Fresenius Medical Care North Texas

“BICARB CONC DIST-COLOR CODED BLUE & SEALED CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: color coded blue & sealed Bicarbonate concentrate delivery piping should be color-coded blue at the point of use (at the jug filling station or dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. This Standard is not met as evidenced by: 50181 During a tour of the in-center treatment area on the morning of 04/16/2024 multiple wall boxes were noted to have white, crusted residue present. The Facility Administrator (Personnel #1) and Charge Nurse II (Personnel #2) were on the tour and confirmed the wall boxes had visible white, crusted residue. A review of the CDC guidelines related to dialysis wall boxes revealed the following: “Dialysis wall boxes are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water and dispose of waste products. There are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections.” An interview with Personnel #1 on 04/16/2024 confirmed the wall boxes had visible white, crusted residue present.”

“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: 50181 Based on observation and interview it was determined that the facility failed to maintain a functional emergency system that could be activated by patients in one of the patient restrooms within the unit. Findings: During observations on 04/16/2024, the patient restroom located in the treatment area had an emergency pull-cord wrapped around the grab bar. This can inhibit the function of the emergency system and posed a threat to patient safety in the event of an emergency where a call for help is required. The above findings were confirmed by the Facility Administrator (Personnel #1) and Charge Nurse II (Personnel #2) during the same observation period.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, 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 04/03/2024 revealed the BFR was ordered to run at 400mL/min. Review of the intradialytic records revealed the BFR ran at 250 mL/min for the duration of the treatment 0930-1315 with no documentation reporting the variation in the BFR to the charge nurse by the patient care technician and no supporting documentation from the nurse related to the variation in hemodialysis orders for the treatment. Review of Patient #2 treatment record for 03/09/2024 revealed the BFR was ordered to run at 400mL/min. Review of the intradialytic records revealed the BFR ran at 350 mL/min for the duration of the treatment 0647-1048 with no documentation reporting the variation in the BFR to the charge nurse by the patient care technician and no supporting documentation from the nurse related to the variation in hemodialysis orders for the treatment.”

“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 facility policy titled, “Nursing Supervision and Delegation,” version 6 with a published date of 11/06/2023 includes the following guidance: “Purpose: The purpose of this policy is to provide guidance regarding nursing supervision and delegation of tasks to other licensed and unlicensed staff in the outpatient setting. Reporting of Patient Care Findings to the Team Nurse in Charge: The staff member who collects information pre, post and during treatment will document their findings. Any observed changes or abnormal findings in the patient’s condition or vascular access, changes reported by the patient, recent hospitalizations, or other medical procedures (ex. Dental procedures) must be reported to the registered nurse who will assess the patient. Registered Nurses who are not the nurse in charge must report abnormal findings and interventions to the nurse in charge. Guidelines for Patient Care Technician (PCT)/Licensed Practical Nurse (LPN)/Licensed Vocational Nurse (LVN)/Registered Nurse (RN): When to Refer a Patient to the Team Leader/Charge Nurse for Further Assessment: The following criteria can be used as a guideline to identify when a PCT/LPN/LVN or RN shall refer a patient to the Team Lead/Charge Nurse for further assessment pre, during or post treatment. The Team Leader/Charge Nurse will use their clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. *Fluid Status Any weight gains greater than 4kg pre-treatment. Any swelling in the facial area and lower extremity edema. Any post treatment weight with a variance from the estimated dry weight of 1.0 kg. Any weight loss or no change in weight from a patient’s last treatment post weight *Blood Pressure (BP) A systolic blood pressure great than 180 mm/Hg and/or a diastolic blood pressure greater than 100 mm/Hg at any time before, during or after the treatment. If B/P less than or equal to 100 mm/Hg systolic during treatment. A systolic BP less than 100 mm/Hg post treatment when standing. A drop in systolic BP of 20 mm/Hg between sitting and standing. *Heart Rate/Cardiac A heart rate that is a new onset and is below 60 beats per minute or greater than 100 beats per minute or an irregular heart rate that is a new onset.” Patient #2 treatment record dated 03/09/2024 revealed the following: 06:47: Blood Pressure 194/105 07:08: Blood Pressure 186/100 There is no documentation acknowledging the BP was a reportable finding and was reported to the RN by the DPC staff. Patient #3 treatment record dated 03/04/2024 revealed the following: 09:06: Blood Pressure 181/82 There is no documentation acknowledging the BP was a reportable finding and was reported to the RN by the DPC staff. Patient #3 treatment record dated 03/06/2024 revealed the following: 12:45: Blood Pressure 184/97 There is no documentation acknowledging the BP was a reportable finding and was reported to the RN by the DPC staff. Patient #4 treatment record dated 03/08/2024 revealed the following: 12:02: Heart Rate 58 12:34: Heart Rate 58 12:40: Heart Rate 57 There is no documentation acknowledging the heart rate was a reportable finding and was reported to the RN by the DPC staff. Patient #4 treatment record dated 03/11/2024 revealed the following: 11:35: BP 94/49 There is no documentation acknowledging the BP was a reportable finding and was reported to the RN by the DPC staff. 12:10: BP 94/48 13:10: BP 96/42 13:40: BP 93/41 There is no documentation that the out of parameter BP was reported to the RN by the DPC staff. Patient # 6 treatment record dated 02/13/2024 revealed the following: 06:00: Heart Rate 58 There is no documentation acknowledging the heart rate was a reportable finding and was reported to the RN by the DPC staff. Patient #6 treatment record dated 02/15/2024 revealed the following: 05:40: BP 97/44 06:35: BP 96/45 There is no documentation acknowledging the BP was a reportable finding and was reported to the RN by the DPC staff. 05:07: Heart Rate 58 There is no documentation acknowledging the heart rate was a reportable finding and was reported to the RN by the DPC staff. On 04/16/2024, an interview with the Facility Administrator (Personnel #1) and CN II (Personnel #2) confirmed the facility’s reportable parameters and documentation required for out of parameter findings pre/intra/post dialysis treatment by the DPC staff to the registered nurse.”