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 laboratory's Quality Assessment (QA) Policies, competency assessment records review, and interview with the Technical Consultant (TC)#1, the laboratory failed to have a competency assessment (CA) policy for the 1 of 1 Clinical Consultant (CC), 2 of 2 Technical Consultants (TC), 1 of 1 Technical Supervisor (TS), and 1 of 1 General Supervisor (GS) for their supervisory responsibilities in 2020 and 2021. Findings include: 1. On the day of survey, 01/25/2022 at 09:28 a.m., the TC#1 could not provide a CA policy to assess the competency of 1 of 1 CC (CMS- 209 personnel #2) , 2 of 2 TC (CMS-209 personnel #3 and #4), 1 of 1 TS ( CMS-209 personnel #4), and 1 of 1 GS (CMS-209 personnel #3) for their supervisory responsibilities in 2020 and 2021. 2. The TC#1 could not provide a competency assessment records for 1 of 1 CC from 01/25/2020 to 01/25/2022. 3. The TC#1 confirmed the findings above on 01/25/2022 around 12:00 p.m. 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 --