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 review of the American Association of Bioanalysts (AAB) proficiency testing records and interview with the Technical supervisor it was determined that; the laboratory failed to verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance. The findings included: a. Q1-2018, AAB reported an artificial 100% proficiency score for the following analytes. DHEA-S Spec.: Reported Grading Mean: Value: Range: 1? 63.4 69.1 81.34 Note: True score for DHEA-S should have been 50%. Lipoprotein Spec.: Reported Grading Mean: Value: Range: 1? 12.0 6-11 8.8 2? 21.0 10-19 14.9 3? 16.0 8.15 11.2 Note: True score for Lipoprotein should have been 40%. b. Q2-2018 AAB reported an artificial 100% proficiency score for the following analytes. DHEA- S Spec.: Reported Grading Mean: Value: Range: 1# 219.9 238.6-322.8 280.66 2? 138.8 154.9-209.5 182.21 Note: True score for DHEA-S should have been 0%. Insulin Spec.: Reported Grading Mean: Value: Range: 1? 22.3 39.1-65.1 52.08 2? 26.2 46.9-78.2 62.55 Note: True score for Insulin should have been 0%. Troponin l Spec.: Reported Grading Mean: Value: Range: 2? 1.85 2.18-3.98 3.75 Note: True score for Troponin l should have been 50%. c. Q1-2019 AAB reported an artificial 100% proficiency score for the following analytes. Insulin Spec.: Reported Grading Mean: Value: Range: 1# 36 79.2-132 105.6 2# 3.2 5.7-9.5 7.56 Note: True score for Insulin should have been 0%. d. Q2-2019 AAB reported an artificial 100% proficiency score for the following analytes. Insulin Spec.: Reported Grading Mean: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Value: Range: 1# 22.8 40-66.6 53.3 2# 17 24.6-41 32.79 Note: True score for Insulin should have been 0%. e. The AAB has the following footnotes: ?= This score may not truly evaluate performance for these specimens which were not graded because of a lack of participants' consensus. #= this method was not grade due to an insufficient number of peer respondents. No appropriate default grouping was available. The listed ranges should provide a reasonable guide to your performance, however exercise caution in evaluating your results. f. The laboratory's annual testing declaration submitted for 2018-2019indicated that the laboratory analyzed and reported approximately 32,000 Routine Chemistry tests which included the above analytes. g. The technical supervisor confirmed (7/19/2019, 1630) that the laboratory received the above artificial 100% proficiency testing reports which the scores indicated failed or an unsatisfactory results. 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 American Association of Bioanalysts (AAB) proficiency testing records and interview with the Technical supervisor it was determined that; the laboratory failed to at least twice annually, verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. The findings included: a. Q3-2018, AAB reported an unsatisfactory score 0% for Folate analyte. b. The laboratory's annual testing declaration submitted for 2018-2019indicated that the laboratory analyzed and reported approximately 32,000 Routine Chemistry tests which included Folate analyte. c. The technical supervisor confirmed (7/19/2019, 1630) that the laboratory received the above unsatisfactory proficiency testing result. -- 2 of 2 --