Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted on-site at Cire Labs, LLC on October 18-19, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The onsite inspection also included a virtual exit interview with the laboratory director, administrative business manager, technical supervisor, and managing member on 10/20/22. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and was in compliance with the applicable COVID- 19 reporting requirements. The laboratory was surveyed under 42 CRC part 493 CLIA Requirements. Specific deficiencies cited are as follows and includes three Conditions under 42 CRC part 493 CLIA Regulation: D5400 -42 CRC. 493.1250 Analytic Systems D6076 -42 CRC. 493.1441 Laboratory Director D6168 -42 CRC. 493.1487 Condition Testing Personnel D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a tour, review of procedures, manufacturer's package inserts, daily temperature/environment logs, result data logs, lack of documentation, and interviews the laboratory failed to: 1. ensure that two (2) of 2 patient Seasun Biomaterials TOP viral specimens for COVID-19 testing were stored at 2-8 degrees Celsius (C) per the approved procedure as observed during the inspection on October 18, 2022; 2. monitor daily room relative humidity (%) levels to ensure manufacturer's requirements were followed for the Seasun Biomaterials SmartAmp Gene Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- Amplificator analyzer for the timeframe of the test validation steps in April 2022 to the date of the inspection on October 18-19, 2022; 3. evaluate, verify/validate the performance specifications for the high complexity AQ-TOP COVID-19 reverse transcriptase Real-Time Loop Mediated Isothermal Amplification (RT-LAMP) assay on the Seasun Biomaterials SmartAmp Gene Amplificator instrument for patient COVID-19 testing prior to reporting eighty patient results during the timeframe of August 2, 2022 up to the inspection on October 18-19, 2022; 4. document relative centrifugal force verification for the microplate centrifuge utilized in patient sample processing for RT-LAMP COVID-19 assays during the timeframe of the test validation steps in April 2022 and up to the date of the inspection on October 18-19, 2022. See D5401, D5413, D5421, D5435. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a tour, review of procedures, manufacturer's package inserts, and interviews, the laboratory failed to ensure that two (2) of 2 patient Seasun Biomaterials TOP viral specimens for COVID-19 testing were stored at 2-8 degrees Celsius (C) per their approved procedure as observed during the inspection on October 18, 2022. Findings include: 1. During a tour on 10/18/22 at approximately 1 PM, the inspector noted the laboratory's freezer temperature recorded as -20.78 degrees Celsius (C) on the attached Delta Trac digital thermometer. A review of the freezer contents revealed Seasun Biomaterials test reagents and the following patient Seasun Biomaterials TOP viral collection tube specimens labeled with accompanying requisitions for Cire Labs, LLC PCR COVID-19 testing stored for future batch testing: ID #8791 collected on 10 /17/22 at 5 PM, ID #1625 collected on 10/18/22 at 12:29 PM 2. Review of the laboratory's policy manual revealed a procedure (titled: COVID-19 PCR Testing) that stated under Specimen Collection, Storage and Handling: "Specimens may be stored at 2-8 degrees Celsius for up to 72 hours". 3. Review of the Seasun Biomaterials TOP Virus Collection Kit for COVID-19 manufacturer's package insert revealed the following instructions: Warnings and Limitations: "Freezing of samples should be avoided" 4. The inspector inquired regarding a description of the laboratory's routine specimen storage protocols. The administrative business manager stated on 10/18/22 at approximately 2:30 PM, "The samples are routinely placed with the requisitions in the freezer because we batch them before we make a run." 5. The inspector inquired regarding the observed lack of refrigerator unit in the laboratory as it pertained to the policy and manufacturer's instructions for the COVID-19 PCR samples to be store at refrigerated 2-8 C. The laboratory's managing member stated on 10/18/22 at approximately 3:00 PM, "We do not have a refrigerator for the laboratory. I will get one ordered today." 6. A virtual exit interview with the lab director, administrative business manager, lab technical supervisor, and managing member on 10/20/22 at approximately 4:00 PM, confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) -- 2 of 10 -- The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of procedures, manufacturer's user manual, daily temperature /environment logs, patient test logs, lack of documentation, and interviews, the laboratory failed to monitor daily room relative humidity (%) levels to ensure manufacturer's requirements were followed for the Seasun Biomaterials SmartAmp Gene Amplificator analyzer for the timeframe of the test validation steps in April 2022 to the date of the inspection on October 18-19, 2022. Findings include: 1. Review of the facility's laboratory procedure manual revealed a Seasun Real-Time Gene Amplificator User Manual that stated, "Section 4.4 Storage and Use Conditions: Relative Humidity limit of 15-95 % ". The inspector noted that the procedure manual included a validation correlation was conducted for the Seasun Gene Amplificator in April 2022. 2. Review of the available temperature/environment log records from April 2022 to 10/18/22 revealed no laboratory room humidity monitoring. 3. Review of the Seasun Real-Time Gene Amplificator patient test logs revealed the following dates that patient COVID-19 results were reported: 8/2/22, 8/4/22, 8/9/22, 8/16/22, 8 /17/22, 8/19/22, 8/23/22, 8/25/22, 8/26/22, 8/30/22, 9/9/22, 9/14/22, 9/16/22, 9/21/22, 9/22/22, 9/23/22, 9/28/22, 10/4/22, 10/5/22, 10/6/22, 10/11/22, 10/13/22, 10/14/22. 4. The inspector requested to review