Summary:
Summary Statement of Deficiencies D0000 Based on an announced validation inspection, the laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. 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)