Fresenius Medical Care Stone Mountain

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 32734 Based on observation, staff interviews and facility record review, 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 54 hemodialysis patients who were under the care of this facility. Findings include: Cross-Reference: V757 - Failure of the Facility Administrator 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.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 32734 Based on observation, staff interview and a review of facility policy, it was determined that the Governing Body failed to ensure that the Infection Control Committee implemented facility policy as evidenced by failure of one of one Patient Care Technician (PCT AA) observed, to wear personal protective equipment (PPE) when appropriate, to prevent exposure to blood, body fluids and other potentially contaminated substances. This deficient practice increased the risk for cross contamination and spread of infection to PCT AA and the dialysis unit. The facility census was 54. Findings include: - During observation in the Patient Treatment Room at 10:13 a.m. on 2/12/2025, the following was observed: - PCT AA terminated the dialysis treatment on a patient (P) (P#7), with an arteriovenous fistula (AVF), at Station (S), S14. PCT AA was not wearing goggles or a face shield when he removed P#7’s fistula needles from P#7’s access site, which had the potential for blood spurting after fistula needle removal. - During an interview with PCT AA (immediately after removing P#7’s fistula needles), this surveyor asked PCT AA if he was aware that he was not wearing goggles or a face shield when he performed this task. PCT AA responded, “I forgot”. -A review of Facility Policy, titled, “Personal Protective Equipment”, Published 11/06/23, Version 6, stated: Policy: Employees shall use personal protective equipment in accordance with the type of patient contact expected and anticipated exposure. Eyewear: Protective eyewear is provided by the facility and must be eye protection designed under normal conditions of use to prevent blood and OPIM (other potential infectious material) from reaching the eyes. - During the exit interview on 2/14/25 at 4:45 p.m., the Interim Charge Nurse II, Facility Administrator and Director of Operations, were informed of the above observation.”

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. This Standard is not met as evidenced by: 32734 Based on a review of facility records and staff interviews, it was determined that the facility failed to ensure that this facility had a full-time Registered Nurse (RN), who was responsible for nursing services, to provide oversight and direction to twelve of twelve Direct Patient Care Staff (one full-time Registered Nurse (RN CC), three part-time RNs - RN AA, RN BB, RN EE, six full-time Patient Care Technicians (PCTs) - PCT AA, PCT BB, PCT CC, PCT DD, PCT EE, and PCT GG) and one part-time PCT FF), who provided nursing care and dialysis care to 54 in-center hemodialysis patients who were under the care of this facility. Findings include: - A review of the facility’s Governing Body Meeting minutes dated 1/16/25 showed that RN DD, who was employed as full-time Clinical Manager (CM) at a sister facility, was adapted by the Governing Body as Interim Charge Nurse II, at this facility. During an interview on 2/12/25 at 10:15 a.m., the Facility Administrator (FA) stated that the facility was open six days per week with two scheduled groups, namely: Mondays-Wednesdays-Fridays (MWF) and Tuesdays-Thursdays-Saturdays (TTS), and with two shifts for both MWF and TTS groups. The FA also added that the facility have had one full-time Registered Nurse (RN CC), who was usually scheduled on MWF, since the last Charge Nurse (CN) went out on leave and had not returned. The FA also explained that she used their float pool and part-time nurses most of the time since 12/2022, on the TTS schedule. During an interview with the Director of Operations (DO) on 2/13/25 at 10:45 a.m., he stated that he provided daily RN coverage to manage the treatment floor with multiple float RNs from sister facilities. The DO was shown the federal regulation requirements for the “Nurse in Charge of Nursing Services” and the requirements for the role of CN. After reviewing the requirements, the DO acknowledged the difference in the roles and requirements. - RN DD had no personnel file at this facility and she stated on 2/14/25 at 2:00 p.m., that she signed her job description as Interim Charge Nurse II, in charge of Nursing Services at this facility, during this survey. In addition, RN DD stated that she worked full time at another sister facility as the Facility Administrator/Clinical Manager and came to this facility maybe once a week to review labs with the Medical Director, assist occasionally with inputting doctor’s orders, and attended some QAPI (Quality Assurance and Performance Improvement) meetings. - During the exit interview on 2/14/25 at 4:45 p.m., the Interim Charge Nurse II, Facility Administrator and Director of Operations, acknowledged the above findings.”

“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: 32734 Based on staff interviews, observation, and a review of records, it was determined that the Facility Administrator failed 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. 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, access sites, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, 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. This deficient practice had the potential to negatively affect the health and safety of 54 patients who dialyzed at this facility. Findings include: - During an interview on 2/12/25 at 10:15 a.m., the Facility Administrator (FA) stated that the facility was open six days per week with two scheduled groups, namely: Mondays-Wednesdays-Fridays (MWF) and Tuesdays-Thursdays-Saturdays (TTS), and with two shifts for both MWF and TTS groups. The FA also added that the facility have had one full-time Registered Nurse (RN CC), since the last Charge Nurse (CN) went out on leave and had not returned. The FA also explained that she used their float pool and part-time nurses most of the time since 12/2022. - During an interview on 2/13/25 at 10:06 a.m., the Medical Director stated that she was aware of and had been concerned about staffing for several months, and had discussed about this staffing concern with the Director of Operations and Leadership. - During observation in the Patient Treatment Room on 2/13/25 between 11:00 a.m. and 12:30 p.m., the following was revealed: - There were two Registered Nurses (RN AA and RN BB), and two Patient Care Technicians (PCT AA and PCT BB), providing care for 11 patients on the first shift and seven patients on the second shift. PCT AA had just recently completed her training. - During an interview on 2/13/25 at 11:10 a.m., RN AA stated, “It’s usually just one RN, and two PCTs scheduled on TTS for 11 patients on the first shift and seven patients on second shift. Two of the patients (P), (P#1 and P#6), on first shift had Central Venous Catheters (CVC - a soft plastic tube that’s inserted into a large vein close to the heart and used as an access to provide hemodialysis). RN AA added that he was assigned as direct care giver to these two patients and oversee the care of the remaining patients. RN AA also explained that he just worked part time at this facility and it can get a little hectic at times. RN AA further explained that his responsibilities as a direct care giver to the two patients (P#1 and P#6), included machine set up, initiation and termination of treatment, breaking down the machine post treatment, removal of the bloodlines, cleaning/disinfecting the machine and patients’ hemodialysis chairs, in addition to the primary responsibilities of nurses, such as: pre and post nursing assessments, preparation and administration of medications, monitoring and providing intervention if any issues arose with patients during dialysis, provide chairside education, review laboratory (lab) reports and report lab results to the doctor, schedule vascular appointments, order medication refills, supervise and assist the PCTs, etcetera (etc.). - A review of the facility’s TTS Staff/Patient schedule from February 4, 2025 - February 8, 2025, revealed the following: 2/4/25 (Tuesday): One RN and two PCTs scheduled; 11 patients dialyzed on first shift. 2/6/25 (Thursday): One RN and two PCTs scheduled; 10 patients dialyzed on first shift. 2/8/25(Saturday): One RN and Two PCTs scheduled; 10 patients dialyzed on first shift. A review of the “Patient Treatment Flowsheets” dated 2/4/25, 2/6/25, and 2/8/25, revealed the following: On 2/4/25: - RN AA was assigned as direct care giver to P#6 and P#7 (who had CVCs) at Stations (S) (S1 and S14), in addition to his duties as a charge nurse to all 11 patients on first shift. PCT BB was assigned to four patients (P#8, P#9, P#10 and P#11), at S15, S16, S17 and S18. PCT DD was assigned to five patients (P#12, P#13, P#14, P#15, and P#16), at S19, S20, S2, S11 and S13. On 2/6/25: - RN AA was assigned as direct care giver to P#6 and P#7, in addition to his duties as a charge nurse to all 10 patients on first shift. PCT CC was assigned to three patients (P#8, P#9, P#11), at S15, S16, and S18 (since S17 was vacant). PCT AA was assigned to five patients (P#12, P#13, P#14, P#15, and P#16), at S19, S20, S2, S11, and S13. PCT AA was assisted by PCT CC. On 2/8/25: - RN BB was assigned as direct care giver to P#6 and P#7, in addition to her duties as a charge nurse to all 10 patients on first shift. PCT CC was assigned to three patients (P#8, P#9, P#11), at S15, S16, and S18 (since S17 was vacant). PCT DD was assigned to (P#12, P#13, P#14, P#15, and P#16), at S19, S20, S2 and S11, and S13. PCT DD was assisted by PCT CC. - During an interview on 2/13/25 at 3:12 p.m., PCT BB stated, “We try to use two or three Pods (sections), with four patient stations each, to keep the patients close together and make it easier to monitor on TTS. PCTs usually monitor five patients each, especially if the nurse got busy”. - Both RN AA and PCT BB confirmed that the staffing observed on 2/13/25 was not the usual staffing. The usual schedule was only one RN and two PCTs consistently on TTS. - During the exit interview on 2/14/25 at 4:45 p.m., the Interim Charge Nurse II, Facility Administrator and Director of Operations, acknowledged the above findings.”