Davita Rutgers Park Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that the Facility failed to comply with the Condition for Coverage 42 CFR 494.40, Water and Dialysate Quality. Findings include: 1. The Facility failed to ensure the water distribution system was heat disinfected weekly as required and also failed to maintained a historical record of successful disinfections (temperature and time) of the water purification (RO) system. (V-218) 2. The Facility failed to ensure that pH (measure of acidity/alkalinity) testing was conducted according to the manufacturer’s instructions for use (IFU) and policy. (V-250) 3. The Facility failed to ensure that dialysate samples were collected from at least two machines monthly. (V-253) 4. The Facility failed to ensure that samples for microbial monitoring were collected before sanitization/disinfection of the water distribution system. (V-254)”

“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: 39802 Based on document review and interview, it was determined that for 3 (Pts. #1, #5, and #6) of 9 patients reviewed for hepatitis B surveillance, the Facility failed to ensure that Hepatitis B surveillance was completed routinely as required. Findings include: 1. The Facility’s policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” (dated October 2023), was reviewed and required, “All patients will be routinely tested... Routine Surveillance Testing: [If] Antigen Negative [and] Antibody < (less than) 10 [then] Monthly antigen... [If] Core Positive [then] Monthly antigen and annual antibody...” 2. The Facility’s Hepatitis B Report for Peritoneal Dialysis Patients, dated 11/20/2023, was reviewed and indicated the following: - Pt. #1 was core positive since 4/6/2023 and the record lacked monthly antigen labs from July to October 2023. - Pt. #5 was susceptible to Hepatitis B since 6/16/2023 and the record lacked monthly antigen labs from July to October 2023. - Pt. #6 was susceptible to Hepatitis B since 6/16/2023 and the record lacked monthly antigen labs after 6/16/2023. 3. An interview was conducted with the Facility Administrator (E#1) on 11/21/2023, at approximately 3:00 PM. E#1 stated that both susceptible and core positive patients should be tested monthly for the antigen. E#1 stated that E#1 was not sure why the antigens were not drawn monthly and could not find any documentation in the records to indicate why they were missed.”

“HOT H20 DISINF SYS-MONITORING CFR(s): 494.40(a) 6.3.4 Bacterial control devices 6.3.4.3 Hot water disinfection systems: monitoring Hot water disinfection systems should be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Also, hot water disinfection should be performed at least as often as recommended by the manufacturer. The temperature of the water should be recorded at a point farthest from the water heater-that is, where the lowest water temperature is likely to occur ...and measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection should be maintained. Successful completion is defined as meeting temperature and time requirements specified by the equipment manufacturer. This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that for 1 of 1 reverse osmosis (RO) water treatment system and 1 of 1 water distribution system, the Facility failed to ensure the distribution system was heat disinfected weekly as required and also failed to maintained a historical record of successful disinfections (temperature and time) of the RO water treatment system. This had the potential to affect all in-center hemodialysis patients on census. Findings include: 1. The Facility’s policy titled, “Water Treatment System Disinfection” (dated October 2021), was reviewed and required, “...Disinfection processes will vary based on whether water system configuration is direct feed (systems that do not utilize a holding tank), indirect feed (systems utilizing a holding tank), and whether disinfection is accomplished using chemicals or hot water... Some hot water-disinfected direct feed systems utilize chemicals for the RO and hot water for the distribution system: The RO is disinfected at least weekly using peracetic acid (PAA) solution. The distribution system is disinfected at least weekly...” The policy did not address the disinfection intervals required for RO systems using hot water disinfection only (instead of chemical disinfection). 2. The AmeriWater MediQA (RO Manufacturer) Operation & Maintenance Manual (Rev. H) was reviewed and required, “...Regular cleaning and sanitization of the unit is recommended to maximize the life of the RO membrane/s and ensure high performance... It is recommended that RO heat disinfection is completed at least weekly in order to protect against possible bio-film formulation...” 3. During a tour of the water room on 11/20/2023 at approximately 9:30 AM, the water system was noted to be a direct feed system (RO continuously running during treatments with no holding tank). The following was observed: - The Heatsan (equipment used to heat disinfect the distribution system) was programmed to automatically perform heat disinfections every Sunday. The operation history between 8/6/2023-11/21/2023 was observed on the unit’s display panel with Biomedical Technician (E#7) and indicated that weekly heat disinfections were not completed on 8/20/2023 (aborted), 10/29/2023 (aborted), 11/12/2023 (aborted), and 11/19/2023 (no heat cycle started). - The RO was programmed to automatically perform heat disinfections on Sundays. The temperature and disinfection cycle history was observed on the RO’s display panel with E#7 and indicated that heat disinfections were completed weekly between 8/17/2023-11/19/2023; however, the RO’s data system did not contain any historical operation data older than 8/17/2023. 4. An interview was conducted with the E#7 on 11/21/2023, at approximately 10:00 AM. E#7 stated that the Heatsan is programmed to complete a heat disinfection of the water loop each Sunday. E#7 was not sure why the heat disinfection cycles were aborted on 8/20/2023, 10/29/2023, and 11/12/2023. E#7 stated that when E#7 came in on 11/20/2023, E#7 noticed there was an alarm on the Heatsan and it had to be reset. E#7 was unsure why the heat disinfection cycle was not even attempted or started on 11/19/2023. E#7 stated that the RO is also programmed to disinfect the RO weekly. E#7 stated that E#7 does not routinely download the data from the RO to keep records of the disinfections.”

“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: 39802 Based on document review, observation, and interview, it was determined that for 3 of 3 staff observed (E#4-#6), the Facility failed to ensure that pH (measure of acidity/alkalinity) testing was conducted according to the manufacturer’s instructions for use (IFU) and policy. This had the potential to affect all in-center dialysis patients as of 11/20/2023. Findings include: 1. The Facility’s procedure titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8-8.5 Test Strips” (dated October 2020), was reviewed and required, “2. Obtain dialysate sample by using a disposable cup, then dip the strip in the solution for one (1) second. Or using new syringe, obtain dialysate sample from sample port, then allow fluid to flow over the pad for one (1) second. 3. Remove the strip from the fluid and shake off excess dialysate. 4. At 10 seconds, immediately compare the color reaction on strip to the color chart on bottle to determine the closest match...” 2. The RPC E-Z Chek K100-0117CT manufacturer’s “Important Application Note” (undated), was reviewed and required, “...Read carefully, the entire instructions for use (IFUs)... For every test, use a stop watch or second hand of a clock/watch to make sure the dip/swish time and wait time called for in the IFUs is correct. Proper test sample exposure time and wait time are critical for test strip accuracy...” 3. During a tour of the dialysis treatment area on 11/20/2023, the following was observed: - At approximately 9:34 AM, a Patient Care Technician/PCT (E#4) obtained a sample of dialysate. E#4 dipped the pH test strip into the sample and read the test strip right away (without waiting the required 10 seconds). - At approximately 9:50 AM, PCT (E#5) obtained a sample of dialysate. E#5 dipped the pH test strip into the sample and read the test strip right away (without waiting the required 10 seconds). - At approximately 9:58 AM, PCT (E#6) obtained a sample of dialysate. E#6 swirled the pH test strip into the sample for approximately 10 seconds (instead of the required 1 second), took the strip out, and then read the test strip right away (without waiting the required 10 seconds). 4. Interviews were conducted with PCTs E#4-#6 on 11/20/2023. E#4-E#6 stated that after removing the test strip from the sample and shaking off the excess solution, the strip is compared to the bottle and the result is read right away. E#6 stated that the strip should be swirled in the sample for 10 seconds. .”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 5 of 10 months (March 2023-July 2023) of microbial monitoring records reviewed, the Facility failed to ensure that dialysate samples were collected from at least two machines monthly. This had the potential to affect all in-center hemodialysis patients on census. Findings include: 1. The Facility’s policy titled, “Dialysate Culture Policy” (dated October 2020), was reviewed and required, “...Monthly sample sites include: 10% of all dialysis machines... two (2) machines should be sampled monthly...” 2. The Facility’s Microbial Records were reviewed from 1/1/2023-10/31/2023 and indicated that dialysate cultures and endotoxins were not completed on at least two machines monthly from March 2023-July 2023. 3. An interview was conducted with the Biomedical Technician (E#7) on 11/21/2023, at approximately 9:15 AM. E#7 stated that each dialysis machine should be tested for cultures/endotoxins at least once or twice a year. E#7 stated that E#7 tested all the machines in the first couple months (January and February) of the year. E#7 was not aware that there was a minimum number of required machines to be tested each month.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 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. This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that for 3 of 10 months (January, June, and July 2023) reviewed, the Facility failed to ensure that samples for microbial monitoring were collected before sanitization/disinfection of the water distribution system. Findings include: 1. The Facility’s policy titled, “Water Culture Policy” (dated April 2021), was reviewed and required, “...Routine water cultures are collected monthly and within 72 hours prior to scheduled disinfection of distribution systems...” 2. The Facility’s Water Culture/Endotoxin Logs for 2023 were reviewed and included the following: - Cultures were drawn on Monday 1/30/2023 (one day after scheduled disinfection on Sunday 1/29/2023) - Cultures were drawn on Monday 6/26/2023 (one day after scheduled disinfection on Sunday 6/25/2023). - Cultures were drawn on Monday 7/24/2023 (one day after scheduled disinfection on Sunday 7/23/2023). 3. An interview was conducted with the Biomedical Technician (E#7) on 11/21/2023, at approximately 9:30 AM. E#7 stated that we would normally draw cultures before disinfection; however, the heatsan is schedule to disinfect on Sundays when the lab is closed. When asked if there was a timeframe to draw the cultures before disinfection, E#7 stated that there was no timeframe E#7 was aware of and that they draw the cultures when they have time that month to draw them.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 4 of 7 patient grievances filed, the Facility failed to ensure that grievances were reviewed/investigated and steps were taken to resolve the grievance. Findings include: 1. The Facility’s policy titled, “Patient Grievance” (dated October 2021), was reviewed and required, “...Internal Grievance Process: ... The FA [Facility Administrator] (or her/his designee) is to discuss the grievance with the patient, investigate and take appropriate action towards a solution...” 2. The Facility’s Patient Grievance Log from May 2023-November 2023 was reviewed and indicated that there were 7 grievances filed. The Grievance Binder and the Risk Event Management System/REM (reviewed with Facility Administrator E#1) did not contain completed Grievance/Investigation Documentation for 4 of the grievances to indicate that the grievances were investigated and what steps were taken to resolve the grievances. 3. An interview was conducted with the Facility Administrator (E#1) on 11/20/2023, at approximately 2:00 PM. E#1 stated that complaints/grievances are entered in the REM system as well. E#1 stated that they should be documenting the follow-up done on the grievances. E#1 stated, “We haven’t been filing out the complaint resolution forms, but we should be able to show that we investigated and tried resolve the grievance.””