6515--CUSTOM PACKS BRIDGE EMERGENCY Mod to extend POP 12 months & raise ceiling $5M

CUSTOM STERILE PROCEDURE PACK EXTENSTION VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 01 Effective Date: 04/01/23 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C776-23-AP-2102 1. Contracting Activity: Department of Veterans Affairs (VA), Procurement Contracting Activity Central (PCAC), on behalf of the Veteran Integrated System Networks (VISNs) 9, 10, 12, 15, 16 and 23. 2. Nature and/or Description of the Action Being Processed: The Central region (VISNs 5, 9, 10, 12, 15, 16, and 23) has an existing contract (36C77623D0002) for custom sterile procedure packs to support 28 VA Medical Centers (VAMC) throughout the central region. The contract is with Manus Medical, LLC located at 3420 Pump RD STE 348, Richmond, VA 23233, which expires on March 31, 2024. The Government intends to increase the contract ceiling amount and extend the ordering period under this contract on a sole source basis by twelve months. 3. Description of Supplies/Services Required to Meet the Agency s Needs: Current Contract Number 36C77623D0002 was awarded on April 1, 2023, and will expire on March 31, 2024. It is the intent of the government to continue to procure these packs from Manus Medical for a new period of April 1, 2024 through March 31, 2025. This extension will increase the contract ceiling by $5,000,000.00 making the new contract ceiling $22,000,000.00. The Central region (VISNs 5, 9, 10, 12, 15, 16, and 23) does not have the capabilities to produce/manufacturer 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. 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 re-procurement process for custom sterile procedure packs in December 2019. At that time, it was VA s intention 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. However, during that acquisition, it became apparent that standardization could not be achieved because the various physicians enterprise-wide required specific specialized components, drapes, and gowns suited to their own needs, so the effort was halted. It was then hoped that VA could utilize Defense Logistics Agency s (DLA) Electronic Cataloging system (ECAT) to add and order custom sterile procedures packs. At that point, VA s contract for custom sterile procedure packs (Contract number VA240C-16-D-0008) with Avid Medical, Inc., was set to expire March 31, 2021, which would have left a gap in supply while a long-term solution was being solicited and awarded. In February 2021, a sole-sourced short-term single award IDIQ contract for VISNs 9, 10,12, 15, 16 and 23 (contract number 36C77621D0019) was awarded to Manus Medical, the contractor who had supplied the various customized packs under the previous long-term contract. The contract period of performance was April 15, 2021 through March 31, 2023. It was essential that the bridge contract be that long so that each facility in the region could identify specifically what needed to be contained in the packs they required, an acquisition package could be produced, and then, after award, a contractor had enough ramp-up time to customize all these various packs before ordering could begin. It was anticipated that a new long-term contract would be awarded before expiration of the bridge contract. However, in July 2021, DLA informed VHA that the process for procuring custom sterile procedure packs fell outside the scope of ECAT contract vehicles. In April 2023 a brand name sole source bridge contract 36C77623D0002 was awarded to Manus Medical, LLC as they are the current contractor and an authorized distributor of custom sterile procedure packs for Avid Medical. Because of the long lead time that is needed for customization of the packs if award of this short-term contract were made to any other company, Manus Medical as the incumbent contractor, was in a unique position to continue supplying the packs to VA until a new contract could be awarded and ordering can begin. While the long-term contract effort solicitation and subsequent proposals were in the evaluation stages of the procurement process the VA discovered a key piece of information during the evaluation phase of the process that revealed the prerequisite to set-aside this requirement was not fully accomplished. Therefore, the solicitation had to be cancelled, new market research needed to be conducted and a new set-aside decision needed to be made before a new solicitation could be published. It is anticipated that award and ordering under the new long-term contract under this effort will occur approximately one year from now. Due to the advanced lead time (240 days) needed, this would require all new custom sterile procedure packs to be processed for a brief period 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. Therefore, it is in the best interest of the Government to extend the ordering period to Manus Medical, LLC to support the Agency s mission and to maintain its critical life sustaining supply. Manus Medical as the incumbent contractor, is in a unique position to continue supplying the packs to VA for the additional twelve months until a new contract can be awarded, and ordering can resume. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought notice was posted to SAM.gov for 15 days. The notice included key characteristics of the requirements of the action and provided the opportunity for all responsible sources to submit a capability statement. There were no responses received from any vendors to this announcement. 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 $17,000,000.00. The contract effective date in Schedule B.3 will be revised to April 1, 2024 through March 31, 2025. FAR Clause 52.216-18(a) will be revised to reflect the new ordering period as April 1, 2024 through March 31, 2025. FAR Clause 52.216-22(d) will be revised to reflect that the contractor shall not be required to accept any orders after 3:00 PM local, March 31, 2025. Based upon the current burn rate of an approximate average of $956,929.11 per month, the obligated amount for the current contract will be approximately $11,483,149.34. This will add an additional (12) months to the ordering period and effective period. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Contracting Officer conducted limited market research for the sole source ordering period extension and confirmed that the commercial marketplace has not changed since the initial market research was conducted May 26, 2022. However, because of the 240-day lead time that will be needed for a new contractor to customize packs after contract award, no contractor would be qualified to perform under this short-term extension except the incumbent. 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: N/A 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 extending the ordering period to the current contract will provide the VA vital time to 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.