Fmc - Nephrology - Elkhart

“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: 44714 Based on observation, record review, and interview, the agency failed to ensure employees followed standards of practice for hand hygiene to reduce the spread of infections for 1of 2 PCTs who worked on 09/04/2025 (PCT 1). Findings include: The agency Hand Hygiene policy, dated 11/06/2023, indicated hand hygiene with alcohol-based hand rub was required after touching a potentially soiled area in the treatment area, removal of a soiled dressing, and moving from a dirty site to a clean area. During an observation on 09/04/2025 at 11:37 AM, PCT 1 prepared to discontinue Patient #8’s dialysis. PCT 1 adjusted the dialysis machine, then used antiseptic to disinfect the CVC hubs. PCT 1 failed to complete hand hygiene after touching the dialysis machine and before completing a clean procedure. After dialysis was discontinued, PCT 1 performed care to Patient #8’s CVC (provides access to a large vein near the heart) exit site. PCT 1 failed to change gloves and complete hand hygiene after removing the soiled dressing and prior to disinfecting the CVC exit site. During an interview on 09/09/2025 beginning at 10:15 AM, PCT 1 indicated hand hygiene was required after touching the dialysis machine and after removing a soiled dressing. PCT 1 did not recall that they had not completed hand hygiene per policy.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 44714 Based on observation, record review, and interview, the facility failed to ensure patient restrooms contained soap for handwashing for 1 of 2 patient restrooms. Findings include: The facility “Hand Hygiene” policy, dated 11/06/2023, indicated sinks would have soap and hot and cold running water. During an observation on 09/04/2025 at 01:30 PM, one patient restroom soap dispenser failed to provide soap when a hand was under the dispenser. During an interview on 09/04/2025 at 03:14 PM, the Administrator indicated there was soap in the dispenser, but the batteries did not work so the soap was not dispensed.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 44714 Based on observation, record review, and interview, the agency failed to ensure emergency medications were available for use and were not expired for 1 of 1 emergency cart. Findings include: The facility “Storage of Supplies,” dated 04/05/2021, indicated staff must dispose of expired supplies. During a treatment floor observation on 09/04/2025 at 12:04 PM, observed one bottle of Nitroglycerin tablets with an expiration date of 07/2025 in the emergency cart. During an interview on 09/04/2025 beginning at 03:30 PM, the FA indicated the CM checked the contents of the emergency cart every month and there should not be any expired medication.”

“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: 44714 Based on observation, record review, and interview, the facility failed to ensure emergency supplies were available and were not expired for 1 of 1 emergency cart. Findings include: The facility “Storage of Supplies,” dated 04/05/2021, indicated staff must dispose of expired supplies. During a treatment floor observation on 09/04/2025 at 12:04 PM, observed Yankauer suction tip (used to suction secretions in the mouth and back of throat), with an expiration date of 08/2025. Three nasal cannulas (tubing for an oxygen face mask) expired 08/15/2025. During an interview on 09/04/2025 beginning at 03:30 PM, the FA indicated there should be no expired supplies in the emergency cart.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 44714 Based on record review and interview, the IDT failed to monitor and maintain Patient #1’s blood pressure to ensure the vascular access remained intact, for 1 of 1 patient with an arteriovenous graft of the thigh. Findings include: A review of Patient #1’s treatment sheets evidenced a section titled “Special Attentions,” which stated, “Patient must maintain systolic b/p >110 while on treatment to prevent access from clotting.” Treatment sheets for 09/03/2025, 08/29/2025, and 08/22/2025, included systolic blood pressures below 110. There was no documentation the PCT notified the nurse, and no action was taken by the nurse to address the systolic blood pressure. During an interview on 09/09/2025 beginning at 12:20 PM, the CM indicated Patient #1 had limited options for another access site and it was important to maintain the current access. The CM confirmed there was no action taken when systolic blood pressure was below 110.”

“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: 44714 Based on record review and interview, the Medical Director failed to ensure direct care staff followed policy and notified the nurse when blood pressure readings were outside the parameters for 4 of 7 patient records reviewed (Patients #2, 3, 5, and 7) and failed to ensure staff monitored and maintained blood pressure to ensure the vascular access remained intact, for 1 of 1 patient with an arteriovenous graft of the thigh. (Patient #1) Findings include: 1. The facility policy “Patient Assessment and Monitoring,” dated 05/01/2023, identified blood pressure parameters that require notification to the nurse. Parameters are Systolic blood pressure more than 180 or equal to or less than 100; diastolic blood pressure greater than 100. 2. Patient #2’s treatment sheets dated 08/29/2025, 08/27/2025, 08/25/2025, and 08/22/2025, identified blood pressure readings over 180 systolic and over 100 diastolic. There was no documentation the PCT notified the nurse of the out-of-range blood pressure readings. 3. Patient #3’s treatment sheets dated 05/28/2025 and 05/07/2025 identified significantly high blood pressure readings, with both systolic and diastolic out of range. 4. Patient #5’s treatment sheet dated 08/29/2025 indicated a diastolic blood pressure reading over 100. There was no documentation the PCT notified the nurse. 5. Patient #7’s treatment sheets for 09/01/2025, 08/29/2025, 08/27/2025, 08/25/2025, and 08/13/2025 identified blood pressure readings over 180 systolic and over 100 diastolic. There was no documentation the PCT notified the nurse of the out-of-range blood pressure readings. 6. During an interview on 09/09/2025 beginning at 12:35 PM, the Clinical Manager indicated they were aware PCTs did not document when they spoke to the nurse about a patient issue, and they were auditing the notes for compliance. 7. A review of Patient #1’s treatment sheets evidenced a section titled “Special Attentions,” which stated, “Patient must maintain systolic b/p >110 while on treatment to prevent access from clotting.” Treatment sheets for 09/03/2025, 08/29/2025, and 08/22/2025, included systolic blood pressures below 110. There was no documentation the PCT notified the nurse, and no action was taken by the nurse to address the systolic blood pressure. During an interview on 09/09/2025 beginning at 12:20 PM, the CM indicated Patient #1 had limited options for another access site and it was important to maintain the current access. The CM confirmed there was no action taken when systolic blood pressure was below 110.”