Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 04/15/2025. The laboratory was found in 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. D3003 FACILITIES CFR(s): 493.1101(a)(2) (a)(2) Contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, laboratory's records and staff interview, the laboratory failed to document cleaning of specimen processing equipment to minimize cross contamination between samples for one of one test performed by the laboratory in 2023 and 2024, grossing of histology tissue samples. Findings included: 1. Review of laboratory's "Embedding Procedure" policy (Document 16228721, Last Revised 02/2024) revealed: "Blocks (cassettes) are opened and embedded one at a time with non-serrated forceps being cleaned each time." 2. Review of laboratory's "Specimen Accessioning/Processing" policy (Document 16228711, Last Revised 05/2023) revealed: "To prevent cross contamination from one specimen to the next a rinse or cleaning of the non-serrated forceps will be performed between each specimen container that is grossed." 3. Review of laboratory's "Grossing Technician Responsibilities" policy (Document 17291679, Last Revised 03/2025) revealed: "Extra precaution will be taken to prevent cross contamination via the forceps and the work surface. Forceps will be cleaned between the handling of each specimen. In addition, the working surface will be maintained as to not permit cross contamination from one specimen to another." 4. Review of laboratory's records revealed the laboratory did not have documentation of cleaning of specimen processing equipment (forceps/surfaces) to minimize cross 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 -- contamination between samples. 5. In an interview on 04/15/2025 at 1050 hours in the breakroom, the laboratory's General Supervisor (as indicated on submitted Form CMS 209), stated that the laboratory does not document cleaning of specimen processing equipment to minimize cross contamination between samples. This confirmed the findings. Key: CMS - Centers for Medicare and Medicaid -- 2 of 2 --