Summary:
Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on October 7, 2025, at the laboratory of Pediatric Associates of Kershaw County 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 condition 42 CFR Part 493, CLIA requirements for laboratories. The following is a list of standard level deficiencies cited as a result of the October 7, 2025 recertification survey. 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 records review and staff interview, the laboratory failed to follow its own policy for competency assessments in the first year of employment for initial and at 6- months. Findings included: 1. Review of the laboratory's policy and procedure manual reveals the requirement for competency assessments to occur after new employee training is complete (Initial),and at 6-months, and annually thereafter. 2. Review personnel competencies reveals only annual competencies documented. 3. In an interview with TP 11 in the laboratory at 11:35am on October 7, 2025, the findings were confirmed. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on records review and staff interview, the laboratory director failed to ensure initial competency assessments were completed on 12 out of 12 employee files reviewed. Findings included: 1. Review of the laboratory's policy and procedure manual reveals the requirement for competency assessments to occur after new employee training is complete (Initial), and at 6-months, and annually thereafter. 2. Review personnel competencies reveals only annual competencies documented. 3. In an interview with TP 11 in the laboratory at 11:35am on October 7, 2025, the findings were confirmed. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on records review and staff interview, the technical consultant failed to ensure 6-month competency assessments were performed for 12 out of 12 testing personnel. Findings included: 1. Review of the laboratory's policy and procedure manual reveals the requirement for competency assessments to occur after new employee training is complete (Initial),and at 6-months, and annually thereafter. 2. Review personnel competencies reveals only annual competencies documented. 3. In an interview with TP 11 in the laboratory at 11:35am on October 7, 2025, the findings were confirmed. -- 2 of 2 --