Fresenius Kidney Care - Bartow 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, a review of Centers for Disease Control and Prevention (CDC) recommendations, staff interview, 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] 6, 9, and 13, who held pressure to their access sites for hemostasis (stopping of the flow of blood) after dialysis, performed hand hygiene after removing used gloves; two of two Registered Nurses (RN/CM, RN JJ) and two of two Patient Care Technicians (PCT EE and PCT KK) observed, removed used gloves and performed hand hygiene between glove changes. This deficient practice had the potential for cross contamination and increased risk of infection and could negatively affect the health and safety of 54 hemodialysis patients who dialyzed at this facility. Findings include: During observation in the Patient Treatment Room on 4/30/25 between 8:30 a.m. and 9:48 a.m., the following was revealed: - Three patients, seated at Stations [S] 6, 9, and 13, 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 three patients were not reminded by the staff (nurses nor PCTs), to wash their hands nor offered to use a hand sanitizer after glove removal. The Clinical Manager (RN/CM) and the Director of Operations (DO) were informed about observations made of patients removing gloves after holding pressure to access sites and leaving the Patient Treatment Room without performing hand hygiene on 4/30/25 at 9:50 a.m. During observation in the Patient Treatment Room on 5/1/25 between 5:30 a.m. and 7:10 a.m., the following was revealed: - RN/CM was observed at 5:43 a.m., performing initiation of hemodialysis treatment tasks to a patient with a Central Venous Catheter (CVC) at S1. RN/CM did not perform hand hygiene when she changed gloves or between glove changes during the following tasks: (after removal of old CVC dressing, after cleansing CVC access insertion site and applying clean dressing, when changing gloves to connect syringes to CVC ports, and before clamping tubing to patient’s clothing). - PCT EE was observed at 5:50 a.m., performing initiation of hemodialysis treatment tasks to a patient with an arterio-venous access at S2 with gloved hands without removing gloves and performing hand hygiene after inserting fistula needles into patient’s access sites. Glove removal and hand hygiene were not performed by PCT EE until all initiation tasks were completed. - PCT KK was observed at 6:13 a.m., performing initiation of hemodialysis treatment tasks to a patient with an arterio-venous access at S11 with gloved hands without removing gloves and performing hand hygiene after inserting fistula needles into patient’s access sites. Glove removal and hand hygiene were not performed by PCT KK until all initiation tasks were completed. - RN JJ was observed at 6:58 a.m., performing initiation of hemodialysis treatment tasks to a patient with a CVC at S12. RN JJ did not remove gloves and did not perform hand hygiene until all initiation tasks were completed. 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) was informed about the above observations on 5/1/25 at 7:16 a.m. The DO stated that staff will receive an infection control inservice. A review of Policy 47664 titled, “Hand Hygiene” and published 11/06/2023 stated the following: 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-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 03383 Based on observation and staff interview, it was determined that the facility failed to maintain a clean, orderly, and safe environment. These environmental concerns were observed in one of one Patient Treatment Room, one of one Storage Room, and one of one Biomedical Technician’s (BMT’s) Room. This deficient practice could negatively affect the health and safety of all staff and 54 patients who were receiving dialysis treatment at this facility. Findings include: During a tour of the facility with the Clinical Manager (CM) on 4/30/25 at 9:38 a.m. and a tour with Patient Care Technician (PCT EE) on 5/1/25 at 4:20 a.m., the following were observed: In the Patient Treatment Room: - The flooring in front, side, and back of stations (S)1, 2, 3, 4, 5, were buckling and discolored, with one piece of the floor tile, (measuring about 3-4 centimeters (cm) in diameter) and other smaller pieces, missing. - The walls had nicks, scrapes, and holes throughout the Patient Treatment Room. In the Dialysate Preparation Room, Storage Room, BMT’s Room: - The walls in the corridor leading to the Dialysate Preparation Room, as well as the walls in the Storage Room, Dialysate Preparation Room and the BMT’s Room, had nicks, scrapes, and holes throughout the walls. -The flooring in the Dialysate Preparation Room and Storage Room were buckling and large chunks of the flooring concrete material were missing, which were approximately 12 - 14 inches in diameter. -The floor in the BMT’s Room was dirty with black debris and there were chunks of plaster and powder on the floor. -The exit door from the Dialysate Preparation Room/Storage Room area near the BMT’s Room, was scuffed up and dirty. The above findings were confirmed with the Clinical Manager and Director of Operations on 5/1/25 at 5:00 a.m. The CM stated that a purchase order was approved to repair flooring on 1/28/25 but they were still waiting for repairs to be initiated.”

“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 and staff interview, it was determined that the facility failed to ensure that two of 13 patients (P#11 and P#12) observed, had their vascular access sites uncovered/visible to the staff throughout their dialysis treatment, to ensure patient safety. 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 54. Findings include: During observation in the Patient Treatment Room on 4/30/25 between 8:30 a.m. and 9:48 a.m., the following was revealed: - P#11and P#12 were seated at Stations (S) 15 and 16, respectively. Both patients’ access sites were completely covered with a blanket at 9:02 a.m. These patients’ (P#11’s and P#12’s) dialysis access sites were not visible during their treatment. The Direct Patient Care (DPC) Staff (Licensed Practical Nurse - LPN CC and Patient Care Technician - PCT DD), were right by P#11 and P#12, (LPN CC was at the sink between S15 and S16 and PCT DD was working with dialysis machine at S15), but both LPN CC and PCT DD, failed to educate/instruct P#11 and P#12 on the importance of keeping their access sites uncovered, and visible to the DPC Staff during their dialysis treatment. The Clinical Manager was informed of the above findings on 4/30/25 at 9:05 a.m.”

“POC-PT/FAMILY EDUCATION & TRAINING CFR(s): 494.90(d) The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types. This Standard is not met as evidenced by: 03383 Based on a review of medical records and staff interviews, it was determined that the Interdisciplinary Team (IDT) failed to provide education to two of two new to End Stage Renal Disease (ESRD) patients, (P#1 and P#5) sampled, regarding the types, risks, benefits and care of their vascular accesses, (including but not limited to personal hygiene related to dialysis access care, infection control and prevention, handwashing), dietary and fluid management, rights and responsibilities, complaints and grievances, medications, emergency preparedness plan, and involuntary discharge. This deficient practice had the potential to negatively affect the health and safety of P#1 and P#5). The facility census was 54. Findings include: A review of the medical records of P#1 and P#5, who were both admitted to this facility on 2/18/25, (less than 90 days), revealed the following: P#1’s and P#5’s Care Plans and patient records were missing the following proof of education and training: - A review of the medical records provided by the Clinical Manager, lacked documentation to show that both P#1 and P#5, received education and training that included but not limited to: Emergency Preparedness Plan, Medications, Infection Control, Access Care, Handwashing, Fluid Management, Central Venous Catheter (CVC) care, Permanent Access, Rights and Responsibilities, Complaints and Grievance Procedure, Involuntary Discharge, and Fire and Disaster drills. - On 5/2/25 at 8:49 a.m., the Clinical Manager confirmed that there were no documented evidences that the patients listed above received education and training covering the above topics.”

“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: 03383 Based on a review of medical records, staff interviews, and review of facility Policy and Procedures (P & P), it was determined that the Medical Director failed to ensure that all direct patient care staff, (Registered Nurses [RNs] and Patient Care Technicians [PCTs]), adhered to facility P & P pertaining to high blood pressure (BP) readings, to ensure that one of one patient (P), (P#4) sampled, who experienced high BP readings before, during, and after dialysis treatment, received medical care and supervision appropriate to their dialysis needs. The professionally accepted clinical practice standards for volume status for an adult hemodialysis patient was euvolemic (normal volume of blood or fluids in the body) and BP below 140/90 mmHg {millimeters of mercury) before dialysis and below 130/80mmHg after dialysis. This was based on the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations and the Measures Assessment Tool (MAT) per Centers for Medicare and Medicaid Services (CMS) -Version 2. 5. Uncontrolled BP in dialysis patients can lead to severe consequences such as increased risk of heart attack, stroke, and heart failure, as the damaged kidneys are unable to regulate fluid and BP effectively, making cardiovascular complications a major concern for dialysis patients. The facility census was 54. Findings include: - A review of the facility’s Hospital Discharge Summaries showed that P#4 was admitted to the hospital with Hypertensive Urgency on the following dates: - On 11/26/24 - From 12/10/24 to 12/12/24 - From 1/4/25 to 1/5/25 - From 1/10/25 to 1/11/25 and; - From 1/21/25 to 1/23/25. A review of P#4’s “Treatment Flowsheets” from 4/17/25 - 4/29/25 revealed the following: On 4/24/25: Pre-Dialysis Vitals and Evaluation entered by LPN CC at 10:13 a.m. on 4/24/25, showed that P#4’s sitting BP was 213/114 and LPN CC documented, “No new findings.” There was no documentary evidence of any interventions, nor acknowledgement of the high BP readings by LPN CC. -At 10:24 a.m., BP was 221/116 mmHg. Treatment was initiated by LPN CC -At 11:01 a.m., BP was 209/111 mmHg. -At 11:39 a.m., BP was 221/115 mmHg. -At 12:05 p.m., BP was 218/89 mmHg. -At 12:06 p.m., BP was 218/89 mmHg. -At 12:34 p.m., BP was 223/111 mmHg. -At 1:04 p.m., BP was 187/96 mmHg. -At 1:32 p.m., BP was 184/102 mmHg. RN AA did not acknowledge elevated BP. -At 2:01 p.m., BP was 192/106 mmHg. -At 2:23 p.m., BP was 187/112 mmHg. -At 2:24 p.m., Post dialysis sitting BP was 207/106 mmHg. Between 11:01 a.m. and 2:24 p.m., (except at 1:32 p.m.), PCT EE checked the BP readings (as shown above), however, there were no documentary evidences that PCT EE acknowledged nor reported P#4’s high BP readings to RN AA. - The Post Dialysis Nursing Evaluation documented by RN AA on 4/24/25 at 2:24 p.m., stated: “No unusual findings noted. pt tolerated tx well, no new findings - post HD. fluid status improved. tx terminated without issue. VS stable for discharge ...” The Nursing Evaluation note did not acknowledge nor address elevated BP readings throughout P#4’s dialysis treatment nor any interventions provided to address P#4’s elevated BP readings per facility P & P and MD order. In addition, there was no documentary evidence that LPN CC or PCT EE notified RN AA regarding P#4’s elevated BP readings. - A review of P#4’s medication orders showed that P#4 had a PRN (as needed) order, dated 7/23/24, which stated: Clonidine HCl 0.1 mg ORAL PRN-may repeat x1 for (systolic BP) SBP > (greater than) 160 ...Essential (primary) hypertension. Pt#4’s Treatment Records were reviewed with the Clinical Manager (CM) on 5/2/25 at 7:51 a.m. The CM stated, “The patient will not take her BP meds as scheduled”. However, the CM agreed that staff should have addressed elevated BP readings on 4/24/25. A review of facility Policy titled, “Hypertension” and published on 09/07/2021 stated the following: Staff will recognize, report, and immediately address systolic blood pressures greater than 180 mm/Hg and/or diastolic blood pressures greater than 100 mm/Hg. Follow the steps below to address hypertension: - Notify the nurse in charge if a patient has a systolic blood pressure greater than 180 mm/Hg and / or diastolic blood pressure greater than 100 mm/Hg. - The RN will assess the patient and determine if further nursing interventions are needed. - If hypertension is related to hypervolemia, decrease EDW: Follow CMAB Fluid Management algorithm or notify physician for possible estimated dry weight adjustment outside of algorithm parameters. - If hypertension is not related to hypervolemia, notify the physician for additional orders/interventions. - Document in patient’s treatment record.”