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 surveyor record review and interview Technical Consultant (TC) #2 and #3, Technical Consultant #1 (Laboratory Director) failed to have a written Competency Assessment (CA) procedure to assess the regulatory responsibilities of 2 of 2 TC's from 2016 through the date of survey. Findings Include: 1. On the date of survey, 05 /02/2018, after review of the Laboratories Annual Competency Policy for Clinical Staff, it was revealed that the policy did not include how to assess the regulatory responsibilities of the TC's. 2. Review of TC #2 (1 of 2) competency assessment records form 2017 and 2016, revealed they were not assess for their regulatory responsibilities. 3. TC #2 and TC #3 confirmed the finding above on 05/02/2018 around 10:30 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 --