Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at K Wade Foster MD PA on 5/14/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure the quality assessment program was maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur for two of two years (2024-2025). Findings included: 1. The laboratory Policy and Procedure reviewed and approved by the Laboratory Director 1/3/25 and 1/10/24 included a procedure titled Quality Management Plan. Review of the procedure showed "The lab director shall review and appraise the events annually to measure improvement of the lab's quality, identify trends or patterns and initiate corrective and/or preventive actions as appropriate." 2. The annual Quality Assurance (QA) report dated 2/10/25 failed to have documentation of review by the Lab Director. The annual QA report dated 3/11 /2024 documented it was for a different address and failed to have documentation of review by the Lab Director. 3. The Lab Supervisor confirmed on 5/14/25 at 11:45 AM the procedure required the Laboratory Director to review the annual QA reports, and the annual QA reports for 2025 and 2024 did not have documentation of review by the Laboratory Director. 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 --