Sole Source JA - Custom Procedure Packs Bridge - ALLSIGNED.pdf

Acquisition Plan Action 36C776-23-AP-0467 Custom Sterile Procedure Pack Emergency

Rev: 13 Effective Date: 02/01/22 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C776-23-AP-0467

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

Central (PCAC), on behalf of the Veteran Integrated System Networks (VISNs) 9, 10, 15, 16 and 23. It is the intent of the contracting activity to award a short-term single award IDIQ contract on a sole source 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, 15, 16, and 23) has an urgent and ongoing requirement for custom sterile procedure packs to support 28 VA Medical Centers (VAMC). The Government intends to award a short-term single award IDIQ sole source contract pursuant to FAR Part 6.302-1 Only One Responsible Source and no Other Supplies will Satisfy Agency Requirements. It is the intent of the government to award to Manus Medical, LLC located at 3420 Pump RD STE 348, Richmond, VA 23233, for the period of April 1, 2023, through March 31, 2024.

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

Custom sterile procedure packs are used in surgical and medical procedures and have a variety of different components sequenced, assembled, and sterilized to each individual provider’s specifications. Custom sterile procedure packs require the contractor to coordinate with medical facilities to develop each custom sterile procedure pack bill of materials, first article testing, sample pack processing, and finalized pack(s) for delivery. The process in its entirety can take an estimated 6-12 months. Current contract number 36C77621D0019 expires March 31, 2023, and the Central Region (VISNs 9, 10, 15, 16, and 23) does not have the capabilities to produce/manufacturer custom sterile procedure packs. Therefore, there will be an immediate need to continue receiving custom sterile procedure packs on a continual basis to prevent disruption of these critical healthcare supplies and services for clinics and surgery services.

The resulting contract shall be an Indefinite Delivery Indefinite Quantity (IDIQ) with an Independent Government Estimate of $16,556,265.60

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

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.

i. Avid Medical is the current manufacturer of custom sterile procedure packs and utilizing the manufacturer was considered. However, using the current manufacturer would require a transition time of 6-8 weeks which would create a break in supply and associated services. Since Manus Medical is the current contractor, there will be no disruption in supply as the distributor already has packs established. Manus Medical, LLC is currently distributing custom sterile procedure packs for the Central

Effective Date: 02/01/22 Page 2 of 5 region in its entirety under contract number 36C77621D0019. Furthermore, Manus Medical, LLC has the capability to distribute custom sterile procedure packs manufactured by Avid Medical. There is no other small business authorized distributor to distribute on behalf of Avid Medical. Manus Medical, LLC has relevant experience in providing custom sterile procedure packs and the associated services and has been doing so for the Central region since 2021. Furthermore, Manus Medical, LLC can provide Avid Medical custom sterile procedure packs in its entirety immediately upon award and without transitioning an estimated 900 packs.

ii. The Contracting Officer has determined that award will be made to Manus Medical, LLC at a fair and reasonable price. The Contracting Officer utilized the pricing under current contract number 36C77621D0019 as well as contract VA240C-16-D-0008 where prices were determined to be fair and reasonable, which assisted in the determination that the pricing for this short-term sole source contract is fair and reasonable.

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 to conduct market research via Industry Day presentations. The IPT discussed the importance of custom sterile procedure packs being customized to meet each facility’s needs. The IPT attempted to standardize custom sterile procedure packs, so that each facility would have the same packs containing the same components. This would have created consistency among all medical facilities. It was thought that if there was more standardization, facilities could use other facilities’ custom sterile procedure packs if there was an emergent need for specific packs. It was determined that standardization could not be achieved due to specialized components, drapes, and gowns that are specific to the physician. Industry Day participants discussed the option of utilizing Defense Logistics Agency’s (DLA) Electronic Cataloging system (ECAT) to add and order custom sterile procedures packs. It was determined that working with DLA was the best path forward. Therefore, the IPT team concluded that they would work with DLA contract holders to add custom sterile procedure packs to ECAT.

February 2020, the IPT chairs and PCAC Contracting Officers met with DLA Contracting Officers to discuss transitioning custom sterile procedure packs to ECAT. DLA stated that they would be able to transition VHA packs to ECAT by the expiration date of the current VHA contract.

September 2020, VHA was informed that DLA would not be able to meet the contract award and transition date of April 2021 but would be able to have an award in place by April 2022.

July 18, 2021, DLA informed VHA that the process for procuring custom sterile procedure packs and the ordering methods were outside the scope of ECAT contract vehicles. DLA concluded that it could not accommodate VHA’s requirement through DLA solicitation and ECAT contract vehicles.

The government determined that it would need a short-term contract to avoid disruption of supply/service. Contract number VA240C-16-D-0008 expired March 31, 2021, which would have left a gap in supply/services while a long-term solution was being solicited and

Effective Date: 02/01/22 Page 3 of 5 awarded. On February 16, 2021, solicitation number 36C77621R0021, in accordance with FAR 15-Contracting by Negotiation, was released on Beta Sam resulting in one (1) short-term single award IDIQ contract for VISNs 9, 10,15, 16 and 23 via contract number 36C77621D0019. The contract period for the contract is April 15, 2021 through March 31, 2023.

The purpose of the current short-term contract is to bridge the gap of supply/services until the long-term solution is awarded and transitioned. Since the solicitation, award and transition will not be complete prior to the expiration of short term contract number 36C77621D0019, another short-term contract is required to bridge the gap until the long term award has been made. Therefore, a sole source contract is paramount in avoiding disruption or interruption to the medical facilities. It is the intent of the Contracting Officer to solicit the long-term procurement action on SAM.gov Contract Opportunities on or around March 6, 2023.

If this requirement was solicited and awarded to a new manufacturer, the overall process from development to ordering would take 6-12 months. This would require all new custom sterile procedure packs to be processed for a short period of time until a long-term contract was awarded. The current process is as follows:

a) Selecting the instruments for the custom sterile procedure packs

b) Preparing and finalizing bill of materials for each custom sterile procedure pack

c) Working with each facility to determine how the pack will be assembled

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

e) Making any corrections and/or updates to the pack(s); including first article testing

f) Manufacturing of the pack(s)

g) Distribution of packs.

This approach would be irresponsible and unreasonable because there is a high chance that a manufacturer would not provide packs for a short period of time; if the manufacturer is willing to provide packs for this period, there is the strong likelihood that pricing would be so blatantly high that Government could not determine price fair and reasonable. Therefore, the most advantageous option is to sole-source to Manus Medical, LLC to support the Agency’s mission and to maintain its critical life sustaining supply.

It is the intent of the Government to award a sole source single award IDIQ contract to Manus Medical, LLC for the distribution of custom sterile procedure packs until the long-term contract is awarded and transitioned. The tentative period of performance for the sole source contract will be April 1, 2023 through March 31, 2024 or through transition for the upcoming long term contract, whichever comes first.

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

This justification relates solely to the need of providing custom sterile procedure packs for the ordering period of April 1, 2023, through March 31, 2024 (or through transition of the long-term solution, whichever comes first). The Contracting Officer is establishing a long-term solution, which will afford several potential sources to participate in the upcoming acquisition. Manus Medical, LLC is the only contractor authorized to distribute Avid Medical manufactured custom sterile procedure packs until the long-term contract is solicited, awarded, and transitioned.

Effective Date: 02/01/22 Page 4 of 5

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

The Contracting Officer utilized the pricing under the current short-term contract 36C77621D0019 and expired contract VA240C-16-D-0008, where prices were previously determined to be fair and reasonable to assist in the determination that the pricing for this short-term sole source contract will be fair and reasonable.

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

It is paramount to award a short-term sole source contract while the pending long-term solution is being solicited, awarded, and transitioned. The Contracting Officer conducted market research for the sole source procurement and confirmed that the commercial marketplace has not changed since the initial market research was conducted May 26, 2022.

Market research also confirmed that Manus Medical, LLC. is the only SDVOSB authorized distributor of Avid Medical custom sterile procedure packs; no other SDVOSB is an authorized distributor for Avid Medical custom sterile procedure packs or has the capability to satisfy the short-term sole source award.

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

N/A.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Manus Medical, LLC and Avid Medical, Inc.

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 Contracting Officer anticipates that the solicitation for the long-term contract will remove and overcome barriers to competition and will ensure that all interested parties will have the ability to compete for the upcoming long-term contract.

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.

Robin Collins Date Supervisory Supply Management

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.

DEBORAH

FORD

Digitally signed by

DEBORAH FORD

Date: 2023.02.17 13:09:48 -06'00'

Effective Date: 02/01/22 Page 5 of 5

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 ($750K to $75 million) for other than full and open competition.

Date

Terry L. Spitzmiller Executive Director Regional Procurement Office Central (VHA)

NICOLE

KUTSI

Digitally signed by

NICOLE KUTSI

Date: 2023.02.15 07:47:19 -06'00'

Jane A. Oney 338045

Digitally signed by Jane A. Oney 338045 Date: 2023.02.17 07:03:43 -05'00'