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: . Through a review of the laboratory policy and procedure manual, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to establish policies to assess the competency of the technical consultant. As evidenced by: A. A review of the laboratory policy and procedure manual revealed the laboratory failed to have a written policy for assessing the competency of the technical consultant. B. A review of personnel records for three of three laboratory employees revealed laboratory employee #1 (listed as the technical consultant on the form CMS-209) failed to include competency assessments for 2018 and 2019. C. In an interview at 1030 on 7/18/2019, laboratory employee #1 (listed as the technical consultant on form CMS 209) confirmed there was no competency assessment in 2018 or 2019 for the technical consultant 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 --