P03 - JA - Part 806.3 - Atch2 - Roche COVID Reagents - 1178 - Redacted.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Page 1 of 5 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

Justification For

Other Than Full and Open Competition

Acquisition Plan Action ID: 36C257-20-AP-2756

RPO-West Tracking #: 2020-05-20T07:49:27

1. Agency: Department of Veterans Affairs (VA)

Contracting Activity: Network Contracting Office 17 (NCO-17) 7201 Interstate 40, Ste. 100 Amarillo, TX 79106

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

NCO-17 intends to award new six-month firm-fixed price (FFP) contract for the acquisition of COVID- 19 testing reagents from Roche Diagnostics Corporation. The contract will be identified as a standing-order – which items are to be requested on an as-needed (weekly) basis throughout the period of performance.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Roche COVID test kits. 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 test kits in support of the VA North Texas Health Care System (VANTHCS), Pathology & Laboratory Medicine Service. The following kits are required:

Description Item Number Unit Quantity COBAS SARS-CoV-2 Kit 09175431190 KT 264 COBAS SARS-CoV-2 Control Kit 09175440190 KT 48 COBAS Buffer Negative Control Kit 07002238190 KT 48

Estimated Value: $REDACTED

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) https://www.acquisition.gov/content/part-6-competition-requirements

OFOC SOP Revision 09 Page 2 of 5

Revision 09 Date: 04/17/2020

( ) (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):

Due to the nature of this requirement related to the current COVID-19 World-Wide pandemic, Roche Diagnostics Corporation is the only firm capable of providing the required reagents without the Veterans Health Administration (VHA) experiencing unacceptable delays in fulfilling its requirements. As such, adverse patient outcomes would be unavoidable.

The VANTHCS Pathology & Laboratory Medicine Service, is currently operating a Roche cobas® 6800 System under a lease/rental agreement under a separate Molecular Cost-Per-Test contract. This cobas® 6800 System requires special reagents to ensure there are minimum false-negative or false-positive test results from COVID-19 patient specimen samples. Roche Diagnostics Corporation develops and manufactures products that simplify and automate complex biomedical testing. The Emergency Use Authorization (EUA) cobas® SARS-CoV-2 is a qualitative RT-PCR test for use on the cobas® 6800 System and cobas® 8800 System for the detection of the 2019 novel coronavirus (SARS- CoV-2) RNA in nasal, nasopharyngeal, and oropharyngeal swab samples collected in Copan Universal Transport Medium System (UTM-RT), BD™ Universal Viral Transport System (UVT), cobas® PCR media, or 0.9% physiological saline.

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

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 proposed prices will be fair and reasonable. The prices of the items in purchase order number 36C25720P0898 were compared to similar Roche reagent products and were determined to be fair and reasonable.

Description Item # Unit Price Quantity/Comment COBAS SARS-CoV-2 Kit 09175431190 $REDACTED 192 ($REDACTED CPT) COBAS SARS-CoV-2 Controls 09175440190 $REDACTED COBAS Buffer, Negative Controls 07002238190 $REDACTED

OFOC SOP Revision 09 Page 3 of 5

Revision 09 Date: 04/17/2020

FSS Comparison:

COBAS AmpliPrep HCV 2.0 05480442190 $REDACTED 72 ($REDACTED CPT) COBAS HBV/HCV/HIV Controls 06998887190 $REDACTED 768 ($REDACTED CPT) COBAS Wash Buffer Kit 05235871190 $REDACTED 960 ($REDACTED CPT)

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 Roche products. A search was conducted using GSA Advantage; the results from the search found that the required products are not available and are not listed on Roche’s National Acquisition Center (NAC) contract (V797D-70105) Federal Supply Schedule (FSS) pricelist. Additionally, a search of the Western States Network Consortium’s BPAs and contracts did not find these Roche products. Lastly, 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 Roche products.

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

The Centers for Disease Control and Prevention (CDC), Coronavirus Disease (COVID-19) provides priorities for COVID-19 testing, of which the highest priority is hospitalized patients with symptoms and healthcare facility workers and first responders. As such, COVID-19 testing is crucial for the VANTHCS to help treat, isolate or hospitalize people who are infected. Furthermore, early testing also helps to identify anyone who came into contact with infected people so they too can be quickly treated.

The diagnostic use of the Roche testing reagents or assays are based on methods, reference ranges and physician input. Due to the transport and treatment of the patients in various facilities within the VANTHCS, it is imperative the methods of reference ranges be identical to meet the Standard of Care Requirements for the Joint Commission.

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

Roche Diagnostics Corporation

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.

OFOC SOP Revision 09 Page 4 of 5

Signature:

//SIGNED// 05/26/2020

REDACTED Date:

Chief, Pathology & Laboratory Medicine Service VA North Texas Health Care System

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.

Contracting Officer

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

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.

Director of Contracting Network Contracting Office 17 http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

OFOC SOP Revision 09 Page 5 of 5

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// 05/27/2020

Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)