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 a review of the "Frozen section, turnaround time and cryostat maintenance" log, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, a lack of competency assessments and an interview with the compliance officer on 7/14 /2023, the laboratory failed to follow policies to evaluate the competency for four of four testing personnel in 2022 and 2023. The findings include: 1. A review of the "Frozen section, turnaround time and cryostat maintenance" log identified four testing personnel that were not listed on the CMS 209 performing frozen section procedures in 2022 and 2023. 2. A lack of competency assessments identified that the laboratory failed to perform competency assessments on four of four frozen section testing personnel in 2022 and 2023. 3. An interview with the compliance officer on 7/14 /2023 at 9:40 am confirmed the above findings. 4. The laboratory reports performing 26 frozen sections annually. 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 --