Summary:
Summary Statement of Deficiencies 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 Standard Operating Procedures (SOPs), personnel training records, competency evaluation documentation, as well as interview with the Site Manager (SM), the laboratory failed to follow written policies and procedures to assess employee competency. FINDINGS: 1. There was no documentation of Technical Personnel (TP) annual competency evaluation performance for 2024 and 2025. 2. This was contrary to instructions indicated in the current, approved SOP, "Mohs Laboratory Policy & Procedure for Evaluation of Technical Personnel". 3. The SM confirmed the findings on January 27, 2026, at 11:00 A.M. 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 --