Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 review of laboratory policy, maintenance logs, and confirmed in interview, the laboratory failed to follow its own written policy for changing staining solutions for one of two staining solutions reviewed in February 2024. Findings Included: 1. Review of laboratory policy, "H & E Staining Procedure For Frozen Tissue Sections" (Approved by the Laboratory Director on 09/12/2014) revealed the following: "Quality Control: Stains are filtered daily and grossly examined for any evidence of contaminants or precipitates. Solutions are changed as follows: hematoxylin and eosin stains are changed weekly ..." 2. Review of laboratory daily maintenance logs (October 2023-January 2024) revealed the following weeks the laboratory failed to document hematoxylin solution changes weekly: a. 10/23/2023 - 10/27/2023 b. 12/04 /2023 - 12/08/2023 c. 12/11/2023 - 12/15/2023 d. 12/18/2023 - 12/22/2023 e. 01/08 /2024 - 01/12/2024 f. 01/22/2024 - 01/26/2024 The surveyor requested documentation of changing the hematoxylin solution for the above weeks, and none was provided. 3. During an interview in the facility breakroom on 02/07/2024 at 10:48 AM, the laboratory consultant confirmed the laboratory failed to follow its own written policy for changing staining solutions for one of two solutions reviewed in February 2024. D5403 PROCEDURE MANUAL 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 -- 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)