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 the competency assessment records and interview with the technical consultant (TC), the laboratory failed to establish written policies and procedures to assess the competency for 1 of 1 TC for their supervisory responsibilities from 2021 to the date of the survey. Findings Include: 1. On the day of the survey, 06/26/2023 at 10:00 am, the laboratory could not provide a written procedure to assess the competency of 1 of 1 TC for their supervisory responsibilities from 2021 to the date of the survey. 2. The laboratory could not provide competency assessment records for 1 of 1 TC for their supervisory responsibilities in 2021 and 2022. 3. The TC confirmed the findings above on 06/26/2023 around 12:00 pm. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on review of competency assessment records, and interview with the technical consultant (TC), the TC failed to provide documentation of the direct observation of performance of instrument maintenance and function checks for 59 of 59 testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- personnel (TP) that perform blood gas testing in chemistry from 2021 to the date of survey. Findings include: 1. On the day of survey, 06/26/2023 at 10:15 am, the competency assessment records revealed that the TC failed to document the direct observation of performance of instrument maintenance and function checks for 59 of 59 TP in 2021 and 2022 for the Werfen GEM Premier 5000 analyzer in 2021 and 2022. 2. The TC confirmed the findings above on 06/26/2023 around 12:00 pm. -- 2 of 2 --