Davita North Haledon Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 37656 Based on staff interviews and review of facility documents, it was determined that the facility failed to ensure that: 1) all patients’ routine laboratory test results are obtained and reviewed when Hepatitis B seroconversion occurs; and 2) staff are re-educated regarding infection control practices and special precautions for Hepatitis B surface Antigen (HBsAg)(a protein found on the surface of the hepatitis B virus) positive patients, after a patient tests positive (+) for the virus. Findings include: On 05/21/25 at 1:11 PM, an Immediate Jeopardy (IJ) was identified for the facility’s failure to ensure that all patients are tested after receiving a positive Hepatitis B surface antigen (HBsAg) test result. On 05/21/25 at 4:03 PM, the IJ template was presented to the Facility Administrator (FA) and the Clinical Manager, and a removal plan was requested. On 05/22/25 at 11:40 AM, an acceptable Removal Plan was received. The facility implemented the following to address the IJ: a Governing Body meeting was held to develop, approve, and implement a Removal Plan; to draw laboratory tests for Hepatitis B surface Antigen on all patients and all clinical staff were re-educated on facility policy, titled, “Infection Control for Dialysis Facilities” and “Hepatitis B Surveillance, Vaccination, Infection Control measures and Isolation Guidelines.” The IJ was removed on 05/22/25 at 11:40 AM, after the State Survey Agency verified the full implementation of the removal plan, and Condition Level non-compliance remains (V-110). Cross Reference: 494.30(a)(1)(i) - Routine testing for Hepatitis B: Seroconversion - Infection Control Training and Education”

“IC-HBV-SEROCONVERSION=INVESTIGATION CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B: seroconversion When a seroconversion occurs, review all patients’ routine laboratory test results to identify additional cases. Investigate potential sources for infection to determine if transmission might have occurred within the dialysis unit, including review of newly infected patients’ recent medical history (e.g., blood transfusion, hospitalization), history of high-risk behavior (e.g., injecting-drug use, sexual activity), and unit practices and procedures. This Standard is not met as evidenced by: 51990 Based on medical record review, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that all patients are tested upon discovery of a positive Hepatitis B Surface Antigen (HBsAg)(a protein found on the surface of the hepatitis B virus). Findings include: On 03/31/25, Patient (P)1’s test results for HBsAg were received, resulted as positive (+), and was identified with a HBV (Hepatitis B virus) seroconversion (the change from being positive for a viral antigen to being positive for the corresponding antibody). A review of a facility document titled “Vaccinations and Surveillance Report” printed on 05/21/25 revealed that the following patients were not tested on April 23, 2025: P2, P3, P4, P5, P6, P7, P8, P9, P10, P11, P12, P13, P14, P15, P16, P17, P18, P19, P20, P21, P22, P23, P24, P25, P26, and P27. Twenty-six out of 64 patients did not have HBsAg testing in April 2025 after P1’s seroconversion had occurred. During an interview on 5/21/25 at 3:55 PM with Staff (S)2 (Clinical Manager) and S5 (Manager of Clinical Services), stated the HBV susceptible (Blood Hepatitis Surface Antibody [HBsAb] level less than 10 mlU/ml [milli-international units/milliliter] patients HBsAg testing was completed in April 2025. The HBV immune (HBsAb level greater than 10 mlU/ml) patients HBsAg testing were not done.”

“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: 37656 Based on staff interviews and a review of facility documents, it was determined that the facility failed to ensure that staff are re-educated regarding infection control practices and special precautions for Hepatitis B surface Antigen (HBsAg)(a protein found on the surface of the hepatitis B virus) positive patients, after a patient tested positive (+) for the virus. Findings include: A review of Patient (P)1’s medical record, a new patient, revealed the following: On 03/28/25, P1 received his/her first dialysis at the facility. The facility obtained P1’s initial admission labs (laboratory testing) on 03/28/25. The result of the lab tests was received by the facility on 03/31/25, which indicated that P1’s HBsAg was positive. Upon request of evidence of re-education of the staff members, Staff (S)2 (Clinic Manager) provided a form titled, “TRAINING/INSERVICE DOCUMENTATION FORM,” that contained five signatures of staff that were educated on “Hepatitis B Quick Reference Guide” regarding infection management on 04/04/25. A review of the Staff Roster indicated there are 12 clinical staff providing direct care to patients. On 05/21/25 at 10:20 AM, the second surveyor conducted a tour of the Treatment Room and interviewed S6 (Patient Care Technician [PCT]), S7 and S9 (Registered Nurses [RN]), and S8 (Licensed Practical Nurse [LPN]). All stated they were not aware of the seroconversion on March 31, 2025. The staff interviews revealed that the staff had no recent education on dialyzing patients with a positive (+) Hepatitis B surface antigen (HBsAg). S2 confirmed that only five of the clinical staff were given education on 04/04/25.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 51227 Based on medical record review, staff interview, and review facility documents, it was determined that the facility failed to ensure that the patients receive the prescribed BFR (blood flow rate, the speed at which blood is pumped through the dialyzer during hemodialysis) as ordered by the physician for three of nine hemodialysis treatment sheets. Findings include: A review of Patient (P) 6’s Plan of Care, dated 1/8/25, stated, “... Adequacy, Maintain adequacy goal ...” A review of P6’s treatment records revealed the prescribed BFR for this patient was 350 milliliters per minute (350 mL/min). Further review revealed the following: On 2/22/25, hemodialysis treatment was initiated at 10:18 AM with a BFR at 250 mL/min. At 10:32 AM, the BFR was changed to 300 mL/min for the remainder of the treatment. There was no documentation in the medical record that the Patient Care Technician (PCT) notified the Registered Nurse (RN) of the change in BFR, or that the RN notified the physician that the BFR was set lower than the prescribed rate. On 2/25/25, hemodialysis treatment was initiated at 10:35 AM with a BFR at 350 mL/min. At 11:30 AM, the BFR was changed to 300 mL/min. At 12:00 PM, the BFR was changed to 250 mL/min for the remainder of the treatment There was no documentation in the medical record that the PCT notified the RN of the change in BFR. On 2/27/25, hemodialysis treatment was initiated at 10:13 AM with a BFR at 350 mL/min. At 11:00 AM, the BFR was changed to 250 mL/min for the remainder of the treatment. There was no documentation in the medical record that the Licensed Practical Nurse (LPN) notified the RN of the change in BFR. During an interview on 3/12/25 at 1:50 PM, Staff (S) 2, the Clinical Coordinator (CC), stated he/she would expect the PCT to notify the RN if the BFR was changed and document that the RN was notified. S2 also stated he/she would expect the RN to assess the patient within an hour and document the findings and make the MD aware. Facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2024, stated, “... Intradialytic Data Collection/Assessment ... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed ...””

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 51227 Based on one of two observations of the initiation of hemodialysis through an arteriovenous fistula (AVF, a type of vascular access used for hemodialysis), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy. Findings include: On 3/12/25 at 10:20 AM in Station 9, Staff (S) 6, a Patient Care Technician (PCT), began the process of initiating hemodialysis on Patient (P) 1 without the benefit of first assessing the AVF’s bruit (the sound heard with a stethoscope) or the thrill (the vibration of blood felt with the fingertips). S6 rubbed a gauze saturated with ExSept (a disinfection solution) on P1’s left arm AVF for 10 seconds. S6 proceeded to cleanse the second AVF site with another ExSept solution soaked gauze for 10 seconds. This was 50 seconds less than required by facility policy. S6 proceeded to clean the first and second access sites with an alcohol preparation (prep) pad for 10 seconds. According to facility policy, an alcohol prep pad is not to be used after the use of ExSept to cleanse the site. During an interview at 10:35 AM, S6, stated he/she should access the vascular access before cleaning. S6 also stated that the vascular access site should be cleaned for one minute when using ExSept. Facility policy titled, “AV Fistula or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose”, revised October 2022, stated, “Skin Antiseptic ... Hypochlorite (ExSept Plus) ... Effective Contact Time ... 60 seconds ... Procedure: ... 5. Perform inspection, auscultation and palpation on the entire length of access. Determine presence of bruit and thrill ... 11. While maintain aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allow to dry (For contact and dry time refer to table above). 12. For patients who have a documented allergy to povidone iodine or ExSept Plus, necessitating alcohol alone, apply alcohol using a circular rubbing motion, center out for 60 seconds and allow to dry for 15 seconds prior to cannulation ...””