City COVID-19 Testing
Hello, all. Our city has bought 5,000 COVID-19 immunological testing kits and will be offering them for Tier 1 testing, to all those who are on monitoring/quarantine without having been tested, and then to the public, possibly through a drive thru testing center. Those details remain to be finalized. I've just gotten an email from the local health department denying all liability and informing me that I need to review "FDA disclosures and all pertinent testing documentation for validation." Has anyone done such a thing? I'm pretty sure I don't have the expertise to do such a review. And what might our potential liabilities be? Would governmental immunities apply to a testing program?
We will have licensed health care providers doing the finger sticks and reading the tests. Since they are finger sticks, we don't run the risk of injuring anyone with a q-tip to the brain.
My mayor and a former mayor, both physicians, are the driving force for the purchase of the kits, and they say they've reviewed the literature.
Any suggestions would be most appreciated.
Stephanie H. Harris
City Attorney
City of Paris, Texas
135 1st St. SE
Paris, Texas 75460
(903) 784-9258
sharris@paristexas.gov
In addition to all other possible immunities, Georgia includes in the Emergency Management law further blanket immunity. I would check your state emergency code.
From: Disasterrelief disasterrelief-bounces@lists.imla.org On Behalf Of Stephanie Harris
Sent: Tuesday, April 14, 2020 3:27 PM
To: disasterrelief@lists.imla.org
Subject: [Disasterrelief] City COVID-19 Testing
Hello, all. Our city has bought 5,000 COVID-19 immunological testing kits and will be offering them for Tier 1 testing, to all those who are on monitoring/quarantine without having been tested, and then to the public, possibly through a drive thru testing center. Those details remain to be finalized. I've just gotten an email from the local health department denying all liability and informing me that I need to review "FDA disclosures and all pertinent testing documentation for validation." Has anyone done such a thing? I'm pretty sure I don't have the expertise to do such a review. And what might our potential liabilities be? Would governmental immunities apply to a testing program?
We will have licensed health care providers doing the finger sticks and reading the tests. Since they are finger sticks, we don't run the risk of injuring anyone with a q-tip to the brain.
My mayor and a former mayor, both physicians, are the driving force for the purchase of the kits, and they say they've reviewed the literature.
Any suggestions would be most appreciated.
Stephanie H. Harris
City Attorney
City of Paris, Texas
135 1st St. SE
Paris, Texas 75460
(903) 784-9258
sharris@paristexas.govmailto:sharris@paristexas.gov
Our government purchased 25,000 antibody tests and then FDA intervened and said that we were required to have a highly complex CLIA lab because these tests are approved under the Emergency Authorization requirement and they have to be verified in the field. We had to take a refund because no qualified lab would take it on.
Joann Leykam
St. Charles County
100 North Second Street Suite 318
Saint Charles, Missouri 63301
From: Disasterrelief disasterrelief-bounces@lists.imla.org On Behalf Of Jennifer Davenport
Sent: Tuesday, April 14, 2020 2:54 PM
To: Stephanie Harris sharris@paristexas.gov; disasterrelief@lists.imla.org
Subject: Re: [Disasterrelief] City COVID-19 Testing
CAUTION: This email originated from outside of St. Charles County Government. Always use CAUTION when opening attachments or clicking links from unknown senders or when receiving unexpected emails. - IS Dept.
In addition to all other possible immunities, Georgia includes in the Emergency Management law further blanket immunity. I would check your state emergency code.
From: Disasterrelief <disasterrelief-bounces@lists.imla.orgmailto:disasterrelief-bounces@lists.imla.org> On Behalf Of Stephanie Harris
Sent: Tuesday, April 14, 2020 3:27 PM
To: disasterrelief@lists.imla.orgmailto:disasterrelief@lists.imla.org
Subject: [Disasterrelief] City COVID-19 Testing
Hello, all. Our city has bought 5,000 COVID-19 immunological testing kits and will be offering them for Tier 1 testing, to all those who are on monitoring/quarantine without having been tested, and then to the public, possibly through a drive thru testing center. Those details remain to be finalized. I've just gotten an email from the local health department denying all liability and informing me that I need to review "FDA disclosures and all pertinent testing documentation for validation." Has anyone done such a thing? I'm pretty sure I don't have the expertise to do such a review. And what might our potential liabilities be? Would governmental immunities apply to a testing program?
We will have licensed health care providers doing the finger sticks and reading the tests. Since they are finger sticks, we don't run the risk of injuring anyone with a q-tip to the brain.
My mayor and a former mayor, both physicians, are the driving force for the purchase of the kits, and they say they've reviewed the literature.
Any suggestions would be most appreciated.
Stephanie H. Harris
City Attorney
City of Paris, Texas
135 1st St. SE
Paris, Texas 75460
(903) 784-9258
sharris@paristexas.govmailto:sharris@paristexas.gov
Here is the Unemployment FAQ we prepared for our members I mentioned on the call. We have a current survey out to see how many are furloughing
https://cdn.ymaws.com/www.lkm.org/resource/resmgr/education/covid-19/unemployment_faqs_4.10.20.pdf
Amanda L. Stanley
General Counsel
astanley@lkm.orgmailto:astanley@lkm.org
785-354-9565
From: Disasterrelief disasterrelief-bounces@lists.imla.org On Behalf Of Jennifer Davenport
Sent: Tuesday, April 14, 2020 2:54 PM
To: Stephanie Harris sharris@paristexas.gov; disasterrelief@lists.imla.org
Subject: Re: [Disasterrelief] City COVID-19 Testing
In addition to all other possible immunities, Georgia includes in the Emergency Management law further blanket immunity. I would check your state emergency code.
From: Disasterrelief <disasterrelief-bounces@lists.imla.orgmailto:disasterrelief-bounces@lists.imla.org> On Behalf Of Stephanie Harris
Sent: Tuesday, April 14, 2020 3:27 PM
To: disasterrelief@lists.imla.orgmailto:disasterrelief@lists.imla.org
Subject: [Disasterrelief] City COVID-19 Testing
Hello, all. Our city has bought 5,000 COVID-19 immunological testing kits and will be offering them for Tier 1 testing, to all those who are on monitoring/quarantine without having been tested, and then to the public, possibly through a drive thru testing center. Those details remain to be finalized. I've just gotten an email from the local health department denying all liability and informing me that I need to review "FDA disclosures and all pertinent testing documentation for validation." Has anyone done such a thing? I'm pretty sure I don't have the expertise to do such a review. And what might our potential liabilities be? Would governmental immunities apply to a testing program?
We will have licensed health care providers doing the finger sticks and reading the tests. Since they are finger sticks, we don't run the risk of injuring anyone with a q-tip to the brain.
My mayor and a former mayor, both physicians, are the driving force for the purchase of the kits, and they say they've reviewed the literature.
Any suggestions would be most appreciated.
Stephanie H. Harris
City Attorney
City of Paris, Texas
135 1st St. SE
Paris, Texas 75460
(903) 784-9258
sharris@paristexas.govmailto:sharris@paristexas.gov
Did the FDA say you had to have all of them run through the fancy lab, or just a few to check the lot?
From: Leykam, Joann JLeykam@sccmo.org
Sent: Tuesday, April 14, 2020 3:00 PM
To: Jennifer Davenport jdavenport@chathamcounty.org; Stephanie Harris sharris@paristexas.gov; disasterrelief@lists.imla.org
Subject: RE: City COVID-19 Testing
Our government purchased 25,000 antibody tests and then FDA intervened and said that we were required to have a highly complex CLIA lab because these tests are approved under the Emergency Authorization requirement and they have to be verified in the field. We had to take a refund because no qualified lab would take it on.
Joann Leykam
St. Charles County
100 North Second Street Suite 318
Saint Charles, Missouri 63301
From: Disasterrelief <disasterrelief-bounces@lists.imla.orgmailto:disasterrelief-bounces@lists.imla.org> On Behalf Of Jennifer Davenport
Sent: Tuesday, April 14, 2020 2:54 PM
To: Stephanie Harris <sharris@paristexas.govmailto:sharris@paristexas.gov>; disasterrelief@lists.imla.orgmailto:disasterrelief@lists.imla.org
Subject: Re: [Disasterrelief] City COVID-19 Testing
CAUTION: This email originated from outside of St. Charles County Government. Always use CAUTION when opening attachments or clicking links from unknown senders or when receiving unexpected emails. - IS Dept.
In addition to all other possible immunities, Georgia includes in the Emergency Management law further blanket immunity. I would check your state emergency code.
From: Disasterrelief <disasterrelief-bounces@lists.imla.orgmailto:disasterrelief-bounces@lists.imla.org> On Behalf Of Stephanie Harris
Sent: Tuesday, April 14, 2020 3:27 PM
To: disasterrelief@lists.imla.orgmailto:disasterrelief@lists.imla.org
Subject: [Disasterrelief] City COVID-19 Testing
Hello, all. Our city has bought 5,000 COVID-19 immunological testing kits and will be offering them for Tier 1 testing, to all those who are on monitoring/quarantine without having been tested, and then to the public, possibly through a drive thru testing center. Those details remain to be finalized. I've just gotten an email from the local health department denying all liability and informing me that I need to review "FDA disclosures and all pertinent testing documentation for validation." Has anyone done such a thing? I'm pretty sure I don't have the expertise to do such a review. And what might our potential liabilities be? Would governmental immunities apply to a testing program?
We will have licensed health care providers doing the finger sticks and reading the tests. Since they are finger sticks, we don't run the risk of injuring anyone with a q-tip to the brain.
My mayor and a former mayor, both physicians, are the driving force for the purchase of the kits, and they say they've reviewed the literature.
Any suggestions would be most appreciated.
Stephanie H. Harris
City Attorney
City of Paris, Texas
135 1st St. SE
Paris, Texas 75460
(903) 784-9258
sharris@paristexas.govmailto:sharris@paristexas.gov
All. Can only be sold to that type of lab.
On Apr 14, 2020, at 4:19 PM, Stephanie Harris sharris@paristexas.gov wrote:
CAUTION: This email originated from outside of St. Charles County Government. Always use CAUTION when opening attachments or clicking links from unknown senders or when receiving unexpected emails. - IS Dept.
Did the FDA say you had to have all of them run through the fancy lab, or just a few to check the lot?
From: Leykam, Joann JLeykam@sccmo.org
Sent: Tuesday, April 14, 2020 3:00 PM
To: Jennifer Davenport jdavenport@chathamcounty.org; Stephanie Harris sharris@paristexas.gov; disasterrelief@lists.imla.org
Subject: RE: City COVID-19 Testing
Our government purchased 25,000 antibody tests and then FDA intervened and said that we were required to have a highly complex CLIA lab because these tests are approved under the Emergency Authorization requirement and they have to be verified in the field. We had to take a refund because no qualified lab would take it on.
Joann Leykam
St. Charles County
100 North Second Street Suite 318
Saint Charles, Missouri 63301
From: Disasterrelief <disasterrelief-bounces@lists.imla.orgmailto:disasterrelief-bounces@lists.imla.org> On Behalf Of Jennifer Davenport
Sent: Tuesday, April 14, 2020 2:54 PM
To: Stephanie Harris <sharris@paristexas.govmailto:sharris@paristexas.gov>; disasterrelief@lists.imla.orgmailto:disasterrelief@lists.imla.org
Subject: Re: [Disasterrelief] City COVID-19 Testing
CAUTION: This email originated from outside of St. Charles County Government. Always use CAUTION when opening attachments or clicking links from unknown senders or when receiving unexpected emails. - IS Dept.
In addition to all other possible immunities, Georgia includes in the Emergency Management law further blanket immunity. I would check your state emergency code.
From: Disasterrelief <disasterrelief-bounces@lists.imla.orgmailto:disasterrelief-bounces@lists.imla.org> On Behalf Of Stephanie Harris
Sent: Tuesday, April 14, 2020 3:27 PM
To: disasterrelief@lists.imla.orgmailto:disasterrelief@lists.imla.org
Subject: [Disasterrelief] City COVID-19 Testing
Hello, all. Our city has bought 5,000 COVID-19 immunological testing kits and will be offering them for Tier 1 testing, to all those who are on monitoring/quarantine without having been tested, and then to the public, possibly through a drive thru testing center. Those details remain to be finalized. I’ve just gotten an email from the local health department denying all liability and informing me that I need to review “FDA disclosures and all pertinent testing documentation for validation.” Has anyone done such a thing? I’m pretty sure I don’t have the expertise to do such a review. And what might our potential liabilities be? Would governmental immunities apply to a testing program?
We will have licensed health care providers doing the finger sticks and reading the tests. Since they are finger sticks, we don’t run the risk of injuring anyone with a q-tip to the brain.
My mayor and a former mayor, both physicians, are the driving force for the purchase of the kits, and they say they’ve reviewed the literature.
Any suggestions would be most appreciated.
Stephanie H. Harris
City Attorney
City of Paris, Texas
135 1st St. SE
Paris, Texas 75460
(903) 784-9258
sharris@paristexas.govmailto:sharris@paristexas.gov