JA - COVID - BD COVID Testing Reagents - Redacted.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP 2020-08-20T13:05:02

Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Page 1 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C257-20-AP-4007

RPO-West Tracker #: 2020-08-20T13:05:02

1. Agency: Department of Veterans Affairs

Contracting Activity: Network Contracting Office 17 5441 Babcock Rd., Ste. 302 San Antonio, TX 78240

2. Nature and/or Description of the Action Being Processed:

NCO-17 intends to negotiate a sole source contract for the procurement of SARS-CoV-2 (COVID-19) testing reagents from Becton, Dickinson and Company (BD). The proposed contract will be awarded as a new firm-fixed price action, identified as a standing-order – which items are to be requested on an as-needed basis, with a delivery period of twelve (12) months.

FAR13.5 Simplified Procedures for Certain Commercial Items:

This procurement is for Becton Dickinson COVID testing reagents. In accordance with FAR 13.5, Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The proposed action is to provide COVID-19 testing kits in support of the Central Texas Veterans Health Care System (CTVHCS) Pathology & Laboratory Medicine Service. The following kits are required:

Description Item Number Unit Quantity BD SARS-CoV-2 Reagents 445003-01 KT 800 BioGX SARS-CoV-2 Reagents 444213 KT 400 BioGX SARS-CoV2 & RNase P Synthetic Single- Stranded RNA Control Templates

444214 KT 72

BD MAX ExK TNA-3 442827 KT 400 BD MAX PCR Cartridge 437519 KT 138

Estimated Value: $REDACTED

OFOC SOP Revision 09 Page 2 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

4. Statutory Authority Permitting Other than Full and Open Competition:

41 USC §1903(a)(4) and 41 USC §3304(e)(1)(B)(i), as implemented by FAR 13.106-1(b)(2)

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( X ) (2) Unusual and Compelling Urgency per 41 USC §1903(a)(4) as implemented by FAR 13.106- 1(b)(2);

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The BD SARS-CoV-2 and BioGX SARS-CoV-2 Reagents for the BD MAX™ System are real-time Polymerase Chain Reaction (RT-PCR) tests intended for the qualitative detection of nucleic acid from the 2019-nCoV in nasal, nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria. COVID-19 testing is critical for the CTVHCS to help treat, isolate or hospitalize people who are infected.

The US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the new diagnostic test that will enable hospitals to screen for COVID-19 and get results in under three hours.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Market research conducted for the requirement only identified one small business that could potentially offer the requested BD products. Correspondence with the vendor stated that they do not offer the new BD COVID testing reagents.

Due to the urgent and compelling nature of the requirement, no additional efforts were made to solicit the requirement to potential sources. In accordance with the exception at FAR 5.202(a)(2), the proposed contract action is made under the conditions described in FAR 6.302-2 (unusual and compelling urgency precludes competition to the maximum extent practicable) and the government would be seriously injured if the agency complies with the time periods specified at FAR 5.203.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The Contracting Officer has determined that the anticipated cost will be fair and reasonable. The proposed prices will be compared to the prices on purchase order 36C25720P0646.

OFOC SOP Revision 09 Page 3 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

NCO-17 conducted market research by searching the mandatory sources for the procurement of supplies, UNICOR and Ability One. Neither of these mandatory sources offer BD products. A search was conducted using GSA Advantage; the results found that the required products are not listed on BD’s VA National Acquisition Center (NAC) contract (V797D-40095) Federal Supply Schedule (FSS) pricelist, or on GSA Advantage. A search of the Western States Network Consortium’s BPAs and contacts did not find these BD products. A search of the Office of Small & Disadvantaged Business Utilization’s (OSDBU) Vendor Information Pages (VIP) did not identify a SDVOSB or VOSB that can provide the requested BD products. Lastly, a search on the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS) did not identify a small business that can provide the requested BD products.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The CTVHCS Pathology & Laboratory Medicine Service owns and operates a BD Max analyzer. BD is the only firm capable of providing the required reagents without the Veterans Health Administration (VHA) experiencing unacceptable delays in fulfilling its requirements. Considering the acquisition of another vendor’s RT-PCR analyzer and EAU COVID reagents would not be cost effective.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

None

11. 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:

Market research will be conducted prior to placing any new order requirements to determine if there have been any changes in the marketplace.

12. Requirements Certification:

I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

//SIGNED// 08/27/2020

REDACTED Date:

Laboratory Chief Technologist Pathology & Laboratory Medicine Service Central Texas Veterans Health Care System

OFOC SOP Revision 09 Page 4 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

//SIGNED// 08/27/2020

REDACTED Date:

Contracting Officer

b. One Level Above the Contracting Officer: I certify the justification meets requirements for other than full and open competition.

//SIGNED// 08/27/2020

REDACTED Date:

Acting Branch Chief, Services III Network Contracting Office 17

Director of Contracting: I have reviewed the forgoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval for other than full and open competition.

//SIGNED// 08/28/2020

REDACTED Date:

Director of Contracting Network Contracting Office 17

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($700K to $68 million) for other than full and open competition.

//SIGNED// 08/31/2020

REDACTED Date:

Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx