SOW_HCP Apothecary CME Training_Draft_v3.pdf

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.

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:

• 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 device reference resource.

Quick-Reference Tools

Downloadable, clinician-facing support materials.

Course Evaluation Standardized evaluation form that meets CME accreditation requirements.

Platform Deployment

Coordination and final upload of the course onto an industry-recognized, ACCME-accredited CME platform.

Deliverable Description

Technical Source Assets

All editable source files and raw assets (see Section 3.2).

3.1 Deliverable Review and Acceptance Process:

• Submission: The Contractor shall submit each draft deliverable to the HSI Project Manager (PM) in electronic format.

• Review Period: HSI shall have 5 business days to review the deliverable and provide consolidated feedback.

• Revision: Upon receipt of feedback, the Contractor shall have 5business days to incorporate revisions and resubmit the deliverable.

• Approval: A deliverable is considered "Accepted" only upon written notification (i.e.

email or formal memo) from the HSI PM. If the HSI PM does not provide feedback within the designated review period, the deliverable will be considered approved unless otherwise notified by the Government.

3.2 Delivery of Source Files and Raw Assets:

The Contractor shall provide all raw project files to ensure the Government retains the independent ability to edit or revise content beyond the period of performance.

• Technical Requirements: All deliverables shall be provided in non-proprietary or industry-standard, editable formats (e.g., .psd, .ai, .aep, .prproj, .story, .docx, .pptx).

• Non-Proprietary Condition: No custom-coded proprietary plugins or "locked" software shall be used that prevents the Government from editing files using standard industry-grade software.

• Transfer of Assets: Assets shall be transferred via secure, encrypted digital transfer upon completion of each module, with a final repository provided at the conclusion of the contract.

4.0 INTELLECTUAL PROPERTY AND DATA RIGHTS

Pursuant to FAR 52.227-14 ("Rights in Data—General"), the Government shall hold Unlimited Rights to all deliverables produced under this contract.

1. Work Made for Hire: All deliverables produced under this contract shall be considered "works made for hire" for the U.S. Government.

2. Unlimited Rights: The Government shall have the right to use, disclose, reproduce, prepare derivative works, and distribute the content without further compensation to the Contractor or any third-party platform provider.

3. Third-Party Materials: The Contractor shall ensure all third-party materials are cleared for use by the U.S. Government in perpetuity.

4. Background IP: Any pre-existing IP incorporated into the course must be identified in the proposal. The Contractor hereby grants the Government a non-exclusive, royalty-free, perpetual, worldwide license to use, modify, and distribute said IP as part of the Government’s training course.

5.0 PERIOD OF PERFORMANCE

The period of performance shall be one (1) year from the date of award, estimated as September 1, 2026, through August 31, 2027.

6.0 PERFORMANCE STANDARDS AND COMPLIANCE

The Contractor shall ensure the project meets the following federal and professional standards:

• Accessibility: All content must comply with WCAG 2.1 (Level AA) standards. All content must also be Section 508 compliant. All videos must include open or closed captions synchronized with audio; audio descriptions for any visual-only content; full written transcripts available for download.

• Accreditation: The course content must meet all applicable ACCME standards to qualify for CME credits. The Contractor shall ensure the hosting platform maintains the necessary accreditation throughout the performance period.

• Data Integrity and Records Management: Training completion data must be managed in compliance with the Federal Records Act and NARA guidance.

• Evidence Base: All content must be derived from Institutional Review Board (IRB)-approved or peer-reviewed primary research.

• Accreditation Continuity: The Contractor shall ensure that the selected hosting platform maintains the necessary ACCME accreditation status throughout the duration of the performance period to ensure all learners receive valid CME/professional development credits upon successful course completion.

7.0 PLATFORM AND TECHNICAL REQUIREMENTS

The Contractor shall be responsible for ensuring the following regarding the hosting platform:

• Industry Standards: The selected platform must be a widely recognized industry leader in medical professional development, capable of supporting the scale and specific requirements of the targeted healthcare specialties (physicians, pharmacists, and nurses).

• Reporting: The platform shall provide administrative analytics, allowing the IPR Center to monitor enrollment and completion rates. In addition. the Contractor shall provide report on course utilization, including the number of participants, completion rates, and feedback/evaluation scores. The Contractor must ensure that all data reporting complies with federal privacy requirements and that no Personally Identifiable Information (PII) is improperly shared.

• Accessibility: As per Section 6.0, the hosting environment itself—not just the course content—must meet WCAG 2.1 (Level AA) accessibility standards.

• Integration: The Contractor shall coordinate with the IPR Center to ensure the course remains accessible or appropriately linked through the IPR Center’s centralized pharmaceutical training resource hub. Contractor shall ensure that the chosen platform is compatible with ICE-issued hardware and browsers and must adhere to all applicable cybersecurity policies regarding data protection and host security.

• Technical Support: The Contractor shall provide technical support for users during the delivery period, including troubleshooting platform access issues and navigation errors.

Additionally, the vendor shall ensure the course content remains current, proposing updates to content if evidence-based research or FDA/WHO guidance changes during the period of performance

8.0 GOVERNMENT FURNISHED INFORMATION (GFI)

The IPR Center will provide access to existing organizational branding guidelines and necessary programmatic context to ensure alignment with agency messaging. Additionally, the IPR Center will share selected criminal case examples to support learning objectives, ensuring that all provided materials are fully adjudicated and approved for public release.