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 the API (American Proficiency Institute) proficiency testing (PT) records and an interview with Testing Personnel (TP) #1, the laboratory failed to ensure Rh (Anti-D) card testing on PT specimens was performed in the same manner as patient Rh testing. This was noted on four of four 2017 - 2018 survey events reviewed. The findings include: 1. A review of the API PT records revealed TP #1 and #2 had each signed the attestation statements from 2017 Events #2 and #3, and 2018 Event #1, with "Rh" listed as the "test/set" performed. The 2017 Event #1 attestation was signed by TP #1 and a previous employee with "Rh" as the "test/set" performed. 2. In an interview on 5/17/2018 at 10:30 AM (with the Administrative Health Center Manager from the Atlanta Office present), TP #1 was asked which PT samples each of the testing personnel performed, and how they each tested the specimens. TP #1 stated she had performed all of the PT testing and TP #2 had watched her do the testing. When asked if this was how the patient Rh tests were performed, TP #1 answered "No". Thus, the above noted findings were confirmed. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor 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 --