W9127822Q0003 Solicitation.pdf

SEE ADDENDUM

(No Collect Calls)

W9127822Q0003 27-Jan-2022

b. TELEPHONE NUMBER

251-694-3868

8. OFFER DUE DATE/LOCAL TIME

02:00 PM 28 Feb 2022

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W912789. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

KEVIN H WILLIAMS

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

ENDIST MOBILE CONTRACTING DIVISION

109 ST JOSEPH ST

MOBILE AL 36602

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE 16. ADMINISTERED BY

SEE SCHEDULE

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

$35,000,000

NAICS:

621511

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF57

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

Section SF 1449 - CONTINUATION SHEET

SUBMISSION INSTRUCTIONS

Provide Laboratory Services and COVID-19 testing for Regional Occupational Health Program (ROHC), U.S. Army Corps of Engineers, South Atlantic Division (SAD)

Proposals are due by the time and date specified in the solicitation. Proposals will not be accepted at any other location.

E-Mail responses are NOT authorized for this procurement for the purpose of timely proposal submission.

Facsimile responses are NOT authorized for this procurement.

Proposals are due in accordance with the date on the Solicitation. Any proposals received after this time will be considered non-responsive and shall not be considered for award.

Proposals shall be divided into two (2) separate volumes:

1. Volume I: Technical Proposal

a) Client Portal

b) Same-day Courier Service

c) On-site specimen processing

d) Test kits

e) Accounting

f) Invoicing

g) Request forms

h) Lab Reports

i) Schedule

j) Experience

2. Volume II: Price and Administrative Proposal

a) Signed SF 1449 and any Amendments

b) ENCLOSURE 1

c) Representations and Certifications (FAR 52.212-3 Alternate I and FAR

52.219-1Alternate I) or SAM.gov

d) Past Performance

e) Company Information

This check sheet is provided only as a guide to assist contractors in submitting the required information. Prior to submitting the following, a Contractor Shall:

1. Submit quotes on the attached form SF1449.

2. Fill out all applicable boxes on the form SF1449.

3. Bid on all or none of the items.

4. Comply with all solicitation requirements. DO NOT FORGET TO ACKNOWLEDGE ALL

AMENDMENTS!

5. Offeror should reference FAR Clause 52.212-2 – EVALUATION – COMMERCIAL ITEMS for important information regarding how your proposal will be evaluated.

6. Offeror shall complete FAR Clause 52.212-3 Alternate I – OFFEROR REPRESENTATIONS AND CERTIFICATIONS – COMMERCIAL ITEMS and submit one copy (SAM.gov preferred).

7. Offeror shall complete FAR Clause 52.219-1 Alternate I – SMALL BUSINESS PROGRAM REPRESENTATION and submit one copy (SAM.gov preferred).

8. Request for Information. Any questions about this solicitation, including technical questions about the Specification, shall be submitted via the Bidder Inquiry Portal in ProjNet at https://www.projnet.org/projnet. Questions should be submitted no later than 09 February 2022, at 2:00 p.m. Central Standard Time to allow time for a response, and an amendment to the solicitation, if necessary. On this date and time, the portal will be closed. For technical questions, no other means of communication (e-mail, fax or telephone) will be accepted. Oral exchanges between offerors and the Government prior to award of the contract will not be binding. In addition to the information available to the offerors on the Bidder Inquiry Portal, any information concerning this solicitation will be furnished to all offerors as an amendment to the solicitation if the information is necessary to the submittal of offers.

To submit and review inquiries, an offeror needs to be a current registered user of the ProjNet system. To register, go to https://www.projnet.org/projnet, click the “BID” tab, select “Bidder Inquiry”, select agency “USACE”, enter the “Bidder Inquiry Key” for the solicitation listed below, and your e-mail address, and then click login. Complete all required information and then click “Create User”. Verify that information on the next screen is correct and click “Continue”.

From this page you can view all bidder inquiries for this solicitation or submit an inquiry.

Offerors will receive an acknowledgement of their question via e-mail, and the Mobile District’s technical team will post a response to the ProjNet system after it has been processed.

SOLICITATION NUMBER is: W9127822Q0003

BIDDER INQUIRY KEY is: E5RI7R-N7PFCD

Note: Any inquiry submitted and answered within this system, will be accessible to view by all interested offerors on this solicitation.

If there are any conflicts between the solicitation and the responses provided in the ProjNet system, the solicitation governs. Changes to the solicitation will be made by amendment.

9. Proposal Submission Address and Deadline: Submit proposal packages electronically, as described below. The proposal shall not contain classified data. The use of hyperlinks in proposals is prohibited. The Government must receive your proposal no later than the time and date specified in Block 9 of the SF33. Any and all amendments to the solicitation shall be acknowledged by completion of Block 14 of the SF33.

NOTE: The only authorized transmission method for proposals in response to this solicitation is electronically via DoD SAFE online submission. NO OTHER TRANSMISSION METHODS

(E-MAIL, FACSIMILE, REGULAR MAIL, HAND CARRIED, ETC.) WILL BE ACCEPTED.

Offerors shall submit their proposals using the following link: https://safe.apps.mil/.

Submit proposals using the link above to:

Contract Specialist: Mr. Kevin Williams at kevin.h.williams@usace.army.mil AND Contracting Officer: Ms. Sonya Rodgers at sonya.d.rodgers@usace.army.mil

9.1. Instructions for Submitting Electronic Proposals. In an effort to reduce paperwork and cost, all proposals shall be submitted electronically through the SAFE site. You are limited to five (5) maximum files per upload (total size cannot exceed 2GB). If you have a large number of files, it is recommended that you combine or ZIP your files before uploading to the SAFE site. Offerors may use compression utility software, such as WinZip or PKZip, to reduce file size and facilitate transmission.

9.2. Request for Upload Code. Offerors must email the Contract Specialist Kevin Williams at kevin.h.williams@usace.army.mil and the Contracting Officer Sonya Rodgers at sonya.d.rodgers@usace.army.mil no later than five (5) working days prior to the proposal due date to receive a request code which will allow for file uploads via the SAFE site. Offerors that fail to request a code at least five (5) working days before the proposal due date may not be able to receive a request code in time to upload their proposal submission. Offerors will receive an email from the SAFE site with a link to upload files. The link is only valid for 14 days from the time of the email.

9.3. File Description. Include a “File Description” for each file(s) you upload. The “File Description” will be included in the e-mail notice to each of the recipients you choose to have access your file(s).

NOTE: Do NOT enter Privacy Act Data (Personal Identification Information (PII)) in the File Description.

9.4. Instructions for the SAFE Website:

a. Click on the link in the email received in response to paragraph 9.0 or copy the link and paste it into your browser, OR once at the SAFE website, select the “Drop-off” icon.

Enter your “Request Code” which are the numbers at the end of the link contained in the email received in response to paragraph 9.2. This allows users without a Common Access Card (CAC), or users whose computer is not configured to read a CAC, the option to access the SAFE site as a Guest.

b. After selecting the “Next” link, you will be prompted to enter your personal information, file information, recipient (Government representative) information and email settings.

c. When completing your file information for transmittal via the SAFE website, you will be required to enter the e-mail address for all recipients. For this solicitation, the recipients are the Contract Specialist kevin.h.williams@usace.army.mil and the Contracting Officer sonya.d.rodgers@usace.army.mil.The e-mail address of the Government Employee who initiated the request code will be automatically entered. The Offeror must enter the e-mail addresses for both the Contract Specialist and the Contracting Officer. The Offeror may enter an additional e-mail address if desired. After entering the e-mail address, click the “Add” button to add the recipient’s e-mail address to the “Recipients List” of your response. After your proposal has been submitted, a notification will be sent to the recipients that you added.

NOTE: Do NOT send the SAFE site packages to group e-mail accounts.

Even if your proposal has been successfully uploaded to the SAFE site, notification will not be sent to the Government recipients until you have verified your e-mail address. Entering an incorrect e-mail address may result in the rejection of your proposal submission for lateness. An Offeror can confirm proper submission by the ‘Drop-Off Completed” screen which generates based on proper file submission.

NOTE: It has been reported that documents are more quickly uploaded into the SAFE website when using a Firefox web browser. The Government cannot verify that this is true and offers no guarantee that Offerors will have more success utilizing any particular browser.

9.5. Receipt of Submissions. For the purposes of establishing whether a proposal submission is considered timely, the Government considers the date and time the submission is completely uploaded into the SAFE website. For proposals larger than the 2GB capacity of the SAFE website that require multiple submissions, the Government will consider the date and time the last submission is completely uploaded into the SAFE website. Do not assume that electronic communication is instantaneous. It can take several minutes, or even hours, in some cases.

The Government will not be responsible for submissions delivered to any location or to anyone other than those designated to receive proposals. Offerors are responsible for ensuring that proposals are submitted so as to reach the designated recipient. Offerors are responsible for allowing sufficient time for the proposal to be received in accordance with the instructions provided.

COMPANY INFORMATION

1. Company’s TAX ID#: ________________________

2. Company’s DUNS#: _________________________

3. Company’s CAGE Code: __________________________________________

4. Submit a primary point of contact Name: __________________________________________

5. Submit a primary point of contact Cell Phone#: _____________________________________

6. Submit a primary point of contact E-Mail Address: __________________________________

PERFORMANCE WORK STATEMENT

Performance Work Statement Regional Occupational Health Center (ROHC) Laboratory Services

This contract work performance is to provide laboratory services as needed for the Regional Occupational Health Center. Laboratory services are needed to execute this program medical surveillance, deployment, disaster response and fitness for duty programs throughout the continental United States. Services will be needed primarily within the U.S. Corps of Engineers, South Atlantic Division of the following eight states and territories: Alabama, Florida, Georgia, Mississippi, North Carolina, South Carolina, Tennessee, Virginia, Puerto Rico and the US Virgin Islands.

Laboratory services requested are as follows:

1. Establish on primary account covering all work under this contract (Itemized by employee/patient, medical care provider and lab procedure), centrally billed to the ROHC with a separate sub-account for each regional district (Mobile, AL; Jacksonville, FL; Savannah, GA; Charleston, SC; Wilmington, NC). Each sub-account would remain active throughout the period of the contract even when there is a lack of activity in any particular sub-account.

2. Provide start up procedures and timeline involved to set up the primary ROHC account and establish sub-accounts when contract awarded.

3. Provide list of established collection sites in AL, FL, GA, MS, NC, SC, TN, VA, Puerto Rico and US Virgin Islands, Complete addresses required.

4. The use of the contractor’s network of collection sites will be required. Network collection sites will charge collection fee and testing in accordance with bid scheduled pricing.

5. Provide lab report to the medical care provider no more than 24 hours after completion of the analytical test.

6. Collection kit quantities identified in bid schedule will be provided to the ROHC (Mobile, Jacksonville & Savannah locations) and established network collection sites for remote collection by licensed healthcare professionals.

7. Collection kits will contain all testing components, pre-paid air bill, shipping supplies and collection and packing instructions.

8. Provide lab report to the medical care provider no more than 24 hours after completion of the analytical test.

9. Ensure all requisitions and diagnostic reporting secures Protected Health Information (PHI) IAW The Privacy Act of 1974 and HIPAA.

10. Services for this contract should include all chemistry, hematologic, toxicological, serologic, urine testing and RT-PCR. Those lab tests listed in Enclosure 1 – Lab Tests would constitute the majority of the ROHCs laboratory testing needs. RT-PCR for SARS-COV-2RNA testing should be done in accordance with FDA Policy for Coronavirus Disease 2019 Tests during the Public Health Emergency (revised) in Enclosure 2.

11. Provide a customized lab request form, including the primary account information, the sub-account information, and selection boxes matching the specific panels and other lab tests listed in Enclosure 1.

12. Provide a monthly invoice to the ROHC, itemized by each medical care provider (sub-account) with the name of the employee/patient, the test(s) performed and the cost associated with each.

13. Provide web access or a list of the contractor’s network providers, local officers and representatives in the ROHCs region.

14. Provide toxicology and/or professional medical support for the laboratory test interpretations and consultation if needed.

15. Respond to accounting questions/concerns from the ROHC Contract Administrator and/or Nurse Manager.

16. Promptly alert the medical care provider and the ROHC of critical values identified during analyses.

All samples will be processed as routine unless specified as STAT according to bid schedule for 2 to 4 hour turnaround time. If STAT test results fall in critical range the results will be called to the ordering physician’s office immediately and followed with faxed results to ROHC as for any critical values identified in routine analysis.

17. Provide a contingency plan for the contractor’s reaction to inoperative laboratory analytical equipment, such as gas chromatographs, etc.

18. Provide copies of licensure and applicable certifications held by your laboratory and any supporting laboratories if requested.

19. Provide resumes of key personnel, including Company Principals, Analytical Laboratory Director, Toxicologists, Consulting Occupational Health Physicians and Medical Records Managers.

20. List at least three other clients for whom you have recently performed similar work, including a reference POC with name and phone number, a description and per annum value of the services provided and the inclusive dates of the contract period.

AT/OPSEC

15. Pre-screen candidates using E-Verify Program. The Contractor must pre-screen Candidates using the E-verify Program(http://www.uscis.gov/e-verify) website to meet the established employment eligibility requirements. The Vendor must ensure that the Candidate has two valid forms of Government issued identification prior to enrollment to ensure the correct information is entered into the E-verify system. An initial list of verified/eligible Candidates must be provided to the COR no later than 3 business days after the initial contract award." *When contracts are with individuals, the individuals will be required to complete a Form I-9, Employment Eligibility Verification, with the designated Government representative. This Form will be provided to the Contracting Officer and shall become part of the official contract file.

Enclosure 1 – Lab testing and estimated annual quantities Lab Test Estimated Annual Quantity

ABO Grouping & RHO (D) Typing (Blood Type) 25 Chromium, Plasma 8 Chromium, Urine 20

Panel – CMP + Lipid Panel + CBC + Urinalysis 100 G6PD, Quant, Blood & RBC 20

Heavy Metals Profile, Blood; Arsenic, Lead, Mercury 35 Hemoglobin A1C 20

Lead Standard Profile, Blood (Lead, FEP, ZPP) 20 MMR Titer 10

HIV ½ Ag/Ab Combo (includes confirmatory) 25 Pregnancy Test, Urine 10

Routine Urinalysis 20 Serum & RBC Cholinesterase 15

Cadmium, Urine 5 Cadmium, Plasma 5

Hepatitis B Surface Antibody 5 Hepatitis B Surface Antigen 5

Hepatitis C Antibody 5 Collection Fee, Urine 30 Collection Fee, Blood 30

Testing not otherwise listed 50 Stat Results 30

RT-PCR 500

Collection Fee, RT-PCR 500 RT-PCR Self-Test Kit 250

Enclosure 2- FDA Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (revised)

Policy for Coronavirus Disease- 2019 Tests During the Public Health Emergency (Revised)

Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration

Staff Document issued on the web on May 11, 2020.

This document supersedes “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency:

Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration

Staff” issued May 4, 2020.

U.S. Department of Health and Human Services Food and Drug Administration

Center for Devices and Radiological Health

Public Comment

Preface

This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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.

Comments may be submitted at any time for Agency consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov.

All comments should be identified with the docket number FDA-2020-D-0987 and complete title of the guidance in the request.

Additional Copies

Additional copies are available from the FDA webpage titled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders ,” available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, and the FDA webpage titled “Search for FDA Guidance Documents,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. You may also send an e-mail request to CDRH- Guidance@fda.hhs.gov to receive an additional copy of the guidance. Please include the document number 20010-R3 and complete title of the guidance in the request.

Questions

For questions about this document, contact CDRH-EUA-Templates@fda.hhs.gov.

Table of Contents

I. Introduction

II. Background

III. Scope

IV. Policy

A. Laboratories Certified under CLIA that Meet the CLIA Regulatory Requirements to Perform High-Complexity Testing Using Their Validated Diagnostic Tests Prior to EUA Submission

1. Validation

2. FDA Notification

4. EUA Request

5. Clinical Testing

B. State Authorization of Laboratories Certified under CLIA that Meet the CLIA Regulatory Requirements to Perform High-Complexity Testing

C. Commercial Manufacturer Development and Distribution of Diagnostic Tests Prior to EUA Submission

1. Validation

2. FDA Notification

4. EUA Request

5. Clinical Testing

D. Commercial Manufacturer Development and Distribution and Laboratory Development and Use of Serology Tests Prior to or Without an EUA

1. Validation

2. FDA Notification

4. EUA Request

V. Validation Study Recommendations Based on the Technological Principles of Tests

A. Molecular Diagnostic Tests

(1) Limit of Detection

(2) Clinical Evaluation

(3) Inclusivity

(4) Cross-reactivity

B. Antigen Detection Tests

C. Serological Tests

VI. Availability of EUA Templates

Policy for Coronavirus Disease-2019 Tests During the Public Health

Emergency

Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug

Administration Staff

I. Introduction

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act).

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.

Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,” available at https://www.govinfo.gov/content/pkg/FR-2020-03- 25/pdf/2020-06222.pdf, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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.

In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

II. Background

There is currently a pandemic of respiratory disease caused by a novel coronavirus. The virus has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, HHS issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.1 In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.2

SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the United States. To respond effectively to the COVID- 19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. FDA believes the policies set forth in this guidance will help address these urgent public health concerns by helping to expand the number and variety of tests,3 as well as available testing capabilities in reference and commercial laboratories and healthcare settings, while helping ensure these tests are accurate and reliable.

1 Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists, (Jan. 31, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx). The declaration was renewed on April 21, 2020, effective April 26, 2020.

2 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.

3 Throughout this guidance, the term “diagnostic test” is generally used to refer to molecular or antigen tests, both of which can be used to diagnose infection with the SARS-CoV-2 virus. Molecular tests detect the presence of viral RNA and antigen tests detect the presence of viral proteins that are part of the SARS-CoV-2 virus. The terms “serological” or “antibody” tests are generally used to refer to tests that detect antibodies to the SARS-CoV-2 virus.

Because the antibodies are part of the body’s immune response to exposure and not the virus itself, such testing cannot be used for diagnosis of infection.

The Centers for Disease Control and Prevention (CDC) laboratories have supported the COVID- 19 response, including development of a diagnostic assay that was issued an Emergency Use Authorization (EUA) on February 4, 2020.4 Since authorizing CDC’s EUA, FDA has been actively working with other SARS-CoV-2 diagnostic test developers to help accelerate development programs and respond to requests for in vitro diagnostic EUAs.5 However, the severity and scope of the current COVID-19 situation around the globe necessitates greater testing capacity for the virus than is currently available.6

The EUA authorities allow FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures initiatives (MCMs) needed during certain public health emergencies. Under section 564 of the FD&C Act, the FDA Commissioner may authorize the use of unapproved medical products, or unapproved uses of approved medical products, in certain emergency circumstances, after the HHS Secretary has made a declaration of emergency or threat justifying authorization of emergency use, to diagnose, treat, or prevent serious or life-threatening disease or conditions caused by CBRN threat agents when certain criteria are met.

III. Scope

The policies described in this guidance for accelerating availability of testing for COVID-19 apply to certain laboratories and commercial manufacturers developing SARS-CoV-2 tests during the public health emergency, as described below.

IV. Policy

This guidance describes policies intended to help rapidly expand testing capacity by facilitating the development and use of SARS-CoV-2 tests during the public health emergency.

This guidance describes two policies for accelerating the development of certain laboratory-developed diagnostic tests for COVID-19 – one leading to an EUA submission to FDA, and the other not leading to an EUA submission when the test is developed under the authorities of the State in which the laboratory resides and the State takes responsibility for COVID-19 testing by laboratories in its State. The policy leading to an EUA remains unchanged from the initial publication of this guidance on February 29, 2020, though some process updates and clarifications have been made as discussed further below. The policy for State oversight remains unchanged from the second publication of this guidance on March 16, 2020.

4 See FDA’s February 4, 2020, letter authorizing CDC’s 2019-nCoV (RT)-PCR Diagnostic Panel for the presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens, available at https://www.fda.gov/media/134919/download. This EUA was re-issued in its entirety on March 15, 2020 to reflect a number of amendments including changes to the intended use and primer and probe materials.

5 See FDA’s Guidance, Emergency Use Authorization of Medical Products and Related Authorities, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities.

6 Nothing in this guidance is intended to impact or supersede CDC’s recommendations regarding which patients should be tested for COVID-19.

Contains Nonbinding Recommendations

In addition, this guidance describes a policy for commercial manufacturers to more rapidly distribute their SARS-CoV-2 diagnostic tests to laboratories for specimen testing after validation, while an EUA is being prepared for submission to FDA. This policy remains unchanged from the second publication of this guidance on March 16, 2020, though some process updates and clarification have been made as discussed further below.

This guidance also describes a policy regarding SARS-CoV-2 serological testing, which was modified in the May 4, 2020 publication of this guidance as it pertains to commercial manufacturers but not laboratories. At the time of prior issuance on March 16, 2020, FDA provided flexibility for serology tests to be marketed with notification to FDA and certain labeling information, but without submission of an EUA. FDA’s policy was based on the considerations that serology tests are not meant to diagnose active SARS-CoV-2 infection and that early availability and use of these tests could help answer critical questions about the prevalence of COVID-19 infections in different communities, whether the presence of antibodies conveys immunity, and, if so, for how long. That policy succeeded in encouraging development of serology tests.

In addition to this policy, FDA has authorized several serology tests under individual EUAs and has issued an umbrella EUA providing a streamlined approach for EUA authorization of commercial serology tests that are evaluated by the National Institutes of Health’s National Cancer Institute (NIH/NCI).7 Also since the March 16, 2020 publication of this guidance, FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH,8 indicating that greater FDA oversight of commercial serology tests is important to protect the public health.

As outlined in the May 4, 2020 update, FDA does not intend to object as described below where commercial manufacturers develop and distribute their serology tests after validation, for a limited period of time, while an EUA is being prepared for submission to FDA. Appendices with templates for such submissions have been added to facilitate and streamline the EUA process.

The policy for serological tests developed and used by laboratories that are certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing has not changed from the March 16, 2020 guidance, though FDA continues to encourage such laboratories to submit EUAs for their laboratory developed tests.

In the context of a public health emergency involving pandemic infectious disease, it is critically important that tests are validated because false results not only can negatively impact the

7 https://www.fda.gov/media/137470/download 8 The FDA is working with the NIH, the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA) to assess the performance of serology tests offered under the policy outlined in the March 16th guidance. As part of this project, the FDA, working with partnering agencies, has designed a performance assessment protocol that offers a mechanism for evaluation of lateral flow SARS-CoV-2 serological tests rapidly in a laboratory environment. Under this protocol, each test submitted to NIH will be evaluated with positive and negative plasma and serum samples. The approach represents a balanced attempt to provide a reasonable understanding of the potential performance of a significant number of the tests within a short time period. Performance results can be included by the test developer in an EUA submission.

individual patient but also can have broad public health impact. In this guidance, FDA provides recommendations regarding validation of COVID-19 tests based on the available information.

FDA encourages test developers to discuss any alternative technological approaches to validating their test with FDA.

The latest update addresses availability, through download from our website, of a series of templates that developers may choose to use to facilitate the preparation, submission, and authorization of an EUA for various types of COVID-19 tests.

A. Laboratories Certified under CLIA that Meet the CLIA Regulatory Requirements to Perform High-Complexity Testing Using Their Validated Diagnostic Tests Prior to EUA Submission

The policy described in this subsection applies to laboratories certified under CLIA that meet the CLIA regulatory requirements to perform high-complexity testing and that seek to develop and perform diagnostic tests to detect the SARS-CoV-2 virus and pursue an EUA from FDA for those tests. This policy does not apply to home collection of specimens to be sent for testing at a laboratory certified under CLIA for high-complexity testing.

FDA anticipates that clinical laboratories may need to design and manufacture the individual test kit components (e.g., primers, probes, etc.), or to purchase research use only (RUO) components from third party manufacturers, for the development of their assays.

In light of the increasing numbers of COVID-19 cases throughout the country and the urgent need to expand the nation’s capacity for COVID-19 testing during the public health emergency, FDA does not intend to object to the use of these SARS-CoV-2 tests for specimen testing for a reasonable period of time, where the test has been validated and while the laboratory is preparing their EUA request, and where the laboratory gives notification of validation to FDA, as described below. FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test that has already been validated.

1. Validation

All clinical tests should be validated prior to use. In the context of a public health emergency, it is critically important that tests are validated because false results can negatively impact not only the individual patient but also can have broad public health impact. FDA has provided recommendations regarding testing that should be performed to ensure analytical and clinical validity in section V below. FDA encourages laboratories to discuss any alternative technological approaches to validating their test with FDA through CDRH-EUA- Templates@FDA.HHS.GOV.

2. FDA Notification Following completion of assay validation, laboratories should notify FDA (e.g., email to CDRH- EUA-Templates@FDA.HHS.GOV) that their assay has been validated. This notification should include the name of the laboratory, name of the laboratory director, laboratory address, and contact person in this email. FDA will acknowledge receipt of this notification via auto-reply, and generally will add the laboratory name to FDA’s website listing. As noted above, FDA recommends that laboratories submit a completed EUA request within 15 business days of the notification to FDA that the assay has been successfully validated. If an EUA request is not submitted within this timeframe, FDA intends to remove the laboratory from its website listing of laboratories that have notified FDA and may take additional actions as appropriate.

It would be helpful to FDA if laboratories provide information on testing capacity. This information will help the Agency and Department monitor the landscape as we work to ensure adequate testing capacity across the country.

3. Reporting of Results

In order to provide transparency, FDA recommends that test reports include a general statement that the test has been validated but FDA’s independent review of this validation is pending.

Laboratories should immediately notify appropriate Federal, State, and local public health agencies of all positive results.

4. EUA Request

FDA has made available, through download from our website, a template that laboratories may choose to use to facilitate the preparation, submission, and authorization of an EUA for a molecular diagnostic test.9 Laboratories that intend to use alternative approaches should consider seeking FDA’s feedback or recommendation to help them through the pre-EUA and EUA process. FDA encourages laboratories to discuss any alternative technological approaches to validating their test with FDA through CDRH-EUA-Templates@FDA.HHS.GOV.

Soon after receiving the EUA request, FDA intends to perform a preliminary review to identify if there are any problems with the performance data. If a problem is identified, FDA intends to work with the laboratory to address the problem (e.g., through labeling or bench testing). If any problems are significant and cannot be addressed in a timely manner, FDA would expect the laboratory to stop testing and issue corrected test reports indicating prior results may not be accurate. In such circumstances, FDA intends to remove the laboratory from the website listing of notifications.

Issued EUAs are posted on FDA’s website.

9 See https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019

When a laboratory makes a modification to an EUA authorized test for use of a new specimen type, FDA does not intend to object to the use of such a modified test without notification to FDA or a new or amended EUA where the new specimen type has been previously authorized for another test of the same technology10 and where the EUA authorized test is validated for the new specimen type. Modifications to an EUA authorized test for use of a new specimen type that has not been previously authorized for another test of the same technology must be authorized under a new or amended EUA prior to clinical use.

For all other types of modifications, FDA does not intend to object to the use of a test, without notification to FDA or a new or amended EUA, where the test is a modification of an EUA-authorized test and the modified test is validated using a bridging study to the EUA-authorized test.11 One way to bridge to a new component is to establish equivalent performance between parallel testing of the same specimens with the new and original components. We recommend testing 3-fold serial dilutions of SARS-CoV-2 viral materials (e.g., whole genomic viral RNA or inactivated virus, etc.) in a pooled respiratory sample matrix in triplicate until you achieve a hit rate of <100%. If the resultant Limit of Detection (LoD) is the same as the LoD for the unmodified authorized test (i.e., ≤3xLOD), then FDA believes the two tests can be considered to have equivalent performance.

When validating through a bridging study and not pursuing an EUA amendment for the modification, FDA would like to see the laboratory’s validation data informally through an email to CDRH-EUA-Templates@FDA.HHS.GOV. If FDA’s review of the bridged validation data indicates that it could be applicable to modifications of other tests with an EUA, or to other laboratories modifying the same authorized test, and the laboratory agrees to FDA sharing that information on our website for use by other laboratories, FDA intends to update our FAQs so other laboratories can refer to the validation for their testing, without conducting their own bridging study for the same modification. This informal sharing of data would not be considered to be a notification, as discussed above, or an EUA request.

5. Clinical Testing

While awaiting an FDA determination on the EUA request, FDA recommends that clinical laboratories obtain confirmation of the first five positive and the first five negative clinical specimens using an EUA-authorized assay. This testing may be performed within the same laboratory using an EUA-authorized assay or may involve sending these ten specimens to another laboratory for confirmation. If any of these results cannot be confirmed, the laboratory should notify FDA at CDRH-EUA-Templates@FDA.HHS.GOV, and take other appropriate actions such as terminating testing patient specimens, and issuing corrected test reports indicating prior test results may not be accurate.

10 For the purposes of this guidance, all nucleic acid amplification tests are considered to have the same technology.

11 This policy applies to modifications to any EUA-authorized test, including a laboratory’s own test with an EUA or a purchased kit from a manufacturer with an EUA.

B. State Authorization of Laboratories Certified under CLIA that Meet the CLIA Regulatory Requirements to Perform High-Complexity Testing

On March 12, 2020, FDA issued enforcement discretion and stated that it was not objecting to the Wadsworth Center authorizing certain laboratories in the State of New York to begin patient testing under certain circumstances to increase availability of COVID-19 testing in response to a request from the Wadsworth Center of the New York State Department of Health (Wadsworth).

Wadsworth had informed FDA that it would be willing to have clinical laboratories that currently hold a New York State Department of Health clinical laboratory permit to notify Wadsworth that they have validated a test for COVID-19, and to submit validation studies to Wadsworth.

Wadsworth likewise said it would notify the laboratory if it identified any concerns, and request that the laboratory terminate testing patient specimens and issue corrected test reports indicating prior test results might not be accurate.

On March 13, 2020, the President issued a “Memorandum on Expanding State-Approved Diagnostic Tests” (Memorandum), which refers to the flexibility that FDA allowed New York State and states as follows:

“Should additional States request flexibility to authorize laboratories within the State to develop and perform tests used to detect COVID-19, the Secretary shall take appropriate action, consistent with law, to facilitate the request.”

In accordance with the Memorandum, FDA describes below its policy regarding States and territories that authorize laboratories within their State or territory to develop their own COVID- 19 tests and perform specimen testing, where the notification of SARS-CoV-2 test validation is not submitted to FDA and the laboratory does not submit an EUA request to FDA.

A State or territory choosing to authorize laboratories within that State or territory to develop and perform a test for COVID-19 would do so under authority of its own State law, and under a process that it establishes. FDA does not intend to object to the use of such tests for specimen testing where the notification of SARS-CoV-2 test validation is not submitted to FDA and the laboratory does not submit an EUA request to FDA, and where instead the State or territory takes responsibility for COVID-19 testing by laboratories in its State during the COVID-19 outbreak.

FDA requests that the State or territory notify us if they choose to use this flexibility to expedite COVID-19 testing.12 FDA will not be reviewing the process adopted by the State or territory, which we understand may be different than the process adopted by New York State. FDA expects that such states as part of their oversight process will require laboratories developing SARS-CoV-2 tests to validate those tests prior to use. FDA encourages laboratories that develop and perform a test for COVID-19 under this policy to notify FDA that they have started clinical testing by sending an email to that effect to CDRH-EUA-Templates@FDA.HHS.GOV. It would be helpful to FDA if laboratories provide information on testing capacity. This information will

12 A list of States who have notified FDA under this policy is available on FDA’s FAQ website at:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2.

help the Agency and Department monitor the landscape as we work to ensure adequate testing capacity across the country.

C. Commercial Manufacturer Development and Distribution of Diagnostic Tests Prior to EUA Submission

The policy described in this subsection applies to commercial manufacturers that seek to develop and distribute diagnostic test kits to detect the SARS-CoV-2 virus to clinical laboratories or to healthcare workers for point-of-care testing. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, including testing at the point-of-care when the site is covered by the laboratory’s CLIA certificate for high-complexity testing.

This policy does not apply to at-home testing, including at-home specimen collection.

In light of the increasing numbers of COVID-19 cases throughout the country and the urgent need to expand the nation’s capacity for COVID-19 testing during the public health emergency, FDA does not intend to object to a commercial manufacturer’s development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification of validation to FDA as described below, and where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users.

FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test that has already been validated.