Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) and interview, the laboratory failed to attest that proficiency testing samples were handled in the same manner as patient samples. Findings: 1. Review of the three PT events performed during 2019 and the third event of 2018 from the provider American Academy of Family Physicians (AAFP) revealed that the attestation statement: a. Did not contain the signature of the laboratory director (LD) or designee for 2 of the 4 events reviewed. b. Did not contain the signatures of the testing personnel for 4 of the 4 events reviewed. 2. Interview with the Technical Consultant on February 26, 2020 at 11:30 a.m. confirmed, the laboratory failed to attest that proficiency testing samples were handled in the same manner as patient samples. 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 --