JA_23-RHCO-C-422- Redacted.pdf

PDF 189 KB Posted

Attached to
Bone Marrow Donor Services Federal contract opportunity
Solicitation number
W81K00
Issued by
Department of the Army Medical Command

About this file

This memorandum documents a sole source justification for a bone marrow transplant requirement. The National Marrow Donor Program will provide bone marrow, stem cells, or cord blood units for a patient diagnosed with aplastic anemia requiring immediate treatment at Brooke Army Medical Center. The estimated value of the purchase order is redacted. Due to the patient's declining condition, treatment must commence as soon as possible. The National Marrow Donor Program is cited as the only source that can fulfill this urgent requirement through its global donor registries and established processes for safely transporting cell products.

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Text version

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Medical Readiness Contracting Office-West

3551 Roger Brooke Drive, BLDG 1103 Joint Base San Antonio — Fort Sam Houston, TX 78234.

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order W81K00-23-P-0175

Pricing/Contract Type: Fixed Price

Funds: Operations & Maintenance, Army (OMA) Other Funds: DHP FY: 23_

Name of Proposed Contractor(s) and Address:

National Marrow Donor Program

500 N 5th St.

Minneapolis, MN 55401-1206 Phone: 612-617-8367

Brand Name Buy: Yes No

3. Description of Services or Supplies: The Government’s requirement is to is for an urgent sole source acquisition with the National Marrow Donor Program for a requirement requiring a bone marrow, stem cells or cord blood units transplants for patient who was diagnosed with Aplastic Anemia and requiring bone marrow transplant. Patient is currently receiving treatment at the Zachary and Elizabeth M. Fisher Bone Marrow Transplant Program at Brooke Army Medical Center. A bone marrow transplant represents the only potential curative therapy for this patient. The purchase order shall not exceed .

Delaying the search for donors may allow further progression of patient's disease and have significant negative impact on the outcome in this case.

NOTE: Due to the urgent nature of this requirement, the Contracting Officer gave authorization to the contractor to proceed with commencing services

Period of Performance: 28 June 2023 to 30 September 2023: Value:

4. Authority:

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

Or

FAR 8.405-6(a)(1)(i)(B) and 8.405-6(b)(1) Brand Name FAR 8.405-6(a)(1)(i)(A) Urgency FAR 8.405-6(a)(1)(i)(B) Only One Source is Capable FAR 8.405-6(a)(1)(i)(C) Logical Follow-on

Or

FAR 16.505(b)(2)(i)(B) Only One Awardee is Capable FAR 16.505(a)(4) Brand Name FAR 16.505(b)(2)(i)(A) Urgency FAR 16.505(b)(2)(i)(C) Logical Follow-on FAR 16.505(b)(2)(i)(D) Minimum Guarantee

5. Reasons for Authority Cited:

Due to patient declining condition, it is imperative that the treatment commence as soon as possible. The National Marrow Donor Program (NMDP) is the only source reasonably available due to access to donor and cord blood registries and banks throughout the world.

The NMDP registry includes more than 50,000 cord blood units and 10 million potential donors. Through their connections with other national registries, the NMDP can access more than 20.5 million potential donors worldwide. They are the largest registry of cord blood in the United States and report a 95% success rate in matching patients to cord blood donors.

They report the average likelihood of finding a potential donor of stem cells at least 86% of the time. In addition to maintaining the registry, they ensure safe transport of cell products by using trained, experienced certified couriers. Delaying the search will allow further progression of the patient's diagnosis and will have a negative impact on patient's health.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, apply and will be followed, or do not apply due to an exception at 5.202 (2) .

Requirement to post justification in accordance with FAR 16.505(a)(4)(iii)(A)

Action is NOT a brand name restriction and is under SAT, no posting required Action is a brand name restriction, under $25K, no posting required

Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

FAR 6.305(f) FAR 8.405-6(b)(3)(iii)(A) FAR 8.405-6(b)(3)(iii)(B) FAR 8.405-6(b)(3)(iii)(C) FAR 16.505(a)(4)(iii(C)

7. Market Research: Research was done by using public search engines such as Google and Bing. The search was done by using key words "Bone Marrow" and the majority of results found were for the National Marrow Donor Program. A Dynamic Small Business Search was also conducted using key words "bone and marrow" and "transplant" with NAICS code 621991, Blood and Organ Banks; the results found do not indicate the capability to fulfill the Government's requirements. Upon final approvals, this J&A will be posted to https://beta.sam.gov, the Government Point of Entry.

8. Other Facts: The government will continue to monitor the market for additional sources, but at this time there is only one source that can provide these services due to having access to over 20 million donors with the possibility of success in finding a match. Past requirements of this nature have been solicited and posted on Government point of entry without obtaining responses from industry. The government will continue to seek new resources that will satisfy this requirement through continued market research to determine if there are new technologies and companies that can provide these services.

9. Technical/Requirements Certification: I certify 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.

Typed Name:

Title: Contracting Officer Representative

Signature:

10. Supervisor Certification: I certify 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.

Title: Lead, Contract Management Branch

11. Contracting Officer Certification/Approval: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. Historical procurement data from similar contracts and market research will be used to determine that the price is fair and reasonable. Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government.

Additionally, I approve this justification to limit competition subject to the availability of fund and provided that the services or supplies herein described have otherwise been authorized for acquisition.

File details come from the government source that posted it. Updated .