Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 13, 2022. Gastro-Intestinal Consultants of Central Florida clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document quality control information including the expiration dates, open dates and lot numbers for all reagents used in their Hematoxylin & Eosin (H & E), Alcian Blue/Periodic Acid Schiff's (AB/PAS), and Diff Quik from 12/21/2021 to 09/13/2022. Findings: Review of the laboratory's procedure for quality control records revealed there was no reagent log. On 09/13/2022 at 10:47 AM, the Histotechnologist stated she had never seen a reagent log in the laboratory. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --