Davita Rockbridge Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of policies and procedures (P&P) and 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 Charge Nurse (CN) and two of two Patient Care Technicians (PCT AA and PCT BB) observed, to correctly verify the hemodialysis (HD) machine’s dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to facility P&P and manufacturer’s Directions For Use (DFU). This failure had the potential to negatively affect the health and safety of three of three patients (P#7, P#8, and P#9) observed, during the initiation of dialysis treatment; and the other two patients (P#10 and P#11) who were undergoing hemodialysis at the time of this observation. The facility had 50 In-Center Hemodialysis (ICHD) patients who dialyzed at this facility. Findings were: Cross Reference: V250 - Failure of the facility to ensure that PCT AA, PCT BB and CN, adhered to facility’s P&P and followed the Manufacturer’s Directions For Use (DFU) for testing the machines’ dialysate pH and conductivity prior to each patient treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 25727 Based on a review of facility records 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 50 in-center hemodialysis patients who were under the care of this facility. Findings were: Cross Reference: V250 - Failure of the facility to ensure that PCT AA, PCT BB and CN, adhered to facility’s P&P and followed the Manufacturer’s Directions For Use (DFU) for testing the machines’ dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH and conductivity prior to each patient treatment.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 49321 Based on observation, a review of facility records, and staff interviews it was determined that the facility failed to ensure that one of two automatic external defibrillators (AED - a portable device used for emergency situations involving cardiac arrest) was ready for use. This failure had the potential to negatively affect the health and safety of 10 peritoneal dialysis (PD) patients who were under the care of this facility. Findings were: During a tour of the Home PD Training Room on 5/1/24 between 10:55 a.m. and 11:30 a.m., the following was revealed: - The battery in AED was completely discharged thus, the AED was not ready for use in an emergency situation. The Manager of Clinical Services confirmed the above finding on 5/1/24 at 11:05 a.m. and stated, “I checked the AED in March 2024 during my monthly safety check. Because the nurse is covering more than one PD program, the administrative assistant for the PD program was the person doing the AED audit”. During an interview with the PD nurse on 5/1/24 at 11:20 a.m., it was revealed that the PD nurse was unaware of the date when AED was last checked.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 49321 Based on a review of records, staff interviews, and review of facility’s Policy and Procedure (P&P), it was determined that the facility failed to ensure that staff adhered to P&P relative to tuberculosis infection control for one of one peritoneal dialysis (PD) patient (P#6) sampled. The facility had 10 PD patients. Finding were: A review of P#6’s medical records revealed a lack of current TB screening/surveillance. P#6’s last documented tubercullin (TB) skin test was done in January 2023. During an interview on 5/3/24 at 10:30 a.m., the PD nurse stated none of the PD patients has received annual TB skin test but all had been entered in the computer and they will be completed this month. The Facility Administrator (FA) was notified of the above findings on 5/3/24 at 2:30 p.m. The FA stated that she was aware that PD patients had not received their annual TB skin test yet because one of the PD patients called her, and informed her that she needed to have TB skin test done before she could travel. A review of Policy 1-05-03 titled “Tuberculosis Infection Control Policy” dated April 2024 showed: 1. Patients with chronic kidney disease (CKD) are considered high risk... will be screened for TB prior to first treatment, as well as participate in an ongoing surveillance following admission... 2. Tuberculosis surveillance will be performed on admission, annually and as indicated.”

“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: 49321 Based on observation, staff interviews, and a review of policies and procedures (P&P) and 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 Charge Nurse (CN) and two of two Patient Care Technicians (PCT AA and PCT BB) observed, to correctly verify the hemodialysis (HD) machine’s dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to facility P&P and manufacturer’s Directions For Use (DFU). This failure had the potential to negatively affect the health and safety of three of three patients (P#7, P#8, and P#9) observed, during the initiation of dialysis treatment; and the other two patients (P#10 and P#11) who were undergoing hemodialysis at the time of this observation. The facility had 50 In-Center Hemodialysis (ICHD) patients who dialyzed at this facility. Findings were: During observation in the Patient Treatment Room on 5/1/24 between 10:15 a.m. and 12:00 p.m., the following was revealed: - PCT AA was observed testing the dialysate sample for conductivity from Station (S) 9 at 10:15 a.m., using the Myron L Conductivity Meter. PCT AA filled the cell cup with the dialysate sample and inserted the plunger. She agitated the sample with the plunger by moving it up and down three times and pressed the Read/Check button on the meter. When the pointer stopped, she read and released the button and recorded the conductivity reading. PCT AA did not perform the procedure for rinsing the cell cup (fill meter cell cup with sample and agitate sample with plunger) at least three times to ensure that any prior sample solution has been rinsed free from the cell; and did not correctly perform the procedure for obtaining the conductivity reading. - PCT AA was also observed testing the machine’s dialysate pH. She used RPC E-Z Chek K100-0117 6.8 - 8.5 pH test strip. PCT AA dipped the pH test strip in a medication cup filled with dialysate and moved the test strip back and forth for three seconds. She then pulled the strip out of the solution, turned around and watch the clock on the wall behind her (the second hand was on one) and when she turned back around, she compared the test strip to the color chart on the test strip bottle (the clock’s second hand was on three), and documented the result. PCT AA did not perform correct procedure for testing pH. During an interview on 5/1/24 at 10:25 a.m., PCT AA stated “You only need to rinse the Myron L once with the R.O. (Reverse Osmosis) water”. She also stated to dip the RPC test strip for 10 to 15 seconds and immediately read the result. - At 11:00 a.m., PCT BB obtained approximately 45 cc [filled one 30 cc medicine cup and another medicine cup that was filled half way (15 cc)] of dialysate sample from dialysis machine at S6. PCT BB poured dialysate sample into the meter cell cup and discarded the sample. This procedure was repeated four times and then she poured the remaining sample from the second medicine cup in the meter cell cup but the upper electrode was not immersed. PCT BB then pressed the Read/Check button on the meter and recorded conductivity reading. PCT BB did not use the plunger during the whole procedure. - PCT BB also tested the dialysate pH. She used RPC E-Z Chek K100-0117 6.8 - 8.5 pH test strip. PCT BB dipped the pH test strip in sample that was left in the Myron L meter cell cup. She moved the test strip back and forth for three seconds, paused for 13 seconds (this surveyor watched the clock), and then compared the test strip to the color chart. PCT BB did not look at the clock or use a timer. During an interview with PCT BB on 5/1/24 at 11:30 a.m, PCT BB stated “I counted in my head”. - At 11:45 a.m., the Charge Nurse (CN) was observed during machine set-up at S4. This surveyor requested for the CN to check the pH and conductivity on the dialysis machine at S4. The CN requested instructions from PCT AA on how to open the shunt door and detach the Hansen connector [dialyzer (artificial kidney) dialysate port quick disconnects - these connectors are used for connecting a dialysate port of a dialyzer to a dialysate-delivery line of a dialysis machine) to allow dialysate to freely flow out of the Hansen into a sample cup. The CN collected the sample and tested the dialysate’s conductivity using the Myron L meter. She poured dialysate sample into the Myron L meter cell cup while the plunger was in the Myron L meter cell cup. She then pressed the Read/Check button and stated “I think it says 14.5”. The CN did not perform the correct procedure for verifying conductivity. - The CN was also observed testing the machine’s dialysate pH. She dipped an RPC E-Z Chek K100-0117 6.8 - 8.5 pH test strip in sample, moved the test strip back and forth for 15 seconds, removed the strip, and immediately compared the strip to the color chart and stated “I think it says 7.0”. The CN did not perform correct procedure for testing pH. During an interview on 5/1/24 at 11:50 a.m., CN stated “I am not the one who do this, the PCTs check for pH and conductivity on the machines”. The Manager of Clinical Services was notified of the above findings on 5/1/24 at 11:58 p.m. She stated that all staff were trained on how to test for pH and conductivity per P&P. 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, showed the following: 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 manufacturer’s DFU and 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 February 2024, showed: 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. Within 5 - 10 seconds, compare the strip to the color chart on the bottle. Rationale: Retest if the results are not read within 10 seconds. A review of annual skills competency evaluation for testing pH and conductivity revealed the following: - PCT AA is a float PCT and her skills competency checklist was not available at this facility. - PCT BB’s skills competency checklist was dated 10/6/23. - CN’s skills competency checklist was dated 10/6/23.”

“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: 32734 Based on a review of facility records and staff interviews, it was determined that the interdisciplinary team (IDT) failed to develop, implement, and evaluate a plan to attain and sustain improved health outcomes for mineral metabolism and renal bone disease, specifically phosphorus on six of six months (October 2023 - March 2024) of quality assessment and performance improvement (QAPI) meeting minutes reviewed. The current professionally-accepted clinical practice standards for phosphorus ranged between 3.5-5.5 mg/dL. This deficient practice could negatively affect the health and safety of 10 peritoneal dialysis (PD) patients under the care of this facility. Findings were: A review of the facility’s QAPI meeting minutes from Oct 2023 - March 2024 revealed the following percentage of PD patients with Phosphorus > 7 mg/dL: - March 2024 - 50.0 % - February 2024 - 37.5 % - January 2024 - 50.0 % - December 2023 - 42.9 % - November 2023 -8.3 % - October 2023 - 16.7 % There was a lack of documented action plans that were developed and implemented to ensure improvements were attained and sustained. During an interview with the Facility Administrator (FA) and the Manager of Clinical Services on 5/2/24 at approximately 4:00 p.m., the FA acknowledged the lack of documented plans to improve this outcome.”