Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 07/20/2026. The laboratory was found in substantial compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, specimen transport records and staff interview, the laboratory failed to follow its own policy and document monitoring of transport conditions to ensure specimen integrity for one of one type of specimen transported by the laboratory, stained histopathology slides. Findings included: 1. Review of laboratory's "Slide Transport Policy" [document 493-1241(B)] revealed: "4.2 Slide Packaging and Handling ... Temperature and humidity confirmed during transport." The policy did not define the acceptable temperature and humidity levels during transport required to ensure specimen integrity. 2. Review of laboratory's specimen transport records revealed the laboratory did not have documentation of verifying temperature or humidity during histopathology slides' transport. 3. In an interview on 07/20/2026 at 1720 hours in the laboratory, the Laboratory Director confirmed the findings. 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 2 -- 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, 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)