Summary:
Summary Statement of Deficiencies D0000 An announced routine recertification survey of the laboratory was conducted on 06/13 /2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. Standard level deficiencies were cited. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (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. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records and confirmed in interview, the laboratory failed to have documentation of the intended reactivity of quality control slides for Hematoxylin & Eosin (H&E) stain used for Mohs testing for 58 of 58 patient testing days from January to March 2025. Findings include: 1. Review of the laboratory's QC log titled "Quality Control Analysis log Sheet for H and E Staining Procedure" stated: "(+) Control used: Mohs tissue - Results expected: Visual detection of Basal Cell or Squamous Cell Carcinoma under microscope (-) control used: Mohs tissue - Results expected: Normal tissue with clear margins" Further review of the laboratory's QC records determined the laboratory failed to have documentation for the intended reactivity of QC slides for the H&E stain reviewed from January to March 2025. The laboratory was asked to provide documentation for the intended reactivity of the QC slides for the H&E stain for each patient testing day. No documentation was provided. 2. The Histotechnician confirmed the findings in an interview conducted on 06/13/2025 at 1052 hours in the break room. 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 --