Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 the lack of a laboratory's policies and procedures manual and interviews with the office manager (OM) on December 18, 2025; the laboratory failed to provide a procedure manual for policies and procedures. The findings included: 1. It was the practice of the laboratory to perform Dermatopathology -Mohs processing in house with no policies and procedures approved, signed, and dated by the laboratory director available for: Mohs specimen processing, quality assurance, preventive maintenance, peer review, reagent use, reagent log, microscope use, retention of documents and slides, safety procedures etc. 2. All CLIA compliant protocols for histopathology practice were not available on the day of the survey. 3. The OM confirmed by interview on December 18, 2025, at approximately 2:45, that standard operation procedures and policies were not available, approved, signed, and dated by the laboratory director. 4. The laboratory's testing declaration form, signed by the laboratory director on December 16, 2025, stated that the laboratory performed approximately 2,648 histopathology tests annually with no CLIA compliant policies and procedures available to be followed by the testing personnel. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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 4 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)