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 submitted Centers for Medicare and Medicaid Services (CMS) 209 form, laboratory's policy, personnel records, and staff interview, it was revealed the laboratory's policy failed to include semi-annual and annual competency evaluation as required in Subpart M of the State Operations Manual (SOM) Appendix C and failed to have documentation of semi-annual and/or annual competency performed by the Laboratory Director/Technical Supervisor listed on the CMS 209 form for two of three testing personnel. Findings included: 1. A review of the submitted Centers for Medicare and Medicaid Services (CMS) 209 form listed three testing personnel for high complexity testing. 2. A review of the laboratory's Quality Assurance Plan policy revealed that it failed to include semi-annual and annual competency assessments for testing personnel performing high-complexity testing. 3. A review of laboratory personnel records revealed the following: -No documented semi-annual competency or annual competency assessments by the Laboratory Director/Technical Supervisor listed on the CMS 209 form for testing personnel one (TP1) as listed on the CMS 209. -No documented annual competency assessment by the Laboratory Director/Technical Supervisor listed on the CMS 209 form for testing personnel two (TP2) as listed on the CMS 209. 4. An interview with the laboratory liaison on 09.10.2025 at 12:15 p.m. confirmed the above survey findings 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 --