36C77623D0002 P00005_1.docx

SUBJECT*

Custom Packs VISNs 9,10,15,16,23

GENERAL INFORMATION

SOLICITATION NUMBER*

BASE NOTICE TYPE

Program Contracting Activity Central Supply 1 6100 Oak Tree Blvd, Suite 490 Independence OH 44131

POINT OF CONTACT*

Contract Specialist Sharif Ra El sharif.ra-el@va.gov 216-800-5076

AWARD INFORMATION

AWARDEE NAME*

CONTRACTOR’S UEI

MANUS MEDICAL, LLC

M4UBTVGBJMT7

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition

Acquisition Plan Action ID: 36C776-25-AP-0513 Contract: 36C77623D0002

1. Contracting Activity: Department of Veterans Affairs, Procurement Contracting Activity Central (PCAC), on behalf of the Veteran Integrated Services Networks (VISNs) 9, 10, 15, 16, and 23.

2. Nature and/or Description of the Action Being Processed: The Central Region (VISNs 9, 10, 15, 16, and 23) has an existing contract (36C77623D0002) for custom sterile procedure packs to support VA Medical Centers (VAMC) throughout the central region. The Government intends to increase the contract ceiling amount and extend the ordering period under this contract on a sole source basis by eight (8) months to Manus Medical, LLC located at 209 E 20th St, Cheyenne, WY 82001, which expires on March 31, 2025.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: VA needs to be able to procure custom sterile surgical packs until a new long-term contract can be awarded. Award is anticipated to be made within the next 8 months. The current contract (36C77623D0002) has a contract ceiling of $22,000,000 and will expire on March 31,2025, or sooner, if ceiling is reached.

It is the intent of the Government to continue to procure these packs from Manus Medical for a new period of April 1, 2025, through November 30, 2025. This extension will increase the contract ceiling by $16,000,000 making the new contract ceiling $38,000,000. The Central region (VISNs 9, 10, 15, 16, and 23) does not have the capabilities to procure or manufacture custom sterile procedure packs; therefore, at the expiration of the current contract, 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 for clinics and surgery services until a new contract is awarded.

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.

a. Manus Medical is the current contractor supplying custom sterile procedure packs. A solicitation for new long-term custom sterile procedure pack was issued on January 13, 2025 and is scheduled to close on March 31, 2025. Awarding a new contract would be a 4-8 month process due to the coordination with medical facilities on developing each custom sterile procedure pack bill of materials, first article testing, sample pack processing, and finalized pack(s) for delivery. Awarding a new contract with new custom packs and a new contractor would create a break in supply and associated services. Manus Medical, LLC is currently distributing custom sterile procedure packs for the Central region in its entirety under contract number 36C77623D0002 and is able to continue supplying custom packs with no break in service. Therefore, extending the current contract to will prevent a disruption in supply/services, as the incumbent already has the packs established and in production and inventory. 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. Their performance has been satisfactory. Furthermore, Manus Medical can provide the custom packs in its entirety immediately upon award without transitioning an estimated 312 packs.

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 government determined that it would need an eight (8) month extension to avoid a disruption of supply/service. Contract number 36C77623D0002 expires March 31, 2025, which would leave a gap in supply/services while a long-term solution is being solicited and awarded.

If this requirement was solicited and awarded to a new manufacturer, the overall process, from development to ordering would take 4-8 months. This would require all custom sterile procedure packs to be created and 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 and sterilizing the pack(s)

g) Distribution of packs.

Manus Medical, LLC is currently distributing custom sterile procedure packs for the Central region in its entirety under contract number 36C77623D0002. Therefore, an eight month extension of the current contract will prevent a disruption in supply/services, as Manus already has the packs established and in production and inventory. 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. Their performance has been satisfactory. Furthermore, Manus Medical can provide the custom packs in its entirety immediately upon award without transitioning an estimated 312 packs.

Awarding a contract to a different contractor would be irresponsible and unreasonable because there is a high chance that a new contractor would not be willing to go through all the necessary steps to provide packs for a short period of time. There is a strong likelihood that pricing would be unreasonably high due to the extensive amount of work and the short time frame, preventing a determination of fair and reasonable pricing. Therefore, the most advantageous option is to extend the current contract by eight months to support the Agency’s mission and to maintain its critical surgical sustaining supply.

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, 2025, through November 30, 2025. The government determined that it would need an extension to avoid a disruption of supply/services. Contract number 36C77623D0002 expires March 31, 2025, which would leave a gap in supply/services while a long-term solution is being solicited and awarded.

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 contract 36C77623D0002 where prices were determined to be fair and reasonable to assist in the determination that the pricing for this short-term extension will be fair and reasonable. The current contract has a ceiling of $22,000,000. The contract effective date in Schedule B.3 will be revised to April 1, 2025 through November 30, 2025. FAR Clause 52.216-18(a) will be revised to reflect the new ordering period as April 1, 2025 through November 30, 2025. FAR Clause 52.216-22(d) will be revised to reflect that the contractor shall not be required to accept any orders after November 30, 2025. Based upon the current monthly burn rate of $2 million, this extension will increase the contract ceiling by $16,000,000 making the new ceiling $38,000,000.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: It is essential to extend the current contract while the pending long-term solution is being solicited, awarded, and transitioned. The Contracting Officer conducted market research for the extension and confirmed that the commercial marketplace has not changed since the initial market research was conducted May 26, 2022 and updated in August 2024. Market research also confirmed that Manus Medical, LLC is the current distributor of custom sterile procedure packs. The government has determined no other contractor can satisfy the extension because it takes up to 120 days for the contractor to submit custom packs and the government’s approval of each custom pack to complete the transition period. Due to the timing of the current contract’s expiration date, the government does not have 120 days to approve a new contractor’s custom pack submittals.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The government has determined only one source can fulfill this urgent need for the continuation of custom sterile procedure packs without a disruption in services. No other contractor can satisfy this requirement due to the transition time of 120 days for a contractor to review custom pack components, receive government’s pack approval, order, assemble, sterilize, and deliver custom packs to VA facilities. Due to the timing of the current contract’s expiration date, the government does not have 120 days to approve a new contractor’s custom pack submittals.

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

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 follow-on 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 follow-on 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.

End of Document