Patient Recruitment- Recompetition

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) The availability and capability of qualified small business sources; (2) Whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) Their size classification relative to the North American Industry Classification System (NAICS) code 541690. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. A. Background The purpose of this contract is to assist the National Institute of Allergy and Infectious Diseases (NIAID) investigations of infectious and inflammatory diseases by facilitating patient recruitment both locally and nationally. This is primarily accomplished by: 1. Establishing and maintaining written collaborative relationships with community-based, public health and hospital-based clinics in the Washington-Baltimore metropolitan area within 50 miles of the National Institutes of Health (NIH), Bethesda campus. The purpose of such relationships is to promote recruitment of eligible patients into various NIAID clinical studies. Immigrant populations served by health facilities within this catchment area represent virtually every area of emerging infectious diseases in the world, especially Africa, Latin America and Asia. 2. In addition to efforts focused on the Washington metropolitan area, the contractor will also provide support to selected NIAID protocols for which nation-wide recruitment is desired. The national recruitment efforts consist of targeted physician mailings, Internet ad campaigns, and ads placed on national disease support groups' web pages. B. Objective: The NIAID intramural activities and the Division for Clinical Research would like to broaden recruitment for Phase I and Phase II clinical trials of drugs and immunomodulating agents both nationally and in the increasingly diverse Washington metropolitan area. C. Requirements: 1. Mandatory Criteria. A Mandatory Qualification Criteria (MQC) or a special standard for contractor responsibility under FAR 9.104, will be included in the solicitation. An MQC establishes conditions that must be met by each offeror in order for that offeror to be considered for award. For this acquisition, Contractors must provide letters of commitment from eleven (11) of the clinics where NIAID currently has patient referral relationships (see paragraph C. 2 below). The letters of commitment must cover the agreements and arrangements for access to the organizations' site by the offeror's trained recruitment specialists, in order to pre-screen potential participants on NIAID studies. 2. Form Collaborative relationship with the patient referral clinics who provide clinical trial assets. NIAID/DIR currently has established relationships with the following Clinics: 1. Upper Cardozo Health Center, Unity Health Care, Inc. (Washington, DC) 2. Metro Health (Washington, DC) 3. La Clinica Del Pueblo (Washington, DC.) 4. Family and Medical Counseling Services (Washington, DC) 5. INOVA Juniper Program (Arlington, VA) 6. Unity Health Care, Minnesota Avenue (Washington, DC) 7. Unity Health Care, Brentwood Health Center (Washington, DC) 8. Parkside Health Center, Unity Health Care (Washington, DC) 9. Unity Health Care, Minnesota Avenue (Washington, DC) 10. MedStar Washington Hospital Center, Infectious Diseases Clinic (Washington, DC) 11. Casey Health Center (Alexandria, VA) 12. Walker-Jones Health Center, Unity Health Care (Washington, DC) 13. Greater Baden Medical Services (Prince Georges County) 14. Dennis Avenue Health Center (Silver Spring, MD) 3. Maintain liaisons with the above listed clinics that are diagnosing and treating communities regularly presenting with diseases of interest to the current intramural NIAID research program, such as HIV, tuberculosis chronic hepatitis, and Lyme disease. To facilitate clinic and patient relationships, the contractor shall have established practices and systems to handle Personal Identifying Information (PII) and Protected Health Information (PHI). 4. Develop informational materials appropriate for patient and physician populations. 5. Design, develop, implement and monitor results for NIAID clinical study recruitment campaigns comprised of the following: 1. Major media campaigns 2. Quarterly outreach campaigns that consist of meetings in a community of interest (those who speak Spanish, for instance. 3. National recruitment efforts 6. Recruitment and outreach liaison activities shall incorporate: 1. The transportation of patients to the NIH Clinical Center or affiliated clinics for study related visits. Patient transportation for approximately 40 patient-visits per week. Only patients who live within a 50-mile radius of the NIH Clinical Center (Bethesda, MD) will be eligible for transportation. 2. On site pre-screening of potential participants for intramural NIAID studies by trained recruitment specialists. 3. Provision of translation services as needed for outreach patients. The COR will identify specific volunteer recruitment requests, specifying the projected study start date and number of study subjects (volunteers) based on approved protocols. The contractor will be expected to fulfill the recruitment quotas within the specified time frame for study commencement. 7. Arrange periodic meetings with key staff of participating facilities and NIH investigators to discuss protocol recruitment and referral. 8. Administrative support to both NIAID activities in the community and to community facilities and organizations in order to facilitate the participation of providers and patients in clinical and basic research projects. 9. Targeted monthly referrals shall be approximately twenty (20) appropriately screened candidates to NIAID per month. 10. Timely transportation of biologically viable clinical materials (such as blood, blood products, and microbiologic specimens) collected by participating clinics as part of NIAID Institutional Review Board approved research protocols. The Contractor will transport such specimens from the health care facilities, to the NIH, Bethesda or Rockville, Maryland, or NIH-associated research facilities in Frederick, Maryland. The Contractor shall have provisions for the safe transportation of potentially hazardous biological materials. The Contractor shall ensure that staff has appropriate training and that appropriate facilities and waste handling techniques are used for work with this contract. The contractor shall assume responsibility for compliance with all state, local, and federal regulations for shipping and transporting bio logical and/or hazardous materials. 11. Key Personnel Based on the requirements above, the contractor is expected to provide, community outreach workers, along with administrative support, data management and web support staff. D. Period of Performance Base: March 29, 2020 through March 28, 2021 Option One: March 29, 2021 through March 28, 2022 Option Two: March 29, 2022 through March 28, 2023 Option Three March 29, 2023 through March 28, 2024 Option Four March 29, 2024 through March 28, 2025 E. Submission of Capability Statement and Delivery Instructions: In 10 pages or less, respondents should submit a capability statement of their organization which demonstrates their ability to supply the above requirements (see paragraph C. Requirements). Responses must reference the sources sought number and include the following: 1. Name and Address of the Company, DUNS number. 2. Size and type of business, pursuant to the applicable NAICS code 541690. 3. Point of contact with name, title, address, phone, fax and email. 4. Capability to provide the specifics of this requirement, with appropriate documentation supporting claims of organizational and staff capability. 5. Capability of quickly attaining an agreement with the clinics specified above (under C. 2.) including the intended strategy to maintain this relationship. 6. Examples of prior completed Government contracts, references, the dollar value of that work, and other related information; 7. List of organizations to whom similar types of services have been previously provided and the dollar value of that work. 8. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/SAM/. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Please respond by e-mail with a capability statement to Chantal Guetat at chantal.guetat@nih.gov by June 7, 2019 at 3:00 PM EST. Capability Statements Received After this Date and Time Will Not be Considered. F. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. G. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).