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) during calendar year 2018 from the PT provider, College of American Pathologists (CAP) and interview, the laboratory failed to attest that proficiency testing samples were handled in the same manner as patient samples. Findings were: 1. A review of proficiency testing events during 2018, PT kit HER2-A and HER2-B revealed that attestation statement did not contain the signature of the laboratory director (LD) or designee, and the signature of the testing personnel, attesting that the laboratory handled proficiency testing samples in the same manner as patients. 2. Interview with the LD on September 16, 2019 at 2:30 PM, 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 --