Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to run proficiency testing samples the same number of times as it routinely tests patient samples. Findings: Review of the laboratory's proficiency testing with American Proficiency Institute from April 17, 2016 to April 17, 2018 showed that the laboratory reran proficiency sample more than once. The laboratory's "Proficiency Testing Plan" policy read, "Proficiency testing samples are to be treated as the same as patient sample processing." The laboratory's "Critical Results" policy read, "All critical results must be recheck and verified of accuracy." The following samples were run more than once. 2016 Hematology/Coagulation 2nd Event reran 5 out of 5 samples, sample number 6, 7, 8, 9, 10 2017 Hematology/Coagulation 1st Event reran 5 out of 5 samples, sample number 1, 2, 3, 4, 5 2017 Hematology/Coagulation 2nd Event reran 2 out of 5 samples, sample number 6, 10 2017 Hematology/Coagulation 3rd Event reran 5 out of 5 samples, sample number 11, 12, 13, 14, 15 During an interview on 4/17/18 at 10:10 AM, Technical Consultant B acknowledged that the testing personnel ran the proficiency samples more than once. 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 --