Davita Harvey Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 32741 Based on document review, observation and interview, it was determined that the Facility failed to comply with Condition for Coverage 42 CFR 494.40, Water and Dialysate Quality. Findings include: 1. The Facility failed to ensure the dialysate pH for dialysis machines were checked according to manufacturer’s guidelines. (V250) 2. The Facility failed to ensure that testing of RO performance (which included 2 RO machines) were taken and recorded daily. (V199) An immediate jeopardy (IJ) was identified on 7/25/2024, due to Facility’s failure to ensure that testing of the water treatment system, which included 2 RO machines (reverse osmosis water purification system), was completed and recorded daily, as required, at 42 CF 494.40, Water and Dialysate Quality. The IJ was announced on 7/25/2024 at 12:45 PM, during a meeting with the Facility Administrator, Biomed Technician and Corporate Biomed Technician, and was not removed by the survey exit date of 7/25/2024.”

“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: 50411 Based on document review and interview, it was determined that for 5 of 43 patients (Pts. #7-#11) susceptible to Hepatitis B (liver infection), the Facility failed to ensure that patients were routinely tested every month to determine the presence or absence of infection. Findings include: 1. The Facility’s policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” (revised October 2023), was reviewed and required, “...All patients will be routinely tested... Routine Surveillance Testing: ...Antibody [HBsAb] <10 = Susceptible = Monthly Antigen [HBsAg]...Core Positive = Immune due to past infection = Monthly antigen...” 2. Hepatitis B Surveillance report from 1/2024 to 7/2024 was reviewed and indicated the following: - The clinical record of Pt. #7 was reviewed. Pt. #7’s lab results, dated 12/10/2025, indicated that Pt. #7 was core positive; however, the record lacked a monthly antigen result for May 2024. - The clinical record of Pt. #8 was reviewed. Pt. #8’s lab results, dated 4/9/2024, indicated that Pt. #8 was susceptible to Hepatitis B infection; however, the record lacked a monthly antigen result for May 2024. - The clinical record of Pt. #9 was reviewed. Pt. #9’s lab results, dated 5/24/2024, indicated that Pt. #9 was susceptible to Hepatitis B infection. The record lacked a monthly antigen result for June 2024 due to Pt. #9 missing treatments at the end of June. Pt. #9’s clinical record indicated that Pt. #9 returned for treatment on 7/5/2024; however, the record indicated that the antigen lab was not drawn until 7/19/2024 (approximately 2 weeks, 5 treatments later). - The clinical record of Pt. #10 was reviewed. Pt. #10’s lab results, dated 5/22/2024, indicated that Pt. #10 was susceptible to Hepatitis B infection; however, the record lacked a monthly antigen result for June 2024. - The clinical record of Pt. #11 was reviewed. Pt. #11’s lab results, dated 4/19/2024, indicated that Pt. #11 was susceptible to Hepatitis B infection; however, the record lacked monthly antigen test results for May and June 2024. 3. An interview was conducted with the Clinical Coordinator (E#2) on 7/24/2024, at approximately 1:20 PM. E#2 stated that susceptible patients and patients who are core positive should be tested monthly for the presence of the antigen. E#2 stated that they typically draw the Hepatitis labs during the third week of the month. E#2 stated that if the patient is absent and misses the labs during that week, they should draw the lab the next time the patient comes in for treatment.”

“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: 32741 Based on document review, observation and interview, it was determined that for 1 of 1 Registered Nurse (E #2) and 1 of 1 Patient Care Technician - PCT ( E #5) observed performing CVC (central venous catheter - used for dialysis access) discontinuation of treatment, the Facility failed to ensure that staff demonstrated knowledge of the Facility’s infection control practices for the disinfection of CVC access site for discontinuation of the dialysis treatment, as required. Findings include: 1. On 7/22/2024, the Facility’s policy titled, “Central Venous Catheter (CVC) with Clearguard HD Microbial End Caps and Tegaderm Chg Dressing Procedure” (dated October 2023) was reviewed and indicated, “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason...” 2. On 7/22/2024 between 8:45 AM to 11:35 AM, an observational tour of the dialysis treatment area was conducted. - At approximately 9:30 AM, the Registered Nurse (E #2) was observed disinfecting the CVC hubs after disconnection at station #7. E #2 disinfected the CVC hub with alcohol wipe for 8 seconds, instead of 15 seconds, as required. - At approximately 9:40 AM, E #2 was observed disinfecting the CVC hubs after disconnection at station #15. E #2 disinfected the CVC hubs for 5 seconds with alcohol wipe instead of 15 seconds, as required. -At approximately 10:23 AM, the Patient Care Technician (E #5) was observed disinfecting the CVC hubs after disconnection at station #5. E #5 disinfected the CVC hubs for 3 seconds with alcohol wipe instead of 15 seconds, as required. 3. On 7/22/2024 at 1:45 PM, an interview was conducted with the Patient Care Technician (E #5). E #3 stated that the CVC hubs should be disinfected for 30 seconds with alcohol.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 39802 Based on observation, document review and interview, it was determined that for the water treatment system, which including 2 ROs (reverse osmosis water purification system), the Facility failed to ensure that testing of both RO machines were completed and recorded daily, as required. This is likely to affect the current census of 43 in-center hemodialysis patients by putting patients at risk for poor quality water for dialysis treatment. Findings include: 1. An observational tour of the incenter hemodialysis water treatment room was conducted on 7/22/2024. There were 2 ROs present. Both ROS fed into one water storage tank. Both ROs fed into one water storage tank. There was an “RO Alternator” system present that was sent to “Auto” which meant that the system could alternate operation between the two ROs to purify water for dialysis treatments throughout the day. 2. The Facility’s policy titled, “Daily Water Treatment System Monitoring” (revised April 2023), was reviewed and required, “Purpose: To verify the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters... All observations and test results must be recorded on the approved Daily Water Treatment Log... Observations and test results listed on the Daily Water Treatment Log... are entered each facility operating day prior to the use of dialysis quality water for any process and the start of dialysis treatments....” 3. The Daily Water Treatment Logs from 5/1/2024-7/24/2024 were reviewed and indicated that water quality and performance parameters were checked and documented for only one RO each operating day (morning). The log included the entry “N/A [not applicable]” for the other RO. The log indicated that the Facility was open for patient treatments 3 days a week (Monday, Wednesday, and Friday). 4. An interview was conducted with Biomedical Technician (E#6) on 7/24/2024, at approximately 2:45 PM. E#6 stated that the system is designed to alternate between both ROs. E#6 stated that one RO will run until the tank is full and then stops, the next RO will kick on when the tank empties to a certain point. E#6 stated that in the morning when the system is turned on, one RO will kick on (whichever ones turn it is), and the staff will test it after it has been running for 15 minutes. E#6 stated that during any given day, the ROs could switch from one to the other. E#6 was not aware if there was a way to track which RO was running throughout each day. 5. An interview was conducted with Registered Nurse/Clinical Coordinator (E#2) on 7/24/2024, at approximately 3:00 PM. E#2 stated that they turn on the water system each morning and let it run for 15 minutes before they do the water checks. E#2 stated that whichever RO turns on in the morning is the only one they will check that day and document on the log. E#2 stated that system will turn on either RO#1 or RO#2 automatically each day. E#2 stated that they do not check both ROs daily and do not track if and when the system switches between the two ROs.”

“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: 32741 Based on document review, observation and interview, it was determined that for 3 of 3 Patient Care Technicians - PCT (E #3, E #4 & E #5) observed for pH testing, the Facility failed to ensure that the pH testing was conducted according to manufacturer’s guidelines and failed to demonstrate staff knowlege of pH range for pH testing. Findings include: 1. On 7/22/2024, the Facility’s manufacturer’s guidelines for pH test strips, “K100-0117CT, E-Z Chek 6.8-8.5 pH Test Strips Instructions for Use” (undated), was reviewed and required, “...Remove one strip from the bottle and immediately recap the bottle, dip or wet the test strip pad for one second with fresh solution to be tested, briskly shake off excess solution, compare test results to color scale on bottle between 20 and 25 seconds. Retest if the results are not read within the 25 second time frame...” 2. On 7/22/2024, the Facility’s policy titled, “Testing pH of Citric Acid Base Dialysate...” (dated 2/2024) was reviewed and required, “Procedure - Remove strip from the vial and immediately recap the vial, obtain dialysate sample by using a disposable collection cup, then dip the strip in the solution for one (1) second...within 20 to 25 seconds, compare the color reaction on strip to the color chart on bottle to determine the closest match...if results are outside the limit of 6.9 -7.6, repeat test on another dialysate sample...if repeat test is outside limit of 6.9-7.6, the dialysis delivery system is unsafe to use for patient treatment... pH test results should be between 6.9 - 7.6.” 3. On 7/22/2024 between 8:45 AM and 11:30 AM, an observational tour was conducted of the in-center dialysis treatment area. The following was observed: -At 9:50 AM, E #3 was observed at Station #12 checking the pH. E #3 left the pH test strip bottle open while testing the pH. E #3 initially stated that E #3 should check the pH results after 20 seconds and then E #3 stated the pH should be checked after 10 seconds. The results noted that the pH was out of range after E #3 checked the results in 20 seconds. E #3 rechecked the pH results after 15 minutes, and the pH was still out of range. The patient at Station #12 was not started on their dialysis treatment. -At 10:15 AM, E #3 was observed at Station #10 checking the pH. The pH was out of range. E #3 notified the Charge Nurse (E #2). E #2 stated that Station #10 would not be used for dialysis treatment. -At 10:30 and 10:40 AM, E #4 was observed at Station #13 & Station #15 checking the pH. The pH was out of range. The Facility Manager (E #1) was notified. Station #13 & Station #15 would not be used for dialysis treatments according to E #1. -At 11:45 AM, the pH (with a new bottle of pH test strips) was checked at Station #10, Station #12, Station #13 and Station #15. The pH was observed to be within range at each Station. 4. On 7/22/2024 at 10:50 AM, an interview was conducted with E #4. E #4 stated that the pH range is 7.2 to 7.5. 5. On 7/22/2024 at 10:55 AM, an interview was conducted with E #5. E #5 stated that the pH range is 7.2 to 7.5. 6. On 7/22/2024 at 11:00 AM, E #1 stated that patients at Station #10, #12, #13 & #15 would be rescheduled for later in the day. E #1 stated that the pH has to be within normal range or dialysis treatment will not begin. E #1 stated that the problem was the pH test strip bottle was left open while testing and the pH ranges were not within normal limits of 6.9-7.6 to begin treatment.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 50411 Based on document review, observation, and interview, it was determined that for 1 of 2 (E #4) Patient Care Technicians observed discontinuing dialysis treatment for patients with AV fistulas or grafts (permanent vascular access), the Facility failed to ensure that vascular access sites were assessed post dialysis treatment for the presence of a bruit (sound of blood flowing through access) and a thrill (vibration felt on palpation indicating flow). Findings include: 1. The Facility’s procedure titled, “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles” (Revised April 2023), was reviewed and required that “ ...Observe for edema, redness, prolonged bleeding and presence of thrill/bruit ...” 2. During a tour of the dialysis treatment area, on 7/22/24, the following was observed: - At approximately 9:10 AM, PCT (Patient care technician) E#4 was observed removing dialysis access needles from Pt. #5 (Station #1). E#4 did not assess the patient’s vascular access post dialysis treatment for thrill and bruit before leaving the treatment floor as required. - At approximately 9:32 AM, E#4 was observed removing the dialysis access needles from Pt. # 6 (Station # 18). E#4 did not assess the patient’s vascular access post dialysis treatment for thrill and bruit before leaving the treatment floor as required. - At approximately 10:00 AM, E#4 was observed removing dialysis access needles from Pt.# 2 (Station#2). E#4 did not assess patient’s access post dialysis for thrill and bruit before leaving the treatment floor as required. 3. An interview conducted with PCT (E#5) on 7/22/2024, at approximately 1:40 pm. E#5 stated that fistulas and grafts are assessed for thrill and bruit prior to treatment start and not post treatment.”

“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: 32741 A. Based on document review and interview, it was determined that for 2 of 4 (Pt. #2 & Pt. #4) in-center hemodialysis clinical records reviewed for shortened treatments, the Medical Director failed to ensure that the staff adhered to patient care policies, by notifying the physician of shortened hemodialysis treatments and ensuring that an AMA (against medical advice) form was completed. Findings include: 1. On 7/24/2024,the Facility’s policy titled, “Prescribed Treatment Time Not Met” (dated 10/2024), was reviewed and required, “A. Completion of the Early Termination of Treatment Against Medical Advice Form. 1. The RN [Registered Nurse] will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time...If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention...” 2. On 7/24/2024, Pt. #2 was admitted to the Facility on 5/13/2024, with a diagnosis of end stage renal disease. The Treatment Orders (dated 7/8/2024), included a treatment time of 225 minutes (3 hours and 25 minutes). Pt. #2 treatment sheets, from 7/8/2024 thru 7/19/2024, were reviewed and included the following days with shortened treatment: - On 7/15/2024: Treatment duration 180 minutes (not the required 225 minutes). -Pt. #2’s clinical record lacked completed AMA forms or notification to the physician of shortened treatments for these shortened treatment dates. 3. On 7/24/2024, Pt #4 was admitted to the Facility on 9/28/2020, with a diagnosis of end stage renal disease. The Treatment Orders (dated 6/17/2024), included a treatment time of 210 minutes (3 hours and 30 minutes). Pt #4’s treatment sheets, from 7/8/2024 thru 7/19/2024, were reviewed and included the following days with shortened treatments: - On 7/10/2024: Treatment duration 164 minutes (not the required 210 minutes). - On 7/15/2024: Treatment duration 179 minutes (not the required 210 minutes). Pt #4’s clinical record lacked completed AMA forms or notification to the physician of shortened treatments for these shortened treatment dates. 4. On 7/24/2024 at 11:00 AM, an interview was conducted with the Facility Administrator (E #1). E #1 stated that the patient should sign the AMA form if they have a shortened treatment. E #1 stated that the completed forms should be kept in the patient’s medical record. 50411 B. Based on document review, observation and interview, it was determined that for 1 of 1 Registered Nurse (E#2) observed for medication supervision, the Facility failed to ensure that all medications were stored in an area to prevent patient access. This had the potential to affect all 43 patients on census. Findings include: 1. On 7/22/2024, the Facility’s policy titled, “Medication Policy” (Revised November 2023) was reviewed and indicated, “11. ...Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under the supervision by the licensed teammate or per state regulations...” 2. On 7/22/2024 between 9:00 AM and 11:30 AM an observational tour was conducted in the dialysis treatment area. The following was observed: -There were 2 syringes (labeled Heparin [blood thinner] with patient name) filled with a medication on top of the counter at the nurses’ station at 9:05 AM which were left unattended. -There was a cup with 3 pills (label noted calcitriol [Vitamin D] with patient name) left on the counter by the nurses’ station at 9:05 AM which was left unattended. 3. On 7/22/2024 at approximately 9:08 AM, an interview was conducted with Registered Nurse (E #2). E #2 stated that any prepared medications should never be left unattended.”