Summary:
Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted on 10/22/2025. The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, Centers for Medicare & Medicaid Services (CMS) 209 form, personnel records, and confirmed in interview, the laboratory failed to establish written procedures to ensure competency assessment for 1 of 1 Clinical Consultant (CC)/Technical Supervisor (TS)/General Supervisor (GS) in 2024 who provided oversight of dermatopathology slide interpretations. Findings included: 1. Review of the laboratory's written procedures did not include a procedure for competency assessments for individuals designated as the clinical consultant, technical supervisor, and general supervisor, as required. The clinical consultant and supervisors provided oversight of dermatopathology slide interpretations. 2. Review of the CMS 209 form and personnel records for CC/TS/GS - 1 did not include competency assessments performed and documented based on position responsibilities as defined in Subpart M (493.1351) in 2024. 3. During an interview on 10/22/2025 at 2:00 p.m., the laboratory representative confirmed written procedures did not include performing and documenting competency assessments for the technical supervisor, general supervisor, and clinical consultant. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (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 laboratory policies, laboratory quality control (QC) records, patient records, and confirmed in staff interview, the laboratory failed to define test staining materials for intended reactivity to ensure the predictable staining characteristics each day of use for one of one stain (Hematoxylin and Eosin (H & E)), and failed to test and document QC for H & E staining on each day of patient testing for five of five days from August 2024 to October 2024. Findings included: 1. Review of laboratory policy "MOHS SECTION PROCEDURE" stated: "PROCEDURE ... Once the slide is stained, coverslip applied, check the quality under the microscope and deliver to Dr. [XX] for review." The procedure failed to define the staining characteristics for intended reactivity of the H&E stain. 2. Review of the "Daily Maintenance Record" revealed the following: "Technician Instructions ... 2) Indicate acceptability of Control Slides" The log had a column for "Control Slide Acceptability Yes/No" each day stain quality was documented as "Yes", "check mark" or "Y" in the column and initialed by the laboratory director. A legend at the bottom of the log for stain documentation revealed: "Yes = Meets H/E Standards (No actions Needed) No = Changes Needed See