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 laboratory procedure manuals and interview with the laboratory consultants, the laboratory failed to establish a complete competency assessment (CA) procedure to assess the competency of technical consultants (TC) for their supervisory responsibilities from 2019 the date of survey. Findings Include: 1. On the day of survey, 07/01/2021, the laboratory could not provide a written procedure to assess the competency of TC for their supervisory responsibilities from 07/10/2019 to 07/01 /2021. 2. Review of testing personnel records revealed, the clinical consultant (CC) performed duties of the TC. 3. The laboratory could not provide competency assessment records performed on the CC performing TC responsibilities in 2019, 2020 and 2021. 4. The laboratory consultants confirmed the findings above on 07/01 /2021 around 09:48 am. 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 --