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 Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the technical consultant on 2/24/2025, the laboratory failed to follow written policies and procedures to assess testing personnel competency in 2024. The findings include: 1. The CMS 209 identified three (3) testing personnel (TP) performing moderate complexity testing. 2. A review of laboratory procedures identified that the laboratory established policies and procedures to assess TP initial training, semiannual and annual competency. 3. A review of training and competency assessment records identified that the laboratory failed to have six month competency assessments for three (3) of three (3) TP for the Abbott Alinity in 2024. 4. An interview with the TC on 2/24/2025 at 1:50 pm confirmed the above finding. 5. The laboratory reports performing 104,189 chemistry tests 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 --