Summary:
Summary Statement of Deficiencies D0000 An onsite Complaint survey was completed on May 14, 2026, to investigate complaint intake number GA00257071. The allegations were substantiated. The deficiencies were CORRECTED on Site 05/14/2026. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a Complaint survey performed and interview with the laboratory director, the laboratory director failed to ensure that the laboratory was operating under a valid CLIA license as required by Clinical Laboratory Improvement Amendments of 1988 (CLIA) in the specialty of Histopathology from December 2025 to May 2026. Findings: 1. A Complaint survey GA00257071 performed on the above facility on May 14, 2026 confirmed the laboratory was operating without a valid CLIA license. The CLIA license 11D2298204 was terminated in September 2025 by the lab director and a request for reinstatement was sent to CLIA in December 2025. The reinstatement request was not processed, but lab director decided to restart operations from December 2025 to the day of survey May 14, 2026. 2. An interview with the 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 -- laboratory director in his office on 05/14/2026, at approximately 11:00 AM confirmed the lab director failed to ensure that the laboratory was operating with a valid current CLIA license as of May 14, 2026. -- 2 of 2 --