Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted on August 15, 2025 at the laboratory of The Children's Center of Greenwood by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laborarory was found to be out of compliance with Medicare condition 42 CFR Part 493, CLIA requirements for laboratories. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Laboratory director must ensure a reviewed and approved procedure manual is available to all personnel responsible for patient testing. Findings included : 1. Review of policies and procedures for CBC testing reveals the laboratory's use of the Cell- Dyn' s operators manual as a procedure manual for CBC testing. 2. Review of the procedure manual for CBC testing reveals a lack of documentation of review and approval by the laboratory director (LD). 3. In an interview with the laboratory's technical consultant (TC) on August 15,2025 at 1:30pm in the laboratory office, the 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 --