Fresenius Medical Care Abilene Lone Star

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 50181 Based on observation and interview, the facility staff failed to ensure that clean areas are clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle or store medication or clean supplies in the same or adjacent area to that where used equipment or blood samples are handled. During a tour of the facility’s in-center treatment area with the Clinic Manager (Staff #1) on the morning of 05/08/2024, the surveyor observed drawers in the laboratory area labeled for storage of fistula needles. Upon opening the drawers, unopened fistula needles were noted to be stored in the drawers located directly below the laboratory preparation area. During a tour of the facility’s in-center treatment area with the Clinic Manager (Staff #1) on the morning of 05/08/2024, the surveyor observed two face shields used by staff members as personal protective equipment (PPE) laying on the clean counter where clean supplies are stored while not in use by the staff members. During a tour of the facility’s storage and supply room with the Clinic Manager (Staff #1) on the morning of 05/08/2024, the surveyor observed a medication refrigerator with medications stored for use placed adjacent to a second refrigerator labeled, “Lab Only, Blood Specimens Only,” with a biohazard sticker placed on the outside. During a tour of the facility’s storage and supply room with the Clinic Manager (Staff #1) on the morning of 05/08/2024, the surveyor observed a box of Pneumococcal Vaccine (Pneumovax 23) inside the above-mentioned medication refrigerator with an expiration date of, “2023Aug10” printed on the box. The facility staff failed to recognize the vaccines had expired and discard on or before the printed expiration date. During the tour of the facility on 05/08/2024, the above findings were confirmed and acknowledged by the Clinic Manager (Staff #1).”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 50181 Based on observation and staff interview, the facility failed to ensure the external transducer protector was replaced immediately when it was visibly wet with blood on 1 of 16 patients receiving treatment to prevent blood contamination of the dialysis machines’ pressure monitors. The surveyor informed the Clinic Manager (Staff #1) of the observation during the tour. She discussed the findings with the patient care technician (Staff #3) who changed the wet transducer without incident.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 50181 Based on observation and staff interview during a facility tour on 05/08/2024 the facility failed to ensure expired supplies were discarded on or before the expiration date and not available for patient use in the facility. Findings included: During a tour of the facility treatment floor on the morning of 05/08/2024, the following expired supplies were found and available for patient use: 4 Hand sanitizers installed at clean sinks on the treatment floor in use beyond the printed manufacturer’s expiration date2 blue top laboratory blood sample tubes in the labororatory area for use with a printed manufacturer’s expiration date of 2024-05-04 In an interview with the Facility Administrator (Staff #1) on 05/08/2024 she confirmed the supplies were expired and still available for patient and staff use.”

“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: 50181 Based on observation and staff interview during a facility tour on 05/08/2024 the facility failed to ensure expired medications were discarded on or before the expiration date and not available for patient use in the facility. Findings included: During a tour of the facility on the morning of 05/08/2024, the following expired supplies and medications were found and available for patient and staff use: 1 box of Pneumococcal Vaccine (Pneumovax 23) in the medication refrigerator with an expiration date of, “2023Aug10” printed on the box In an interview with the Facility Administrator (Staff #1) on 05/08/2024 she confirmed the medications were expired and still available for patient use.”

“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: 50181 Based on observation and interview, the facility staff failed to ensure the citric acid pick-up wands were being rinsed and stored appropriately. This deficient practice allowed for possible contamination due to the wands not being cleaned thoroughly and stored in a clean area. During a tour of the facility on 05/08/2024, in the storage room the surveyor observed acid pick-up wands located on a rolling cart with citric acid containers. The acid pick-up wands were laying on a blue chux pad with noted discoloration and crystallization. There were noted spots of a dark colored substance inside the tubing of multiple wands. An interview with the Clinic Manager (Staff #1) on 05/08/2024 confirmed the findings.”

“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: 50181 Based on observation and interview, the facility staff failed to ensure the dialysis facility was maintained in a safe, functional, and comfortable treatment environment. This deficient practice has the likelihood to increase the risk of injury and increase the risk of infections to dialysis patients receiving treatment at the facility. During a tour of the facility on the morning of 05/08/2024 the following were noted: *Multiple areas of wall damage and floor damage entering the treatment area and on the treatment floor. The Clinic Manager (Staff #1) indicated this was a result of a past water leak in the facility with a pending work order for repairs to be completed. *Acid build-up noted on primary and secondary acid storage tanks located in the water room *White, crystallized substance noted on the water room floor in multiple locations *White residue noted on the tiles of the water room floor *Dust and dirt noted throughout the water room and storage room *Hand crank, hand sanitizer bottle and equipment part noted on the floor under the sink in the technical work area location in the storage room *White, crystallized substance noted on rolling cart, in the storage room, storing citric acid bottles and wands *Trash, dirt and used testing strips on the water drain grate located in the water room floor *Dried, white residue noted on treatment area floors, backs of machines and walls surrounding the wall boxes *Missing and damaged trim on the floor scale on the treatment floor *Dirt, hair and gauze in the bottom shelf of the laboratory refrigerator located on the treatment floor The Clinic Manager (Staff #1) accompanied the surveyor on the tour of the facility and all findings were acknowledged and confirmed.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 50181 Based on medical record review, policy review and staff interview the facility failed to ensure the direct patient care (DPC) staff reported patient status changes during treatment to the Registered Nurse (RN) to ensure a reassessment was performed and documented with appropriate interventions and/or physician notification, if required. Findings included: A review of the facility’s protocol titled, “Patient Evaluations reportable by Direct Patient Care Staff to Registered Nurse,” includes the following guidance: “PRE-HEMODIALYSIS TREATMENT Weight Below estimated dry weight (EDW) or Weight Gain greater than 3.0kg Blood Pressure Systolic <100 or >180 Diastolic <50 or >100 Respirations <14 or >24 IE: Cyanosis INTRADIALYTIC Blood pressure Systolic <100 or >180 Diastolic <50 or >100 Pulse <60 or >100 Respirations <14 or >24 labored breathing-cyanosis POST HEMODIALYSIS Weight +/- 1.0 kg from EDW Blood Pressure Systolic <100 or >180 Diastolic <50 or >100 Pulse <60 or >100” Patient #4 treatment record dated 05/06/2024 reveals the following: 08:32: Pulse 58 09:32: Pulse 57 There is no documentation acknowledging the low pulse readings were a reportable finding and was reported to the RN by the DPC staff. There is no follow-up documentation from the RN regarding the low pulse during treatment or in the post assessment by the RN indicating the low pulse during treatment was resolved prior to discharge from the facility. Patient #5 treatment record dated 05/06/2024 reveals the following: 09:33: Pulse 101 There is no documentation acknowledging the high pulse reading was a reportable finding and was reported to the RN by the DPC staff or rechecked for accuracy of the reading. There is no follow-up documentation from the RN regarding the high pulse during treatment. Patient #6 treatment record dated 05/06/2024 reveals the following: 08:17: Pulse 56 08:34: Pulse 55 09:03: Pulse 56 09:34: Pulse 58 10:03: Pulse 59 11:05: Pulse 58 There is no documentation acknowledging the low pulse readings were a reportable finding and was reported to the RN by the DPC staff. There is no follow-up documentation from the RN regarding the low pulse during treatment or in the post assessment by the RN indicating the low pulse during treatment was resolved prior to discharge from the facility. 12:12: Blood Pressure 90/48 Comments: “Access visible; RN notified, Green AMP Light, Denies Complaints, UF off, Patient alert; UF off rest of treatment, monitoring patients bp.” RN post discharge note at 12:21 reads: “pt discharged home, stable. EDW met.” There is no follow up by the RN regarding the low BP and interventions completed by the DPC. The post RN assessment completed does not discuss the out of parameter vitals and interventions completed during treatment or note that the BP and pulse were stable at discharge. Patient #9 treatment record dated 05/06/2024 reveals the following: 07:06: Pulse 58 07:33: Pulse 59 08:05: Pulse 57 RN post discharge note at 10:46 reads: “pt discharged home, stable. EDW met.” There is no documentation acknowledging the low pulse readings were a reportable finding and was reported to the RN by the DPC staff. There is no follow-up documentation from the RN regarding the low pulse during treatment or in the post assessment by the RN indicating the low pulse during treatment was resolved prior to discharge from the facility. On 05/08/2024, the findings were reviewed with the Clinic Manager (Staff #1) and Area Team Lead (Staff #2) they acknowledged the findings.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 50181 Based on record review, the facility failed to follow the patient’s ordered plan of care by not following the ordered blood flow rate (BFR) and/or dialysate flow rate (DFR) for one or more treatment records reviewed. The specific BFR is needed to ensure that the blood pump is at constant speed to push the patient’s blood through the dialyzer and back into the patient’s body and is a part the patient’s dialysis prescription. Review of Patient #1 treatment record for 05/06/2024 revealed the BFR was ordered to run at 500 mL/min. Review of the intradialytic records revealed the BFR ran at 400 mL/min from the treatment start time of 06:12 until 06:32. The BFR ran at the prescribed rate of 500 mL/min from 06:33 until the end of the treatment at 10:17. There is no evidence of documentation from the direct patient care staff indicating the reason the BFR was not set to the prescribed rate or that the registered nurse (RN) was notified of the variation. There is no documentation from the RN related to the variation in hemodialysis orders for the treatment. Review of Patient #2 treatment record for 05/06/2024 revealed the BFR was ordered to run at 400 mL/min. Review of the intradialytic records revealed the BFR ran at 300 mL/min from the treatment start time of 08:00 until 08:33. The BFR ran at the prescribed rate of 400 mL/min from 08:33 until the end of the treatment at 11:50. There is no evidence of documentation from the direct patient care staff indicating the reason the BFR was not set to the prescribed rate or that the registered nurse (RN) was notified of the variation. There is no documentation from the RN related to the variation in hemodialysis orders for the treatment. Review of Patient #3 treatment record for 05/06/2024 revealed the BFR was ordered to run at 450 mL/min. Review of the intradialytic records revealed the BFR ran at 400 mL/min for the duration of the treatment (07:55-11:58). There is no evidence of documentation from the direct patient care staff indicating the reason the BFR was not set to the prescribed rate or that the registered nurse (RN) was notified of the variation. There is no documentation from the RN related to the variation in hemodialysis orders for the treatment. Review of Patient #4 treatment record for 05/07/2024 revealed the BFR was ordered to run at 500 mL/min. Review of the intradialytic records revealed the BFR ran at 410 mL/min for the duration of the treatment (11:43-15:30). There is no evidence of documentation from the direct patient care staff indicating the reason the BFR was not set to the prescribed rate or that the registered nurse (RN) was notified of the variation. There is no documentation from the RN related to the variation in hemodialysis orders for the treatment. Review of Patient #5 treatment record for 05/07/2024 revealed the BFR was ordered to run at 400 mL/min. Review of the intradialytic records revealed the BFR ran at 450 mL/min for the duration of the treatment (11:14-15:02). There is no evidence of documentation from the direct patient care staff indicating the reason the BFR was not set to the prescribed rate or that the registered nurse (RN) was notified of the variation. There is no documentation from the RN related to the variation in hemodialysis orders for the treatment.”