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 record review, and an interview with the Laboratory Manager, the laboratory failed to establish a written policy and procedure to assess competency of the Technical Supervisor (TS), as specified in the personnel requirements in subpart M. All patients tested at this laboratory have the potential to be affected. Findings Include: 1. Review of the laboratory's CMS-209 Personnel Report form, approved and signed by the Laboratory Director on 6/26/19, found 10 individuals serving as both the TS. 2. Review of the laboratory's 'Competency Assessment' policy and procedure failed to find a policy and procedure for assessing the competency of the TS based on the regulatory responsibility of that role, at a frequency determined by the laboratory. 3. An interview with the Laboratory Director, on 6/27/19 at 2:13 pm, confirmed that the lab failed to establish a policy and procedure for assessing the competency of the TS based on the regulatory responsibility of those roles, at a frequency determined by the laboratory. 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 --