Hi Erik!
I once remember hearing a Tradeline speaker say:
"If you had an earthquake predictor which we knew was 50% accurate and its alarm bell went off, what would you tell the Mayor of San Francisco?"
Sometimes, marginal data is inactionable!
Dr. Bob Haugen
Director of Product and Technology Development
Flow Sciences, Inc.
910 332 4878
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From: ACS Division of Chemical Health and Safety <DCHAS-L**At_Symbol_Here**PRINCETON.EDU>
On Behalf Of Erik B. Pietrowicz
Sent: Wednesday, May 20, 2020 10:50 AM
To: DCHAS-L**At_Symbol_Here**PRINCETON.EDU
Subject: Re: [DCHAS-L] Covid Testing and Universities
I apologize if this has already been mentioned, but if a facility was to perform "unofficial" COVID-19 testing and has a positive result, there would be an ethical obligation to refer that individual for clinical follow-up. Not telling
them would delay seeking of treatment until symptoms develop or progress further, increasing risk of adverse outcomes, and would allow that person to continue potentially exposing other people.
While I agree caution should be used with unofficial tests, using a non-FDA approved/non-clinical lab test only constitutes diagnosing without a license if you are actually diagnosing, especially for positive results. This should be approved
by HR/ legal counsel, but generally it should be okay to inform someone of a positive result as long as it comes with the caveat that it isn't diagnostic and includes a statement that the individual should follow up with their health care provider or official
testing site for further assessment and confirmation. This isn't fundamentally different that our state-required daily temperature checks as a condition of returning to work.
My frame of reference for this is the research MRI we have in our brain imaging center. The MRI is not registered, certified, or maintained as a diagnostic machine, but sometimes abnormalities are identified. Our research images are not
used for clinical decision making but when a potential problem is found there is an ethical obligation to let the subject know. Imagine if you volunteered for a research study and the MRI operator found a possible brain tumor but dismissed it because they
aren't a licensed radiologist. They should inform you so you can follow up with a medical center for clinical scans rather than ignoring it and letting your condition continue to worsen.
A question for using anonymous unofficial sampling to monitor the situation is what end points you are looking for. If you get a positive result but don't know who it was, you can't inform that person or perform contact tracing. Short of
shutting down the facility until everyone is clinically tested or quarantined for two weeks, the utility of that approach is very limited. The other alternative is having knowledge of a tentative positive result and not acting on it, which would be
more problematic from an ethical and liability perspective.
-Erik
---
Erik Pietrowicz, MS, NRP
Research Safety Officer
Hazmat Program Coordinator
DARTMOUTH
Office of Environmental Health & Safety
37 Dewey Field Road, HB 6216
Hanover, NH 03755
P: 603-646-9790, F: 603-646-2622
http://www.dartmouth.edu/~ehs
Good morning,
HEPA laws in the US prohibit an employer from viewing an employee's health records. This includes COVID test results. An employer has only the right to know about a
confirmed positive case in order to enact internal policies that protect other workers. Policies such as closing a facility for deep cleaning and granting the affected employee extended sick time to meet quarantine requirements.
The way laws, policies, and insurance contracts work in the US, basically prohibit you from initiate these protocols without having a medical lab confirm the case.
Also, results from a non-medical lab cannot be disclosed to the test subject because that would likely constitute "diagnosing without a medical license".
As this thought exercise progresses, I've come to the conclusion that data gathered in this manner could only be used to "monitor the situation" at a facility by random testing of
anonymous individuals.
Thank you all for your input!
Yaritza Brinker
260.827.5402
The mental health of individuals is cause for concern as all kits have certain false negative and false positive results.
An unconfirmed positive test result might cause Depression or worse , a suicide attempt.
A medical professional( physician) is recommended to educate and evaluate the results of these tests.
.
Michael I. Schaffer, Ph.D., F.A.B.F.T., NRCC-TC
VP Laboratory Operations
Psychemedics Corporation
{5832 Uplander Way}
{Culver City, CA 90230}
310-216-7776 (phone)
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Hello All,
I am interested in learning more on if anyone has started to administer these tests yet in a non-CLEA certified lab. If we are interested in checking for the health and safety for staff daily, are you using a saliva test or nasal swab for
testing? Is there anyone who can share any protocols they are currently using? We are considering moving in this direction and I really would appreciate your advise. We want to be able to test in-house, get results within a few hours and provide feedback to
staff by end of day.
Please let me know your thoughts and any recommendations.
My point was that if it is not a research project then it comes under FDA and state regulation of medical labs.
Peter Zavon
Penfield, NY
PZAVON**At_Symbol_Here**Rochester.rr.com
Peter- you're absolutely right that an IRB wouldn't be required to be involved if it weren't a research project. And many businesses would not have qualms about proceeding down
this path, with an HR review by some and not by others.
I was thinking of a university setting, where again an IRB review wouldn't be a regulatory requirement but I believe most colleges and universities would feel a strong need for
some type of ethics review. Sloppy phrasing on my part..
Margaret
?
It is not a research project if you are using the results to guide your administrative actions.
I would also point out that, although we think it likely, and hope, that having antibodies indicates at least temporary immunity, that has yet to be shown to be the case and there
are a few cases that may suggest otherwise.
Peter Zavon, CIH
Penfield, NY
PZAVON**At_Symbol_Here**Rochester.rr.com
The question is more around the lines of what if you just tested your staff only as a "research study". Can you do it without going thru the certification hoops necessary to test
the general public?
This article talks about 1/3 of test subjects testing positive for antibodies in Massachusetts. The random screening of 200 was done on the street. That's a lot of people that are
immune and no-longer contagious (it takes 3+wks post recovery to build enough antibodies to be detectable in the test).
https://www.bostonglobe.com/2020/04/17/business/nearly-third-200-blood-samples-taken-chelsea-show-exposure-coronavirus/
Thank you,
Yaritza Brinker
260.827.5402
Yaritza,
Just be prepared for the time and effort - it took 20 some staff, many grad students trained to perform the procedures, a board-certified pathologist to lead the group, a CLIA application,
working through an FDA Emergency Use Authorization, tying up two laboratories, and a host of other management issues. Well worth it, but it takes work to start a testing lab from scratch. If you are seriously interested in starting one, message me privately
and I'll put you in touch with the people that got it up and running.
Here's a thought provoking questionÉ
Although research laboratories are not approved health laboratories, many do have the facilities to provide accurate testing. So, the question isÉ would it be okay for universities
to test their employees and paid student staff in order to guide decision about resuming activities on campus. And could you extend testing to students enrolled in courses that require face-to-face interaction such as labs.
Of course, you'd have to have a health care professional collect the samples. "Test subjects" would have to voluntarily agree. EtcÉ
Thank you,
Yaritza Brinker
260.827.5402
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Best Regards,
Tamara Vartanian
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