Fmcna - Sapulpa Dialysis

“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: 34696 Based on observation, record review, and interview, the facility failed ensure expired medications were discarded in accordance with the manufacturer’s directions in one of five areas (Medication area). Findings included: A review of the “Medication and Preparation and Administration” policy dated 02/06/2023 indicated, “Monitoring Expired Medications...Expiration dates for all stored medications are to be monitored on a monthly basis...Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law.” On 03/10/2025, the following was observed during a tour of the facility: ~ At 9:50 AM, it was observed in the Medication area, three 100 ml (milliliter) bags of intravenous (IV) normal saline was not stored in the manufacturer’s protective packaging. The normal saline bags expired in 11/2024. On 03/10/2025 at 9:50 AM, the Clinic Manager (Personnel #1) said the IV bags were expired. The Clinic Manager said the staff nurses used the saline for reconstituting medications. She said the nurses should check the expiration dates prior to administering medications.”

“BICARB JUGS RINSED DAILY/STORED DRY CFR(s): 494.40(a) 6.5 Concentrate distribution: bicarb jugs rinsed daily/stored dry Bicarbonate concentrate jugs should be rinsed with treated water and stored inverted at the end of each treatment day. Pick-up tubes should also be rinsed with treated water and allowed to air dry at the end of each treatment day. This Standard is not met as evidenced by: 34696 Based on observation, interview, and record review, the facility failed to ensure that bicarbonate concentrate jugs that were available for use in two of five areas (Bicarb Mixing area and Concentrate area) were rinsed with treated water and stored inverted. Findings included: A review of the “Rinsing, Disinfection, and Storage of Bicarbonate Concentrate Containers, Caps, and Wands” policy dated 02/03/2025 indicated, “Storage....Concentrate containers should be stored in a manner that prevents contamination and reduces environmental exposure to dust and debris.” On 03/10/2025, during a tour of the facility, the following was observed: ~ At 10:15 AM, three bicarbonate jugs were observed sitting underneath a utility sink At the time of the findings, the Biomed (Personnel #2) said the jugs should be stored in the concentrate area. ~ At 10:25 AM, it was further observed in the Concentrate area that approximately 30 bicarbonate jugs sat on an overhead shelf. The jugs were not stored inverted. On 03/10/2025 at 10:30 AMs, Personnel 2 said the jugs should be inverted when stored away.”

“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: 34696 Based on observation, record review, and interview, the facility failed to maintain the building to ensure the safety of the patients, staff, and the public in two of five areas (Bicarb Mixing and Concentrate areas). Findings included: A review of the “General Cleanliness and Infection Control Guidelines” policy published 02/07/2022 indicated, “All areas must be kept clean and organized, including but not limited to the treatment area , water supply room...Facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff...Such cleaning should be done regularly using a schedule developed by the facility...A written schedule of cleaning procedures shall be established, reviewed, documented annually in Governing Body and implemented which sets forth the cleaning and method of decontamination considering the types of surfaces, soils, and tasks and procedures being performed per policy.” On 03/10/2025, during a tour of the facility, the following was observed: ~ At 10:15 AM, it was observed that the floors in the Bicarb Mixing area and the Concentrate area had not been cleaned. The floors were gray with dirt and tire tracks. On 03/10/2025 at 10:20 AM, the Clinic Manager (Personnel #1) and the Biomed (Personnel #2) said the janitorial service cleans the facility every night, but they were not allowed in the water treatment areas. The Biomed said the staff at the facility should be maintaining the floors.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 34696 Based on record review and interview, the IDT (Interdisciplinary Team) failed to develop and implement a completely written, individualized POC (Plan of Care) for one of four patients (Patient #2). Findings included: A review of the “Comprehensive Interdisciplinary Assessment and Plan of Care” policy dated 07/03/2023 included, “Responsibility ...Interdisciplinary Care Team (Registered Nurse, Attending Physician, and Physician extenders ...Social Worker, Registered Dietitian ...The CIA (Comprehensive Interdisciplinary Assessment) and POC must be developed and implemented by an IDT ...The CIA includes ...Evaluations of factors associated with anemia and potential treatment plan for anemia.” The facility’s goal for anemia management is 10 to 11 Plan of Care process. ~Patient #2: The “Lab Results and Medication Administration Summary” dated from 12/10/2024 to 03/10/2025 indicated that Patient #2’s low hemoglobin ranged from 7.4 g/dL (grams per deciliter) to 9.0 g/dL from 01/02/2025 to 02/06/2025. The Clinical Record did not include documented evidence that the IDT developed and implemented a completely written, individualized initial POC for Patient #2. The POC dated 01/24/2025 did not include a plan for anemia. ~Patient #3: The “Lab Results and Medication Administration Summary” dated from 12/10/2024 to 03/10/2025 indicated that Patient #3’s low hemoglobin ranged from 7.4 g/dL to 9.4 g/dL from 12/11/2024 to 03/05/2025. The Clinical Record did not include documented evidence that the IDT developed and implemented a completely written, individualized unstable POC for Patient #3. The POC dated 01/10/2025 did not include a plan for anemia. On 03/11/2025 at 1:45 PM, the Director of Operations said Patient #2 and Patient #3’s POCs did not include the anemia section and/or a plan for anemia.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 34696 Based on record review and interview, the facility failed to identify and report all near miss and/or adverse events for one of one patient (Patient #1). Findings included: A review of the “Patient Safety Event Reporting and Documentation” policy dated 02/06/2023 included, “Near Miss does not result in patient clinical harm, either through early detection or sheerluck. It is an unsafe situation that is indistinguishable from a safety event except for the outcome....Policy...When a Near Miss...occurs, staff are required to report, document, and review the event as noted in this policy. Staff are responsible for timely completion of these policy requirements.” ~ On 03/10/2025 at 10:50 AM, Patient #1 was interviewed at in-center hemodialysis station #5. Patient #1 said they were given the wrong antibiotic in January 2025. Patient #1 said when the nurse realized what happened, she stopped the medication and gave it to the patient sitting across from them. Patient #1 did not know the other patient’s name. Patient #1 said they mentioned the incident to the Clinic Manager (Personnel #1). Patent #1 said the Clinic Manager did not indicate that there would be an investigation. A review of the physician’s order dated 12/06/2024 indicated, “Order...Administer IV (Intravenous) Meropenem (A medication used to treat infections) one gram oh HD (hemodialysis) days Monday-Wednesday-Friday through 01/24/2025.” The hemodialysis treatment record dated 01/17/2025 did not include documented evidence Patient #1 received the Meropenem. The facility’s “Adverse Event” listing dated from 03/10/2024 through 03/10/2025 did not include that an adverse event report had been created. The “Early Termination of Treatment Against Medical Advice” form dated 01/17/2025 included the following note from patient #1, “My antibiotics take one hour to run in. My antibiotics was finished in 15 minutes with 45 minutes left of run time. That’s 45 minutes to dialyze out.” On 03/11/2025 at 11:15 AM, the Clinic Manager said she was made aware by the agency RN (Registered Nurse, Personnel #12) that she had the medication at chair side but did not connect the line. The Clinic Manager said “Like it was a near miss.” On 03/11/2025 at 11:15 AM, the Facility Administrator (Personnel #11) said there was no documented evidence of a near miss report.”