A02 Redacted JA Brooks Life Sciences.docx 21 September 2021.pdf v2.pdf

Control Number: JA 21 08-00387 CUI

CUI

(Source Selection information - See FAR 2.101 and 3.104-4)

Title: Date Reviewed: 24 August 2021

Sole Source Justification and Approval Review Document Under FAR 13.501

Program/Equipment: Onsite Defragmentation of Government Owned Biospecimen/biosample Collections, Diagnostics and Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army Institute of Research

(WRAIR)

Authority: "41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items” Amount: $1,220,100.00

Title: Date:

E-mail:

Contracting Officer:

Typed Name:

Date Reviewed: 13 August 2021 E-Mail: l

Technical Representative:

Requirements Representative:

Typed Name: l

-04'00'

Title: Date Reviewed: 24 August 2021 mailto:Sheila.a.peel.civ@mail.mil mailto:laura.a.tomitz.civ@mail.mil

(Source Selection Information - See FAR 2.101 and 3.104-

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Onsite Defragmentation of Government Owned Biospecimen/biosample Collections, Diagnostics and Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army

Institute of Research (WRAIR) Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel

Date

Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army

Institute of Research (WRAIR)

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Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: The Contracting Activity is the United States Army Medical Research Acquisition Activity (USAMRAA). The Requiring Activity is the Walter Reed Army Institute of Research (WRAIR).

2. Description of Action: The DCB, WRAIR requires a new firm, fixed price award for the onsite consolidation and defragging of government owned biospecimen collections. The Government projects award mid-September 2021. This requirement is currently on the Unfunded List as an expense item. Operations and Maintenance funds will be used for the contract. PR number 11682080 in the amount of $ 5000 shall be used to initiate this requirement. Additional funds are expected imminently.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

This requirement is expected not to exceed a 12-month duration, valued at approximately $850,000.00. The Federal Acquisition Regulation clause 52.217-8, Option to Extend Services, is added as a USAMRAA best practice and makes the total value of this requirement approximately $1,220,100.00 for one 12- month and one optional 6-month period of performance.

3. Description of Supplies/Services: The Contractor shall provide onsite services to perform comprehensive inventory, consolidation/defragmentation, and audit of the U.S.

government biospecimen collections housed within liquid nitrogen freezers. The contractor shall consolidate biospecimen aliquots, update freezer inventories, and conduct audits to ensure integrity of work completed; and provide validated Standard operating procedures (SOPs) for defragmentation/consolidation, inventory methods, and audits of the government collection of approximately 511K to 682Ktotalaliquots.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items".

5. Reason for Authority Cited: Based on processes validated by Brooks Life Sciences as part of a pilot project under cooperative agreement, W81XWH1820040, Henry M.

Jackson Foundation. Brooks Life Sciences is the only company that can provide immediate execution of timely and effective real time services to generate the urgently required archival storage space for biospecimens from pending high priority U.S.

Military countermeasure efforts (clinical trials) without the need and cost of moving to a larger facility.

Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army Institute of Research (WRAIR)

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Biospecimens have continuously been added to and/or retrieved from the collection throughout its 30 year history without consolidation/defragmentation of any freezer to reclaim critical, sequential, archival storage space. The facility has run out of space for additional freezer units; it urgently requires compression of current biospecimen collection to provide room for specimens acquired through pending clinical trials.

Brooks Life Sciences can immediately provide (1) on-site defragmentation services, 2) trained personnel; 3) validated and deploy effective, time efficient processes for real time decisions for retention, cull, or destruction of biospecimen collections; and 4) validated proprietary, standard operating procedures (SOPs) executed under rigorous Biorepository industry standards of(College of American Pathologist (CAP) BioRepository Accreditation; National Quality Assurance (NQA) Global Assurance Certificate [ISO 9001:2015]); and, under 21 Codification of Federal Regulations (CFR) 11, 32 CFR 219 which govern biorepository standards and privacy laws related to human specimens.

The USG biospecimen collection dates to 1989, contains over 2.1 million specimens in 38 liquid nitrogen (LN2) freezers and 31 mechanical freezer. Biospecimen collections are highly diverse containing biospecimens obtained through (1) Institutional Review Board approved clinical research trials / studies of Present & Emerging (P&E) pathogens of U.S. Military and US National interest, e.g. Phase I, first in human, Phase II/III HIV, Ebola, MERs-CoV, Zika, Yellow Fever, and SARS- CoV-2; (2) surveillance studies; (3) HIV force-wide testing; clinical trials sponsored by public/private partnerships; and transshipments from WRAIR’s outside the continental US clinical trial sites. The biospecimen collection is constantly in a dynamic state of flux through the receipt, processing, storage, and/or transshipment of individual biospecimens to and from both US and global collaborators on an ongoing bases. Due to the daily, prospective addition and removal of biospecimens and the fact that some biospecimens contain Personal Health Information (PHI) covered under 21 CFR 11 regulation and Privacy laws, defragmentation/compression services must be conducted on site by the vendor.

Competing this requirement and changing to a new contractor would negate the benefits gained from the 5-month pilot project which has resulted in the immediate, timely and efficient capacity for decisions to retain, cull, or destroy biospecimens; gain urgently required space for pending clinical trials. A new contractor must restart all phases of the required services: assessment of the collection, design phase for defragmentation/compression, contractor training, validation and implementation of standard operating procedures for defragmentation, inventory, and audit processes.

This would be costly in terms of time and efficiency. The current 5-month project is valued at approximately $353,000.

Onsite Defragmentation of Government Owned Biospecimen/biosample Collections, Diagnostics and Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed

Army Institute of Research (WRAIR)

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6. Efforts to Obtain Competition: A Notice of Intent to Sole Source was posted 4 August 2021 and closed with no response.

a. Effective competition. Competition for these services are highly unlikely as Brooks Life Sciences is the only company that can immediately provide this service on site without costly delays in time and efficiencies. On site defragmentation services are required as: 1) this is an active collection participating in on-going research efforts;

and 2) the collection must be maintained in a way that does not compromise CFR regulations or privacy laws.

b. Subcontracting competition. Subcontracting is unlikely as the contractor performs highly specialized services requiring training to rigorous standards. Should any subcontracting opportunities arise, the COR, the Contracting Officer and the contractor will assess at that point.

7. Actions to Increase Competition: This requirement is for a one-time contract. It will not be an enduring need.

8. Market Research: An internet search indicates that the biobanking industry has undergone consolidation with two large commercial entities remaining. The great majority of the services offered are commercial entities providing repository services for archival storage of biospecimens, biospecimen laboratory processing, biospecimen transport logistics, or sale of biospecimens, but not for defragmentation, compression, and inventory consolidation efforts.

Only two potential commercial vendors are available, Brooks Life Sciences and Fisher Bioservices. Fisher does not advertise defragmentation, consolidation, or inventory at customer’s institution. The other, Brooks, offers capacity for immediate, timely, efficient on site repository assessments, defragmentation, consolidation, reconciliation, and inventory management services at a customer’s location.

9. Interested Sources:

On 4 August 2021, a Notice of Intent to Sole Source was posted in BetaSAM. As of closing due date of 3 August 2021, no responses were received from the industry.

On 15 August 2021, Contract Specialist posted a Sources Sought in BetaSAM.

Two (2) Capability Statements were received as a result of the SourcesSought.

The Contracting Officer’s Representative conducted an assessment of the two (2) Capability Statements received by Tatra Solutions and Fisher Bioservices. Tatra Solutions was found unacceptable due to no discernable experience or capability to conduct the requested defragmentation services. Fisher Bioservices was found to be capable of providing the service. However, Fisher would have to conduct an assessment, develop a defragmentation plan, train their personnel, develop

Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army Institute of Research (WRAIR) standard operating procedures which would seriously negate the forward momentum of the current 5-month effort. Fisher would not be able to simply hire the current employees of Brooks Life Sciences as this is a 12-month project.

Current Brooks employees would not chose to leave their current employment for a 12-month project.

Fisher would not be able to simply assume the Brooks defragmentation plan and continue performance as the plan was developed by Brooks as part of their assessment of the total project, employing trained personnel who are also trained in the auditing of the Brooks plan. The government would lose the lessons learned over the 5-month project to include the training time, the labor, and the expended funds of $353k.

10. Other Facts:

a. Procurement history.

(1) W81XWH1820040, part of Henry M. Jackson Foundation cooperativeagreement, $353,000.

(2) The competitive status of these actions. Not applicable for the subcontractedneed for Brooks Life Sciences

(3) Authority previously cited if less than full and open competition was used. Not applicable

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. Not applicable.

b. Other facts.

The DCB collection is an active, regulated collection which has been acquired through IRB approved and US Army/Pharmaceutic Sponsored FDA Phase I,II, and/or III clinical trials, surveillance studies, and HIV force wide testing efforts with constant specimen retrievals for transshipment to collaborators/collaborating institutions. Freezers cannot be shipped off site for services sought.

(Source Selection Information - See FAR 2.101 and 3.104-4)

Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army Institute of Research (WRAIR)

11. Technical 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.

12. 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.

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. The award shall be a firm fixed price award using market research and the previous pilot award to determine fair and reasonable pricing.

14. Contracting Officer Certification:

(Source Selection Information - See FAR 2.101 and 3.104-4)

Typed Name:

Typed Name: Title:

Signature:

Typed Name: Title: Contracting Officer

I certify that this justification is accurate and complete to the best of my knowledge and belief. Digitally signed by

Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army Institute of Research (WRAIR)

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Title: Contracting Officer Signature:

On Site Defragmentation of Government Owned Biospecimen/biosample Collections, Diagnostics and Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army Institute of Research (WRAIR)

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Approval

Based on the foregoing justification, I hereby approve the procurement of defragging of government specimens onsite services to perform comprehensive inventory, consolidation/defragmentation, and audit of the U.S. government biospecimen/biosample collections on an other than full and open competition basis pursuant to the authority of 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items", subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Typed Name: Title: Command Advocate for Competition

Signature: Date: