Fmc - Piedmont Dialysis North

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 03383 Based on facility record review and staff interviews, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This deficient practice had the potential to negatively affect the health and safety of 39 patients who dialyzed at this facility. Findings include: Cross-Reference: V757 - Failure of the Governing Body to ensure that the facility had adequate number of qualified staff to meet the needs of all patients and provide safe patient care; and to be in compliance with the minimum State required staffing ratios of one licensed and qualified nurse for every 12 patients who were receiving dialysis care and one qualified patient care giver for every four patients.”

“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: 03383 Based on staff interviews, a review of facility records, and a review of minimum state required staffing ratios, it was determined that the Governing Body 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 39. Findings include: During an interview on 2/5/25 at 9:05 a.m., Patient Care Technician (PCT) BB stated there were two shifts and some days, there were call outs in the morning and it was hard to find someone to cover that early in the morning. Stated they usually work with four staff on Monday, Wednesday, and Friday (MWF) and the charge nurse does not work the floor. During an interview on 2/5/25 at 9:13 a.m., Registered Nurse/Charge Nurse (RN/CN) AA stated the facility recently started dialysis treatments on Tuesday,Thursday, and Saturday (TTS). There were seven patients on first shift and two patients on second shift and was staffed with one RN and one PCT. The nurse was responsible for initiating and terminating dialysis treatment for patients with a central venous catheter (CVC - a thin, flexible tube inserted into a large vein near the heart to provide access for hemodialysis) and the PCT was responsible for patients with other types of access. RN/CN AA stated she did not have to complete some of the duties of a charge nurse on TTS and she and the PCT worked well together to get the work done. RN/CN AA stated this was the way TTS was scheduled, one nurse and one PCT. A review of treatment flowsheets and staff/patients assignment sheets dated 1/21/25 and 1/23/25 revealed the following: On Tuesday, 1/21/25 First Shift: A review of records showed there were seven patients on the first shift who dialyzed on 1/21/25. There was one Registered Nurse (RN DD) and one Patient Care Technician (PCT CC) who worked on 1/21/25. A review of staff/patients assignment sheet showed that PCT CC was assigned to three patients (P) in Pod B (P#2, P#4, and P#9). There was no patient care giver who was assigned to care for four patients in Pod A (P#3, P#6, P#7 and P#8). - There were five patients (P#3, P#4, P#7, P#8, and P#9) with a CVC access. RN DD was responsible for the initiation and termination of dialysis treatment, assessment and performing catheter care for P#3, P#4, P#7, P#8, and P#9 in addition to conducting all pre and post dialysis assessments, preparation and administration of all prescribed medications, addressing patient complaints, physician notification, dealing with unforeseen complications of dialysis/medical issues, and emergency situations that could arise during dialysis treatment for seven patients. - A review of treatment flowsheets dated 1/21/25 showed that PCT CC initiated and discontinued dialysis treatment for five patients (P#2, P#3, P#4, P#6, and P#9). PCT CC monitored P#2, P#3, P#4, P#6, P#7, and P#8. In addition, it was documented that PCT CC initiated, terminated, and/or completed assessments on the following patients with a CVC: assessed CVC and terminated dialysis treatment on P#3; terminated dialysis treatment on P#4; assessed and terminated dialysis treatment on P#7; and assessed and terminated dialysis treatment on P#9 via CVC. On Thursday, 1/23/25 First Shift: A review of records showed there were eight patients on the first shift who dialyzed on 1/23/25. There was one RN/Charge Nurse (RN AA) and one PCT (PCT CC) who worked on 1/23/25. A review of staff/patients assignment sheet showed PCT CC was assigned to patients in Pod B (P#1, P#2, P#4, and P#5). There was no patient care giver who was assigned to care for four patients in Pod A (P#3, P#6, P#7 and P#8) on 1/23/25. - There were five patients (P#3, P#4, P#5, P#7, and P#8) with a CVC access. RN AA was responsible for the initiation and termination of dialysis treatment, assessment and performing catheter care for P#3, P#4, P#5, P#7, and P#8 in addition to conducting all pre and post dialysis assessments, preparation and administration of all prescribed medications, and performing other routine nursing duties. Furthermore, RN AA was also responsible for dealing with unforeseen complications of dialysis/medical issues and emergency situations that could arise during dialysis treatment for eight patients. - PCT CC initiated and discontinued dialysis treatment for two patients (P#2, and P#6) and primarily monitored P#2 and P#6 during treatment. RN AA and PCT CC both monitored P#3 and P#8. It was also documented that PCT CC initiated and terminated dialysis treatment and assessed CVC on P#3; and terminated treatment on P#4 via CVC. During an interview on 2/5/25 at 11:00 a.m., the Facility Administrator stated that the nurse performed CVC assessments, initiation, and termination of treatment for patients with a CVC access. During an interview on 2/5/25 at 11:28 a.m., RN DD stated that she initiated and terminated dialysis treatment and performed dressing changes for patients with CVC on 1/21/25. RN DD could not explain why PCT CC documented performing those tasks. An interview was conducted with the Director of Operations (DO), Facility Administrator, and Senior Director of Regulatory Affairs (SDRA) on 2/5/25 at 11:45 a.m. related to staffing requirements. The SDRA had additional questions to clarify the deficient practice with staffing issues. A call was placed to Specialized Care Unit Program Manager. During a telephonic interview with the Program Manager, DO, Facility Administrator, and SDRA on 2/5/25 at 12:05 p.m., the Program Manager explained the minimum state required staffing ratios of one licensed and qualified nurse for every 12 patients receiving dialysis care AND (emphasis was made on the word “AND”) one dialysis care giver for each four patients. The Program Manager further explained that when a nurse is assigned to care for patients in a Pod, the nurse is designated as a patient care giver. There must be one nurse who is not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients, who is readily available to provide nursing care, take charge and deal with unexpected complications of dialysis, other medical issues and emergencies, for every 12 patients receiving dialysis care.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 49321 Based on a review of records and facility’s Quality Assessment and Performance Improvement (QAPI) meeting minutes, and staff interview, it was determined that the Interdisciplinary Team (IDT) failed to identify and analyze trends, investigate all infections, develop recommendations, and take remedial actions to minimize the facility’s infection rates, specifically Peritonitis (an inflammation of the abdominal membranes, most commonly due to bacterial infection), in six of six months (October 2023 - March 2024) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 13 Peritoneal Dialysis (PD) patients who were under the care of this facility. Findings were: - A review of facility infection report showed nine episodes of peritonitis between 5/2/23 and 2/8/24. - During a medical record review of Patient (P) #6, who was sampled for Peritonitis, it was revealed that P#6 had Peritonitis on 9/20/23, 11/30/23, and again on 1/11/24. - A review of QAPI meeting minutes from October 2023 - March 2024 revealed no documentary evidence that trends in Peritonitis were evaluated and investigated. There was no evidence that the IDT developed recommendations and take remedial actions to minimize the facility’s infection rates, specifically Peritonitis . During an interview with the PD nurse on 4/4/24 at 9:30 a.m., she stated that she covered multiple facilities.”