Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Through a review of laboratory personnel files, proficiency testing attestation documentation for 2018 and 2019, testing personnel authorizations, lack of documentation, as well as interviews with staff, it was determined proficiency testing samples were not tested by all personnel who routinely perform patient testing in the laboratory. As evidence by: A. The laboratory performs Comprehensive Metabolic Panel using the Siemens Expand Dimension Chemistry Analyzer, and Complete Blood Counts using the Abbott Ruby Hematology Analyzer. B. A review of laboratory personnel records revealed the testing personnel who were approved, by the laboratory director, to perform Moderate Complexity testing. Laboratory personnel #3 through #4 (as listed on the form CMS-209) were approved to perform Chemistry and Hematology. Laboratory personnel #5 (as listed on form CMS 209) was approved to perform Hematology only. C. A review of attestation statements for 4 out of 4 Hematology proficiency testing events in 2018 and 2019 revealed the laboratory personnel approved to perform Hematology (Complete Blood Counts) (personnel #5 as listed on form CMS-209) had not participated in Hematology proficiency testing in 2018 ( three of three testing events) or 2019 (one of one testing event). The proficiency testing had been performed by laboratory testing personnel #3 and #4. D. In an interview, at 1100 on 05/29/2019, technical consultant confirmed that laboratory personnel #5 who routinely performs Hematology patient testing had not participated in proficiency testing. 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 --