B04 - DF Consolidation_Scientific and Technical Research Support_GPE Posting_Redacted.pdf

DETERMINATION AND FINDING

COORDINATION AND APPROVAL PAGE

Purpose: Request approval from the Chief of the Contracting Officer (COCO) for consolidation of contract requirements determination for Scientific and Technical Research Support Services in support of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).

Title of Effort: Scientific and Technical Research Support Services

Contract Vehicle: The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to issue a firm-fixed price, sole source, 8(a) contract as a result of this consolidated requirement.

Requesting Agency: USAMRIID

Requirements POC: Microbiologist/Contracting Officer’s Representative

Contracting Activity: USAMRAA

Purchase Request/Local Identification Number: Purchase Request

Requirement Description: This requirement provides for scientific and technical research support services to the various sciences divisions at USAMRIID.

Estimated Cost/Price of the Action (including options) and type of funds: Total estimated value, inclusive of options, is . Army and Defense Health Program Research, Development, Test and Evaluation funds are anticipated for this action.

Authority: FAR Part 19.8

Type Determination: Individual

CONSOLIDATION OF CONTRACT REQUIREMENTS DETERMINATION

FOR SCIENTIFIC AND TECHNICAL RESEARCH SUPPORT SERIVES

RATIONALE

1. Consolidation may provide substantial benefits to the Government. However, because of the potential impact on small business participation, before conducting an acquisition that is a consolidation of requirements with an estimated total dollar value exceeding $2 million, a written determination shall be made that the consolidation is necessary and justified in accordance with 15 U.S.C. 657q, after ensuring that--

(a) Market research has been conducted;

(b) Any alternative contracting approaches that would involve a lesser degree of consolidation have been identified;

(c) The determination is coordinated with the agency's Office of Small Disadvantaged Business Utilization or the Office of Small Business Programs;

(d) Any negative impact by the acquisition strategy on contracting with small business concerns has been identified; and

(e) Steps are taken to include small business concerns in the acquisition strategy.

2. Introduction: The U.S. Army Medical Research Acquisition Activity (USAMRAA) plans to solicit offers for scientific and technical research support services in support of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) located at Fort Detrick, MD, and has conducted market research that demonstrates consolidation of this procurement to be both necessary and justified. Federal Acquisition Regulation (FAR) Part 2.101 defines consolidation as (1) a solicitation for a single contract, a contract, a task order, or a delivery order to satisfy-- (i) two or more requirements of the Federal agency for supplies or services that have been provided to or performed for the Federal agency under two or more separate contracts, each of which was lower in cost than the total cost of the contract for which offers are solicited;

or (ii) requirements of the Federal agency for construction projects to be performed at two or more discrete sites; or (2) "separate contract" as used in this definition, means a contract that has been performed by any business, including small and other than small business concerns.

This procurement, submitted under PANMRA-22-P-0000 002437, USAMRIID Scientific and Research Support Services, meets the definition corresponding to consolidation of requirements incorporating work currently performed under two separate task orders:

contract W81XWH-16-D-0002, task order 0003 and contract W81XWH-16-D-0005, task order W81XWH-19-F-0619.

In August 2017, contract W81XWH-16-D-0002, task order 0003 was awarded to Cherokee Nation Assurance, LLC for scientific and technical support services in support of USAMRIID. The task order was awarded with a period of performance of 07 September 2017 through 31 August 2020 (36 months) and a total award value of $40,948,453.08, Firm-Fixed Price. Following award, USAMRAA received a protest and a stop-work order was issued on 14 August 2017. The stop-work order was lifted on 05 March 2018 and the period of performance was adjusted to reflect 01 March 2018 through 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 and increased the total award value to $45,182,749.60; the option to extend the services was evaluated as part of the initial competition. On 26 August 2021 an eight and a half (8.5) month bridge was issued, via modification, to continue to provide the existing scientific and technical support services in support of USAMRIID in anticipation of award of the Defense Health Agency (DHA) OMNIBUS IV Multiple Award Indefinite Delivery Indefinite Quantity (MA-IDIQ) contracts. As a result of the bridge, the total task order value increased to $58,127,409.61. Specifically, the services being performed under this task order provide scientific research support to the USAMRIID Bacteriology (BACT) Division, Molecular Biology Division (MBD), Virology (VIRO) Division, Diagnostic Systems Division (DSD), Core Laboratory Services (CLS) Division, Core Support Directorate, Research Program Office and the BioSafety Office.

This task order was originally competed as a firm-fixed price, task order among the the USAMRIID Research and Development Support Services (ROSS) MA-IDIQ contract holders; four proposals were received in response to the solicitation.

In September 2019, contract W81XWH-16-D-0005, task order W81XWH-19-F-0619 was awarded to Laulima Government Solutions, LLC for aerobiology, animal clinical pathology, telemetry, medical, pathology, and core laboratory support services in support of USAMRIID. The task order was awarded with a period of performance of 30 September 2019 through 29 September 2021 (24 months) and a total award value of $9,472,198.76, Firm-Fixed Price. A 6-month option period was exercised on 19 August 2021, in accordance with FAR Part 52.217-8, and extended the period of performance end date to 31 March 2022 and increased the total award value to $9,948,148.43; the option to extend the services was evaluated as part of the initial competition. The Government intends to issue a one and a half (1.5) month bridge no later than 31 March 2022, via modification, to continue to provide the existing aerobiology, animal clinical pathology, telemetry, medical, pathology, and core laboratory support services in support of USAMRIID in anticipation of award of a sole source 8(a) award in accordance with FAR 19.8. As a result of the bridge, the total task order value is expected to increase to $10,305,071.03. Specifically, the services being performed under this task order provide scientific and technical research support to the USAMRIID Division of Medicine (DoM), Pathology Division, Core Laboratory Services Division (CLS), and Aerobiology, Animal Clinical Pathology and Telemetry Services (AAT). This task order was originally competed as a firm-fixed price task order among the USAMRIID Research and Development Support Services (ROSS) MA-IDIQ contract holders; three proposals were received in response to the solicitation.

The USAMRIID ROSS MA-IDIQ contracts were awarded as a result of a competitive 8(a) small business set-aside.

3. Description of the Procurement Action: This procurement provides for scientific and research support services to the various sciences divisions at USAMRIID. Services include, but are not limited to:

- Providing research support;

- Providing technical support for technology development and evaluation, and animal research protocols;

- Providing equipment maintenance and validation for Food and Drug

Administration (FDA) Good Laboratory Practices (GLP) compliance;

- Performing clinical pathology sample evaluation and reporting of data;

- Organizing study rooms with necessary equipment;

- Maintaining a current inventory of telemetry implants;

- Configuring hardware and software for data acquisition;

- Providing clinical and administrative support for clinical research programs associated with biological warfare defenses;

- Providing overall administration of medical and non-medical operations;

- Providing administrative and technical guidance with medical background;

- Working in conjunction with the various sciences divisions to project and identify research needs, develop and coordinate study protocols, and execute approved research projects;

- Providing scientific and technical support necessary to execute all aspects of the sciences divisions and USAMRIID's current missions;

- Providing FDA GLP expertise;

- Maintaining all laboratory equipment and supplies;

- Developing new ultrastructural and molecular pathology techniques ;

- Providing necropsy support in Biosafety Level (BSL) 2 - 4 containment;

- Being responsible for the overall performance of high complexity clinical and general laboratory testing in BSL 2 - 4 containment;

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

- 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 support to conduct viral pathogenesis research, viral biologyresearch, 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 (21 CFR) Good Laboratory Practices/Current Good Manufacturing Practices, 42 CFR 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 BSL 2 - 4 laboratories;

- 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;

- Provide technical and program management suite supervision support for BSL 2 - 4 containment suites;

- 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.

Various personnel providing services under this procurement will be required to be enrolled in the Army's Biological Personnel Reliability Program and will provide services within BSL 2 - 4 laboratory environments.

The new consolidated effort under consideration is for Scientific and Technical Research Support Services in support of the various USAMRIID sciences divisions located at Fort Detrick in Frederick, Maryland. The consolidation of the requirements will assist the Government in meeting mission objectives by reducing the administrative burden and removing duplicated performance task areas by the contractor, as well as minimizing the risks and vulnerabilities for the Agency by ensuring functional expertise required for mission success. The previous task orders were competed against the USAMRIID Research and Development Support Services (ROSS) Multiple-Award Indefinite Delivery Indefinite Quantity (MA-IDIQ). The ROSS MA-IDIQ was awarded as a result of a competitive, 8(a) Small Business set-aside. This procurement is intended to be awarded as a sole source award to an 8(a) small business in accordance with FAR 19.8, having little effect on set-aside concerns. The type of contract under consideration is a firm fixed price contract and will utilize North American Industry Classification System (NAICS) code 541714 with a size standard of 1,000 employees. The base period of performance for this acquisition is anticipated to begin on 20 May 2022 and continue through 31 March 2023. The proposed acquisition will contain two, 12-month option periods.

4. Results of Market Research: Market research has been conducted that demonstrates consolidation of this procurement to be both necessary and justified.FAR

2.101 defines consolidation as a solicitation for a single contract, a multiple-award contract, a task order, or a delivery order to satisfy- (i) Two or more requirements of the Federal agency for supplies or services that have been provided to or performedfor the Federal agency under two or more separate contracts, each of which was lower in cost than the total cost of the contract for which offers are solicited; or (ii) Requirements of the Federal agency for construction projects to be performed at two or more discrete sites. A separate contract as used in this definition, means a contract that has been performed by any business, including small and other than small business concerns.

In January and February 2022, USAMRAA engaged with knowledgeable individuals within the Government and identified five 8(a), small businesses who have previously provided similar services and have provided those services satisfactorily and in accordance with previous contracts. This RFI was issued for informational and planning purposes only, and the information was used to conduct market research to identify qualified, experienced, and interested potential 8(a), small business sources in support of the Government's requirements. In February 2022, a Request for Information (RFI) seeking information in the form of capability statements was issued, via email, to all five 8(a) small businesses.

Three 8(a) small businesses responded to the RFI: Chenega Professional & Technical Services, LLC (Chenega); Goldbelt Frontier, LLC (Goldbelt); and, Katmai Management Services, LLC (Katmai). All respondents were determined to be a certified, 8(a) small business under NAICS Code 541714; have an active System of Award Management (SAM) registration; have no active exclusions in SAM; and, have updated Representations and Certifications in SAM.

Each capability statement was evaluated by USAMRIID, specifically the Contracting Officer's Representative and the Chief, Acquisition & Manpower Branch. The purpose of the evaluation was to make an informed decision on the capabilities and possibilities of an 8(a), small business satisfactorily performing and delivering the required services as the prime contractor.

5. Benefit Analysis: Contract support within the USAMRIID sciences divisions is currently provided by the following two separate contracUtask orders: W81XWH-16- D-0002/0003, Scientific Research Support Services, and W81XWH-16-D-0005/ W81XWH-19-F-0619, Aerobiology, Animal Clinical Pathology, Telemetry, Medical, Pathology, and Core Laboratory Support Services. The Sciences Divisions' consolidated contract will be of critical importance to USAMRIID's mission and the overall U.S. Army Medical Research and Development Command's (USAMRDC) mission. Consolidating these task orders will increase cost-efficient use of resources; adhere to a schedule for meeting the Sciences Divisions' and USAMRIID's mission; and, reduce the current amount of Government oversight and administrative burden associated with managing two task orders. Managing two separate task orders requires 28 deliverables per month and at least two (2) meetings per month from two (2) separate contractors. When consolidated, the Government anticipates 12 deliverables per month and one (1) meeting per month from only one contractor. Additionally, consolidation of these two task orders under one company will allow movement of positions across divisions in response to workload fluctuations, crisis response, maximizing task support and minimizing redundancy in active and surge requirements.

The Government is anticipating efficiencies and improvement of performance by consolidating technical support with functional expertise. It is anticipated that the new, consolidated scope will provide synergy for the requirements, and ultimately the overall mission, by avoiding overlap in tasking and eliminating confusion. Further benefits to this strategy include cost savings by decreasing the surge capability and reducing contractor management oversight. The total award value for task order W81XWH-16-D- 0002/0003, which included a base period of 12 months and two, 12-month option periods for a total of 36 months, was $40,948,453.08. The total award value for task order W81XWH-19-F-0619, which included a base period of 12 months and one, 12-month option period for a total of 24 months, was $9,472,198.76. The combined total award value for both task orders was $50,420,651.84.

If task order W81XWH-19-F-0619 would have been executed for three (3) years using an inflation factor of 2.0% for the third year, the total estimated award value would have been, approximately, $14,349,541.37. The total award value for both task orders combined would have been, approximately, $64,770,193.21.

The work performed under both task orders is very similar in nature and it will benefit USAMRIID and its Sciences Divisions to consolidate the two efforts into one new requirement. The overall result of consolidating the two task orders into one 8(a) small business award is estimated at for three years. By consolidating the two task orders, it is estimated that the Government would receive a cost savings of approximately $15,672,049.02 or 24%. This estimate does not take into account the pricing on the current two task orders was provided five (5) years ago and inflation rates have increased significantly over the last five (5) years. Thus, the Government's cost savings are estimated to be higher than $15,672,049.02.

6. Alternative Contracting Approaches and Rationale for Rejection: The alternative contracting approach would be to continue with two (2) separate contracts, which increases the contract overhead costs and the administrative burden to manage those contracts. Separate contracts required twice the amount of deliverables, meetings, invoices, contract surveillance and modifications.

As stated in paragraph 5, above, the Government is anticipating efficiencies and improvement of performance by consolidating technical support with functional expertise. It is anticipated that the new, consolidated contracts will provide synergy for the requirement, and ultimately the overall mission, by avoiding overlap and conflicts in tasks and labor categories, eliminating confusion. Historically and currently, the two task orders have areas of similar tasks and scope that introduce confusion with regard to tasking and responsibilities. If no consolidation is undertaken this confusion would continue, especially if the task orders were again awarded to two different contractors.

Consolidating would help ensure a more cohesive team approach within USAMRIID and its sciences divisions.

There are no viable alternative contracting approaches that would involve a lesser degree of consolidation at this time. As indicated above, this requirement is being consolidated to align services under one requirement to improve efficiencies and reduce costs.

7. Bundling: In accordance with FAR Part 2.101, "Bundling," this procurement does not meet the criteria associated with contract bundling. Although both task orders are currently being performed by 8(a) small businesses, the intent is to award the consolidated procurement to another 8(a) small business. Thus, the consolidated procurement has been determined to be suitable for award to a small business and is therefore not considered "bundling".

8. Considerations, Facts, Reasoning Supporting the Determination: In addition to the justification provided, the Small Business Coordination Record (DO2579) will also be submitted to be approved/concurred by the Small Business Specialist and Procurement Center Representative (PCR) prior to soliciting for the consolidated procurement.

9. Summary: Consolidating contract/task orders W81XWH-16-D-0002/0003 and W81XWH-16-D-0005/W81XWH-19-F-0619 will reduce the duplication of effort and increase the efficiency of work within the USAMRIID Sciences Divisions. The alternative contracting approach would be to continue with two (2) separate contracts, which increases contract overhead costs and the administrative burden to manage those contracts. Separate contracts require twice the amount of deliverables, invoices, meetings, and contract surveillance. As previously mentioned, the consolidation of these task orders will provide the Government an approximate cost savings of $15,672,049.02 or 24%. In addition, the consolidation of these task orders will result in the savings of at least one (1) meeting per month and 16 deliverables per month.

10. Program Manager/Requiring Activity Justification: Pursuant to AFARS Part 5119.202-1(1), I hereby support the consolidation of the requirements from contract/task orders W81XWH-16-D-0002/0003, for scientific research support services, and W81XWH-16-D-0005/W81XWH-19-F-0619, for aerobiology, animal clinical pathology, telemetry, medical, pathology, and core laboratory support services, into one consolidated effort entitled USAMRIID Scientific Research and Technical Support Services (SRTSS).

DETERMINATION

Based on the foregoing rationale, I hereby determine, pursuant to the FAR Part 7.107-2 and AFARS Part 5107.170, that the consolidation of the requirements for USAMRIID Scientific Research and Technical Support Services (SRTSS) is both necessary and justified and will serve the best interests of the Government.

The Senior Procurement Executive has delegated authority to make the consolidation determination prescribed at FAR Part 7.107-2 and AFARS Part 5107.107-2(b)(ii) as follows:

Where the total value of the consolidated procurement is above $2 million but less than $500 million, the HCA delegated to the SCO to make the determination.