JOFOC - FOUNDATION CARE.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Pursuant to the Federal Acquisition Regulation (FAR) 6.302-1(a)(2) and 6.302-1(b)(1)(i), and Federal Bureau of Prisons Acquisition Policy (BPAP) 6.304(a), the Federal Bureau of Prisons (BOP) has determined that the procurement of Iclusig (Posatinib) for the Federal Medical Center (FMC) and the Federal Prison Camp (FPC), hereinafter referred to as FMC Lexington, located in Lexington, KY, meets the criteria established for other than full and open competition. It is further determined that only one responsible source and no other supplies and/or services will satisfy agency requirements. Delays in award would result in serious injury, financial, or other liabilities to the government. This limitation on competition is justified as supported by the following information in accordance with FAR Part 6.303-2:

1. Agency:

Department of Justice Federal Bureau of Prisons Federal Medical Center 3301 Leestown Rd.

Lexington, KY 40511

2. Nature and/or Description of Action being Approved:

This action is for the acquisition of medication (Iclusig (Posatinib) 30MG tablets) for an inmate at FMC Lexington, located in Lexington, KY. The procurement of this medication is also urgent in nature in order to provide continuity of care to the inmate population.

The award will be issued to Foundation Care, LLC.

3. Description of Supplies or Services Required to Meet the Agency Needs:

As part of the mission of FMC Lexington, medication is provided to the inmate population. The facility is required to provide continued medications and to ensure the continuity of care, it is the best value to the government and this is the sole source for this particular medication. This medication is provided by this vendor and can be delivered timely. The medication supply will be procured by way of purchase order. The estimated total cost for each lot of medication is $17,310.55 (30mg), for a total award of $34,621.10.

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

This action is being procured under authority of 41 U.S.C. 253(c)(1) and implemented by FAR 6.302-1(b)(1)(i), Only one responsible source.

5. Determination that Proposed Contractor’s Unique Qualifications or the Nature of the Acquisition Requires Use of the Authority Cited:

The institution has a responsibility to provide necessary medical care to inmates incarcerated at this facility. Failure to procure the necessary products could result in neglect of the inmate’s needs, as well as, substantial liability risk to the government. This price is the best value to the government. Market research shows Foundation Care, LLC has been given sole distributor rights by the manufacturer of the drug, Takeda.

Specifically, there is a Federal Supply Schedule Contract with Millennium Pharmaceuticals for this supply. However, upon further research, it has been determined that Millennium does not accept medication orders directly from customers and requires all orders to be processed through their sole distributor, Foundation Care, LLC.

Millennium Pharmaceuticals is a wholly owned subsidiary of Takeda, the manufacturer of the drug Iclusig. Documentation from Takeda, as well as VA National Acquisitions has been obtained, equally stating that orders must be completed through Foundation Care, LLC. Any further delay in providing the medication to FMC Lexington would severely disrupt appropriate medical treatment and health risk to the inmate.

6. Efforts Made to Solicit from as Many Sources as Practicable Including Whether or

Not a Notice Was or Will be Publicized as Required by FAR Part 5.2:

The proposed contract action is for the purchase of Iclusig and only one source is available, which precludes competition to the maximum extent practicable. Delay of a contract award would result in serious injury, financial, or other, to the Government if the agency complies with the time periods specified in FAR 5.203. Therefore, due to the urgent nature of this procurement action, a synopsis notice was not required.

7. Contracting Officer’s Determination that the Cost to the Government Will be Fair and Reasonable:

The estimated total cost for each lot of medication is $17,310.55 (30mg). Prices have been analyzed by the Contracting Office with the assistance of the Pharmacist in order to determine the price is fair and reasonable. As previously stated, contract pricing does exist for this drug thru VA Contract 36F79718D0586, with Millennium Pharmaceuticals.

Due to the circumstances listed above, FMC Lexington is not able to use the contract vehicle that is currently in place. Communication from Takeda and Foundation Care, LLC, indicates that FMC Lexington will receive the FSS pricing that exists. Pursuant to FAR 15.404-1(b)(2)(ii), prices for these services are deemed fair and reasonable. The Contracting Officer will monitor pricing to ensure that it continues to satisfy this determination.

8. Description of the Market Survey Conducted:

Market research was conducted for the acquisition for potential providers and included the utilization of the GSA Advantage website and a general internet search. Market research for this action was limited due to availability of only one distributor of the product.

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

Not applicable. Please refer to section 5.

10. List of Sources, Expressing in Writing, Interest in the Acquisition:

There are no other sources available that would be able to provide the product in the timeframe required by the government.

11. Actions Taken by the Agency to Remove or Overcome Barriers to Competitions:

The acquisition of these supplies is necessary for continuity of care. If future requirements exist for this product, the Bureau will continue to monitor the market trends to seek competition or sources that may be able to meet the minimum needs of the government and its requirements. Should opportunities for competition arise in the future the Bureau will take appropriate action to ensure these services are competed.

12. Contracting Officer’s Certification:

In accordance with FAR 6.303-2(12), I hereby certify that this justification is accurate and complete to the best of my knowledge and belief. I further certify in accordance with BPAP 6.301, to the best of my knowledge and belief that this request is not the result of a lack of acquisition planning, or a desire to expend funds while those funds are still available.

Submitted by:

_______ 08/18/2021 Victor Crump, Supervisory Contract Specialist Date FMC Lexington

Nina Johnson-Whitenack, Pharmacist Date FMC Lexington