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 laboratory Blood Volume Analysis report, test accuracy verification record and interview with the laboratory testing personnel (TP) #7, the laboratory failed to verify test (radio-bioassay) accuracies at least twice in 2017. Findings include: 1. The 2017 laboratory Blood Analysis reports show total 14 radio- bioassays tested. 2. None (14 of 14) of these tests had accuracy verification records. 3. The laboratory had no other test accuracy verification documents. 4. The laboratory resulted all these 14 tests electronically. 5. The TP #7 confirmed above findings on 06 /05/2018 at 10:30 AM. 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 --