Childrens Hospital of Michigan Dialysis

“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: 38269 Based on observation, interview and policy review the facility failed to provide the functionality required in dialysis treatment chairs to ensure disinfection of all surfaces in 12 of 12 (11treatment stations and one chair the training room)patient treatment chairs observed, resulting in the potential for ineffective cleaning of chairs, possible transmission of infectious agents to 6 patients being treated at the time of observation. Findings include: On 04/23/2025 between 1015 and 1125, while observing hemodialysis treatment station cleaning it was observed that the arms/wings of the treatment chairs were not opened allowing disinfection and dwell time after each patient treatment. During the observations, an interview was conducted with Registered Nurse Staff O. When queried regarding the expectation for cleaning the treatment chairs and how the space between the arms and seat were cleaned, Staff O stated, “The arms are stationary, they do not swing out so we just do our best to reach our hands between the arm and seat.” On 04/23/2025, at 1300, an interview with Staff L confirmed that the chair arms do not open like a typical dialysis treatment chair allowing visualization of the inner arm surfaces. The facility can not ensure thorough cleaning and disinfection, while allowing for the required disinfectant dwell time, and airdry time is done.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 38269 Based on observation, interview, and record review, the facility failed to don and doff Personal Protective Equipment (PPE) per policy; failed to ensure staff were provided education and implemented education regarding infection control, resulting in the potential for the spread of infectious agents to all patients served by the facility. Findings include: See Specific Tags: V-115 Failure to don PPE prior to initiation of dialysis V-116 Failure to ensure PPE was removed prior to entering a common area V-122 Failure to clean contaminated surfaces V-132 Failure to provide staff infection prevention education V-147 Failure to follow guidelines for vascular access care”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 38269 Based on Iterview and record review, the facility failed to comply with the condition of compliance for Quality Assessment Performance Improvement in the areas of aggregated data, plan development, implementation, prioritization, and monitoring for improvement of care, resulting in the potential for poor patient outcomes and ongoing unmet patient care goals for all 24 patients receiving services from the facility. Findings include: See tags: V-627 Failure to have ongoing program monitoring indicators. V-628 Failure to monitor quality indicators that reflect performance components. V-633 Failure to monitor vascular access data. V-636 Failure to monitor and track grievances and patient satisfaction surveys. V-639 Failure to prioritize performance improvement activities.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 38269 Based on interview and record review, the facility failed to ensure the Medical Director provided oversight of the QAPI program, staff competency, and implementation of the facility’s policies and procedures, resulting in unrecognized patient needs and less than optimal outcomes for all patients served by the facility. Findings include: V-712 Failure to monitor the QAPI program and communicate QAPI status with the Governing Body. V-713 Failure to ensure facility staff members were competent in dialysis care. V-715 Failure to ensure staff implemented policies and procedures.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 45245 Based on observation and interview, the facility failed to ensure that staff and visitors wore personal protective equipment (PPE) during initiation or termination of dialysis, resulting in the increased risk for transmission of infectious agents among the 6 patients who were receiving treatments at the time of observations. Findings include: During observations of patient care on 03/10/25 at 1150, Staff E was observed assisting RN (Staff D), who was attempting to establish the patient’s dialysis access (dialysis initiation) in station #3. Staff E was holding the patient’s hand and appeared to be comforting the patient during the procedure. Staff D was observed to be wearing a gown, face shield and gloves, and Staff E was not wearing a face shield or gloves. Review of facility policy titled, “Hemodialysis: Infection Control,” # CHM MOD IC 002, effective 10/31/22, stated under “Provisions,” revealed, (4.) Staff follow Standard Precautions for all patients according to DMC Policy (2 IC 005). a. Gloves are worn when caring for the patient or touching the patient’s equipment at the station and are removed and hands are cleansed between each patient and station. b. Gloves, face protection and impervious gowns are worn during initiation and termination of hemodialysis. Observations of patient care on 03/12/25 at 1350 revealed the mother of P-3 remained in station #6 during dialysis initiation without donning PPE. The observation was confirmed with unit manager (Staff C) at 1352. Staff C immediately offered PPE to the parent and provided education regarding her option to step out of the dialysis station during initiation and discontinuation of the dialysis access. Review of the facility policy titled, “Hemodialysis: Infection Control,” # CHM MOD IC 002, effective 10/31/22, stated under “Provisions,” (4.) (f.) “Ancillary HCWs and visitors are asked to step out during initiation and termination of dialysis.””

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 45245 Based on observation, interview, and record review, the facility failed to ensure items taken into the dialysis station are cleaned or disposed of prior to entering common areas, resulting in the potential spread of infectious agents to the 6 patients receiving treatment at the time of observation. Findings include: Upon survey entrance at 0945 on 03/10/25, a telephone located outside the locked dialysis unit was used to contact the unit and request entrance. Moments later a staff member opened the unit door and welcomed the surveyors. The staff member was observed wearing a full face shield and gown in the entrance and common waiting area hallways. The staff member provided access to the dialysis treatment floor before resuming patient care in station #11. An interview was conducted with Staff E at 1008 on 03/10/25. Staff E was questioned about her training and role in the unit. Staff E stated that she was a ‘float’ nurse who works twice a week in the dialysis unit, for the past three months. Staff E was questioned if she knows she cannot leave the dialysis unit wearing soiled personal protective equipment (PPE). Staff E stated she did not. Review of facility policy titled, “Hemodialysis: Infection Control,” # CHM MOD IC 002, effective 10/31/22, stated under “Provisions,” (6.) Supplies or equipment taken to the dialysis station are either for single patient use or, if non-disposable, are disinfected before use on another patient with hospital-approved disinfectants defined in 2 IC 039 Antiseptics and Disinfectants (facility) Approved. Unused supplies at the station are not returned to stock or used on other patients.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 38269 Based on observation, interview, and record review, the facility failed to ensure that 1 (#5) of 12 dialysis stations were cleaned and disinfected according to facility policy and nationally recognized guidelines, resulting in the potential to spread infectious agents to the 6 patients receiving treatment at the time of observations. Findings include: On 03/10/2025 at 1213 Staff E was observed cleaning dialysis station #5. Staff E was queried at the time of observation regarding the importance of cleaning all surfaces. Staff E stated, “I clean what I was taught to clean. I do not clean the back of the treatment chair, or the back of the machine. I don’t open the wings of the chairs when cleaning either.” During the interview Staff E indicated that she is a Registered Nurse from the hospital and has been floating to the ESRD for a “few months”. Staff E confirmed that she does not run treatments but that she does do vital signs and cleans all the stations while she is in the ESRD unit. When queried regarding the policy for cleaning treatment stations Staff E stated, “I am not sure about the policy. One of the team trained me to clean the station.” Review of facility policy, Title: Hemodialysis: Infection Control Page 3 of 3 Effective Date: October 31, 2022 revealed: 10. Dialysis stations are cleaned and disinfected between patients. Chairs, pillows, tray tables, blood pressure cuffs, control panels on machines are wiped with hospital-approved disinfectant. Dialyzers, tubing and prime waste are discarded appropriately. Waste buckets are disinfected with bleach. Machines are disinfected according to HCM OD IC 001 (Hemodialysis): Cleaning/Sterilizing the Hemodialysis Systems. CDC.GOV/CDC Dialysis station cleaning recommended checklist dated 03/26/2024 This list can be used if there is no visible soil on surfaces of the dialysis station. If visible blood or other soil is present, surfaces must be cleaned prior to disinfection. The proper steps for cleaning and disinfecting surfaces that have visible soil on them are not described herein. Additional or different steps might be warranted in an outbreak situation. Consider gathering necessary supplies prior to part A period. Part A: Before beginning routine disinfection of the dialysis station. 1) Disinfect and take down used blood tubing and dialyzer from the dialysis machine. 2) 2) Discard tubing and dialyzer in a leak proof container. 3) Check that there is no visible soil or blood on surfaces. 4) Ensure that the priming bucket has been emptied. 5) Ensure that the patient has left the dialysis station. 6) Discard all single use supplies. Move any reusable supplies to an area where they will be cleaned and disinfected. Before being stored or returned to the dialysis station. 7) Remove gloves and perform hand hygiene. Part B: Routine disinfection of the dialysis station after patient has left the station. 1) Wear clean gloves. 2) Apply disinfectant to all surfaces in the dialysis station. Using a wiping motion with friction. 3) Ensure surfaces are visibly wet with disinfectant. Allow surfaces to air dry. 4) Disinfect all surfaces of the emptied priming bucket. Allow the bucket to air dry before reconnecting or reuse. 5) Keep used or potentially contaminated items away from the disinfected surfaces. 6) Remove gloves and perform hand hygiene. Do not bring patient or clean supplies to station until these steps have been completed. Centers for Disease Control and Prevention.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 45246 Based on interview and record review, the facility failed to ensure that staff was educated and received hemodialysis unit specific training in infection control, resulting in the potential for adverse patient outcomes for all patients receiving treatments in the facility. Findings include: On 03/12/25 facility’s personnel files were reviewed with the Chief of Human resources, Staff R. During review the following staff files were reviewed for dialysis specific education and training in infection control: registered nurse float, Staff E, registered nurse, Staff D, and interim unit nurse manager, Staff C. There was no unit specific training for infection control for hemodialysis evident in the staff files. Documentation was requested from facility and was not provided prior to exit. Facility policy “Hemodialysis: Infection Control”, effective 10/31/2022, was reviewed and revealed: “10. Annual education is accomplished via a combination of methods, including [facility name] computer based learning modules, annual [facility name]-specific nursing competency infection control module, and specific unit-based topics. Documentation is located in staff files”.”

“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: 45246 Based on observation, interview and record review, the facility failed to ensure that clinical staff adhered to policy and procedures regarding CVC (central venous catheter) care and performed CVC care per policy for 3 (#3, 5, 7) of 6 patient stations observed, resulting in the potential for adverse patient outcomes for all patients with CVC catheters receiving treatments in the facility. Findings include: On 03/10/25 at 1142 registered nurse, Staff J, was observed performing CVC dressing change for patient at station #7. Staff J performed scrub of the area around insertion site, immediately reached out to the dressing and applied it to the site without the appropriate dry time. Staff J was observed wearing non-sterile gloves during procedure. On 03/10/25 at 1146 registered nurse, Staff J, was observed performing CVC care at station #5. Nurse scrubbed two cap connection sites with 5 scrubbing motions each (about 5 seconds total). Staff J was wearing non-sterile gloves during procedure. Immediately after the observation, nurse J was asked for how long she usually cleans connection sites in CVCs. Staff J said that per policy it was required to scrub the connections for 15 seconds. When asked if she did scrub for 15 seconds, she said that she did not. On 03/10/25 at 1215 registered nurse, Staff D, was observed performing CVC dressing change and cap change procedures at station # 3. During care Staff D performed scrub of the area around CVC insertion site, immediately reached out to the dressing and applied it to the site without allowing the site to dry. After dressing change, the nurse performed cap exchange. She scrubbed one cap connection site with 5 scrubbing motions (about 6 seconds total) and the second connection site with 5 scrubbing motions (about 6 seconds total). Staff I was observed wearing non-sterile gloves during both procedures. On 03/12/25 personnel file of Staff J was reviewed with the Chief of Human resources, Staff R. In the orientation documentation (page 12) under week 5 topic/skill there was the following: “demonstrates proper technique to access CVC’s including 15 second scrub and 15 second dry time, Independent demonstration competent dated 2/28/25”. Facility policy “CHM House-Wide Central Venous Catheter Bundle”, effective 01/13/23, was revied and revealed: “II. Objective/Purpose. To provide standardized expectations for the care of central venous catheters. IV. Policy. All members of the health care team provide care for all CVCs in the manner outlined below. V. Provisions. Required standardized practices are: 3. External CVC dressing change procedure: A. Perform hand hygiene with approved alcohol handrub or approved soap. B. Utilize dressing change kit. C. Assess exit site when dressing removed for signs of infection or complications. D. Mask for all providers and assistants. E. Shield patient’s face, ETT or trach with mask or drape. F. Perform hand hygiene with approved alcohol handrub or approved soap immediately before gloving. G. Don sterile gloves. F. 30 second Chloroprep scrub followed by 30-60 second dry time for insertion site (2 minute scrub if catheter is in groin with 30-60 second dry time). i. Use Chloroprep on patients more than 34 weeks gestational age. ii. If patient is less than 34 weeks gestational age, must be 2 weeks old. iii. Use alcohol (or betadine) for patients who do not meet CHG criteria or have CHG allergy G. Do not use ointments at insertion site. H. Place appropriate size Biopatch. Change every 7 days with dressing or PRN. I. Sterile transparent, semi permeable dressing: change every 7 days or PRN if soiled, saturated, loose or lifting edges. J. Gauze dressing for oozing or bleeding exit site: change every 2 days for inspection; PRN if soiled, saturated, loose or lifting edges. K. Label dressing and document date dressing changed. 5. Cap (at hub of catheter) change procedure: A. Perform hand hygiene with approved alcohol handrub or approved soap. B. Utilize cap change kit. C. Mask all providers and assistants. D. Perform hand hygiene with approved alcohol handrub or approved soap immediately before gloving. E. Don sterile gloves. F. Cap connection site scrubbed with alcohol: 15 second scrub, 15 second dry, no exceptions.””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 45245 Based on observation and interview, the facility failed to ensure that patients at 7 (#3, 4, 5, 6, 7, 10, 11) of 12 hemodialysis stations had their accesses sites visible throughout the dialysis treatment, resulting in the potential risk for unrecognized rapid blood loss or death for all patients receiving hemodialysis services at the facility. Findings include: On 03/10/25 at 0950, observations of dialysis care were conducted. Observation of (P-7) in station #11 showed that his left femoral catheter site was not visible and the patient was covered with a blanket, up to his chin. RN (Staff E) was questioned how she would know if P-7’s access was disconnected and if he was bleeding? Staff E replied, “We do visual checks, well, the nurses do, I’m just here to do vitals.” Staff E stated that she is a nurse from the ‘float’ pool and works as a tech on the unit twice a week for the past three months. Staff E was asked to confirm that P-7 was not actively bleeding underneath his blanket. Staff E lifted the blanket to demonstrate that P-7’s access was not bleeding and replaced the blanket over the patient’s access. On 03/10/2025, additional observations at 0952, of stations #10 (P-5), station #7 (P-8) and station #3 (P-1) also demonstrated patients receiving dialysis with no visible access site. An interview was conducted on 03/10/25 at 1000 with RN Orientee (Staff J). Staff J stated that she is two weeks from completion of her 12-week orientation. Staff J was questioned if she had been trained on the risks of hemodialysis? Staff J stated, “Yes, the risks are blood pressure issues, complications, breathing problems, nausea and dizziness.” Staff J was queried if bleeding is a risk? Staff J replied, “Yes, we cannulate fistulas or grafts. Bleeding is a risk if a needle pulls out, we check connections and make sure they’re ok. The machines will notify us if there is a problem with the line or bleeding.” Staff J was next questioned if she could identify bleeding sooner, by seeing it, rather than waiting for an alarm? Staff J replied, “Yes, we are supposed to visualize the access. We go around and check them.” Observations from 0950-1205 failed to demonstrate staff visualizing any patient accesses as the sites were still covered. At 1045 on 03/10/25, an interview was conducted with Charge RN and Preceptor (Staff J’s), Staff I. Staff I was questioned why no patient access sites were visible? Staff I replied, “We do try to visualize, but patients cover up.” Staff I was next questioned about her experience in Hemodialysis. Staff I stated that she had 22 years of experience in hemodialysis. Staff I was next questioned if she had ever witnessed a bleeding event in dialysis? Staff I stated that she had witnessed when a “needle shot out” which resulted in blood loss, but not death. Staff I was next asked if she recognized the significance of visualizing accesses? Staff I replied, “Oh yes.” On 03/10/2025, observations following the conversation did not reveal Staff I making any patient’s access site visible or informing other staff that access sites are to remain visible. Observations at 1150 on 03/10/25 revealed that patients in stations #10,# 11 and #3, remained covered and accesses were not visualized until dialysis completion. Further observations at 1436 revealed that stations #7, #6 ,#5, #4 and #3 all had their accesses covered with blankets. 45246 Upon entrance to facility on 03/10/24 at 0950 the patients’ vascular access sites at stations # 10 and 11 were observed covered with blankets. Later, at 1025, P-5 at station #10 was observed lying on his side completely covered with blanket, including patient’s access site and his face. On 3/10/25 at 1030 registered nurse, Staff J, was asked if she noticed that some of the patients’ access sites were covered and not visible to the staff. Staff J said yes. When asked if she understood importance of visualizing vascular access during dialysis treatment nurse stated yes. On 03/10/25 at 1117 registered nurse, Staff D, was observed approaching station #10 to address the machine’s alarm. Patient’s vascular access site was not visible and covered with blanket. Nurse adjusted the alarm and left the station area without attempting to make the access site visible. A minute later, the alarm sounded again. Staff D returned to the station, made necessary adjustments to the alarm and left the area. Patient’s access site was observed still to be covered. On 03/10/25 at 1130 both patients’ access sites at station #10 and 11 were observed covered by blankets. At 1205 patient’s access sites at station #7 was observed to be covered by his black t-shirt. At 1207 Staff D was queried regarding patient’s vascular access cites being covered and not visible to staff. Nurse shared that the access sites are not covered on initiation of the dialysis, however, as treatment continues kids tend to cover themselves with blankets and it is hard to persuade them to keep sites visible. Staff D stated that it was an “ongoing issue”. After the interview Staff D walked to the other patient area. Patient’s access site at station #7 remained covered. Registered nurse, Staff E, was performing vital signs check on the patient at station #7 and did not address the covered site either. At 1213 patient’s access site remained covered. On 03/10/25 at 1239 patient’s access site at station #11 was observed being covered by the blanket.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 45246 Based on interview and record review, the facility failed to complete the initial comprehensive assessment for one patient (P-3) of 1 patients reviewed for initial assessments, resulting in the potential for unmet patient treatment needs and possible negative outcomes for the patient. Findings include: On 03/11/25 at 1400 P-3’s medical record was reviewed with registered nurse, Staff S. During review it was identified that the patient was admitted to the dialysis facility on 12/20/24. P-3’s comprehensive multidisciplinary patient assessment documentation was reviewed and revealed that assessment was incomplete and not signed by nursing and a care giver/parent. Staff S confirmed the finding and was asked when initial comprehensive assessment must be completed. Nurse stated that it usually done within 30 days after admission. Facility policy “Frequency of Patient Assessment for Patients Admitted to the [facility name] Dialysis Program”, effective 04/01/22, revealed: “Objective. To establish a timeframe for performing patient assessments for patients admitted to the [facility name] End-Stage Renal Disease Dialysis Program. Scope. End Stage Renal Disease Multidisciplinary Team. Provisions. 3. Each new patient has a comprehensive assessment completed within 30 days or 13 treatments.””

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 38269 Based on document review and interview, the facility failed to include variance data for patient satisfaction and patient grievance reports in the Quality Assessment Performance Improvement (QAPI) Program resulting in the potential for missed opportunities for improvement of patient care for all 24 patients served by the facility. Findings include: On 03/11/2025 at 1015, interview and review of the tracking logs and quality meeting minutes with the Clinic Manager (staff C), revealed no QAPI meetings have been held since September 2024. When queried, the Clinic Manager stated, “I am not aware of any QAPI meetings being held since the coordinator went on leave.” On 03/11/2025 at 1020, interview with the Director of Patient Care Services (Staff L), revealed an uncertainty regarding the QAPI meetings. When queried Staff L stated, “I am not sure, I will have to look into the minutes to see if QAPI was held.” On 03/12/2025 at 1035, an interview with the Chief Nursing Officer (CNO) confirmed that there had been no updates related to QAPI since the coordinator went on leave in September of 2024. Upon request there was no data received that included quality indicators, tracking and trending of any aggregated data, and no action plans in place to improve outcomes due to lack of collected data. The facility-based engagement of staff involved in monitoring clinical outcomes of the patients they provide care to was not able to be produced. The expected recognition of needed performance improvement and individualized opportunities for improvement was not available leading to no prioritization or action plans. Requested policy was not received prior to discharge. On 03/12/2025 at 1100 an interview with the Medical Director Staff B confirmed the above documented, and confirmed the QAPI team is expected to meet on a monthly basis.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 38269 Based on interview and record review, the facility failed to monitor all aspects of the End Stage Renal Disease (ESRD) program by tracking and keeping current, their monitoring logs of the assessment and improvement of care in the facility, resulting in the potential for missed/un-identified opportunities for improvement related to medical injuries/errors, patient satisfaction & grievance intervention and infection control compliance, and less than optimal outcomes for all patients served by the facility. Findings include: On 03/11/2025 at 1340 a review of the documentation titled “quality meeting minutes” and tracking documentation revealed that the facility did not keep up-to-date logs for analyzing and tracking quality indicators to influence desired patient outcomes. Review of electronic logs for tracking quality indicators, provided by the Director of Patient Services (staff L) revealed that the documentation did not address medical injuries/errors or patient satisfaction/grievances, and did not prioritize any improvement activities. The document titled “quality meeting minutes” dated 09/2024 through 03/11/2025 lacked information regarding any data driven focus areas of concern to identify potential problems and to identify and prioritize opportunities for improvement. On 03/11/2025, the lack of content of meeting minutes and tracking logs were discussed and confirmed with the Clinic Manager (staff C), Director of Patient Services (Staff L), The Chief Nursing Officer (Staff N) and the Medical Director (Staff B). The lack of QAPI meetings, content and actions associated were confirmed to be missing due to the “coordinator being on a medical leave” hence there were no QAPI meetings held or evidence that the requirements to meet the conditions of coverage were met.”

“QAPI-INDICATOR-VASCULAR ACCESS CFR(s): 494.110(a)(2)(v) The program must include, but not be limited to, the following: (v) Vascular access. This Standard is not met as evidenced by: 38269 Based on Interview and record review, the facility failed to identify opportunities for improvement and failed to track progress for the management of vascular access sites, resulting in the potential for an increase in infections and negative outcomes for all patients served by the facility with vascular access sites. Findings include: On 03/11/2025 at 1035 review of Quality Assurance Improvement (QAPI) meeting minutes dated September 2024-March 2025 revealed the facility failed to implement, sustain, and report on any action plan devised to reduce catheter use, and/or follow policy on catheter care to reduce potential infection (reference tag V-147). In addition, there was no documentation as to whether a process improvement plan was in place or needed to be revised. On 03/11/2025 at 1020, interview with the Director of Patient Care Services (Staff L), revealed an uncertainty regarding the QAPI meetings. When queried Staff L stated, “I am not sure, I will have to look into the minutes to see if QAPI was held.” On 03/12/2025 at 1035, an interview with the Chief Nursing Officer (CNO) confirmed that there had been no updates related to QAPI since the coordinator went on leave in September of 2024. No updates including data collection, action plans and implementation.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 38269 Based on interview and record review, the facility failed to include variance data for patient satisfaction and patient grievance reports in the Quality Assessment Performance Improvement (QAPI) Program resulting in the potential for missed opportunities for improvement of patient care for all 24 patients served by the facility. Findings include: On 03/10/2025 at 1410, during interview and review of audits/tracking logs and quality meeting minutes with the Clinic Manager (staff C) and the Director of Patient Services (Staff L), it was revealed there was no evidence of the facility tracking patient satisfaction or grievances for 2025. When queried, the Clinic Manager Staff C stated, “I started in January and no satisfaction, complaint and/or grievances were discussed since they have not had a QAPI meeting in six (6) months.” On 03/10/2025 at 1415, during an interview with the Director of Patient Services (Staff L) it was confirmed that there have been no QAPI meetings held in six (6) Months (September/2024 -March/2025). That there was no direct patient oversight until recently when the manager (Staff C) was put in place. However, when queried regarding Staff C’s education related to ESRD, it was confirmed that Staff C did not have previous dialysis experience as required.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 38269 Based on interview and record review, the facility failed to incorporate data report results and prioritize performance improvement actions, resulting in the potential for poor patient outcomes for all 24 patients receiving services from the facility. Findings include: On 03/11/2025 at 1315, during review of documents titled “quality,” it was determined that the quality documentation lacked data for the months of September 2024 through March 2025. The quality documents also lacked designation as to what improvement projects the facility considered a high priority, moderate priority or low priority for meeting targeted outcome goals. At the time of record review, the Clinic Manger (staff C) was queried about the prioritization he stated “No, that has not been done.” When asked about the lack of data for the months of September 2024 through March 2025, staff C stated, “It looks like it hasn’t been done, I started with ESRD in January.””

“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: 38269 Based on record review, and interview the facility failed to ensure all staff files contained evidence of education and competency of the skills required to manage the complex care of dialysis patients, resulting in the potential for poor outcomes to the 24 patients served by the facility. Findings include: On 03/12/2025 at 1010, personnel files were reviewed with the Chief of Human resources, Staff R. During review, the following staff files were reviewed for dialysis specific education and training in infection control: File for Staff D-Registered Nurse had no evidence of unit specific training for infection control in a dialysis unit. There was no up-to-date (required) certification for Basic Life Support (BLS). Staff D’s BLS expired 01/2025. File for Staff C- Interim unit nurse manager, had no evidence of unit specific training for infection control for hemodialysis. There was no evidence of dialysis specific training. File for Staff E-Registered Nurse float, had no evidence of unit specific training for infection control in a dialysis unit. Documentation was requested from facility and was not provided prior to exit. During the review of personnel files, Staff R confirmed the above findings.”

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. This Standard is not met as evidenced by: 38269 Based on record review and interview the facility failed to ensure that the Nurse Manager (Staff C) met the required qualifications of the position, resulting in the potential for negative outcomes to all patients in the facility. Findings include: The facility was unable to produce any documentation that Nurse Manager Staff C was employed full time under the Facility (ESRD) specific CCN, and had six (6) months of experience in providing nursing care to patients on maintenance dialysis. During an interview on 03/11/2025 at 1445, with the Director of Patient Care (Staff L) and the Manager of ESRD (Staff C) it was identified that neither staff member had direct patient care experience with patients receiving maintenance dialysis. The patient care coordinator had been on a medical leave for the past six months (September 2024 to current) without a qualified replacement. When queried as to who was taking the place of the coordinator while she was on leave Staff L stated, “one of the nurses (Staff D) has stepped up to do the heavy lifting.” On 03/12/2025 upon review of Staff D’s personnel file it was revealed that Staff D, did not have current Basic Life Support (BLS) training, or dialysis specific infection control training. It was confirmed that Staff D’s BLS expired in January 2025. On 03/12/2025 at 1010, facility personnel files were reviewed with the Chief of Human resources, Staff R. During review the following staff files were reviewed for dialysis specific education and training in infection control: registered nurse, Staff D, interim unit nurse manager, Staff C, and registered nurse float, Staff E. There was no unit specific training for infection control in the dialysis unit available in the staff files. Documentation was requested from facility and was not provided prior to exit.”

“MD RESP-QAPI PROGRAM CFR(s): 494.150(a) Medical director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program. This Standard is not met as evidenced by: 38269 Based on interview and record review, the Medical Director failed to ensure that the facility had an operational quality assurance and performance improvement program that reviewed all aspects of the dialysis program including established quality indicators and prioritized performance improvement projects. Findings include: (see citations listed below and previously cited) V-627, V-628, V-633, V-636, V-639 Review of policy Title: Responsibilities of the Medical Director, effective date: April 1, 2022 revealed: The Medical Director is responsible to ensure the delivery of quality patient care and clinical outcomes. PROVISIONS The Medical Director 1. Must meet qualifications as defined in ESRD job description. 2. Is responsible for educating dialysis staff. 3. Will have a single medical director. a. Other physicians may take on a component of the dialysis program (e.g. home dialysis), but he/she must ultimately report to the Medical Director. 4. Ensure the delivery of quality patient care and clinical outcomes a. Clinical and laboratory review of patient data occurs monthly by MD or his/her designee b. QAPI review of dialysis outcomes with Interdisciplinary Team to occur quarterly. c. Water and dialysate quality data to be reviewed by MD or his/her designee monthly 5. Managing the Quality Assessment and Performance Improvement (QAPI) program a. Medical Director must review quality indicators related to improved patient outcomes b. MD must monitor this data on a regular basis c. Educate facility and staff regarding areas of improvement 6. Participate in the development, periodic review and approval of patient care policies and procedures. 7. Ensure dialysis staff adherence to policies and procedures. 8. Must sign all involuntary patient discharges. REFERENCES Condition for coverage 494.1500: Tag number: V710, V711, V712, V713, V714, V715, V716. ADMINISTRATIVE RESPONSIBILITY The Medical Director has overall responsibility and authority for administration of directives related to the ESRD program”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 38269 Based on interview and record review, the medical director failed to ensure the manager of the facility’s infection control program met the required qualifications to be responsible for oversite of the infection control program, resulting in the increased risk for infection for the 24 patients being served by the facility. Findings include: On 03/12/2025 at 1120 during an interview with the Medical Director Staff B it was confirmed that there was not a dedicated infection prevention nurse for the ESRD. When queried regarding why there was not a designated infection prevention nurse. Staff B stated, “I know the person that was responsible for the infection data has been on a leave and administration was informed of the lack of oversite.” On 03/11/2025 at 1445, during an interview with the Director of Patient Care (Staff L) was queried regarding training for oversite of the facility’s infection control program. Staff L stated, “staff have all had the annual basic infection control training.” See tag V-132 On 03/12/25 facility’s personnel files were reviewed with the Chief of Human resources, Staff R. During review the following staff files were review for dialysis specific education and training in infection control: registered nurse float, Staff E, registered nurse, Staff D, and interim unit nurse manager, Staff C. There was no unit specific training for infection control for hemodialysis evident in the staff files. Documentation was requested from facility and was not provided prior to exit. Facility policy “Hemodialysis: Infection Control”, effective 10/31/2022, was reviewed and revealed: “10. Annual education is accomplished via a combination of methods, including [facility name] computer based learning modules, annual [facility name]-specific nursing competency infection control module, and specific unit-based topics. Documentation located in staff files”.”

“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: 45246 Based on interview and record review, the facility’s medical director failed to ensure staff adhered to policy and procedure regarding initial comprehensive assessments, treatment choice, and plan of care documentation for one patient (P-3), resulting in the potential for adverse patient outcomes. Findings include: On 03/11/25 at 1400 P-3’s medical record was reviewed with registered nurse, Staff S. During review it was identified that patient was admitted to dialysis facility on 12/20/24. P-3’s comprehensive multidisciplinary patient assessment documentation was reviewed and revealed that assessment was incomplete and not signed by nursing and a care giver/parent. P-3’s Plan of Care documentation was reviewed and revealed that nursing portion was not complete, and form was not signed by nursing, dietician and care giver/parent. Treatment choice form was reviewed and was found to be incomplete and did not have parent’s and witness signatures. Staff S confirmed the finding and was asked when initial comprehensive assessment have to be completed. Nurse stated that it usually done within 30 days after admission. Further, Staff S was asked if treatment choice options are discussed prior to the first dialysis treatment. She stated yes. Staff S was also asked if all members of the interdisciplinary team have to sign plan of care for hemodialysis including responsible care giver/parent, she said yes. Facility policy “Frequency of Patient Assessment for Patients Admitted to the [facility name] Dialysis Program”, effective 04/01/22, revealed: “Objective. To establish a timeframe for performing patient assessments for patients admitted to the [facility name] End-Stage Renal Disease Dialysis Program. Scope. End Stage Renal Disease Multidisciplinary Team. Provisions. 3. Each new patient has a comprehensive assessment completed within 30 days or 13 treatments.” Facility policy “Pediatric Dialysis Patient Plan of Care”, effective 10/25/22, was reviewed and revealed: “Objective. To outline the goals of the pediatric dialysis Patient Plan of care. In general, the goals are that patients consistently receive effective dialysis and treatment according to an established individual plan of care which is based on the patient assessment. Scope. Nephrologist, Registered Nurse (RN), Renal Dietician, Renal Social Worker. Provisions. Prior to initiation of dialysis the physician, patient (if >= 18 years of age), family (including patient if <18 years of age and able to assent), and other members of the IDT (interdisciplinary team) discuss the advantages and disadvantages of each dialysis modality to select the modality that best meets the needs, wishes, and goals of the patient and family. 11. PPOC (patient plan of care) completion. A. The PPOC is completed by members of the IDT including the patient and/or patient family if desired by the patient and/or patient family. B. The PPOC is signed by members of the IDT (indicating their participation/contribution to the plan). C. The PPOC is signed by the patient, patient/family, or patient designee to acknowledge information in the plan. i. If patient and/or patient/family chooses not to sign the PPOC, 1. The choice not to sign is documented and 2. The reason for the absent signature is explained ii. The patient and/or patient family is encouraged to participate by members of the IDT. 12.PPOC Initiation. A. The target for initiation of the initial PPOC is within 30 days from date of admission to dialysis (excluding any hospitalized days during that period) or within 13 hemodialysis treatments at [facility name], whichever is later.””

“GOV-ADM RESP FOR RESOURCES FOR QAPI CFR(s): 494.180(a)(4) The governing body or designated person responsible must appoint an individual who serves as the dialysis facility’s chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, including, but not limited to- (4) Allocation of necessary staff and other resources for the facility’s quality assessment and performance improvement program as described in §494.110. This Standard is not met as evidenced by: 38269 Based on interview and record review, the facility failed to provide the necessary resources for the facility’s quality assessment and performance improvement program (QAPI), resulting in lack of oversight and process improvement resulting in the potential for negative outcomes to all patients in the facility. Findings include: During the QAPI (quality assurance performance improvement) interviews, the Chief Nursing Officer (Staff N) confirmed that there was not a clinical coordinator in place for the past six months due to medical leave. When queried regarding replacing the clinical coordinator, Staff N stated, “we have been working on it.” There was no documented evidence of consistent QAPI reports to the Governing body regarding monitoring for improvements and implementation of any action plans to implement sustained improvements.. Furthermore, based on current survey findings, it was identified that staff is not compliant with facility policies and procedures for monitoring patients while receiving hemodialysis treatments related to safety monitoring, CVC care, infection prevention, lack of educational updates, maintaining required education/evidence of competency, and failure to follow policies. During interview with facility Medical Director, Staff B, on 03/12/2025 at 1200 he stated he has shared the CMS regulations with all of the physician staff as well as administrative and direct patient care staff. He further shared that he has questioned the replacement/interim of the coordinator but has been told it is being worked on. During the above interview Staff B indicated that staff were not utilizing the regulations to ensure the CMS guidelines for patients receiving maintenance dialysis treatments were followed.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 38269 Based on interview and record review, the governing body or designated person failed to provide an adequate number of qualified personnel to ensure safe and timely patient care resulting in the potential to compromise patient safety for all patients served by the facility. Findings include: Upon entry to the dialysis unit on 03/10/2025 at 0930, six patients were observed receiving hemodialysis in the 11 station unit. There were three staff members (Registered Nurses RN) present at the time of entrance. Staff D Charge RN - Preceptor for RN Staff J on orientation, while BLS card expired in January 2025, failed to complete CVC care per facility policy, failed to monitor patients for visible access throughout the dialysis treatment. Staff J RN on orientation- no orientation documentation was available for review. Failed to complete CVC care per facility policy, failed to monitor patients for visible access throughout the dialysis treatment. Staff E RN float (for past two months) had no education or orientation documentation specific to dialysis available for review. Staff E was observed wearing contaminated PPE into a common clean area (V-0115), failed to clean patient stations per policy (V-0122), Failed to recognize the risks related to not monitoring, educating patients and maintaining visible patient access at all times during a hemodialysis treatment. (V-0407) Further findings revealed the clinical coordinator has been on medical leave since September 2024 to current, with no replacement until January 2025, when interim Nurse Manager Staff C was named. Upon request the facility was unable to produce any documentation that Nurse Manager Staff C met the required qualifications to manage patients receiving maintenance dialysis: Staff C was not employed full time under the Facility (ESRD) specific CCN, did not have six (6) months of experience in providing nursing care to patients on maintenance dialysis and did not obtain the required ESRD specific education. On 03/12/2025 facility personnel files were reviewed with the Chief of Human resources, Staff R. During review the following staff files were reviewed for dialysis specific education and training in infection control: registered nurse, Staff D, interim unit nurse manager, Staff C, and registered nurse float, Staff E,. There was no unit specific training for infection control in the dialysis unit available in the staff files. Documentation was requested from facility and was not provided prior to exit. On 03/11/2025 at 1510, administrative staff including the Chief Nursing Officer (Staff O), and Director of Patient Care (Staff L), confirmed they were aware of the lack of qualified staff oversight in the dialysis unit. There was no documented evidence of the Governing Body being aware of, reviewing, or implementation of an intervention to mitigate the above staffing concerns.”