Fresenius Medical Care Henry County

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 03383 Based on observation, staff interviews, a review of Centers for Disease Control and Prevention (CDC) recommendations, and a review of facility Policy and Procedures (P & P), it was determined that the Infection Control Committee failed to ensure that three of three patients observed, seated at Stations (S) (S8, S9, and S17), who held pressure to their access sites for hemostasis (stopping of the flow of blood) after dialysis, performed hand hygiene (wash hands with soap and water or use an alcohol-based hand sanitizer), after removing used gloves. This deficient practice had the potential for cross contamination and increased risk of infection that could negatively affect the health and safety of all 107 hemodialysis patients who dialyzed at this facility. Findings include: During observation in the Patient Treatment Room on 6/25/25 between 9:12 a.m. and 9:50 a.m., the following was revealed: - Three patients, seated at S8, S9, and S17, were observed applying pressure to their access sites with a gloved hand for hemostasis. All three patients did not perform hand hygiene after removing their gloves and before leaving the Patient Treatment Room. - The patient sitting at S9 and S17 donned a visibly bloody glove after their access bled. The three patients were not reminded by the Direct Patient Care (DPC) staff (nurses and Patient Care Technicians-PCTs), to wash their hands nor offered to use a hand sanitizer after glove removal. - PCT GG was informed about observations made of patients removing gloves after holding pressure to access site and leaving the Patient Treatment Room without performing hand hygiene on 6/25/25 at 10:05 a.m., and that patients should perform hand hygiene after glove removal just like DPC staff did. PCT GG stated, “They do? I will do it from now on”. PCT DD was also informed about the above observations made of patients removing gloves after holding pressure to access site and leaving the Patient Treatment Room without performing hand hygiene on 6/25/25 at 10:08 a.m. And this surveyor informed PCT DD that patients needed to perform hand hygiene after glove removal. PCT DD stated, “Okay thanks”! PCT DD also added, “We don’t have enough time between patients to do things properly, patients are scheduled too close together”. According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal. The Director of Operations (DO) and Facility Administrator were informed about the above observations on 6/26/25 at 2:30 p.m. A review of Policy 47664, titled, “Hand Hygiene” and published 11/06/2023, stated: Hands will be: Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water: - Before and after direct contact with patients - Entering and leaving the treatment area - Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications - Immediately after removing gloves ... - When moving from a contaminated body site to a clean body site of the same patient.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 03383 Based on observation and staff interview, it was determined that the facility failed to ensure that there was a comfortable and safe environment for all patients and direct patient care (DPC) staff (nurses and patient care technicians - PCTs), as evidenced by the presence of gnats in one of one Patient Treatment Room. This deficient practice made patients and staff uncomfortable and could negatively affect the health and safety of patients and DPC staff. The facility census was 107. Findings include: - During a tour with the Charge Nurse (CN AA) on 6/23/25 at 11:53 a.m., CN AA stated, “The gnats are bad, pest control has been here several times, it’s summer”. - The Biomed Technician (BMT), who was present during the tour on 6/23/25 at approximately 12:00 p.m., stated that drains in the Patient Treatment Room had been flushed and the BMT provided this surveyor a Purchase order documentation that showed that the last time the drains were treated was on 5/27/25. - During observation in the Patient Treatment Room on 6/23/25 between 11:57 a.m. and 12:05 p.m., the following was revealed: - Multiple gnats were observed flying around and alighting on patients and staff in the Patient Treatment Room. The patients, DPC staff, and this surveyor were constantly swatting the gnats away. - Patient sitting at Station (S) 9 on 6/25/25 at 9:12 a.m., was observed swatting at gnats with a piece of cardboard and stated to surveyor, “Please try to do something to get them [staff] to get rid of these gnats”! - On 6/25/25 at 9:26 a.m., PCT GG stated, “They got to do something about these gnats”, as she was swatting them away.”

“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 patient and staff interviews, it was determined that the facility failed to maintain a safe environment as evidenced by a standing water on the floor from one of one leaking dialysis machine at Station (S) 17, observed in one of one Patient Treatment Room. This deficient practice could negatively affect the health and safety of patient (P) (P#15), who was undergoing hemodialysis treatment at S17, and all the other patients who will be assigned to dialyze at S17, as well as all direct patient care staff (nurses and patient care technicians- PCTs). The facility census was 107 in-center hemodialysis patients. Findings include: During observation in the Patient Treatment Room on 6/24/25 at 6:40 a.m., there was standing water on the floor behind S17 and on the side and front of S17. - During an interview with patient (P) (P#15) on 6/24/25 at 6:43 a.m., P#15 stated that there was always water on the floor behind his machine that seeped to the side and front of Station (S) 17. P#15 also stated that, “It has been like this since starting here on 6/5/14”. - On 6/25/25 at 9:47 a.m., PCT DD was observed mopping water from the side and back of S17. PCT DD stated, that the machine was leaking and pointed to a hose behind the machine. The Director of Operations and Facility administrator were informed about the above observation on 6/26/25 at 2:35 p.m.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 03383 Based on observation, a review of facility policy and procedures (P & P), and staff interview, it was determined that the facility failed to ensure that four of 9 patients sitting at Station (S) 11, S12, 14, and S15 observed, had their vascular access sites uncovered and visible to the Direct Patient Care (DPC) staff (nurse and Patient Care Technicians-PCTs), throughout their dialysis treatment. This deficient practice could provide an opportunity for accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood). The facility census was 107. Findings include: During observation in the Patient Treatment Room on 6/25/25 between 9:12 a.m. and 9:50 a.m., the following was revealed: - Patients who were sitting at S11, S12, 14, and S15 had a blanket completely covering their body from neck to toe. These patients’ dialysis access sites were not visible to staff. - PCT GG was informed about the above observation of patients with covered accesses on 6/25/25 at 10:05 a.m. PCT GG responded, “I know”. - PCT DD was also informed about the above observation of patients with covered accesses on 6/25/25 at 10:08 a.m. PCT DD stated, “We don’t have enough time between patients to do things properly, patients are scheduled too close together”. A review of facility Policy 45284, titled, “Patient Assessment and Monitoring” and published 05/01/2023, stated: Access: - Observe connections are secure and visible - If an external catheter is in use, observe and document that the HemaClip device is in place. - Ensure access remains uncovered throughout the treatment Observe and ensure: - Tape is secure - Needles are intact - No bleeding or infiltration is noted”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 03383 Based on medical record review and staff interview, it was determined that the facility failed to ensure that five of 11 in-center hemodialysis (ICHD) patients (P) (P#2, P#6, P#8, P#9 and P#11) sampled, had a Patient Care Plan/Plan of Care (POC) that reflected participation of all members of the Interdisciplinary Team (IDT), including the patient or patient representative. This lack of IDT collaboration and participation had the potential failure to identify new patient concerns and outcomes that were not achieved. This deficient practice had the potential to negatively affect the health and safety of all 107 ICHD patients who were under the care of this facility. Findings include: A review of (P#2’s, P#6’s, P#8’s, P#9’s and P#11’s POC revealed the following: - P#2’s POC, dated 11/8/24, was not signed by P#2 or P2’s representative. - P#6’s POC dated 5/1/25 was not signed by P#6 or representative. - P#8’s POC dated 4/7/25 was not signed by P#8 or representative. - P#9’s POC dated 7/7/23 was not signed by P#9 or representative. - P#11’s POC dated 7/4/24 was not signed by P#11, or by P#11’s representative and was not signed by all the other members of the IDT. The Charge Nurse confirmed the above observation on 6/25/25 at 9:08 a.m., without offering an explanation as to why the signature page was not signed.”

“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: 03383 Based on a review of the facility’s Fiscal Year (FY) 2025 Quarterly Dialysis Facility Report (QDFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients), a review of facility records, and staff interview, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to make changes to plans of action to improve and sustain the facility’s mineral metabolism/bone disorder and vascular access outcomes for in-center hemodialysis (ICHD) patients in six of six months (December 2024 - May 2025) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 107 patients who were receiving dialysis services at this facility. Findings include: A review of the FY2025 QDFR, revealed that the facility was above the United States (US) threshold in the following: 1. Mineral Metabolism and Bone Disorder: (Uncorrected Calcium greater than [>] 10.2) - facility was 2.3%, whereas the US was 1.0% nationally. In Comparison, a review of the facility’s QAPI meeting minutes from December 2024 to May 2025 revealed that the facility was above the United States (US) threshold in the following: Calcium Uncorrected: >10.2 mg/dL (milligrams per deciliter) December 2024 - 3.5% January 2025 - 4.7% February 2025 - 2.6% March 2025 -3.7% April 2025 - 4.6% May 2025 - 11.2%; while the US was at 1.0% nationally. Long-term Catheter Rate - patients with Central Venous Catheters (CVCs) as primary dialysis access >90 days: December 2024 - 16.1% January 2025 - 17.3% February 2025 - 18.9% March 2025 - 19.2% April 2025 - 20.6% May 2025 - 20.8%; while the US was at 17.9% nationally. Additionally, the facility’s QAPI meeting minutes from December 2024 - May 2025 revealed documentary evidence that although the Interdisciplinary Team (IDT), was tracking mineral metabolism and bone disorder, and vascular access (CVC), there were no changes made to the action plans to attain and sustain improvement. The Director of Operations and Facility Administrator were present during the review on 6/25/25 at approximately 12:31 p.m., and both stated that the IDT will work towards improvement of these outcomes. The Facility Administrator also confirmed there were no changes made to the plans for uncorrected calcium or vascular access from December 2024 through May 2025. A review of Policy: 25799, titled, “Quality Assessment and Performance Improvement Program” published 11/4/24, stated: The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. Elements to be reviewed will include: - Patient care outcomes ... A developed appropriate action plan will include: - Implementing the action plan with a specific goal - Identifying staff member(s) responsible for action - Identifying staff member(s) responsible for action plan - Monitoring progress and effectiveness of the action plan - Review and document monthly updates in eQUIP until a resolution is achieved - Reassessment of plan if portions are unsuccessful - Sustaining the plan if successful”

“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: 03383 Based on record review and staff interview, it was determined that the facility failed to ensure that the dialysis facility maintained a complete and accurate records for one of one patient (P) (P#14), sampled. This deficient practice could negatively affect the health and safety of P#14. The facility census was 107 in-center hemodialysis patients. Findings include: A review of P#14’s hemodialysis treatment flowsheets from 6/6/25 to 6/23/25, revealed the following: - On 6/6/25 and 6/9/25, P#14’s dialysis treatment record was blank which indicated that P#14 did not receive hemodialysis treatment on both dates. The treatment record lacked documentation to show why P#14 did not receive hemodialysis treatment. - On 6/13/25, P#14’s dialysis treatment record showed P#14’s weight, however, there was no dialysis treatment data documented, nor any explanation why P#14 did not receive hemodialysis treatment. - On 6/18/25, P#14’s dialysis treatment record was blank which indicated that P#14 did not receive hemodialysis treatment and there was no documented explanation of why P#14 did not receive hemodialysis treatment. A review of the 6/6/25, 6/9/25, 6/13/25, and 6/18/25 of P#14’s dialysis treatment flowsheets with the Charge Nurse, Facility Administrator, and Director of Operations on 6/26/25 at 11:27 a.m., revealed the following: The Facility Administrator stated that they were short staffed on those dates. P#14 was always called when there were delayed dialysis treatment schedules because P#14’s dialysis treatments started later at 7:00 a.m. (first shift), while the other first shift patients started at 5:15 a.m. The Facility Administrator confirmed that P#14’s dialysis treatment record did not show why P#14 did not receive his dialysis treatment, and there was no documented evidence if P#14’s dialysis treatment was rescheduled. The Charge Nurse stated on 6/26/25 at 11:30 a.m., that P#14 had a problem with waiting. A Patient Care Technician (PCT HH) called out on 6/13/25. The Administrative Assistant (AA), who was also a PCT, covered as a PCT when a scheduled PCT called out. P#14 left the facility when the AA arrived at 7:25 a.m. The Licensed Practical Nurse (LPN FF) tried to find P#14 but he had already left. The Charge Nurse added that P#14 still worked at his regular job. P#14’s dialysis treatment on 6/18/25 was rescheduled for 6/19/25. Although P#14 came to the facility for dialysis treatment, P#14 didn’t stay. The Charge Nurse explained that a PCT called P#14 but he stated that he was on his way to work and did not show up for his dialysis treatment. The Charge Nurse did not offer any documentary evidence to confirm that P#14’s dialysis treatment was rescheduled. The Facility Administrator and the Charge Nurse, on 6/26/25 at 11:30 a.m., were not able to provide any documentary evidence of the reason why P#14 did not have dialysis treatments on the above mentioned dates, the reason for missed treatments, or if P#14’s dialysis treatments were rescheduled. P#14’s dialysis treatment flowsheet dated 6/13/25, after P#14’s weight was obtained at 7:03 a.m., did not show the disposition of P#14 when dialysis treatment was not performed and the treatment record did not show that P#14’s dialysis treatment was rescheduled. A review of facility Policy 46940, titled, “Medical Record Documentation Standards” and published on 02/05/2024, stated: - The dialysis facility must monitor and maintain complete, accurate, and accessible records on all patients ... - These records will reflect the condition of the patient from the time of the first dialysis treatment until the patient is discharged. During a telephonic interview on 6/30/25 at 8:00 a.m., P#14 revealed the following: P#14 stated that he always showed up for his treatments but had been turned away because his treatments started later on the first shift; and if a staff member did not show up for work, the Direct Patient Care (DPC) staff (nurses and PCTs), told him that per State regulation they can only dialyze 16 patients per shift, so they turned P#14 away. P#14 also stated that he was told by the DPC staff that he can give them a call later to see if they can reschedule his treatment for that day or the next day. P#14 added that he still worked but needed his dialysis treatments at his scheduled time. P#14 explained that his start time for dialysis was at 7:00 a.m. He usually arrived around 6:45 a.m., on his regular dialysis treatment days and rang the doorbell in the Patient Lobby after waiting past his dialysis start time. P#14 added that he rang the doorbell every 10 minutes for 30 minutes but nobody came. The DPC staff told him that they didn’t hear the doorbell. P#14 also added that he lived 20 minutes away and they called him after he was almost home, and asked him to come back. P#14 also stated that LPN FF tried to convince the other staff to let him stay, and LPN FF had told Registered Nurse (RN II) that he needed to have his dialysis treatment, but RN II said that P#14 couldn’t stay because of the 16-patient rule per shift.”