hospital next to the parking lot and drive leading to the rear of the building. Observed in the water runoff area was approximately 4 inches of standing murky water. Also observed were multiple clusters of cattails and marsh type grass approximately 3-4 feet high. The water runoff was approximately 25-35 feet in length along the driveway of the hospital. Further observation revealed a drainage pipe coming out of the side of the parking area and draining into the water runoff area. The drainage pipe was under the parking area concrete and was noted to originate on the hospital side of parking area where a drainage pipe coming out of a wall on the side of the hospital itself drained into the drainage pipe that led to the water runoff. Employee #4 confirmed on 03/28/2024 that the water in the water runoff was from the hospital’s MRI scanner. Employee #4 stated the water runoff was suppose to feed directly into the city sewer that right next to the drainage runoff. 6. Observation of the exterior of the building on 03/27/2024 and 03/28/2024 revealed the weeds and dead shrubbery covered the hospital’s rock landscaping. Weeds up to approximately 8-10 inches high and multiple dead shrubs were noted over the entire landscaped area. Employee #4 confirmed on 03/28/2024 that landscapers had not been to the hospital lately. 7. Observation of the seclusion room in the ED while on tour on 03/28/2024 revealed the following potential ligature risks: · The patient bed and table were not bolted down to the floor · Visible gaps of approximately 1 centimeter were present between the bathroom wall and the toilet and sink · One grab bar in the bathroom was installed vertically instead of horizontally Employee #4 confirmed on 03/28/2024 that the seclusion room in the ED did have potential ligature risks and would put in a work order to correct the issues. 8. Observation on 03/28/2024 revealed in the MOSU a storage room accessible from both sides of the MOSU by two doors. Observed in the storage room were dirty linens, trash, and biohazardous waste bins. Further observation revealed no Biohazardous Waste signs posted at each entrance to the storage room and both doors to the storage rooms were not secured or locked. Further observation revealed both doors were directly across from patient care rooms. Employee #1 confirmed there was no biohazard waste signs on the entrances and the doors were not secured. 9. Observation while on tour of the Emergency Department revealed a sign taped over the eyewash station across from the nurse’s station that read “Do Not Use, Not Functioning”. Employee #4 confirmed on 03/28/24 that the eyewash station was not working. 10. Observation on tour on 03/28/2024 revealed used and unused oxygen cylinders in a metal oxygen tank holder in a supply room on the MOSU. Further observation revealed no signs posted on the two entrances to the storage room indicating oxygen was in the room. Further observation on 03/28/2024 in the Emergency Department revealed another metal oxygen tank storage bin with used and unused oxygen cylinders places under the counter of the nurse’s station accessible from the hallway side of the nurse’s desk. Employee #1, #2 and #4 confirmed the oxygen tanks should be in a storage room with proper oxygen signs present.”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(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: 37489 Florence Hospital Based on document review and interview, it was determined that the facility failed to: 1. perform Association for the Advancement of Medical Instrumentation (AAMI) water analysis testing after new installation, and on tap (source) water and device product water was conducted on each dialysis machine’s reverse osmosis (RO) system as required. This deficient practice poses a risk of toxicity to patients if chemical contaminates in dialysis water such as aluminum, copper, chloramines, fluoride, nitrate, sulfate, and zinc are in excess of maximum levels set forth in AAMI standards; 2. perform initial water and dialysate microbiological testing for bacteria and endotoxins and then monthly thereafter which poses a risk to dialysis patients for pyrogenic reactions, bacteremia, septicemia, and/or chronic inflammation if water and dialysate are not monitored for bacteria and endotoxins in excess of maximum levels set forth in AAMI standards; and 3. provide evidence of routine chlorine/chloramine testing prior to treatment and approximately every 4 hours while the RO system was in operation to produce dialysis water for patient treatments which poses a risk of hemolysis and/or death if excess chlorine contaminates in dialysis water is not identified and reaches the patient during treatment. Findings include: 1. The policy titled “Routine Water Testing Guidelines for the Tablo Dialysis System” requires: “...Association for the Advancement of Medial Instruments (AAMI): provides guideline for water treatment equipment and quality of dialysis fluids for hemodialysis and other therapies...AAMI Water Analysis Testing...Water analysis testing will be conducted after new installation and at a minimum annually...Dialysis water analysis log...All sampling should be documented using the log (Refer to Attachment A: Water and Dialysate Testing Log)...Log shall be maintained for a period of 3 years...Documentation will be managed through the Water Management Program...AAMI testing as identified by water management will be performed bi-annually...Validation procedure shall require initial AAMI water analysis on tap (source/feed) water and device product water....” The document titled “ANSI/AAMI RD52:2004” requires: “...4.1.1 Water...4.1.1 Maximum level of chemical contaminants in water: chem analysis...Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall not contain chemical contaminants at concentrations in excess of those listed in ANSI/AAMI RD62....” Observation on 03/27/2024 and 03/28/2024 revealed the following dialysis machines with the corresponding serial numbers listed below were found in the Florence facility. Outset SN-603630 (in service) Outset SN-603631 (placed out of service on 03/26/2024) Outset SN-603634 (in service) Observation on 04/01/2024 revealed the following dialysis machines with the corresponding serial numbers listed below were found in the Mountain Vista facility. SN-603620 SN-603623 SN-603624 SN-603627 SN-603628 SN-603629 Machine 603631 was noted out of service and located in a patient room in the MOSU. Machines 603630 and 603634 were noted in service providing dialysis treatments to patients located in the facility “correctional” unit which houses Arizona Department of Corrections inmates admitted for treatment. AAMI water analysis testing for initial tap water and product water testing was requested. No log or copy of the “Water and Dialysate Testing Log” was provided as outlined in the facility policy that requires documentation of initial and routine water analysis testing for chemical contaminants. Two documents titled “DD Laboratory, LLC AAMI Water Analysis” dated 08/04/2023 were provided for each dialysis machine 603630 and machine 603631. An AAMI Water Analysis report was not provided for machine 603634. No AAMI Water Analysis reports for initial tap (source/feed) water were provided for any of the dialysis machines at either facility. No additional/bi-annual AAMI Water Analysis reports were provided for any of the machines located at either facility. Employee #1 confirmed on 03/28/2024 that Florence Hospital did not maintain the log for water and dialysate testing and that AAMI water analysis testing was not performed as outlined in the facility policy. Employee #1 also confirmed in an interview on 04/01/2024, AAMI water analysis testing was not performed as outlined in the facility policy on the machines at Mountain Vista Medical Center. 2. The policy titled “Routine Water Testing Guidelines for the Tablo Dialysis System” requires: “...Documentation will be managed through the Water Management Program...Initial water (water and dialysate culture) testing is weekly, times 4 weeks, then will occur monthly...Water and Dialysate Microbiological Testing for Bacteria and Endotoxins...Testing will be completed monthly...When the Tablo System is initially installed or when the system is modified, initial testing and validation should be completed before use...Validation procedure shall require initial AAMI water analysis on tap water and device product water, colony count and LAL ’ s on water and dialysate of each device weekly and repeated for 3 weeks. Patient treatments may be performed if the first 2 weeks of testing are within acceptable limits and completed, reviewed, and approved by the Nephrologist/Designee...Recommended Microbiology and Endotoxin Results Log (Refer to Attachment A: Water and Dialysate Testing Log)...All sampling should be documented using the log...Each machine shall have one log and the log should be maintained for 3 years....” The document titled “ANSI/AAMI RD52:2004” requires: “...7.2 Microbial monitoring methods...7.2.1 General: samples before disinfect...Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines....” The “Tablo Hemodialysis System” user manual for professional users requires: “...Warning: Water samples should be periodically tested per your sites policies to ensure they continue to meet ANSI/AAMI/ISO 23500 or other appropriate quality standards. Failure to periodically test water samples to quality standards may result in serious injury or patient harm....” Observation on 03/27/2024 and 03/28/2024 revealed the following dialysis machines with the corresponding serial numbers listed below were found in the Florence facility. Outset SN-603630 (in service) Outset SN-603631 (placed out of service on 03/26/2024) Outset SN-603634 (in service) Observation on 04/01/2024 revealed the following dialysis machines with the corresponding serial numbers listed below were found in the Mountain Vista facility. SN-603620 SN-603623 SN-603624 SN-603627 SN-603628 SN-603629 A copy of the “Water and Dialysate Testing Log” with results of microbiological testing for each machine in the Florence facility was requested. None was provided for review. Documents titled “Microbiology (Colony Count/LAL) were provided for machine 603630 and machine 603631. The microbiology report for machine 603630 and machine 603631 revealed testing conducted and reported on the following dates. 08/04/2023 08/08/2023 08/15/2023 08/22/2023 11/21/2023 There were only four days between the first and second weekly validations for machine 603630 and machine 603631. Only one month of microbiology culture and endotoxin testing was completed in November 2023 for machine 603630 and machine 603631. There were no microbiology culture and endotoxin testing performed for the month of October 2023, on the six machines at Mountain Vista Medical Center. No initial weekly validation testing or subsequent monthly microbiological testing of water and dialysate were provided for machine 603634. Machine 603631 and machine 603634 were observed in service providing dialysis treatment on 03/27/2024. Neither machine had appropriate initial validation testing weekly for four weeks and did not have subsequent monthly microbiological testing at the time of the survey/observation on 03/27/2024. Employee #1 confirmed on 03/28/2024 that initial validation microbiological culture and endotoxin testing and subsequent monthly testing were not conducted for the dialysis machines listed above as required by AAMI guidelines and facility policy. Employee #1 confirmed in an interview conducted on 04/01/2024, the microbiology testing and endotoxin testing was not performed on the dialysis machines due to payment issues. 3. The document titled “ANSI/AAMI RD52:2004” requires: “...6.2.5 Carbon adsorption: monitoring, testing frequency...Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are not set patient shifts, testing should be performed approximately every 4 hours...Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet... The facility policy titled “Routine Water Testing Guidelines for the Tablo Dialysis System” requires: “...Chlorine/Chloramine: defined as the major disinfectants used in household water. Water used for dialysis, must be completely free of chloramine because if it enters a patient ’ s bloodstream, it can cause hemolysis and anemia...Chlorine/Chloramine Testing...To ensure that water used to produce dialysate meets AAMI standards, testing is done for Total Chlorine/Chloramine...Document the results of the test on log (Refer to Attachment C: Dialysis Water Chlorine/Chloramine Testing Log)....” The chlorine/chloramine testing logs for the last 12 months for each dialysis machine at Mountain Vista Medical Center and Florence Hospital were requested. None were provided. Observation on 03/27/2024 and 03/28/2024 revealed Florence Hospital provided dialysis services, had three dialysis machines to provide patient treatments, and that one of the three machines had signage that it was placed out of service on 03/26/2024. Employees #1 and 8 confirmed on 03/27/2024 that Florence Hospital did not maintain a “Dialysis Water Chlorine/Chloramine Testing Log” for each dialysis machine to demonstrate compliance with AAMI standards for testing for chlorine/chloramines approximately every four hours and as required in the facility policy. Employee #1 confirmed in an interview on 04/01/2024, there were no Dialysis Water Chlorine/Chloramine Testing Logs, completed per policy, for the six dialysis machines at Mountain Vista”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 37489 Florence Hospital Based on document review and interview, it was determined that the facility failed to implement an infection prevention and control program that included surveillance, prevention, and control of HAIs by maintaining dialysis equipment for hemodialysis treatment provided to long term patients housed in the facility “correctional” unit in the hospital. The facility failed to perform initial water and dialysate microbiological testing for bacteria and endotoxins and then monthly thereafter according to policy and procedure which poses a risk to dialysis patients for pyrogenic reactions, bacteremia, septicemia, and/or chronic inflammation if water and dialysate are not monitored for bacteria and endotoxins in excess of maximum levels set forth in AAMI standards. Cross reference tag A0724, A0747, A0772, A0774 for additional information. Findings include: The quality management program document titled “Quality and Patient Safety Plan” effective for 2023-2024 calendar year was last updated/reviewed December 2022. The plan did not outline an infection and prevention program that included surveillance, prevention, and control of HAIs associated with dialysis equipment and patients receiving dialysis at the facility. The policy titled “Routine Water Testing Guidelines for the Tablo Dialysis System” requires: “...Dialysis water analysis log...Abnormal results and plan of correction should be documented using the log...Abnormal results and plan of correction should be discussed in Quality Committee, Medical Executive Committee, and Infection Control Committee...The Medical Director or designee should review and sign off all water analysis (AAMI) results, abnormal results, and associated plan of correction. The results and action plan should be shared with infection control....Documentation will be managed through the Water Management Program...Initial water (water and dialysate culture) testing is weekly, times 4 weeks, then will occur monthly...Water and Dialysate Microbiological Testing for Bacteria and Endotoxins...Testing will be completed monthly...When the Tablo System is initially installed or when the system is modified, initial testing and validation should be completed before use...Validation procedure shall require initial AAMI water analysis on tap water and device product water, colony count and LAL ’ s on water and dialysate of each device weekly and repeated for 3 weeks. Patient treatments may be performed if the first 2 weeks of testing are within acceptable limits and completed, reviewed, and approved by the Nephrologist/Designee...Recommended Microbiology and Endotoxin Results Log (Refer to Attachment A: Water and Dialysate Testing Log)...All sampling should be documented using the log...Each machine shall have one log and the log should be maintained for 3 years....” The document titled “ANSI/AAMI RD52:2004” requires: “...7.2 Microbial monitoring methods...7.2.1 General: samples before disinfect...Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines....” The “Tablo Hemodialysis System” user manual for professional users requires: “...Warning: Water samples should be periodically tested per your sites policies to ensure they continue to meet ANSI/AAMI/ISO 23500 or other appropriate quality standards. Failure to periodically test water samples to quality standards may result in serious injury or patient harm....” Observation on 03/27/2024 and 03/28/2024 revealed the following dialysis machines with the corresponding serial numbers listed below were found at Florence Hospital. Outset SN-603630 Outset SN-603631 Outset SN-603634 Observation on 04/01/2024 revealed the following dialysis machines with the corresponding serial numbers listed below were found in the Mountain Vista facility. SN-603620 SN-603623 SN-603624 SN-603627 SN-603628 SN-603629 A copy of the “Water and Dialysate Testing Log” with results of microbiological testing for each machine in the facility was requested. None was provided for review. Documents titled “Microbiology (Colony Count/LAL) were provided for machine 603630 and machine 603631. The microbiology report for machine 603630 and machine 603631 revealed testing conducted and reported on the following dates. 08/04/2023 08/08/2023 08/15/2023 08/22/2023 11/21/2023 There were only four days between the first and second weekly validations for machine 603630 and machine 603631. Only one month of microbiology culture and endotoxin testing was completed in November 2023 for machine 603630 and machine 603631. No initial weekly validation testing or subsequent monthly microbiological testing of water and dialysate were provided for machine 603634. Machine 603631 and machine 603634 were observed in service providing dialysis treatment on 03/27/2024. Neither machine had appropriate initial validation testing weekly for four weeks and did not have subsequent monthly microbiological testing at the time of the survey/observation on 03/27/2024. There were no microbiology cultures and endotoxin testing performed for the month of October 2023, on the six machines at Mountain Vista Medical Center. Evidence that the Nephrologist/Designee or Dialysis Director had completed, reviewed, and approved the use of equipment after initial validation and subsequent monthly microbiological testing was requested but not provided. Employee #1 confirmed on 03/28/2024 that microbiologicial monitoring of water and dialysate had not been completed on the dialysis machines providing treatment to patients in the facility as required by facility policy and AAMI standard. Employee #1 confirmed in an interview performed on 04/01/2024, the six dialysis machines at Mountain Vista did not have microbiology cultures performed in October 2023, due to payment issues. Employee #1 also confirmed there is no documentation of the Nephrologist/Designee or Dialysis Director, reviewing and approving initial validation testing or monthly microbiology cultures on the dialysis machines.”

“IC PROFESSIONAL RESPONSIBILITIES POLICIES CFR(s): Standard: Leadership responsibilities (2) The infection preventionist(s)/infection control professional(s) is responsible for: (i) The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. This Standard is not met as evidenced by: 37489 Florence Hospital Based on document review and interview, it was determined that the Governing Body failed to ensure the facility had policy and procedures in place that address who is responsible for obtaining/processing AAMI analysis water, and microbiological monitoring samples and address actions to be taken for out or range results. Cross reference: A0747, A0750, A0774 Findings include: The facility policy titled “Water Testing Guidelines for the Tablo Dialysis System” revealed: “...This policy provides guidelines for routine water culture testing for contaminants, for residual chlorine/chloramine levels, pH testing (when applicable), and monthly and bi-annually (AAMI) water analysis....” The policy did not address who is responsible to collect, process, maintain, and report on AAMI analysis of water, and for water and dialysate culture and endotoxin testing for the dialysis equipment in the facility. Employees #8 and 9 confirmed on 03/27/2024 that they were unsure who had responsibility of collecting and gathering/disseminating water analysis and water/dialysate microbiological testing for dialysis equipment at the facility and each stated they were not responsible for the collection, maintenance, and reporting of data.”

“IC PROFESSIONAL COMMUNICATION QAPI CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (iii) Communication and collaboration with the hospital’s QAPI program on infection prevention and control issues. This Standard is not met as evidenced by: 37489 Florene Hospital Based on document review and interview, it was determined that the facility failed to ensure an infection preventionist collaborated with the quality committee on infection prevention and control issues as related to following standards for microbiological monitoring of water and dialysate from dialysis machines used to provide hemodialysis treatment to patients in the facility. The facility failed to perform initial water and dialysate microbiological testing for bacteria and endotoxins and then monthly thereafter according to policy and procedure which poses a risk to dialysis patients for pyrogenic reactions, bacteremia, septicemia, and/or chronic inflammation if water and dialysate are not monitored for bacteria and endotoxins in excess of maximum levels set forth in AAMI standards. Cross reference tag A0724, A0747,A0750, A0772 for additional information. Findings include: The quality management program document titled “Quality and Patient Safety Plan” effective for 2023-2024 calendar year was last updated/reviewed December 2022. The plan did not outline an infection and prevention program that included surveillance, prevention, and control of HAIs associated with dialysis equipment and patients receiving dialysis at the facility. The policy titled “Routine Water Testing Guidelines for the Tablo Dialysis System” requires: “...Dialysis water analysis log...Abnormal results and plan of correction should be documented using the log...Abnormal results and plan of correction should be discussed in Quality Committee, Medical Executive Committee, and Infection Control Committee...The Medical Director or designee should review and sign off all water analysis (AAMI) results, abnormal results, and associated plan of correction. The results and action plan should be shared with infection control....Documentation will be managed through the Water Management Program...Initial water (water and dialysate culture) testing is weekly, times 4 weeks, then will occur monthly...Water and Dialysate Microbiological Testing for Bacteria and Endotoxins...Testing will be completed monthly...When the Tablo System is initially installed or when the system is modified, initial testing and validation should be completed before use...Validation procedure shall require initial AAMI water analysis on tap water and device product water, colony count and LAL ’ s on water and dialysate of each device weekly and repeated for 3 weeks. Patient treatments may be performed if the first 2 weeks of testing are within acceptable limits and completed, reviewed, and approved by the Nephrologist/Designee...Recommended Microbiology and Endotoxin Results Log (Refer to Attachment A: Water and Dialysate Testing Log)...All sampling should be documented using the log...Each machine shall have one log and the log should be maintained for 3 years....” The document titled “ANSI/AAMI RD52:2004” requires: “...7.2 Microbial monitoring methods...7.2.1 General: samples before disinfect...Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines....” The “Tablo Hemodialysis System” user manual for professional users requires: “...Warning: Water samples should be periodically tested per your sites policies to ensure they continue to meet ANSI/AAMI/ISO 23500 or other appropriate quality standards. Failure to periodically test water samples to quality standards may result in serious injury or patient harm....” Observation on 03/27/2024 and 03/28/2024 revealed the following dialysis machines with the corresponding serial numbers listed below were found in the facility. Outset SN-603630 Outset SN-603631 Outset SN-603634 A copy of the “Water and Dialysate Testing Log” with results of microbiological testing for each machine in the facility was requested. None was provided for review. Documents titled “Microbiology (Colony Count/LAL) were provided for machine 603630 and machine 603631. The microbiology report for machine 603630 and machine 603631 revealed testing conducted and reported on the following dates. 08/04/2023 08/08/2023 08/15/2023 08/22/2023 11/21/2023 There were only four days between the first and second weekly validations for machine 603630 and machine 603631. Only one month of microbiology culture and endotoxin testing was completed in November 2023 for machine 603630 and machine 603631. No initial weekly validation testing or subsequent monthly microbiological testing of water and dialysate were provided for machine 603634. Machine 603631 and machine 603634 were observed in service providing dialysis treatment on 03/27/2024. Neither machine had appropriate initial validation testing weekly for four weeks and did not have subsequent monthly microbiological testing at the time of the survey/observation on 03/27/2024. Evidence that the Nephrologist/Designee or Dialysis Director had completed, reviewed, and approved the use of equipment after initial validation and subsequent monthly microbiological testing was requested but not provided. The facility did not provide documentation that the infection preventionist/infection control committee communicated and collaborated with the quality program related to water analysis and microbiological testing for cultures and endotoxins of dialysis machines used in the facility. The Governing Board meeting minutes dated June 2023 through February 2024 did not contain any quality data that included tracking and/or monitoring of microbial testing for in-house dialysis treatments and equipment overseen by the Infection Control committee. The “Quality Management Review Board” reports dated August, September, October, and November 2023, and January 2024 did not reveal any communication, collaboration, or tracking of data related to the provision of dialysis services and lack of microbiological testing on water and dialysate for the machines used to provide patient treatments at the facility. Employee #8 confirmed on 03/28/2024 that s/he did not participate in the collection of water and dialysate samples for microbiological testing because s/he was never present to collect the samples after disinfection of dialysis machines/reverse osmosis systems as the disinfection process takes between 7 and 9 hours to complete. Employee #8 was unaware that AAMI standards require the samples to be collected prior to disinfection of equipment. Employee #1 confirmed on 03/28/2024 that there was no documentation of collaboration between the infection control committee and the hospital quality program on microbiological culture and endotoxin testing and subsequent monthly testing for dialysis machines used to provide treatment at the facility.”

“ORGANIZATION OF SURGICAL SERVICES CFR(s): 482.51(a) The organization of the surgical services must be appropriate to the scope of the services offered. This Standard is not met as evidenced by: 43788 Based on the review of documents, the hospital website, the Arizona Department of Health Licensing file, observation, and staff interviews, it was determined that the Governing Body failed to ensure that the hospital is providing surgical services. This deficient practice is a potential risk to the health and safety of patients who are seeking specific medical treatment and services and are not able to receive them at the hospital upon arrival to the hospital. Cross reference: A0022, A0043, A0057 Findings include: A request for the hospital’s Scope of Services was requested on 03/27/2024. A site specific Scope of Services documentation was not provided. The Scope of Services provided encompassed Mountain Vista Medical Center with Florence Hospital listed as part of the Mountain Vista Campus. Review of the document revealed no specific listings of Florence Hospital Scope of Services. Hospital website revealed the following service provided: “...Our surgical team at Florence Hospital consists of board-certified general and specialty surgeons, anesthesiologists, highly trained nurses, technologists, and other support staff. Surgeries are performed on-site in one of our state-of-the-art surgical suites...We offer the convenience of same-day outpatient surgery, as well as traditional inpatient surgical services. Our services include: General Surgery, Orthopedic Surgery, and Urological Surgery....” Arizona Department of Health Licensing file dated 08/29/2019 revealed the hospital was approved for: “...Surgery Department: one (1) Operating Room, two (2) Pre-Op stations, two (2) PACU stations, one (1) PACU all room, instrument processing, and sterilization room....” Observation while on tour of the facility on 03/27/2024 revealed the Operating Room (OR) was closed and non-operational. Employee #1 confirmed that the hospital had stopped providing surgical services “over a year ago.” Employee #2 confirmed that the hospital had failed to notify the Department that the hospital had stopped providing surgical services. Employee #2 confirmed in an interview on 03/27/2024 the Operating Room (OR) was used for one surgery since the facility had opened in 2019 and has remained closed for at least 2-3 years from present date. Employee #2 stated, “We can’t get any surgeons here.””