Monarch Molecular, Old Dominion University

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Monarch Molecular, Old Dominion University on March 30-31, 2023 by the Virginia Department of Health's Office of Licensure and Certification. 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 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of the laboratory's equipment maintenance /calibration records, lack of documentation, and interviews, the laboratory failed to document performance of every six month maintenance protocols for twenty-four (24) of 24 pipettes utilized for patient molecular SARS-COV-2 (COVID-19) and respiratory pathogen panel testing according to their policy during a twenty (20) month review timeframe (July 2021 to the date of the inspection, March 30, 2023). Findings include: 1. During a tour of the laboratory on 3/30/23 at approximately 10:30 AM, the inspector noted the following pipettes in the molecular specimen preparation area -listed by by Serial Number (SN) and manufacturer: RU02091 ThermoFisher 1000 ul SU03021 ThermoFisher 100 ul RU08359 ThermoFisher 20ul RU08374 ThermoFisher 2 ul 046460J Eppendorf 300 ul 046449J Eppendorf 300 ul 1152466J 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 -- Eppendorf 10 ul QU43032 ThermoFisher 1000 ul RU00987 ThermoFisher 1000 ul SU02961 ThermoFisher 1000 ul RU00937 ThermoFisher 200 ul RU09728 ThermoFisher 200 ul RU02036 ThermoFisher 100 ul QU42258 ThermoFisher 100 ul RU01097 ThermoFisher 20 ul RU09628 ThermoFisher 20 ul SU02991 ThermoFisher 10 ul QU42333 ThermoFisher 10 ul RU09678 ThermoFisher 2 ul RU00872 ThermoFisher 2 ul RU09578 ThermoFisher 1000 ul RU07034 ThermoFisher 1000 ul RU08339 ThermoFisher 200 ul RU02056 ThermoFisher 10 ul The inspector inquired regarding the pipettes' use and pipette calibration protocols. The Technical Supervisor (TS)/General Supervisor (GS) described the pipette uses were for reagent, quality control, and specimen preparation for COVID-19 and respiratory viral sample assays on the Biofire Diagnostics, Roche 6800, and Diasorin Molecular analyzers. The TS /GS and lead testing personnel stated on 3/30/23 at approximately 10:45 AM "We have Precision Calibration Services come in every six months to calibrate our pipettes. The calibration records are not stored here in the lab but are in my office and we can get them out for you to review." 2. Review of the laboratory's equipment calibration records from July 2021 to the date of the recertification inspection on 3/30 /2 revealed pipette calibration for the 24 pipettes outlined above was performed by outside vendor, Precision Calibration Services, on 12/13/21 (with note by vendor "next calibration is due 06/2022") and on 09/16/22. 3. The inspector requested to review additional pipette calibration records during the 20 months of review. The lead testing personnel stated on 3/30/23 at approximately 12:45, "We may not have had the pipettes calibrated in June 2022 as planned but had them come in September last year." The TS/GS stated on 3/30/23 at approximately 12:45 PM, "I can reach out to the rep at Precision Calibration to find out if he has additional records." No additional records were available for review. 4. A follow up exit interview with the TS/GS on 3 /31/23 at approximately 1:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Monarch Molecular, Old Dominion University on July 14, 2021 by the Virginia Department of Health's Office of Licensure and Certification. 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 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the Condition under 42 CFR part 493 CLIA Regulation: D6168 -42 CFR. 493.1487 Condition Testing Personnel. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a review of the CLIA Laboratory Personnel Report Form (CMS-209), available testing personnel (TP) files, lack of documentation, and an interview, the laboratory failed to ensure that one of seven TP qualified to perform high complexity testing from October 1, 2020 and up to the date of the inspection on July 14, 2021. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a review of the CLIA Laboratory Personnel Report Form (CMS-209 Form), available testing personnel (TP) files, lack of documentation, and an interview, the laboratory failed to ensure that one (1) of seven (7) TP qualified to perform high -- 2 of 3 -- complexity testing during the eight month review timeframe (October 1, 2020 and up to the date of the inspection on July 14, 2021). Findings include: 1. Review of the laboratory's CMS 209 form revealed that the lab director identified 7 TP as responsible for high complexity SARS-CoV-2 nucleic acid amplification testing during the review timeframe of 10/1/20 to 7/14/21. 2. Review of the available laboratory personnel records for TP A revealed a foreign diploma (University of Malaya). The inspector requested to review US education equivalency documentation. No records were available for review. (See Personnel Code Sheet attached.) 3. An interview with the Technical Supervisor on 7/14/21 at approximately 1 PM confirmed the above findings. -- 3 of 3 --