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 second quarter (Q2-2017) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, 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 Group A Strep Antigen. The findings included: a. Q2-2017, API reported 50% for Group A Strep Antigen. b. For three (3) out of three (3) random patient sampling test results reviewed covering period from 11/30/2017 to 1/30/2019, the laboratory analyzed and reported Group A Strep Antigen during the time the laboratory received an unsatisfactory proficiency testing score. c. The technical consultant confirmed (5/2/2019, 1300), that the laboratory received the above unsatisfactory proficiency test 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 reviews of the American Proficiency Institute (API) proficiency testing performance summary records, 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 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 -- I of this part. The findings included: a. Q2-2018, API reported the 40% for Low Density Lipoprotein (LDL) Cholesterol analyte. b. For one (1) out of seven (7 ) random patient test results reviewed covering period from 111/30/2017 to 1/30/2019, one (1) patient had an LDL ordered, analyzed and reported during the approximate time the laboratory failed the proficiency testing. c. The technical consultant confirmed (5/2/2019, 1300) that the laboratory received the above unsatisfactory proficiency testing score. -- 2 of 2 --