Davita Belmar Dialysis

“CFC-MEDICAL RECORDS CFR(s): 494.170 This Condition is not met as evidenced by: 30177 Based on medical record review, facility document review, and staff interview, it was determined that the facility failed to ensure that the Condition of Medical Records is met. Findings include: 1. The facility failed to ensure the medical record included a complete and comprehensive history and physical (H&P) that addressed the patient’s health status for two of twelve sampled patients (Patient (P) 2 and P12). In addition, there were no progress notes from nursing and/or medical staff regarding the condition and care for P1 who was confirmed as hepatitis B surface antigen (HBsAg) negative, which indicates no current hepatitis B virus infection, receiving treatments in the Isolation Room. (Cross refer, Tag V726) 2. The Medical Director failed to ensure care interventions were properly documented and transcribed in the medical record for one of one patient (Patient (P)1). In addition, there was no documented medical order or justification within P1’s medical record from the physician indicating P1 was to dialyze in the Isolation Room where there were confirmed patients (P2, P3, and P4) who were hepatitis B virus positive (HBV+) on census and dialyzed each treatment in the Isolation Room. (Cross refer, Tag V729)”

“PA-TRANSPLANTATION REFERRAL CFR(s): 494.80(a)(10) The patient’s comprehensive assessment must include, but is not limited to, the following: (10) Evaluation of suitability for a transplantation referral, based on criteria developed by the prospective transplantation center and its surgeon(s). If the patient is not suitable for transplantation referral, the basis for nonreferral must be documented in the patient’s medical record. This Standard is not met as evidenced by: 30177 Based on interview and policy review, it was determined that the facility failed to have the selection criteria on file and available to patients for three of three commonly referred transplant centers. The failure to have the selection criteria on file and available to patients for the transplant centers to which patients are commonly referred creates missed opportunities to inform and educate patients about their suitability for kidney transplants based on the selection criteria used by local transplant centers. This failed practice has the potential to prevent specific kidney transplant center’s selection criteria from reaching patients interested in kidney transplantation. Findings include: During an interview on 06/19/24 at 3:30 PM, the Social Worker was asked about the top three kidney transplantation centers where patients at the facility are commonly referred. The Social Worker stated that most patients are referred to three “named facilities.” When asked if there were selection criteria for these transplant centers available on file, the Social Worker replied that they did not have them. The Social Worker was asked if he/she was familiar with the “named facilities” selection criteria for kidney transplantation, he/she replied, “No, I am not.” Review of the facility’s policy titled, “Transplant Referral and Tracking Process,” revised in April 2022, revealed, “The Social Worker or designee must obtain the transplant center’s guidelines and criteria for selecting appropriate candidates. The transplant center evaluates and determines the patient status as a transplant candidate.” N.J.A.C. 8:43A-24.4(a)”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 30177 Based on staff interviews and a review of the facility’s policies and procedures, it was determined that the facility failed to establish a threshold for monitoring dynamic venous pressure (DVP) for vascular access surveillance by the Medical Director. This oversight has prevented the facility from setting a baseline for surveillance of trend analysis in patients with arteriovenous fistula (AVF) and arteriovenous graft (AVG) vascular accesses. The absence of a clear threshold for DVP readings had the potential to lead to missed opportunities for early access intervention for all patients with an AVF or AVG receiving in-center hemodialysis treatments at this facility. Findings include: An interview with the Clinical Coordinator on 06/19/24 at 11:55 AM, revealed that the facility uses DVP as vascular access surveillance for early recognition of signs and symptoms of access dysfunction to eliminate needle placement variation effects. When asked what the threshold is when clinical staff should report the DVP as concerning, the Clinical Coordinator revealed that the policy does not include an established threshold and that parameter should be set by the Medical Director. The Clinical Coordinator agreed that a reference for clinical staff to know when to report the DVP as alarming should include established thresholds where applicable. During an interview with the on-call covering Medical Director on 06/19/24 at 4:30 PM, he/she stated that the policy should have included an established threshold for the facility to use for monitoring of the DVP for vascular access surveillance. The Medical Director confirmed that parameters should have been set to provide guidance and a reference to indicate when clinical staff should notify the Nephrologist of access concerns. During an interview with the Group Facility Administrator on 06/19/24 at 2:45 PM, he/she stated that the facility had not established parameters related to the DVP. He/she confirmed that thresholds are needed to govern surveillance of DVP. A review of the facility’s policy titled, “Vascular Access Monitoring and Surveillance,” revised in October 2020, revealed, “To promote routine monitoring and surveillance of arteriovenous fistula (AVF) and arteriovenous graft (AVG) vascular accesses for early recognition of signs and symptoms of stenosis, infection, or other access dysfunction ... The Medical Director is responsible for the technique (s) used by the facility for vascular access monitoring, surveillance, frequency, and acceptable parameters. A review of the facility’s procedure, “Vascular Access Surveillance: Using Dynamic Venous Pressure,” revised in April 2023, revealed, “The Medical Director is responsible for establishing the threshold used by the facility. Trend analysis is more important than any single measurement.” N.J.A.C. 8:43A-24.4(a)”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 30177 Based on interview, record review, and policy review, it was determined that the facility failed to ensure the medical record includes a complete and comprehensive history and physical (H&P) that addresses the patient’s health status for two of twelve sampled patients (Patient (P) 2 and P12). In addition, there were no progress notes from nursing and/or medical staff regarding the condition and care for P1 who was confirmed as hepatitis B surface antigen (HBsAg) negative, which indicates no current hepatitis B virus infection, receiving treatments in the Isolation Room. There were confirmed three patients (P2, P3, and P4) who were HBsAg positive, which indicates an active hepatitis B infection that can spread the hepatitis B virus to others through blood. These failed practices have the potential to inhibit coordinated care for P1. Findings include: Review of the medical records for P2, admitted on 01/23/24, and P12, admitted on 08/12/22, both diagnosed with end-stage renal disease (ESRD), it was noted that there was no comprehensive H&P for P2 and P12. Further review revealed P1’s medical record contained no progress notes detailing the care and progress as it relates to co-mingling HBsAg positive and HBsAg negative patients in a single isolation room with designated equipment shared between the patients. During an interview on 06/19/24 at 12:50 PM, the Clinical Coordinator confirmed the findings above. When asked if the provider was expected to document or obtain an H&P, the Clinical Coordinator responded, “Yes.” The Clinical Coordinator was then asked about the expectations for documenting nursing progress notes. He/she replied that nurses’ notes are documented after any occurrence and monthly. In an interview with the Senior Manager of Clinical Services on 06/19/24 at 1:00 PM, he/she confirmed the absence of an H&P for P2 and P12 and progress notes from nursing staff related to P1 receiving dialysis treatment in the isolation room. Review of the facility’s policy titled, “History and Physical,” revised 10/21, revealed, “A comprehensive medical H&P that addresses the patient’s current presentation and health status, including the patient’s medical condition related to his or her renal disease, is to be completed or obtained for all new patients within 30 days of admission.” N.J.A.C. 8:43A-13.1(a) N.J.A.C. 8:43A-24.14(4)”

“MR-COMPLETE RECORDS PROMPTLY CFR(s): 494.170(b)(1) (1) Current medical records and those of discharged patients must be completed promptly. This Standard is not met as evidenced by: 30177 Based on medical record review, staff interview, review of the facility’s policy, and review of the Centers for Disease Control (CDC) prevention guidance, it was determined that the Medical Director failed to ensure care interventions are properly documented and transcribed in the medical record for one of one patient (Patient (P)1. In addition, there was no documented medical order or justification within P1’s medical record from the physician indicating P1 was to dialyze in the Isolation Room where there were confirmed patients (P2, P3, and P4) who were hepatitis B virus positive (HBV+) on census and dialyzed each treatment in the Isolation Room. The failure to ensure medical orders (a diagnostic or therapeutic patient care directive from a licensed and credentialed practitioner) were documented, transcribed, and verified by medical staff had the potential for patients to receive care not ordered or directed by the medical provider. This failed practice has the potential to negatively impact all 63 patients receiving in-center hemodialysis treatment at this facility. Findings include: In an interview on 06/17/24 at 10:30 AM, the Group Facility Administrator was asked if the facility currently accepts and treats patients with HBV virus. He/she replied, “Yes, we have four patients with HBV.” During observation and review of facility isolation practices on 06/18/24 from 9:00 - 9: 45 AM, the facility was noted to have an Isolation Room with one hemodialysis station designated for isolation services. P1, who is HBsAg negative, which indicates no current hepatitis B virus infection, was observed dialyzing in the Isolation Room on 06/18/24 at 9:45 AM. The facility was noted to have three patients (P1, P2, and P3) who were currently hepatitis B surface antigen (HBsAg) positive on census and dialyze in the same isolation room for each treatment. During medical record review for P1’s revealed P1 was admitted on 09/19/23 with a diagnosis of end stage renal disease (ESRD) and human immunodeficiency virus (HIV). P1 was shown to have had a positive HBsAg on 08/01/23 and 08/10/23 prior to admission to this facility and then reverted to negative as indicated by labs drawn on admission on 09/19/23, and has remained negative since admission as evidence by monthly HBsAg labs. A review of the “Physician Progress Notes,” revealed no medical director oversight, and/or a physician order documented, transcribed, or medically justified P1 to dialyze in the Isolation Room where patients who were currently HBsAg positive were dialyzed. Review of the “Vaccination and Surveillance Report” from P1’s electronic medical record revealed the following HBsAg results from 07/07/22 through 06/06/24: 07/07/22 - HBsAg negative (no current hepatitis B virus infection) 08/04/ 22 - HBsAg negative 09/08/22 - HBsAg negative 10/06/22 - HBsAg negative 11/10/22 - HBsAg negative 02/08/22 - HBsAg negative 01/05/23 - HBsAg negative 02/09/23 - HBsAg negative 03/02/23 - HBsAg negative 04/06/23 - HBsAg negative 05/11/23 - HBsAg negative Non documented in June 2023 Non documented in July 2023 08/01/23 - HBsAg positive 08/10/23 - HBsAg positive 09/19/23 - HBsAg negative (Patient admitted to current facility) 10/26/23 - HBsAg negative 11/20/23 - HBsAg negative 12/07/23 - HBsAg negative 01/04/24 - HBsAg negative 02/08/24 - HBsAg negative 03/07/24 - HBsAg negative 04/04/24 - HBsAg negative 05/09/24 - HBsAg negative 06/24/24 - HBsAg negative In an interview with the Clinical Coordinator on 06/17/24 at 4:10 PM, he/she stated that there is no documentation in the patient’s medical record reflecting the discussion of isolation placement with the Medical Director. In an interview with the Medical Director on 06/17/24 at 5:15 PM, when asked about HBsAg-negative patients dialyzing in the same Isolation Room with patients who are HBsAg-positive, the Medical Director stated, “It’s better to be safe than sorry.” The Medical Director confirmed that there was no documentation of an order or progress notes for P1’s isolation placement. According to the Centers for Disease Control (CDC) prevention, HBV+ patients must dialyze in a separate isolation room during dialysis to prevent contact and transmission by contact with blood spills, splattering, or spurting of blood and other body fluids. Review of the facility’s policy titled, “Physician Orders for Patient Care,” revised in October 2022, revealed, “... To verify that orders are properly documented, transcribed, verified, and implemented in a timely manner for patient care ... An order is a diagnostic or therapeutic patient care directive from am appropriately facility-specific licensed and credentialed practitioner that includes at least the following components: Date and time order given, medical justification, ordering physician signature that includes date and time ... Orders must be received prior to the delivery of any treatment or service ordered ...A registered Nurse verifies the ordered entered in the computer against the written order ... Unclear or incomplete orders must be clarified with the physician by the licensed nurse prior to implementation ... Medical justification for all orders will be contained within the medical record. If medical justification is unclear or absent, the medical justification must be clarified or obtained from the physician. Licensed nurse seeking clarification on the medical justification must update the patient medical record as appropriate and the physician must validate the medical justification... All orders must be entered into the electronic medical record. All orders entered into the electronic medical record must be signed and dated by the ordering physician within seven days ... Written orders are to be filed in the patient’s medical record in the Physician’s Orders section ...” N.J.A.C. 8:43A-13.1(a)”