Summary:
Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Skin Dermatology and Cosmetic Services was found not to be in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 staff interview, the laboratory failed to maintain complete Histopathology quality control documentation for 1 of 2 years reviewed (August 2022 until August 2023). Findings include: The record review of quality control documentation showed there was no record of lot numbers and expiration dates for the Hematoxylin and Eosin (H&E) stains that were used on patient histopathology slides during processing from August 2022 through August 2023. The interview with the Testing Person B on 6/3/24 at 9:30am confirmed that she was unable to locate a reagent log prior to when she was hired in August 2023. 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 --