A03-_J&A_Cambodia_Clinical_Trials_Redacted.pdf

For Official Use Only

Control No: JA-18-85

Justification and Approval for Other Than Full and Open Competition

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702- 5014. The requiring activity is the Armed Forces Research Institute of Medical Sciences (AFRIMS).

2. Description of Action: This approval is being requested to initiate a Firm Fixed Price Bridge Contract Modification. To execute an extension under FAR clause 52.217-8 for a (three) 3-month base period, and (three) 3-month option period of the current award, W81XWH-14-P-0180 to conduct clinical trials in support of AFRIMS research projects in Cambodia. The estimated tot.al cost of the extension is . Purchase request number 11140506 is submitted to fund the requirement with 2 Year Enhanced DHP funds in the amount of .

3. Description of Services: This requirement is to provide research support services, facility and office space in Phnom Penh for USAMD-AFRIMS that is secure, inspected and approved by the US Embassy. AFRIMS Department of Immunology and Medicine has a requirement for research projects involving surveillance of emerging infectious diseases and to conduct clinical trials within Cambodia. The task objectives include: clinical and epidemiological research services, research site infrastructure, purchases of supplies, laboratory testing, transportation support, and sample shipments. AFRIMS disease surveillance pathogens may include respiratory viral pathogens, leptospirosis, bacterial pathogens, agents of parasitic disease including malaria, and other emerging infections. The contractor will locate and make all arrangements and agreements for the use of, access, visitation, and care-provider approvals of physical sites for biomedical research such as clinics, health centers, laboratories, office space, and/or hospitals that are appropriate to the scientific and medical requirements of the research projects. The contractor will be responsible for making and maintaining agreements with Cambodian national program entities (MoPH and/or CNM) for access to MoPH and or CNM clinics, hospitals, and facilities for conduct of studies supported. The contractor must provide for all utilities (mobiles phones and land line, drinking water, AC, electricity, internet, etc.). ·

Contractor will provide services provided by qualified licensed medical and/or epidemiological staff (i.e. physicians, nurses, allied health professionals, and others) that will best suit project requirements for subject recruitment and enrollment, clinical and epidemiological evaluations, specimen collection, data gathering, and data management.

This bridge extension would continue to provide current level of support to the Immunology and Medicine Department within AFRIMS in Cambodia.

4. Authority Cited: The statutory authority permitting other than full and open competition is 1O U.S.C. 2304 (c) (1) as implemented in Federal Acquisition Regulation (FAR) 6.302-1(a) (2) (iii) (B), services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in unacceptable delays in fulfilling the agency's requirements. The services being executed under this requirement support the USAMD-AFRIMS emerging infectious diseases program. The Department of Immunology and Medicine's missions are to support medical product development to protect the war fighter, and conduct surveillance of diseases of military importance in SE Asia. Their focus is on diseases of relevance to the public health means that their mission is integrated with the public health efforts of our host nation partners.

5. Reason for Authority Cited: The follow-on contract package for this requirement has been received and is currently being executed. The final award will not be accomplished in time for award execution prior to the expiration of the current award. Chenda Poly-Trauma Clinic is the incumbent contractor currently performing the required services and is uniquely qualified and currently positioned to continue the performances of the services. The services being performed are vital to the mission work of USAMD-AFRIMS. Currently there are five major ongoing clinical tries being conducted in Cambodia. A stop in work on these would constitute a protocol deviation and must be reported to the IRBs in the US, Thailand, and in the host country. In addition this award provides office and administrative support space to AFRIMS personnel to work and execute · all required activities to support the clinical studies in Cambodia. If the services are not extended it would mean mission failure.

The modification for the extension of the award will continue to maintain continuity of the research support services in this mission critical effort that oversees on-going clinical trials and surveillance programs in Cambodia.

6. Efforts to Obtain Competition: There are no other contract vehicles to assume these mission critical services at the present time. No effort will be made to solicit offers from as many potential sources as is practicable as this is a short-term requirement in order to provide time required to execute the competitive follow on-award. No effective or efficient competition is anticipated for this short-term performance period.

7. Actions to Increase Competition: The competitive package requirement is currently being executed. This package will be advertise full and open on FedBizOpps.

8. Market Research: Market research has been conducted for the follow on competitive requirement through the issuance of a Request for Information (RFI) on 24 January 2018. The result of the RFI was four responses received

9. Interested Sources: In accordance with FAR 5.207, a notice of intent to sole source a modification to the current contract was published. To this date no responses have been received.

10. Other Facts:

a. Procurement History.

i. Contract numbers and dates of the last several awards. W81XWH-1O-P-0113 awarded on 25 JAN 201O for base year and three (3) option periods;

W81XWH-14-P-0180 awarded on 19 MAR 2014 for a base year and three (3) option periods.

ii. Competitive status of these actions. Other than full and open competition.

iii. Authority previously used for less than full and open competition. The FAR citation is 6.302-1(a)(2)(iii), only one responsible source and no other supplies or services will satisfy agency requirements, was used for the previous sole source awards.

iv. 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. Market surveillance was conducted but no other organizations with the capabilities to meet the requirements were identified.

v. If any prior award was accomplished by full and open competition, a detailed explanation of the changed circumstances. Not Applicable.

vi. An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive urgent buys. Not Applicable.

vii. 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. Current market research shows that there are sources able to compete for this requirement, additional time is needed in executing the follow-on requirement. A competitive package has been submitted to execute as full and open competition procurement.

b. Acquisition data availability. None (limited resources).

c. Unusual and compelling urgency. Not Applicable

d. Subcontracting competition. Not applicable

A price analysis will be done to determine the propsed price fair and reasonable.