Fresenius Medical Care Clayton County

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 32734 Based on a review of records and facility Policy and Procedures (P & P), and staff interviews, it was determined that the Medical Director failed to demonstrate accountability for the clinical operations of the facility to ensure the delivery of safe patient care. This failure resulted in Patient #1’s exsanguination during dialysis treatment. The facility had 108 patients who were receiving hemodialysis treatment at this facility. Findings include: Cross Reference: V 715 - Failure of the Medical Director to ensure that two direct patient care staff (Licensed Practical Nurse [LPN] AA and Patient Care Technician [PCT] AA) adhered to P & P relative to patient assessment and monitoring during dialysis treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 32734 Based on 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 108 in-center hemodialysis patients who were receiving dialysis treatment at this facility. Findings include: Cross-References: V 715 - Failure of the Medical Director to ensure that two direct patient care staff (Licensed Practical Nurse [LPN] AA and Patient Care Technician [PCT] AA) adhered to P & P relative to patient assessment and monitoring during dialysis treatment. V 757 - 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.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 32734 Based on a review of records and facility Policy and Procedures (P & P), and staff interviews, it was determined that the Medical Director failed to ensure that staff adhered to P & P relative to patient assessment and monitoring during dialysis treatment, as evidenced by failure of two direct patient care staff (Licensed Practical Nurse [LPN] AA and Patient Care Technician [PCT] AA) to monitor assigned patients per P & P. This failure resulted in Patient (P) #1’s unresponsiveness due to exsanguination (a substantial blood loss that can be fatal) during dialysis treatment. The facility had 108 patients who were receiving hemodialysis treatment at this facility. Findings include: A review of the facility’s Adverse Occurrence Reports Log revealed the following: 9/14/24 - Needle dislodgement - blood loss < (less than) 100 cc; No treatment given. 9/16/24 - Needle dislodgement - blood loss <100 cc; No treatment given. 11/8/24 - Needle dislodgement - blood loss <100 cc; No treatment given. 1/20/25 - Needle dislodgement - blood loss >500 cc; Patient (P) #1 was sent to the hospital for evaluation and treatment. A review of P#1’s treatment sheet dated 1/20/25 revealed the following: - P#1’s dialysis treatment was initiated at 11:13 a.m., by Patient Care Technician (PCT) AA and documented “without problem”. P#1’s blood pressure (BP) was 147/89 mm/Hg (millimeters of mercury) and his pulse rate (PR) was 64. “Denies complaints” was also documented. - At 11:30 a.m., P#1’s BP was 131/83 mm/Hg with a PR of 59. “Denies complaints” was documented by PCT AA. NOTE: Every 30 minutes monitoring of BP, PR, general observation/mental status, access inspection per P & P that was due at 12:00 p.m., was missed. - At 12:15 p.m., “Ended” was documented. There was a lack of documented BP, PR, observation, or other notes. - At 1:18 p.m., the following was documented by Licensed Practical Nurse (LPN) AA under Multidisciplinary Notes: “12:15 pt (Patient) venous needle noted to be dislodged, not responding. 500 cc saline given. bp 108/76 pulse 38. Approximately 600 cc of blood loss. Pt saline 140/107 pulse 68. 911 called. (Named) NP (Nurse Practitioner) on treatment floor. Informed. Family contacted of transport to er (Emergency Room)” [sic]. During an interview on 2/19/25 at 4:12 p.m., when asked about the blood loss incident that occurred on 1/20/25, LPN AA stated, “It gets busy in that area (referred to Pod 7, where P#1 was seated at). The nurse was assigned to two patients for total care and conducted assessments and prepared/administered medications on the remaining eight patients. I saw blood on the machine and we did all our normal steps with blood loss and sent the patient to the hospital. Patient is aphasic (has difficulty speaking/communicating) and moves around a lot. The patient’s sister was supposed to come sit with him.” During a telephonic interview on 2/19/25 at 4:24 p.m., PCT AA stated she was the tech assigned to P#1. Stated “I remember getting him situated. He was my second patient. I was putting on my fourth patient when the nurse told me about the blood. We thought it was coming from the patient who was seated next to him. I was putting on (initiating treatment) another patient and I missed taking the 12:00 p.m. BP on him. We have 15 minutes to put the patient on the machine. Everything happened so fast”. A review of facility policy titled, “Patient Assessment and Monitoring” published 5/1/23 Version 4 showed the following: Page 4: During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Page 5: General Observation/Mental Status: Access- Observe connections are secure and visible. Ensure access remains uncovered throughout treatment; No bleeding or infiltration noted. During the exit interview on 2/19/25 at 5:45 p.m., the Facility Administrator 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 observation, a review of records, interviews, and a review of minimum state required staffing ratios, it was determined that the Governing Body 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. The facility had 108 incenter hemodialysis patients. Findings include: During observation in the Patient Treatment Room on 2/19/25 between 10:40 a.m. and 1:00 p.m., the following was revealed: - There were two Registered Nurses (RN AA and RN BB), two Licensed Practical Nurses (LPN AA and LPN BB), three Patient Care Technicians (PCT BB, PCT CC, and the Facility Administrator, who is also a PCT) who provided direct patient care on 2/19/25. - There were 30 patients who were scheduled to dialyze on the first and second shifts. However, due to hospitalizations and other reasons, there were 26 patients who dialyzed on the first shift and 25 patients on second shift. A review of the staff/patients assignment sheet dated 2/19/25 showed the following: First shift: - PCT AA who was originally assigned to care for patients at Station (S) 1, S2, S3, and S4 called out. - The Facility Administrator cared for six patients who were seated at S1, S2, S3, S4, S18, and S29. - PCT BB was assigned and cared for three patients in S20, S21, and S23. - RN AA functioned as a dialysis care giver (total care) to two patients in S24 and S25. In addition, RN AA was also assigned to perform all nursing duties such as conducting pre and post nursing assessments, preparation and administration of all 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 in S1, S2, S3, S4, S20, S21, and S23, who were assigned to PCTs (Facility Administrator and PCT BB). - RN BB functioned as a dialysis care giver for two patients in S26 and S27. In addition, RN BB was also assigned to take charge and perform all nursing care and duties such as pre and post nursing assessments, preparation and administration of all medications, addressing patient complaints, dealing with unforeseen complications of dialysis/medical issues, and emergency situations that could arise during dialysis treatment for eight patients in S5, S6, S7, S8, S18, S19, S28, and S29, who were assigned to PCTs (PCT CC and Facility Administrator). - PCT CC was assigned to care for six patients at S5, S6, S7, S8, S19, and S28. - LPN AA was assigned to care for five patients at Station Buffer Zone (SBZ) 11, SBZ12, SBZ 13, SBZ15, and SBZ17. - LPN BB functioned as a dialysis care giver for two patients in SBZ16 and SBZ30. In addition, LPN BB was also assigned to assist with nursing duties for five other patients in SBZ11, SBZ12, SBZ 13, SBZ15, and SBZ17. - Furthermore, RN AA, RN BB, and LPN BB were also responsible for the initiation and termination of dialysis treatment, assessment and performing catheter care 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), who were assigned to PCTs. A review of staff/patients assignment sheets from February 10, 2025 through February 18, 2025 revealed the following: On 2/10/25: There were 29 patients scheduled on the first shift and 27 patients on second shift. There were six PCTs, two LPNs and one RN. On 2/11/25: There were 30 patients scheduled on the first shift and 25 patients on second shift. There were six PCTs, two LPNs and one RN. On 2/12/25: There were 30 patients scheduled on the first shift and 29 patients on second shift. There were seven PCTs, two LPNs and one RN who were scheduled to work. However, there were only five PCTs, two LPNs and one RN who worked due to call outs. The patient’s appointments were not adjusted accordingly, to ensure a safe patient care environment. On 2/13/25: There were 30 patients scheduled on the first shift and 27 patients on second shift. There were seven PCTs, two LPNs and one RN. On 2/14/25: There were 30 patients scheduled on the first shift and 28 patients on second shift. There were six PCTs, two LPNs and one RN. On 2/15/25: There were 26 patients scheduled on the first shift and 23 patients on second shift. There were five PCTs, two LPNs and one RN. On 2/17/25: There were 30 patients scheduled on the first shift and 29 patients on second shift. There were six PCTs, two LPNs and one RN. On 2/18/25: There were 30 patients scheduled on the first shift and 24 patients on second shift. There were six PCTs, two LPNs and one RN. - When there were three nurses on the schedule, each nurse functioned as a dialysis care giver and provided total patient care for two patients. In addition, each nurse was assigned to take charge, perform all nursing duties and deal with unforeseen complications of dialysis/medical issues, and emergency situations that could arise during dialysis treatment for eight patients who were assigned to PCTs. - When four nurses were scheduled to work, the fourth nurse functioned as a dialysis care giver for at least four patients. During an interview on 2/19/25 at approximately 12:40 p.m., Patient (P) (P#2) who was seated at S16 stated that the facility is sometimes short-staffed, but the staff do the best they can. An interview with the Facility Administrator on 2/19/25 at 11:45 a.m. revealed that direct care staffing was an issue. The Facility Administrator stated that on some days, she was part of staffing as a PCT throughout the day. During an interview on 2/19/25 at 12:50 p.m., the Charge Nurse (CN) stated that staffing usually consisted of two LPNs, two staff RNs and six PCTs. The CN usually did not have a patient assignment. However, the facility had been short-staffed for about two to three months and was being assisted by float staff from other facilities. Stated that it was overwhelming at times for the RNs and LPNs to be assigned to the Nurse Pod of two patients per shift, and to be responsible for eight other patient’s medications and nursing assessments. In addition, cross reference V 715 - Failure of the Medical Director to ensure all staff adhered to P & P relative to patient assessment and monitoring during dialysis treatment. This failure resulted in exsanguination during dialysis treatment.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 03383 Based on observation and staff interviews, it was determined that the facility failed to maintain a safe environment as evidenced by the malfunctioning bicarbonate (bicarb) alarm loudly sounding in the treatment area; and the presence and broken mechanisms and/or torn leather upholstery on seven of 31 patient treatment chairs (at Station (S) 5, S15, S16, S18, S19, S26, and S30) in the patient treatment area. This deficient practice could hinder effective cleaning/disinfection and could have a negative effect on the health and safety of 110 patients who were receiving dialysis treatment at this facility. Findings include: 1. During observation in the patient treatment area on 8/19/24 at 12:14 p.m. with the Charge Nurse, the following was revealed: - During a tour of the treatment area, a loud shrill alarm was constantly sounding in the patient treatment area. The charge nurse indicated on 8/19/24 at 12:15 p.m., that it is the bicarb level indicator alarming. During an interview on 8/19/24 at 12:20 p.m., Licensed Practical Nurse (LPN) KK stated the bicarb system is broken and it’s been like this for the last month. During observation in the water treatment room on 8/20/24 at 3:53 a.m., Patient Care Technician (PCT) AA was observed mixing bicarb and revealed that the mixer motor is broken, and she must hold the button down on bicarb system for 10 minutes while bicarb is mixing and 10 to 15 minutes while bicarb is transferred over to the holding/distribution tank. During an interview on 8/20/24 at 8:26 a.m., the Biomedical Area Manager (BAM) revealed the bicarb system was alarming because staff allowed the bicarb system to flood (overflow); this has occurred at least three times. The manufacturer of the bicarb system had been at this facility several times and attempted to repair the bicarb system but made it worse. A new bicarb system is being built and it will probably take another month before it is completed. The BMA disconnected the alarm in the patient treatment area to stop the alarm from sounding on 8/21/24 at 3:00 p.m. The bicarb alarm is inoperable. 2. During observation in the patient treatment area on 8/19/24 between 3:31 p.m. and 4:00 p.m., the following was revealed: - Broken mechanisms and/or torn leather upholstery was observed in seven of 31 patient treatment chairs at S 5, S15, S16, S18, S19, S26, and S30 in the patient treatment area. - Registered Nurse (RN) NN confirmed the above findings on 8/19/24 at 3:50 p.m. The Director of Operations was informed about the above findings during exit interview on 8/22/24 at 1:15 p.m.”