Virus Isolation And Serology Lab

Summary Statement of Deficiencies D0000 A Federal Surveyor from the Division of Clinical Laboratory Improvement and Quality (DCLIQ) Survey Branch conducted an announced CLIA recertification survey at the Virus Isolation and Serology Laboratory on January 14, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and was found to be out of compliance with standard level CLIA requirements. The following standard level deficiency was found. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) 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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 observation during a laboratory tour, review of laboratory room temperature records, review of instrument manufacturer's specification sheet and interview with the Technical Supervisor (TS), the laboratory failed to establish an acceptable room temperature range consistent with instrument manufacturer's operating room temperature requirements for 31 of 31 days in December 2025. Findings: 1. During a tour of the laboratory room 105 on 01/14/2026 at 11:45 AM, an illumina MiSeq System instrument, S/N: MO-7814, was observed used for specimen testing. 2. A review of the Rees Scientific automated room temperature monitoring system records revealed an acceptable room temperature range for room 105 as 59F to 77F (15C to 25C), which was established by the laboratory. 3. A review of the illumina MiSeq 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 -- System specifications revealed the following room temperature requirement for operation of the instrument, 22C =/- 3C (66.2F to 77F). 4. In an interview on 01/14 /2026 at 12:00 PM, the TS confirmed the laboratory failed to establish an acceptable room temperature range consistent with the instrument manufacturer's operating requirements in room 105 for 31 of 31 days in December 2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Centers for Medicare and Medicaid Services (CMS) Philadelphia Office CLIA Surveyors conducted an announced routine CLIA recertification survey at VIRUS ISOLATION AND SEROLOGY LAB on January 15, 2021. D1002 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 review of SARS-CoV-2 documentation, Standard Operating Procedure (SOP), form CMS-116 application for certification, and interview with Technical Supervisor, the laboratory failed to report SARS-CoV-2 test results to the Secretary. 1. In review of form CMS-116 application for certification, the lab listed SARS-CoV- 2 Serology, RightSign Rapid Test (FDA EUA). The lab resulted 256 tests since August 11, 2020. 2. In review of Standard Operating Procedure, "SARS-COV-2 Antibody Detection Using the RightSign COVID-19 IgG/IgM Rapid Test Cassette," the reporting section stated: "Report for all patient samples tested are reviewed by the VISL Technical Supervisor and entered into Crimson for access by NIH clinicians." There was no indication of reporting test results to the Secretary. 3. In an interview on January 15, 2021 at 11:45 AM, Technical Supervisor stated that the lab has not reported SARS-CoV-2 test results to the Secretary and she was unaware of a requirement to do so. D5807 TEST REPORT CFR(s): 493.1291(d) 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 -- Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of test report, and interview with Technical Supervisor, the laboratory failed to put normal values in the test report. 1. In review of excel sheet that contains patient test report and electronically send to the NIH Clinical Center, the normal value was missing. 2. In an interview on January 15, 2021 at 11:50 AM, Technical Supervisor confirmed that the lab has not put the normal value in the test report. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Centers for Medicare and Medicaid Services (CMS) Philadelphia Office CLIA Surveyors conducted an announced routine CLIA recertification survey at VIRUS ISOLATION AND SEROLOGY LAB on January 15, 2021. D1002 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 review of SARS-CoV-2 documentation, Standard Operating Procedure (SOP), form CMS-116 application for certification, and interview with Technical Supervisor, the laboratory failed to report SARS-CoV-2 test results to the Secretary. 1. In review of form CMS-116 application for certification, the lab listed SARS-CoV- 2 Serology, RightSign Rapid Test (FDA EUA). The lab resulted 256 tests since August 11, 2020. 2. In review of Standard Operating Procedure, "SARS-COV-2 Antibody Detection Using the RightSign COVID-19 IgG/IgM Rapid Test Cassette," the reporting section stated: "Report for all patient samples tested are reviewed by the VISL Technical Supervisor and entered into Crimson for access by NIH clinicians." There was no indication of reporting test results to the Secretary. 3. In an interview on January 15, 2021 at 11:45 AM, Technical Supervisor stated that the lab has not reported SARS-CoV-2 test results to the Secretary and she was unaware of a requirement to do so. D5807 TEST REPORT CFR(s): 493.1291(d) 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 -- Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of test report, and interview with Technical Supervisor, the laboratory failed to put normal values in the test report. 1. In review of excel sheet that contains patient test report and electronically send to the NIH Clinical Center, the normal value was missing. 2. In an interview on January 15, 2021 at 11:50 AM, Technical Supervisor confirmed that the lab has not put the normal value in the test report. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --