A03_GLOBE_JA_Final_-_Redacted_Redacted.pdf

Control Number: NCD-16-57

JUSTIFICATION REVIEW DOCUMENT

FOR OTHER THAN FULL AND OPEN COMPETITION

Program/Equipment: Ghana Laboratory Operations, Biosurveillance, and Epidemiology (GLOBE)

Authority: 10 U.S.C2304(c)(1) and FAR 6.302-1 Amount: $1,000,000

Prepared by:

24 May 2016

DSN:

Contracting Officer: 24 May 2016

Technical/Requirements Representative 24 May 2016

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

Branch Chief, ACC-APG-NCD, Ft. Detrick:

25 May 2016

Legal Counsel

3 Jun 2016

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Agency/Contracting Activity: ACC-APG-NCD, Ft. Detrick, Frederick, MD 21702

2. Description of Action: Approval is requested to solicit on the basis of other than full and open competition for a new contract in support of Naval Medical Research Unit No. 3 (NAMRU-3) Ghana Detachment (GD) for a Firm Fixed Price Single Award Indefinite Delivery/Indefinite Quantity with a two (2) year ordering period.

Nature: New Requirement X Follow-on Requirement

Mod to Existing Purchase Order/Contract Number

Pricing: X Firm-Fixed Price Time & Materials Cost

For Hybrid Contracts, list percentage of each type of pricing:

Firm Fixed Price:

Time & Materials:

Cost:

Funds: Operations and Maintenance, Army (OMA) X Other Funds:

Fiscal Year of Funds: FY16 Operations and Maintenance (OMA), Navy; FY15-16 Research and Development, Test and Evaluation (RDT&E), Navy

Name of Proposed Contractor(s): Noguchi Memorial Institute for Medical Research (NMIMR) Street Address: University of Ghana, PO Box LG 581 City, State, Zip: Legon, Accra GHANA Phone:

3. Description of Services or Supplies:

The total estimated value of the proposed action is $1,000,000.

This acquisition will provide contractor services to support ongoing research activities and host nation capacity building, including comprehensive support for laboratory operations, field-based infectious disease surveillance, and epidemiological studies conducted in consonance with the mission of NAMRU-3 GD. Contractor services are valued at $1M over a 24-month period of performance. The uniqueness associated with this acquisition is that NAMRU-3, a foreign entity within a host nation, does not have laboratory or research office facilities in Ghana; all continuing and tangential research and biosurveillance activities require collaboration with local institutions. NAMRU-3 GD collaboration personnel are currently hosted at the Noguchi Memorial Institute for Medical Research (NMIMR) or Institute, where the bulk of laboratory work under this contract will be performed in support of continuing and tangential activities. Although NAMRU-3 GD also works with Ghanaian government institutions, hospitals, field sites, and other local partners, NMIMR is its base of operations for receiving pathogenic specimens and conducting laboratory testing. As such, NMIMR is a driving force in the development and performance of research protocols collaborated on with NAMRU-3 GD and, as a result, has proprietary stake and unique corporate knowledge in the research performed. In addition, NMIMR plays a key role in engaging local solution partners for advancing host nation capacity building and obtaining biosurveillance field sites.

4. Authority:

Actions other than simplified acquisition procedures (select one):

X FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 10 USC 2304(c)(1)

FAR 6.302-2: Unusual and compelling urgency, 10 USC 2304(c)(2)

FAR 6.302-5: Authorized or Required by Statute, 10 USC 2304(c)(5)

Other: insert appropriate authority here

5. Reasons for Authority Cited:

a. In accordance with FAR 6.302-1 (a) (2) (iii) (A) and (B), only one responsible source exists for this follow on contract. The contract requires the continued performance of critical tasks. The United States Government (USG) via NAMRU-3 has been conducting in situ long-term research in CENTCOM and AFRICOM Areas of Responsibility (AOR) as it pertains to infectious disease outbreaks, emerging pathogens, incidence studies and surveillance, laboratory testing and analysis, epidemiology, and vaccine trials. The USG’s approach has been to concentrate its scientific efforts at the geographical disease sources (ground zero) before such diseases impact US soldiers/personnel in the region and eventual transmission back to US soil. A key hotspot has been long-time recognized as the region in Ghana and its surrounding area. Various resources have poured into the area and as a result a center of excellence has grown within the Noguchi Memorial Institute for Medical Research at the University of Ghana. Resident within this Institute is the unique expertise and corporate knowledge representing many years of collaboration with various USG commands such as NAMRU-3, Naval Medical Research Center, and Naval Health Research Center. Should such collaboration end with the Institute, the in situ research performed by the USG would not mature to a level of effective vaccines responding to evolving variant form of diseases. Further competing this requirement would result in substantial duplication of costs estimated in excess of $1,000,000.00, which are not expected to be recovered through competition, and unacceptable delays of approximately 2 years, while another resource (if found) was brought up to the level of maturity required to fulfill this requirement. The $1M of cost duplication was estimated by reviewing the contract history of NMIMR’s support for NAMRU-3 GD; since FY13, there have been six contracts total for individual research projects, all under the Simplified Acquisition Threshold (SAT) of $150K, thus totaling roughly $900K- $1M of performance. During this time period, NMIMR has built a tremendous amount of corporate knowledge and expertise in its collaborations with USG research entities – especially NAMRU-3 GD – that would not be easily recovered without substantial delay to performance, which is estimated at 4 years or more based on the history of collaborative support thus far, considering this investment in resources and advanced biomedical research in a developing country like Ghana where such capabilities are largely unavailable. A delay of this length is unacceptable as it would ensure failure for the infectious disease research mission of NAMRU-3 GD, thereby opening a gap in the biosurveillance network and putting at risk the health of US service members operating in West Africa and public health stakeholders in-country.

b. NMIMR is the only responsible source capable of effectively supporting this requirement, based on the following rationale:

i. Many of the staff at the Institute have the corporate knowledge representing years of field research and laboratory analysis. As mentioned above, NAMRU-3 GD collaborating staff are located on the NMIMR premises and conduct all laboratory work there. NMIMR drives much of the research protocol development that NAMRU-3 GD researchers collaborate on and, as such, they have a significant proprietary stake in research performed in collaboration with NAMRU-3 GD. No other vendors are known that could facilitate the continuation of research required for these efforts in this area.

ii. Resources – The higher the disease risk, the higher the biosafety level.

Contractually, we are looking at a biosafety level (BSL) -2, but, because of the unpredictable incidence risk associated with mutated diseases, a BSL-3 could become a necessity. Ghana is a developing country that generally lacks industry capability to support advanced biomedical research undertaken by NAMRU-3. NMIMR is the only source in Accra (and Ghana as a whole) that can provide NAMRU-3 GD the facilities and resources needed to carry out its research mission. For example, NMIMR has the only BSL-3 laboratory in Accra, which is required when dealing with highly pathogenic specimens.

They are also uniquely capable of performing high-level lab procedures on advanced diagnostic platforms such as (but not limited to) Luminex, RT-PCR, and genetic sequencing, and have highly trained staff to support such operations. Lastly, NMIMR has an insectary that is unmatched in Accra, and is fully capable of supporting NAMRU-3 GD vector studies.

6. Efforts to Obtain Competition: A Sources Sought Notice (SSN) was released in April 2016 to obtain information from industry concerning interest and capabilities for this potential requirement, to include field-based testing and etiological lab analysis within the host nation.

Responses were received from three (3) vendors: Metabiota, NMIMR, and Washington State University. Metabiota does not have a footprint in Ghana. Washington State’s demonstrative expertise is too limited in scope, having experience in tick-borne infectious diseases affecting livestock in West Africa. Only NMIMR was found to have a reasonable expectation of supporting this the global requirement, including footprint and breadth of scope expertise. This finding reinforced the market research, indicating that a sole source would be the only acquisition strategy that can meet the Government need.

7. Actions to Increase Competition:

In the future, should this requirement still exist, market research shall be conducted to ensure that it will be competed to the maximum extent possible.

8. Market Research:

Market research conducted in April 2016 by members of the NHRC office to identify qualified sources included techniques such as contacting Government subject matter experts; conducting a SSN/Request for Information (RFI); querying Government databases such as SAM and SBA;

general internet searches, and reviewing recent market research conducted for the legacy contract.

9. Interested Sources: IAW FAR 5.201, the contracting officer shall issue an intent to award a sole source contract notice on Federal Business Opportunities at least 15 days prior to award of the contract, and any bids or proposal received shall be considered.

10. Procurement History:

Previous Purchase Order(s) or Contract(s): X Yes No

If "Yes", for each purchase order or contract provide:

Purchase order or contract number: W911QY-15-P-0440 was awarded on 17 September 2015 to NMIMR for a total value of $136,400.00. It was a follow-on requirement with a 12-month period of performance, and was issued on a sole source basis.

Was action competed? Yes X No If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof: Legacy contract W911QY-15-P-0440 was issued as a sole source under the simplified acquisition procedures IAW FAR 13.106-1(b)(1), as only one source was deemed reasonably available based on similar rationale as found herein. That is, NMIMR was identified as having unique capability due to its BSL-3 laboratory facilities, capacity to carry out high-level laboratory biomedical procedures on advanced platforms, and its corporate knowledge derived from years of collaborative research development alongside NAMRU-3 on-site at NMIMR.

11. Technical / Requirements Certification: I certify that the supporting data under my cognizance which is included in this J&A is accurate and complete to the best of my knowledge and belief.

12. Fair and Reasonable Price Determination: As contracting officer, I hereby determine that the anticipated cost to the government for this contract action will be fair and reasonable.

A price analysis will be conducted to determine that the proposed price is fair and reasonable, based on comparison with historical pricing as well as comparison of proposed prices with the independent Government cost estimate. Certified cost or pricing data will be required in accordance with FAR 15.403.

SIGNATURE: Date: 16 June 2016

NAME:

TITLE: Procuring Contracting Officer

13. Reviews: I have reviewed this justification and find it legally sufficient.

Legal Counsel Typed Name:

Signature: Date:

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

SIGNATURE: DATE: 16 Jun 2016 NAME:

TITLE: Procuring Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the procurement of the above mentioned services to Noguchi Memorial Institute for Medical Research in the amount of $1,000,000 on an Other Than Full and Open Competition basis pursuant to the authority of Title 10 United States Code Section 2304(c) (1) and FAR 6.302-1, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

SIGNATURE DATE: 17 June 2016

NAME:

TITLE: Competition Advocate