DHA CLINICAL STUDIES AND HEALTH SYSTEMS APPLICATIONS SUPPORT
1.1 The Department of Defense (DoD), Defense Health Agency (DHA) is issuing this request for information as a means of conducting market research to support the requirements to provide the Public Health Division (PHD) Immunization Healthcare Division (IHD) support for vaccine safety and evaluation studies as well as management of the related IT health systems applications. This is in accordance with the Federal Acquisition Regulation (FAR) Part 10. The result of this market research will assist in understanding market capability and resources. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 541611 - Administrative Management and General Management Consulting Services.
1.2 THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This request for information does not commit the Government to contract for any supply or service whatsoever. Further, the DHA is not at this time seeking quotes or proposals and will not accept unsolicited proposals. Respondents are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. If a solicitation is released, it may be synopsized on the beta.SAM.gov website or solicited through other Government points of entry such as GSA eBuy for PSS Schedules, OASIS, etc. It is the responsibility of the potential offerors to monitor all sites for additional information pertaining to this requirement.
The government will evaluate market information to ascertain potential market capacity to 1) provide services consistent in scope and scale with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes: compliance with program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation; and, 4) provide services under a performance based service acquisition contract.
Based on the responses to this notice and appendices, this requirement may be set-aside for small businesses or procured through full and open competition, and multiple awards may be made. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.
The IHD supports the DoD immunization programs protecting military service members and eligible beneficiaries, and supports education, training and clinical and epidemiologic studies of vaccine safety and effectiveness. The IHD Vision, Mission, and Strategic Goals are as follows:
Commitment to provide and enable the best quality and responsive patient-centered immunization healthcare, which in turn greatly augments readiness.
To enhance the Military Health System (MHS) focus on health and healing by supporting immunization program efficacy, safety, and acceptability, enabling solutions that address personalized medicine and improved evidence based practices.
IHD Strategic Goals
• Synchronize, integrate and coordinate DoD/Services vaccine policies and information.
• Promote excellence in immunization standards of practice.
• Provide dynamic and responsive expert clinical consultation services supporting quality immunization policy and practice.
• Advocate for evidence based practice improvements in immunization healthcare.
• Deliver best quality immunization healthcare information, educational resources/tools and training services.
• Support enhanced population vaccine safety surveillance & research.
• Develop and implement communication strategies and activities.
• Contribute to the body of knowledge in immunization healthcare through investigations, surveillance, and clinical research.
Per the listing above, one of the strategic goals of the IHD is to contribute to the body of knowledge in immunization healthcare studies in support of all DoD beneficiaries. Specifically, the Vaccine Safety and Evaluation Section (VSE) promotes quality improvements in immunization healthcare through public health investigations, surveillance, epidemiologic projects, and clinical studies. The VSE manages funding for external studies and also internally conducts a portfolio of clinical investigations to improve vaccine safety and effectiveness. The IHD’s role in enhancing vaccine safety surveillance and improved clinical study methods continues to expand. The IHD has identified and leveraged various clinical investigations opportunities and must have the ability to easily modify (expand/decrease) its current contract staffing in order to complete both new and ongoing clinical studies projects. Studies will address multiple vaccines, including, for example, anthrax, smallpox, yellow fever, and influenza vaccines, and potentially newly licensed vaccines, reflecting the complex mixtures of vaccines delivered to service members.
Currently, studies are taking place at all IHD Regional Vaccine Safety Hubs (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 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. Vaccine safety and evaluation studies hold enormous potential for improving the quality of care and reducing the rate and severity of adverse events following immunization. For example, efforts to understand genetic risk factors for more serious adverse events like myocarditis after smallpox vaccine or encephalitis (as well as other immune mediated neurologic events) have not been adequately resourced. Benefits of such studies also include improved quality of life for those who are adversely impacted by immunization, reduced healthcare costs, reduction of disease rates through increased vaccination rates, and increased acceptability of vaccine programs.
3.0 Requested Information
Companies/Vendors that provided vaccine safety and evaluation studies and management of the related IT health systems applications support services, as described below. In responding to this RFI, please indicate the organization’s capabilities that address the Government requirements.
Requirements: Provide support services in the areas of protocol development, regulatory approval and sustainment subject recruitment and enrollment, data entry and quality control, data management, abstraction and validation, statistical analyses, biospecimen processing, shipment and storage, and generation of publications and presentations in support of clinical investigations projects related to the safety, acceptability and effectiveness of immunizations within the military and beneficiary population. Additional support services include development and implementation of healthcare-related information management systems, equipment and services, and systems design for data capture generated by clinical investigations. All study activities will be performed in strict accordance with applicable protection of human subjects regulations, and all clinical investigations records will be in compliance with applicable regulations and Institutional Review Board approved clinical investigations protocols.
3.1 Clinical investigations projects support
3.1.1 Recruitment and Enrollment: Contractor shall recruit potential study subjects, and determine initial eligibility for participating in study protocols. Contractor shall enroll subjects in clinical studies protocols. Contractor shall review and obtain informed consent from the subjects prior to enrollment in the clinical investigations protocol. Contractor shall coordinate and conduct study subject visits and assure all procedures are conducted in compliance with the clinical study protocol.
3.1.2 Specimen Collection and Handling: Contractor shall obtain specimens via venipuncture and other methods, as required per study protocols. Contractor shall perform vital signs and other necessary clinical procedures as dictated by clinical investigations protocols. Contractor shall perform specimen handling and processing, to include but not limited to drawing blood, obtaining saliva samples, and storing and/or shipping such samples to external collaborators, as required per study protocols. Contractor shall obtain laboratory testing as required. Contractor shall maintain inventory of clinical investigations project specimens and detailed audit tracking of the movement of specimens.
3.1.3 Adverse Events: Contractor shall inform Principal Investigator and/or his/her designee of abnormal testing values or other issues requiring attention, and facilitate subject follow-up. Contractor shall also inform Principal Investigator and/or his/her designee of any expected or unexpected reportable events and proceed with the reporting plan as required by the IRB of record.
3.1.4 Statistical Analyses: Contractor shall contribute to design of statistical analyses, and complete statistical power calculations to determine study enrollment targets. Contractor shall implement these analyses for clinical and epidemiologic vaccine safety, acceptability, and effectiveness studies. Contractor will write and execute SAS programs to extract, combine, and manage datasets, and perform data analyses.
3.2 Secure maintenance of clinical investigations project records:
3.2.1 Contractor shall securely maintain complete and accurate clinical investigations subject records, in accordance with applicable research regulations.
3.3 Development of new clinical study protocols:
3.3.1 Contractor shall assist investigators with writing and development of new clinical study protocols. Contractor shall provide recommendations on laboratory methods, procedures, and data interpretation. Contractor shall facilitate drafting of questionnaires, informed consent documents, regulatory forms, tracking forms, HIPAA authorization forms, and other forms as required by the study protocol.
3.3.2 Contractor shall provide statistical support for new clinical study protocols, to include performing power calculations and drafting statistical analysis plans.
3.4 Support for information technology needs of IHD:
3.4.1 With close coordination and direction of IHD Government civilian employees, contractor shall plan, define, develop, revise, and implement healthcare information management systems, equipment and services with COR coordination, review and approval (with approval by the CO when necessary) to benefit the Clinical Investigations section and other sections within IHD. Contractor shall 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. Contractor shall provide project management, design, and programming for existing data management and analysis tools used by the IHD, including but not limited to:
4.1 Interested parties are requested to respond to this RFI with a Capability Statement to include two Sections, Section 1 – Administrative Information per RFI Section 4.3 and Section 2 – Requested Information per RFI Section 3.0. Capability Statements should be tailored to the particulars of this effort. In addition, if significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management approach for such arrangements.
4.2 Capability Statements in Microsoft Word for Office 2013 compatible format are due no later than July 15, 2020 1:00 PM EST.
Responses shall be limited to 10 pages for Section 2 and submitted via e-mail to Pedro Godinez at email@example.com and Robert E. LeBlanc at firstname.lastname@example.org.
Only electronic submissions will be accepted. Electronic files larger than 10 MB should be broken down into multiple files with no one (1) file exceeding 10 MB. Each electronic submission shall include: a) RFI number HT0011-21-RFI-0077 and "Clinical Studies and Health Systems Applications Support" in the subject line; b) If the submission includes more than one (1) electronic email, the file number and total files being submitted (e.g., File 1 of 4, File 2 of 4, etc.) in the subject line; and c) A brief summary of the email's content, the vendor's name, and mailing address.
Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid the Government, please segregate proprietary information. Please be advised that all submissions become Government property and will not be returned. RFI submissions submitted after the due date of July 15, 2020, 1:00 PM EST will not be assessed.
4.3 Section 1 of the Capability Statement shall provide administrative information, and shall include the following as a minimum:
4.3.1 Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number, and e-mail of designated point of contact.
4.3.2 In order for us to know if the capacity at your company or organization may be suitable for administering one or more aspects of providing support for vaccine safety and evaluation studies as well as management of the related information technology health systems applications, please provide answers to the following questions:
4.4 The number of pages in Section 1 of the Capability Statement shall not be included in the 15-page limitation for Section 2 of the white paper. Section 2 of the Capability Statement shall provide the information as requested in Section 3 of this RFI and shall be limited to 15 pages.
5.0 Industry Discussion N/A
THIS IS A REQUEST FOR INFORMATION (RFI) ONLY to identify sources that can provide support for vaccine safety and evaluation studies as well as management of the related information technology health systems applications. The information provided in the RFI is subject to change and is not binding on the Government. The DHA has not made a commitment to procure any of the items discussed, and release of this RFI should not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.