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 procedure manual and record review and interview with the laboratory director (LD), the laboratory did not ensure that there is an approved policy for all duties and tasks performed in the laboratory. Findings: 1. Record review showed that the laboratory documents monthly eye wash "operational checks" (maintenance) on an "Eye Wash Station Log." Laboratory staff check "Y" if the eye wash is "in good working condition." 2. Procedure manual review showed that the laboratory did not have an approved, written procedure for how to perform monthly eye wash maintenance, including how to check if the eye wash station is "in good working condition." 3. Record review showed that the laboratory has a blank log for documenting when histology slides are sent out to another doctor to review as part of the laboratory's proficiency testing (PT) program. 4. Procedure manual review showed that the laboratory did not have an approved, written procedure for how to perform and evaluate PT. 5. During an interview on 09/15/2023 at 2:50 PM, the LD confirmed that the laboratory's procedure manual did not include a policy for all duties and tasks performed in the laboratory. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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)