Summary:
Summary Statement of Deficiencies D5815 TEST REPORT CFR(s): 493.1291(h) (h) When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed testing. This STANDARD is not met as evidenced by: Based on review of laboratory's policies and procedures, patient test records review from 11/2/2023 to 5/27/2025, and interview with the technical consultant (TC); the laboratory failed to have a policy for turn-around time (TAT) for all histopathology tests performed in the laboratory. 1. The laboratory failed to provide TAT of testing for five (5) out of five (5) randomly selected patients at the time of the survey (July 1, 2025). The laboratory did not provide a TAT policy which may adversely impact patient management. 2. The laboratory TC on July 1, 2025, at approximately 2:15 p. m. affirmed that the laboratory did not have a TAT policy to notify any delay on testing to the submitters. 3. The laboratory's testing declaration form, signed by the laboratory director on 6/20/25025, stated that the laboratory performs 1,5000 tests annually. 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 --