Hampton University Clinical Laboratory (Covid-19)

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Hampton University Clinical Laboratory (COVID-19) on April 12, 2022 by the Virginia Department of Health's Office of Licensure and Certification. 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: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of procedures, proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to retain an attestation statement signed by the laboratory director (LD) for one (1) of three (3) events reviewed on April 12, 2022. Findings include: 1. Review of the laboratory procedure manual revealed a Proficiency Testing (HU-ADMIN 113) policy that outlined: "The individual testing/examining the samples and the laboratory director must attest to routine integration of the samples into the patient workload using the laboratory's routine methods". 2. Review of the laboratory's College of American Pathologists (CAP) SARS-CoV-2 proficiency records (3 events: 2021 A, 2021 B, 2022 A) revealed no signed LD attestation statement for the following event: CAP 2022 COV2Q-A, received by the laboratory in February 2022. The inspector requested to review the LD attestation documentation for the event outlined above. No record was retained /available for review. 3. An interview with the Vice President for Research and Clinical Laboratory Manager, on 4/12/22 at approximately 4:30 PM, confirmed the above findings. 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 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on a tour, review of procedures, lack of documentation, and interviews, the laboratory failed to label two (2) of five (5) nuclease-free invitrogen reagent bottles utilized for polymerase chain reaction (PCR) SARS-CoV-2 testing with appropriate open-expiration dates at the time of the survey on April 12, 2022. Findings include: 1. During a laboratory tour on 4/12/22 at approximately 1:45 PM, the inspector noted 2 Thermo Fisher Scientific Ambion Nuclease-Free reagent containers (Lot Number 2110477) in use without a revised open-expiration date. The inspector inquired regarding the protocols for storage/handling to maintain purity of the reagent once opened for use. The laboratory manager stated: "We use the Nuclease-Free reagent water in our negative control process. Our reagents should have a receive date and opened stability date on all of those bottles". 2. Review of the laboratory procedures revealed a quality assurance protocol (title: Quality Assessment Plan, HU-PRO)that outlined: "Laboratory reagents, testing kits, control sets and all supplies will be dated upon receipt and when opened for use. The expiration date of all supplies will be noted." The inspector requested to review Thermo Fisher Scientific Ambion Nuclease- Free package insert. No record was retained/available for review. 3. An interview with the Vice President for Research and Clinical Laboratory Manager, on 4/12/22 at approximately 4:30 PM, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA complaint investigation (VA00053225) was conducted at Hampton University-COVID-19 Laboratory on 11/3/21-11/9/21 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Based on the tour of the testing site(s), review of documents and interviews, the allegations of the absence of lab technologists or qualified testing personnel, untrained staff performing sample collection, proper specimen collection, testing not conducted on-site and concerns of sample transportation off-site was unsubstantiated due to lack of evidence. The allegation of lack of test validity and supervision was substantiated. Specific deficiencies cited are as follows: The laboratory is not in compliance with the following 42 CFR Part 493 CLIA requirements: D5400 - 42 C.F.R. 493-1250 Condition: Analytic Systems, and D6076- 42 C.F.R. 493-1441 Condition: High Complexity Laboratory Director. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interviews, the lab failed to report SARS-CoV-2 (COVID- 19) negative test results for 83 of 83 testing dates from 05/01/21 through 11/01/21. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Findings include: 1. An interview and review of available COVID-19 daily testing log with the lab director, Vice President for Research and testing personnel (TP) A on 11 /09/21 at 1300 revealed the site performed Abbott BinaxNow COVID-19 Ag Card test method on 05/01/21 through 11/01/21. 2. 13,276 negative results were not reported as required during the period of review (83 testing dates). 3. The laboratory performed 13,298 COVID-19 tests during the period of review. 4. An exit interview with the lab director, Vice President for Research and testing personnel TP A on 11/09/21 at approximately 1300 confirmed the findings. 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 the review of the Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification form (CMS 116), tour of the lab and remote testing site, manufacturer's instructions for use (IFU), policy and procedures (P&P), lack of documentation, patient testing data log, and interviews, the laboratory failed to: 1. have a written policy for reporting the Abbott BinaxNow COVID-19 Ag Card patient SARS-CoV-2 (COVID-19) positive and negative results to the State agency from 05/01/21 and up to 11/03/21 (Refer to D5403), 2. monitor the room, refrigerator and freezer temperatures for 171 of 171 days and reporting 11,109 patients (Refer to D5413 part A), 3. document monitoring of temperatures to ensure storage and stability requirements for the Abbott BinaxNow COVID-19 AG cards/kits from 05/01/21 up to 11/02/21 while reporting 13,298 patient results (Refer to D5413 part B), 4. provide documentation of the initial verification of accuracy and precision for testing of patient samples using the new test methods (Refer to D5421) and 5. provide documentation the quality assessment (QA) mechanism defined in the written policy to identify and address analytic in the sub-specialty of virology for nine of nine months (Refer to D5791). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 An unannounced CLIA complaint investigation (VA00053225) was conducted at Hampton University COVID 19 Laboratory on 11/03-09/21 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D3000 - 42 C.F.R. 493-1100 Condition: Reporting of SARS-CoV- 2 Test Reports. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interviews, the lab failed to report SARS-CoV-2 (COVID- 19) negative test results for 83 of 83 testing dates from 05/01/21 through 11/01/21. Findings include: 1. An interview and review of available COVID-19 daily testing log with the lab director, Vice President for Research and testing personnel (TP) A on 11 /09/21 at 1300 revealed the site performed Abbott BinaxNow COVID-19 Ag Card test method on 05/01/21 through 11/01/21. 2. 13,276 negative results were not reported as required during the period of review (83 testing dates). 3. The laboratory performed 13,298 COVID-19 tests during the period of review. 4. An exit interview with the lab Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- director, Vice President for Research and testing personnel TP A on 11/09/21 at approximately 1300 confirmed the findings. 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 the review of the Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification form (CMS 116), tour of the lab and remote testing site, manufacturer's instructions for use (IFU), policy and procedures (P&P), lack of documentation, patient testing data log, and interviews, the laboratory failed to: 1. have a written policy for reporting the Abbott BinaxNow COVID-19 Ag Card patient SARS-CoV-2 (COVID-19) positive and negative results to the State agency from 05/01/21 and up to 11/03/21 (Refer to D5403), 2. monitor the room, refrigerator and freezer temperatures for 171 of 171 days and reporting 11,109 patients (Refer to D5413 part A), 3. document monitoring of temperatures to ensure storage and stability requirements for the Abbott BinaxNow COVID-19 AG cards/kits from 05/01/21 up to 11/02/21 while reporting 13,298 patient results (Refer to D5413 part B), 4. provide documentation of the initial verification of accuracy and precision for testing of patient samples using the new test methods (Refer to D5421) and 5. provide documentation the quality assessment (QA) mechanism defined in the written policy to identify and address analytic in the sub-specialty of virology for nine of nine months (Refer to D5791). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)