This is unlikely to be correct.
A covered entity under HIPPA is
"(1) A health plan.
(2) A health care clearinghouse.
(3) A health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter"
Covered entities are the entities that are required to comply with the HIPPA regulations.
An employer arranging COVID testing of employees outside the health insurance process is not a covered entity. Even a hospital doing this in its capacity as an employer would not be a covered entity, in my opinion.
Too may people automatically assume that HIPPA covers anything involving health or health testing.
Peter Zavon, CIH
Penfield, NY
PZAVON**At_Symbol_Here**Rochester.rr.com
From: ACS Division of Chemical Health and Safety <DCHAS-L**At_Symbol_Here**PRINCETON.EDU> On Behalf Of Yaritza Brinker
Sent: Wednesday, May 20, 2020 9:42 AM
To: DCHAS-L**At_Symbol_Here**PRINCETON.EDU
Subject: Re: [DCHAS-L] Covid Testing and Universities
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
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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
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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 question-
Although research laboratories are not approved health laboratories, many do have the facilities to provide accurate testing. So, the question is- 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. Etc-
Thank you,
Yaritza Brinker
260.827.5402
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Jeff Lewin
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Best Regards,
Tamara Vartanian
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