Fresenius Medical Care Columbia Home

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 28883 Based on record review, interview, and review of manufacturer’s vaccine dosing and administration information from the Internet, clinic nursing staff failed to adhere to the recommended minimum dosing interval for administration of the Heplisav-B vaccine for Patient #2, one of two patients reviewed who received the vaccine from the clinic. The findings included: On 3/20/24 at 12:28 PM, review of Patient #2’s Heplisav-B vaccination record revealed information that dialysis dependent patients 18 years or older receive Heplisav-B 20 micrograms at a schedule of 0, 1, 2, and 4 months. The form showed Registered Nurse (RN) #2 documented the administration of Heplisav-B doses to Patient #2 on 12/29/23, 1/2/24, and 2/22/24. There were 4 days between the administration of doses 0 and 1. During an interview on 3/20/24 at 12:30 PM, RN #2 stated several times that she/he had administered the Heplisav-B vaccine as documented on the form and stated once that she/he knew she/he had administered the vaccine to Patient #2 on 12/29/23 and then again on 1/2/24. When asked why she/he had administered the vaccine with 4 days in between, RN 2 stated patients were to receive a dose each month for 3 months, and then the last dose in the fourth month. RN #2 stated she/he had given a dose in December 2023 and so the patient would need to receive a dose in January 2024. RN #3, who was also present for the interview, reviewed the record and verified the second Heplisav dose had been originally scheduled for 2/2/24, but had been rescheduled to 1/2/24. On 3/20/24, review of information obtained from the Internet by the manufacturer of the vaccine, Dynavax Technologies Corporation copyright 2022, on Dosing and Administration, Interchangeability and Dosing Schedule Scenarios for Heplisav-B revealed information that the minimum interval recommended for administration of Heplisav-B vaccine was at least four weeks or 1 month. The pdf information showed for patients 18 or older, a 2 dose regimen administered at least 1 month apart is recommended. Per the ACIP (Advisory Committee on Immunization Practices), a 2-dose dose series at least 1 month apart is recommended for immunocompromised patients. “...The ACIP guidance for interchangeability indicates that when feasible, the same manufacturer’s vaccines should be used to complete a hepatitis B series. A 2-dose Heplisav-B vaccine series only applies when both doses in the series consist of Heplisav-B. A dosing regimen consisting of 2 different vaccine products should consist of a total of 3 doses...Adhere to minimum windows: 4 weeks between dose 1 and 2...”.”

“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: 28883 Based on observations and interview, the home dialysis clinic’s nursing staff failed to ensure expired supplies had been removed from staff access in the lab area and supply room. In one of seven home therapy training rooms were supplies out of their packaging and/or past the beyond use date. The findings included: Observations on 3/19/24 at 10:12 AM in the lab area revealed six transplant lab tubes that expired on 1/31/24. Observations in the supply storage room at 10:15 AM revealed #30 Intravenous administration sets that expired on 6/30/23, and #29 luer lock APD adapter sets. The findings were verified by the Clinic Manager during an interview on 3/19/24 at 10:20 AM. Observations on 3/19/24 at 10:25 AM in peritoneal dialysis training room 6 revealed a home hemodialysis cassette that had been opened, out of its packaging, and not labeled for training use and one dialysate sak (home hemodialysis dialysate) that had a use by date of 7/14/2020. The findings were verified by the Clinic Manager during an interview on 3/19/24 at 10:35 AM.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 28883 Based on record reviews and interview, the dialysis clinic failed to ensure a plan of care for Patient #2 who was one of six patient charts reviewed had been completed timely. The findings included: The dialysis clinic admitted Patient #2 to the Peritoneal Dialysis Clinic on 12/19/23. Record review on 3/20/24 at 2:51 PM revealed an initial Plan of Care meeting documented as completed on 2/22/24 which is greater than the 30 days from admission. During an interview on 3/20/24 at 3:30 PM, the Clinic Manager verified the patient had been admitted on 12/19/23 and the initial care plan meeting had not been completed until 2/22/24. The Clinic Manager reviewed the record and stated the patient had not been hospitalized so that was not a reason for the delay.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 28883 Based on record reviews and interview, the dialysis clinic nursing staff failed to ensure they had documented orders for intraperitoneal antibiotic therapy for Patient #2, one of two patients reviewed for infections. The nursing staff failed to document sufficiently to show what care had been given and/or to ensure continuity of care could be provided for the patient. Nursing staff failed to follow through with nursing documentation as to whether the patient had received the intraperitoneal antibiotics, received education/training on how to administer the medication, and whether the patient had been able to complete the antibiotic therapy. The findings included: The home therapy peritoneal dialysis clinic admitted Patient #2 on 12/19/23. Review of the patient’s medical record on 3/20/24 revealed a hospital discharge summary dated 2/6/24 with discharge diagnoses that included peritonitis. The discharge summary indicated the patient was seen by Infectious Disease and had been recommended to continue Ceftazidime (Antibiotic) 1.5 grams daily intraperitoneal for at least 7 days at which time the patient could switch over to oral Augmentin for another 7 days. The summary stated that nephrology would make arrangements for intraperitoneal Ceftazidime and the patient had been written a prescription for Augmentin to take once the Ceftazidime had been completed. Review of the clinic’s record for the patient revealed no physician orders had been documented for intraperitoneal or other antibiotics. Review of nursing notes revealed a note dated 2/6/24 which documented the nurse had spoke with the patient (by telephone) regarding coming in on 2/7/24 for education on intraperitoneal antibiotic therapy. There was nothing documented in the nursing notes about a communication of orders for IP antibiotic therapy by a provider. There was nothing documented after the 2/6/24 note regarding whether the patient had received the medication, had been educated, and/or had understanding on administration, or whether the patient had been able to complete the course of antibiotic therapy. During an interview on 3/20/24 at 3:20 PM, the Clinic Manager verified there were no physician orders documented in the clinical record for intraperitoneal antibiotics, no documentation of a pharmacy order or distribution to the patient of intraperitoneal antibiotics, nor documentation that training had been conducted with the patient or that the patient had completed the treatment.”