ATTACHMENT (4) Justification and Approval.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C776-21-AP-0503

1. Contracting Activity: The Department of Veterans Affairs, Procurement Contracting Activity

Central (PCAC), 212 3rd Avenue South, Minneapolis, MN 55401, on behalf of the Veteran Integrated System Networks (VISNs) 9, 10, 12, 15, 16 and 23. It is the intent of the contracting activity to contract on a brand name only basis. This document sets forth the justification and approval in accordance with FAR Part 6.302.

2. Nature and/or Description of the Action Being Processed: The Central Region (VISNs 9, 10, 12, 15, 16, and 23) have established an ongoing requirement for custom sterile procedure packs for an estimated 24 VA medical centers in accordance with FAR Part 6.302 and specifically 6.302-1 Only One Responsible Source and No Other Supplies and Services will Satisfy Agency Requirements. This is a request for a brand name only for the procurement of custom sterile procedure packs and associated services for the period of April 1, 2021 through March 31, 2023.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: VA medical facilities require custom sterile procedure packs that are unique to each facility for surgical and minor procedures. These packs are a combination of sterilized products packaged together and ready for use when they arrive at the facility. The current contract is set to expire as of March 31, 2021 and the medical centers do not have the capabilities to manufacturer and supply custom sterile procedure packs on their own, therefore there will be an immeditate need to continue to receive custom sterile procedure packs with limited disruption to the supply for surgeries and minor medical procedures.

The resulting contracting shall be awarded as an Indefinite Delivery Indefinite Quantity (IDIQ) contract with a base period of April 1, 2021 through March 31, 2023. The Independent Government Estimate (IGE) for this requirement is $19,510,156.41.

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

( 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 6.302-1;

( ) (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): VHA started the procurement process for custom sterile procedure packs in September 2019. In December 2019, the Integrated Product Team (IPT) gathered in person to conduct market research via Industry Day presentations as well as conversations to discuss a path forward. Industry Day participants discussed the option of utilizing Defense Logistics Agency’s (DLA) Electronic Cataloging system (ECAT) to add and order custom sterile procedure packs. The IPT team concluded that they would work with DLA to establish a contract to order custom sterile procedure packs from ECAT.

February of 2020, DLA confirmed that they would be able to establish contracts and an ordering vehicle for VHA to order custom sterile procedure packs. VHA was notified in September of 2020 that DLA would not be able to have a contract in place by April of 2021 and that they would have a contract in place by April of 2022. While DLA works to put a contract vehicle in place, a contract is required to bridge the gap of supply and services temporarily. This gap is not due to a lack of VHA planning but as a result of the current acquisition strategy being delayed which will create a substantial interruption for medical procedures for our veterans. The process for developing new packs takes 6-12 months and the current contract ends March 31, 2021. A new contract with DLA will take approximately one (1) year to award with a transition period of up to one (1) year if awarded to a new contractor, therefore a new contract is not feasible.

The current of process for developing custom sterile procedure pack(s) include:

a) Selecting the instruments for the custom sterile procedure packs

b) Working with each facility to determine how the pack will be built

c) Developing and reviewing each sample pack with the medical center

d) Making any corrections and/or updates to the pack(s)

e) Manufacturing of the pack(s)

Custom sterile procedure packs contain specialized items and customized layouts for each facility.

Part numbers for the current custom sterile procedure packs are proprietary to Avid Medical and can only be utilized by Avid Medical and/or their authorized distributor.

It is most advantageous to the Government to continue to utilize custom sterile procedure packs from the current contract while a long term solution is being established. Without a bridge contract the VA will not have the custom sterile procedure packs that are required to meet the needs of the facilities and physicians to care for veteran patients. The VA is trying to minimize the impact on our physicians and facilities by creating a bridge contract and keeping the same packs without any changes.

Therefore, it is the intent of the Government to solicit a brand name only requirement for the custom sterile procedure packs currently being utilized to ensure minimal disruption to physicians and facilities until the long term contract is awarded by DLA in 2022.

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

The contracting officer conducted market research via conference calls to determine if there were enough potential sources to compete this requirement. The market research dictates that there are two

(2) contractors (Avid Medical, Inc, a Large Business and their authorized distributor Manus Medical, LLC, an SDVOSB) who have the capabilities to provide the brand name custom sterile procedure packs to the medical facilities throughout the Central region. The authorized distributor does not manufacture custom sterile procedure packs, but does have the required certifications and agreements necessary to distribute the packs to each medical facility.

The contracting officer confirmed with Avid Medical that the Geo-Med, LLC, an SDVOSB distributor of custom sterile procedure packs, is not an authorized distributor of their packs, therefore they are not able to meet the requirement of distributing brand name packs for Avid Medical.

The contracting officer confirmed with Avid Medical that the Veterans Healthcare Supply Solutions (VHSS), an SDVOSB distributor of custom sterile procedure packs, is not an authorized distributor of their packs, therefore they are not able to meet the requirement of distributing brand name packs for Avid Medical.

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

Reasonable: The Contracting Officer anticipates that there will be competition for this requirement and that award can be made a a fair and reasonable price that offers the best value to the Government.

The contracting officer may also utilize current contract number VA240C-16-D-0008 and other procurements for custom sterile procedure packs where price fair and reasonableness were already established to assist in the determination of fair and reasonable pricing.

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

Market research was conducted via conference call with Avid Medical, Inc to determine if Avid Medical had SDVOSB and/or small business authorized distributors who had the capability to distribute brand name custom sterile procedure packs. Avid confirmed they have one (1) authorized distributor (Manus Medical, LLC-an SDVSOB) who has the authority to distribute custom sterile procedure packs.

The Contracting Officer conducted further market research via conference call with Manus Medical to determine their capabilities for providing custom sterile procedure packs for the Central region.

Manus confirmed that they do have the capability and capacity to provide distribution of Avid Medical Packs if awarded a bridge contract.

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

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

Avid Medical, Manus Medical, Medline, Geo-Med, Cardinal, and VHSS.

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 on an ongoing basis to take advantage to the maximum extent practicable to identify additional manufacturers and/or distributors available in the market place if the VHA contracts this requirement for custom sterile procedure packs in the future.

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.

Lynda Frey 11/25/2020 Robin R. Collins 11/25/2020

Lynda Frey Robin R. Collins Supervisory, Supply Management Specialist Supervisory, Supply Management Specialist

VISN 15 VISN 15

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.

Nicole C. Kutsi 3329032

Digitally signed by Nicole C.

Kutsi 3329032 Date: 2020.12.15 15:13:59 -06'00'

Nicole Kutsi Date Contracting Officer Program Contracting Activity Central

b. DoC RPO Review and Approval: I certify the justification meets requirements for other than full and open competition.

Richard Dahmen Date Director of Contracting

Program Contracting Activity Central

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.

Date

Terry Spitzmiller Executive Director

Regional Procurement Office Central

Richard C. Dahmen 199197 Digitally signed by Richard C. Dahmen 199197 Date: 2020.12.16 10:01:27 -05'00'

12/16/2020

TERRY L.

SPITZMILLER

394683

Digitally signed by TERRY

L. SPITZMILLER 394683

Date: 2020.12.16 17:17:15 -06'00'