Hhri Cardiac Biomarker Trials Laboratory

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to assess competency at least semi-annually during the first year of patient specimen testing for three of three testing personnel (TP) hired in 2021 and 2022. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) and Laboratory Director (LD) during a tour of the laboratory at 10:10 a.m. on February 14, 2023. 2. The Roche Cobas e 411 analyzer was observed as present and available for use during the tour. 3. Competency checks were required at hire and at 6 months for new employees and annually thereafter as established in the Competency Assessment Policy found in the Cardiac Biomarker Trials Quality Assurance and policy binder. 4. Semi-annual competency assessments were not found for TP1, TP2 or TP3 for the chemistry testing performed on the Roche Cobas e 411. TP1 and TP2 were hired in 2021, and TP3 was hired in 2022. Initial competencies as well as annual competencies were found. 5. The laboratory was unable to provide the missing documents upon request. 6. In an interview at 10:05 a.m. on February 14, 2023, the GS confirmed the above finding. . 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 --

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: . Based on document review and interview with laboratory personnel, the laboratory failed ensure all personnel who routinely perform testing on patient samples were included in testing proficiency testing (PT) samples. Findings are as follows: 1. The laboratory performed Chemistry testing as indicated by the General Supervisor (GS) during a tour of the laboratory on 01/15/19 at 12:40 p.m. The GS indicated she and Testing Personnel 1 routinely performed testing on patient samples. 2. The laboratory enrolled in a PT program for testing Creatine Kinase-MB with the College of American Pathologists (CAP). 3. The GS performed all testing on the CAP samples from 4 of 4 PT events completed in the timeframe reviewed, 08/18/17 through date of survey. 4. In an interview on 01/15/19 at 2:00 p.m., the GS confirmed the above finding. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for 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 -- acceptability. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure the test report included the name and address of the laboratory location (c)(2). Findings are as follows: 1. The laboratory performed Chemistry testing as indicated by the General Supervisor (GS) during a tour of the laboratory on 01/15/19 at 12:40 p.m. 2. Test reports for the patients listed below were reviewed on date of survey. Patient ID Date of testing 1391714 01/04/18 0675555 11/05/18 3. The name and address of the laboratory was not indicated on the test reports for the patients listed above. 4. In an interview on 01/15/19 at 3:50 p.m., the GS confirmed the above finding. -- 2 of 2 --