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 the lack of personnel competency policies and procedures and interview with the laboratory manager, the laboratory failed to establish written policies and procedures to assess employee (testing personnel) competency. Findings: 1. Review of laboratory policies and procedures revealed the laboratory did not establish written personnel policies and procedures to assess testing personnel competency. 2. Interview with the laboratory manager on February 26, 2020 at 11:00 AM confirmed the laboratory failed to establish written policies and procedures to assess testing personnel competency. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require