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 and interview with the Laboratory Director, the laboratory failed to establish policies and procedures to assess the competency of its testing personnel, clinical consultant, technical supervisor, and general supervisor for 8 (February 2023 to October 2023) of 8 months the laboratory has been performing histopathology testing. Findings include: 1. A review of the laboratory's policies and procedures revealed a lack of process for how the laboratory assesses competency for its testing personnel, clinical consultant, technical supervisor, and general supervisor. 2. An interview on 10/24/23 at 10:45 am with the Laboratory Director confirmed the laboratory had not established competency assessment policies and procedures to assess testing personnel, clinical consultant, technical supervisor, and general supervisor. 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 --