Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish an approved written procedure for scabies preparation and dermatophyte test medium (DTM) testing prior to patient testing in the subspecialties of mycology and parasitology. Findings include: 1. Record review on 06/06/2022 of the 'Laboratory Management Manual Index' binder revealed lack of documentation for the following: a. Approved written procedure for scabies preparation. b. Approved written procedure for DTM testing. 2. Staff interview on 06/06/2022 at 12:10 PM with the laboratory histotechnician confirmed the above findings. 3. The laboratory performs 29 tests in the subspecialty of mycology, and 18 tests in the subspecialty of parasitology. 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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)