Davita Meridian Park Dialysis Center

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 47148 Based on interview, review of facility personnel files, review of patients’ medical records, review of policies and procedures and review of the DSD Emergency Preparedness binder, it was determined the facility failed to comply with the Federal Emergency Preparedness (EP) requirement to maintain a comprehensive EP program, 42 CfC § 494.62 - Condition of participation: Emergency preparedness. This Condition-Level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: The DSD facility failed to maintain a comprehensive EP program, as evidenced by the following: 1. Complete an annual hazard and vulnerability assessment. The last date for completion was 11/11/2021. 2. Implement an Emergency Preparedness Training and Testing program: * The DSD failed to participate in any full-scale, facility-based or community drills in 2023 or 2024. The last facility-based exercise was a mock code on 02/25/2022. No further documentation was presented that demonstrated the facility, including staff and physician providers, had participated in a community/facility wide drill or any other tabletop exercises. * The DSD failed to document whether all patients received emergency preparedness or emergency procedure training. * The DSD failed to participate in quarterly fire drills. The last documentation of a fire drill was 02/25/2022. 3. Patient contact information was dated 12/11/2024 which was after the surveyors arrived on site for the recertification survey. 4. Facility emergency contact information was last updated in 2021. 5. Annual letters to the local emergency preparedness agency and other emergency preparedness collaborators were last sent in 10/2021. Review of facility policy 4-07-01 titled, “Facility Emergency Management Plan,” with a last revision date of October 2023, stipulated: * “Facility Hazard Vulnerability Assessment ... FA, or designee, will identify, evaluate and rate each hazard ANNUALLY” * “The facility will conduct and/or participate in one (1) exercise to test the facility EMP at least ANNUALLY, conducted on OPPOSITE years (one year full-scale exercise, next year facility-based/exercise of choice.” The policy further stipulated, “Documentation is required ... Utilize Facility Emergency Plan Activation template and document: Event that occurred ... Plan and policies activated ... Evaluation of plan ... Plan revisions required ... Governing Body review. * “The FA or designee, is responsible to provide training of EMP: a. Teammates ... ANNUALLY ... b. Patients ... ANNUALLY ... c. Physicians ... i. ANNUAL basis” * “Fire Safety Preparedness ... Conduct and review quarterly fire safety and evacuation drills for compliance, identify additional training and education needs” * “Emergency contact information will be reviewed QUARTERLY” * “Copy of each patient’s treatment orders and medication list ... is updated and replaced at least monthly” * “The FA, or designee, shall have communication at least on an ANNUAL basis ... regarding emergency preparedness, event collaboration and communication, needs of the dialysis patients and facility, and reviewing agency’s emergency plan ... documentation of contact is important.” During an interview with the MCS on 12/11/2024 at approximately 1200, they confirmed the above findings.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 37237 Based on interviews, observations and review of documentation, it was determined the facility failed to ensure: 1. To provide and monitor a sanitary environment to minimize the transmission of infectious agents. 2. A sanitary environment to minimize the transmission of infectious agents, that included Hep B vaccine administration. The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the ESRD to provide safe and adequate care. Findings: 1. Refer to findings cited at Tag V111 under CFR 494.30: The ESRD must provide a sanitary environment to minimize the transmission of infectious agents that reflects that policies, procedures, and systems for the provision of a sanitary environment, and to minimize the transmission of infectious agents were not clear, complete, or implemented and resulted in the following: * Failure of the facility to ensure all areas of the physical environment, that included, but were not limited to, the treatment area floor, treatment chairs, walls, counters and patient equipment were able to be sanitized to a standard that will prevent the transmissions of infectious agents. 2. Refer to findings cited at Tag V126 under CFR 494.30 (a)(1)(i): Hepatitis B Vaccination that reflects that policies, procedures, and systems for the provision of a sanitary environment and to minimize the transmission of infectious agents were not clear, complete, or implemented and resulted in the following: * Failure of the facility to ensure all patients and staff were offered and/or received the Hepatitis B vaccination.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 37237 Based on interview and review of documentation, it was determined that the facility failed to ensure: 1. Chlorine tests were performed every four hours. 2. Monthly water system samples were collected and tested for endotoxin and bacterial contamination as required by facility policy, AAMI guidelines and CMS regulations. 3. That staff received annual water system skills and trainings. This Condition-Level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the ESRD to provide safe and adequate care. Findings: 1. Refer to findings cited at Tag V196 under CFR 494.40(a): Carbon adsorption (monitoring and testing frequency) that reflects that policies, procedures, and systems for the provision of water and dialysate quality were not clear, complete, or implemented and resulted in the following: * Failure of the facility to ensure chlorine tests were performed every four hours. Failure to perform the test for chlorine accurately and timely places the patients at risk of exposure to levels of chlorine in the water exceeding AAMI standards. 2. Refer to findings cited at Tag V213 under CFR 494.40(a): Water distribution systems (bacteria and endotoxin testing) that reflects that policies, procedures, and systems for the provision of water and dialysate quality were not clear, complete, or implemented and resulted in the following: * Failure of the facility ensure the Associate Medical Director and Lead Medical Director reviewed and signed monthly AAMI test results * Failure of the facility to ensure monthly AAMI required water samples were drawn and tested to check for endotoxins and bacterial cultures. Failure to collect water and dialysate samples monthly could result in patient exposure to dangerous levels of endotoxins and/or bacterial cultures that could lead to health complications including, but not limited to pyrogenic reactions, infection and/or death. 3. Refer to findings cited at Tag V260 under 494.40(a): Personnel (components of the training program) that reflects that policies, procedures, and systems for the provision of water and dialysate quality were not clear, complete, or implemented and resulted in the following: * Failure of the facility to ensure 6 of 25 clinical staff (Staff #’s 1, 3, 12, 15, 16 and 21) responsible for operating, testing and monitoring the water and dialysate systems completed the required training and annual skills checks required by the facility policy and this regulation. Failure by the facility to ensure that all staff had received the required water room training could result in the contamination of the water system and/or incorrectly mixed dialysate. Exposure to contaminated water or incorrectly prepared dialysate could potentially result in serious negative effects for the patients, including, but not limited to, bacteremia and serum electrolyte imbalance and subsequent complications.”

“CFC-CARE AT HOME CFR(s): 494.100 This Condition is not met as evidenced by: 37237 Based on interviews and review of documentation, it was determined that the facility failed to design, implement, monitor and evaluate an effective system for monitoring the dialysis delivery system at the DSD facility. The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the ESRD to provide safe and adequate care. Findings: - Review of an Organizational Chart received by email from the parent/hub facility MCS on 12/17/2024 at 1617 revealed the DSD facility is certified and operated through the Home Program of the parent/hub facility, Meridian Park Dialysis Center. The DSD facility Leadership Team consisted of the DSD ROM, DSD ROD and the AMD. The parent/hub facility’s Leadership Team consisted of the Lead MD, Lead FA and ROD. The lack of communication between the leadership teams revealed to the following: - The Associate Medical director failed to monitor and review the results of water testing performed at the DSD facility. The Lead MD failed to follow-up about the missed monthly water tests. * Refer to Tag V213 that identified there was no AMD or MD signatures that verified the monthly AAMI results had been reviewed. * During interview with the Medical Director on 12/18/2024 at 0815, they stated the Associate Medical Director (AMD) would be the person to sign off on the water testing at the DSD facility, and that they [the MD] does not have that much to do with the SNF. They also stated there were a couple of transition AMDs while the regular AMD was out on leave. - The Associate Medical Director failed to be cognizant of the 5 months of missing water tests. The Lead MD failed to follow-up on the missed monthly tests. *Refer to findings in Tag V213 that identified the AMD and Lead MD failed to review or sign any monthly water quality tests. During interview with the Medical Director on 12/18/2024 at 0815, they said, in regard to the missed monthly tests, “Why it wasn’t done, I have no idea” and “Why should I be responsible if I’m not running it.” * The DSD ROM and the BOM failed to follow-up with the Biomed tech about the missing monthly water quality tests. - Refer to Tag V111 that identified the DSD facility failed to complete monthly infection control audits. - Refer to Tag E003 that identified the DSD management team failed to ensure that an effective comprehensive Emergency Preparedness Plan was in place for the DSD facility. - Refer to Tag V625 that identified the DSD facility failed to participate in the monthly QAPI meeting for the Meridian Park Dialysis Center, that includes the In-Center Program, Home Training Program, Nocturnal Program and DSD Program. * During interview with the FA and MCS on 12/13/2024 at 1150, they stated the ROM does not participate in the main facility’s monthly QAPI meetings, but reports information on the DSD facility activities to the Lead FA and Lead MD. They also stated there is little communication on what happens at the DSD facility and that no DSD facility documentation was available in monthly FHR meeting minutes. - The internal audit performed on 10/14/2024 by the DSD MCS that identified significant failures at the DSD facility was not addressed by the ROM and was not presented to parent/hub facility during a GB meeting or a QAPI meeting. * During interview with the MCS and FA of the ICHD facility on 12/13/2024 at 1500, they confirmed the audit findings were never brought to the GB or QAPI and had not been addressed by the DSD facility. - Refer to Tag V750 that identified the Governing Body failed to address issues concerning the DSD facility. * Review of documentation of 11 Governing Body (GB) meeting minutes from 06/18/2024 through 11/26/2024 revealed the only GB documentation for the DSD facility was the approval of an interim AMD on 08/01/2024. There was no other documentation regarding the DSD facility.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 37237 Based on interviews and review of documentation, it was determined that the facility failed to continuously monitor its performance, take actions that resulted in performance improvements, and track performance to ensure that improvements were sustained over time. This Condition-Level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: 1. Refer to findings cited at Tag V213 under CFR 494.40(a): Water distribution systems (bacteria and endotoxin testing) that reflects that policies, procedures, and systems for the provision of water and dialysate quality were not clear, complete, or implemented and resulted in the following: * Failure of the facility ensure the Associate Medical Director and Lead Medical Director reviewed and signed monthly AAMI test results. * Failure of the facility to ensure monthly AAMI required water samples were drawn and tested to check for endotoxins and bacterial cultures for 5 of 12 months during 2024. 2. Refer to findings cited at Tag V626 under CFR 494.110: The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, QAPI program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors that reflects that policies, procedures, and systems for the provision of an effective QAPI program were not clear, complete, or implemented and resulted in the following: * Failure of the facility to ensure all adverse events were reported. * Failure of the facility to ensure that QAPI information from the DSD facility was shared with and incorporated into the facility’s QAPI program.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 37237 Based on interviews, observations, review of personnel records and review of documentation, it was determined the Associate Medical Director and the Lead Medical Director failed to ensure that the dialysis delivery system was designed, implemented, monitored and evaluated to provide quality patient care in a safe and sanitary environment. This Condition-Level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: 1. Refer to findings cited at Tag E0003 under CfC 494.62: The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements within the condition that reflects the facility’s failure to maintain a comprehensive EP program that resulted in the following: * The facility failed to ensure the annual hazard and vulnerability assessment was completed for the DSD facility. * The facility failed to ensure staff and patients participated in any emergency preparedness exercises or drills at the DSD facility. * The facility failed to ensure staff and patients at the DSD facility received emergency preparedness training. * The facility failed to ensure all patient and staff contact information was accurate and up to date. 2. Refer to findings cited at Tag V110 under CFR 494.30 - Condition: Infection Control that reflects that policies, procedures, and systems for the provision of a sanitary environment, and to minimize the transmission of infectious agents, were not clear, complete, or implemented and resulted in the following: * Failure of the facility to ensure all areas of the physical environment, that included, but were not limited to, the treatment area floor, treatment chairs, walls, counters and patient equipment were able to be sanitized to a standard that would prevent the transmissions of infectious agents. * Failure of the facility to ensure all staff and patients were offered and/or received the hepatitis vaccine. 3. Refer to findings cited at Tag V175 under CFR 494.40 - Condition: Water and dialysate quality that reflects that policies, procedures, and systems that test the water quality were not implemented or monitored and resulted in the following: * Failure of the facility to ensure chlorine tests were performed every four hours. * Failure of the facility ensure the Associate Medical Director and Lead Medical Director reviewed and signed monthly AAMI test results. * Failure of the facility to ensure monthly AAMI required water samples were drawn and tested to check for endotoxins and bacterial cultures. * Failure of the facility to ensure 6 of 25 clinical staff (Staff #’s 1, 3, 12, 15, 16 and 21) responsible for operating, testing and monitoring the water and dialysate systems completed the required training and annual skills checks required by the facility policy and this regulation. 4. Refer to findings cited at Tag V580 under CFR 494.100 - Condition: Care at home that reflects that policies, procedures, and systems in place to ensure services offered to home patients are at least equivalent to those provided to in-facility patients were not implemented and/or monitored and resulted in the following: * The Home Program’s DSD facility failed to ensure patients received emergency preparedness training. * The Home Program’s DSD facility failed to ensure infection control policies and procedures were followed. * The Home Program’s DSD facility failed to ensure the safety of the dialysis delivery system. * The Home Program’s DSD facility and the main facility failed to effectively communicate during QAPI meetings to ensure the safety of patients receiving treatment at the den. - Refer to findings cited at Tag V625 under CFR 494.110 - Condition: Quality assessment and performance improvement that reflects that policies, procedures, and systems in place to ensure an effective QAPI program were not implemented and/or monitored and resulted in the following: * The DSD facility and the main facility failed to ensure sufficient communication during monthly QAPI meetings. Review of the “Medical Director Qualifications and Responsibilities Policy” dated as effective 07/15/2024 reflected: * “Associate Medical Director ... A Medical Director who works under the direction of a Lead Medical “Director and typically has responsibility for modalities other than in-center hemodialysis (ICHD), mainly home hemodialysis (HHD) or peritoneal dialysis (PD) modalities.” * Lead Medical Director ... The primary Medical Director whom DaVita assigns to oversee a center and the in-center hemodialysis modality. The Lead Medical Director is responsible for overseeing the clinical operation and the quality outcomes of all components of the center, including the activities of any Associate Medical Directors (where applicable).” * “Medical Director Responsibilities ... Medical Director responsibilities include, but are not limited to, the following ... Leadership of Facility Health Meetings (FHMs) ... Oversight of the center’s physical environment, including maintaining a safe treatment environment and supporting center safety activities ... Oversight of the Quality Assurance (QA/Quality Improvement (QI) program ... Oversight of staff education, training and performance ... “ * “The Lead Medical Director is responsible for overseeing the clinical operation of all modalities at the center, including the activities of all Associate Medical Directors who are responsible for different program components at the center.””

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 37237 Based on observations, interviews and review of documentation, it was determined that the Governing Body failed to: - Ensure the Emergency Preparedness plan was current, staff and patients were trained in emergency procedures, staff and patients participated in emergency testing exercises and that patient and staff contact information was up to date in the DSD facility. - Ensure an effective infection control system was implemented, monitored and evaluated. - Ensure the dialysis water distribution system was effectively monitored. - Ensure that opportunities for improvement were identified, implemented, monitored and evaluated through the quality assurances process QAPI program reviewed. - Ensure results of an internal audit completed at the DSD facility on 10/14/2024 were reviewed and corrections implemented. - Ensure the DSD facility was appropriately monitored. This Condition-Level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: * Refer to Tag E003 that identified the facility’s failure to implement the DSD facility’s Emergency Preparedness Plan. * Refer to Tag V110 that identified the facility’s failure to implement an effective infection control program. * Refer to Tag V175 that identified the facility’s failure to effectively monitor the water & dialysate system and to ensure all staff received the required annual water trainings. * Refer to Tag V580 that identified the parent/hub facility’s failure to monitor the DSD facility through the Home Training Program. * Refer to Tag V625 that identified the facility’s failure to identify patient care and safety concerns and to implement plans of correction to prevent repeat citations. * Refer to Tag 710 that identified the Medical Directors’ failures to ensure all policies and procedures were adhered to, including but not limited to: patient care, infection control, staff training, QAPI, and emergency preparedness.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 37237 Based on observation, interview and review of documentation, it was determined that the facility failed to ensure a sanitary environment to minimize the transmission of infectious agents within the facility and other public areas. Findings: Observation of the facility on 12/10/2024 beginning at 0900 revealed: - The drain cover in the clean sink in HHD room #1 showed signs of rust and oxidation in areas where the silver coating was chipped and etched. - Cabinets in the medication room of the Home Training Program area had scotch tape and tape residue on the surfaces that could not be cleaned effectively for infection control purposes. - Dialysis machines 8 and 11 each had a black streak down the front of the machine from the acid connector. - The velcro of numerous blood pressure cuffs was dirty and full of debris. - There was a small hole the size of a quarter in the floor of the isolation room that exposed the underflooring. - One of the eyewash stations had a green biofilm built up inside the sink. A second eyewash station was missing one of the caps that covered the nozzles, and the other cap was cracked. - Numerous wall boxes had precipitate buildup around the connectors and in the wall boxes. - Treatment chairs had rips and tears in the upholstery. The chairs could not be effectively cleaned for infection control purposes. - Areas of chipped and peeling paint that exposed drywall that could not be effectively cleaned were found throughout the in-center treatment floor area and in the home training area. - Areas of the flooring inside the treatment area: * Were peeling off or peeling away from the edges; * Had long areas where the floor seams failed to meet leaving gaps for debris to accumulate; and * Were scratched and abraded so the top layer of the laminate had worn away. These areas were numerous and around most treatment chairs. - Review of “Monthly Infection Control Audit” sheets between June and November 2024 revealed no monthly audits were completed for July and November 2024 for the ICHD, PD and HHD modalities. The PD and HHD modalities were only checked as audited during the month of September 2024. During interview with the MCS on 12/13/2024 at approximately 1200, they confirmed the above findings. - Only the June “Monthly Infection Control Audit” sheets from the DSD facility were presented for review. During interview with the MCS on 12/11/2024 at 1015, they confirmed June was the last month that a “Monthly Infection Control Audit” was completed at the DSD facility.”

“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: 47148 Based on interview and review of documentation, it was determined that the facility failed to ensure the following: - That all susceptible patients were offered Hepatitis B vaccination as required to manage care appropriately. - Patients had all lab values necessary to determine their HBV serological status. - All staff were offered a Hepatitis B vaccination upon hire. Findings: - Review of the “Vaccinations and Surveillance Report,” dated 12/10/2024, that included documentation of Hepatitis B vaccination status of 123 patients revealed the following: Examples included, but were not limited to: * Three (3) patients who were tested and determined to be susceptible to hepatitis B, lacked documentation of receiving the vaccine series or documented refusal. * One (1) patient with a Hep B serological status of “Inactive/HBcAb pos/HBsAG<10 and HBsAg Neg” failed to have documentation of IgM HBcAb lab results as required per screening guidelines. * One (1) patient with a Hep B serological status of “Isolation Required/HBsAg” lacked documentation HBsAb and IgM HBcAb lab results as required per admission screening guidelines. - Review of the Personnel Audit form revealed that Staff #26 failed to have documentation of either receiving the Hepatitis B vaccination or had signed a declaration. Review of the facility’s policy, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” dated as “April 2024” stipulated, “HBV serological status (i.e. the results of Hepatitis B surface antigen (HBsAg), Total Hepatitis B core antibody (total anti-HBc or HBcAb, and Hepatitis B surface antibody (HBsAb) of all patients should be known before admission to the dialysis facility ... Review results and determine status and next steps (refer to Admission Screening table) ... Status ... currently inactive ... Draw IgM ... Status ... susceptible ... Offer vaccination series.” During an interview with the MCS and FA on 12/13/2024 at approximately 1000, they confirmed the above findings.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 37237 Based on observation, interviews, and review of documentation it was determined that the facility failed to ensure that medications were prepared and stored correctly. Findings: Observation of the DSD facility treatment area on 12/11/2024 beginning at 0900 revealed: - An opened MDV of Tubersol with “Opened 11-8-24” written on the box. The MDV discard date should have been 12/08/2024, 30 days after 1st use. - Numerous IV bags of 0.9% Sodium Chloride, 250 mL expired on 11/30/2024. During interview with the MCS on 12/11/2024 at 1530, they confirmed that the Sodium Chloride IV bags were expired and that they were unaware if the Governing Body determined if the IV bags had an extended expiration date. During an interview with the MCS and FA on 12/13/2024 at 1000, the above findings were confirmed.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 37237 Based on observation and review of documentation, it was determined that the facility failed to ensure they followed their policy for monitoring the brine tank. Findings: Observation of the brine tank at 0935 on 12/10/2024 revealed it was slightly less than half full with four to five inches of water visible above the salt line. The visible water was 70% covered with a brown residue. The lid to the brine tank was not completely closed, it rested at an angle that left a gap where debris could enter the tank. Review of the “CWP Daily Water Log” document for 12/09/2024 through 12/14/2024 revealed that on 12/09/2024 the log sheet indicated that the “Brine Tank Salt Level (Y/N) ... Above water level” was “N,2”. In an email received on 01/02/2025 at 1205, the MCS wrote “[on] 12/9 the water level was noted to be below the water level. The clinic added 2 bags of salt after shipment was received that day.” Further review of the “CWP Daily Water Log” revealed that on 12/10/2024, the log sheet indicated that the “Brine Tank Salt Level (Y/N) ... Above water level” was marked with a “Y” indicating that, yes, the salt level was above water level. Signage on the brine tank stipulated “Check the brine tank level daily to be sure the tank is at least half filled with salt, adding salt pellets if necessary. Water may become “hard” if salt pellet level is low. Add salt pellets as required ... Factors Affecting Operation ... Abnormal operation could be a result of compacted salt (salt bridge). Faulty brine float, debris, and improper water softener operation. The brine tank should be kept closed to eliminate debris from coming in contact with the salt and the brine float valve should be clear for smooth operation.” Review of facility policy # 1-17-02, “Daily Water Treatment System Monitoring,” dated as last revised April 2023 stipulated: - “3. Observations and test results listed on the Daily Water Treatment Log and in the IT Clinical System are entered each facility operating day PRIOR to the use of dialysis quality water for any process and the start of dialysis treatments, except for hardness testing, done at the end of the treatment day.” - “5. All observations and test results will be within the limits specified on the Daily Water Treatment Log. If observations or test results are found outside the specified limits, follow the instructions given on the Daily Water Treatment Log for the parameter(s) in question. In addition to following the log form instructions, the teammate completing the log will notify the Facility Administrator/designee and Biomed teammate assigned to the facility of any observation or test result found outside the limit specified on the Daily Water Treatment Log.” - “6. The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the Daily Water Treatment Log.” - “7. A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits. Upon satisfactory completion of this review, the licensed nurse initials and signs the log form where indicated.” Should the brine tank not have an adequate amount of salt, the water softener would not function correctly resulting in water with potentially high levels of sodium and calcium being delivered to the RO system that could potentially cause the RO to not function correctly.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 37237 Based on interview and review of Total Chlorine testing logs, it was determined the DSD facility failed to ensure chlorine test results were accurately documented to ensure tests were performed approximately every 4 hours. Findings: Review of the “DaVita - Water Treatment Safety Record” logs between 10/01/2024 and 12/11/2024 revealed: - On 10/14/2024, the RN failed to verify the chlorine test done at 1205 for RO Serial Number 5. - On 11/01/2024, a chlorine test was completed at 0901 and 1320, an interval of 4 hours and 19 minutes for RO Serial Number 3. - On 11/04/2024, a chlorine test was completed at 0500 and at 0900, an interval of 4 hours for RO Serial Number 4. - On 11/08/2024, a chlorine test was completed at 0800 and at 1250, an interval of 4 hours and 50 minutes for RO Serial Number 5. - On 11/15/2024, a chlorine test was completed at 0515 and at 0915, an interval of 4 hours for RO Serial Number 7. - On 12/06/2024, a chlorine test was completed at 0907 and at 1310, an interval of 4 hours and 3 minutes for RO Serial Number 3. - On 12/06/2024, a chlorine test was completed at 0905 and at 1312, an interval of 4 hours and 7 minutes for RO Serial Number 5. - On 12/11/2024, the RN failed to verify all chlorine tests done between 1225 and 1232 for RO Serial Numbers 3, 4, 5, 6, 7 and 8. Review of the facility policy 1-12-26 titled, “DSD Total Chlorine Monitoring of Portable Reverse Osmosis (RO) Water Treatment Systems,” dated as last revised October 2024 stipulated “Total Chlorine testing is performed prior to the use of dialysis quality water for any process prior to treatment, and every four (4) hours after the initial test while dialysis quality water is being utilized.” During interview with the MCS an FA on 12/11/2024 at 1500 and on 12/13/2024 at approximately 1150, the above findings were confirmed.”

“DIST SYS-CULTURE/LAL/SITES/FREQ(NEW)/LOG CFR(s): 494.40(a) 6.3.3 Water distribution systems: culture/LAL sample sites/frequency (new)/log Water distribution piping systems should be monitored for bacteria and endotoxin levels. Bacteria and endotoxins shall not exceed the levels specified in [AAMI] 4.1.2. [(i.e., bacteria <200 CFU/mL and endotoxin <2 EU/mL] Bacteria and endotoxin testing should be conducted at least monthly. For a newly-installed water distribution piping system, or when a change has been made to an existing system, it is recommended that weekly testing be conducted for 1 month to verify that bacteria or endotoxin levels are consistently within the allowed limits. Monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop and the outlets supplying reuse equipment and bicarbonate concentrate mixing tanks. If the results of this testing are unsatisfactory, additional testing (e.g., ultrafilter inlet and outlet, RO product water, and storage tank outlet) should be undertaken as a troubleshooting strategy to identify the source of contamination, after which appropriate corrective actions can be taken. Bacteria and endotoxin levels shall be measured as specified in ANSI/AAMI RD62:2001 (see 2.3). All bacteria and endotoxin results should be recorded on a log sheet to identify trends that may indicate the need for corrective action. This Standard is not met as evidenced by: 37237 Based on interviews and review of documentation it was determined that the facility failed to ensure the water system was monitored monthly for endotoxins and bacterial contamination as required by facility policy, AAMI guidelines and CMS regulations for 5 of 12 months. Findings: Review of the AAMI water quality lab results from the DSD facility revealed water quality tests were resulted on 10/30/2024 and 11/19/2024. There was no documentation that the Associate Medical Director or the Medical Director reviewed and signed off on the results of 10/30/2024 and 11/19/2024. During interview with the DSD Biomed tech on 12/11/2024 at 1200, they stated that results from previous months of the water quality tests were in a binder that was lost. The Biomed tech also stated that they didn’t know the name of the Medical Director, but emailed the monthly results to a medical director whose name was listed on a recurring email. The Biomed tech failed to produce documentation that any water quality tests results were emailed to the DSD Associate Medical Director. During interview with the FA and MCS on 12/13/2024 at 1140, they stated: - There were no water cultures drawn or resulted for the months of August and September 2024 at the DSD facility. - There was no documentation that the ROM verified that cultures were obtained, that results were recorded and reviewed. - There was no documentation that the Associate Medical Director of the DSD facility reviewed or signed any water quality tests. - There was no documentation that the Lead Medical Director reviewed or signed any water quality tests. - There was no documentation that water quality results were presented or discussed at the monthly FHR meetings. Review of the document titled, “Machine and Water Labs Historical Report - Snappy Data Jan 1, 2024 - Dec 12, 2024 ... SNF Dialysis at Milwaukie-Meridian Park” received on 01/10/2025, revealed no AAMI water lab tests were drawn for February, May and July 2024. In an email received on 01/07/2025 at 0921, the BOM confirmed that endotoxin and culture labs were missed for February, May and July 2025, “I can confirm there are missing labs for Feb and May. I see where January labs were drawn end of the month and resulted in Feb and again for May, they were pulled at the end of April and resulted in May. July is when the SNF changed to Bart Labs and that was when we had issues with the manifest and not being processed.” Review of facility policy #1-12-30 titled, “DSD Water Culture Policy for the Post-Acute Portable Reverse Osmosis (RO) System,” dated as last revised April 2024, stipulated: - “The Regional Operations Manager (ROM) or designee is responsible for verifying that cultures are obtained, results recorded, reviewed and necessary actions taken, as applicable.” - “The ROM/designee and Biomed Services review all water culture results monthly. The Medical Director, if applicable reviews all water culture results monthly.” - “Results and trends are reviewed during the joint DaVita and SNF Quality Assurance Performance Improvement meeting and documented in the meeting minutes ...” Review of the document for an internal audit titled, “DSD Safety Snapshot,” dated as completed 10/14/2024 by the CMR revealed: - “Question 23 - Water and Dialysate: RO Systems ... RO system disinfected/maintained. Review logs to verify appropriate disinfect per facility specific procedures.” The box “NO” was checked. In the comment section the MCS wrote, “ROM was not able to present to MCS bio-meds was monthly machine cultures no evidence that the MD and ROM has reviewed [sic].” - In the column “Improvement Plan ... An Improvement Plan is required for this item, please select from the following recommended actions or enter a custom action below.” Two items were checked, and a custom item was entered that stipulated “Biomed needs to retain records in the dialysis den. Biomed will send electronic copies to the FA and AMD for review - at which point the FA and AMD will acknowledge review and acceptance. Biomed shall then file the electronic reviews/acceptance with the water logs.” - In the column “Attestation ... Improvement Plan Completion Attestation [DSD ROD only: DSD ROD Attestations should be completed by the DSD ROD of the CCN regardless of delegate status for other users].” The box was not checked for “By checking this box you are attesting that all of the actions assigned for this improvement plan have been reviewed, and completed as indicated.” During interview with the FA and MCS on 12/13/2024 at 1500, they stated “These findings were never brought up to the GB. This has not been addressed in DSD or GB.” They stated the Safety Snapshot was completed on-site at the dialysis den by an MCS who resides in Missouri. Culture and endotoxin results must be obtained from all the required locations to ensure that water systems used to prepare dialysate are not contaminated with bacteria and/or endotoxins. All bacteria and endotoxin results should be recorded on a log sheet to identify trends that may indicate the need for corrective action. Exposure of patients to levels of bacteria and endotoxin in the water could lead to health complications including, but not limited to pyrogenic reactions, infection and/or death.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 37237 Based on interview, review of personnel records and review of documentation, it was determined that the facility failed to ensure that 6 of 25 clinical staff (Staff #’s 1, 3, 12, 15, 16 and 21) responsible for operating, testing and monitoring the water and dialysate systems completed the required training and annual skills checks required by the facility policy and this regulation. Findings: Review of the personnel file worksheet presented on 12/13/2024 revealed: - Staff #1 with a hire date of 09/02/2011 last completed the “Annual Water Skills Checklist (CEC2014, CEC2036 or CEC2037)” on 11/28/2023. - Staff # 3 with a hire date of 09/02/2011 last completed the “Annual Water Skills Checklist (CEC2014, CEC2036 or CEC2037)” on 11/29/2023. - Staff #12 with a hire date of 10/01/1999 last completed the “Annual Water Skills Checklist (CEC2014, CEC2036 or CEC2037)” on 11/29/2023. - Staff #15 with a hire date of 05/22/2023 last completed the “Annual Water Skills Checklist (CEC2014, CEC2036 or CEC2037)” on 12/01/2023. - Staff #16 with a hire date of 05/01/2004 last completed the “Annual Water Skills Checklist (CEC2014, CEC2036 or CEC2037)” on 12/06/2023. - Staff #21 with a hire date of 12/05/2016 last completed the “Annual Water Skills Checklist (CEC2014, CEC2036 or CEC2037)” on 11/29/2023. Review of the facility policy #8-02-08 titled, “Auditing of Clinical Practice Requirements for Water and Dialysate Concentrate,” dated as last revised April 2021 stipulated “The ESRD Conditions for Coverage require the operators of the water/dialysate system equipment to be trained by the manufacturer of the equipment or the training must be done from materials provided by the manufacturers. Initial training will be completed after new hire an annually thereafter.” The above findings were confirmed by the FA and MCS on 12/13/2024 at approximately 1145. Failure by the facility to ensure that all staff had received the required water room training could result in the contamination of the water system and/or incorrectly mixed dialysate. Exposure to contaminated water or incorrectly prepared dialysate could potentially result in serious negative effects for the patients, including but not limited to, pyrogenic reactions, bacteremia and serum electrolyte imbalance and subsequent complications.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 37237 Based on observation and interview, it was determined the facility failed to ensure expired medical supplies were not available for use. Findings: Observation of the ICHD facility treatment area on 12/10/2024 beginning at 0930 revealed: - 4 CRIT-LINE blood chambers with an expiration date of 11/30/24. Observation of the DSD facility treatment area on 12/11/2024 beginning at 0900 revealed: - 6 boxes containing 10 Providone Iodine Antiseptic Swabs with an expiration date of 11/2024 - 9 IV start kits with an expiration date of 03/15/2024 - 1 IV start kit with an expiration date of 05/05/2022 - 4 subcutaneous infusion sets with an expiration date of 06/01/2022 - 1 package of connection tubing with an expiration date of 06/09/24 - 1 bottle of conductivity solution with a handwritten expiration date of “10/12/2024” - 2 packages of connection tubing with an expiration date of 08/04/2024 - 1 Adult manual resuscitator with mask with an expiration date of 07/12/2024 - 4 subcutaneous infusion sets with an expiration date of 06/01/2022. During an interview with the MCS and FA on 12/13/2024 at 1000, the above findings were confirmed.”

“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 and interview, 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 ICHD dialysis facility on 12/10/2024 beginning at 0900 revealed: - The door leading from the treatment floor to a hallway leading to multiple rooms was propped open. - In the Home Training Program area, the hallway had storage racks filled with supplies lined up along one wall that presented a safety hazard to anyone that may need to evacuate. The racks and extruding boxes obstructed easy egress from the exit door in case of emergency or fire. - A gallon of bleach was stored under the sink in the HHD room used for storage. - The dirty sink in HHD #1 did not function. - One of the clean sinks on the treatment floor did not function. - A pump soap container, a box of tissues and Lysol disinfectant were stored underneath one of the clean sinks. The area around the mechanism that operated the sink pedals was surrounded with black and green stains. - A wheelchair was parked in front of the crash cart, blocking easy access. - One of the blue-topped filters in the water room had a buildup of precipitate around the blue top opening. The above findings were confirmed by the FA and MCS on 12/10/2024 at approximately 1500.”

“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 manufacture’s recommendations. Findings: 1. Observation of the ICHD facility on 12/10/2024 at 1028 revealed: - The centrifuge located in the Home Training Program area lacked a preventative maintenance (PM) sticker. The last maintenance date could not be determined. 2. Observation of the DSD facility on 12/11/2024 at 0903 revealed: - The centrifuge lacked a PM sticker. The last maintenance date could not be determined. 3. Review of refrigerator temperature logs revealed: - On 10/03/2024 no PM temperature was recorded for the medication fridge. - On 10/31/2024 no PM temperature was recorded for the medication fridge. - On 11/01/2024 no AM temperature was recorded for the medication fridge. - On 11/18/2024 no AM or PM temperatures were recorded for the medication fridge. - On 10/03/2024 no PM temperature was recorded for the Mircera fridge. - On 10/21/2024, 10/23/2024 and 10/24/2024 no times were recorded for the Mircera fridge. - On 11/07/2024, 11/13/2024, 11/14/2024, 11/16/2024, 11/19/2024, 11/21/2024, 11/22/2024 and 11/23/2024 no staff initialed the temperature readings. 4. Review of the “Fresenius Dialysis Delivery System Clean and Disinfect Log[s]” revealed: - 11/06/2024 a bleach disinfect was circled as completed for Machine #s 1, 2, 3, 5 and 10. There was no accompanying documentation that a bleach residual test was done during the PM on 11/06/2024 or during the AM on 11/07/2024 on those machines. - Similar findings were identified for: 10/02/2024, 10/09/2024, 10/16/2024, 10/18/2024, 10/25/2024, 11/14/2024, 11/18/2024, 11/22/2024 and 11/28/2024 for machine #9. - The facility failed to present documentation that machine disinfection was completed on Friday, 11/01/2024 and Saturday, 11/02/2024. The two dates were included, but blank, on the weekly log sheet that included 10/28/2024 -11/02/2024. - On 11/07/2024 - No staff initialed “Initials PM” for machines 1 - 7. Further review of the “Fresenius Dialysis Delivery System Clean and Disinfect Log” revealed the log sheet was designed so that if a machine was bleach disinfected any day but Tuesday, there was no area to document that the Residual PM and Residual AM checks were completed. Review of facility policy #1-15-01, “Fresenius Dialysis Delivery System Cleaning and Disinfection Policy,” dated as last revised April 2019 stipulated: - “6. Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log in conjunction with the Biomedical Department and with approval by the Biomed Operations Manager (BOM). The specific log will be reviewed and approved by the Governing Body prior to implementation. Cleaning and disinfection of dialysis delivery systems will be documented on this log.” - “7. At a minimum the facility specific log must include the following elements ... Post chemical rinse residual test ... Verification of negative chemical residual test just prior to next use ... Teammate initials ...” - “10. Notification of the type of disinfection is prominently displayed on each dialysis delivery system to indicate the presence of disinfectant in the system. Upon completion of chemical disinfection, negative residual test results for the chemical being used is obtained and recorded on the facility’s Dialysis Delivery System Cleaning and Disinfection Log.” - “11. Teammates will perform a second chemical residual test on each dialysis delivery system that was chemically disinfected prior to the start of dialyzer set up and record on the facility’s Dialysis Delivery System Cleaning and Disinfection Log...” During interview with the ICHD Biomed tech on 12/11/2024 at 1500 they stated they had not gone over the November logs yet for QAPI and could not explain why so many machines were initialed as bleached on 11/06/2024. They confirmed that when a machine is disinfected with bleach, there should be residual tests done and documented.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 37237 47148 Based on observation, it was determined the facility failed to prominently display the current State Agency and the ESRD Network mailing addresses and telephone complaint numbers where it can be easily seen and read by patients. Findings: During observation of the DSD facility on 12/11/2024 beginning at 0900, the facility failed to have any information posted providing the mailing addresses and contact information for the applicable ESRD Network and the State survey agency as well as the complaint telephone numbers for each. During an interview with the MCS and FA on 12/14/2024 at 1000, the above findings were confirmed.”

“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: 37237 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 monitoring or that the dialysis prescription was followed for 9 of 13 patients (Patients #s 1, 2, 3, 4, 6, 7, 9, 12 and 13). Findings: 1. Review of patient treatment flowsheets reflected VS and safety checks were missed and/or abnormal findings were not reported to the RN. Examples included, but were not limited to: * Review of Patient #3’s dialysis orders and treatment sheets dated 11/11/2024 through 12/09/2024 (13 hemodialysis treatments) reflected the following: - On 11/25/2024, the PCT documented a VS and access check at 1059. The next VS and access check was documented 135 minutes later at 1314. - On 12/09/2024, the PCT documented a VS and access check at 1038. The next VS and access check was documented 118 minutes later at 1236. - Similar findings were noted on 11/11/2024, 11/15/2024, 11/18/2024, 11/20/2024, 11/27/2024, 11/29/2024 and 12/04/2024. * Review of Patient #6’s treatment sheets dated 11/09/2024 through 12/07/2024 (13 hemodialysis treatments) reflected the following: - On 11/09/2024, the PCT documented a VS and access check at 1336. The RN documented the next VS and access check 119 minutes later at 1535. - On 11/12/2024, the PCT documented a VS and access check at 1338. The RN documented the next VS and access check 58 minutes later at 1440. * Similar findings were noted on 11/14/2024, 11/16/2024, 11/19/2024, 11/21/2024 and 11/30/2024. * Similar findings were noted for Patient #s 1, 4, 7, 9, 12 and 13. 2. Review of patient treatment flowsheets reflected the BFR and/or DFR was adjusted without documentation to explain why the physician order was not followed. Examples included, but were not limited to: * Review of Patient #6’s dialysis orders and treatment sheets dated 11/09/2024 through 12/07/2024 (13 hemodialysis treatments) reflected the following: - Physician orders for dialysis treatment indicated the DFR was 600 mL/min. - On 11/09/2024, the PCT set the DFR at 500 mL/min at the start of treatment at 1040 without supporting documentation. The RN documented they verified the machine settings matched the prescription at 1101. The DFR remained at 500 mL/min for the duration of the treatment. - On 11/30/2024, the PCT set the DFR at 800 mL/min at the start of treatment at 1055 without supporting documentation. The RN documented they verified the machine settings matched the prescription at 1103. The DFR remained at 800 mL/min for the duration of the treatment. * Review of Patient #9’s dialysis orders and treatment sheets dated 11/13/2024 through 12/11/2024 (13 hemodialysis treatments) reflected the following: - Physician orders for dialysis treatment indicated the BFR was 400 mL/min. - On 11/25/2024, the RN set the BFR at 350 mL/min and documented they verified the machine settings matched the prescription at 1133. The BFR remained at 350 until the RN changed the BFR to 275 without supporting documentation. At 1500, the RN changed the BFR to 300 where it remained until the duration of the treatment. - On 12/09/2024, the RN set the BFR at 400 mL/min at the start of treatment at 1143 then between 1230 and 1430, it was at 350 without supporting documentation. * Similar findings were noted for Patient #s 4, 7, 12 and 13. 3. Review of patient treatment flowsheets reflected the hemodialysis order was not administered as ordered and lacked documentation to explain why the physician order was not followed. Examples included, but were not limited to: *Review of Patient #2’s dialysis orders and treatment sheets dated 10/28/2024 through 12/02/2024 (13 hemodialysis treatments) reflected the following: - Physician orders for treatment medication included a prescription for “Heparin Pork ... Order stop time for hourly dose before end of treatment: 60 minutes.” - On 11/29/2024, the PCT documented the treatment was terminated at 2131. The heparin infusion was started at 1800 and ended at 2137 without supporting documentation. - On 12/02/2024, the PCT documented the treatment was terminated at 2126. The heparin infusion was started at 1755 and ended at 2125 without supporting documentation. * Similar findings were noted for Patient #13. 4. Review of the 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 ... Prescription components include but are not necessarily limited to: ... f. Blood Flow Rate ... g. Dialysate flow rate ... j. Heparinization (intradialytic infusion setting).” - “Intradialytic treatment monitoring and data collection which my be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring for non-nocturnal treatments is completed at least every thirty (30) minutes and includes vital signs, access checks and BFR.” - “If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed.” During an interview with the MCS and FA on 12/13/2024 at 1500, they verified 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: 47148 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 32 of 123 patients (Patient #s 2, 5, 8, 13-41). Findings: 1. Review of the “Vaccinations and Surveillance Report,” printed on 12/10/2024, revealed 13 patients (Patient #s 23-24, 27-29, 31-33, 36-38 and 40-41), were eligible to receive the PCV20 vaccine, but it was not administered. Examples included, but not limited to: * Patient #23 had documentation showing they received the PCV13 in 2015. According to facility policy and CDC guidelines, this patient should have received a pneumococcal vaccine in 2020. * Patient #27 had documentation showing they received the PCV13 in 2022. The vaccine was administered to Patient #27 prior to the age of 65 years. According to facility policy and CDC guidelines, this patient should have received a pneumococcal vaccine in 2023. 2. Review of the Vaccination and Surveillance Report for pneumococcal vaccinations dated 12/20/2024 revealed 7 patients (Patient #s 13-16 and 18-20) failed to have documentation of any pneumococcal vaccination in their medical record. Examples included, but not limited to: * Patient #13 with an admit date of 07/22/2024 lacked pneumococcal vaccination documentation. * Patient #14 with an admit date of 08/12/2024 lacked pneumococcal vaccination documentation. 3. Review of the Vaccination and Surveillance Report for pneumococcal vaccinations printed on 12/10/2024 revealed 12 patients whose vaccine history simply stated, “Pneumococcal Vaccination” (Patient #s 2, 5, 8, 17, 21-22, 25-26, 30, 34-35 and 39). As a result, staff were not able to determine what follow-up vaccines would be required, if applicable. Review of the facility policy titled, “Pneumococcal Vaccine for Adult Patients,” dated 10/2023, stipulated the following: * Patients of any age who have only received PPSV23 required “PCV20 at least one year after most recent PPSV23” to complete the vaccination series. * Patients who received PPSV23 before age 65 and also received PCV13 required “PCV20 at least 5 years after most recent pneumococcal dose” to complete the vaccination series. 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: * Patients who have only received PPSV23 regardless of risk condition required “1 dose of PCV15 or PCV20 at least 1 year after the most recent PPSV23 vaccination.” * Patients who have received PCV13 and 1 dose of PPSV23 required 1 dose of PCV20 “at least 5 years after the last pneumococcal vaccine” to be complete. During an interview with the MCS and FA on 12/13/2024 at 1000, they confirmed the above findings.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 37237 Based on interview and review of documentation, it was determined that the facility failed to develop, implement, maintain and evaluate and effective data driven quality assessment and performance improvement program that reflected the complexity of the dialysis facility’s organization and services. Findings: - During interview with the MCS on 12/12/2024 at 1300, they stated there were no REMs reported by the DSD facility for the past six months. - During QAPI review on 12/13/2024 beginning at approximately 1100, no information on the DSD facility was available to review. - During interview with the FA and MCS on 12/13/2024 at 1150, they stated the ROM does not participate in the main facility’s monthly QAPI meetings, but reports information on the DSD facility activities to the Lead FA and Lead MD. They also stated there is little communication on what happens at the DSD facility and that no DSD facility documentation was available in monthly QAPI/FHR meeting minutes. The Lead FA stated, “The den is doing their own thing,” and the ROM does not report to the FA. - Review of facility policy 1-14-06, “Continuous Quality Improvement Program,” dated as last revised April 2021 stipulated: * “Each dialysis facility will have a Continuous Quality Improvement (CQI) Committee comprised of at least the following individuals from the interdisciplinary team... Facility Medical Director ... Facility Administrator (FA)/designee ... Registered Nurse ... Biomed Technician ... Registered Dietitian ... Social Worker.” * “Facility Administrators (FAs) conduct periodic Facility Health Meetings (FHM) (also known as QAPI in the CMS Conditions for Coverage) with the CQI committee to review issues and indicators regarding facility’s management and performance. FHMs are conducted monthly.” * “The Facility Medical Director is responsible for verifying the execution as well as participation in the Quality Improvement Program including implementation, continuous monitoring, development of action plans and program evaluation. The FA or designee of the facility will serve as the facility program coordinator unless otherwise appointed by the CQI Committee. * “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but are not limited to the following: - Patient Safety ... Review of sentinel events ... Review of trends of adverse patient occurrences including falls and blood loss ... Review of product, equipment, or medication notices or recalls - Infection Control ... - Other indicators as reflected in the Facility Health Record application.””

“LAB-CLIA LABS/MEET NEEDS OF PTS CFR(s): 494.130 The dialysis facility must provide or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter. This Standard is not met as evidenced by: 47148 Based on observation and interview, the facility provided laboratory services without having their facility CLIA certificate posted. Findings: During observation of the DSD facility on 12/11/2024 at approximately 0910, the facility failed to have a CLIA certificate posted anywhere in the facility. During an interview with the MCS on 12/11/2024 at approximately 1200, the above finding was confirmed.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 37237 Based on the review of documentation it was determined the facility failed to ensure all staff met the personnel qualifications and demonstrated competencies necessary to meet the comprehensive care needs of the patients. Findings: The review of documentation included the “Personnel Audit Tool-ESRD” worksheet, completed by the FA on 12/13/2024. The Personnel Audit Tool revealed: - Staff #16 was identified as Biomed with a DOH of 05/01/2004. The worksheet listed the most recent “Annual Skills Checklist” was completed 12/06/2023.”