Class J-A Rapid Antibody Tests.pdf

Justification and Approval (J&A) for Other Than Full and Open Competition

FOR OFFICIAL USE ONLY

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Was a J&A approved for the preceding acquisition? Yes No

Is this a new or amended J&A Document? New Amended ( Prior to Award Only! )

Is this a Bridge Action as defined at AFFARS 5302.101? Yes No

Dollar Value of this Acquisition: < $700K > $700K and < $13.5M > $13.5M and < $93M > $93M

Contracting Activity: AFLCMC/ WV, 773rd CONS, 82nd CONS, 6 CONS, 764 SCONS, 766 SCONS

Purchase Request (if available):

Program / Project (and PE, if applicable): Joint Acquisition Task Force / COVID-19 Rapid Antibody Test Kits

Program Type (PEO, Enterprise, of Operational): Operational

Authority: 6.302-2 – 10 USC 2304(c)(2), Unusual and Compelling Urgency

Estimated Contract Cost (including options): $ 13,000,000 J&A Type: Class Individual

! ! Provide estimated cost of all contracts.

COORDINATION (AFFARS 5306.304(a) ) Sign and Save Procedure

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Date

30 Apr 2020

Project Lead / Program Mgr / Requiring Activity

MATTHEW S. KELLY, NH-04, DAF

AFLCMC/ AQ-AZ, 937-344-1624

Signature

X

Date

30 Apr 2020

Contracting Officer

WILLIAM F. PING III, NH-04, DAF

AFLCMC/ WV, 937-656-9300

Signature

X

Date

30 Apr 2020

Local Legal Reviewer

THOMAS M. POWERS, NH-04, DAF

AFMCLO/JANS, 440-773-2344

Signature

X

Date

30 Apr 2020

Chief of the Contracting Office (COCO)

LEON A. MABLE, NH-04, DAF

AFLCMC/ WV, 937-321-1320

Signature

X

APPROVAL (AFFARS 5306.304(a) )

Date

01 May 2020

Competition Advocate

CHRISTOPHER J. KIRBABAS, NH-04, DAF

AFLCMC/PK, 937-785-7030

Signature

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I. Agency and Contracting Activity.

United States Air Force

AFLCMC/WVB

Bldg 558, Room 13 2590 Loop Road West

WPAFB, OH 45433-7222

II. Nature and/or description of the action being approved.

This Class J&A provides Unusual and Compelling Urgency justification for new contracts for completion of production and sustainment efforts for Rapid Antibody COVID-19 Test Kits in response to the COVID-19 pandemic for a period of one (1) year from the approval date of this J&A. The applicable authorities are Federal Acquisition Regulation (FAR) 6.302-2(a)(2) and 10 United States Code 2304(c)(2) Unusual and Compelling Urgency. Multiple new contracts will be awarded throughout the period covered under this Class J&A.

The scope of this J&A comprises all components of Rapid Antibody Test Kits including, but not limited to currently available Food and Drug Administration (FDA) approved test kit components and new component development and upgrades pending FDA Emergency Use Authorization (EUA) that satisfy the USAF COVID-19 Task Force and the Joint Acquisition Task Force (JATF) requirements. Therefore, this Class J&A applies to contract actions for Rapid Antibody Test Kits, including the development and upgrade of components thereof, that provide Point of Care (POC), serological rapid antibody tests, that screen for IgG and IgM antibodies or total antibody screening, and are manufactured in the U.S.

In order to procure all requirements in the most expeditious manner, new contracts actions may need to be initiated prior to FDA approval. Contract actions awarded under the authority of this Class J&A will be executed using Firm Fixed-Price (FFP) purchase orders, contracts, or Indefinite-Delivery Indefinite-Quantity (IDIQ) vehicles. However, other contract types may be used when determined appropriate. Vendors being considered for award include but are not limited to Axon, Lovell, Luminostics, Henry Schein, and Becton & Dickinson Company.

III. Description of supplies/services required to meet agency needs (including the estimated value).

This effort will acquire COVID-19 Rapid Antibody Test Kits and Diagnostics equipment for medical professionals to determine if patients have been infected with COVID-19. This requirement is for test kits that provide rapid presumptive qualitative detection of antibodies to COVID-19 in human whole blood, serum, or plasma. These test typically provide Positive/Negative results in a matter of minutes at the test site using fingerstick, whole blood, serum, or plasma samples with increased screening for specific antibody detection. Rapid Antibody Tests reduce the risk of transmission from infected patients to medical personnel and conserves Personal Protective Equipment (PPE) in the process.

Additionally, Rapid Antibody Tests require minimal user training for laboratory technicians and the FDA waives Clinical Laboratory Improvement Amendment (CLIA) requirements and does not require a College of American Pathologist (CAP) accredited facility to administer the tests/obtain the results.

IV. Statutory authority permitting other than full and open competition.

The statutory authority that permits other than full and open competition for these acquisitions is 10 USC 2304(c)(2), as implemented by FAR 6.302-2(a)(2) Unusual and Compelling Urgency, and required by FAR 6.303-2(b)(4).

V. Demonstration that the contractor's unique qualifications or the nature of the acquisition requires use of the authority cited above (applicability of authority).

FAR 6.302-2(a)(2) states, "When the agency’s need for the supplies or services is of such an unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals, full and open competition need not be provided for."

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The vendors in the Rapid Antibody Test market segment provide test kits and associated diagnostics equipment for COVID-19 with the ability to scale production capacity up to 1 million tests per day and a testing capability of up to 350,000 tests per day. The U.S. is experiencing a shortage of test kits due to a lack of critical test kit and diagnostics equipment components. Start-up firms and other vendors have developed tests that do not depend on current supply chains for tubes, nasal swabs, preservatives, or reagents that are currently awaiting FDA EUA approval. Their supply chain structure will allow the companies to rapidly provide COVID-19 test kits without competing for materials with other vendors supporting public health agencies and the Center for Disease Control and Prevention in response to the current pandemic. Beginning the acquisition process with a source once it has FDA approval will be too late to ensure award. FDA approval is public knowledge and all Federal and State Government entities are competing for the same requirements from a limited number of vendors.

This requirement is urgent and compelling based on the negative impacts the spread of COVID-19 has had and will continue to have on the U.S. economy and military readiness world-wide. Mitigating, and eventually eradicating, the transmission of COVID-19 is exceptionally time sensitive. Validating and assessing antibody testing capabilities to provide fast and reliable COVID-19 testing capability can literally mean the difference between life and death for those afflicted with the disease. Therefore, the additional time it would take to conduct even a limited competition is not practicable under these unprecedented circumstances.

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under FAR 5.202 applies.

The Joint Acquisition Task Force (JATF) has conducted exhaustive market research and intelligence in search of all viable Rapid Antibody Test Kit and Diagnostics Equipment vendors in the U.S. A notice was not publicized to the GPE IAW FAR 5.202(a)(2); the Government would be seriously injured if the agency complies with the time periods specified in FAR 5.203.

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

Commercially available serology tests exist for other illnesses. Proposed prices will be evaluated based on market research including comparison to commercial vendors, and other agency pricing on similar buys. Based on this price analysis, the anticipated cost to the Government will be fair and reasonable.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

Market research was conducted for this requirement and is ongoing. As of 27 April 2020, the FDA has issued Emergency Use Authorization (EUA) for 49 tests / test kits. The Department of Defense (DoD) has traditionally sourced viral PCR testing kits from large manufacturers that are currently experiencing one of two (or both) issues: (1) they do not have the material/ inventory to produce at their normal capacity, let alone increased output, or (2) their future production is already allocated for other customers. The FDA's testing kit and diagnostics equipment approval is public information, meaning every entity supporting the COVID-19 response are contacting the same vendors. Based on the team's findings, Rapid Antibody Test Kit vendors offer an inexpensive solution to this requirement that does not need additional equipment to administer a test and triage patients according to their test results. Serological Point of Care (POC) test provide hospitals and clinics devices that screen patients that have previously been infected by the presence of IgG antibodies and/or identify patients currently have the SARS-CoV-2 virus by the presence of IgM. Of the 49 with FDA EUA approval, only 5 meet the USAF COVID-19 Task Force and JATF requirements of (1) serological rapid antibody tests, (2) that are POC devices, (3) screen for both IgG and IgM antibodies, or total antibody screening, and (4) are manufactured in the U.S. As described above, the market base is volatile as there is a daily influx of new entrants. Conversely, some vendors capacity becomes saturated and are unable to fulfill customer demands.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

N/A

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X. List of any sources that expressed, in writing, an interest in the acquisition.

See Section VI above; no notice was publicized for this acquisition.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

The events of the COVID-19 pandemic that led to this requirement were unprecedented and put unforeseen stress on a specific market segment that has struggled to manage the surge of medical facilities in need of test kits. Adequate competition exists during periods not subject to a pandemic. After this period of compelling urgency has ended, but no longer than one year the Contracting Officer and the Requiring Activity will re-evaluate to ensure this effort is returned to Full and Open Competition.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.

Remove the Guidance pages below. Remove the IACR pages below.

March 2020 Page of International Agreement Competitive Restrictions (IACR) Page of March 2020 Was a J&A approved for the preceding acquisition?

!! Attach the preceding J&A in the staff package for this J&A. The preceding J&A will be used as a reference document.

Is this a new or amended J&A Document?

Is this a Bridge Action as defined at AFFARS 5302.101?

Dollar Value of this Acquisition:

J&A Type:

!! Provide estimated cost of all contracts.

COORDINATION (AFFARS 5306.304(a)) ** The text in the signature blocks below is editable, including the title.

** To remove a row, click the "X" next to the signature block. CAUTION: Once removed, it can only be restored by downloading the BLANK FORM again.

APPROVAL (AFFARS 5306.304(a)) NOTE: A signature block will appear here based on the "Dollar Value of this Acquisition" selected above.

(See "Specific Guidance for Completing this Template" below.)

I. Agency and Contracting Activity.

II. Nature and/or description of the action being approved.

III. Description of supplies/services required to meet agency needs (including the estimated value).

IV. Statutory authority permitting other than full and open competition.

V. Demonstration that the contractor's unique qualifications or the nature of the acquisition requires use of the authority cited above (applicability of authority).

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under FAR 5.202 applies.

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

X. List of any sources that expressed, in writing, an interest in the acquisition.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

XII. Certification by the Contracting Officer.

XIII. Certification by the technical/requirements personnel.

Specific Guidance for Completing this Template

I. Agency and Contracting Activity.

II. Nature and/or description of the action being processed. (FAR 6.303-2(b)(2))

State whether the action is a new contract or a modification to an existing contract (identify contract number) and identify the contract type planned (e.g., firm-fixed-price, cost-plus-incentive-fee, hybrid etc.). If exception 2 is cited (unusual or compelling urgency), include the date of UCA/contract/modification issuance and amount.

For class J&As, where the number of contracts in the class can be identified: Provide the nature and/or description of each contract action and contract type. If the same information applies to more than one contract, it need only be stated once.

III. Description of the supplies/services required to meet agency needs (including the estimated value).

(FAR 6.303-2(b)(3))

Describe the supplies and/or services to be acquired and include the total estimated value of the acquisition and, for class J&As, by contract action, and the estimated periods of performance.

For ID/IQ or requirements contracts, use the maximum dollar value of the total estimated orders as the estimated J&A dollar value.

IV. Statutory authority permitting other than full and open competition. (FAR 6.303-2(b)(4))

10 USC 2304(c)(?) (see Note 1), as implemented by FAR 6.302-? (see Note 2), and required by FAR 6.303-2(b)(4).

Note 1: Complete the 10 USC 2304(c) citation with the statutory subparagraph cited in the (a) Authority (1) Citations portion of the Competition exception used for your J&A. Do not provide more than one citation.

Note 2: Complete the FAR citation with the appropriate subparagraph.

Note 3: For class J&As, all contracts within the class must fall within the same statutory authority.

V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above. (FAR 6.303-2(b)(5))

Provide an explanation to support the use of the authority cited. The explanation should tie back to the conditions described in the FAR for using the particular authority cited.

A. Only One Responsible Source (FAR 6.302-1) (DFARS 206.302-1 and DFARS PGI 206.302-1)

When using this authority, thoroughly describe the contractor's unique/highly specialized capabilities and/or qualifications (e.g., facilities, personnel, special tooling acquired), and why no other type of supplies or services will satisfy the agency requirements. This authority shall be used, if appropriate, in preference to the authority in FAR 6.302-7. This authority shall not be used when any of the other authorities apply.

For example, in the case of a follow-on contract for continued development or production of a major system or highly specialized equipment/services, the rationale must first justify the supplies/services as being a “major system” or “highly specialized.” The rationale must then justify “either” substantial duplication of cost to the government that is not expected to be recovered through competition, or unacceptable delays in fulfilling the agency's requirements, whichever situation applies.

In accordance with DFARS 206.302-1(c)(2) Application for brand-name descriptions. Notwithstanding FAR 6.302-1(c)(2), in accordance with section 888(a) of the National Defense Authorization Act for Fiscal Year 2017 (Pub. L. 114-328), the justification and approval addressed in FAR 6.303 is required in order to use brand name or equal descriptions.

B. Unusual and Compelling Urgency (FAR 6.302-2, DFARS 206.302-2, and DFARS PGI 206.302-2)

Contracting Officers must notify SAF/AQC as soon as practicable when contemplating the use of this authority for a J&A requiring SPE approval.

Provide an explanation why (1) the supplies or services are needed at once and/or (2) essential equipment or repairs to that equipment are needed at once to preclude the ability to meet critical mission needs of the USAF and Defense of the Nation. In other words, identify the anticipated serious injury to the Government, the nature of the urgency, the reasons for it occurring and why it is “urgent and compelling” to preclude adverse impact to military readiness. Merely citing a Joint Urgent Operational Need (JUON), Force Activity Designator (FAD) rating, Program Management Directive (PMD)/Program Action Directive (PAD) guidance, or DX priority rating is not in and of itself sufficient reason to use this exception from the requirement to obtain full and open competition. Note that only the minimum quantity required to satisfy the unusual and compelling urgency qualifies for this exception. In addition, the period of performance may not exceed one year, including all options [FAR 6.302-2(d)(ii)]; thus, the inclusion of options, when using this authority, is not advised.

Note: This statutory authority requires that agencies request offers from as many potential sources as is practicable under the circumstances.

C. Industrial Mobilization; or Engineering, Developmental, or Research Capability (FAR 6.302-3)

Justifications citing this authority must demonstrate the need to establish or maintain an essential capability, or a contract for supplies or services incidental to establishing or maintaining an essential capability, possessed by the identified source(s). Some form of market survey must support the need to establish or maintain the capability being procured.

D. Authorized or Required by Statute (FAR 6.302-5)

Identify what is being acquired and the applicable statute authorizing other than full and open competition in accordance with FAR 6.302-5(b).

Note: Some statutes do not require a written J&A.

E. National Security (FAR 6.302-6)

This authority may be used for any acquisition when disclosure of the Government's needs would compromise the national security (e.g., would violate security requirements); it shall not be used merely because the acquisition is classified, or merely because access to classified material will be necessary to submit a proposal or to perform the contract. Full and open competition need not be provided for when the disclosure of the agency's needs would compromise the national security unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. This statutory authority requires that agencies shall request offers from as many potential sources as dis practicable under the circumstances.

F. Public Interest (FAR 6.302-7 and DFARS 206.302-7)

The use of this authority requires a written Determination and Finding (D&F) in accordance with FAR 1.7 in lieu of J&A. The D&F shall not be made on a class basis.

This authority may only be used when none of the other authorities apply. Provide detail addressing the reasons full and open competition is not in the public interest and why no other authority is appropriate for use.

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable, including whether a notice was or will be publicized as required by FAR 5.2 and, if not, which exception under FAR 5.202 applies. (FAR 6.303-2(b)(6))

Describe all efforts taken, or to be to be taken, to ensure that offers are solicited from as many potential sources as practicable under the circumstances. Although market research is covered in Section VIII, the information in Section VI should correlate with the market research described in Section VIII. To ensure completeness, it is best to provide information such as the following:

If a sources sought synopsis or an RFI was issued, provide the date the synopsis was issued along with a brief description of its content. Identify the number of responses received, the results of the screening process, and the rationale for determining the unacceptability of any respondents. Note: An RFI or Sources Sought Synopsis is mandatory IAW DFARS PGI 206.303-2(b)(i) when citing the authority of 10 USC 2304(c)(1), “Only one (or a limited number of) responsible source(s)”.

Specify whether this acquisition will require a Notice of proposed Contract Action (NOCA) IAW FAR 5.201 and if not, provide the exception IAW FAR 5.202. If a NOCA was or will be publicized provide the dates or expected dates of publication of the NOCA. Address any other actions taken or planned to facilitate competition for this acquisition.

Qualifying Country Sources. If qualifying country sources have expressed interest, but are to be excluded, provide supporting rationale.

VII. Determination by the contracting officer that the anticipated cost to the government will be fair and reasonable. (FAR 6.303-2(b)(7))

Provide the basis for this determination.

VIII. Description of the market research conducted and the results, or explain why market research was not conducted. (FAR 6.303-2(b)(8))

Discuss any market research conducted pursuant to FAR Part 10 and describe results of that research.

When other exceptions from the requirement to obtain full and open competition are relied upon, the market research might be limited to an examination of the acquisition history and experience with the marketplace under previous acquisitions for the same or similar items.

If market research was not conducted, so state and provide the rationale.

IX. Any other facts supporting the use of Other Than Full and Open Competition. (FAR 6.303-2(b)(9)(i))

X. List of sources, if any, that expressed interest in the acquisition. (FAR 6.303-2(b)(10))

If a sources sought synopsis or RFI was issued and all interested sources are included in Section VI, it is acceptable to state, “See Section VI above.”

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required. (FAR 6.303-2(b)(11))

If no actions are planned, provide rationale (i.e., sole-source to OEM, unable to compete due to inability to procure data rights, etc.) IAW DFARS PGI 206.304(a)(S-70)(ii), for a non-competitive follow-on acquisition to a previous award for the same supply or service supported by a J&A citing the authority at FAR 6.302-1. Include a copy of the previous J&A and include a discussion of the actions planned to overcome barriers to competition established in the previous justification, the status of those actions, and the results of those actions; and

The approval authority shall determine whether the planned actions were completed. If the planned actions were not completed, the justification for the follow-on acquisition shall be approved by the approval authority one-level above the approval authority for the previous justification (see DFARS 206.304). If the previous justification was approved by the Senior Procurement Executive (SPE), the approval remains at the SPE level.

XII. Certification by the Contracting Officer. (FAR 6.303-2(b)(12))

As evidenced by his/her signature, the contracting officer has determined this document to be both accurate and complete to the best of his/her knowledge and belief.

XIII. Certification by the technical/requirements personnel. (FAR 6.303-2(c))

As evidenced by their signatures, the technical and/or requirements personnel have certified that any supporting data contained herein, which is their responsibility, is both accurate and complete.

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The following page contains a suggested template for “International Agreement Competitive Restrictions (IACR)”.

The authority to prepare an IACR has been delegated from the HCA to the Contracting Officer.

(AFFARS 5306.302-4)

IV. Statutory Authority: 10 USC 2304(c)(4) as implemented by FAR 6.302-4, International Agreement.

VI. Certification of Accuracy and Completeness:

As evidenced by his/her signature, the contracting officer has determined the IACR to be both accurate and complete to the best of his/her knowledge and belief. The CO also approves the IACR.

As evidenced by his/her signature, the program/technical/requirements manager(s) have/has determined that any supporting data contained in the IACR, which is his/her responsibility, is both accurate and complete.

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