Summary:
Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on August 26, 2026, at the laboratory of the Carolina Physician Network (CPN), INC Atrium Health LC Rock Hill by 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 conditions of participation for the Clinical Laboratory Improvement Amendments (CLIA) of 1988 requirements found at 42 CFR Part 493. The following is a list of deficiencies cited as a result of the August 26, 2026, recertification survey. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and staff interview, the laboratory director failed to document onsite visits at least once every 6 months, with at least 4 months between the minimum two on-site visits for the 2 out of 2 years reviewed (2025 and 2026). Findings included: 1. Review of CMS 209 Personnel Report (CLIA) Form reveals: a. 1 Laboratory Director (LD) b. 1 Clinical Consultant (CC) c. 1 Technical Consultant (TC) d. 19 Testing Personnel (TP) 2. The surveyor requested and the laboratory failed to provide documentation of laboratory director's visits, including evidence of performing activities that are part of the laboratory director's responsibilities. 3. In an interview on August 26, 2026, at 2:40 pm in the conference room, the TC confirmed the above findings. 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 --