Davita Mcduffie Dialysis

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on facility record review, and staff interviews, it was determined that the Governing Body failed to demostrate responsibility and accountability for the operation of the facility. This deficient pratice had the potential to negatively affect the health and safety of 62 in-center hemodialysis patients who were under the care of this facility. Findings include: Cross Reference: V 757 - Failure of the Facility Administrator to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients and provide safe patient care, as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care.”

“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: 49321 Based on a review of facility records, staff interviews, a review of facility Policies and Procedures (P&P), and Governing Body Bylaws, it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT AA/newRN, who recently obtained licensure as a Registered Nurse [RN on 9/11/25] and currently on orientation as a RN, but did not have a documentary evidence of completing Procedural Skills Verification Checklist), was not assigned to perform nursing duties to her assigned patients without a preceptor. This deficient practice had the potential for medication errors, inadequate pre- and post- nursing assessments, delayed recognition of critical patient assessment findings, staff burnout, patient harm, and patients’ confidence. The facility census was 62. Findings include : During a review of facility records the following was revealed: - PCT AA/new RN was hired on 1/28/2023) as a Patient Care Technician (PCT). - PCT AA/new RN passed the National Council Licensure Examination (NCLEX) September 2025 and was licensed as a Professional Registered Nurse (RN) on 9/11/25. - PCT AA/new RN completed the computer training for New Inexperienced Nurses on 9/23/25. A review of the facility’s TEAMMATE SCHEDULE revealed : - PCT AA/new RN was scheduled to work with a RN preceptor on 10/13/25 and 10/15/25. - A review of PCT AA’s/new RN’s personnel file revealed that she did not complete any Procedural Skills Verification Checklist for RN proficiency. A review of the “Treatment Details Report” (Dialysis Treatment Sheets) revealed: 11/1/25 Due to staffing issues (per Patient/Staff Schedule), PCT AA/new RN, was assigned to Stations (S) 1, S2, S3, and S4 with four patients per shift. - PCT AA/new RN was performing nursing responsibilities in addition to CCHT/PCT duties (as dialysis caregiver), including pre- and post- nursing assessments, administering medications (intravenously - intravenous push, intravenous infusion and per orem), and nursing prescription verifications without a RN preceptor. During an interview with the covering Facility Administrator on 11/18/25 at 1:50 p.m., this surveyor asked whether PCT AA/new RN, who had recently been granted a nursing license, was practicing as a PCT or as a RN. The covering Facility Administrator stated that PCT AA/new RN had not been “checked off “ as a nurse (no nursing skills-checklist documentation was available) and should only be working in the capacity of a PCT when she was not with a preceptor. During an interview on 11/18/25 at 3:30 p.m., the Regional Operations Director stated that the facility had a float pool and had hired new staff who were currently in training. When asked about PCT AA’s/new RN’s role in the facility, she stated that PCT AA/new RN was currently in training with a nurse preceptor and is not in staffing as a nurse in the facility until her training and skills verification are complete. A review of Policy # 8 -02-05, titled: TRAINING PROGRAM FOR NEW PATIENT CARE PROVIDER TEAMMATES, revised, October 2025, stated: Page 2. Successful completion of the following theory and clinical elements are required before a new teamate can receive an independent patient care assignment: - Successful completion of the theory component of the DaVita Clinical Training for New Teammates Program includes participation in scheduled modality specific Davita Theory classes and completion of the final examination with a score of > 80% (unless the state requires a higher score). Successful completion of the clinical component of the modality specific DaVita Clinical Training for New Teammates Program includes documentation of proficiency as evidenced by the completion of the Procedural Skills Verification Checklist and the review of applicable policies and procedures. The checklist is to be completed by the preceptor WITH the new teammate. A registered nurse will sign off satisfactory performance of new skills. The Facility Administrator/designee will verify that all critical components of the modality specific training are completed prior to the new teammate receiving an independent patient care assignment. Completion of the critical components are outlined in the modality specific Verification of Competency for New Teammate form. The form is to be signed by the clinical new teammate RN trainer, the Medical Director, and the Facility Administrator. For additional information, please Cross Reference: E 617 - failure of the Facility Administrator to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients and provide safe patient care, as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis caregiver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care services.”

“GOV-ADM RESP FOR RELATIONSHIP W/ESRD NW CFR(s): 494.180(a)(3) 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- (3) The relationship with the ESRD networks; This Standard is not met as evidenced by: 49321 Based on facility record review and staff interviews, it was determined that the Governing Body failed to notify the IPRO ESRD Network (the organization that manages several regional ESRD [End Stage Renal Disease] Network for the Centers for Medicare & Medicaid Services [CMS], focusing on improving care quality, safety and patient outcomes for people with kidney failure through data analysis, provider support, and patient engagement), relative to staffing shortages on 11/1/25, 11/3/25, and 11/5/25, as required. This failure to notify and collaborate with the ESRD Network had the potential to negatively affect the health and safety of patients who received dialysis services at this facility. The facility census was 62. Findings include: A review of facility records showed that: - There was no documented evidence of Governing Body Meeting minutes between 11/1/25 and 11/5/25 regarding shortened treatments resulting from a facility emergency or staffing shortages. There was no documented evidence that the IPRO ESRD Network was notified of patients’ shortened treatments. During an interview with the covering Facility Administrator on 11/18/25 at 1:50 p.m., the covering Facility Administrator reported that IPRO ESRD Network was not notified about the shortened treatments on 11/1/25, 11/3/25 and 11/5/25. A review of the DaVita Governing Body By laws revealed: Article III : MANAGEMENT (e). Ensures that the Facility provides to the ESRD Network any information that may be required, and the facility acts on recommendations of ESRD Network. 3.3 Services The Governing Body shall: (b). Ensure that the Facility is in compliance with all applicable state, federal, and local rules and requirements related to all services it provide. For additional information, please cross reference V 757 - Failure of the Facility Administrator to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients and provide safe patient care, as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care.”

“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: 49321 Based on a review of facility records, patient and staff interviews, a review of facility Policy and Procedures (P&P), and an evaluation of the minimum state-required staffing ratios, it was determined that the Facility Administrator failed to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients and provide safe patient care, as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care, resulting in 46 of 97 patients’ dialysis treatments being shortened during the 11/1/25, 11/3/25, and 11/5/25 patients’ dialysis treatments reviewed. Additionally, Patient Care Technician (PCT AA/new RN), who was recently licensed as a Registered Nurse (RN) on 9/11/25, (and currently undergoing orientation and who did not complete Procedural Skills Verification Checklist), was performing nursing duties to her assigned patients. This ongoing deficient practice placed patients at risk for missed or incomplete/shortened hemodialysis treatments, delayed responses to machine alarms, increased likelihood of medication errors and nursing responsibility errors. In addition, failure to provide patients their prescribed dialysis treatment duration each treatment, may lead to serious complications including, but not limited to: intradialytic hypotension (sudden decreases in blood pressure caused by rapid fluid removal), arrhythmias (irregular heart rhythms), fluid overload, dialysis adequacy/clearance and other hemodialysis-related medical emergencies. The facility’s census was 62. Findings include: - Upon entrance to the facility’s lobby on 11/18/25 at 10:30 a.m., patient (P), (P#1) reported that the facility were shortening patients’ dialysis treatment duration by at least one hour or more due to short-staffing. P#1 also added that they were not notified about the shortened treatments and were not informed about any corrective plans regarding shortened treatments. - P#2, who was also in the lobby and sitting in front of P#1, stated, “that’s right”, in agreement with P#1’s statements. During a review of the facility’s Staff/Patient schedule for 11/1//25, the following was revealed: - The facility had 17 patient stations, (including one Isolation Room), which was divided into four Pods (Pod - a section of four patient stations). There were three shifts on the Mondays-Wednesdays-Fridays (MWF) schedule, with 16 patients on first shift, 16 patients on second shift and one patient on third shift. There were two shifts on the Tuesdays-Thursdays-Saturdays (TTS) schedule, with 15 patients per shift. - PCT AA/new RN (newly licensed), was assigned to patients at Station (S) 1, S2, S3, and S4 during the first and second shifts. On the first shift, there were three patients (P), (P#4, P#5, and P#6), who were perscribed four hours of dialysis treatments but only received three hours of treatments, and P#7, whose prescribed dialysis treatment was three hours and 45 minutes, but only dialyzed for three hours. - On the second shift PCT AA/new RN had four patients and two of the four patients, (P#8 and P#9), whose prescribed dialysis treatment was four hours, but only received three hours of treatment. P#10, was prescribed three hours and 45 minutes dialysis treatment, but only received three hours of treatment. - In addition to PCT duties (dialysis caregiver), PCT AA/new RN also performed nursing duties (without completing orientation and Procedural Skills Verification Checklist), such as performing pre- and post- nursing assessments, administering medications (via intravenous push/intravenous infusion and per orem), to patients at S1, S2, S3, and S4, and also verifying dialysis prescriptions by herself (without another nurse), per facility policy. - PCT BB was assigned to four patients at S11, S12, S13, and S14, during the first and second shifts. On first shift three of four patients (P#11, P#12, and P#13) only ran three hours of the four-hour perscribed dialysis treatment. - On the second shift, PCT BB was assigned to four patients. Three of four patients (P#14, P#15, P#16), ran their treatments full time. - Licensed Practical Nurse (LPN AA), was assigned as a dialysis caregiver and perform nursing duties to her assigned four patients per shift, at S7, S8, S9, and S10. Two of four patients (P#17 and P#18) on the first shift, who were prescribed to run four hours of dialysis treatments but were only dialyzed for three hours. - On second shift LPN AA had four patients, and one of four patients (P#19), was prescribed to run for three hours and 45 minutes but dialyzed for only three hours. - PCT CC clocked in at 7:30 a.m. and was assigned to four patients at S5, S6, S15, S16. On first shift two of four patients (P#20 and P#21), were prescribed four hours of dialysis treatments but were dialyzed for only three hours. - RN/CN (Charge Nurse), initiated and terminated dialysis treatment for the patient at S6 (as a dialysis caregiver). - On 11/3/25, according the facility’s Patient/Staff schedule, the total number of DPC staff were four, namely: RN AA, PCTAA/new RN, PCT DD, and PCT EE. There were 13 patients on first shift, 12 patients on second shift and three patients on third shift. Patients who had shortened dialysis treatments were: - P#22 and P#23, were prescribed for three hours, but were dialyzed for only two hours. - P#24 and P#25), were prescribed three hours 30 minutes, but were dialyzed for only two hours. - P#26, was prescribed three hours and 45 minutes, but was dialyzed for three hours. - P#27 and P#28), were prescribed four hours, but were dialyzed for two hours. - Seven patients (P#29, P#30, P#31, P#32, P#33, P#34 and P#35), were prescribed four hours, but received only three hours of treatment. - P#36, P#37, and P#38), were prescribed four hours, but were dialyzed between two hours and two hours and 35 minutes. - P#39 and P#40, were prescribed four hours and 15 minutes, but were dialyzed between two hours and 47 minutes to three hours. - P#41 and P#42), were prescribed four hours and 30 minutes, but were dialyzed for three hours. On 11/5/25: Wednesday According the facility’s Patient/Staff schedule, the total number of DPC staff were three, namely: RN/CN, RN AA, and PCT FF. On first shift, there was a total of eight patients, second shift was a total of seven patients and six patients on third shift. - P#43, was prescribed for three hours, but dialyzed for one hour and 56 minutes. - P#44, was prescribed for four hours and 15 minutes, but dialyzed for two hours and 47 minutes. - P#45, P#46 and P#47, were prescribed for four-hour treatments, but were dialyzed for three hours. - P#48, was prescribed for four hours of treatment, but was dialyzed for two hours and 46 minutes. - P#49, was prescribed for three hours and 45 minutes, but dialyzed for two hours and 20 minutes. - A review of the patients’ “Treatment Details Report” on 11/1/25, 11/3/25, and 11/5/25, showed that all patients whose dialysis treatments were shortened, still had their original prescribed dialysis treatment duration on their “Treatment Details Report”, and there was no documentation that their prescribed treatment was changed nor an indication that a new shortened treatment was prescribed. The three sampled Patient/Staff schedule and “Treatment Details Report” of patients’ dialysis treatments for 11/1/25, 11/3/25, and 11/5/25, showed that the documented reason for the shortened treatments was, “Facility Emergency (water issue, power outage, fire, flood)”. - On 11/18/25, the Biomedical Technician (BMT), was contacted by telephone by the covering Facility Administrator, in the presence of this surveyor. During the telephonic interview conducted on 11/18/25 at 1:45 p.m., the BMT confirmed that he had not been notified of, nor was he aware of, any Facility Emergency (water issue, power outage, fire, or flood), that occurred at the facility between 11/1/25 and 11/5/25. - There was no documented evidence of Governing Body meeting minutes between 11/1/25 and 11/18/25 to verify, address and to make action plans regarding Facility Emergency (water issue, power outage, fire, flood). There was no documented evidence that the shortened patients’ treatments were addressed. There was no documented evidence that IPRO ESRD Network Program was notified of patients’ dialysis prescription duration adjustments/shortened. - During an interview with the covering Facility Administrator on 11/18/25 at 1:50 p.m., she stated that the previous Facility Administrator had resigned, two PCTs were out on medical leave, and another PCT had been terminated. The covering Facility Administrator also reported that the facility was short-staffed and stated that this was the reason patients were not receiving their full prescribed treatment times. - During a telephonic interview with the Medical Director on 11/18/25 at 2:03 p.m., the Medical Director stated that he was aware of staffing shortages at the facility. He reported that nursing staff contacted him on days when staffing was inadequate. The Medical Director stated he preferred that patients received some dialysis treatment rather than none. He stated that nursing staff were responsible for documenting on the treatment sheets and in the nursing notes, when there was a reason to change any dialysis prescription and to do so in a timely manner. The Medical Director confirmed that there had not been any Governing Body Meetings conducted in November 2025 to date (11/18/25), and no action plans regarding staffing shortages. There was no documented evidence of the Medical Director’s orders regarding the shortened treatments. - During an interview on 11/18/25 at 3:30 p.m., the Regional Operations Director stated that she was serving as the covering Facility Administrator until the new Facility Administrator was trained and in place. She reported that staffing shortages were handled on a daily basis. The facility had a float pool and had hired new staff who were currently in training. When asked if the patients were notified of their shortened treatments, the Regional Operations Director stated that she did not make patient rounds nor speak directly with patients about the staffing shortages and was unsure if nursing staff or Social Services personnel met with patients to address their concerns. She reported that she conducted a meeting with staff to discuss adding a third shift to better accommodate patients during the staffing shortage. - During an interview with P#3 on 11/18/25 at approximately 5:00 p.m., she stated that on 11/1/25, she arrived at this facility and was told that they were short-staffed and they will get her on as soon as they could, but she sat waiting in the lobby for one hour and a half. The staff did not come for her and she got mad and left the facility without receiving her dialysis treatment. A review of Policy #8-02-01, titled, “Teammate Qualifications, Licensure and Adequate Teammate Staffing”, last revised October 2017, stated: POLICY: 4. 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 giving and meets the need of the patients. A review of Policy # 8 -02-05, titled: TRAINING PROGRAM FOR NEW PATIENT CARE PROVIDER TEAMMATES, revised, October 2025, stated: Page 2. Successful completion of the following theory and clinical elements are required before a new teamate can receive an independent patient care assignment: - Successful completion of the theory component of the DaVita Clinical Training for New Teammates Program includes participation in scheduled modality specific Davita Theory classes and completion of the final examination with a score of > 80% (unless the state requires a higher score). Successful completion of the clinical component of the modality specific DaVita Clinical Training for New Teammates Program includes documentation of proficiency as evidenced by the completion of the Procedural Skills Verification Checklist and the review of applicable policies and procedures. The checklist is to be completed by the preceptor WITH the new teammate. A registered nurse will sign off satisfactory performance of new skills. The Facility Administrator/designee will verify that all critical components of the modality specific training are completed prior to the new teammate recieving an independent patient care assignment. Completion of the critical components are outlined in the modality specific Verification of Competency for New Teammate form. The form is to be signed by the clinical new teammate RN trainer, the Medical Director, and the Facility Administrator. A review of facility Policy: 4-07-01, titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, with latest revision date of April 2024, stated: - Patient identity, prescription and machine settings are verified by the teammate prior to initiation of treatment with the exception of the blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one hour of the treatment initiation along with the nursing assessment or as allowable by state law. A review of the DaVita Governing Body By laws revealed: Article III : MANAGEMENT 3.1 Operational Management of Facility The Governing Body Shall maintain responsibility for the governance and operation of the facility. 3.2 Quality of Care The Governing Body shall ensure the health and safety of Facility patients. (e). Ensures that the Facility provides to the ESRD Network any information that may be required, and the facility acts on recommendations of ESRD Network. 3.3 Services The Governing Body shall: (b). Ensure that the Facility is in compliance with all applicable state, federal, and local rules and requirements related to all services it provide. 4.2. Meetings. (a) The Governing Body shall meet at least annually but as often as necessary to carry out the governance and operation of the facility as described in these Bylaws. The Governing Body may meet in person or telephonically, and ALL members of the Governing Body must be present in person or represented through written or verbal ballot or proxy in order to have a quorum.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, a review of facility Policy and Procedures (P & P), a review of the manufacturer’s Directions for Use (DFU) and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of one of one Patient Care Technician (PCT BB), to independently verify the hemodialysis machines’ final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity) prior to initiating patient’s (P), (P#6’s) hemodialysis treatment; failure of two of two PCTs, (PCT AA and PCT CC) and one of one Licensed Practical Nurse (LPN AA) observed, to verify the hemodialysis machines’ final dialysate conductivity according to the manufacturer’s DFU; and failure of LPN AA to test the dialysate’s pH according to the manufacturer’s DFU per ANSI/AAMI RD52: 2004 guidelines. This deficient practice had the potential to negatively affect the health and safety of twelve of twelve patients, (P), (P#6, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, and P#18), who were receiving hemodialysis treatment at the time of this observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. And if conductivity is out of range, the effectiveness of the treatment could be reduced, and patient electrolyte balance could be altered. The facility census was 63. Findings include: Cross Reference: V 250 - Failure of the facility to ensure that PCT BB independently verified the machine’s dialysate pH and conductivity prior to initiating P#6’s hemodialysis treatment; PCT AA, PCT CC and LPN AA verified the dialysate conductivity according to the manufacturer’s DFU and facility P & P; and LPN AA tested the dialysate pH accurately according to the manufacturer’s DFU.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 49321 Based on observation, interviews, and a review of the Governing Body Bylaws, it was determined that the facility failed to ensure that all equipment and the building in which dialysis services were furnished were sanitary and maintained free from damage and defects to ensure the safety of all patients and staff. This failure to maintain the integrity of all surfaces hindered effective cleaning and disinfection of surfaces thus, had the potential for microbial growth and could lead to the transmission of bloodborne pathogens. This deficient practice could negatively affect the health and safety of all staff and the 63 patients who were dialyzing at this facility. Findings include: Cross Reference: V402 - Failure of the facility to provide a safe, clean and comfortable treatment environment for all dialysis patients and staff.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, a review of facility Policy and Procedures (P & P), and a review of the manufacturer’s Directions for Use (DFU), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross References: V 250 - Failure of the facility to ensure that PCT BB independently verified the machine’s dialysate pH and conductivity prior to initiating patient’s (P) P#6’s hemodialysis treatment; Patient Care Technicians (PCTs) - PCT AA, PCT CC and Licensed Practical Nurse - LPN AA verified the dialysate conductivity according to the manufacturer’s DFU and facility P & P; and LPN AA tested the dialysate pH accurately according to the manufacturer’s DFU. V 402 - Failure of the facility to provide a safe, clean and comfortable treatment environment for all dialysis patients and staff. V 757 - Failure of the Facility Administrator to ensure the facility had adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 49321 Based on observation, a review of facility Policy and Procedures (P&P), and staff interview, it was determined that the Infection Control Committee failed to implement P & P for prevention of cross-contamination and spread of bacteria/infections. One of one Patient Care Technician (PCT BB ) observed, failed to utilize appropriate infection control techniques to prevent cross contamination during preparation of access sites (needle insertion sites) and cannulation (insertion of fistula needles), prior to the initiation of hemodialysis treatment of one of one patient (P), (P#18). Failure to practice aseptic techniques increased the risks of cross contamination which could negatively affect the health and safety of four of four patients, P#18, P#19, P#20, and P#21, who were under the care of PCT BB. The facility census was 63. Findings were: During observation in the Patient Treatment Room on 3/19/25 between 10:00 a.m. and 12:00 p.m., the following was revealed: - PCT BB was observed at Station (S) S11, during initiation of hemodialysis treatment of P#18. After disinfecting P#18’s access sites, PCT BB palpated (examined by touch) P#18’s access site again, wearing the same contaminated gloves, thus re-contaminating the access sites. - During an interview on 3/19/25 at 10:28 a.m., PCT BB acknowledged that she forgot to perform hand hygiene and put on a new pair of gloves before cannulation. PCT BB further explained that she touched the access sites (after disinfection) to try to stabilize the artery or vein at the arterio-venous fistula (AVF) access sites. A review of the facility’s Procedure: 1-04-01E, titled, “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SNF) and Administration of Heparin Loading Dose”, with latest revision date of October 2022, stated: 13. Do no palpate insertion site once area has been prepped. RATIONALE: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. 19. Without contaminating the fistula needle, pull skin taut with non-dominant thumb below anticipated insertion site in opposite direction of needle insertion. RATIONALE: Pulling the skin taut anchors the vessels and ease the cannulation process. - The Charge Nurse (Registered Nurse - RN BB), was notified of the above observation on 3/19/25 at 12:48 p.m. RN BB made no comment.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, a review of facility Policy and Procedures (P & P), a review of the manufacturer’s Directions for Use (DFU) and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of one of one Patient Care Technician (PCT BB), to independently verify the hemodialysis machines’ final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity) prior to initiating patient’s (P), (P#6’s) hemodialysis treatment; failure of two of two PCTs, (PCT AA and PCT CC) and one of one Licensed Practical Nurse (LPN AA) observed, to verify the hemodialysis machines’ final dialysate conductivity according to the manufacturer’s DFU; and failure of LPN AA to test the dialysate’s pH according to the manufacturer’s DFU per ANSI/AAMI RD52: 2004 guidelines. This deficient practice had the potential to negatively affect the health and safety of twelve of twelve patients, (P), (P#6, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, and P#18), who were receiving hemodialysis treatment at the time of this observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. And if conductivity is out of range, the effectiveness of the treatment could be reduced, and patient electrolyte balance could be altered. The facility census was 63. Findings include: During observation in the Patient Treatment Room on 3/19/25 between 10:00 a.m. and 12:00 p.m., the following was observed: - At 10:57 a.m., PCT BB was observed initiating dialysis treatment on P#6 at S13. PCT BB did not verify the machine’s final dialysate for conductivity and pH prior to the initiation of hemodialysis treatment on P#6. - During an interview on 3/19/25 at 11:00 a.m., PCT BB acknowledged that the final dialysate’s pH and conductivity were not checked. PCT BB further explained that the reason she did not verify the final dialysate’s pH and conductivity of P#6’s machine, was because the machine’s dialysate pH and conductivity were checked early that morning before the first patient got on the dialysis machine. - LPN AA was also interviewed on 3/19/25 at 11:03 a.m. LPN AA stated that the pH and conductivity must be checked before each new patient treatment. - LPN AA was observed at S13 obtaining a dialysate sample, then LPN AA filled the cell cup of the Myron L Conductivity Meter with the dialysate sample. LPN AA then pressed the black button to read the conductivity result. He then dipped the RPC E-Z CHEK K100-0117 test strip (used to test the dialysate’s pH), in the sample and swished it for five seconds and immediately read the pH result. - PCT AA was also observed verifying the dialysate’s conductivity at S8. PCT AA obtained the dialysate sample from the dialysis machine three times without pouring the samples into the Myron L Meter cell cup. The fourth sample was poured into the cell cup, then PCT AA pushed the black button and read the conductivity result. - During an interview on 3/19/25 at 11:15 a.m., PCT AA stated that her Preceptor taught her to discard three dialysate samples from the dialysis machine. The fourth dialysate sample was to be poured into the Myron L cell cup, press the black button and document the conductivity result. - PCT CC was also observed verifying the dialysate’s conductivity at S2. PCT CC performed the conductivity verification procedure the same way that PCT AA did as mentioned above. - During an interview on 3/19/25 at 11:45 a.m., PCT CC confirmed PCT AA’s statement regarding the conductivity verification procedure per the Preceptor’s instructions. A review of “Fresenius Medical Care 2008K Hemodialysis Machine Operator’s Manual” showed the following DFU: Page 55. Recirculation and Final Set-up Procedure 2. Check the conductivity and pH of the dialysate... Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g. using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment. Verify that the conductivity is reasonably close to the theoretical conductivity value (TCD) and the pH is between 6.9 and 7.6. If they are not, do not initiate dialysis. - A review of facility Policy # 1-03-02, titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” with last revision date of October 2024, stated: Notes: Manual pH testing must be performed prior to each patient’s treatment. A review of Procedure: 1-21-02, titled, “Operation of Portable Myron L Conductivity Meter (D-1)”, with latest revision date of April 2020, stated: 2. Obtain proportioned dialysate sample... 3. Fill meter cell cup with sample so upper electrode is immersed. Insert plunger. 4. Agitate sample with plunger by moving up and down 3 or 4 times and then discard sample. 5. Repeat steps #3 and #4 - at least 3 times. Rationale: Verifies that any prior sample solution has been rinsed free from the cell. 6. Obtain another proportioned dialysate sample and fill the meter, drop plunger in the solution and press the black button. When the pointer stops, immediately read and release the button. 7. Repeat step #6 twice and press. Read/Check button and record conductivity reading. Rationale: Helps assure accurate reading. - A review of facility Procedure: 1-21-08, titled, “Testing pH for Acetate Based Dialysate using RPC E-Z CHEK K100-0117 6.8 - 8.5 Test Strips”, with latest revision date of February 2024, stated: 1. Perform hand hygiene and put on PPE (Personal Protective Equipment). Remove strip from the vial and immediately recap the vial. 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for (1) one second or using a new syringe obtain dialysate sample from the sample port, then allow fluid to flow over the pad for (1) one second. 3. Remove the strip from the fluid and shake off excess dialysate. Within 5-10 seconds, compare the strip to the color chart on the bottle. - On 3/19/25 at 12:05 p.m., the Facility Administrator and the Charge Nurse (Registered Nurse - RN BB) were notified of the above findings and both did not make a comment.”

“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: 49321 Based on observation, staff interview, and a review of the Governing Body Bylaws, it was determined that the facility failed to ensure that the building in which dialysis services were provided, was clean and maintained free from trash, damage and defects to ensure the safety of the patients and staff. Failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. These environmental concerns were observed in one of one Supply Room, one of one Dialysate Preparation Room, one of one Patient Treatment Room and one of one Isolation Room. The facility census was 63. Findings include: During a tour of the facility with the Charge Nurse (Registered Nurse - RN BB) on 3/19/25 between 9:00 a.m. and 10:00 a.m., the following was observed: In the Supply Room: - The right lower side of the wall leading towards the Supply Room had a long open crack (approximately 3.5 feet long and two inches wide). - The epoxy floor in the supply room had thick dirt particles and covered with a 4-wheel cart tire tracks. There was also a white flaky substance on the floor around and under a pallet of bleach next to an old small freezer. -The long floor drain between the dialysate preparation room and the supply room was covered in dirt and dust particles. In the Dialysate Preparation Room: - The floor was covered with a thick layer of dirt and was littered with used RPC strips (used for testing the water for total chlorine). -The floor behind the large RO (Reverse Osmosis) Water Holding Tank had a thick grayish white substance, and littered with some used RPC strips, small pieces of insulation and small dark brownish black cylinder-shaped particles. - The middle part of the Booster Pump (between the base and the top), had a rust-colored stain. - The black hose leading from the Booster Pump to the large Holding Tank was covered in a thick white crystalized substance. - The drain, used to dump or dispose of neutralized concentrate, was covered with a brownish black and grayish-colored, fuzzy substance. - The floor in front of the Acid Mixing Tank was covered with a thick rust-colored substance. There was a thick white substance behind, under, and around the Acid Mixing Tank. - The floor behind the Bicarbonate Mixing Tank had large pieces of wet paper, used RPC strips and small dark brownish black cylinder-shape particles. - The floor in between and behind the two large Carbon Tanks was strewn with used RPC strips and copious amounts of small dark brownish black cylinder-shaped particles. - There was a cart in front of the Mar Cor CWP (Central Water Platform), water purification unit. The cart had a large plastic shower curtain covering two white plastic buckets. The shower curtain, the buckets, and the cart were covered with a thick white sticky substance. - The floor in front of the Mar Cor CWP water purification unit was covered with a rust-colored thick substance. - On the right side of the front steel panel of the Mar Cor CWP water purification unit, had a rust-colored, flaky, and friable substance approximately 5 inches long and 1 inch wide. - Around both Hot Water Heaters was a rust-colored substance and a moderate amount of small dark brownish black cylinder-shape particles. - The walls leading back into the Patient Treatment Room were covered with scratches, dents and scuff marks. In the Patient Treatment Room: - At the right side of the wall boxes (frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products) behind stations (S) 1, S2, S3, S4, S5, S6, S7, S8, S9, S10, S11, S12, S13, S14, S15, S16, and S17, (under the acid ports near the drain), were covered with a thick, rust-colored substance. - The floor of the Patient Treatment Room and the Patients’ Bathroom, had a thick layer of dirt and dirt particles covering them. - The wall in front of the crash cart had numerous holes and dents in different shapes and sizes, (approximately ranging between 2-3 centimeters), as well as scuff marks, and scratches. - The wall at the floor level, on the right side of S4, was soft, and falling apart. - The wall at the right side and left side of the Patients’ Weighing Scale, (from approximately 5.5 feet height down to the floor level), had scratches and dark gray scuff marks. - The handwashing sink (clean sink) facing S11 and S12, was out of order (no water coming out of it) and there was a sign stating, “Out of Order”. - PCT AA stated on 3/19/25 at approximately 10:00 a.m., that the sink had been out of order for two weeks. The four base legs with the rolling casters, including the middle main support of the rolling computer carts, had thick white film and solid white particles on them. These rolling computer carts were located at: - The isolation room - In between S15 and S16 - At the right hand side of S13 - In between S3 and S4 - In between S5 and S6 - In between S9 and S10, and; - In between S7 and S8 - In the Isolation Room: - The floor had a thick layer of dirt on it. - There was a mop bucket under the clean sink. Inside the mop bucket, was a large amount of green, thick slimy substance in it. - There was a moderate amount of white substance in clumps on the floor under the wall box and drain. The white, clumpy substance covered the blue and black hoses leading from the wall box to the dialysis machine. - There was also a moderate amount of grayish green fuzzy clumpy substance on the floor (on the left side of the room) between the vinyl floor and the interior aluminum glass partition. - The door leading to the outside (next to the Conference Room), had a gap between the bottom of the door and the floor (threshold) of approximately 3 feet long and 5 inches wide, with a bright light coming in from the outside. This wide gap had the potential for bugs to come in from the outside. - The Charge Nurse (RN BB), acknowledged these observations on 3/19/25 at approximately 10:05 a.m. A review of the Governing Body Bylaws revealed: 3.6 Physical Enviroment a. Ensure that the physical enviroment in which ESRD facilities provide services is functional, sanitary, safe, and comfortable for patients and staff.”

“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: 52051 Based on observation, staff interview, and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that two of two licensed nurses (Licensed Practical Nurse- LPN AA and Registered Nurse - RN AA) followed facility policy relative to the preparation and administration of medications, specifically, Heparin (anticoagulant). This deficient practice had the potential to negatively affect the health and safety of patient (P) (P#7), and the other nine patients (P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, and P#16), who were undergoing hemodialysis treatment at the time of this observation. The facility census was 63. Findings include: During observation in the Patient Treatment Room on 3/19/25 between 10:00 a.m. to 12:00 p.m., the following was revealed: - LPN AA administered Heparin in a 5 mL (milliLiter) syringe for bolus infusion by intravenous (IV) push to P#7 at Station (S) 8. LPN AA also attached another Heparin maintenance dose in a 10 mL syringe (for hourly infusion to prevent clotting in the extracorporeal circuit). Both Heparin syringes were labeled with patient’s name and name of medication (Heparin) only. The label was missing the dose of each medication (Heparin bolus and maintenance), date and time of preparation, as well as the initials of the person who prepared them. - During an interview with LPN AA on 3/19/25 at 11:30 a.m., he acknowledged that the Heparin syringes were not labeled properly and he also stated that he did not prepare the given Heparin but it was RN AA, (charge nurse) who prepared and drew up the Heparin. - RN AA on 3/19/25 at 11:37 a.m., stated that he had prepared the Heparin doses, and he admitted that they were not labeled correctly. -A review of the facility’s Policy #1-06-01, titled, “Medication Policy”, revised November 2023, stated: 20. If medications are prepared and administered immediately by the same licensed nurse teammate, they do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient’s name, name of the medication, date, time prepared, dose, and initials of the teammate preparing the medication. The facility Policy failed to include that all medications shall be administered by the individual who prepared them.”

“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: 49321 Based on a review of facility records, staff interviews, and a review of minimum state required staffing ratios, it was determined that the Facility Administrator failed to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge and deal with unexpected complications of dialysis, for every 12 patients receiving dialysis care and that each care giver was not assigned more than four patients at any given time. This deficient practice had the potential to cause a delay in monitoring patients for issues such as fluid overload (an excessive amount of fluid in the body), changes in vital signs, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, delayed adjustments, or missed complications including but not limited to: intradialytic hypotension (sudden drops in blood pressure which can occur when fluid is removed too rapidly), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility census was 63. Findings include: During a review of the facility’s Staff/Patient schedule between 3/4/25 and 3/18/25, the following was revealed: - The facility had 17 patient stations, (including one Isolation Room), which was divided into four Pods (Pod - a section of four patient stations). There were two shifts on the Mondays-Wednesdays-Fridays (MWF) schedule, with 16 patients on first shift and 15 patients on second shift. There were also two shifts on the Tuesdays-Thursdays-Saturdays (TTS) schedule, with 15 patients per shift. - A review of the 3/4/2025, 3/6/25, 3/17/25 and 3/18/25 schedule, showed the following staff/patient ratio: - On the 3/4/2025, 3/6/25, 3/17/25 and 3/18/25 schedule, there were three Patient Care Technicians (PCTs) on these dates. Each PCT was assigned to a Pod of four patients. A Licensed Practical Nurse (LPN) was also assigned to a Pod of four patients as a direct caregiver (total care). A Registered Nurse (RN) was assigned as the Charge Nurse who was responsible to have oversight of the 12 patients who were under the care of the three PCTs, in addition to her nursing duties. - However, during Staff interviews on 3/21/25 between 9:00 a.m. and 9:20 a.m., the following was revealed: - RN BB stated that when a nurse was assigned to a Pod (as a direct caregiver), she still had to do other duties such as pre and post assessments and preparing and administering medications to four other patients outside her assigned Pod. Sometimes patients came in very short of breath, so the LPN who was assigned to a Pod as direct caregiver, had to leave her Pod and assess these patients because the traveling nurse was not familiar with them. These situations further delayed the LPN’s assigned duties. - LPN BB confirmed RN BB’s above statement and added that she also had to push Heparin (anticoagulant) before patients (who were under the care of the PCTs), can start their treatments (according to their prescribed orders). The RN, who was usually a travel nurse, did not know their patients well and needed assistance too. LPN BB also added that on two separate occations, the facility was not able to open for patients’ hemodialysis treatments because the travel nurse did not show up. LPN BB further stated that it was unsafe how they worked and had to rely on traveling nurses to show up. - PCT CC stated that there was no way one nurse can push all the heparin doses and do all the patients assessments. PCT CC further stated that she felt sorry for the nurse who was assigned in a Pod because the nurse had to prepare their patient stations, put patients on the dialysis machine to start treatments, take patients off the dialysis machine after treatment, help the nurse (charge nurse) covering the floor with heparin pushes and assessments, and give medications. PCT CC also stated that they were short-staffed a lot and they had complained about it in the past but nobody did anything about it. - On 3/15/25, there were only two PCTs on the schedule and each PCT was assigned to four patients. There were two nurses (RN BB and LPN BB). LPN BB was assigned to Pod C with four patients as direct caregiver (total care). RN BB was assigned to Pod B with three patients per shift as a direct caregiver (total care). Each nurse also had responsibilities to oversee the care of patients at the PCTs’ Pods, and to perform all nursing duties such as conducting pre and post nursing assessments, preparation and administration of all medications, addressing patient complaints, physician notification, dealing with unforeseen complications of dialysis/medical issues, and emergency situations that could arise during dialysis treatment. - During an interview with the Facility Administrator on 3/21/25 at 9:25 a. m., the Facility Administrator stated that she just took over the facility and was not aware that on 3/15/25 the facility had only two PCTs and two nurses to run 15 patients in the morning and 10 patients in the afternoon. A review of Policy #8-02-01, titled, “Teammate Qualifications, Licensure and Adequate Teammate Staffing”, last revised October 2017, stated: POLICY: 4. An adequate number of qualified personal are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care giving and meets the need of the patients.”