B04 - DF Coordination and Approval Page FINAL W81XWH-22-R-0038 REDACT 2.0.pdf

CUI

DETERMINATION AND FINDING

COORDINATION AND APPROVAL PAGE

Purpose: Request approval from Thea R. Maddox Hofgesang, Senior Contracting Official (SCO) to issue a Firm-Fixed Price contract for the purchase of Clinical Studies and Health Applications Systems Support. Clinical Studies contract has existing Health Information Technology (HIT) services and would benefit the government to absorb separate IT contract into one contract.

Title of Effort: Clinical Studies and Health Systems Applications Support

Contract Vehicle: Solicitation #W81XWH-22-R-0038

Requesting Agency: DHA-PH-Immunization Healthcare Division

Requirements POC: Joyce Simon, Contracting Officer’s Representative (COR), Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA)

Purchase Request/Local Identification Number:

Requirement Description: This is a non-personal services contract to support vaccine safety and evaluation studies and management of the related IT health systems applications. To include, but not limited to, providing project management, design, programming, technical support services, analysis, and supervision for DHA IHD Systems Management Modules.

Estimated Cost/Price of the Action (including options) and type of funds:

Authority: 15 U.S.C. 657q; FAR 7.107

Type Determination: Individual

Contracting Officer

Controlled by: Army CUI Category: Source Selection Information Distribution/Limited Dissemination Control: FED ONLY POC: Barton J. Vint, 301-619-3689

Operations and Maintenance $17,187,622.70 (Including all Options and evaluated FAR 52.217-8), FY22 DHP

GFEBS PR #0011764357

910- 432-4015

Reviews: I have reviewed this D&F and find it adequate to support the findings as stated.

Acquisition Law Attorney

Chief of Contracting Office

Deputy Director/Command Advocate for Competition

CONSOLIDATION OF CONTRACT REQUIREMENTS DETERMINATION

FOR CLINICAL STUDIES AND HEALTH SYSTEMS APPLICATIONS SUPPORT

(As prescribed by FAR 7.107-2 and AFARS 5107.107-2)

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 United States Army Medical Research Acquisition Activity (USAMRAA) plans to solicit offers for Defense Health Agency (DHA) Clinical Studies and Health Systems Applications Support services at multiple locations to include: Fort Bragg, NC, Bethesda, MD, Joint Base San Antonio, TX, and San Diego, CA; and has conducted market research that demonstrates consolidation of this procurement to be both necessary and justified. FAR 2.102 defines consolidation as (1) 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 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 requirement, submitted under CAE-22- 07958, Clinical Studies and Health Systems Applications Support, meets the definition corresponding to consolidation of requirements incorporating work currently performed under two separate contracts: contract HT0011-16-C-0014 support services for Immunization Healthcare Clinical Studies and contract HT0011-16-C-0009 Immunization Healthcare Branch Information Technology (IT) Health Systems Applications and Management Support.

3. Description of the Procurement Action: The Government's requirements described in the Performance Work Statement (PWS) of Contract HT0011-16-C-0014 and HT0011-16-C-0009, which expired on 26 August 2021 and 15 September 2021 respectively, are currently being met by the short-term bridge contracts HT0011-21-F- 0092 and HT0011-21-F-0093 which will continue to meet the Government's needs until this new consolidated requirement is put into place.

Contract HT0011-16-C-0014 was for support for Immunization Healthcare Clinical Studies. The contract was awarded to MD Consulting LLC with a Period of Performance (POP) of 27 February 2016 through 26 February 2021. The objective of this contract was to provide clinical, laboratory, statistical, and informatics support to develop and conduct studies to improve vaccine safety, acceptability, and effectiveness.

Contract HT0011-16-C-0009 was for support for Immunization Healthcare Branch IT Health Systems Applications and Management. The contract was awarded to Link Solutions, Inc., with a POP of 16 March 2016 through 15 March 2021. The objective of the contract was to provide project management, design, programming, technical support services, analysis, and supervision for the DHA Public Health (PH) Immunization Healthcare Division (IHD) Systems Management Modules.

The new consolidated effort under consideration is a non-personal services contract to provide Clinical Studies and Health Systems Applications Support. Specifically, the contract will provide support for Vaccine Safety and Evaluation studies, to include the management of the related IT health systems applications based on the requirements of ongoing, emerging, and evolving vaccine safety and evaluation studies. Services include but are not limited to developing and coordinating protocols, submitting protocols to Institutional Review Boards (IRB) for review and approval, recruiting, obtaining consent, and enrolling study subjects, providing lab expertise and support, providing clinical expertise, providing informatics support, conducting data management, quality control, and statistical analyses, and writing and editing posters, presentations, and manuscripts to communicate study findings.

This contract will support critical study requirements located at all Immunization Healthcare Division (IHD) Regional Vaccine Safety Hubs (RVSH) and satellite locations.

Additionally, support of potential IHD vaccine safety and evaluation studies at To Be Determined (TBD) locations, by way of the two Optional PWS Tasks and related CLINs depending on studies magnitude. This contract is also necessary to provide for the updating of existing systems and provide new IT functionality to cover existing and new system development, as well as new functionality for integrated new, yet undefined, systems related to vaccine clinical studies/and integrated efforts with the Centers for Disease Control (CDC) in support and response to unknown vaccine-related emergency requirements, responding to urgencies such as emerging pandemic threats. As system updates and new functionality are identified, this contract will ensure timely and quality delivery of both system updates and systems development.

Currently, studies are taking place at all IHD RVSHs, at the following Military Treatment Facilities: Walter Reed National Military Medical Center (WRNMMC) at Bethesda, MD;

Womack Army Medical Center (WAMC) at Fort Bragg, NC; Wilford Hall Medical Center (WHMC), San Antonio, TX; and Naval Medical Center San Diego (NMCSD), San Diego, CA. Studies are also proposed at locations such as Carl R. Darnall Army Medical Center, Fort Hood, TX, where the IHD has a satellite site, as well as other military medical facilities, inclusive of Army, Air Force, Navy, and Marine Corps facilities, to enroll service members and their beneficiaries.

The consolidation of the requirements will assist the Government in meeting mission objectives by reducing overall price and administrative burden, minimizing confusion in regards to tasking and responsibility, as well as minimizing the risks and vulnerability for the Agency by ensuring functional expertise to make certain of mission success as the tasks of the two consolidated contracts are highly dependent on each other and the current structure is inefficient. Combining these two requirements above into a single Firm Fixed Price (FFP) contract will be more beneficial for both the Government and for small business. The requirement has grown in scope, magnitude and complexity from the original two awards; however, the Government market research indicates that this consolidated requirement can still be met by small business, despite the overall value of the contract nearly doubling while reducing risk to both contractor and Government.

The current contracts are awarded to two different small businesses. Both are necessary from a clinical studies and IT perspective to complete the mission. The IT contract is directly connected to the Clinical Studies contract because the efforts exist only to complement and support the Clinical Studies projects. The current Clinical Studies contract has PWS Tasks supported by a single FTE for a Health Informatics Manager who works directly with the other contractors to maintain the systems and databases that correlate with the various studies they facilitate under the two contracts.

The IT contract itself will be consolidated with the other Clinical Studies contract. This performance based contract is written for a single FTE and consolidating the two contracts will increase efficiencies and optimize performance.

As discussed above, the value of the new contract is estimated to be approximately twice the value of the previous requirements combined. The monthly price of the current two contracts are as follows:

Monthly Value for HT0011-16-C-0014 = $64,767.25 Monthly Value for HT0011-16-C-0009 = $24,862.81 Total monthly value for current contracts = $89,630.06 New IGE Estimated Monthly Amount= $286,460.38 *Note: Contracting Officer shows Monthly Rate as the Periods of Performance for the Bridge contract are significantly shorter than the new requirement, and a view of the total contract values would not represent the changes in a meaningful way.

There are no regional or national contract implications from this consolidation. The previous contracts were both 8(a) directed awards and this requirement will also be an

8(a) directed award, having little effect on set-aside concerns. It is anticipated there will be small business subcontracting opportunities, however these are not required as the Government’s intention is to make this an 8(a) directed award. The type of contract under consideration is a Firm Fixed Price (FFP) contract.

The base POP for this acquisition is anticipated to begin on 27 August 2022 and continue through 26 February 2023. The proposed acquisition will contain a Base Period of six (6) months as well as four (4) twelve (12) month Option Periods and will allow for an optional clause 52.217-8, Extension of Services to be evaluated. The estimated total value of the proposed acquisition is $17,187,622.70.

The North American Industry Classification System Code (NAICS) being used for the new requirement is 541990: All other professional, scientific, and technical services, with a size standard of $17,000,000.

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

2.102 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 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 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 November 2021, USAMRAA, on behalf of the IHD, issued a Request for Information (RFI) seeking information in the form of capabilities statements and availability from capable small business contract holders under the NAICS code of 541990 – All Other Professional, Scientific, and Technical Services. This RFI was posted from 9 November 2021 - 19 November 2021.

This RFI was issued in support of Clinical Studies and Health Systems Applications Support of the DHA Immunization Healthcare Division. 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 small business sources in support of the Government's requirements. Interested contract holders were required to submit the following information as part of their capabilities statements:

1. Please describe or provide examples of your ability to facilitate writing and development of clinical studies protocols, as well as perform recruitment, enrollment, specimen collection, handling, and shipment; collect, analyze, and interpret data;

and all other activities required in order to execute vaccine safety, effectiveness, and acceptability studies within the Military Health System (MHS), or other large civilian, research, or academic medical centers. Be specific about the scope of your support and your role (Prime vs Subcontractor).

2. Please describe or provide examples of your ability to perform all regulatory tasks related to clinical studies protocols. For example, please demonstrate your company’s experience with writing and submitting protocols, continuing review reports, reportable event forms, consent forms, HIPAA authorizations, Data Sharing Agreements, Business Agreements, and other relevant clinical studies and regulatory submissions. Be specific about the level of Government sponsor(s), Government staff participating, methodology used and tasks completed, impact to the organization, and your role (Prime vs Subcontractor).

3. Please describe your company’s ability to plan, define, develop, revise, and implement existing healthcare information management systems, equipment and services to benefit the Immunization Healthcare Division. Please describe or provide examples of your ability to provide secure solutions to complex data management and reporting challenges, including but not limited to, creating data forms, clinical data tracking systems, development of online survey distribution tools, etc. Be specific about the level of Government sponsor(s), Government staff participating, methodology used and tasks completed, impact to the organization, and your role (Prime vs Subcontractor).

4. Please demonstrate your company’s ability to recruit, hire, and retain specialized, qualified clinical studies personnel who can carry out the tasks listed in the Performance Work Statement. Please provide specific examples of your ability to partner with non-profit organizations that are able to recruit more specialized scientific personnel such as Research Physicians, Nurse Practitioners/Physicians Assistants, skilled Clinical Research Nurse Coordinators, etc. Be specific about the level of Government sponsor(s), Government staff participating, methodology used and tasks completed, impact to the organization, and your role (Prime vs Subcontractor). Furthermore, your ability to team with subcontractors that can meet the unique staffing needs of this requirement, to include non-profit contracts.

Ten (10) small businesses responded to the RFI: Cherokee Nation Strategic Programs, Eagle Global Scientific, LLC, Eagle Health, EP360, GiaCare, Glacier Support Services, LLC, MDC Global Solutions, MDM Technologies, LLC, MicroHealth, and Vista Global Solutions. Seven (7) out of the ten (10) small businesses were 8(a)’s. The capability statements were forwarded to the COR on 19 November 2021 for assessment. The COR returned the RFI assessment on 1 December 2021 and indicated that out of the 10 responses received, at least five (5) were deemed capable of performing the PWS tasks based on their responses to the RFI information request. Five (5) out of the five

(5) deemed capable were 8(a)’s. The market research conducted including the RFI led us to believe that 8(a) companies could meet the Government’s requirement and do the work to a higher level than what was currently performed.

To gain further knowledge of the interested party’s capabilities, USAMRAA worked with the IHD team to pick two 8(a) Business Development companies that had presented the strongest information and represented what we believed to have the lowest risk, and seek additional information through a telephone meeting. The first company was Cherokee Nation Strategic Programs (CNSP), an 8(a) Tribally Owned firm. The second company was Glacier Support Services (GSS), LLC, an 8(a) Alaskan Native Corporation (ANC). Both meetings were held on 10 December 2021 and were one hour in length. After meeting with the two companies, the IHD team concluded that both GSS and CNSP were really good choices for them, but after the phone conversations, the IHD team felt GSS was much more versed in vaccine safety and effectiveness studies, which is what most of their clinical studies are focused towards. They also seemed to have more experience and familiarity with the databases and applications that are used in research. They articulated their grasp on the projects better than CNSP. For clarification, CNSP was never found to be "Unacceptable"; rather the market research indicated that GSS was the least risk for an 8(a) directed award and was therefore selected by the Contracting Officer.

It is important to note that the Government did consider the current contractors, Link Solutions (Prime Contractor) and their subcontractor MDM Technologies and MD Consulting Global Solutions, LLC. MDM Technologies has done the work on the smaller IT contract since about 2002. They are actually subcontracted by Link Solutions. MDM Technologies did respond to the RFI and the evaluation team commented, "No Clinical experience, current IT Incumbent, would recommend subcontract." The program office would like for the next company to consider subcontracting them again for the IT side.

Link Solutions itself hasn't performed any of the work, as they relied wholly on MDM Technologies to complete it; therefore the IHD team is wary about Link Solutions taking on an even broader contract with more than just IT support such as the consolidation.

For context, the smaller IT contract is currently one (1) FTE; however, the new contract will see even this smaller aspect of the contract grow considerably and the growth of the consolidated contract is magnitudes greater and more complex. While Link Solutions has performed well, their 100% subcontracting of the work to MDM Technologies and the limited experience with the combined work leaves a great deal of risks that makes them a high risk choice as a prime contractor for the consolidated and vastly expanded requirement.

MD Consulting Global Solutions, LLC., is the current vendor for the Clinical Studies contract (the larger of the two contracts that are being consolidated) and they did respond to the RFI as well. In the evaluation, the team noted "Does not mention participant recruitment, enrollment, or any vaccine safety. IT portion is reflecting work subcontracted to MDM Technologies. Does not discuss retention perhaps why they have a bad turnover rate currently." This contractor has had issues with hiring and retaining qualified clinical personnel. Unfortunately, these issues continue to persist and they affect the productivity of the contract. While the contract’s performance is "Satisfactory," the continuous and repeated issues with recruitment and retention constantly threaten to make their performance "Marginal". Simply put, the program office is ready for a change, and believe their requirement could be performed consistently at a higher level. Therefore, USAMRAA conducted market research as thoroughly as possible to ensure that we could select an 8(a) that would meet and hopefully exceed their performance metrics.

5. Alternative Contracting Approaches and Rationale for Rejection: One alternative contracting approach would be to continue with two (2) separate contracts, which increases contract price, risk of unsuccessful contract performance and the administrative burden to manage those contracts.

The Government is anticipating efficiencies and improvement of performance by consolidating IT support with clinical expertise. It is anticipated that the new, consolidated scope will provide synergy for the requirement, and ultimately the overall mission, by avoiding overlap, conflicts with tasking, and eliminating confusion. Currently, the two contracts have areas of similar scope that introduce confusion with regard to tasking and responsibilities. If no consolidation is undertaken this confusion would continue, especially if the contracts were again awarded to two different contractors.

Consolidation would ensure a more cohesive team approach.

There are no viable alternative contracting approaches that would involve a lesser degree of consolidation at this time due to the minimal performance level on one of the contracts (Only a single FTE on the IT contract), it would be impossible to consolidate any more or less than proposed. As indicated above, this requirement is being consolidated to align services under one requirement to improve efficiencies and reduce costs and risk.

6. Consolidation Benefit Analysis: Contract support within the IHD is currently provided by the following two contracts: HT0011-16-C-0014 Immunization Healthcare Clinical Studies support and HT0011-16-C-0009 Immunization Healthcare Branch IT Health Systems Applications and Management support. Consolidation provides the opportunity for the Contractor to support the DHA as a whole rather than many Contractors supporting separate actions. The IHD’s consolidated contract will be of critical importance to the DHA and to the overall MHS mission. Consolidating these contracts will increase cost-efficient use of resources, adhere to a schedule for meeting the IHD’s mission and long-term goals; and reduce the current, large amount of Government oversight and administrative burden associated with managing two contracts.

As described in section #3, the two requirements which will be consolidated have changed significantly in magnitude, volume and price, such that the estimated value of the new requirement is approximately double the value of the two previous requirements when combined. As both requirements would grow significantly if not combined, the additional cost of keeping both contract separate is estimated to be at least 5% more expensive than combining the requirement. This additional cost would primarily be a result of additional program management and contractor oversight on the IT requirement as performance of the current unconsolidated requirement is struggling to meet the Government’s minimal PWS requirement. The current IT contract has a single FTE and with the increased scope, and performance issues, the Government would need to add some Program Management functions to the contract to reduce risk of continued poor performance. This additional cost would be an estimated 20% increase to the price of the IT requirement and 5% of the overall price of the combined requirements. It is the Contracting Officer’s intent to meet the requirement as an 8(a) directed award; therefore, the Government will benefit from a more efficient and logically structured contract. This efficient contract would combine related services and reduce both Government administrative burdens and risk of unsuccessful performance as the IT tasks of the smaller two contracts are so inter-dependent to the performance of the Clinical Studies that it increased risk that both small business contractors would fail due to delays caused by having the requirements separate.

The smaller of these two contracts for Immunization Healthcare Branch IT Health Systems Applications and Management support has PWS Tasks which are logically related to the scope of the Clinical Study requirement. Many of the administrative requirements of the contract and some of the specific tasks are redundant and inefficient to have on two separate contracts. Consolidating those tasks benefit the Government by reducing the duplicate oversight required under two awards administered separately by both Government and contractor.

The Government would also realize reduced administrative costs associated with both pre-award and post-award administration. When consolidated, the Government anticipates ten (10) quarterly deliverables and one (1) meeting per month from one contractor. Additionally, this consolidation effort will allow for the Government to obtain the stability and strength required to respond to the need for new functionality for integrated, yet undefined, systems related to vaccine clinical studies/and integrated efforts with CDC in support and response to unknown vaccine-related emergency requirements responding to urgencies such as emerging pandemic threats.

7. Bundling: In accordance with FAR 2.101, "Bundling," this requirement does not meet the criteria associated with contract bundling. This is not a bundled requirement as the consolidated contracts were performed by small businesses and the proposed contract is suitable for award to one or more small business concerns.

8. Considerations, Facts, Reasoning Supporting the Determination: In addition to the justification provided, the Small Business Coordination Record (DD2579) will also be submitted to be approved/concurred by the Small Business Specialist and Procurement Center Representative (PCR) prior to soliciting for the consolidated requirement. In addition, approval will be sought from the Small Business Administration

(SBA).

9. Summary: The consolidation of contracts HT0011-16-C-0014 and HT0011-16-C- 0009 will assist the Government in meeting mission objectives by increasing the efficiency of work, reducing administrative burden, and removing duplicated performance task areas by the contractors. In addition, consolidation will assist in minimizing the risks and vulnerability for the Agency by ensuring functional expertise to make certain of mission success as the tasks of the two consolidated contracts are highly dependent on each other. Consolidation will enable efficiencies within the current structure. The Government and small business benefit from combining these growing requirements and reduce risk to both Government and contractor.

Request approval from Thea R. Maddox Hofgesang, Senior Contracting Official (SCO) to approve a FFP contract for the acquisition of Clinical Studies and Health Applications Systems Support. Clinical Studies contract has existing Health Information Technology (HIT) services and would benefit the Government to consolidate separate IT and Clinical Study requirements into a single contract.

10. Program Manager/Requiring Activity Justification: Pursuant to AFARS 5119.202-1(1), I hereby support the consolidation of the Clinical Studies and Health Applications Systems Support.

Joyce Simon Contracting Officer’s Representative

11. Office of Small Business Program Coordination: Pursuant to FAR 7.107-2(a)(3), I agree that a consolidated requirement for Clinical Studies and Health Applications Systems Support is justified and necessary.

Jerome Maultsby Office of Small Business Programs

DETERMINATION

Based on the foregoing rationale, I hereby determine, pursuant to the Federal Acquisition Regulation 7.107-2 and Army Federal Acquisition Regulation Supplement 5107.107-2, that the consolidation of the requirements for Clinical Studies and Health Applications Systems Support is both necessary and justified and will serve the best interests of the Government.

Thea R. Maddox Hofgesang Senior Contracting Official