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 competency assessment (CA), quality assurance and quality control records (QA/QC), lack of documentation, and interview with the Technical Consultant (TC) #1, the laboratory failed to assess the competency of 1 of 1 testing personnel (TP) that performed the position responsiblities of a TC from 7/5/2023 to 7 /17/2025. Findings Include: 1. On the day of survey, 7/17/2025 at 10:30 am, review of CA and QA/QC records revealed 1 of 1 TP (CMS 209, TP#1) performed the following duties of a CLIA TC based on 493.1413(b)(8) Standard, Technical Consultant Responsibilities: - Direct observations for CA for TP #2 and TP #3 (Form CMS 209, dated 7/11/2025) in 2024. - QA/QC reviews for the following 6 of 24 months from 7/5/2023 to 7/17/2025: August 2023 December 2023 March 2024 September 2024 January 2025 June 2025 2. The laboratory failed to provide a competency assessment for TP #1 (CMS 209 form dated 7/11/2025) for their TC responsibilities performed in the laboratory from 7/5/2023 to 7/17/2025. 3. The laboratory failed to provide written documentation for which responsibilities the Laboratory Director delegated to TP #1 from 7/5/2023 to 7/17/2025. 4. Technical Consultant (TC) #1 confirmed the findings above on 7/17/2025 at 11:30 am. 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 --