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 (CMS-209), the laboratory's policy, personnel records, and staff interview, revealed that the laboratory failed to follow the established policy for competency assessment for one of five testing personnel (TP) who performed gross examination of surgical pathology specimens in 2024. Findings included: 1. A review of the submitted CMS-209 form listed five testing personnel for high complexity testing who performed gross examination of surgical pathology specimens. 2. A review of the laboratory's "Competency Assessment Policy Grossing Personnel (High Complexity Testing)" policy revealed, "All personnel performing grossing of surgical pathology specimens are classified as performing high complexity testing and will undergo competency assessment: Initially (prior to independent testing), at six months and annually thereafter." 3. A review of laboratory personnel records revealed no documented annual competency assessment in 2024 for testing personnel two (TP2) as listed on the CMS-209 form. 4. An interview on 04.01.2026 at 12:45 p.m. with the Laboratory Director 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 --