Summary:
Summary Statement of Deficiencies 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 third quarter (Q3-2017) of the American Proficiency Institute (API) proficiency testing report, 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 for PCO2. The findings included: a. Q3-2017, API reported unsatisfactory proficiency testing score of 60% for PCO2 test. b. Based on the laboratory's annual testing declaration submitted for 2018-2019, the laboratory analyzed and reported 61 Blood Gas which included PCO2 tests. b. The technical consultant affirmed (7/25 /2019, 1400) that the laboratory received the above unsatisfactory proficiency testing score. D2121 HEMATOLOGY CFR(s): 493.851(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 first quarter (Q1-2019 of the American Proficiency Institute (API) performance summary report, random patient sampling records 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 Granulocytes, Lymphocytes, Eosinophils, Basophils, and Monocytes. The findings included: a. Q1-2019, API 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 -- reported the following unsatisfactory proficiency testing scores; Analyte: Score: Event /Year Granulocytes 0% Q1-2019 Lymphocytes 0% Q1-2019 Monocytes 0% Q1-2019 Eosinophils 0% Q1--2019 Basophils 0% Q1-2019 b. For seven (7) out of seven (7) random patient test results reviewed covering period from 7/1/2017 to 3/4/2019, the laboratory analyzed and reported Complete Blood Count (CBC) with auto differential during the approximate time the laboratory received the unsatisfactory scores. c. The technical consultant confirmed (7/25/2019, 1400) that the laboratory received the above unsatisfactory scores for White Blood Cells (WBC) differential counts. d. Based on the laboratory's annual testing declaration submitted for 2018-2019, the laboratory analyzed and reported approximately 4,448 CBC which included the Granulocytes, Lymphocytes, Eosinophils, Basophils and Monocytes auto differential counts. 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 the review of the American Proficiency Institute (API) proficiency testing reports and interview with the technical consultant, the laboratory failed to verify the accuracy of the Sedimentation Rate (ESR, Polymedco). The findings included: a. Q1- 2018, API reported an unsatisfactory score of 50% for ESR. b. Based on the laboratory's annual testing declaration submitted for 2018-2019, the laboratory analyzed and reported 1,002 ESR test during the approximate time that the laboratory failed in the proficiency testing for ESR. c. The technical consultant confirmed (7/25 /2019, 1400) that the laboratory received the above unsatisfactory proficiency testing score for ESR. -- 2 of 2 --