Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at East Lake Pediatrics on 11/12/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. A Standard 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 11/12/2025. Findings included: 1. The Laboratory Policy and Procedure policy signed by the Laboratory Director on 5/02/2022, failed to contain a policy to be onsite once every six months and to document any onsite visits. 2. Testing Personnel B and E, who were staff onsite during the recertification survey, on 11/12/2025 at 11:40 a.m., stated the Laboratory Director came onsite to the laboratory frequently but there was no documentation of the visits and what was performed during the visits. 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 --