Summary:
Summary Statement of Deficiencies D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on review of laboratory procedure, 2024 "Competency Assessment - Toxicology Data Analysis and Data Review" testing personnel (TP) competency records and phone interview with technical supervisor (TS) #2, 02/27/25, the TS failed to documentation the assessment of the test performance of 8 of 8 data analysis and data review TP reviewed at time of survey. Findings: Review of laboratory procedure "SYSTEM LEVEL PROCEDURE: Competency" revealed "5.3... Competency testing includes the following six areas of assessment: 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and...". Review of 2024 "Competency Assessment - Toxicology Data Analysis and Data Review" TP competency records revealed a checklist, with 7 tasks. The "tasks" are given a "N" - Does not meet standard and/or expectation; "Y" - Meets standard and/or expectation; or n/a - Not applicable. Review of 8 of 8 TP Task #7 - Blinded Sample Assessment - Data Review revealed a "Y". The assessment failed to include documentation of the results obtained by TP and a comparison of the results obtained from the "Blinded Sample". The assessment also fails to include the expectation or standard that is to be met to determine test performance. During phone interview with TS #2 at approximately 2:15 p.m., the TS stated all TP who perform data analytics and review perform a blind sample using previously analyzed data. She confirmed the competency assessment records failed to include documentation of the results obtained by TP and the comparison of the results obtained from the blind sample. She also confirmed the assessment records fail to include the expectation or standard that is to be met to determine test performance. 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 --