Summary:
Summary Statement of Deficiencies D0000 A onsite recertification survey was conducted on August 18, 2026, at the laboratory of MUSC Physicians PCP by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with Medicare conditions of participation at 42 CFR Part 493, CLIA requirements for laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and staff interview, the laboratory failed to evaluate personnel consistency in slide review (manual differential and urine sediment) for 3 out of 3 employees performing moderately complex testing. Findings included: 1. Based on Proficiency Testing record review, the laboratory performs moderately complex testing of Urine Sediment and Blood Cell Identification for 2 years reviewed (2024 and 2025). 2. The surveyor requested but the laboratory failed to provide documentation of an assessment evaluating personnel consistency in slide review for the following test: a. Urine sediment counted in a microscopic test. b. Blood cells counted in a manual differential. 3. In an interview on August 18, 2026, at 4:00 pm in the office with laboratory manager, director of business operations and previous clinic director, the above findings were confirmed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --