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 record review, the Laboratory Personnel Report (CMS 209), and an interview with the laboratory director (LD), the laboratory failed to establish written policies and procedures to assess employees performing Histopathology testing, affecting 2 out of 2 testing personnel (TP). Findings: 1. The CMS 209, personnel records, and procedures manual were reviewed. 2. The laboratory failed to have a written competency policy and procedure to evaluate TP performing Histopathology tissue processing. 3. The CMS 209 listed 2 employees (TP2 and TP3) performing tissue grossing and staining in the laboratory. 4. The personnel documents provided for TP2 and TP3 did not include employee assessments to perform tissue grossing and staining. 5. On an Initial survey conducted on 06/08/2021 at 12:30 PM, the LD confirmed the above 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 --