Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatrics Associates on 12/18/25 to 12/22/25. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. A Standard level deficiency was cited as follows: 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 and interview, the Laboratory Director failed to establish a policy to be onsite once every six months and failed to document any onsite visits from 1/1/2025 to 12/18/2025. Findings included: 1. The Quality Event Review dated 12/15/2025 was presented as proof of process for the Laboratory Director to perform documented onsite visits. The Quality Event Review dated 12/15/2025 failed to be an approved procedure for onsite once every six months and there failed to be any documentation of onsite visits from 1/1/2025 to 12/18/2025 performed by the Laboratory Director 2. On 12/18/2025 at 11:42 a.m., the Diagnostic Director verified via call there failed to be an established policy to be onsite once every six months and failed to document any onsite visits from 1/1/2025 to 12/18/2025. 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 --