36C24820A0027-001.pdf

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

36C248-20-AP-2357 VISN 08 COVID-19 Immunoassay Cost Per Test (CPT)

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval {J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C248-20-AP-2357

1. Contracting Activity: Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 08, Laboratory Service, is seeking Coronavirus Disease 2019 (COVID-19) Immunoassay antibody testing supplies. 673-20-3-956-0141.

2. Nature and/or Description of the Action Being Processed: EMERGENCY COVID-19 immunoassay test supplies are needed for multiple sites in VISN 08. The action will be awarded as a Firm Fixed Price (FFP) single award Blanket Purchase Agreement (BPA) for one year. This will be a cost per test (CPT) BPA with estimated quantities for five sites in VISN 08.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for COVID-19 antibody test supplies 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: COVID-19 testing supplies includes SARS-CoV-2 lgG antibody assay /test kits, calibrators, and controls. The total estimated value of the one-year BPA is $1,651,190.00. Supplies estimated delivery is 1-day ARO (overnight shipping). Period of performance: Base year: 04/17/2020 and end 04/16/2021 estimated amount $1,651,190.00.

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

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per 41 USC §3304(a)(l) as implemented by FAR 6.302-1;

(X) (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;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-l(b)(2).

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 Coronavirus is a highly

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

36C248-20-AP-2357 VISN 08 COVID-19 Immunoassay Cost Per Test (CPT) infectious disease and can be easily transmitted to our VA population in VISN 08. There is an unusual and compelling urgent need for the VA to test for Coronavirus so that they can treat Coronavirus patients and determine patients who developed immunity to the virus. Due to limited stock availability in the industry, and the level of the virus threat, testing supplies are needed immediately. Reference VA memorandum dated 03-15-2020 Emergency Acquisition Flexibilities - Emergency Assistance Activities in support of Global Pandemic for Coronavirus Disease 2019

(COVID-19).

Abbott Laboratories is the only manufacturer and source to offer all SARS-CoV-2 immunoassay antibody testing to assist with emergency global pandemic response. Abbott is the original equipment manufacturer (OEM) of Architect IA i2000 and ilO00 analyzers currently leased by five sites in VISN 08 (546 - Miami, 516 - Bay Pines, 673 -Tampa (includes New Port Richey outpatient clinic), 548 - West Palm Beach, and 675 - Orlando). No remanufacturers or gray market items will be accepted. Delaying the EMERGENCY contract and order would have a negative impact on Veterans seeking Coronavirus treatment in response to Coronavirus crisis.

There are no other products in the marketplace that will be compatible with existing Architect analyzers. Only the Architect version of antibody testing is compatible with the Architect analyzers.

The use of another brand of antibody testing would produce inaccurate testing which could result in spread of the virus and additional loss of life in the veteran population. Competition will require the government to replace all immunoassay Architect analyzers which will create a substantial duplication of costs for replacement of equipment to the government that is not expected to be recovered thru competition and will create unacceptable delays for procurement of supplies.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Abbott Laboratories under NAICS code 325413 In-Vitro Diagnostic Substance Manufacturing, DUNS 127208879 is the only known source that can meet the emergency demand due to limited availability of COVID-19 testing supplies in industry. Abbott does not have any authorized SDVOSB/VOSB/SB distributors/resellers who can provide COVID-19 test supplies.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: A fixed price single award BPA with estimated quantities will be awarded. Abbott is the only vendor that can meet the emergency high priority repetitive need for COVID-19 testing supplies under FAR 6.302 and FAR support 18.1 and 18.2 as they apply to emergency for the direct purposes of responding to the COVID-19 National Emergency. The government will determine the proposed prices are fair and reasonable by comparing vendor quote to proposed prices found reasonable on previous purchases, and comparison with similar items in related industry.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Vetbiz search NAICS 325413 In-Vitro Diagnostic Substance Manufacturing produced 29 results. CO reviewed VIP database results in accordance with VAAR Class Deviation 810.001-70 to determine if there are two or more service-disabled veteran-owned businesses {SDVOSBs) and veteran-owned small businesses (VOSBs). All supplies needed are manufactured and sold directly through Abbott Laboratories. There are no SDVOSB/VOSB/SB authorized distributors for COVID-19 assay supplies that are compatible with existing Abbott Architect equipment. CO queried GSA ebuy, SAC, NAC, FSS contracts and items are not available

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

36C248-20-AP-2357 VISN 08 COVID-19 Immunoassay Cost Per Test (CPT) under mandatory contracts or GSA contacts. Queries were done in FPDS, eCMS, and Vista to research procurement history.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: COVID-19 test supplies must compatible with existing Architect i2000 and i1000 analyzers. There are five sites with existing Architect analyzer equipment currently under CPT contract with Abbott.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Abbott is the only source that expressed in writing, an interest, that can meet the unusual and compelling urgent need of the VA.

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: The Government will conduct a competitive Base and Four option year period acquisition in FY21.

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 inclu ed in the ·ustification, are accurate and complete to the best of my knowledge and belief.

04/17/2020 Date

Title: Manager Pathology and Lab Medicine Service West Palm Beach Medical Center

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 cornolete to the best of my knowledge and belief.

Dfg,taTiy s1gn'ed 6y CAMTLLt CAMILLE s. s. ALDERMAN 715551

ALDERMAN 715551 ~~'.~~7020.04.1112:26:34 04/17/2020

Name: Camille Alderman Date Title: Contracting Officer/VISN 08

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

04/17/2020 Name: Johnny Jones Date Commodities Product Line Supervisor Contracting Officer, VISN 8

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 recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

Name: Joseph P. Maletta VHA Head of Contracting Activity (HCA)

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

04/17/2020 Date