Davita Bel Air Dialysis

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that there were a sufficient number of clean sinks dedicated for handwashing only. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to staff and patients. Findings included: On 02/27/2024 at 11:25 a.m., during review of the facility’s policy “Infection Control for Dialysis Facilities” (Policy: 01-05-01), page 5 number 16 states “Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.” Maintaining proper hygiene and preventing contamination is crucial in healthcare facilities. Clean sinks should be specifically designated for handwashing only. This helps ensure that handwashing is conducted in a clean and hygienic environment. These dedicated handwashing sinks should not be used for any other purposes such as placing, cleaning, or draining used items. To handle such tasks, utility sinks or other appropriate facilities should be used. Each sink, including the dedicated handwashing sinks, should be equipped with soap and paper towels. This ensures that individuals have the necessary supplies to clean their hands effectively and prevent contamination. On 02/21/2024 at 10:00 a.m., during observations of the treatment floor, the surveyor observed disinfecting items such as “bleach 1:100” mixed solution as well as a bleach container located on the sink labeled “clean sink” near stations number 3 and 13”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, review of the dialysis machine disinfection logs and a review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the clinical staff followed the standard regulations in the cleaning and disinfection of contaminated equipment being used in the facility. This failure placed the patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings Included: On 02/27/2024 at 11:25 a.m., during record review of the facility’s policy on Infection Control in Dialysis Facilities, (Policy 1-05-01) Page 3 Number 13 states, “At the end of each treatment, the dialysis station will be cleaned and disinfected... A. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings... and frequently contacted by healthcare personnel” Number 13 Letter B states “Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient. On 02/27/2024 at 11:27 a.m., during review of the facility’s policy, Fresenius Dialysis Delivery System Cleaning and Disinfection Policy (Policy 02-02-01), Page 2 number 6 states “Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log in conjunction with the Biomedical Department and with approval by the Biomed Operations Manager (BOM). The specific log will be reviewed and approved by the governing body prior to implementation. Cleaning and disinfection of the dialysis delivery system will be documented on this log.” On 02/22/2024, during observations of the treatment floor the surveyor observed the following: 1. At 09:15 a.m., [Staff #1] disinfected and set up the dialysis machine located in Station #3 before the previous patient vacated the station. 2. At 09:32 a.m., [Staff #3] started to set up the dialysis machine located in Station #5 without proper disinfection of the dialysis machine. Staff #6 then informed Staff #3 that the station has not been disinfected and asked Staff #3 to disinfect and set up the station once more. 3. At 09:55 a.m., [Staff #1] disinfected and set up the dialysis machine located in Station #2 before the previous patient vacated the station. On 02/22/2024, at 12:35 p.m. during interviews with the biomedical service specialist, machine disinfection must be done monday through saturday utilizing citric thermal and on thursdays utilizing integrated heat. However, on 02/22/2024 at 12:00 p.m., upon review of the facility’s machine daily disinfection logs, the following dates:[01/11/2024, 01/25/2024, 02/15/2024, 02/21/2024] showed no documentation proving that the machines were disinfected nor did the 2 month audit show that integrated heat was performed every Thursday.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 47759 Based on review of the facility’s policies and procedures and review of the facility’s hepatitis serology report, the facility’s governing body failed to ensure routine testing was done for all patients. This failure placed patients and staff at risk of contracting infectious diseases. Patients: A, B, C, D, E, F, and G Findings Included: On 02/27/2024 at 11:20 a.m., during record review of the facility’s policy, Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance (Policy 1-05-02) Page 4 states that If HBsAb is less than 10 mIU/mL, consider the patient susceptible and perform a monthly surveillance testing According to the Centers for Disease Control and Prevention (CDC), preventing transmission depends on timely detection of patients converting from HBsAg negative to HBsAg positive and rapid implementation of isolation procedures before cross-contamination can occur. On 02/21/2024 at 01:00 p.m., during record review of the facility’s Hepatitis B Audit Report, the surveyor observed the following: 1. Patient A, a susceptible patient with a HBsAb <10 has missing HBsAg for the month of 12/2023. 2. Patient B, a susceptible patient with a HBsAb <10 has missing HBsAg for the months of 11/2023, 12/2023, and 01/2024 3. Patient C, a susceptible patient with a HBsAb <10 has missing HBsAg for the months of 08/2023 and 09/2023 4. Patient D, a susceptible patient with a HBsAb <10 has missing HBsAg for the months of 12/2023 and 01/2024 5. Patient E, a susceptible patient with a HBsAb <10 has missing HBsAg for the month of 11/2023 6. Patient F, a susceptible patient with a HBsAb <10 has missing HBsAg for the months of 10/2023, 11/2023, 12/2023, 01/2024, 02/2024 7. Patient G, a susceptible patient with a HBsAb <10 has missing HBsAg for the months of 10/2023, 11/2023, 12/2023, 01/2024, 02/2024”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 47759 Based on observations and review of policies and procedures, the facility’s governing body failed to ensure that staff utilized aseptic technique when accessing central venous catheters. This failure places the affected patients at an increase risk of infection(s). Findings Included: On 02/27/2024, at 11:40 a.m., during record review of the facility’s policies and procedure titled Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps (Procedure 1-04-02 B) page 4 number 4 states, “Remove old dressing and discard.Observe site for signs and symptoms of infection such as redness, drainage, swelling or tenderness. If present, report to RN/physician. If drainage is present, obtain order for exit site culture. Observe CVC at exit site for evidence of cuff migration, cracks, or leaks in the catheter limbs. If present, do not initiate dialysis. Report to RN/physician for further follow-up.” Page 4 number 8 states, “Clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab.” Page 6 number 16 states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly...” On 02/21/2024, during observations of the clinical treatment floor, the surveyor observed the following: 1. At 10:30 a.m., during CVC treatment initiation, the surveyor observed Staff #3 disinfect and access [Patient B]’s CVC hub first prior to assessing [Patient B]’s exit site. 2. At 10:50 a.m., during CVC treatment initiation, the surveyor observed Staff #4 disinfect and access [Patient H]’s CVC hub first prior to assessing [Patient H]’s exit site. 3. At 11:10 a.m., during CVC treatment initiation, the surveyor observed Staff #1 disinfect and access [the patient in Station #24]’s CVC hub first prior to assessing [the patient in Station #24]’s exit site. On 02/22/2024, during observations of the clinical treatment floor, the surveyor observed Staff #6 disinfect [Patient I]’s exit site for 10 seconds total.”

“ENVIRONMENT-ACCESS TO PORTS/METERS CFR(s): 494.40(a) 8 Environment: access to ports/meters The layout of the water purification system should provide easy access to all components of the system, including all meters, gauges, and sampling ports used for monitoring system performance. This Standard is not met as evidenced by: 47759 Based on observations, the facility’s governing body failed to ensure easy access to all components of the system such as: (1) water valves and (2) sample ports. This failure placed the water system at risk for possible damage that may affect patient care. Findings Included: According to the American National Standards Institute (ANSI/AAMI RD52:2004), the layout of the water purification system should provide easy access to all components of the system, including all meters, gauges and sampling ports used for monitoring system performance. On 02/22/2024 at 12:05 p.m., during observations of the water room, the surveyor observed that piles of granuloflo 2 Potassium 2.5 Calcium acid boxes that were stored in the water room were blocking water valves (Valves A4, C1, G1, G3, and H1) and sample ports (primary and secondary chlorine sample port).”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 47759 Based on observations, record review and staff interview, the facility’s governing body failed to ensure that pH was performed before starting the treatment of each patient. This failure placed the affected patients at potential risk of harm. Findings Included: On 02/27/2024 at 11:32 a.m., during record review of the facility’s policies and procedure titled “Testing pH and conductivity of proportioned dialysate and verification of temperature of proportioned dialysate” page 1 number 6 states “Independent pH is required to be performed prior to each treatment” On 02/22/2024., during observations of the clinical treatment floor, the surveyor observed the following: 1. At 09:50 a.m., the surveyor did not observe Staff #6 conduct a pH test on Station #4’s machine prior to initiating treatment. 2. At 10:32 a.m., the surveyor did not observe Staff #7 conduct a pH test on Station #16 ’ s machine prior to initiating treatment. On 02/22/2024, in order to confirm the surveyor’s findings, the surveyor interviewed the clinical staff and asked them the question “What is the facility’s policy on checking the pH.” See the responses below: 1. According to Staff #7, there is no need to check the pH. 2. According to the Clinical Coordinator, [s/he] was aware that checking the pH was policy. However, it was not something that [s/he] had audited nor paid attention to. 3. According to Staff #1, pH testing is not something that the staff do on a regular and consistent basis.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 47759 Based on review of the facility’s policies and procedures and observations, the facility’s governing body failed to maintain an environment that is constructed, equipped, and maintained to provide dialysis patients and the public a safe, functional, and comfortable treatment environment Findings Included: On 01/27/2024 at 11:30 a.m., during review of the facility’s policies and procedures titled “Physical Environment” (Policy: 08-04-01) page 1 number 1 states “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public safe, functional, and comfortable treatment environment.” Number 2 states “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public.” On 02/26/2024 at 01:44 p.m., during environmental inspection of the facility, the surveyor observed the following: 1. Unattached cabinet handles near stations #7, isolation room and #18 2. Unattached cabinet doors near Station #18 3. Water room floor with brown stains near the drains”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47759 Based on record review and staff interview, the facility’s governing body failed to ensure that the dialysis prescriptions were the same as what the patients received. The failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm or injury. Findings included: On 02/27/2024 at 11:00 a.m. during review of the facility’s policies and procedures titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, (Policy 1-03-08) page 4 number 10 states, “If the dialysis prescription is not being met (including dialysis flow rate or change to inability to obtain prescribed blood flow rate or BFR) the reason will be documented, and the licensed nurse informed.” Page 5 states, “Members of the patient care team should report any changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ...Post-treatment: If patient is above or below 1 kg from the target weight” On 02/21/2024 at 01:00 p.m.-02:00 p.m., during record review of the sampled patients’ treatment flowsheet, the surveyor noted the following: 1. On treatment date 02/15/2024, [Patient L] had a BFR prescription order of 450 mL/minute. During record review of Patient L’s treatment flowsheet, the surveyor observed that the BFR was set at 350 mL/minute from 11:58 a.m. -02:23 p.m. with no supporting documentation explaining why the BFR was not followed. 2. On treatment date 02/20/2024, [Patient P] had a BFR prescription order of 450 mL/minute and the DFR prescription order of 600 mL/minute. During record review of Patient P ’ s treatment flowsheet, the surveyor observed that the BFR was set at 330 mL/minute from 10:22 a.m. -11:52 a.m. and the DFR was set at 820 from 10:22 a.m. -12:16 p.m. with no supporting documentation explaining why the BFR or the DFR was not followed. 3. On treatment date 02/13/2024, [Patient P] had a BFR prescription order of 450 mL/minute. During record review of Patient P’s treatment flowsheet, the surveyor observed that the BFR was set at 400 mL/minute from 10:23 a.m. -10:53 a.m. and at 330 mL/minute from 11:23 a.m. -12:12 p.m. with no supporting documentation explaining why the BFR was not followed. 4. On treatment dates 02/20/2024, 02/17/2024 and 02/13/2024, [Patient O] did not meet the prescribed target weight. See the data below: a. On 02/20/2024, [Patient O] was 3.3 kg above the target weight. b. On 02/17/2024, [Patient O] was 4.1 kg above the target weight. c. On 02/13/2024, [Patient O] was 2.0 kg above the target weight. 5. On treatment dates 02/20/2024, 02/17/2024, and 02/15/2024, [Patient K] did not meet the prescribed target weight. See the data below: a. On 02/20/2024, [Patient K] was 1.3 kg above the target weight. b. On 02/17/2024, [Patient K] was 1.9 kg above the target weight. c. On 02/15/2024, [Patient K] was 2.0 kg above the target weight.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 47759 Based on review of policies and procedures and review of selected patients’ plan of care the facility’s governing body failed to ensure that an initial comprehensive assessment has been conducted on all new patients within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first outpatient dialysis session. This failure placed the affected patient at potential risk of harm and denied patients right to a minimum standard of care. Findings included: On 02/27/2024 at 11:05 a.m., during record review of the facility’s Interdisciplinary team (IDT) Patient Assessment and Plan of Care (Policy 01-14-01) page 4 number 10 states “An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” On 02/23/2024 at 08:20 a.m., during record review of the selected patients’ Plan of care (PoC), the surveyor observed the following: 1. Patient N was admitted on 11/17/2023. During record review, when the surveyor requested for the 30 day PoC for Patient N due 12/17/2023, the Facility Administrator presented a PoC that was completed on 01/22/2024, which was approximately 1 month late. 2. Patient O was admitted on 10/03//2023. During record review, when the surveyor requested for the 30 day PoC for Patient O due 11/03/2023, the Facility Administrator presented a PoC that was completed on 12/01/2024, which was approximately 1 month late. 3. Patient K was admitted on 05/16/2023. During record review, when the surveyor requested for the 30 day PoC for Patient K due 06/16/2023, the Facility Administrator presented a PoC that was completed on 08/01/2023, which was approximately 2 months late.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the clinical staff complied with the facility’s implemented infection control protocol. This failure placed the safety and wellbeing of the patients at potential risk of harm in maintaining their vascular access. Findings included: On 02/27/2024 at 11:50 a.m., during review of the facility’s policies and procedures titled “AV Fistula or Graft Cannulation with Nipro Or Medsystems Safety Fistula Needles (SFN) And Administration of Heparin Loading Dose” Page 2 number 5 states, “Perform inspection, auscultation and palpation on entire length of access. Determine the presence of bruit and thrill. If bruit or thrill is not present or if signs and symptoms of infection are present, do not cannulate. Notify the licensed nurse of access status for follow-up.” Page 3 number 13 states “Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” 1. On 02/21/2024 at 10:23 a.m., during observations on the treatment floor, the surveyor observed that (1) Staff #2 did not use a stethoscope to assess [Patient J]’s access site, (2) disinfected [Patient J]’s access site and palpated prior to cannulation without disinfecting the access site again. 2. On 02/22/2024 at 10:10 a.m., during observations on the treatment floor, the surveyor observed that (1) Staff #3 did not use a stethoscope to assess [Patient K]’s access site, (2) disinfected [Patient K]’s access site for 11 seconds total and (3) palpated [Patient K]’s access site prior to cannulation without disinfecting the access site again. This observation was witnessed by the Facility Administrator who corroborated that Staff #3 should have used a stethoscope to assess [Patient K]’s access site and should have disinfected [Patient K]’s access site once more.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 47759 Based on record review, observation and staff interviews, the facility’s governing body failed to (1) Ensure that all staff members are knowledgeable how to report Adverse Events (2) collect and aggregate data regarding adverse event occurrences and (3) analyze and review the collected data on Quality Assurance and Performance Improvement (QAPI). This failure places the patients at potential risk for harm. Findings included: On 02/27/2024 at 11:35 a.m., during review of the facility’s policy titled Risk Event Reporting Policy, (Policy 13-01-02) Page 1 number 2 states “All risk events will be promptly reported to the Facility Administrator/Manager or designee ...The teammate will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened.” On page 2 number 3 states, “Risk Event Management (REM) Reports are to be trended and reviewed during the Facility Health Meeting (FHM). This includes “Near Miss” events. Any negative trend should result in a plan of action.” 1. On 02/21/2024 at 10:35 a.m. and 10:55 a.m., the surveyor observed a delivery issue. At 10:35 a.m. and 10:55 a.m.,the surveyor observed that the machine located in station #13 had automatically shut down while the patient was dialyzing. Upon interview with Staff #9, the surveyor discovered that the facility has had electrical issues and has a preexisting work order in place. According to Staff #9, when the staff switched outlets, it resolved the problem immediately and the patient in station #13 was able to resume treatment immediately. a. On 02/27/2024 at 11:35 a.m., the surveyor asked the Facility Administrator (FA) and Staff #8 if they were aware of the electrical problem that had occurred on 02/21/2024 and if that incident was documented anywhere, according to the Facility Administrator and Staff #8, no they were not aware of the incident. b. The surveyor then asked both the FA and Staff #8 if they have a tracker that monitored the frequency of the electrical issue. The FA stated no. 2. On 02/22/2024 at 09:32 a.m., the surveyor observed a possible near miss disinfection opportunity. At 09:32 a.m., the surveyor observed that [Staff #3] started to set up the dialysis machine located in Station #5 without proper disinfection. Staff #6 then informed Staff #3 that the station has not been disinfected and asked Staff #3 to disinfect and set up the station once more. a. On 02/27/2024, at 12:25 p.m., the surveyor then asked the FA if the staff members involved had any documentation of the incident. However, the FA was not able to find documentation of the incident. 3. On 02/27/2024 at 12:00 p.m., during review of the refrigeration log, the surveyor observed a date (November 13, 2023) in which the facility was closed. According to the interview conducted with the Facility Administrator, the facility was closed that day due to a water system failure and had to reschedule patients the following day and/or redirect patients to another facility. The Facility Administrator corroborated that the incident was not documented on the adverse event log and corroborated that based on the facility policy, Water System Failure is one of the reportable risk events that should have been documented on the Adverse Event log. 4. On 02/26/2024 at 01:45 p.m., during interviews with the Staff members that were present that date, 3 of the 4 (75%) [Staff #10, #11, and #12] staff members interviewed stated that they do not know how to document adverse event occurrences. 5. On 02/27/2024, at 12:30 p.m., during interviews with the Facility Administrator [FA], the FA corroborated that further education is needed when it comes to documenting Adverse Event occurrences. The FA also corroborated that adverse event occurrences should be addressed in QAPI with data, analysis and action plan in order to minimize the number of occurrences and limit the number of patients and staff who are adversely affected by such occurrences.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 47759 Based on review of the facility’s policies and procedure, review of Quality Assessment and Performance Improvement (QAPI) meeting minutes, and interviews with staff, the facility’s governing body failed to (1) ensure that the facility incorporated mortality data in QAPI meetings, (2) tracked mortality data in QAPI, and (3) analyzed each data to identify potential problems and opportunities for improving care. This failure placed patients at potential risk of harm by failing to utilize the data gathered to identify potential problems in the facility resulting in delay in interventions aimed at improvement. Findings Included: On 02/27/2024 at 11:15 a.m., during record review of the facility’s Continuous Quality Improvement Program (Policy 12-16-06) page 1 number 7 states “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: mortality (review of deaths); hospitalizations. Number 8 states “continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to ensure improvements are sustained.” On 02/26/2024 at 09:00 a.m., during record review of the facility’s mortality data, the surveyor discovered that from January 2023-February 2024, the facility’s overall mortality was 23. On 02/26/2024 at 09:30 a.m., during an interview with the Facility Administrator and record review of the facility’s FHM (Facility Health Meeting), also known as quality assurance performance improvement (QAPI), the surveyor discovered that the facility had not been documenting the facility’s mortality reviews on their FHM. This was evident in the facility’s FHM from January 2023 through February 2024 in which (1) no mortality data was documented on the FHM (2) no tracking of mortality was documented on the FHM and (3) no evidence of analysis and actions taken to identify potential problem and identify opportunities for improving care was documented on the FHM. During the interview, the FA corroborated that verbal discussion of the mortality data is insufficient and corroborated that the analysis and the discussions of the mortality data will be documented moving forward.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47759 Based on review of the facility’s policies and procedures, the medical director and the facility’s administration failed to ensure that the staff adhered to their own policies and procedures. This failure posed a potential risk of safety to the patients and denied patients their rights to a minimum standard of medical care. Findings included: 1. Infection Control for Dialysis Facilities (Policy: 01-05-01), page 5 number 16 states “Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.” 2. Infection Control in Dialysis Facilities, (Policy 1-05-01) Page 3 Number 13 states, “At the end of each treatment, the dialysis station will be cleaned and disinfected ... .A. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings ... and frequently contacted by healthcare personnel” Number 13 Letter B states “Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient. 3. Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance (Policy 1-05-02) page 2 number 8 states “All permanent patients including Acute Kidney Injury (AKI) patients will have HBV serologic testing drawn immediately upon admission to the facility and results known within 7 days of admission (I.e., hepatitis B surface antigen [HBsAg], Hepatitis B Core Antibody [HBcAb], and Hepatitis B surface antibody [HBsAb]).” Page 4 states that If HBsAb is less than 10 mIU/mL, consider the patient susceptible and perform a monthly surveillance testing 4. Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps (Procedure 1-04-02 B) page 4 number 4 states, “Remove old dressing and discard.Observe site for signs and symptoms of infection such as redness, drainage, swelling or tenderness. If present, report to RN/physician. If drainage is present, obtain order for exit site culture. Observe CVC at exit site for evidence of cuff migration, cracks, or leaks in the catheter limbs. If present, do not initiate dialysis. Report to RN/physician for further follow-up.” Page 4 number 8 states, “Clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab.” Page 6 number 16 states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly...” 5. Testing pH and conductivity of proportioned dialysate and verification of temperature of proportioned dialysate page 1 number 6 states “Independent pH is required to be performed prior to each treatment” 6. Physical Environment (Policy: 08-04-01) page 1 number 1 states “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public safe, functional, and comfortable treatment environment.” Number 2 states “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public.” 7. Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, (Policy 1-03-08) page 4 number 10 states, “If the dialysis prescription is not being met (including dialysis flow rate or change to inability to obtain prescribed blood flow rate or BFR) the reason will be documented, and the licensed nurse informed.” Page 5 states, “Members of the patient care team should report any changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ...Post-treatment: If patient is above or below 1 kg from the target weight” 8. Interdisciplinary team (IDT) Patient Assessment and Plan of Care (Policy 01-14-01) page 4 number 10 states “An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” 9. AV Fistula or Graft Cannulation with Nipro Or Medsystems Safety Fistula Needles (SFN) And Administration of Heparin Loading Dose Page 2 number 5 states, “Perform inspection, auscultation and palpation on entire length of access. Determine the presence of bruit and thrill. If bruit or thrill is not present or if signs and symptoms of infection are present, do not cannulate. Notify the licensed nurse of access status for follow-up.” Page 3 number 13 states “Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” 10. Risk Event Reporting Policy, (Policy 13-01-02) Page 1 number 2 states “All risk events will be promptly reported to the Facility Administrator/Manager or designee ...The teammate will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened.” On page 2 number 3 states, “Risk Event Management (REM) Reports are to be trended and reviewed during the Facility Health Meeting (FHM). This includes “Near Miss” events. Any negative trend should result in a plan of action.” 11. Continuous Quality Improvement Program (Policy 12-16-06) page 1 number 7 states “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: mortality (review of deaths); hospitalizations. Number 8 states “continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to ensure improvements are sustained.””