Fresenius Kidney Care Louisa

“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: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure 2 (Registered Nurse (RN) 2 and Patient Care Technician (PCT) 6) of 5 staff observed providing patient care, performed hand hygiene per facility policy. The findings include: Review of the facility’s policy titled, “Hand Hygiene,” published 11/06/2023, revealed, “The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination.” The policy indicated hands would be “Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water” in the following situations: “- 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. - After contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled. - After contact with inanimate objects near the patient. - When moving from a contaminated body site to a clean body site of the same patient. - After contact with the dialysis wall box, concentrate, drain, or water lines. - After contact with other objects within the patient station or treatment space.” During an observation on 04/28/2025 at 4:51 PM, PCT6 was observed at Patient Treatment Station 8 providing central venous catheter (CVC) exit site care. PCT6 removed the patient’s CVC dressing, cleaned the exit site, and applied a new dressing. PCT6 failed to perform hand hygiene after removing the dirty CVC dressing. During an interview on 04/28/2025 at 5:30 PM, PCT6 stated that their normal practice when changing a CVC dressing was to perform hand hygiene, don gloves, remove the CVC dressing, and perform hand hygiene and change gloves before cleaning the exit site. PCT6 stated that they forgot because they were nervous. During an observation on 04/30/2025 at 10:08 AM, RN2 was observed at Patient Treatment Station 10 discontinuing dialysis treatment for a patient with an arteriovenous fistula (AVF). RN2 performed hand hygiene, donned clean gloves, reinfused the patient’s blood, disconnected the bloodlines, then removed the cannulation needle from the AVF. RN2 failed to perform hand hygiene or change her gloves prior to removing the cannulation needle. During an interview on 04/30/2025 at 4:53 PM, RN2 revealed the facility expectation was to perform hand hygiene prior to removing cannulation needles. RN2 stated that she normally performed hand hygiene and changed gloves prior to removing cannulation needles but failed to do so during this observation because she was nervous. During an interview on 05/01/2025 at 2:00 PM, the Medical Director revealed that the facility expectation was for the staff to perform hand hygiene per facility policy.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure that all environmental surfaces in 2 (Patient Treatment Station 8 and Patient Treatment Station 10) of 13 patient dialysis stations observed were disinfected post-treatment. The findings include: Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station,” published 09/05/2023, revealed, “Background - The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses.” The policy revealed a dialysis station was the “Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment, patient training, and/or patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments such as IV [intravenous] pole, BP [blood pressure] cuff and hand sanitizer/holder, organizer.” During an observation of the hemodialysis treatment area on 04/28/2025 at 4:50 PM, Patient Care Technician (PCT) 6 and PCT7 were observed disinfecting Patient Treatment Station 8 following a dialysis treatment. The observation revealed the PCTs failed to disinfect the counter behind the treatment chair. During an interview on 04/28/2025 at 4:59 PM, PCT6 stated the counter behind the treatment chair was part of the treatment station and should be cleaned as part of treatment station disinfection. PCT6 stated, “I always do it. I just forgot.” During an observation of the hemodialysis treatment area on 04/30/2025 at 10:18 AM, Registered Nurse (RN) 1 and RN2 were observed disinfecting Patient Treatment Station 10 following a dialysis treatment. The observation revealed the RNs failed to disinfect the counter behind the treatment chair. During an interview on 04/30/2025 at 4:53 PM, RN2 revealed the counter behind the treatment chair was not disinfected. RN2 stated it was not disinfected, likely due to a lack of communication between the RNs as they were cleaning the station together. During an interview on 05/01/2025 at 2:00 PM, the Medical Director stated the facility’s expectation was that all dialysis treatment stations, including the back counters, be cleaned per facility policy after every dialysis treatment.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the facility failed to monitor fluid volume status for 2 (Patient (P) 1 and P2) of 3 patients sampled for in-center hemodialysis medical record review. The findings include: Review of the facility’s policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, revealed, “Report to the nurse: -Systolic blood pressures greater than 180 mm/Hg [millimeters of mercury, unit of measurement for blood pressure] -Diastolic blood pressure greater than 100 mm/Hg -Blood pressure less than or equal to 100 mm/Hg systolic” The policy further indicated, “Report to the nurse patients whose heart rates have dropped below 60 [beats per minute, bpm], risen above 100 [bpm] or become irregular.” 1. Review of P1’s “Treatment Sheet For Facility,” dated 04/14/2025, revealed Patient Care Technician (PCT) 6 documented the patient’s heart rate was 102 beats per minute (bpm) at 12:09 PM, 103 bpm at 2:30 PM, and 103 bpm at 3:04 PM. The treatment sheet revealed no documentation that showed PCT6 notified a Registered Nurse (RN) of P1’s out-of-range heart rates. During an interview on 04/28/2025 at 5:50 PM, the Clinical Manager verified the facility’s policy was for PCTs to notify RNs if patients had systolic blood pressures greater than 180 or less than 100, diastolic blood pressures greater than 100, and heart rates greater than 100 bpm or less than 60 bpm. She confirmed there was no evidence that the PCT reported P1’s heart rate readings of greater than 100 bpm on 04/14/2025 to an RN. 2. Review of P2’s “Treatment Sheet For Facility,” dated 04/18/2025, indicated PCT6 documented the patient’s blood pressure was 99/51 millimeters of mercury (mmHg) at 9:30 AM and 99/55 mmHg at 10:07 AM. The treatment sheet revealed no documentation that PCT6 notified an RN of P2’s out-of-range blood pressures. During an interview on 04/29/2025 at 10:17 AM, the Clinical Manager stated there was no evidence that the PCT reported P2’s systolic blood pressure of less than 100 to an RN. During an interview on 04/30/2025 at 12:33 PM, PCT5 stated PCTs were supposed to document patients’ vital signs, including their blood pressure and heart rate, every 30 minutes, and report out-of-range values to the nurse. In contrast with the facility policy, PCT5 stated out-of-range vital signs would include systolic blood pressure readings greater than 200 or less than 90 and heart rates greater than 100 bpm or less than 50 bpm. During an interview on 04/30/2025 at 2:50 PM, RN1 stated the facility’s expectation was for PCTs to report to the RNs if patients had systolic blood pressures greater than 180 and less than 100, diastolic blood pressure readings greater than 100, or heart rates greater than 100 bpm or less than 50 bpm. RN1 stated patients were monitored constantly, and checks were documented every 30 minutes, to include their heart rate, blood pressure, and status. During an interview on 05/01/2025 at 2:00 PM, the Medical Director confirmed his expectation was PCTs would monitor patients and report to the RNs according to the facility’s policy.”

“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: 50873 Based on interview, record review, and facility policy review, the Medical Director failed to ensure the facility adhered to policy and procedures related to patient care for 2 (Patient (P) 2 and P3) of 3 patients sampled for in-center hemodialysis. The findings include: Review of the facility’s policy titled, “Medication Preparation and Administration,” published 02/06/2023, revealed, “Medications must be administered with an order by a physician (or physician extender where allowed) on the medical staff of the facility.” The policy specified, “Follow the principles below for medication preparation and administration. -Right Drug -Right Dose -Right Route -Right Time -Right Patient -Right Documentation.” 1. Review of P2’s “Treatment Sheet For Facility,” dated 04/18/2025, revealed an order for the patient to receive heparin (an anticoagulant or blood thinner) during treatment. The treatment sheet indicated Registered Nurse (RN) 1 started the patient’s heparin pump at 8:15 AM and the Clinical Manager stopped the infusion at 12:12 PM. The treatment sheet revealed the total amount of heparin administered was 2.0 milliliters (ml) for a total of 2,000 units. Review of P2’s “Treatment Sheet For Facility,” dated 04/21/2025, revealed an order for the patient to receive heparin during treatment. The treatment sheet indicated Patient Care Technician (PCT) 6 started the patient’s heparin pump at 8:53 AM and RN1 stopped the infusion at 10:53 AM. The document revealed the total amount of heparin administered was 1.5 ml, for a total of 1,500 units. Review of P2’s “Treatment Sheet For Facility,” dated 04/23/2025, revealed an order for the patient to receive heparin during treatment. The treatment sheet indicated that PCT6 started the patient’s heparin pump at 7:56 AM and stopped the infusion at 12:00 PM. The treatment sheet revealed that the total amount of heparin administered was 2.8 ml, for a total of 2,800 units. Review of P2’s “Treatment Sheet For Facility,” dated 04/25/2025, revealed an order for the patient to receive heparin during treatment. The treatment sheet indicated the Clinical Manager started the patient’s heparin pump at 11:42 AM and stopped the infusion at 3:42 PM. The treatment sheet revealed the total amount of heparin administered was 2 ml, for a total of 2,000 units. During an interview on 04/28/2025 at 5:50 PM, the Clinical Manager confirmed that current orders pulled into the patient treatment sheets. During an interview on 04/29/2025 at 10:17 AM, the Clinical Manager identified P2’s ordered dose of heparin was 1,000 units per hour (units/hour). She stated P2 received 2 ml or 2000 units of heparin over four hours on 04/18/2025, instead of the 4 ml or 4,000 units of heparin they should have received. Per the Clinical Manager, P2 received 1,500 units of heparin on 04/21/2025, but they should have received 2 ml, or 2,000 units. She confirmed P2 received 2,800 units of heparin on 04/23/2025 instead of 4 ml or 4,000 units as ordered. The Clinical Manager confirmed P2 should have received a total of 4.0 ml, or 4,000 units of heparin on 04/25/2025, but the documentation showed they received 2,000 units. The Clinical Manager stated there were no notes or documentation of rationales regarding the deviation from the prescription, including one-time orders. 2. Review of P3’s “Treatment Sheet For Facility,” dated 04/16/2025, revealed an order for the patient to receive heparin during treatment. The treatment sheet indicated RN1 started the patient’s heparin pump at 5:42 AM and stopped the infusion at 8:42 AM. The treatment sheet revealed the total amount of heparin administered was 1.5 ml, for a total of 1,500 units. Review of P3’s “Treatment Sheet For Facility,” dated 04/21/2025, revealed an order for the patient to receive heparin during treatment. The treatment sheet indicated RN2 started the patient’s heparin pump at 5:56 AM and stopped the infusion at 8:50 AM. The treatment sheet revealed the total amount of heparin administered was 1.5 ml, for a total of 1,500 units. Review of P3’s “Treatment Sheet For Facility,” dated 04/25/2025, revealed an order for the patient to receive heparin during treatment. The treatment sheet indicated RN1 started the patient’s heparin pump at 5:47 AM and PCT6 stopped the infusion at 9:38 AM. The treatment sheet revealed the total amount of heparin administered was 1.5 ml, for a total of 1,500 units. During an interview on 04/28/2025 at 5:50 PM, the Clinical Manager confirmed that current orders pulled into the patient treatment sheets. During an interview on 04/29/2025 at 12:15 PM, the Float Clinical Manager confirmed P3’s ordered dose of heparin was 500 units per hour (units/hour) with a 30-minute stop time. She stated on 04/16/2025 and 04/21/2025, P3’s heparin pump infusion stopped after three hours and 1,500 units, and not after 3.5 hours and 1.7 ml, or 1,700 units of heparin as ordered. The Float Clinical Manager confirmed that on 04/25/2025, P3’s heparin pump was stopped after the infusion of 1,500 units, but they should have received 1.7 ml, or 1,700 units. During an interview on 04/30/2025 at 12:33 PM, PCT5 stated staff had to stop the heparin pumps on the dialysis machines to ensure the documented stop time was correct. She stated patients with central venous catheters (CVCs) did not have a stop time, and patients “with a stick” (an arteriovenous fistula or arteriovenous graft that is cannulated with a dialysis needle for treatment) had a 1-hour stop time. When informed that some patients were noted to have a 30-minute stop time per the provider orders, PCT5 said, “I was not aware of that.” During an interview on 04/30/2025 at 2:50 PM, RN1 stated when staff set up the heparin pump, they would enter how long the pump was supposed to run, based on the provider’s order, and the machine would stop based on that time. RN1 stated patients who were “a stick” usually had a stop time of one hour, and CVCs did not have a stop time. During an interview on 04/28/2025 at 10:17 AM, the Clinical Manager confirmed the facility’s expectation was that all medications would be delivered as prescribed. On 05/01/2025 at 2:00 PM, the Medical Director stated he was responsible for ensuring all facility policies and procedures were followed. The Medical Director confirmed the facility’s expectation was that heparin would be delivered to patients as ordered by the provider.”