A02-Approved_J&A_Redacted_W81XWH19P0153.pdf

Control No:JA-19-07-0160 Contractor: The Songklanagarind Hospital/Prince of Songkla University

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 Southern Thailand

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

Amount:

Prepared by: DSN: N/A Date:

Email:

Contracting Officer: DSN: 343-2054 Date:

Email:

Technical: DSN: N/A Date:

Email:

Requirements: DSN: N/A ogy Date:

Email:

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

Program Manager:

Typed Name:

DSN: N/A

Signature:

Program: The Armed Forces Research Institute of Medical Sciences

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 Songklanagarind Hospital (Prince of Songkla University [PSU]). 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 Southern Thailand. 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 Southern Thailand, 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 in Southern Thailand, clinical trials of vaccines or therapeutic, validation of diagnostic devices.

Base Period: 23 Sep 2019 to 22 Sep 2020 Value:

Option Period 1: 23 Sep 2020 to 22 Sep 2021 Value:

Option Period 2: 23 Sep 2021 to 22 Sep 2022 Value:

Option Period 3: 23 Sep 2022 to 22 Sep 2023 Value:

Option Period 4: 23 Sep 2023 to 22 Sep 2024 Value:

FAR Clause 52.217-8 option: 23 Sep 2024 to 22 March 2025Value:

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)

Program: The Armed Forces Research Institute of Medical Sciences

Version – March 2017 FOR OFFICIAL USE ONLY

5. Reason for Authority Cited:

a. This proposed action is for a new contract for biomedical, clinical and surveillance study support in Southern Thailand. The Songklanagarind Hospital (Prince of Songkla University) [herein referred to as PSU Hospital] has been identified to provide these services. The previous contract with PSU for this surveillance work expired in August 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 PSU Hospital 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 Southern Thailand, led by PSU. 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 PSU 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.

PSU 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 PSU 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. PSU Hospital 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

Program: The Armed Forces Research Institute of Medical Sciences

Version – March 2017 FOR OFFICIAL USE ONLY already running studies in association with AFRIMS and approved at WRAIR IRB and 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 to Federal Business Opportunities (FBO) on 12 July 2019 to announce the Government’s requirement for these services. Responses to the announcement were due on 19 July 2019 by 1000 hours Eastern Standard Time.

7. Actions to Increase Competition: Actions to increase competition are not possible since the proposed Vendor, PSU Hospital, is the only one capable of meeting the requirement. No steps can be taken to increase competition as a result of PSU 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 Southern Thailand 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

Program: The Armed Forces Research Institute of Medical Sciences

Version – March 2017 FOR OFFICIAL USE ONLY capabilities to support this requirement as needed without creating an unacceptable and unnecessary delay with the ongoing study.

9. Interested Sources:

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 PSU Hospital 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) Contract W81XWH-12-P-0437; 1 Sep 2012 through 31 August 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 Songklanagarind Hospital (Prince of Songkla University) 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.

Program: The Armed Forces Research Institute of Medical Sciences

Version – March 2017 FOR OFFICIAL USE ONLY

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.

Typed Name: Date:

Title: 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: Date:

Title: Signature:

Program: The Armed Forces Research Institute of Medical Sciences

Version – March 2017 FOR OFFICIAL USE ONLY

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 IGCE 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: 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: Signature: