Prodigy-Home Dialysis Care

“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: 44820 Based on review of facility policy, OSHA standards, and personnel files (PF), and interviews with staff (EMP), the facility failed to maintain/obtain Hepatitis B virus (HBV) vaccination records and failed to obtain statements attesting to the employee having received the vaccine with dates (or approximate dates) signed by the employee for three (3) of four (4) personnel files (PF#1-4). Findings: Review of facility policy on January 30, 2026, at 8:20 a.m. revealed: “Infection Control Manual... G. Hepatitis B Vaccination... Personnel files should demonstrate compliance with this regulation: OSHA requires facilities to maintain a record of their employees ’ Hepatitis B immunization history and to contact past employers to obtain records of vaccination, if applicable. OSHA requires these records be maintained for 30 years after the person leaves employment. If the employee states he/she has been vaccinated, but the records are not obtainable, the personnel record must include a statement attesting to the employee having received the vaccine with dates (or approximate dates) signed by the employee...” Review of OSHA “Hepatitis B Vaccination Protection”... “OSHA Bloodborne Pathogen Standards” on January 30, 2026, at approximately 8:40 a.m., “1910.1030(f) Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up -- 1910.1030(f)(1) ... 1910.1030(f)(2) Hepatitis B Vaccination. 1910.1030(f)(2)(i) Hepatitis B vaccination shall be made available ... to all employees who have occupational exposure unless the employee has previously received the complete hepatitis vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons. ... 1910.1030(f)(6) Medical Recordkeeping. Medical records required by this standard shall be maintained in accordance with paragraph (h)(1) of this section. ... 1910.1030(h)(1) Medical Records. 1910.1030(h)(1)(i) The employer shall establish and maintain an accurate record for each employee with occupational exposure, in accordance with 29 CFR 1910.1020 [requires 30 year maintenance of HBV vaccination records]. ... 1910.1030(h)(1)(ii) This record shall include: ...1910.1030(h)(1)(ii)(B) A copy of the employee’s hepatitis B vaccination status including the dates of all the hepatitis B vaccinations and any special records relative to the employee’s ability to receive vaccinations as required by paragraph (f)(2);” Retrieved from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030 Review of Clinical staff/direct patient care personnel files (PF) was conducted on January 14, 2026 at approximately 1:00 pm revealed: PF1 (social worker) date of hire (DOH): 2/1/2020 - did not contain dates when PF1 received the complete hepatitis B vaccine series to ensure immunity would be sustained. PF2 (dietitian) date of hire (DOH): 11/6/2025- did not contain dates when PF2 received the complete hepatitis B vaccine series to ensure immunity would be sustained. PF4 (registered nurse) date of hire (DOH): 8/4/2025 - did not contain dates when PF4 received the complete hepatitis B vaccine series to ensure immunity would be sustained. Interview with facility administrator on 1/30/26, at approximately 10:10 a.m. confirmed above employees were vaccinated against hepatitis B at some point but that their files lacked dates when they received their vaccines. “Labwork results showed immunity. I do not have vaccination records or attestations.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 44820 Based on review of policy/procedure, observations and an interview with the Facility administrator, interview with employees (EMP); the facility Medical Director failed to ensure all personnel adhere to facillity policies and procedures for three (3) of three (3) observations (OBS). (OBS#1-3). Findings include: Review of policy on 1/14/26 at approximately 9:00 AM revealed: “Policy Section 3 - Medications... Purpose: All medication in the facility should be stored safely and effectively and routinely checked to ensure integrity and to provide the patient with a safe, therapeutic treatment... Procedure:... 4. Medication inventory is to be chedked monthly. Assess for: ... b. expired (outdated) medication... 7. Multi-dose vials, once opened are to be stored according to manufacturer’s recommendations. 8. Inspect each open vial and bottle each day for the following... b. Date (month/day/year) vial was opened; c. Initials of staff memeber who opened the vial; 9. Discard medication if: a. Expired; b. Opened without completed date and/or initials; c. Opened for longer than 30 days or as per manufacturer’s recommendations...” Review of policy on 1/14/26 at approximately 1:30 PM revealed: “Subject: Roles and Responsibilities... (c) Policies and Procedures... The medical director must:... (ii) Ensure that - All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility...” OBS #1 conducted on 1/14/26 at approximately 9:15 AM revealed one (1) opened bottle of Exsept Plus - Antimicrobial Exit Site, skin and wound cleanser with a documented open date of “6/18/25”, no documented staff intitials. OBS #2 conducted on 1/14/26 at approximately 9:15 AM revealed 11 Expired “minicap with providine-iodine solution”; Lot # 24F27H15; Expiration date: 2025-11-28” located/stored in a blue bin in peritoneal dialysis patient exam room. Interview with EMP3 “We have those in the bin to use for patients in need of peritoneal dialysis catheter cap changes.” OBS#3 conducted on 1/14/26 at approximately 9:15 revealed one (1) open vial of “Heparin 30,000 USP units per 30ml” medication vial labed “opened 1/9/26” void of staff initials. An interview with the Facility Administrator completed on 1/23/24 at approximately 11:45AM confirmed the above findings.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 44820 Based on review of policy/procedure, medical records (MR) and interview with the facility Administrator the clinic failed to ensure documentation was completed with signatures and/or dates for five (5) of five (5) records reviewed. (MR #1-#5). Findings include: Review of Registered Dietitian (RD) Policy #GB-07 “Home Dialysis Care Telehealth Nutrition Services; date adopted 11/17/25...” on 1/13/26 at approximately 1:45PM revealed: “... 6.2 Telehealth Visit Requirements... The RD must Review all required components including: Laboratory data...” Review of policy/procedure on 1/13/26 at approximately 2:00PM revealed: “Subject: Section 8 - Dietary Services... To ensure that the facility is in compliance with the required documentation of Dietary Services, the Nurse Manage will do a chart audit... Dietitian’s Responsibility 1. Provide ongoing monitoring of subjective and objective data to determine the need for timely intervention and follow-up. Measurement criteria include, but are not limited to, weight changes, blood chemistries, adequacy of dialysis and medication, which affect nutrition status and potentially cause adver nutrient interactions... Documentation corresponding with the patient’s care plan will be noted on a monthly basis or as needed...” Review of medical records on 1/15/26 between approximately 9:00AM and 11:00AM revealed the following: MR#1, Admit Date: 10/1/2024; Monthly Lab Results date of service (DOS): 10/30/2025 - void of RD, Registered Nurse (RN), Physician, Social Worker signature that labs were reviewed; Monthly Plan of Care DOS: 10/30/2025 - void of RD signature, no monthly note documented for review to verify staff participation. MR#2, Admit Date: 4/24/2025; Monthly Lab Results date of service (DOS): 12/11/2025- void of RD, Registered Nurse (RN), Physician, Social Worker signature that labs were reviewed; Monthly Plan of Care DOS: 12/11/2025 - void of RD signature, void of Social Worker signature, no monthly note documented for review to verify staff participation. MR#3, Admit Date: 9/19/2025; Monthly Lab Results date of service (DOS): 12/11/2025- void of RD, Registered Nurse (RN), Physician, Social Worker signature that labs were reviewed; Monthly Plan of Care DOS: 12/11/2025 - void of RD signature, void of Social Worker signature, no monthly note documented for review to verify staff participation. MR#4, Admit Date: 4/24/2023; Monthly Lab Results date of service (DOS): 11/13/2025 and 12/9/2025- void of RD, Registered Nurse (RN), Physician, Social Worker signature; Monthly Plan of Care DOS: 11/13/2025 and 12/11/2025 - void of RD signature, void of Social Worker signature, no monthly note documented for review to verify staff participation. MR#5, Admit Date: 9/9/2024; Monthly Lab Results date of service (DOS): 10/30/2025 - void of RD, Registered Nurse (RN), Physician, Social Worker signature; Monthly Plan of Care DOS: 10/30/2025 - void of RD signature, no monthly note documented for review to verify staff participation. Interview with Facility Administrator completed 1/15/2026 at approximately 2:30PM confirmed above findings and policy/procedure to be current. Administrator states “We are working on the policies. The dietitian we had quit and we hired a new one that started in the middle of November to fill the position.””