36C77019D0009-002.pdf

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

OFOC SOP Revision 08 Page 1 of 4 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

PHARMACEUTICAL REPACKER SERVICES

Acquisition Plan Action ID: 36C770-19-AP-0372

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 15, Consolidated Mail Outpatient Pharmacy (CMOP) Acquisition.

2. Nature and/or Description of the Action Being Processed: The Consolidated Mail Outpatient Pharmacy (CMOP) intends to enter into a short-term, sole source, bridge contract with Aphena Pharma Solutions LLC. Aphena has the necessary resources to accomplish the repacking functions for all the CMOPs. The purpose of this contract is to provide the National CMOP Program the ability to receive repackaged pharmaceuticals from a FDA-licensed repacker/distributor (contractor) of oral, solid pharmaceuticals. A bridge contract is required to maintain services during the pre-award phase of the new contract. A bridge contract is needed for a base of six (6) months with four (4) three-month options to support the CMOPs until a new 5-year contract is awarded and implemented. This procurement will be a firm-fixed price sole source contract to the incumbent contractor, Aphena Pharma Solutions LLC.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The CMOP Program requires a contractor to serve as a unit-of-use repacker and distributor for pharmaceuticals needed by VA patients. Under the program, CMOP will purchase the pharmaceuticals to be repacked and provide to the repacker for processing. The ordering CMOP facility will provide instructions for repacking of the product into various bottle sizes. The contractor will repack and ship repacked pharmaceuticals FOB Destination to the ordering CMOP, with receipt within ten (10) calendar days, on an as-needed basis. The cost of handling and shipping of orders is a component of the contractor's pricing. Currently, CMOP orders approximately seventeen million (17M) bottles per year on average, using various bottle sizes, to be repacked to meet the needs of CMOP. Failure to provide a bridge contract will result in impending serious delays of needed product delivery to our veterans and will place extreme burden on the individual CMOP's in order to provide these services. The proposed short-term sole source contracting action is for a Firm-Fixed Price contract for a base period of six (6) months from May 1, 2019 to October 31, 2019. The four (3) three-month options will be as follows November 1, 2019 to January 31, 2020, February 1, 2020 to April 30, 2020, May 1, 2020 to July 31, 2020 and August 1, 2020 to October 31, 2020. The estimated value of the sole source bridge contract, if all options are exercised, for this time frame is estimated at $30,006,477.00.

4. Statutory Authority Permitting Other than Full and Open Competition: This document sets forth the justification and approval for other than full and open competition for the acquisition described herein, under the authority of FAR 6.302-1 "Only One Responsible Source". The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(2) . The current contract will expire April 30, 2019 and it is imperative that we keep a contract in place or millions of Veterans will

OFOC SOP Revision 08 Page 2 of 4

Revision 08 Date: 04/18/2018 be without their medications. The CMOP facilities must have continued pharmaceutical repacking services without disruption to ensure Veteran patients receive critical medications. Failure to award this bridge contract will endanger Veteran patient health.

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 existing contract for these services expires on April 30, 2019. The agency worked diligently toward getting a long term contract in place prior to the expiration of the existing contract and was previously on target to have a new contract prior to that expiration. However, due to the unforeseen need for multiple reviews and changes in contracting personnel, the long term contract has not yet been awarded. The long term contract is currently in the pre-award review phase (proposals have been received and evaluated;

the award decision is being finalized). Because this contract is essential for getting critical medications to Veteran patients, interruption in services would endanger Veteran patient health and therefore seriously compromise the agency’s mission to care for Veterans. The incumbent contractor would be able to successfully perform these services without interruption. Aphena already has the requisite Drug Supply Chain Security Act licenses and quarantine area. The awarding of a short-term sole source bridge contract will ensure continuity in services and facilitate the agency’s efforts to move to a successor, long-term contract vehicle.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Due to the critical need for continuity of service to continue this requirement (existing contract expires April 30, 2019) the contracting officer does not have the time to solicit and compete this short term acquisition. Moreover, given the time needed to obtain necessary licenses and FDA approval, were the VA to attempt to solicit multiple offers, only the incumbent would have the requsite resources and licenses to begin providing services by the time that the existing contract expires. Therefore, the only source considered for this short term procurement is the incumbent.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The previous solicitation was competed and pricing received was determined fair and reasonable by comparison of offerors’ prices received. The incumbent will honor the current pricing for the base period of 6 months. The pricing for the option periods will increase to the base year of the quote provided on the RFP for the new contract. The option price is the lowest obtainable or the most advantageous offer, taking into account factors such as market stability and the usual duration of contracts such as this. Also, the pricing was evaluated against a current NAC contract price schedule VA797P-17-C-0025 with pricing being approximately five percent higher but was determined to 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: This is a sole source bridge contract to the current contractor, Aphena Pharma Solutions LLC, who already has the current FDA and DSCSA required licenses. It is not feasible to award to a different contractor as they would not be ready to start work by 5/01/2019 as FDA and DSCSA licenses require a lengthy process.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: A solicitation was posted on FBO for a long-term contract and offers were received. The main concern is to have a bridge contract in place while contracting is finishing the required pre-award reviews to award a contract. The current contractor, Aphena Pharma Solutions LLC already has the current FDA and

OFOC SOP Revision 08 Page 3 of 4

Revision 08 Date: 04/18/2018

DSCSA required licenses. Awarding on a competitive basis would not be feasible as a repacker company would not be ready to start work by 5/01/2019 as the FDA and DSCSA licensing is a lengthy process (i.e. 60 days minimum).

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: This is a sole source bridge contract. No other sources were contacted.

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: A competitive solicitation on RFP VA770-17-R-0417 was posted to FBO.gov with full and open competition is currently being reviewed and is anticipated to be awarded within the next six months.

A long-term contract cannot be awarded by 5/01/2019 therefore; a bridge/interim contract is needed with the incumbent contractor to ensure continutity of services.

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.

Peter J. Carbrey Date National CMOP Logistics Manager

PETER J CARBREY

168392

Digitally signed by PETER J

CARBREY 168392

Date: 2019.03.18 10:41:23 -05'00'

OFOC SOP Revision 08 Page 4 of 4

Revision 08 Date: 04/18/2018

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.

Penny J. Capps Date Supervisory Contract Specialist Network Contracting Office 15 CMOP Acquisitions

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.

James D. Justus Date Division Chief

CMOP Acquisitions

Scott R. Fiscus Date Director of Contracting

c. VHA SAO 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 beliefe and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competion.

Mr. Randy L. Hays Date Acting Executive Director, SAO Central SAO Central Head of Contracting Activity

PENNY J CAPPS 492179

Digitally signed by PENNY J CAPPS 492179 Date: 2019.03.18 12:23:29 -05'00'

James D. Justus 1030208 Digitally signed by James D. Justus 1030208 Date: 2019.03.18 15:25:26 -05'00'

SCOTT R FISCUS 381888 Digitally signed by SCOTT R FISCUS 381888 Date: 2019.03.18 16:17:31 -05'00'

Randy L. Hays 534204 Digitally signed by Randy L. Hays 534204 Date: 2019.04.08 15:17:13 -07'00'