Summary:
Summary Statement of Deficiencies D0000 All deficiencies have been corrected. The facility is in compliance with all regulations surveyed. 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: Review of the CMS 209 form, lack of documentation and interviews with laboratory staff, determined the laboratory failed to assess employee competency as directed in personnel requirements. Survey findings follow: A) Review of the CMS 209 form submitted by the laboratory revealed that the Technical Consultant (TC) #1 and #2 on the CMS 209 form was listed as the technical consultant. B) Review of personnel records for TC #1 and TC #2 on the CMS 209 form, revealed that no competency evaluation for the position of technical consultant was present. C) Upon request, the laboratory was unable to provide documentation of competency determinations for calendar year 2022 or 2023 for the position of technical consultant for the personnel identified above. D) In an interview at 11:44 a.m. on July 25, 2024, the laboratory staff member (TC #1 and on the form CMS 209) confirmed that competency determinations have not been performed on the personnel designated as technical consultant and that she had served as technical consultant for the full year of 2022, 2023 and to date in 2024. A technical competency evaluation was completed on the day of the survey. E) In an interview at 11:44 a.m. on July 25, 2024, the laboratory staff member (TC #2 and on the form CMS 209) confirmed that competency determinations have not been performed on the personnel designated as technical consultant and that she had served as technical consultant for the full year of 2023 and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- to date in 2024. A technical competency evaluation was completed on the day of the survey. -- 2 of 2 --