P03 Sole Source Justificaion 36C24E-22-AP-0855 - CTSI - Salt Lake.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C24E-22-AP-0855

1. Contracting Activity:

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

Requesting Activity:

Department of Veterans Affairs George E. Wahlen, VA Medical Center Research Office 500 Foothill Blvd Salt Lake City, UT 84148

2237: 660-23-1-3205-0002

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

The George E. Wahlen, VA Medical Center Research Office intends to negotiate on a sole source basis a new firm fixed price Indefinity Delivery Indefinite Quantity (IDIQ) contract with the University of Utah, its primary academic affiliate, to support the US Department of Veterans Affairs (VA) research office. This requirement is for the University of Utah Clinical & Translational Science Institute (CTSI)'s Clinical Research Unit (CRU) to provide human subject research services to the Salt Lake City VA, research department through an established service recharge center.

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

The Utah CTSI provides scientific infrastructure and services to support clinical and translational research. The Utah CTSI’s Cores and Services develop and deliver innovative methodologies, tools, and resources to assist investigators at every stage of the research lifecycle.

The Utah CTSI offers fee-for-service support through its four service recharge centers:

• Clinical Research Unit

• Cellular & Translational Research Core

• Biomedical Informatics Core

• Community Collaboration & Engagement Team

The estimated amount for these supplies/services is $658,693.00 for a five-year IDIQ contract. The period of performance is from: 04/01/2023 through 03/31/2028.

The pricing for each item or service used is published on the University website for each service recharge center. This pricing will be included in the IDIQ contract. Task orders will be placed against the IDIQ contract as services are required.

36C24E-22-AP-0855 University of Utah Clinical & Translational Science Institute (CTSI)

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 University of Utah Center of Translational Science Institute (CTSI) provides highly specialized scientific infrastructure and services to support clinical and translational research. The Clinical Translational Science Institute (CTSI)’s Clinical Research Unit (CRU) provides space and nursing services for assistance in the performance of human subject research, including venues that can support the most complex and intensive inpatient and outpatient protocols. CRU’s staff receives specialized training to facilitate research protocols that range from simple outpatient encounters to intensive studies requiring invasive procedures and multiple-day hospital admissions. Due to the precise expertise required by the VA, proximity, and existing affiliate relationship, they are the only vendor practical, without experiencing substantial duplication in costs or delays to VA research.

Furthermore, since the University of Utah is an academic affiliate, the VA is authorized to procure these services pursuant to 38 U.S.C. 8153 described below in number 6.

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

FAR 6.302(a)(2)(i) states, Full and open competition need not be provided when a statue expressly authorized or requires that the acquisition be made through another agency or from a specified source. In accordance with 38 U.S.C. 8153 (a)(3)(A): “If the healthcare 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 procedure for acquiring the resource."

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

Reasonable:

The University of Utah is a not-for- profit organization affiliated with the VA. Previous contracts have demonstrated that the anticipated cost to the government will be fair and reasonable. The established pricing is published within the University website for each of the four service recharge centers and the VA will pay the same rates as University of Utah staff, students, and any other approved user of the centers. The Contracting Officer anticipates the price noted in #3 above to be fair and reasonable; however, price negotiations may be conducted if the CO determines this is necessary.

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 VA’s VIP database using NAICS code 541714, PSC code AN11, and keywords Health Science Research, which resulted in 0 SDVOSB’s and no VOSB available to meet this requirement. A search was also conducted in the Small Business Administration Dynamic Small Business Search (SBA DSBS) using NAICS code 541714 with keywords Health Science Research, which resulted in no small businesses available for this requirement.

This is a collaborative research effort with the affiliated practice group the University of Utah, no other vendors can be considered. The research involves the university’s unique CTSI managed CORE services, which provides scientific infrastructure and services to support clinical and translational research. The Utah CTSI’s Cores and Services develop and deliver innovative methodologies, tools, and resources to assist investigators at every stage of the research lifecycle. The University of Utah CTSI CORE services are a critical part of the investigators research studies.

38 U.S.C. 8153 allows for sole source awards related to research with VA academic affiliates. In this case, the University of Utah is the primary academic affiliate of the Salt Lake City VA, research department and has several CORE groups that the investigators need to utilize during their research studies.

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

The mission of the VA is to discover knowledge and create innovation that advances health care for our Veterans and the nation. VHA is the country’s largest integrated health care system and as such, it embraces close ties to its academic affiliates by partnering on common research interests and leveraging resources. The George E. Wahlen, VA Medical Center and the University of Utah are one of many examples of this strategic academic affiliate partnership recognized by the Secretary of the

VA.

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

The University of Utah 201 Presidents Cir Salt Lake City, UT 84112-9049 Brent Brown, brent.brown@osp.utah.edu

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:

None, there are no other potential sources that can meet the specified requirement due to the highly specialized research services required for this procurement.

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.

Elizabeth Tilley Date Acquisition & Utilization Specialist/COR VA Salt Lake City, Research Office

ELIZABETH

TILLEY

Digitally signed by

ELIZABETH TILLEY

Date: 2023.02.09 12:37:53 -07'00' 02/09/2023

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

a. Contracting Officer or Designee’s 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 Office 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

02/29/2023

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