Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Based on review of American Association of Bioanalysts (AAB) proficiency testing (PT) documentation for 2017 and 2018, confirmed by staff interview, the laboratory failed to test PT samples using the personnel who routinely perform patient testing. Findings: 1. Laboratory PT attestation forms were reviewed. The forms for the first and second events of 2017 showed testing person 1 (CMS form 209) to have performed the testing on all samples. The attestation form for the third event of 2017 was unsigned. 2. In an interview at the site on 05-24-2018, testing person 1 stated that results for the third event 2017 had not been submitted within the time window required and for that reason the attestation form had not been signed. She further stated that she had performed the testing on samples for all 3 testing events of 2017 as well those for the first event of 2018, which had not yet been submitted, and confirmed that none of the proficiency testing for 2017 or 2018 had been performed by the other two testing personnel listed on the CMS form 209. 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 --