Summary:
Summary Statement of Deficiencies D0000 An announced CLIA exempt-state validation survey was performed on April 22, 2024, by CMS Boston CLIA federal surveyor. The laboratory was surveyed under 42 CFR part 493 CLIA regulations. The laboratory was found to be in compliance with standard-level CLIA requirements. The findings were reviewed with the regulatory manager during an exit conference at the conclusion of the survey. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)