Advanced Gastroenterology And Surgery Associates

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Gastroenterology and Surgery Associates on August 25, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies 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 review of quality control documents, and interview, the laboratory failed to document quality control information including lot numbers, expiration dates, and open dates for all reagents used in the Leica XL Autostainer and the Tissue-Tek VIP from 08/3/2023 to 08/25/2025, and the laboratory failed to maintain log documenting preparation of the reagents used in the Leica XL Autostainer and the Tissue-Tek VIP from 05/10/2023 to 08/25/2025. Findings: 1. Review of the Leica XL Autostainer and Coverslipper Quality Control log showed the laboratory used the following reagent in their Autostainer: Xylene, 100% Alcohol, Periodic Acid, Alkane Blue, Schiffs Reagent, Hematoxylin, Acid Alcohol, Bluing Reagent, Diff Quick, and Eosin. 2. Review of the Tissue-Tek VIP Maintenance log showed the laboratory used the following reagent in their Tissue-Tek VIP: 10 % Formalin, 100% Alcohol, 80% Alcohol, 75% Alcohol, and Xylene. 3. Review of the Reagent Log showed the last date any reagent was recorded as received on the log was 08/02/2023. No other reagent logs were available for review. 4. Review of the quality control log revealed there were no logs documenting the preparation of the 75% Alcohol, 80% Alcohol, 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 -- and 0.175 Acid Alcohol. 5. During an interview on 08/25/2025 at 12:10 PM, Testing Personnel A stated they did not have a log documenting the preparation of reagents and did not have a reagent log. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on May 9, 2023. Advanced Gastroenterology and Surgery Associates 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 review of the reagent log and interview, the laboratory failed to record the open dates for all reagents used in their Hematoxylin & Eosin (H & E), Alcain Blue /Periodic Acid-Schiff (AB/PAS), Diff Quick, and Trichrome stains from 08/02/2021 to 05/09/2023. Findings: The laboratory used the following reagents: Acetic Alcohol, Alcain Blue, Bluing Reagent, Diff Quik, Eosin, Hematoxylin, Periodic Acid, Schiffs Reagent, and Xylene. Review of the laboratory's "Reagent Lot Number and Expiration" log showed there were no open dates listed. On 05/09/2023 at 10:35 AM, the Testing Personnel acknowledged the open dates were not recorded. 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 --