HCA Signed R_D P03 Sole Source Justification 36C24E-25-AP-0175 - Research Services Affiliate HERL signed.pdf

Acquisition ID#: 36C24E-25-AP-0175

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C24E-25-AP-0175

1. Contracting Activity:

Department of Veterans Affairs Regional Procurement Office (RPO) East 1010 Delafield Road. Bldg. 32, Suite 1A111 Pittsburgh, PA. 15212

Requesting Activity:

VA Pittsburgh Healthcare System Human Engineering Research Laboratories (HERL) 6425 Penn Avenue, Suite 400 Pittsburgh, PA 15206-4022

Purchase Request: 646-25-1-5411-0005

2. Nature and/or Description of the Action Being Processed:

The Center for Wheelchairs and Assistive Robotics Engineering (WARE), a Rehabilitation Research and Development (RR&D) Center of the VA Pittsburgh Healthcare System, intends to negotiate on a sole source basis a new firm fixed price indefinite delivery requirements type contract with its academic affiliate, the University of Pittsburgh to provide research services to continuously improve the mobility and function of people with disabilities through advanced engineering in clinical research and medical rehabilitation. This acquisition is a continuation of services for contract 36C24E20C0005 with the University of Pittsburgh.

The WARE Center has established strong substantive and active collaborations with the University of Pittsburgh on specific projects critical to the VA Rehabilitation, Research and Development (RR&D) projects. Because of the high level of specialized research involved, and the conditional funding requirements of our VA WARE Center, the WARE Center requires contracted services with their primary academic educational affiliate, the University of Pittsburgh, who has substantive knowledge of Wheelchairs and Rehabilitation and Assistive Technology Engineering Research, and assistive robotics engineering particularly within the VA Pittsburgh Healthcare System.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

To achieve the mission of the HERL RR&D office, the VA Pittsburgh Healthcare System requires the University of Pittsburgh to provide critical services to assist in developing physical, medical-grade products, along with the merging of theory and application, and contributes to developing solutions for Veterans with disabilities by people with disabilities. The contracted services supplied by the University of Pittsburgh has developed highly specialized skills over the years and provides crucial continuity of research studies. The following tasks are functions to be performed by the University of Pittsburgh:

Task 1: Create a realistic representation and assemblies showing how components fit and function together.

Create and show parametric models with editable dimensions and features. Create exploded views illustrating internal components and/or mechanisms.

Task 2: Create and present detailed documentation of research findings, methodologies, and results. Present findings at conferences and in published papers. Create virtual environments to test the new devices under various conditions.

Task 3: Create well-documented datasets for future reference or collaboration. Mentor graduate and undergraduate students, and junior employees working on research projects.

Task 4: Prepares material, performs machining tasks, preparing CNC (Computer Numerical Control) and RP (rapid prototyping) machines for operation, prepare and start jobs on CNC and RP machines, cleaning machines between jobs, and replacing consumable components. Specific equipment includes SLS (selective laser sintering), SLA (stereolithography), FDM (fused deposition modeling), EDM (electrical discharge machining), CNC mills, CNC lathes, laser cutters/etchers, manual mills, and manual lathes.

Task 5: Test newly made devices in current projects.

Task 6: Completes front desk duties to administratively support the Clinical Coordinating team, the Education and Outreach team, and the Engineering team within HERL. These duties include ordering and tracking inventory, complete the Pitt/SHRS annual report, participate in the community and national recruitment events.

Title 38 U.S.C. 8153 allows for sole source awards related to research with VA academic affiliates. In this case, University of Pittsburgh is the primary academic affiliate of the VA Pittsburgh Healthcare System.

Due to the unknown extent and time of need, a Requirements type contract is being implemented. The estimated contract value for the total five (5) year contract is $4,381,678.85 with a period of performance from 05/01/2025 - 04/30/2030.

The pricing broken down per year:

Year 1 - (05/01/2025 - 04/31/2026): $836,906.44 Year 2 - (05/01/2026 - 04/31/2027): $853,645.00 Year 3 - (05/01/2027 - 04/31/2028): $874,986.00 Year 4 - (05/01/2028 - 04/31/2029): $896,860.00 Year 5 - (05/01/2029 - 04/31/2030): $919,282.00

4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

(X) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the

Use of the Authority Cited Above (applicability of authority):

The Human Engineering Research Lab (HERL), VA Center of Excellence WARE is the only center of its kind in the United States. HERL is a collaboration of the Department of Veterans Affairs and the University of Pittsburgh. The University of Pittsburgh is the Pittsburgh VA’s primary academic educational affiliate.

The high level of specialized research involved, requires an ongoing collaboration with the University of Pittsburgh to provide quality study analysis, which provides veterans with the best possible care. The University has the required substantive knowledge of Wheelchairs and Rehabilitation and Assistive Technology Engineering Research, and assistive robotics engineering particularly within the VA Pittsburgh Healthcare System and is necessary for the continuation of the WARE center’s research projects. In accordance with FAR Subpart 6.302-5, the proposed acquisition strategy is consistent with legal precedence for sole sourcing research related affiliate contracts in accordance with 38 U.S.C. 8153. 38 U.S.C.

8153(a)(3)(a) states, if the health-care resource required is a commercial service, the use of medical equipment or space, or research, and is to be acquired from an institution affiliated with the Department in accordance with section 7302 of this title, including medical practice groups and other entities associated with affiliated institutions, blood banks, organ banks, or research centers, the Secretary may make arrangements for acquisition of the resource without regard to any law or regulation (including any Executive order, circular, or other administrative policy) that would otherwise require the use of competitive procedures for acquiring the resource.

This is a continuation of the current contract 36C24E20C0005 with the University of Pittsburgh that provides critical research support to the HERL center. The experience and knowledge the University brings is highly specialized to facilitate the tasks required. The collaboration in technology leads to faster innovation and designs resulting in solutions that improve lives.

The University of Pittsburgh is the only vendor capable of providing the services described in Section III above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements. Because of the high level of specialized research involved, the ongoing collaboration with the University of Pittsburgh is vital to ensure consistency of the various on-going research projects.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Use of 38 U.S.C. 8153 does not require competition when the requirement is for research services from an academic affiliate of the Veterans Health Administration. The University of Pittsburgh’s current academic affiliation has been verified by the contracting officer (CO).

Acquisition history of the previous contract was reviewed; this is a continuation of services for contract 336C24E20C0005. A sources sought notice was not issued for the current contract per statute 38 U.S.C.

8153(a)(3)(A)

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The Contracting Officer will determine fair and reasonable pricing prior to award, through an analysis of the contractor’s submission of a schedule of costs for the firm fixed price line items. These prices have already been evaluated by the National Institutes of Health (NIH) and are considered reasonable as proven by the knowledge that these same services are provided in support of NIH funded research on a regular basis. As part of the Department of Health and Human Services, charges for the support of NIH funded research have been evaluated by the Division of Cost Allocation (DCA), which process proposals from various universities across the country including the University of Pittsburgh.

The University of Pittsburgh is a not-for-profit organization affiliated with the VA. Previous contracts have demonstrated that the anticipated price to the government will be fair and reasonable. The established pricing is published within the University website and the Contractor salaries will be compared to similar salaries located in the Pittsburgh area on sites to include the Consumer Price Index, the Bureau of Labor Statistics, Indeed.com, Payscale.com. or any other available information that the CO determines appropriate to make the determination. As a FAR 15 sole source procurement, the CO will negotiate as necessary to ensure that the contract awarded is fair and reasonable, and in the best interest of the Government.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A search was conducted in the Veteran Small Business Certification (VetCert) database using NAICS code 541720,which resulted in 653 SDVOSBs/VOSBs available. These vendors do not have the past experience or specialized knowledge from prior contracts that is required for these studies. A search was also conducted in the Small Business Administration Dynamic Small Business Search (SBA DSBS) using NAICS code 541720 with keywords “Rehabilitation Research”, which resulted in no small businesses available for this requirement. This is a collaborative research study with the University of Pittsburgh), an affiliated practice group with the VA Pittsburgh Healthcare System, no other vendors can be considered.

This study involves the University of Pittsburgh’s uniquely qualified research support to execute studies and developing physical, medical-grade products. The Human Engineering Research Laboratories (HERL) are a joint venture between the University of Pittsburgh's School of Medicine and the U.S. Department of Veterans Affairs as the VA Center for Wheelchairs and Rehabilitation Engineering.

38 U.S.C. 8153 allows for sole source awards related to research with VA academic affiliates. In this case, the University of Pittsburgh is the primary academic affiliate of VA Pittsburgh Healthcare System and is the only institution that can provide the research support with the prior knowledge and expertise required to meet the requirements and contribute to administrative and research operations for these research studies.

The recommendation is to sole source this requirement for specialized research data analyst support to the University of Pittsburgh.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

University of Pittsburgh - of the Commonwealth System of Higher Education 4200 Fifth Avenue Pittsburgh, PA 15260-0001 POC: Peter Hoegel Email: peh98@pitt.edu or peter.hoegel@pitt.edu Website: https://herl.pitt.edu/ / herl@groups.pitt.edu

The University is the VHA academic affiliate under 38. U.S.C. 8153

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

Given the unique nature of this requirement and the collaborative nature of the professional and scientific specialties involved in this research work, services must be met through the sole source provisions of FAR Subpart 6.302-5 (2) (i) which states that Full and Open Competition need not be provided for when a statute expressly authorizes or requires that the acquisition be made through another agency or from a specified source. No other actions are planned as University of Pittsburgh is the academic affiliate of the VA Pittsburgh Healthcare System.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and 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.

Andrew Gryskewicz Date Administrative Officer (AO) Human Engineering Research Laboratories (HERL)

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Ann Marie Stewart Date Contracting Officer Regional Procurement Office-East R&D

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Seth Custer Date Division Chief

Regional Procurement Office East

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

Gerald F. Jacobs Date Head of Contracting Activity, RPO-East

ANDREW

GRYSKEWICZ

Digitally signed by ANDREW

GRYSKEWICZ

Date: 2025.04.01 11:02:32 -04'00'

04/01/2025

04/01/2025

VHALEBCUSTES

Typewritten Text 4/1/2025