Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 30, 2018. The laboratory was found not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency test (PT) records and interview with the laboratory supervisor, the laboratory failed to review and evaluate the results of the American Association of Bioanalysts (AAB) proficiency test for D (Rho) Typing for 2016, 2017, and August 2018. The finding include: 1. A review of PT records for AAB revealed that attestation statements were not signed and reviewed by Laboratory Director for 2016, 2017, and up to August 2018. 2. The Laboratory Director and testing personnel must attest that PT samples were performed accordingly to the guidelines set forth by the PT provider. 3. The laboratory supervisor confirmed on 8/30 /18, at 3:30 PM in the conference room, that the Laboratory Director failed to review and sign the PT attestation statements for the specialties of Immunohematology for 2016, 2017, and up to August 2018. 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 --