2. Statement of Work - SOW for posting.docx

Statement of Work for Continuing Medical Education Services

This requirement is for Continuing Medical Education (CME) accreditation support for CME activities at the National Institutes of Health (NIH)/Clinical Center (CC) and for awarding of AMA PRA Category 1 Credit(s)

Background:

In order to remain current and up-to-date with evolving and increasingly prescriptive Accreditation Council for Continuing Medical Education (ACCME) requirements and to improve efficiency and timeliness of the accreditation process, contractual support by an entity that is ACCME-accredited has been required by the Office of Clinical Research Training and Medical Education (OCRTME) in the NIH Clinical Center since 2007. Because neither the NIH nor the NIH Clinical Center maintain a CME office that meets ACCME accreditation standards in order to provide CME credits for conferences, meetings or other educational activities sponsored or hosted by the various Institutes or Centers at the NIH, ongoing contractual support by an ACCME-accredited not-for-profit entity, which is also qualified and capable to engage in partnerships to provide CME for other entities, is required for CME activities at the NIH that are administered through the OCRTME.

The NIH, a part of the U.S. Department of Health and Human Services, is the steward of biomedical and behavioral research for the nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. In support of this mission the NIH Clinical Center’s Office of Clinical Research Training and Medical Education (OCRTME) oversees the provision of high-quality educational activities to meet the needs of the NIH physician and the broader medical community that the NIH serves. The NIH also ensures, in partnership with a contractual partner, that the educational events offering CME credit to the participants meet the specific criteria prescribed by the ACCME.

In addition to the more than 1200 physicians who work in the intramural NIH, the CME Program also serves many others who participate in NIH sponsored educational activities offered for CME credit through its contractual partner that are held locally, nationally and in enduring materials (i.e. web-based content). These CME accredited educational activities may occur in diverse formats: (a) traditional educational settings, both regularly scheduled conferences (such as weekly, monthly, etc.) and live conferences (multiple days, multiple speakers, but only one occurrence); (b) live web casts; and (c) enduring materials such as online courses and self-study programs.

The CME Program staff in the OCRTME work closely with Activity Directors and their staffs in all 27 NIH Institutes and Centers as well as with the trans-NIH Continuing Medical Education Committee (CMEC), which is composed of individuals representing a wide range of medical and scientific disciplines.

Objective:

To maintain NIH sponsored CME activities, NIH requires a full-service ACCME-accredited CME provider to cover comprehensive activity and data management support services.

Scope:

This requirement consists of the following major functions: Program Administration, Program Evaluation, Problem Identification and Resolution, Communication, Green Initiatives, Continuity of NIH/CME Operations, Information Technology Support (IT), and Fiscal Responsibility and Financial Accountability, all of which must be executed in 100% compliance with the Accreditation Council for Continuing Medical Education (ACCME) requirements and other requirements as described in this document.

Program Administration involves any action that may include, but is not limited to:

communication with OCRTME staff, acceptance of electronic applications, verification of authenticity of CME activity applications, evaluation of electronic applications, awarding of AMA PRA Category 1 Credit(s), and monitoring of activity directors' and support staff compliance with accreditation requirements.

Program Evaluation involves any activity that may include, but is not limited to, providing the deliverables as identified in Schedule of Deliverables and maintaining the ACCME Accredited Provider status throughout the duration of the requirement and subsequent optional years.

Problem Resolution may include, but is not limited to communications, training of NIH staff regarding accreditation requirements, as well as providing the deliverables as identified in Schedule of Deliverables.

Communication may include, but is not limited to email, phone conversations, and teleconferencing capabilities.

Continuity of NIH/CME Operations refers to, but is not limited to:

1. NIH ownership of all data and activity documents (electronic or hardcopy) and documentation (electronic or hardcopy) associated with all NIH accredited CME activities during and after the period of performance.

2. CME participant access to transcripts issued by the contractor for those at NIH who participated in NIH CME-generating activities. Transcripts must be retained for the life of the contract and transferred to NIH upon termination of the contract.

Information Technology (IT) Support includes, but is not limited to developing, hosting, and maintaining a website that is compliant with DHHS information technology requirements.

· Section 508: Accessibility at NIH https://ocio.nih.gov/ITGovPolicy/NIH508/Pages/Acquisitions.aspx

· HHS Section 508

· https://www.hhs.gov/web/section-508/index.html

· HHS Web Policies http://www.hhs.gov/web/policies/index.html

· US General Services Administration (GSA) Section 508:

· https://section508.gov

· ACCME Accreditation Publicity http://www.accme.org/publicizing-accme-accreditation

Security Any personal data collected and/or used under this contract is subject to the Privacy Act Clause (FAR 52.224-2). The contractor will use any Privacy Act information provided by the Government or other Government contractors for the purposes authorized by this contract only and for no other.

Contractors that operate a third-party website or application to engage with the public on the agency's behalf must satisfy the OMB memorandums issued June 25, 2010, OMB M-10-22, Guidance for Online Use of Web Measurement and Customization Technologies; and OMB M-10-23, Guidance for Agency Use of Third-Party Websites and Applications. The Offeror must submit their Privacy Policy which will identify the web measurement and/or customization technologies employed at their website, indicate if the technology is enabled by default and address whether users can opt-out or opt-in to use the web measurement and/or customization technologies.

Contractors that develop a federal information system(s) at the Contractor's/Subcontractor's facility, or host and/or maintain a federal information system(s) at the Contractor's/Subcontractor's facility must provide the data center security and privacy policy that should include administrative, physical and technical controls in place. Offerors with security and privacy policies that include a secure firewall, segmentation of the government's data from non-government data, encryption technology that is FIPS 140-2 compliant, vulnerability scanning, current patch management and antivirus software, intrusion detection services, personnel access controls to the facility and servers, information system security and privacy training programs for personnel, redundant electricity, heating and cooling, data back up and retention plan incident response plan, contingency plan and disaster recovery plan will be scored higher than Offerors that do not offer these security controls.

Section 508 Compliance Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) is applicable to this Statement of Work (SOW). The Department of Health and Human Services (HHS) requires compliance with Section 508 of any contractor or consultant who (1) produces content in any format that could be placed on a Department-owned or Department-funded Web site; or (2) writes, creates or produces any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or video material that could be placed on a Department-owned or Department-funded Web site.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board's Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board's standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities.

All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

The contractor is responsible for ensuring compliance with Section 508 of the Rehabilitation Act of 1973 by evaluating all web pages and web-based applications to ensure they meet all standards prior to going to production. All of these Section 508 provisions apply to all content or communications material identified in this SOW.

Fiscal Responsibility and Financial Accountability includes, but is not limited to submitting invoices with each item listed and cross-referenced to the appropriate item in the contract, receiving written authorization from the NIH/OCRTME CME Administrator, receiving prior written - authorization for any travel associated with this requirement, and compliance with Federal Travel Regulations.

Specific Services to be Provided by the Contractor:

Initial Set-up and Development

1. On-site meetings with NIH staff for consultation regarding website development and/or maintenance.

2. Establish and/or maintain a NIH CME website that identifies current activities, provides an on-line application process (if needed), with supporting document templates, and provides course attendees confidential password-protected electronic access for their personal CME data.

3. Provide forms and instructions for on-line application process for Activity Directors and their staff on website.

4. Provide information and instructions for on-line review of applications on website.

5. Provide conflict of interest information and disclosure forms for speakers and planners on website.

6. Establish and maintain a tracking system to develop required ACCME and NIH reports to include, but not limited to, accreditation compliance, conflict of interest, participant data, lecture quality, attendance, needs assessment and evaluation outcome reports, as well as other reports as needed, and accurate and timely data entry for individual CME records.

7. Provide a web-based tracking system for all NIH CME records and individual physician participation, including specific requirements of the Joint Commission credentialing process.

8. Transfer historical participant data from any prior or current vendor to an electronic database.

9. Ensure that the CME website meets all U.S. government and ACCME guidelines.

Participation with NIH/OCRTME Staff

1. Perform initial review and evaluation of new applications for CME-accredited activities submitted by Activity Directors to determine if the applications meet ACCME approval criteria.

2. In conjunction with the NIH/OCRTME CME Administrator, review and approve individual CME-accredited activities

3. If applications are incomplete, contact the Activity Director or appropriate staff to request missing items.

4. Assist, if needed, with the determination of whether proposed activities support the mission of the NIH.

5. As necessary, provide special support to individuals at NIH with questions about content, duration, etc. which might impact the development of a CME activity.

Activity Administration

1. Work with the NIH Activity Directors to develop educational meetings, conferences, and on-going regularly scheduled conferences (RSCs) that are in compliance with the requirements set by ACCME, and for maintaining NIH’s ability to support accredited activities.

2. Manage the application process from initial receipt and review to approval and final post activity documentation. Ensure that information entered into the activity log is accurate.

3. Manage and administer CME-accredited activities.

4. Provide interactive multimedia, online and distance learning capabilities as they pertain to the delivery of CME-accredited activities.

5. Evaluate the effectiveness of the NIH CME-accredited activities in meeting identified educational needs and implement improvements as required.

6. Respond to inquiries received by internet, email, fax, and phone from a variety of sources not only within NIH but also from other government agencies, professional and lay individuals, professional societies, and government contractors.

7. Interface with participants, Activity Directors and their staff, and other activity planners to ensure smooth and efficient operations in compliance with ACCME regulations. On-site meetings may be required.

8. Provide compliance reporting.

9. Ensure that all required CME activity information and supporting documentation, and post-activity documentation materials, are maintained and stored in accordance with ACCME requirements.

10. Ensure that all planners and faculty provide completed and signed disclosure forms and that potential conflicts of interest are identified and resolved to guarantee non-biased presentations.

11. Ensure that all media used to advertise CME events include appropriate language and meet ACCME requirements.

12. Assume total responsibility for managing the post-activity documentation process. In so doing, alert Activity Directors when required materials have not been submitted within the allotted time frame. Review submissions for accuracy and completeness. Contact Activity Directors and staff to obtain missing information.

Educational Planning

1. On-site meetings and electronic and phone communications to consult with Activity Directors regarding needs assessment, course objectives, and programmatic design and delivery.

2. Routine on-site meetings, electronic and/or phone communication to liaison with medical education and medical communication organizations that may wish to collaborate with the NIH on activity delivery or create enduring materials.

3. Ensure that all CME-certified activities are in compliance with the Essential Areas and Elements of the ACCME.

4. Work with Activity Directors to ensure approval of activities.

5. Advise on complex issues of joint sponsorship and commercial support.

6. Determine credit hours toward the American Medical Association (AMA) Physician’s Recognition Award for all approved CME-accredited activities.

Data Management and Reporting

1. Maintains a cloud-based IT CME tracking system software that:

· Collects and stores CME attendee, evaluations, and credits earned data

· Generates attendee, evaluation, and credit reports

· Automates the process of tracking and managing credits attendees, ensuring accurate and efficient accreditation

· For live events, facilitates attendee registration by offering a user-friendly interface, and streamlines the registration process

· Automates generation and delivery of CME transcripts

· Provide confidential management of attendee’s personal CME data.

2. Carry out CME Activity monitoring in accordance with ACCME requirements (Regularly Scheduled Series, Enduring Materials, and Live).

3. Carry out annual needs assessment for activity content.

4. Assess the outcomes of each CME-accredited activity.

5. Conduct regular evaluations of the cloud-based IT CME tracking to ensure accuracy and effectiveness.

6. Verify that all data are correctly converted from website to annual reports.

7. Collect and analyze CME-accredited activity evaluation data. Track quality of the activities through evaluations and provide data collected to Activity Directors to improve future events.

8. Prepare summary reports and submit to the NIH and the ACCME as required for accreditation purposes.

9. Prepare final cumulative evaluation summary data for the NIH.

10. Provide reports to NIH Activity Directors and the Director, Office of Clinical Research Training and Medical Education, Clinical Center, in support of charges submitted for payment.

Policy and Analysis Interpret ACCME accreditation requirements on an ongoing basis; draft policy, and communicate updates and revisions to the OCRTME Director and CME Administrator.

Education and Training

1. Develop informational materials on the CME application review and accreditation process for dissemination to current and prospective Activity Directors and periodically conduct small-group training sessions on-site or provide an on-line site containing information useful for faculty.

2. Conduct small group training sessions for the NIH/OCRTME CME Administrator, CME Activity Directors and their staff to address complex ACCME policy issues.

3. Establish and maintain strong relationships with NIH Institutes and Centers and other CME providers to provide a source of new ideas and problem solving, facilitate activity delivery, provide historical information necessary to develop fiscal analysis of future activities, and coordinate the sharing of resources (e.g., mailing lists, and profit and loss statements from previous activities).

Contractor Proposal Instructions:

1. A copy of the Contractor's Accreditation Council for Continuing Medical Education (ACCME) provider accreditation certificate that shows approval period dates and compliance level status.

2. A Risk Assessment and Risk Management Plan to be utilized in the execution of the requirement. At a minimum, the Risk Assessment and Risk Management Plan should include: risk identification, probability of occurrence, impact on Contractor's performance of requirement, risk mitigation techniques, and risk management techniques.

3. Information Systems Security Risk Management Plan to assess for information security risks regarding the electronic database.

4. A sound technical approach, including flow diagram of task approach to accomplishing all the requirements of the Statement of Work.

5. The offeror's approach to Project management regarding communication, processing activity applications, and data management.

6. Availability of Information Technology (IT) Support personnel to host, maintain, and ensure information security of the database or information system used to store data related to CME activities such as participation data.

7. A proposal of staff time or labor hours and personnel classification (professional, technical, others), needed to accomplish the requirements included in the Statement of Work.

8. A list of each of the proposed Contractor staff and their experience with CME programs and activities, as well as in the ACCME accreditation process. The list of Contractor staff should also delineate the availability, qualifications, education, competence, and experience of all personnel involved in the completion of the SOW, as well as recent training, and specific or technical accomplishments of all personnel.

9. Description of prior experience in providing CME services to other entities or organizations as an accredited ACCME provider.

10. Description of prior experience with provision of services at and deliverables to the NIH, and with the U.S. Government, or with analogously structured organization.

11. All additional requirements as identified in this document and in proposal instructions.

Estimated Contract Deliverables - Updated

The below listed activities consist of but are not limited to the current CME accredited activities for the NIH. Additional activities can arise during the course of each year.