Summary:
Summary Statement of Deficiencies D0000 The laboratory director was at the entrance conference conducted 10/22/2019. The survey process was discussed. An opportunity for questions and comments was given. Exit conference was held with the laboratory director on 10/22/2019. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. 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)