36C25721Q0436_4.docx

Contract Opportunity Amendment to a Previous Combined Solicitation

PRODUCT SERVICE CODE

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CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

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RESPONSE DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

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CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

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ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Amendment to a Previous Combined Solicitation Amarillo VA Health Care System Thomas E. Creek VA Medical Center Temperature Monitoring Kiosks Question and Answer 75216 36C25721Q0436 K 03-03-2021

4:30 PM

CENTRAL TIME, CHICAGO, USA

N

SDVOSBC

334510 Department of Veterans Affairs NCO 17 North Texas Healthcare System NCO 17 Network Contracting Activity 4500 S. Lancaster Road Dallas TX 75216 Rastreva D. Upshaw, Contract Specialist rastreva.upshaw@va.gov Danise Burt, Contracting Officer danise.burt@va.gov Department of Veterans Affairs Amarillo VA Health Care System Thomas E. Creek VA Medical Center 6010 Amarillo Boulevard, West Amarillo, TX 79106

79415

USA

rastreva.upshaw@va.gov and danise.burt@va.gov rastreva.upshaw@va.gov and danise.burt@va.gov The purpose of this Amendment to Solicitation 36C25721Q0436 is to include:

a) Extend the closing date to Wednesday, March 3, 2021 at 4:30 p.m. CST.

b) Include the Place of Performance/ Delivery Location.

c) Q&A

All other terms and conditions remain the same.

a) Quotes must be received no later than Wednesday, March 3, 2021 at 4:30 p.m. CST. Email quotes to rastreva.upshaw@va.gov and danise.burt@va.gov. The subject line must specify 36C25721Q0436 – Quote for Temperature Monitoring Kiosks. There will be no automated email notification of receipt of quotes. All quotes received without requested documentation will not be considered.

b) Place of Performance/Delivery Location:

Department of Veterans Affairs Amarillo VA Health Care System Thomas E. Creek VA Medical Center 6010 Amarillo Boulevard, West Amarillo, TX 79106

c) Question and Answers

Due to a question, Contracting sought additional information from a technical standpoint regarding the Salient Characteristics for the Temperature Monitoring Kiosks. Specifically, does CDC guidelines require FDA certification for COVID-19 kiosks for monitoring temperatures, and why?

1. a. The Policy for Telethermographic Systems Intended for Adjunctive Diagnostic Screening was written in response to the shortage of thermometers in April 2020 at the beginning of the public health emergency. The policy states it will only be in effect during the public health emergency and is subject to change.

“This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act (42 U.S.C. 247d(a)(2)).”

“Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.”

This policy contains nonbinding recommendations – meaning this is not legally necessary to follow or obey.

This policy does not bind us to follow current FDA regulations now or any other time. These are only put into place due to the public health emergency.

b. The VA shall utilize temperature monitoring kiosks as medical devices with intended use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.

c. Please refer to CDC resources to obtain guidance on CDC treatment of kiosks for monitoring temperatures.

2. Can you confirm that offerors that are current in SAM only need to include paragraph b, and not their entire Reps and Certs? Yes See attached document: COVID-19-Thermography-Devices-Guidance_0_0.

End of Document