JA - Part806.3 - Atch2 - Over SAT - Roche COVID Reagents and Supplies - Redacted.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP RPO-W Tracker#:

Attachment 2: Request for Sole Source Justification >SAT 2020-11-10T10:39:16

OFOC SOP Revision 10 Page 1 of 4 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C257-21-AP-0269

1. Agency: Department of Veterans Affairs (VA)

Contracting Activity: Network Contracting Office 17 (NCO-17) 5441 Babcock Rd., Ste. 303 San Antonio, TX 78240

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

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

FAR 13.5 Simplified Procedures for Certain Commercial Items:

This procurement is for Roche COVID reagents and supplies. In accordance with FAR13.5, 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 reagents and supplies in support of the VA North Texas Health Care System (VANTHCS), Pathology & Laboratory Medicine Service. The following items are required:

Description Item Number Unit Quantity SARS-CoV-2 Reagents 09175431190 KT 260 SARS-CoV-2 Control Kit 09175440190 KT 52 Buffer Negative Control Kit 07002238190 KT 52 Wash Reagent 06997503190 EA 260 Specimen Diluent 06997511190 EA 52 Lysis Reagent 06997538190 EA 52 MGP Reagent 06997546190 EA 104 Pipette Tips 05534925001 CS 104 Processing Plates 05534917001 CS 52 Amplification Plates 05534941001 CS 26 Waste Bags 07435967001 BX 52

Estimated Value: $REDACTED

OFOC SOP Revision 10 Page 2 of 4 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

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

41 USC §3304(a)(1), as implemented by FAR 13.106-1(b)(2)

( X ) (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 13.106-1(b)(2) ( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (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):

Due to the nature of the requirement related to the current COVID-19 World-Wide pandemic, Roche Diagnostics Corporation is the only firm capable of providing the required reagents and supplies 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 with a lease/rental agreement under a separate molecular Cost-Per-Test contract. The 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 Diagnostic 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:

The requested SARS-CoV-2 reagents and controls have been acquired from Roche Diagnostics before. A redacted copy of the J&A for the previous acquisition was posted with the award notice on 6/8/2020. There has been no response from the notice.

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

Reasonable:

The Contracting Officer has anticipated the proposed prices will be fair and reasonable. The prices of the SARS-CoV-2 products will be compared to the prices on the previous contract and the prices of the other supplies will be compared to Roche’s National Acquisition Center (NAC) FSS price list.

OFOC SOP Revision 10 Page 3 of 4 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

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 Roche products. A search was conducted on GSA Advantage; the results of the search found that the SARS-CoV-2 products are not offered, however most of the other consumable supplies are offered on Roche’s NAC FSS contract (V797D-70105). A search of the Western States Network Consortium’s BPAs and contracts did not find the requested Roche products. A search of the VA’s 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. Lastly, a search using the SBA’s Dynamic Small Business Search (DSBS) tool did not identify a small business 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), provided 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 in contact with infected people so they too can be quickly treated.

The diagnostic use of 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: 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 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// 11/23/2020

REDACTED Date:

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

OFOC SOP Revision 10 Page 4 of 4 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

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// 11/23/2020

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// 11/23/2020

Date: REDACTED

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// 11/24/2020

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// 11/25/2020

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