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 personnel records, review of the standard operating procedure manual (SOPM), and interview with the laboratory director (LD), the laboratory failed to establish procedures for performing personnel competency assessment and failed to assess personnel competency. Findings: 1. The Laboratory Personnel Report (form CMS-209) included testing person (TP) #4 who grossed tissue specimens and performed tissue processing and histopathology slide preparation procedures. 2. Personnel files did not include annual competency assessments for TP #4. 3. The SOPM did not include procedures for performing competency assessments for personnel performing grossing, tissue processing, and slide preparation. 4. During the exit interview on 04/17/2025 at 12:30 PM, the LD confirmed that the SOPM did not include procedures for competency assessment and there was no competency assessment performed for TP #4. 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 --