Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and an interview with the Laboratory Director, the laboratory failed to ensure PT results were submitted within the timeframe specified by the proficiency testing provider. This was noted for one of two 2023 survey events reviewed. The findings include: 1. A review of the AAB- MLE PT records revealed no scores for the 2023-M1 Hematology survey. 2. A review of the MLE Shipping calendar revealed the 2023-M1 survey submission deadline was 2/15/2023. 3. A review of the quality assurance documents with the survey revealed the testing personnel failed to perform the AAB-MLE PT survey because she thought the package contains quality controls, not proficiency testing samples. The laboratory was also having problems with the instrument during this period, however the testing personnel failed to notify the Laboratory Director and the proficiency testing provider till the week after the survey due date. 4. During an interview on 6/22/2023 at 12:30 PM, the Laboratory Director confirmed these findings. SURVEYOR ID #32558 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 --