Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted 3/28/23 and continued to 4/04 /2023 to gather additional information. Dermatology Associates of Bay County PA, clinical laboratory was not in compliance with 42 CFR 493, Requirements for Laboratories. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Person #A, the laboratory failed to make Hematoxylin and Eosin (H & E) stain quality control (QC) slides for 2 of 8 random micrographically oriented histographic surgery (MOHS) patient records reviewed. Findings include: On 3/28/2023 at 1:30 pm, a record review of a random sampling of 8 patient's H & E stain test results and corresponding QC revealed H & E QC slides were missing for days 4/19/2022 and 5/19/2022. The MOHS patient log revealed 7 patients samples were tested and reported on 4/19/2022 and 8 patients were tested and reported on 5/19/2022. Interview with Testing Person #A on 3/28/2023 at 2: 30 pm, confirmed QC slides for H&E stain were not made for patient testing on days 4 /19/2022 and 5/19/2022. 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 --