Davita Mcminnville Dialysis

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 31224 Based on interview and review of documentation, it was determined the facility failed to ensure that all susceptible patients were offered vaccination against hepatitis B. Findings: Review of the facility’s “Vaccinations and Surveillance Report,” dated 04/21/2025, that included documentation of hepatitis B vaccination and immunity status of 65 patients, revealed 4 patients did not receive the hepatitis B vaccine when indicated. Examples included, but were not limited to: * Patient #7 readmitted to the facility in 03/2025 with a history of receiving one dose of the hepatitis B vaccine on 10/14/2024. The HBsAb laboratory result dated 03/13/2025 was less than 10 mIU/mL, indicating Patient #7 was not immune and should receive the hepatitis B vaccine. A consent form could not be located to document the vaccine was offered. * Patient #8 admitted to the facility in 03/2023 and completed one series of the hepatitis B vaccine on 12/05/2024. The HBsAb laboratory results dated 01/21/2025 and 02/06/2025 were less than 10 mIU/mL, indicating Patient #8 was not immune and should receive a second series of the hepatitis B vaccine. * Patient #9 admitted to the facility in 12/2024. The HBsAb laboratory result dated 12/11/2024 was less than 10 mIU/mL, indicating Patient #9 was not immune and should receive the hepatitis B vaccine. There was no history of receiving the hepatitis B vaccine included in the report. A consent form could not be located to document the vaccine was offered. * Patient #10 admitted to the facility in 05/2024 and completed one series of the hepatitis vaccine on 01/10/2025. The HBsAb laboratory results dated 02/10/2025 was less than 10 mIU/mL, indicating Patient #10 was not immune and should receive a second series of the hepatitis B vaccine. Review of the facility policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures And Isolation Guidance,” dated 04/2024, stipulated: * If the hepatitis B surface antibody (HBsAb) is less than 10 mIU/mL on admission, the patient is considered susceptible and the hepatitis B vaccine should be offered. * “Patients who start hemodialysis may have a history of vaccination against hepatitis B. These persons should have responded to the vaccine when their immune status was normal, but if their hepatitis B surface antibody (HBsAB or anti-HBs) levels are less than (<) 10 mIU/mL when they begin dialysis, they should be revaccinated with a complete primary series.” * “Test all vaccinated patients for HBsAb one (1) or two (2) months after the last dose of the full vaccine series ... If hepatitis B surface antibody (HBsAb) is less than (<) 10 mIU/mL, consider the patient susceptible, revaccinate with an additional full series...” During interview on 04/23/2025 at 1210, the MCS confirmed the above findings and additionally reported they had conducted an audit on 02/19/2025 where they had identified Patient #s 8-10 should receive the hepatitis B vaccine series and shared that information with the facility.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 37237 Based on observation, interview and review of documentation, it was determined the facility failed to maintain the building in which dialysis services were provided was constructed and maintained to ensure the safety of the patients, the staff and the public. Findings: Observation of the facility on 04/21/2025 beginning at 1015 revealed: - The door leading from the treatment floor to a hallway leading to multiple offices was propped open during the survey. - The integrity of areas of the countertop laminate on the treatment floor was compromised and not able to be effectively cleaned for infection control purposes. *During interview with the FA on 04/24/2025 at approximately 1400, they stated that work orders had been submitted to fix the countertops. * Review of the countertop work order revealed “Scheduled Start Date: 1/22/2025 12:47:17 PM ... Part of coating on the counter top on the treatment floor is pilling and needs to be replaced.” No other work orders were submitted, and no work had been done on the countertop as of 04/21/2025. - The baseboard of the wall next to the patient handwashing sink was detached from the wall, leaving an opened 3-to-4-inch crevice. - The lid to the brine tank failed to fit properly, it would not securely close. - The wall under the “Ultrafilter (Endotoxin Filter)” sign in the water room was severely damaged. The painted surface was water damaged and peeling away from the water-damaged wood structure underneath. There was a puddle of water on the floor underneath the damaged wall surrounded by black stains on the floor. The DI monitor rack was not connected and leaning against the wall next to the damaged area. * During email exchange with the BOM on 04/23/2025 at 2:37 PM, they stated “I was not previously aware of any wall damage; however, if it has not already been addressed by the Facilities Administrator, we will submit a repair ticket promptly to ensure it is taken care of ... Regarding the DI rack, we have been dealing with an ongoing leak at the UF housing connection. Unfortunately, the parts needed to repair this older system are no longer available. As a result, we are planning to replace that section with assistance from our vendor, Xylem (formerly Marcor) so we remain 510K approved.” *During email exchange with the BOM on 04/23/2025 at 3:27 PM, they stated “I first became aware of the leak earlier this year when [the facility biomed tech] reached out for assistance in identifying replacement parts ... Yes, the observed damage is indeed the result of that leak. Because RO water is significantly more corrosive than standard tap water, due to its high purity, it can be more aggressive in deteriorating materials over time ... In this case, the leak was small and went unnoticed for a period, which unfortunately allowed the damage to progress gradually until it became visibly apparent.””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 37237 Based on interview and the review of documentation, it was determined that the facility failed to ensure that all equipment was maintained and operated in accordance with the manufactures’ recommendations. Findings: Review of the facility’s “Medication Refrigerator Management Log[s]” revealed the following: - Refrigerator #1 lacked: * A recorded PM temperature on 10/27/2024, 10/28/2024, 11/05/2024 and 12/03/2024. * Initials for the AM temperatures recorded on 11/02/2024 and 11/11/2024. * Any temperature readings on 11/06/2024. * The time the PM temperature was recorded on 11/14/2024. - The “Mircera Fridge” lacked a recorded PM temperature on 11/08/2024 and 11/14/2024. Review of the facility’s “Oxygen Concentrator Filter Cleaning Log[s]” revealed: - The following weeks were missed for all oxygen concentrators: The weeks beginning 10/14/2024, 11/18/2024, 12/09/2024, 01/13/2025, 02/17/2025, 03/03/2025 and 03/24/2025. Review of the facility’s “Daily Zoll AED and Emergency Medication Lock Log[s] revealed” - No daily checks were completed for 10/09/2024 and 11/19/2024. Review of the “Fresenius Dialysis Delivery System Clean and Disinfect Log” for December 2024 revealed all machines were bleach cleaned on 12/24/2024. The facility was closed on 12/25/2024. There was no documentation that an AM bleach residual check was completed on 12/26/2024 before patients received treatments. During interview with the MCS on 04/23/2025 at approximately 1530, they confirmed the above findings.”

“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: 31224 Based on interview, review of patient medical records and review of documentation, it was determined that the facility failed to ensure that patients received appropriate and timely hemodialysis treatment and monitoring for 3 of 4 ICHD patients (Patient #s 3, 5 and 6). Findings: Patient #3 Review of Patient #3’s Treatment Details Reports dated 02/11/2025 through 04/15/2025 (12 treatments) revealed: - Physician order for BFR was 375 mL/min. - On 04/12/2025, the PCT initiated treatment at 1246 with the BFR set at 400 mL/min, where it remained for the duration of treatment. - On 04/14/2025, the PCT initiated treatment at 1242 with the BFR set at 400 mL/min, where it remained for the duration of treatment. The documentation indicated the RN verified the patient’s prescription matched what was being delivered during the dialysis treatment for the dates above. There was no documentation to show why the physician orders were not followed or that the RN was notified of the change. * Similar findings were identified for Patient #5. Patient #6 Review of Patient #6’s Treatment Details Reports dated 03/21/2025 through 04/18/2025 (13 treatments) revealed: - Patient VS, visualization and access checks were late for 1 of 13 treatments. * On 04/15/2024, the PCT documented a VS and access check at 1014. The next VS and access check was documented 79 minutes later at 1133. - The RN verification of the dialysis prescription was late on 2 of 13 treatment dates. * On 03/27/2025, treatment was initiated at 1124. The RN verified the patient’s prescription 72 minutes later at 1236. * Similar findings were identified for 03/28/2025. * Similar findings were identified for Patient #5. - Physician order for treatment time was for 195 minutes. * On 04/03/2025, treatment was initiated at 1145 and terminated 165 minutes later at 1430. During this time, the treatment was stopped for 17 minutes between 1357 and 1414 so the patient could use the bathroom. The patient’s actual treatment time was 148 minutes. There was no AMA for the shortened treatment time. * For 7 of 13 treatments, the patient failed to receive the prescribed treatment time due to stopping treatment for bathroom breaks. * On 03/21/2024, treatment was initiated at 1115 and terminated 196 minutes later at 1431. Treatment was stopped for 16 minutes between 1156 and 1212 for patient to use bathroom. The patient’s actual treatment time was 180 minutes. * On 04/16/2025, treatment was initiated at 0852 and terminated at 1159. Treatment was stopped for 21 minutes between 0906 and 0927 for the patient to use the bathroom. The patient’s actual treatment time was 166 minutes. * Similar findings were identified for treatment dates 03/24/2025, 03/27/2025, 04/03/2025, 04/09/2025 and 04/15/2025. - The prescription for “Heparin Pork-Hourly Dose” was “Order Stop time for hourly dose before end of treatment ... 60 minutes.” Staff failed to stop the infusion as prescribed for 6 of 13 treatments. * On 03/21/2024 the heparin infusion was started at 1117 and ended at 1437. The patient’s treatment was terminated at 1435. * Similar findings were identified for 03/24/2025, 03/31/2025, 04/03/2025, 04/15/2025 and 04/16/2025. Review of facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” with a last revision date of April 2024, stipulated: - “Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law.” Prescription components listed included BFR and DFR. - “If the dialysis prescription is not being met (including dialysis flow rate or charge to/inability to obtain prescribed blood flow rate” the reason will be documented and the licensed nurse informed.” During an interview on 04/23/2025 at 1210, the MCS confirmed the above findings.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 31224 Based on interview and review of documentation, it was determined that the facility failed to offer pneumococcal vaccination to patients based on assessment of status as required by facility policy and CDC guidelines for 2 of 68 patients (Patient #s 9 and 11). Findings: Review of the “Vaccinations and Surveillance Report,” printed on 04/21/2025, revealed 2 patients (Patient #s 9 and 11), were eligible to receive the PCV20 vaccine, but it was not administered. Examples included, but not limited to: * Patient #9 was over the age of 50 years and admitted to the facility in 12/2024 with no pneumococcal vaccine immunization history. No documentation was located to demonstrate the vaccine was offered. * Patient #11 was over the age of 50 years and admitted to the facility in 10/2024 with a history of receiving one dose of an unknown vaccine on 10/02/2012. No documentation was located to demonstrate the vaccine was offered. Review of the facility policy titled, “Pneumococcal Vaccination for Adult Patients,” dated 10/2023, stipulated: * Patients with no history of previous pneumococcal vaccinations should be offered the PCV20 vaccine. * The policy did not address patients who are admitted with a history of receiving an unknown pneumococcal vaccine. CDC pneumococcal vaccine recommendations for patients with chronic renal failure were found at: https://www.cdc.gov/vaccines/vpd/pneumo/hcp/who-when-to-vaccinate.html#adults and included: “Routine vaccination ... Administer PCV15, PCV20, or PCV21 for all adults 50 years or older * Who have never received any pneumococcal conjugate vaccine * Whose previous vaccination history is unknown.” During interview on 04/23/2025 at 1210, the MCS confirmed the above findings.”