A02 - JEFO_Bridge W81XWH16D0002-0003 Final Rev_07-13-2021 KO signed CA_SAM POSTING.pdf

Control Number: JA-21-05-00308

APR 2021

Justification Review Document for an Exception to Fair Opportunity

Under FAR 16.505(b)(2)

Program/Equipment: U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Scientific and Technical Support services

Authority: 10 United States Code 2304c (b) (2) as implemented in Federal Acquisition Regulation (FAR) 16.505(b)(2)(i)(B) – Only one awardee is capable of providing the supplies or services at the level of quality required because the supplies or services ordered are unique or highly specialized. The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to issue a bridge, via modification to contract/task order W81XWH-16-D-0002-0003 with Cherokee Nation Assurance, LLC (Cherokee) to continue to provide the existing scientific and technical support services currently being provided in support of USAMRIID.

Justification for an Exception to Fair Opportunity Under FAR 16.505(b)(2)

1. Contracting Activity: The Contracting Activity responsible for this Justification for an Exception to Fair Opportunity (JEFO) is the U.S. Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD on behalf of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD.

2. Description of Action: The government intends to issue a bridge, via a modification, to contract/task order W81XWH-16-D-0002-0003 with Cherokee Nation Assurance, LLC (Cherokee) to continue to provide the existing scientific and technical support services currently being provided in support of USAMRIID.

The contract type for this action is Firm Fixed Price. Army Research, Development, Test and Evaluation funds are anticipated for this action.

3. Description of Supplies/Services: The bridge action will continue to provide the existing scientific and technical support services currently being provided at USAMRIID.

The current task order (W81XWH-16-D-0002-0003) is due to expire on 31 August 2021.

There are currently no contracts in place with sufficient quantity for all current scientific and technical support services at USAMRIID during the bridge period of 01 September 2021 through 19 May 2022; therefore, the above referenced contractor is in the best position to fulfill current requirements during the bridge period.

The bridge contract action will contain the quantity necessary to ensure the new competitive procurement has an appropriate timetable to evaluate, award and implement new contracts and subsequent task orders. Since the acquisition has already experienced delays, the bridge contract action will be issued with an eight and a half (8.5) month period of performance in case any additional delays further impact the contract award. Therefore, the bridge contract action will include one (1), seven (7) month base period and one (1), one and a half (1.5) month option period in an effort to ensure there is sufficient time to transition current services and hundreds of contractor personnel to the new, competitive contracts.

The scientific and technical support services included in this requirement provide support to the Bacteriology, Systems and Structural Biology, Virology, Core Laboratory Services, Countermeasure Development, Diagnostics Systems, Research Program Office, Business Innovation and Programs, and Biosafety/Transition Divisions of USAMRIID to help accomplish its mission. The services include:

- Providing expertise in bacterial pathogenesis, immunology, vaccines, and therapeutics;

- Providing several levels of scientific and technical support to cover genomics and proteomics functional capabilities including pathogen discovery and stock characterization, pathogen population genetics, pathogen genome reconstruction, comparative genomics, host-immune response characterization, technology development and integration, quantitative proteomics, structural biology, metabolomics, small molecule quantitation in bio-fluids, mass spectrometry tissue imaging, high resolution accurate mass determination, and protein characterization to include post-translational modification analysis;

- Establishing research protocols and providing research governance of data integrity and good research conduct;

- Providing expertise in high-level bioinformatics for integration and analysis of approximately four (4) Terabytes of data produced monthly;

- Providing technical support services to include laboratory procedures supporting sample processing with management of standard operating procedures and maintaining compliance with USAMRIID Safety regulations;

- Providing personnel with qualifications to support all mission requirements including principal investigators, staff scientists, and technicians;

- Providing personnel enrolled in the Army’s Biological Personnel Reliability Program

(BPRP);

- Providing support to conduct viral pathogenesis research, viral biology research, viral immunology research, animal modeling (to include telemetry services), cell biology, viral molecular biology, entomology, and vector assessment;

- Providing personnel with qualification to meet regulatory and accredited activities under applicable parts of Code of Federal Regulations (CFR) Title 21 (21CFR) Good Laboratory Practices/Current Good Manufacturing Practices, 42CFR Clinical Laboratory Improvement Program/Clinical Laboratory Improvement Amendments, International Organization for Standardization standards and accreditation agency guidelines as applicable;

- Providing personnel that will be expected to support and execute research, repository, reagent production, verification/validation and diagnostic and service support in Biosafety Level (BSL) 2, BSL3 and BSL4 laboratories;

- Providing personnel capable of maintaining laboratory equipment and supplies;

- Providing personnel capable of conducting immunodiagnostic research, molecular diagnostic research and advanced development of diagnostics to support regulatory approval;

- Provide senior level technical subject matter experts, who have a familiarity with biocontainment procedures, medical product development and Biological Select Agents and Toxin regulations, to advise and assist the Office of the Science Director in the program management of USAMRIID’s research portfolio, including defining the scientific strategy for identifying product candidates and their down-selection to a lead candidate, as well as conducting the translational science required to move the lead candidate from the bench to clinical trials in coordination with USAMRIID’s customers;

- Provide personnel capable of using their knowledge and experience of best pharmaceutical industry practices related to development of medical countermeasures, such as vaccines, therapeutics, and diagnostics, to develop an integrated program. This includes establishment of the tools and models required to conduct nonclinical studies of product candidates.

- Provide project management support to assist the Director of Transition, Biosafety Officer, Health Facilities Planning Agency, and Initial Outfitting and Transition Contractor in transition planning and transition execution to Building 8100;

- Provide technical and program management suite supervision support for BSL-2, BSL-3 and BSL-4 containment suites in Buildings 1301, 1408, 1412, 1425, 1443, 1444 and 8100;

- Provide personnel with a scientific background supplemented with a knowledge base to include protocols, protocol amendments, nonclinical study reports, FDA animal rule and FDA/GLP regulations, who would be capable of serving as an institute resource by providing technical writing expertise and support services.

4. Authority Cited: 10 United States Code 2304c(b) (2) as implemented in FAR 16.505(b)(2)(i)(B) – Only one awardee is capable of providing the supplies or services at the level of quality required because the supplies or services ordered are unique or highly specialized.

5. Reason for Authority Cited: The technical and support services, provided in support of this requirement, are required in order to continue the medical biological defense research efforts at USAMRIID. As a result, the contract employees providing the services are required to be enrolled in the Army’s BPRP. Historically the process to enroll a new individual into the Army BPRP has taken at least 12 months to complete the process. The services require BPRP which is highly specialized and unique.

Cherokee Nation Assurance, LLC already has BPRP certified personnel in place capable of providing scientific and technical support services during the eight and a half (8.5) month requirement; thus, avoiding a lapse in service. Given USAMRIID is the DoD’s lead laboratory for medical biological defense research, any lapse in service could result in USAMRIID not meeting its mission. No other contractors would be able to recruit, submit employee packages, obtain BPRP certification, complete orientation and have their employees in place in order to avoid a lapse in service.

The bridge will be issued in anticipation of award of the Defense Health Agency (DHA) OMNIBUS IV Multiple Award Indefinite Delivery Indefinite Quantity (MA-IDIQ) contracts.

In accordance with the Office of Management and Budget’s Memo M-19-13, government agencies are required to more effectively manage contract spending through the use of Government-wide, agency-wide and local contracts. As a result, it has always been the intent of USAMRAA to compete the scientific and technical support requirements currently under Task Order W81XWH-16-D-0002-0003 onto the new DHA OMNIBUS IV MA-IDIQ contract vehicle upon award. The MA-IDIQ is intended to be either a Tier 1 or Tier 2 contracting vehicle under the government’s category management program. The plan of action and milestones for the new DHA OMINBUS IV MA-IDIQ contracts had an original award date of 01 July 2021; however, while obtaining approvals of pre-solicitation and solicitation documentation, the milestones originally established were not met due to a delay in obtaining the required approvals from higher levels of authority. The revised milestones project an anticipated award date of 01 October 2021.

Due to the upcoming expiration of the task order and the delay in award of the DHA OMINBUS IV MA-IDIQ contracts, a bridge to the current task order, via modification, is proposed. This action is required to establish a stop-gap measure to provide the required services to meet the existing mission of USAMRIID. The Senior Contracting Official (SCO) Approval for Bridge Contract Action with No Scope Increase was approved by the SCO on 11 June 2021.

Cherokee Nation Assurance, LLC is the only known source that is able to meet this short-fused, short-timeframe requirement. There are no known performance issues that would prevent the contractor from performing services for an additional eight and a half (8.5) months.

6. Efforts to Obtain Competition: Not applicable for this action. No competition is sought for this bridge action as any break in service would be unacceptable. Further, in accordance with FAR 5.202(a)(6), a notice is not required for orders under FAR 16.5.

a. Effective competition. Given this is a bridge action, via modification, to contract/task order W81XWH-16-D-0002-0003, no competition is expected for this action.

b. Subcontracting competition. Not Applicable – Base contract W81XWH-16-D-0002 was awarded as the result of a competitive 8(a) requirement. Cherokee’s original proposal referenced two subcontractors, General Dynamics Information Technology, Inc. (GDIT) and Tunnell Government Services, Inc. (TGS). Given this action is for a modification to a task order under an IDIQ and the subcontractors were included with its original proposal, notification of any changes to the subcontractors must be sent to the base IDIQ Contracting Officer 30 days prior to the addition of any subcontractors.

Further, all subcontractors must be approved by the Contracting Officer. In review of any newly proposed subcontractors, the Government would review the vendor’s processes for selecting new subcontractors to help ensure competition procedures were followed.

7. Actions to Increase Competition: The services to be bridged are the existing services currently being provided under contract/task order W81XWH-16-D-0002-0003.

Upon award of the DHA OMNIBUS IV MA-IDIQ the services currently being provided will be competed among the DHA OMNIBUS IV MA-IDIQ awardees. The DHA OMNIBUS IV MA-IDIQ will consist of a five (5) year base ordering period and a five (5) year option ordering period for a total of a 10-year ordering period. Additionally, each Task Order awarded under the DHA OMNIBUS IV MA-IDIQ may extend up to 12 months after the last day of the MA-IDIQ ordering period. USAMRAA posted, to beta.sam, our intent to use the OMNIBUS IV vehicle and links to the beta.sam postings by DHA, to include the Request for Information (RFI), Pre-solicitation Notices/Draft Request for Proposal (RFP)/solicitation, and to the RFP/solicitation. USAMRAA also sent emails to all current contract holders informing of USAMRAA’s intent to use the OMNIBUS IV vehicle in order to maximize contractor participation and increase competition.

8. Market Research: Market research was conducted in May 2021, which revealed that other companies can provide the same or similar services to the scientific and technical support services that Cherokee is currently providing. However, it would take any other company at least 12 months from transition-in to full performance capability (including enrollment of contractor employees in the Army’s BPRP), which would create a loss of efficiencies and critical services. Further, the administrative costs and burden to compete this short-term bridge modification extension would far outweigh the anticipated costs of this bridge with Cherokee. Based on these facts, it is in the Government’s best interest to execute a bridge modification extension with Cherokee.

9. Other Facts:

a. Procurement history.

(1) Contract/task order: W81XWH-16-D-0002-0003 was awarded to Cherokee Nation Assurance, Inc. on 04 August 2017 with an effective date of 01 September 2017.

Following award, USAMRAA received a protest and a stop-work order was issued on 14 August 2017. The stop-work order was lifted on 06 March 2018 and the period of performance was adjusted accordingly. The order was awarded with a 12-month base period and two, 12-month option periods for a total of 36 months and was due to expire on 28 February 2021. A 6-month option period was exercised on 18 February 2021, in accordance with FAR 52.217-8, and extended the period of performance end date to 31 August 2021; the option to extend services was evaluated as part of the initial competition.

(2) Competitive Status: This task order was competed as a firm-fixed price task order against the USAMRIID Research and Development Support Services (RDSS) MA-IDIQ;

four proposals were received in response to the solicitation.

(3) Authority Previously Cited if Less Than Full and Open Competition: Not Applicable

(4) Summary of Actions to Increase Competition: Not Applicable as there was no justification to support the procurement before this one. See paragraph 9.a.(3) above.

(5) Explanation of Changed Circumstances to Limit Sources: As outlined in paragraph 5 above, due to the upcoming expiration of the task order and the delay in award of the DHA OMINBUS IV MA-IDIQ contracts, a bridge to the current task order, via modification, is proposed. This action is required to establish a stop-gap measure to provide the required services to meet the existing mission of USAMRIID. Cherokee Nation Assurance, LLC is the only known source that is able to meet this short-fused, short-timeframe requirement.

(6) Explanation of Unusual Patterns: Not Applicable

(7) Summary of Justification to Support Procurement: Not Applicable

b. Other facts. Prior to the RDSS Multiple Award IDIQ, past support services to USAMRIID divisions were provided by Ke’aki Technologies, Inc. under IDIQ contract W81XWH-08-D-0050. Contract W81XWH-08-D-0050 was awarded utilizing a Competitive 8(a) Small Business Set-Aside in accordance with the Small Business Act (15 U.S.C 631, et seq.) and FAR Part 19 Small Business Programs. The contract was a single award IDIQ labor hour contract with individual task orders.