Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the third quarter (Q3-2017) of the American Proficiency Institute (API) proficiency testing records and interview with the laboratory staff, it was determined that; the laboratory failed to at least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. The findings included: a. Q3-2017, API received an unsatisfactory proficiency testing score of 50% for Urine sediment. b. Based on the laboratory's annual testing declaration submitted for 2017-2019, the laboratory analyzed and reported 398 urine sediments approximately during the time the laboratory received an unsatisfactory proficiency testing score. c. The laboratory staff confirmed (8/21 /2019, 1300) that the laboratory received the above unsatisfactory proficiency testing score. 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 --