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 laboratory observation, a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), laboratory personnel records, laboratory procedure, and staff interviews, the laboratory failed to follow the procedure for personnel competency assessment for three of three testing personnel (TP) who performed grossing procedures for patient tissue removed during micrographic histopathology surgical (Mohs) procedures when annual assessments were not completed in 2025. The findings include: 1. Observation of the laboratory on 06/24/2026 at 9:40 a.m. revealed an Olympus BH2 (serial # 220809) microscope, two Avantik QS cryostats (serial #'s S16069690 and S16079735), Linistat Autostainer (serial # LS1005E0709), and reagents and stains used to process patient tissue removed during Mohs procedures for slide interpretation. 2. A review of the Form CMS-209 revealed four testing personnel (established at the previous survey, 03/24 /2025). The laboratory director was listed as TP 1; TP 2-4 performed grossing procedures. 3. A review of the laboratory's personnel records revealed completed competency assessments for TP 2, TP 3, and TP 4 on 12/09/2024 and 05/27/2026. No documentation of completed competency assessments for 2025 was available on the date of the survey (06/24/2026). 4. A review of the laboratory procedure titled "Quality Assurance Program" on page 7 revealed, "The Lab director will be responsible for personnel assessment yearly." 5. An interview with the laboratory director and TP 4 on 06/24/2026 at 11:50 am confirmed the survey findings. Word Key: CLIA- Clinical Laboratory Improvement Amendments #- number 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 --