Sole Source Justification.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

National Institute for Occupational Safety and Health Respiratory Health Division Morgantown, WV Centers for Disease Control and Prevention Atlanta, GA 30341

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch #3

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Services to support NIOSH in improving participation in the Coal Workers’ Health Surveillance Program and enhancing communication about black lung screening and low-dose CT for lung health monitoring. The contractor will generate foundational audience insights, develop and refine communication strategies, validate optimized messages in a real-world setting, and produce an implementation ready toolkit for use by NIOSH and its partners.

b. Procurement Request (PR) Number (if available): 000HCCHD-2026-97923

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: West Virginia University

b. Estimated Procurement Amount: $150,000

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

Rev. 5/14/19

D. Justification:

1. The justification for this non-competitive action is:

☐ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency ☐ Exclusive licensing agreements/Proprietary data ☐ Brand name required ☐ Industrial mobilization ☐ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☒ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency ☒ Only One Source ☐ Logical Follow Up ☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The proposed contractor, West Virginia University (specifically, the Department of Cancer Prevention and Control within the WVU Cancer Institute), is the only source identified through market research that currently combines all of the specialized capabilities required for this procurement in one organization. This requirement is not for general survey support or general public health communications support. Rather, it requires a single contractor that can: (1) recruit active and retired coal workers in Central Appalachia through established regional partnerships; (2) conduct mixed-methods research on beliefs, attitudes, trust, confidentiality concerns, and screening decision-making related to black lung screening and LDCT; (3) develop theory-informed, evidence-based communication strategies tailored to Appalachian coal worker populations; and (4) validate those messages in a real-world clinical or community outreach setting tied to respiratory/lung screening services in Appalachia.

WVU is uniquely positioned because its CHATS Lab and Core (CHATS Lab and Core | School of Medicine | West Virginia University) are expressly organized around dissemination science, applied communication, and knowledge translation, and around translating research into practical strategies for real-world community use in Appalachia. WVU describes this model as an integrated cycle in which community-https://medicine.wvu.edu/cancer-prevention/population-science/chats-home/ https://medicine.wvu.edu/cancer-prevention/population-science/chats-home/ informed research is used to design, test, and implement communication approaches in actual service settings, rather than stopping at academic analysis alone. That expertise is directly aligned with the SOW, which requires not only characterization of coal miner perspectives, but also development of message concepts, qualitative message testing, field validation, and creation of an implementation-ready communication toolkit for NIOSH and partners. The Government needs a contractor that can move from formative research to message design to implementation testing, not a contractor that can perform only one or two of those steps. WVU also offers a capability that is especially important to this requirement’s LDCT component: its Cancer Prevention and Control program coordinates the LUCAS mobile lung cancer screening program, a real-world mobile LDCT screening operation serving rural West Virginia. LUCAS is a mobile LDCT unit that travels across rural West Virginia and is coordinated by this department. LUCAS has screened thousands of patients since 2021 and is integrated into an existing statewide rural screening infrastructure. That existing infrastructure matters because the SOW requires the contractor to assess perceptions of LDCT for lung health monitoring, refine communication materials, and then conduct field testing of the refined communication approach in partnership with a clinic, health system, or similar entity serving screening-eligible coal workers in Appalachia. WVU is the only source identified that combines Appalachian communication-science capability with an operational mobile LDCT screening platform under the same institutional umbrella. In addition, the SOW requires established community partnerships in Central Appalachia and experience collaborating with respiratory health screening programs in Appalachia. WVU works with hundreds of community partners across the state to bring cancer screening into rural communities, and its mobile screening program is designed specifically to reach underserved Appalachian populations. This existing field infrastructure substantially reduces performance risk for recruitment, outreach, and real-world message validation. For these reasons, WVU can provide an integrated service that other vendors cannot: a single-source capability to study Appalachian coal workers’ screening perceptions, translate those findings into theory-based messages, and validate those messages through existing operations and community partnerships in Appalachia. Based on current market research, no other identified source combines all of those required capabilities at the level of specialization and regional embeddedness required by this SOW.

b. What other products/services were considered and why did they not meet the need?

The Government considered other categories of potential sources, including: (1) black lung clinics and HRSA-funded respiratory clinics serving coal miners in Appalachia; (2) academic institutions with Appalachian health or lung cancer screening research experience; and (3) health systems with mobile LDCT screening capability. Based on market research, these alternatives did not meet the full requirement because they offered only portions of the needed capability.

1. HRSA-funded black lung clinics and regional respiratory clinics: The Government reviewed Appalachian black lung clinic resources, including HRSA-supported programs and state-supported clinic networks. These clinics clearly have important coal miner access and respiratory disease experience. For example, HRSA’s Black Lung Clinics Program funds clinics that provide outreach, education, screening, treatment, and benefits counseling for active and retired coal miners.

West Virginia’s black lung clinic network provides screening, diagnosis, outreach, rehabilitation, and counseling services to coal miners. Community Health of East Tennessee and Stone Mountain Health Services in Virginia provide black lung-focused outreach and respiratory care for coal miners. However, these clinics do not offer the full suite of services required in this SOW. They are care delivery and benefits-support entities, not integrated research-and-implementation centers with demonstrated expertise in dissemination science, message development, qualitative message testing, and implementation-ready health communication toolkit development. Selecting one of these clinics would require NIOSH to assemble multiple vendors or subcontractors to cover survey design, communication-science expertise, and implementation testing, increasing coordination burden, schedule risk, and risk of inconsistent methods.

2. Appalachian academic institutions with related research experience: The Government also considered academic institutions with research activity related to lung cancer screening or Appalachia. For example, the University of Kentucky has conducted work on lung cancer screening focused on knowledge, attitudes, beliefs, and social networks affecting lung cancer screening in Appalachian Kentucky. This demonstrates relevant subject matter expertise, but the Government did not identify the same integrated combination of capabilities required here, e.g.

embedded communication-translation infrastructure plus an operational rural mobile screening platform coordinated by the same program, plus demonstrated regional implementation capacity. Similarly, East Tennessee State University has deep Appalachian studies expertise, but the Government did not identify a comparable integrated program combining coal worker respiratory screening access, dissemination/communication science, and operational infrastructure.

Accordingly, while some academic institutions possess pieces of the requirement, the Government did not identify another academic source that combines all required elements in one place at the level of specialization and operational readiness offered by WVU. If one of these institutions were selected, NIOSH would likely need separate partnerships for screening operations, rural outreach infrastructure, or communication implementation support, increasing performance risk and reducing efficiency.

3. Health systems with mobile LDCT capability: The Government also considered institutions with mobile LDCT screening programs. Ohio State has a mobile lung cancer screening unit serving rural areas in Ohio, and the University of Tennessee Medical Center announced a mobile CT lung screening unit for East Tennessee.

These programs show relevant LDCT service capability. However, the Government did not identify that these entities also possess the required combination of:

established coal worker-specific partnerships across Central Appalachia;

demonstrated dissemination-science and applied health communication infrastructure tailored to Appalachian populations; and the ability to translate formative research into tested communication tools and validate them in the population of interest. Their capability appears centered on service delivery, not the integrated mixed-methods research, communication strategy development, and implementation-science work required here. If one of these LDCT providers were selected, the likely impact would be a contractor that could support screening logistics but not the full communication-research and implementation toolkit objectives of the SOW, requiring additional subcontracting or Government coordination and increasing the likelihood of schedule delay and fragmented deliverables.

3. Program Office efforts to seek potential offerors:

NIOSH conducted market research through direct communications and review of public-facing sources, including university and health system websites, HRSA Black Lung Clinics Program resources, and publicly available information on Appalachian black lung clinics, mobile LDCT screening programs, and academic programs with experience in Appalachian health communication and lung cancer screening. This review included assessment of whether potential sources could meet the full requirement for mixed-methods research, coal worker recruitment in Central Appalachia, communication strategy development, message testing, field validation, and implementation-ready toolkit development tied to LDCT and respiratory screening operations. The market research identified several organizations with partial capabilities, including black lung clinics with coal miner access, academic groups with some Appalachian lung screening research, and health systems with mobile LDCT capability. However, NIOSH did not identify another single source that already combines all required capabilities in one organization. Based on this review, West Virginia University was identified as the only source capable of providing the required services at the level of quality required and with acceptable performance risk.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: Tia McClelland/COR/Assistant Heath Services Officer

Center/Institute/Office COR/Program Official Signature:

Certification Date: June 16, 2026

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Timothy Williams

Contracting Officer Signature:

Certification Date: June 16, 2026