RFI - Development of Accredited Continuing Education Training on Substandard and Falsified (SF) Medical Products

DRAFT STATEMENT OF WORK (SOW) Development of Accredited Continuing Education Training on Substandard and Falsified (SF) Medical Products 1.0 BACKGROUND AND OBJECTIVE Department of Homeland Security (DHS), Immigration and Customs Enforcement (ICE), Homeland Security Investigations (HSI), Intellectual Property Rights (IPR) Center requires the design, development, accreditation, hosting, and delivering of a comprehensive, accredited, web- based training curriculum for healthcare providers (HCPs) on the identification, reporting, and management of counterfeit/substandard and falsified (SF) pharmaceuticals and medical devices, as well as best practices for patient education. The scope also includes the administrative management of the Continuing Medical Education (CME) credit-awarding process. The objective is to produce evidence and research-based training that meets Accreditation Council for Continuing Medical Education (ACCME) standards for CME credit for broad dissemination to physicians, pharmacists, and nurses via online CME platforms. 2.0 SCOPE OF WORK The Contractor will ensure that the course meets technical standards for delivery though an online CME platform recognized for providing accredited CME and professional development for healthcare professionals across multiple health care specialties – doctors, pharmacists, and nurses. The Contractor shall develop a modular, web-based training course grounded in evidence-based research. The Contract will use current industry-accepted terminology and definitions,such as those used by the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA). The vendor will ensure that the course meets all technical and academic requirements for delivery through on online platform recognized for providing accredited CME and professional development for healthcare professionals across multiple identified specialties. The Contractor shall also be responsible for coordinating and executing the deployment of the course onto an industry-recognized online CME platform that meets ACCME standards for integrity and independence. The vendor shall ensure the course receives ACCME accreditation status and that all technical and administrative workflow required for the successful awarding of CME credits to healthcare professionals are implemented and functional at the time of launch. -- 1 of 6 -- 2.1 Curriculum Modules The contractor shall design informative and interactive training modules mapped to the following learning objectives and competencies: 1. Overview of the Trends and Enforcement Landscape of SF pharmaceuticals and medical devices: a. Define substandard and falsified (SF) medical products and describe current global and U.S. trends in the illicit pharmaceutical and medical device markets. b. Categorize high-risk drug categories, including oncology medications and GLP-1 agonists, based on their susceptibility to falsification. c. Analyze the U.S. regulatory and supply chain framework, specifically the roles of the FDA, Homeland Security Investigations (HSI), the Drug Supply Chain Security Act (DSCSA), and any other relevant U.S. federal statutes. 2. Detection and Risk: a. Identify common "red flags" in pharmaceutical packaging and physical product appearance that indicate potential SF medical products. b. Distinguish between clinical treatment failure and medical product failure resulting from SF goods. c. Assess the unique vulnerabilities associated with medical devices and the risks inherent in sourcing products from non-traditional online pharmacies. 3. Patient Education: a. Develop effective communication strategies for educating patients on the risks of sourcing pharmaceuticals or medical devices outside of traditional, regulated supply chains. b. Demonstrate methods to guide patients through the verification process to ensure the authenticity of their medical products. 4. Reporting and Procedures: a. Use official reporting systems—specifically FDA MedWatch and MAUDE—to accurately report suspected SF medical products. b. Implement institutional response protocols for handling and reporting suspected SF products upon discovery. c. Apply clinical decision frameworks to manage the reporting and administrative response to identified SF medical products. The vendor shall provide assessment tools (e.g., knowledge checks, interactive exercises) that explicitly measure the learner's ability to achieve each of these objectives. To this end, each module should include the following: -- 2 of 6 -- • Knowledge check at the end of module to ensure learner understands the material before progressing. • Minimum of one interactive exercise to reinforce learning content. These may include activities such as branching scenario decision-making exercises, drag-and-drop exercises, case studies, etc. 2.2 Instructional Design Requirements The course shall be interactive and multimedia-based, featuring: • Narrated video and animated infographics. • Interactive case vignettes and product recognition visual exercises. • Feedback loops that provide immediate, constructive feedback for incorrect answers on activities and/or knowledge checks. • A "Common Offenders" SF drug/device reference resource. • Downloadable, print-ready quick-reference tools for low-bandwidth settings. • Platform Integration: The course shall be designed and deployed on an established, industry-recognized CME platform that supports user registration, tracking of professional credentials, assessment delivery, and the automatic issuance of CME/professional development certificates. 3.0 DELIVERABLES The Contractor shall provide the following: Deliverable Description Training Curriculum Full course outline mapped to ACCME accreditation standards. Assessment Tools Pre-course and post-course knowledge assessments. Course Modules Four (4) comprehensive instructional modules as defined in Section 2.1. Reference Guide Digital "Common Offenders" SF drug and devi…