Fresenius Medical Care Carroll County

“PE-COMFORTABLE TEMPERATURE CFR(s): 494.60(c)(2) The dialysis facility must: (i) Maintain a comfortable temperature within the facility; and (ii) Make reasonable accommodations for the patients who are not comfortable at this temperature. This Standard is not met as evidenced by: 03383 Based on observation, a review of facility records and patient and staff interviews, it was determined that the facility failed to ensure that all patients and staff were provided with comfortable temperatures within the facility. The facility had 79 in-center hemodialysis patients and 11 staff (two registered Nurses, five Patient Care Technicians, two Licensed Practical Nurses, one part-time Social Worker, one part-time Dietitian, and one part-time Biomed Technician (BMT). Findings were: During survey on 9/24/24 and 9/25/24, six patients were observed completely covered with blanket from neck to feet and two patients were covered from head to toe. The patients indicated they were cold when staff approached them to keep access uncovered and covered access with blanket after blanket was removed. The thermostat on 9/25/24 at 8:45 a.m., showed the temperature in facility was 68 degrees Fahrenheit (F); the air was blowing down on the patients from vents located on ceiling. Staff complained about the temperatures in the facility and wore long sleeves and sweaters to stay warm. This surveyor also experienced frigid temperatures and wore long sleeves and jacket to stay warm. This surveyor noticed a significant difference between outdoor temperature and temperature upon entering the facility; felt like stepping into a freezer in the lobby and temperatures felt colder in the treatment area. Cold temperatures were discussed with the Facility Administrator (FA) and BMT on 9/25/24 at 8:45 a.m. BMT indicated temperatures were controlled by Fresenius and were kept between 68 and 70 and it was blowing down on the patients. The FA stated that she has received multiple complaints from both patients and staff, including herself about how cold it is in the facility; however, did not have any physical documentation of the complaints as the complaints were always verbal. Despite requesting a policy regarding temperature in the facility, the FA did not provide a policy for this. Cross-Reference V407 - Failure of the facility to ensure that patients’ dialysis access sites remained uncovered and visible to the staff throughout dialysis treatment, to ensure patient safety.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 03383 Based on observation and staff interviews, it was determined that the facility failed to ensure that eight of 39 patients (P) (P#11, P#12, P#13, P#14, P#17, P#18, P#19, and P#20) observed in the patient treatment area, had their vascular access (dialysis access) sites uncovered/visible to the staff throughout dialysis treatment, to ensure patient safety. This deficient practice could provide an opportunity for accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood). The facility in-center hemodialysis census was 79. Findings were: An observation in the patient treatment area on 9/24/24 between 8:42 a.m. and 10:50 a.m., revealed the following: - P#11 who was seated at Station (S) 3 had access completely covered by a blanket. - P#12 who was seated at S11 had access completely covered by a blanket. - P#13 who was seated at S7 had access completely covered by a blanket. - P#14 who was seated at S14 had access completely covered by a blanket. The patients’ dialysis access sites were not visible during their treatment. Registered Nurse (RN) CC was informed about patients with covered accesses on 9/24/24 at 11:15 a.m. RN CC stated that patients complained about the cold temperature in the treatment area and refused to keep access uncovered. An observation in the patient treatment area on 9/25/24 between 1:46 p.m. and 2:30 p.m. revealed the following: - P#17 who was seated at S20 had access completely covered by a blanket. - P#18 who was seated at S24 had access completely covered by a blanket. - P#19 who was seated at S2 had access completely covered by a blanket. - P#20 who was seated at S8 had access completely covered by a blanket. The Facility Administrator (FA) was informed and shown the above findings on 9/25/24 between 1:50 p.m. and 2:30 p.m. The FA stated patients were reminded not to cover their access; however, patients complained about the cold temperature in the treatment area and kept cover over access to stay warm.”

“H-MONITOR H20 /DIALYSATE INC ON SITE EVAL CFR(s): 494.100(c)(1)(v) Services include, but are not limited to, the following: (v) Monitoring of the quality of water and dialysate used by home hemodialysis patients including conducting an onsite evaluation This Standard is not met as evidenced by: 03383 Based on a review of facility policy and medical records and staff interviews, it was determined that the facility failed to ensure monitoring of the quality of water and dialysate used by one of one home hemodialysis patient was performed quarterly per facility policy. Findings were: A review of policy titled, NxStage PureFlow SL®: Testing For Microbiological Quality dated 5/2/22 revealed the following: Dialysate (SAK) Bacteriological Culture and Endotoxin analysis will be conducted: Initially: - Test within the first month of patient being at home, near the estimated end of a batch. Quarterly: - Near the estimated end of a batch. A review of cultures and endotoxin testing of NxStage PureFlow for P#10 revealed that NxStage PureFlow testing was performed on 1/8/24 and 9/4/24. Second quarter testing of NxStage PureFlow was not done. This was confirmed by the Home Hemodialysis Nurse (HHN) on 9/25/24 at 3:45 p.m. The HHN stated that the cultures are obtained by dialysis staff and that second quarter was missed.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 03383 Based on a review of the facility’s Fiscal Year 2024 Quarterly Dialysis Facility Report (FY2024 QDFR - A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients), a review of facility records, and staff interview, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to make changes to plans of action to improve and sustain the facility’s Anemia Management, Bone/Mineral, and Nutrition for in-center hemodialysis (ICHD) patients. for three of three months (June 2024 - August 2024) of QAPI meeting minutes reviewed. This facility had 79 ICHD patients and 28 home patients. Findings were: A review of the facility’s FY2024 (third quarter 2024) QAPI meeting minutes, revealed that the facility was above the United States (US) threshold in: - Anemia - (Hemoglobin < (less than) 10.0 g/dl) - for ICHD patients at this facility was 30% in June 2024, 27% in July 2024, and 31.1% in August when compared to US at 23% nationally. - Mineral/Bone - (Phosphorus > (greater than) 7.0 mg/dL) - for ICHD patients at this facility was 20% in May 2024, and 20.1% in July and August 2024 when compared to US at 16% nationally. - Nutrition - (Albumin < 4.0 g/dl) - for ICHD patients at this facility was 72.1% in June 2024, 71.1% in July and 68.1% in August 2024 when compared to US at 51.3% nationally. - Mineral/Bone - (Phosphorus >7.0 mg/dL) - for Peritoneal Dialysis patients at this facility was 16.1% in June and 16.6% in August 2024 when compared to US at 12.6% nationally. Additionally, the facility’s QAPI meeting minutes from (May 2024 - August 2024) revealed documentary evidence that the interdisciplinary team (IDT) conducted a comprehensive review of anemia, but not nutrition or mineral/bone. No changes had been made to the action plans to ensure and sustain improvement in anemia. The Facility Administrator stated on 9/25/24 at approximately 2:36 p.m., that the IDT (interdisciplinary team) will work toward improvement of these outcomes. The FA confirmed no changes were made to the plan for anemia in June, July 2024, or August, and that mineral/bone (PO4) and nutrition (albumin) has not been addressed.”