A02-J&A__27_Aug_2019_-_Redacted.pdf

Control No:JA-19-08-0196 Contractor:

Program: The Armed Forces Research Institute of Medical Sciences

Version –March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program: Biomedical, Clinical and Surveillance Studies in Bangkok

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. as implemented by FAR Subpart 13.5.

Amount: $261,585.00

Prepared by:

Contracting Officer:

Technical:

Requirements:

Reviews: I have reviewed this justification and find it adequate to support sole source.

Version – March 2017 FOR OFFICIAL USE ONLY

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole

Source Justification and Approval

1. Contracting Activity: The Contracting Activity responsible for this action is the United States Army Research Acquisition Activity (USAMRAA), Fort Detrick, Maryland on behalf of the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok, Thailand.

2. Description of Action: AFRIMS requests a firm-fixed-price contract with the

. The Government projects award in September 2019 using fiscal year 2019 Operations and Maintenance funds. 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 action is a new contract.

3. Description of Supplies/Services: This requirement is for services associated with scientific/technical, clinical, epidemiological, laboratory, administrative, database management, quality assurance and logistical support required by biomedical, clinical and surveillance studies and projects being conducted in Bangkok. The Contractor shall complete work items including hiring, maintaining and managing a qualified and experienced contract staff, at adequate levels. In addition, the Contractor shall support the procurement of epidemiological and clinical studies, purchase and ship supplies and equipment, support the procurement of laboratory testing, shipment of supplies and biological specimens within Bangkok, provide communication services, provide venues for meetings, quality assurance and administration for activities related to the preparation and execution of projects, among other related activities. Supported studies and projects include surveillance and epidemiology of arboviruses and respiratory viruses inBangkok, clinical trials of vaccines or therapeutic, validation of diagnostic devices.

Base Period: 24 September 2019 to 23 September 2020 Value:

Option Period 1: 24 September 2020 to 23 September 2021 Value:

Option Period 2: 24 September 2021 to 23 September 2022 Value:

Option Period 3: 24 September 2022 to 23 September 2023 Value:

Option Period 4: 24 September 2023 to 23 September 2024 Value:

FAR Clause 52.217-8 Option: 30 September 2024 to 29 March 2025 Value:

Total:

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5:

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization XX Other: Only one source is reasonably available per FAR 13.501(a)(1)(i)

5. Reason for Authority Cited:

a. This proposed action is for a new contract for biomedical, clinical and surveillance study support in Bangkok. The has been identified to provide these services. The previous contract with for this surveillance work expired in May 2017. AFRIMS continued the surveillance study through the United States Embassy in Bangkok. The option to continue the efforts of this requirement through the Embassy is no longer available to AFRIMS; therefore a new service contract must be established. The proposed acquisition must be accomplished through a sole source because has the approval by the Institutional Review Boards (IRB) to conduct the surveillance study of hospitalized patients and outpatients to identify arboviruses and respiratory viruses of medical importance and can provide personnel and facilities to perform this mission-essential service.

• Sole source is required since important studies that this contract would take over (respiratory and fever surveillance studies) are already taking place in Bangkok, led by PMK. These studies, meet national and international regulatory and quality requirements, have already obtained approvals at the local, national and US IRBs. To discontinue the execution of these studies led by PMK will cause the stoppage of the studies and the need to reinitiate approval processes, a lengthy and expensive option that will result in a 1-year data gap in Indo-Pacific Command (INDOPACOM) disease surveillance requirements.

• is already conducting the studies of interest under an approved IRB protocol that this contract will cover and has access to the desired disease patient pool for these studies. Additionally, the hospital part of the system, is the leading research authority in the areas of surveillance the Government seeks. As such, no other vendor, lacking a university hospital in the region could propose similar research, academic or clinical capacity.

(b) Alternatives: There are no alternatives. is the only source who has personnel with permissions to access the location and source of the data.

(c) Address the following as applicable.

1) What are the verified minimum requirements of the Government? How much further will the current items/services carry you? How much additional items/period of performance will you require? IRB-approved clinical studies supporting the surveillance efforts are five years long, which can be extended for two more years until a new study is approved.

2) If competition would have been feasible had more time been available, discuss other factors that had an impact on the decision to solicit only one source to satisfy the requirement (e.g. time available versus time required, phase-in/phase-out time, complexity of requirement, etc.). The factors relevant to the decision are: the existence of already running studies in association with AFRIMS and approved at WRAIR IRB and

Program: The Armed Forces Research Institute of Medical Sciences

Version – March 2017 FOR OFFICIAL USE ONLY

United States Army Medical Research and Development Command, Human and Animal Research Protection Office; the clear and demonstrated capacity of clinical research staff to meet the studies objectives; locality in region of disease endemicity.

3) Whenever the required action was "directed or mandated" by some higher level, be sure to include full information saying who imposed the requirement, how the mandate was communicated and the rationale for the mandate. Attach the applicable documentation (letter, message, etc.). Not applicable

4) Identify the constraints such as schedule requirements, unique features and mandatory requirements, or the existence of patent, proprietary data, copyright or other such limitations which restrict competition. Not applicable

5) If the requirement is for an interim contract (or contract extension) with the incumbent, discuss why it would be neither cost effective nor realistic to expect another Contractor to perform during the brief interim period. The following items may be relevant: start-up costs; manning problems including recruitment and associated relocation fees; continuity of service, transfer and accountability of a large amount of Government Furnished Property; variety and complexity of requirements; preparation of management plans; etc. Not applicable

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted on Federal Business Opportunities (FBO) from 12 July 2019 – 19 July 2019. Potential sources were given the opportunity to provide capability statements. Three vendors submitted capability statements, Camris, Geneva and Phramongkutklao Hospital. The Government’s subject matter expert conducted reviewed the capabilities statements for each and found PMK to be capable of supporting this requirement. The COR found Geneva and CAMRIS International’s capabilities statements unacceptable as their submission did not address their ability to conduct surveillance studies of hospitalized patients and outpatients, provide personnel and facilities to perform the mission-essential services, nor did they address their ability to provide support for all epidemiology of arboviruses and respiratory viruses in Southern Thailand. To date, no other sources have written to express an interest in the requirement. The Contracting Officer shall publish the notices required by FAR 5.201.

7. Actions to Increase Competition: Actions to increase competition are not possible since the proposed Vendor, , is the only one capable of meeting the requirement. No steps can be taken to increase competition as a result of PMK Hospital is the only source with access to the surveillance study data.

8. Market Research:

The AFRIMS COR conducted market research on 25 June 2019. The COR conducted an internet search, assessed potential vendors located in and around Bangkok and relied upon the experience of local study staff in consultation with clinicians and scientists with local collaborators. No other Vendors were identified to have the capabilities to support this requirement as needed without creating an unacceptable and unnecessary delay with the ongoing study.

9. Interested Sources:

Program: The Armed Forces Research Institute of Medical Sciences

Version – March 2017 FOR OFFICIAL USE ONLY

In accordance with FAR 5.201, a notice was published on 11 August 2019 on FBO announcing the Government’s intent to award a sole source contract to on a non-competitive basis for 15 calendar days. At the closing of the synopsis on 26 August 2019, no other potential sources were obtained.

10. Other Facts:

a. Procurement History:

(1) ContractW81XWH-12-P-0313; 1 Jan 2012 through 31 May 2017

(2) This was “other than full and open competition” contract.

(3) The statutory authority permitting other than full and open competition was 10 U.S.C. 2304(c)(1). The FAR citation was 6.302-1(a) only one responsible source and no other supplies or services would satisfy agency requirements.

(4) The PMK has been approved by the IRB to conduct the surveillance study of hospitalized patients and outpatients to identify arboviruses of medical importance and can provide personnel and facilities to perform this mission essential service. The hospital has been conducting ongoing arbovirus and respiratory virus surveillance and has proven expertise in this area.

(5) Not applicable.

(6) Not applicable.

(7) There have been no significant changes since the previous contract to this new contract.

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.

Signature:

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.

Typed Name:

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: price analysis cost analysis XX IGE audit: N/A other: N/A

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Typed Name: Date:

Title: Contracting Officer Signature:

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

Typed Name: Date:

Title: Contracting Officer Signature: