Dci - Clark Home Training Center

“PERSONNEL QUALIFICATIONS CFR(s): 494.50(b)(1) 5 Personnel qualifications and training 5.1 Qualifications Personnel shall possess adequate education, training, or experience to understand and perform procedures outlined by the individual dialysis facility relevant to the facility’s multiple-use program. Education shall be geared to meet the needs of this wide range of personnel. This Standard is not met as evidenced by: 49321 Based on a review of records and staff interviews, it was determined that the facility failed to ensure that two of two Home Hemodialysis (HHD) registered nurses (RN AA and RN BB) who conducted HHD support services/clinic visits, received adequate education and training to competently perform their duties. This deficient practice had the potential to negatively affect the health and safety of two of two HHD patients (HHD P#1 and HHD P#2) who were receiving support/care at this facility. Findings were: A review of personnel records revealed the following: - RN AA and RN BB had current Peritoneal Dialysis skills competency checklists but lacked documented HHD training and skills competency checklist. - During an interview with the Clinic Manager on 3/13/24 at 3:35 pm, she stated that she was the only trained HHD nurse at this facility. The other HHD nurse had retired in January 2024. - During an interview with RN AA on 3/14/23 at 9:00 a.m., she stated “I am assigned to HHD P#1, but I have never been trained on HHD”. - An interview with RN BB on 3/14/24 at 10:30 a.m., revealed that she had been assigned to support/care for HHD P#2. Stated, “I have never been trained on HHD. We are supposed to be getting trained.” A review of Home Therapies Inexperienced Education Plan stated: The Home Hemodialysis training is 12 weeks. There is a test that nurses must pass with an 80% or better. A skills checklist is completed and signed off by the educator.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 49321 Based on record review, staff interviews, and a review of the facility’s policy and procedure, it was determined that the Interdisciplinary Team (IDT) failed to interact and share information from the comprehensive assessment by conducting IDT conferences, to facilitate the development of an effective and individualized plan of care for one [Peritoneal Dialysis (PD) Patient (P) #1] of two, deemed unstable patients sampled. This deficient practice had the potential to negatively affect the health and safety of two of two home hemodialysis patients and 67 PD patients who were receiving support/care at this facility. Findings include: A review of records revealed the following: - PD P#1’s hemoglobin (Hgb - a protein inside red blood cells that carry oxygen from the lungs to tissue and organs in the body) dropped from 9.7 g/dL in January 2024 to 7.9 g/dL in February 2024. (The acceptable Hgb for dialysis patients is 10 g/dL). The root cause analysis was done in February 2024 by Registered Nurse (RN) CC. The analysis stated that the patient had transportation issues that caused her to miss her scheduled doses of Mircera [a medication used to treat anemia (low red blood cell count] and clinic visits. There was a lack of documented plan of care that was developed by the IDT based on the above assessment and root cause analysis, to meet PD P#1’s needs. - PD P#1 was also followed by a Hematologist. During an interview on 3/24/24 at 9:45 a.m., RN CC stated, “I did not talk to the Social Worker (SW) about PD P#1’s transportation needs. I am waiting for her to pick her hemoccult cards (to detect blood in the stool). She continues to miss appointments including her appointment with the Hematologist”. The SW was interviewed on 3/14/24 at 11:05 a.m. She stated that no one made her aware that PD P#1 was having transportation issues. Stated “PD P#1 and I discussed housing issues. The IDT does not meet to discuss patients.” During an interview on 3/14/24 at 1:30 p.m., the Dietitian stated “The IDT does not meet once a week or once a month. Communication is done with me on a calendar. No one is designated to print unstable patient list for the IDT”. A review of Procedure No: 801 titled, “Care Plans” undated, stated: 3. All disciplines will complete an assessment before the care plan meeting. This may be done using individual assessments for each discipline if they are brought together, shared, discussed, and used to develop a comprehensive assessment of the patients’ needs for the care plan... These assessments will be discussed by the IDT and the problems identified for the care plan. 4. Each problem identified will have action steps entered into the electronic care plan.”

“H-PRECONFIG HD SYS-TEST H20/DIALY PER DFU/FDA CFR(s): 494.100(c)(1)(v) Services include, but are not limited to, the following: testing of the water and dialysate system in accordance with- (A) The recommendations specified in the manufacturers’ instructions; and (B) The system’s FDA-approved labeling for preconfigured systems designed, tested, and validated to meet AAMI quality (which includes standards for chemical and chlorine/chloramine testing) water and dialysate. This Standard is not met as evidenced by: 49321 Based on a review of records and staff interview, it was determined that the facility failed to ensure that there was an effective system in place for routine monitoring of chlorine/chloramine levels prior to the start of each treatment or before use of each new batch of dialysate for two of two Home Hemodialysis (HHD) patients (P#1 and P#2). This deficient practice could negatively affect the health and safety of HHD P#1 and HHD P#2. Findings were: - A review of records showed that HHD patients used NxStage System One Hemodialysis Record (Treatment Flowsheet). - NxStage System One Hemodialysis Record lacked data that indicated date of preparation for each new batch of dialysate. - HHD P#1 and P#2 were not provided treatment flowsheets that could identify the date when each batch of dialysate was prepared, to determine if chlorine/chloramine levels were tested prior to the start of each treatment or before use of each new batch of dialysate. For example: A review of HHD P#1’s treatment records from January - February 2024, showed the following: - Chloramine check was documented on 1/12/24, 1/16/20, 1/24/24, 1/30/24, 2/5/24, 2/12/24, 2/20/24, 2/22/24 , and on 2/26/24. - Thirteen of 22 treatment flowsheets did not have documented chlorine/chloramine test done. However, it was not determined if HHD P#1 used a new batch of dialysate on those days when chlorine/chloramine testing was not done. The Clinic Manager was notified and confirmed the above findings on 3/13/24 at 3:35 p.m. A review of NxStage Hemodialysis Treatment Therapy Hand Book stated: Page 37, Requirements for Product Water and Dialysate: Products produced by the pureflow SL must be tested for Chlorine/Chloramines. The pureflow SL requires total Chlorine/Chloramines testing after the preparation of each batch dialysate. HHD P#1 and HHD P#2 used NxStage Home Hemodialysis Machine with Pureflow SL System.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 49321 Based on a review of the Quarterly Update of the Fiscal Year 2024 Dialysis Facility Report [QDFR: A report prepared for the Centers for Medicare and Medicaid Services(CMS) to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients), review of facility’s records and staff interview, it was determined that the facility failed to effectively manage patient outcomes for adequacy of dialysis (effectiveness of dialysis prescriptions to avoid symptoms of uremia - measured by Kt/V and/or URR lab values), in six of six months of Quality Assessment and Performance Improvement (QAPI) meeting minutes reviewed (September 2023 to Febuary 2024). This deficient practice had the potential to negatively affect the health and saftey of two home hemodialysis (HHD) patients and 67 peritoneal dialysis (PD) patients who were under the care of this facility. . Findings were: 1. A review of QDFR, March 2024 Dialysis Adequacy for PD revealed the following: This Facility: Q2 (Quarter 2): April - June 2023 PD weekly average for Kt/V < (less than) 1.7 was 8.5%. Regional Averages: State: 5.7%; Network: 5.2%; and U.S. was 5.3%. A review of QAPI for the last six months revealed the following percentages for Kt/V <1.7: September 2023 - 10.9% October 2023 - 10.9% November 2023 - 15.5% December 2023 - 11.8% January 2024 - 11.8% Febuary 2024 - 8.8% A review of the QAPI meeting minutes from September 2023 to February 2024, revealed a lack of documented plans of action to improve the PD adequacy outcomes for this facility. 2. A review of QDFR, March 2024 Dialysis Adequacy for Hemodialysis (HD) revealed no data available for Q2 (Quarter 2): April - June 2023 for Kt/V. A review of QAPI meeting minutes revealed the following percentage of HD patients with Kt/V < 2.1: September 2023 - 50% October 2023 - 0% November 2023 - 100% December 2023 - 100% January 2024 - 100% Febuary 2024 - 100% A review of the QAPI meeting minutes from September 2023 to February 2024, revealed a lack of documetation of plans of action to improve and sustain the PD and HD adequacy outcomes for this facility. During an interview with the Clinic Manager on 3/13/24 at 3:13 p.m., she stated “Each nurse is assigned to schedule labs for thier patients. We are scheduling three to four patients a day to make sure adequacy labs are not missed”.”