A_03__REDACTED___J&A_SPECIMEN_SHIPPING.pdf

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Justification and Approval for Other Than Full and

Open Competition

1. Contracting Activity:

U.S Army Medical Research Acquisition Activity (USAMRAA) 820 Chandler Street Fort Detrick, MD 21702 Contracting Officer:

Requiring Activity: WRAIR HDRL

2. Description of Action:

Approval is being requested for one (1) 3-month bridge extension period and three (3) one (1) month bridge extension periods under FAR Clause 52.217-8 Option to Extend Services as a sole source, Firm Fixed Price award, non-personnel HIV specimen shipping support contract to Path-tec Inc., in support of the clinical diagnostic mission of HDRL. The resulting modification to W81XWH-15-P-0170, six (6) months total, with all periods included, is valued at $529,694.71. The bridge will be funded with FY 18 O&M funds. Award must be in place with an effective date of May 11, 2018.

3. Description of Supplies/Services:

The Contractor shall ship HIV Specimens and medical consumables globally for acquisition and routing of specimens to WRAIR for HIV testing. The contractor shall provide:

• Shipping of Biosafety Level 2 (BSL2) specimens in accordance with applicable Code of Federal Regulations (CFR) and International Air Transport Association (IATA) regulations

• Cold chain management through temperature controlled shipping services in accordance with IATA regulations

• Management of shipping material

• Shipment and tracking of material and specimens

• Electronic inventory management of medical consumables at each site, including alerts when inventory is low

• Shipping and management of specimens in accordance with Protected Health

Information (PHI), Personally Identifiable Information (PII), and Health Insurance Portability and Accountability Act (HIPAA) regulations and requirements

• Shipping Logistics and Assistance Customer Support line

4. Authority Cited:

The statutory authority permitting other than full and open competition is U.S.C. 2304 (c)(1), as implemented in FAR 6.302-1 (a)(2) iii, Only one responsible source and no other supplies

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or services will satisfy agency requirements.

5. Reason for Authority Cited:

a) The HDRL must have a contract to maintain DoD mission essential work supporting:

• accessioning HIV-uninfected candidates for US military services;

• ensuring surveillance, identification, monitoring of HIV infection within the Force

(initial and confirmatory testing) ensuring an HIV-free blood supply in battlefield, and in support of operational medicine;

The specimen shipping services are currently being performed by Path-tec. No other contractor can perform the requirements of this award at the level and quality necessary without a break in service and without causing a degradation of the DoD mission. A new contractor would require a substantial learning curve to ramp up services and adhere to specific regulations and laws in shipping BSL2 specimens domestically and internationally.

HDRL receives, through Path-tec shipping support, specimens necessary to perform clinical testing and diagnostics using non-commercial assays for detection of HIV and other infectious pathogens of US Military and US National interest. This is DoD mission essential work that cannot stop. Specifically, the specimens and materials shipped by Path-tec provide a critical role in providing HIV clinical diagnostic, and clinical and therapeutic monitoring as well as clinical research and public health practice services to:

• Mission essential tasks HIV clinical screening /diagnosis (initial and confirmatory) clinical monitoring for HIV and other infections (viral burden) and HIV clinical resistance genotype testing to inform patient antiretroviral drug treatment, for HIV and related diseases for Soldiers (and their beneficiaries);

• HIV clinical laboratory support for public health research /epidemiological consultations, clinical trial endpoints that inform patient care for vaccine and therapeutic trials for HIV and pathogens of US military and US national interest to include current high visibility, high impact ongoing vaccine trials for HIV, Ebola, Middle Eastern Respiratory Syndrome (MERs CoV), and Zika;

• HIV operational / readiness and public health Institutional Review Board (IRB) approved studies with an emphasis on operational threats, blood safety, battlefield operational medicine, and sexually transmitted infections within high risk military populations; and

• Development, evaluation, and deployment of clinical screening / diagnostic/ monitoring algorithms for HIV and pathogens of military and/or national interest; HIV, sexually transmitted infection, and other pathogen detection methodologies

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(in house Laboratory Developed Tests).

Substantial duplication of cost is not expected to be recovered through competition of this short-term extension. In terms of this requirement substantial duplication of costs refers to the length of time for a new contractor to develop the knowledge and skills to meet the requirements of this contract. The learning curve process can be substantial. Path-tec is the only contractor available to ship BSL2 specimens domestically and internationally adhering to all applicable laws and regulations while meeting time sensitive, temperature controlled, and Privacy Act regulated specimen shipping requirements, providing shipment and material tracking, and electronic inventory management.

b) The extension periods are required to complete the procurement process.

Attempting to have another vendor perform these option periods will create an unnecessary duplication of cost. Another contractor without the highly specialized shipping, biosafety hazard, or PHI, PII, HIPPAA knowledge and abilities, greatly increases risk to the Government; thereby rendering WRAIR HDRL unable to perform its DoD mission essential HIV and its patient care mission. The amount of time it would take a new vendor to ramp up to perform would take most of the extension periods.

Currently, there are insufficient numbers of civilians or military personnel to maintain these services in the case of a break in contract services. Without this contract extension to continue shipping services, the DoD cannot complete HIV confirmatory testing stops and tests necessary to ascension recruits and deploy troops.

(c) Unacceptable delays in filling agency requirements. This requirement cannot have a break in service.

Path-tec, Inc. currently possesses the operational expertise required for successful shipping and tracking of specimens. Any other contractor would have a lengthy transition period leaving HDRL without specimens to test, creating an extreme impact on healthcare

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services to HIV-infected soldiers and/or family members, and could leave DoD units incapable of performing their missions.

(d) If applicable, explain why technical data packages, specifications, engineering descriptions, statements of work or purchase descriptions suitable for full and open competition were not developed or are not available.

Not applicable

6. Efforts to Obtain Competition:

a. Effective competition.

A Request for Information (RFI) for the follow-on requirement was released March 23, 2018.

b. Subcontracting competition.

Subcontracting is a component of the requirement.

7. Actions to Increase Competition:

The Government released an RFI in March 2018. A competitive acquisition is in pre-solicitation process.

8. Market Research:

A Request for Information (RFI) for the follow-on requirement was released March 23, 2018.

9. Interested Sources:

RFIs were published May 1, 2017, on fbo.gov for the current contract, and another on March 23, 2018 for the follow-on contract. The Sources Sought served to allow potential Offerors the opportunity to: 1) submit capabilities statements; 2) assess the capability of potential small businesses to perform all or parts of this requirement; and 3) provide advanced notice of the upcoming requirement.

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10. Other Facts: Discuss any other facts supporting the use of Other Than Full and Open Competition, such as the following:

a. Procurement history.

(1) Contract numbers:

(A) The current contract, W81XWH-15-P-0170, was competitively awarded to a small business on May 11, 2015, Path-Tec, Inc. The period of performance (PoP) was for one twelve month base period plus two twelve month option periods and expires on May 10, 2018.

(2) Competitive status of these actions.

Paragraph 10a. (1)(A) details the previous contract requirement.

(3) Authority previously cited if less than full and open competition.

(4) If a justification was prepared to support the procurement made before this one, a summary of paragraph 7…

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(5) If prior contract was accomplished using full and open competition…

(6) An explanation of any unusual patterns…

Not applicable

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated.

9. 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.

REVIEWED

10. 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.

11. 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 basis for this determination shall be historical pricing.

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