A03_JA16315_-_HIV_FINAL_REDACTION.pdf

Justification Review Document for Other Than Full and Open Competition

Program/Equipment: Non Personnel Services Support for Walter Reed Army Institute Research (WRAIR), U.S. Military HIV Research Program (MHRP), Department of Laboratory Diagnostics and Monitoring (DLDM) and Department of Epidemiology and Threat Assessment

(DETA)

Authority: U.S.C. 2304 (c)(1), FAR 6.302-1 (a)(2)iii, Only one responsible source and no other supplies or services will satisfy agency requirements.

Amount: $10,500,000 (base of 12 months and one (1) 6-month option)

Prepared by: REDACTED

Typed Name:

Title:

Date: 25 August 2016

Requirements Representative: REDACTED

Date: 25 August 2016

Contracting Officer: REDACTED

FOR OFFICIAL USE ONLY

Control No: JA16315

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Reviews: I have reviewed this justification and find it adequate to support Other Than Full and Open Competition.

Program Manager/COR: REDACTED

Legal Counsel: REDACTED

Special Advocate for Competition:

Typed Name: Phone:

Signature: Date:

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Justification and Approval for Other Than Full and

Open Competition Justification

1. Contracting Activity:

U.S Army Medical Research Acquisition Activity (USAMRAA) 820 Chandler Street Fort Detrick, MD 21702 Contracting Officer: REDACTED Requiring Activity: Department of Laboratory Diagnostics and Monitoring (DLDM) and Department of Epidemiology and Threat Assessment (DETA), US Military HIV Research Program (MHRP), WRAIR

2. Description of Action:

Approval is being requested for a new contract for one 12-month base period and one 1 6-month option as a sole source, Cost Plus Fixed Fee award, non-personnel service support contract to the Henry M. Jackson Foundation in support of DLDM and DETA, US Military HIV Research Program (MHRP), WRAIR. The resulting award, valued at $10.5 million, will be funded with FY 16 and following year O&M funds. Award must be in place with an effective date of 29 September 2016. REDACTED

It should be noted that this sole source requirement, is a new requirement that evolved from a revised requirement which was approved last year for W81XWH-15-C-0199.

3. Description of Supplies/Services:

The Performance Work Statement (PWS) defines the procurement of the scientific, medical technical, clinical /diagnostic, and administrative services necessary to support the Department of Laboratory Diagnosis and Monitoring (DLDM) and the Department of Epidemiology and Threat Assessment (DETA), US Military HIV Research Program (MHRP), Walter Reed Army Institute of Research (WRAIR) to: (1) execute all phases of clinical screening, supplemental confirmatory testing, clinical monitoring (viral load), and therapeutic monitoring (resistance genotype testing) for HIV, sexually transmitted infections, blood borne infections, and pathogens of Military or U.S. National interests; (2) execute all phases of clinical trials for evaluation of new/novel products for Pre-Market Application to the U.S. Food and Drug Administration and/or execution in clinical diagnostic settings; (3) develop, design, evaluate, validate Laboratory Developed Assays (LDAs) for detection, screening, supplemental confirmatory testing/diagnosis, and/or monitoring (viral load/resistance genotyping) of pathogens of U.S. Military and/or National interest; (4) generate laboratory data for development of evidence based Knowledge Products to inform Service Specific and DOD policy development, and intervention/prevention strategies; (5) execute all phases of clinical screening, supplemental confirmatory testing for diagnostic, clinical, public health, and translational support for MHRP, WRAIR, United States Army Medical Research and Materiel Command (USAMRMC), US Agency, and external (academic/commercial) collaborations for Investigative Drug/Device (IND) vaccine, therapeutic, 4 | P a g e cure clinical trials of pathogens of U.S. Military, US, and Global Health importance; (6) conduct comprehensive characterization of the epidemiology of HIV among Army, Navy, Air Force, and Marine Corps personnel; (7) conduct public health translational studies for evidence based Knowledge Products that inform optimal screening, prevention, and service delivery policy and practice for Service and DOD stakeholders for HIV and HIV-related sexually transmitted and blood borne infections (STIs, BBIs); (8) conduct threat assessment studies of HIV/HIV-related BBIs associated with the battlefield blood supply and HIV-related STIs among U.S. military and foreign military personnel; (9) conduct threat assessment studies of HIV and HIV-related infections among populations of interest to the Combatant Commands (CoCOMs)and in geographic regions of U.S. military operational significance; and (10) comply with HIPAA and all relevant DOD/USG regulations for collection, storage, and transfer of sensitive data and PHI involved in these tasks.

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 or services will satisfy agency requirements.

5. Reason for Authority Cited:

a) The DLDM and DETA departments 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;

• developing and providing clinical screening diagnostic/monitoring detection technologies of infectious diseases and emerging infection of military relevance;

• mission essential public health studies for development of evidenced based Knowledge Products that inform optimal screening, prevention, and service delivery policy and practice for Service specific and DoD stakeholders.

These services are currently being performed by Henry M. Jackson Foundation (HJF). No other contractor can perform the requirements of this award at the level and quality necessary to not cause degradation of the DOD mission.

DLDM provides, through HJF service support, clinical testing and diagnostics using non-commercial assays for detection of HIV and other infectious pathogens of US Military and US National interest. There is no substitute for the non-commercial tests, otherwise known as Laboratory Developed Tests (LDTs). This is DOD mission essential work that cannot stop.

Specifically, the DLDM and DETA provide HIV clinical diagnostic, and clinical and therapeutic monitoring as well as clinical research and public health practice services to:

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1) 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);

2) HIV clinical laboratory support for public health research /epidemiological consultations (EPICONs), 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.

3) 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;

4) 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 (in house Laboratory Developed Tests), and;

5) development of evidenced based Knowledge Products that inform optimal screening, prevention, and service delivery policy and best practice for Service specific and DoD stakeholders.

b) REDACTED

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An 18 months sole source justification will allow a recompete action for a revised follow on requirement of REDACTED which, once the contract is awarded, will have an active contract before a REDACTED.

b) Justifications citing FAR 6.302-1(a)(2)(ii) or (iii) as the authority for less than full and open competition on a follow-on contract must reflect:

(1) Substantial duplication of cost that is not expected to be recovered through competition. In terms of this requirement substantial duplication of costs refers to the length of time for a new contractor to develop the knowledge skills to perform successfully on this contract. The learning curve process can be substantial. HJF is the only contractor with the employees who are trained, certified, and readily available to perform the 60 high complexity HIV, sexually transmitted infection, and blood borne pathogen tests on DLDM/HDRL/LDL test menu. Of the 25 HIV specific clinical tests performed, 19 (minus the starred tests) are non-commercially available, Laboratory Developed Tests (LDTs), that are not available outside of DOD, and more specifically, not available outside of the DLDM. Below lists the 19 non-commercially available tests:

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All International Biological Safety Committees categorize HIV as a Risk Group Level 3 pathogen. A Level 3 pathogen may cause severe human disease and presents a serious hazard to laboratory workers. CLIA/ CLIP categorizes tests as low complexity (waived) or moderate and/or high complexity (non-waived). Most FDA approved tests for HIV screening, supplemental confirmatory testing, and clinical and therapeutic monitoring are classified as high complexity tests. For all high complexity testing the laboratory must be accredited to acquire and perform these specific tests. All laboratory personnel must also be certified to perform HIV and related disease tests.

REDACTED

(2) unacceptable delays in filling agency requirements. REDACTED. This section is concerned with a break or no contract service. The domino effect of a break in service or no contract would have immediate and unsustainable repercussions in DOD deployability requirements, HIV screening for military accession candidates, immediate high risk for DOD Walking Blood Donor Program, immune-compromised individuals at high risk for receipt of vaccines, comprised unit readiness (deployability), lack of care for HIV- infected soldiers and/or family members, and mission essential support for high visibility MERs CoV, ebola, Zika vaccine trials, and ongoing operational/threat public health studies to inform best practices (Pre- Exposure Prophylaxis [PreP]) for surveillance and medical management of Service Members most at risk for HIV.

HJF currently possesses the operational expertise and certifications required for successful conduct of high complexity clinical diagnostic and/or monitoring assays and highly sophisticated laboratory developed tests as per CLIA, CAP and CLIP requirements. Any other contractor would have a lengthy transition and certification period; not only leaving the DLDM/HDRL with service interruption, but have an extreme impact on health care services to HIV-infected soldiers and/or family members, and DOD units incapable of performing their missions.

(e) 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.

A PWS is established for the combined DLDM and DETA requirements.

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6. Efforts to Obtain Competition:

A Sources Sought posted 8 April 2016 with an updated draft PWS which included the DETA tasks. The Request For Information (RFI) generated an unqualified respondent- REDACTED.

This RFI was useful as it highlighted areas in the expanded PWS that needed additional information. The RFI’s also allows potential offerors the opportunity to: 1) submit capabilities statements; 2) submit questions or comments to assist the Government as it refines its requirement; 3) assess the capability of potential small businesses to perform all or parts of this requirement; and 4) provide advanced notice of the upcoming requirement.

REDACTED s capabilities statement was evaluated against the following parameters:

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It should be noted that the April 2016 RFI was the second RFI posted. Prior market research conducted 15 July 2015 for a similar although not the expanded requirement (only the DLDM non personal services were provided in draft for the RFI), generated one unqualified respondent—REDACTED. REDACTED submitted a capabilities statement regarding their reagents, which was deemed unacceptable since the draft PWS referenced clinical laboratory services, not reagents.

DLDM asked for five specific capabilities to be addressed by the vendors.

• Conduct clinical screening and confirmatory diagnosis, clinical monitoring and therapeutic monitoring for HIV, pathogens of Military or U.S. National interests;

1. REDACTED s response states that they will have to recruit the required personnel to meet this requirement. They do not indicate in their response that they have supplied personnel or have experience in supporting clinical diagnostic functions under CLIA/ CAP regulations.

• Conducting clinical research to evaluate new/novel products for Pre-Market

Application to the U.S. Food and Drug Administration and/or execution in a clinical diagnostic settings;

1. REDACTED response states that they have conducted clinical trials;

however, they will have to recruit the required personnel to meet this requirement. Furthermore the research conducted by REDACTED is not clinical diagnostic research. Therefore, does not meet this requirement.

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• Conducting clinical research to develop, evaluate, validate Laboratory Developed Assays for detection, diagnosis and/or monitoring of pathogens of U.S. Military and/or National interest;

1. REDACTED states that they have 22+ years providing research support to federal agencies that advance military medical research. The medical research is not clinical diagnostic research therefore does not meet this requirement.

• Support knowledge product development, generating data and intervention/prevention strategies;

1. REDACTED response states that they will have to recruit the required personnel to meet this requirement. The response does not indicate that they have any experience working under College of American Pathologist or

CLIA.

• Provide diagnostic support with multiple partners and collaborators, to include the

FDA, for vaccine/therapeutic/cure clinical trials of pathogens of U.S. Military and/or US importance.

1. REDACTED response states that they will have to recruit the required personnel to meet this requirement. They also state that they have 22+ years providing research support to federal agencies that advance military medical research, however, the medical research is not clinical diagnostic research therefore does not meet this requirement.

a. Effective competition.

There is no effective competition in the instant requirement. However the Government has refined its PWS incorporating as much information as it can to detail the requirement, the organizational environment, provide the number and type of testing assay details, and public health, threat assessment activities for development of knowledge based products.

b. Subcontracting competition.

A Small Business Participation Plan requirement has been included in the requirement. There is some potential, albeit small, that REDACTED would be able to subcontract parts of this effort.

7. Actions to Increase Competition:

The Government will continue to engage industry as it tries to reduce the high barrier to entry for this highly specialized clinical diagnostics, testing, and epidemiological requirement.

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8. Market Research:

As described in paragraph 6, two RFI’s have been conducted to scan industry, although only one was for like services. The capabilities statements received pointed out PWS vagaries that the Government was able to refine in the PWS.

9. Interested Sources: See paragraph 6. There have been no other inquiries other than the capabilities statements submitted in response to the RFI’s.

Notices required by FAR 5.201 shall be published, and that any bids or proposals received shall be considered.

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) W81XWH-15-C-0199 award to support services to the Department of

Laboratory Diagnostics and Monitoring, U.S. Military HIV Research Program for Non Personal services. The current DLDM contract vehicle is a sole source, (6.302-1 (a)(2) Only one responsible source and no other supplies or services will satisfy agency requirements), non-personal services contract; more specifically, the W81XWH-15-C-0199 award is for 12 months duration to the Henry M. Jackson Foundation, Bethesda, MD which expires 28 September 2016.

The first contract, W81XWH-15-C-0199, was awarded as a sole source contract for a period of 12 months in order to enable the preparation of a competitive follow-on action. Much progress has been made; however there is insufficient time to complete a competitive action;

(B) W81XWH-11-2-0174 Cooperative Agreement (CA) (most recent award number) the origin of this requirement was a Cooperative Agreement. Competitive status –competed

(2) Competitive status of these actions.

As above

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

As above

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

The prior sole source justification para. 7 cited: “The government believes the award of a 1 12-month base with one 6 month option sole source is the most cost effective and efficient

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The contract awarded associated with this sole source justification was for a 12-month period of performance. The 6 month option could not be incorporated due to the prior Solicitation Review Board threshold and insufficient time to board the prior action.

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

Not applicable

(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.

See paragraph 10. A. (1)(B)

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

(1) In support of this DOD mission essential work, the DFARS clause 252-237-7023, Continuation of Essential Contractor Services is incorporated into the solicitation.

(2) REDACTED

(3) Accessions testing for the U.S. Military Entrance Processing Command (USMEPCOM) at WRAIR began with the award of the first contract, W81XWH-15-C-0199. REDACTED

(4) REDACTED

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11. Technical Certification: Include the following statement:

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: REDACTED Date:

Signature:

12. Requirements Certification: Include the following statement:

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: Include the following 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 include cost analysis, cost realism analysis, and a post award audit. Certified cost or pricing data shall be utilized in this award analysis.

Title: Contracting Officer

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Title: Contracting Officer

15. Legal Sufficiency:

Based on the information provided in this document, I hereby determine that this contract action to be fair and reasonable.

Typed Name: REDACTED Date: T

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Approval

Based on the foregoing justification, I hereby approve the procurement of Non Personnel Services Support for Walter Reed Army Institute Research (WRAIR), U.S. Military HIV Research Program (MHRP), Department of Laboratory Diagnostics and Monitoring (DLDM) and Department of Epidemiology and Threat Assessment (DETA) on an Other Than Full and Open Competition basis pursuant to the authority of U.S.C. 2304 (c)(1), FAR 6.302-1 (a)(2)iii, Only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: Signature REDACTED