Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on November 12, 2024. American Institute of Dermatology PA 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 interview, review of the procedure manual and quality control logs, the laboratory failed to have a reagent log for the reagents used for Hematoxylin and Eosin (H&E) stain from 12/03/2022 to 11/12/2024. Findings: Review of the section titled Reagent Preparation in the procedure manual noted "OCT mounting compound, histofreeze, and staining, reagents are commercially available. Receipt of each new batch, lot, or shipment of reagents will be recorded on a Receipt Log." Review of the H&E Staining Procedure Protocol showed the laboratory used 100% Alcohol, Hematoxylin, Eosin, and Ultraclear. Review of the quality control logs showed there was no reagent log. On 11/12/2024 at 10:30 AM, the Practice Administrator acknowledged the laboratory did not have a reagent log. 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 --