Niehs Clinical Research Unit

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the observation of the laboratory, review of laboratory procedures, review of laboratory maintenance records and interview with laboratory staff, the laboratory failed to check centrifuge speed and centrifuge timer for years 2022 and 2023. Findings: 1. During the laboratory tour on May 7, 2024, the following were observed: BD Vacutainer SST tubes (tiger top) Four centrifuges: Sorval Legend XIR Serial Numbers 42324473 and 41531470 Sorval Legend RT Serial Numbers 40598926 and 40598925 2. On May 7, 2024, review of the laboratory's Standard Operating Procedure 4.2.1 Basic Blood Processing Procedure for COVID-19 Serological Survey Specimens, Version 1.0, effective 4/25/2022, found the following: "2.2.1 Separation of Serum from Whole Blood There should be one Tiger top SST blood collection tube per study ... After the specimens have clotted, the specimen tubes are placed in the Sorval Legend RT Centrifuge, Sorval Legend X1R Centrifuge or equivalent [sic] and spun at ambient temperature for 10 minutes at 1150 rcf(g) (range 1000-1300g) with the break set to 3 (in Sorval Legend RT centrifuge) or 9/9 (Sorval Legend X1R centrifuge)" 3. Review of laboratory centrifuge maintenance records for 2022 and 2023 on May 7, 2024, found no records of a timer or speed check for the four 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 -- centrifuges the laboratory used to centrifuge SST tubes collected for SARS COV-2 IGG testing performed by the laboratory. 4. During interview on May 7, 2024, at 12: 15pm, the laboratory directory confirmed the laboratory did not have documentation of timer and speed checks for the four centrifuges used in the laboratory. Key: SST = Serum Separator Tube -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manuals, Centers for Medicare & Medicaid Services Laboratory Personnel Report (CMS-209), and an interview with testing person #2 on May 25, 2022, the laboratory director failed to sign and date his approval of all initial laboratory procedures from June 2020 to May 2022. Findings include: 1. Review of personnel competency procedures and the quality assurance manual revealed the laboratory director had not signed and dated any initial procedures from June 20, 2020, through May 25, 2022. 2. During an interview with testing person #2 (CMS-209) at approximately 11:00 AM on May 25, 2022, he stated the laboratory director had not signed and dated any procedures in the Procedure Manual since the laboratory first opened in June 2020. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of personnel training records, Centers for Medicare & Medicaid Services Laboratory Personnel Report (CMS-209), and an interview with 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 2 -- person #2, the technical consultant (TC) failed to assess all six minimum criteria for testing personnel competency assessment required for moderate complexity testing for Endocrinology COVID-19 qualitative antibody testing from June 2020 to May 2022. Findings include: 1. Review of the personnel training records revealed a Competency Evaluation Checklist consisted of for all six minimum criteria for testing personnel competency assessment required for moderate complexity testing for Endocrinology COVID-19 qualitative antibody testing, but the technical consultant did not conduct any required initial, semi-annual, or annual competency evaluations from June 2020 to May 2022. The Competency Evaluation Checklist had zero documented competencies for the following six minimum criteria: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting of test results. c) Review of intermediated test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficency testing samples. f) Assessment of problem solving skills. 2. During an interview with testing person #2 at approximately 9:30 AM on May 25, 2022, confirmed the technical consultant did not assess testing personnel #1 and #2 for all six minimum criteria for testing personnel competency assessments required for moderate complexity testing for Endocrinology COVID-19 qualitative antibody testing for any required initial, semi-annual, or annual competency evaluations from June 2020 to May 2022. -- 2 of 2 --