Davita West Hiram Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 33921 Based on observation, staff interviews, and a review of facility records, it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of one of one Licensed Practical Nurse (LPN AA) and two of two Patient Care Technicians (PCTs AA and BB) observed, to correctly verify the hemodialysis (HD) machine’s dialysate Conductivity (ability of the dialysate to conduct electricity) and pH (Acidity), according to the manufacturer’s Directions For Use (DFU). This failure had the potential to negatively affect the health and safety of 11 of 11 patients (P), (P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, and P#18, who were undergoing hemodialysis at the time of this observation. The facility had 32 In-Center Hemodialysis (ICHD) patients who dialyzed at this facility. Findings include: Cross Reference: V 250 - Failure of the facility to follow the manufacturer’s DFU in verifying the machine’s dialysate pH and Conductivity prior to the initiation of HD treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 33921 Based on observations, facility record review, and staff interviews, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 32 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross Reference: V 250 - Failure of the facility to follow the manufacturer’s DFU in verifying the machine’s dialysate pH and Conductivity prior to the initiation of each HD treatment.”

“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: 33921 Based on observation and staff interview, it was determined that the facility failed to ensure that three of four handwashing sinks in one of one In-Center Hemodialysis (ICHD) Patient Treatment Room had warm and free-flowing water for hand washing to encourage patients and staff to wash their hands. This deficient practice had the potential to negatively affect the health and safety of eight of eight ICHD patients (P), (P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15), who were undergoing hemodialysis treatment at the time of this observation and five of five Direct Patient Care (DPC) Staff, (Registered Nurse - RN AA, Licensed Practical Nurse - LPN AA, Patient Care Technicians - PCTs AA, BB and CC). The ICHD patient census was 32. Findings include: During observation in the Patient Treatment Room on 2/23/24 at 11:10 a.m., it was revealed that three of four handwashing sinks did not have warm running water and the flow of water from the faucets on these sinks were barely trickling out. Two other sinks labeled as clean sinks were labeled/used for bleach. - The Biomed Technician (BMT) confirmed on 2/23/24 at 11:25 a.m., that there were three handwashing sinks with faucets that were not flowing well, and it could be due to some defect with the auto valve for the auto sensor. He also acknowledged that there was no warm water flowing from these handwashing sink faucets.”

“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: 33921 Based on observation, staff interviews, and a review of facility records, it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of one of one Licensed Practical Nurse (LPN AA) and two of two Patient Care Technicians (PCTs AA and BB) observed, to correctly verify the hemodialysis (HD) machine’s dialysate Conductivity (ability of the dialysate to conduct electricity) and pH (Acidity), according to the manufacturer’s Directions For Use (DFU). This failure had the potential to negatively affect the health and safety of 11 of 11 patients (P), (P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, and P#18), who were undergoing hemodialysis at the time of this observation. The facility had 32 In-Center Hemodialysis (ICHD) patients who dialyzed at this facility. Findings include: During observation in the Patient Treatment Room on 2/21/24, between 11:45 a.m. and 1:05 p.m., the following was revealed: - LPN AA was observed testing the machine’s dialysate pH and Conductivity from Station (S), (S8). LPN AA used RPC E-Z Chek K100-0117 6.8 - 8.5 pH test strip. LPN AA dipped the pH test strip for three seconds and immediately compared the test strip to the color chart on the test strip bottle. According to LPN AA on 2/21/24 at 12:00 p.m., the test strip was to be dipped for three seconds and wait for three seconds to compare the strip to the color chart. - LPN AA also tested the dialysate’s Conductivity using the Myron L - D-1. LPN AA filled the meter cell cup with the dialysate sample and inserted the plunger. LPN AA agitated the sample with the plunger by moving it up and down three times, then she discarded the sample. LPN AA filled the meter again with the dialysate sample, then dropped the plunger in the solution and pressed the black button on the meter. When the pointer stopped, she immediately read and released the button and recorded the Conductivity. - PCT AA and PCT BB were also observed testing the dialysate’s Conductivity from S4 and S16 respectively, on 2/21/24 between 12:08 p.m. and 12:12 p.m. Both PCT AA and PCT BB tested the dialysate’s Conductivity, as above. - PCT BB tested the pH by dipping the pH test strip 10 seconds and waited 20 seconds before comparing the strip to the color chart. PCT BB also stated on 2/21/24 at 12:10 p.m. to dip the strip for 10 seconds and wait 20 seconds before comparing the strip to the color chart. - The manufacturer’s Instructions for Use (IFU) on the RPC Strips bottle showed, to dip the strip for one second and after 10 seconds compare the test strip to the color chart. - A review of the facility’s Procedure: 2-08-01B, titled, “Operation of Portable Myron L Conductivity Meter (D-1)”, with latest revision date of April 2020, stated: 3. Fill meter cell cup with sample so upper electrode is immersed. Insert plunger. 4. Agitate sample with plunger by moving up and down 3 or 4 times and then discard sample. 5. Repeat steps #3 and #4 - at least 3 times. Rationale: Verifies that the prior sample solution has been rinsed free from the cell. 6. Obtain another proportioned dialysate sample and fill the meter, drop plunger in the solution and press the black button. When the pointer stops, immediately read and release the button. 7. Repeat step #6 twice and press/read/check button and record conductivity reading. Rationale: Helps assure accurate reading. - A review of the facility’s Procedure: 2-08-01K, titled, “Testing pH for Acetate Based Dialysate Using RPC E-Z Chek K100-0117 6.8 - 8.5 Test Strips”, with latest revision date of October 2023, stated: 2. Obtain dialysate sample... then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. After 10 seconds, compare the strip to the color chart on the bottle. The Biomed Technician (BMT) and the Facility Administrator were notified of the above observation on 2/21/24 at 12:20 p.m.”

“QAPI-INDICATOR-NUTRITIONAL STATUS CFR(s): 494.110(a)(2)(ii) The program must include, but not be limited to, the following: (ii) Nutritional status. This Standard is not met as evidenced by: 49321 Based on a review of the fiscal year (FY) 2024 Quarterly Dialysis Facility Report (QDFR: A report prepared for ESRD facilities from the Centers for Medicare and Medicaid Services (CMS), to provide a comparative summary of treatment patterns and patient outcomes for End Stage Renal Disease patients, as compared to other facilities in the U.S.), a review of the facility’s Quality Assessment and Performance Improvement (QAPI) meeting minutes from August 2023 to January 2024, and staff interview, it was determined that this facility failed to develop, implement and evaluate a plan to trend and analyze the Serum Albumin (simple protein) outcomes of the facility’s Peritoneal Dialysis, (PD - where the lining of the Peritoneum is used to filter waste from the blood) patients. This deficient practice had the potential to negatively affect the health and safety of all 15 PD patients who were under the care of this facility. Finding Include: - A review of the FY 2024 QDFR for this facility revealed that PD patients whose Serum Albumin <4.0g/dL was 86.5%, whereas the US average for PD was 50.5 %. - A review of the facility’s monthly Serum Albumin outcomes for PD patients with Serum Albumin less than 4.0 g/dL from August 2023 to January 2024, were as follows: August 2023 - 91% September 2023 - 82% October 2023 - 91% November 2023 - 75% December 2023 - 86% January 2024 - 80% A review of the monthly QAPI notes revealed a lack of evaluation and modification of the action plans to ensure improvement in the PD patients’ Albumin levels. The Director of Clinical Services was interviewed on 2/23/2024 at 12:45 p.m. During the interview she stated, “Redistribution of albumin from the plasma into the peritoneum compartment is a huge issue for PD patients.””

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 49321 Based on a review of facility records and staff interview, it was determined that the facility failed to analyze, develop, and implement a plan of action that addressed the effectiveness of the facility’s management of patients with Hemoglobin (Hgb - protein in red blood cells that carries oxygen throughout the body) less than (<)10 g/dL, for five of six months of the facility’s Quality Assessment and Performance Improvement (QAPI) meeting minutes reviewed (August 2023 to January 2024). This deficient pratice had the potential to negatively affect the health and safety of all 32 in-center hemodialysis patients (ICHD) who were under care of this facility. Findings include: - A review of the Quarterly Update of the Fiscal Year 2024 Dialysis Facility Report (QDFR): A report prepared by the Centers for Medicare and Medicaid Services (CMS) to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients, revealed that the average hemoglobin <10 g/dL should not exceed 23.4% for hemodialysis patients, whereas the facility’s Fiscal year 2024 QDFR revealed that ICHD patients who had hemoglobin <10 g/dL was 32.3%. - A review of the facility’s QAPI meeting minutes from August 2023 to January 2024, revealed the following percentage of patients with Hgb <10 g/dL: August 2023 - 44.8% September 2023 - 36.7% October 2023 - 33.3% November 2023 - 23.3% December 2023 - 38.7% January 2024 - 37 % A review of the monthly QAPI notes revealed a lack of documentation of the action plan and follow up to ensure improvement in the patient’s anemia status. During an interview with the Director of Clinical Services on 2/23/2024 at 12:30 p.m., she stated that the facility followed their anemia management protocols and doctor’s orders.”