Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on November 26, 2024. SKIN AND CANCER ASSOCIATES LLP clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical 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 staff interview, the laboratory failed to have documentation of the acceptability of the Quality Control (QC) slide for Hematoxylin & Eosin (H&E) stain by the testing person doing the interpretation of the H&E for two out of two years reviewed. Findings Included: 1-Review of the Laboratory Personnel report (CLIA) FORM CMS-209 signed by the Laboratory Director (LD) on 11/26/2024 revealed that: LD, Clinical Consultant (CC), Technical Supervisor (TS), General Supervisor (GS) and High Complexity Testing Personnel (TP) was the same person. 2-Review of the Quality Control Staining Log for the years 2023 and 2024, revealed that the daily approval of the Quality of the QC slide had the initial of the Mohs technicians (MT) MT1, MT2 and MT3 and failed to show the approval by the TP. During an interview on 11/26/2024 at 10:00 AM with the laboratory consultant, she confirmed that the laboratory failed to document the acceptability of the Daily QC slide for H& E Stain by the TP during 2023 and 2024 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 --