Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the review of the laboratory's CMS 209 Laboratory Personnel Report, the laboratory's personnel competency records, and confirmed in an interview, the laboratory failed to have documentation of competency assessment for four of five technical supervisors. The findings were: 1. Review of the laboratory's CMS 209 Laboratory Personnel Report, signed by the laboratory director on 9/6/2023, revealed the laboratory identified five technical supervisors. 2. Review of the laboratory's personnel competency records revealed the laboratory failed to have documentation of competency assessment for four of five technical supervisors. TS#2 Hired date: 8/16 /2014 TS#3 Hired date: 8/1/2019 TS#4 Hired date: 7/1/2009 TS#5 Hired date: 10/1 /2013 3. An interview with the laboratory director on 9/6/23 at 11:28 am in the office confirmed the above findings. 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 --