SURVEY:  Pop-Up Diagnostic Testing Labs (COVID-19)
This survey is being distributed by the UC Vice Chancellors of Research in support of the Governor’s request to increase California’s COVID-19  diagnostics sample testing capabilities. As the State and UC discuss various scenarios to resuming operations, there is a recognized need to greatly increase our ability to test individuals and determine whether they have been exposed and/or have developed antibodies to the SARS CoV-2 agent.  ***Survey Responses are Requested by 5 PM on May 15th***   Please direct any queries via email to:  research&innovation@ucop.edu

BACKGROUND:  In partnership with UC Health and local and state Departments of Public Health, the UC research enterprise is well-positioned to provide diagnostic testing as we have many academic laboratories currently certified to conduct biosafety level 2 research, along with a wealth of highly trained and knowledgeable researchers.   Although there are other considerations and requirements to meet before starting to analyze COVID-19 molecular diagnostic samples , this survey will provide initial information that will be conveyed to the UC systemwide office and to the State of California.  (*Also note question 10 below about serological testing capabilities.)

The brief survey is intended to inventory and to highlight UC’s academic research laboratory capabilities in the important area of COVID-19 diagnostic testing, with an emphasis on ensuring local pathways for rapid results.  Please note that  laboratories performing clinical diagnostics testing need to be certified by the Clinical Laboratory Improvement Amendments (CLIA), as regulated by the U.S. Health and Human Service Agency's (HSSA) Center for Medicare and Medicaid Services (CMS).  See https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA.

If you would like to apply for a CLIA certificate, please submit your application form (CMS-116, CLIA Application Form) https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf 
to:
CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
Division of Laboratory Science Laboratory Field Services
320 W 4TH ST STE 890
LOS ANGELES CA 90013-2398
(213) 620-6160 FAX: (213) 620-6565
Email: LFSCLIA@cdph.ca.gov

An informational resource for principal investigators interested in adapting their labs to diagnostic testing is available in the following pre-print guide, “Blueprint for a Pop-up SARS-CoV-2 Testing Lab” available at:
https://doi.org/10.1101/2020.04.11.20061424
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1.a Campus (ANR/National Lab)
1.b. Name of Individual Completing the Survey (in order of First, Middle Initial, Last)
1.c Department
1.d Email contact of individual completing the survey
1.e Telephone contact of individual completing the survey
2. Do you have an interest in your lab group supporting COVID-19 molecular diagnostic sample testing?     If yes or maybe, then continue to Question 3. If no, then skip to Question 5.
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3. Is your laboratory certified by your Institutional Biosafety Committee to conduct biosafety level 2 research? Y/N
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4. Does your laboratory include or have access to a certified biological safety cabinet that could be dedicated for this purpose? Y/N
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5.a.  If your laboratory is not CLIA-certified, would you be willing to become a temporary location of a CLIA-certified lab?  (Note that this would require the Laboratory Director of a CLIA-certified lab to oversee Covid-19 testing activities of your lab.  The qualifications for the Laboratory Director of high complexity testing are noted in CLIA regulations.  See https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA, as well as Form 116 provided in the third paragraph of the survey introduction).
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5.b. In addition to the necessary credentials and regulatory responsibilities outlined under CLIA, please narrate the designated Lab Director's proposed active involvement in the laboratory’s operation and availability to the laboratory staff, as needed.  
5.c.  Does your laboratory include or have access to necessary equipment?  Check all that apply.  
5.d. Please specify other laboratory and PPE supplies which are available for use.  
5.e. Please specify if you do not wish to start a diagnostics testing lab but have equipment which could be donated, loaned or rented for a year or two.
6. COVID-19 diagnostic test equipment cannot be deployed for mixed use as that could compromise quality control, quality assurance and cause cross-contamination (this may depend on the test platform and specific instruments being used).  Is the area proposed for sample prep and instrument located in dedicated space (i.e, not a mixed-use area)?  Please briefly explain.
7.a. How many researchers could your laboratory devote to this effort over the next 3, 6, 9, 12, 18 and 24 months?  (Please estimate FTE for each time frame listed below):
1 FTE
2 FTE
3 FTE
4 FTE
5 FTE
>5 FTE
3 months
6 months
9 months
12 months
18 months
24 months
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7.b. For estimates above, please narrate any additional details about FTE estimates by the specified timeframes.
8.  Could your Laboratory Director or researchers potentially work in another laboratory that is already certified to conduct diagnostic sample testing in order to increase our staffing and shift rotation capacity?  
9.a. A number of UC clinical and research labs have developed the capacity to process anywhere from two hundred to over one or two thousand tests a day. Does your laboratory have the personnel, equipment and facilities capacity to conduct high-throughput testing at this level?  If so, do you have an estimate of how many tests your lab can reliably test per day?
9.b. Please provide a preliminary estimate of how much each diagnostic test might cost your laboratory to administer (including costs of supplies and personnel); note that information provided is solely used for aggregate planning purposes.
10.  Beyond molecular diagnostics testing, UC academic labs helping support the newer serology/antibody testing would be an enormous public service benefit going forward (a negative finding on the molecular test could change very quickly for someone who had not yet been exposed or, could also be someone who had been infected, was asymptomatic, recovered and cleared the virus).  Please indicate if your lab might have the capacity to work with clinical serum samples in order to perform an approved antibody detection assay which can identify someone who has previously been infected and recovered from COVID-19
11.  Do you have access to a board certified pathologist who can serve as a partner for testing that will be returned to individuals for the purpose of clinical decision-making?  ***Please note that a partnership with an *existing* high complexity CLIA certified lab, particularly one which has experts in molecular microbiology and already is performing SARS-CoV-2 testing, has proven to be a best practice for most efficiently and seamlessly undergoing rigorous College of Pathologists and CA Department of Public Health inspections.****  
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12. Please share any additional questions or concerns you may have (Limit 250 characters)
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