Summary:
Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing report, random patient test results, and interview with the technical consultant, it was determined that; the laboratory failed to attain an overall testing event score of at least 80 percent in Bacteriology. The findings included: a. Q3-2018, API reported an unsatisfactory score of 0% for Sputum Culture and 50% for Wound Culture-Aerobic. b. For eight (8) out of eight (8) random patient test results reviewed covering period from 11/21/2017 to 4/4/2019, the laboratory analyzed and reported during the time the laboratory failed the above proficiency testing in Bacteriology. c. The technical consultant confirmed (10/22/2019, 1100), that the laboratory received the above unsatisfactory proficiency testing scores. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing report, and interview with the technical consultant, it was determined that; the laboratory failed to attain a score of at least 80 percent of acceptable responses for PO2 analyte. The findings included: a. Q1-2019, API reported an unsatisfactory 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 2 -- of 60% for PO2. b. For two (2) out of two (2) random patient test results reviewed covering period from 3/12/2019 to 4/4/2019 the laboratory analyzed and reported PO2 test during the approximate time the laboratory failed the proficiency testing challenges for PO2 analyte. c. The technical consultant confirmed (10/22/2019, 1100), that the laboratory received the above unsatisfactory proficiency testing score. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API), and interview with the technical consultant, it was determined that; the laboratory failed to attain an overall testing event score of at least 100 percent for Compatibility testing. The findings included: a. Q2-2019, API reported an unsatisfactory score of 60% for Compatibility testing. b. Based on the laboratory's annual testing volume submitted for 2017-2019, the laboratory analyzed and reported 50 Compatibility tests. c. The technical consultant confirmed (10/22/2019, 1100), that the laboratory received the above unsatisfactory proficiency testing score. 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 Proficiency Institute (API), College, and interview with the technical consultant, it was determined that; the laboratory failed to 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: Hematology: a. API reported the following unsatisfactory proficiency testing scores. Analyte: Score: Event/Year: Urine Sediment 25% Q1/2018 CSF Mono 50% Q1/2018 CSF Neut 50% Q1/2018 Sed Rate 50% Q2/2018 CSF Mono 50% Q3-2018 Chemistry Analyte: Score: Event/Year: Acetone 60% Q2/2018 b. Based on the laboratory's annual testing volume submitted for 2017-2019, the laboratory analyzed and reported 66,000 Hematology tests which included the above failed analytes, and 73,000 Routine Chemistry tests which included Acetone tests. c. The technical consultant confirmed (10/22/2019, 1100) that the laboratory received the above unsatisfactory proficiency testing scores. -- 2 of 2 --