SOW_-_05.10.19.docx

Statement of Work

Title: Developing information collection tools for a feasibility study of a mesothelioma patient registry

SECTION 1 – BACKGROUND

The 2019 consolidated appropriations bill (FY 2019 budget) provides funding to NIOSH to conduct a study exploring the feasibility of developing a mesothelioma patient registry.

Specific budget language: The Committee is aware that no formal registry exists to keep track of mesothelioma patients, their demographics, and other important information that could help develop and improve standards of care, as well as identify gaps in current treatment. The recommendation includes funds for CDC to initiate a feasibility study for a patient registry which would include developing case finding methodology to determine incidence and prevalence, demographics and risk factors. The Committee expects a report from CDC after conclusion of the feasibility study.

A future mesothelioma patient registry would have certain functionalities, including tools to: determine mesothelioma incidence, prevalence, demographics, and risk factors; improve standards of care; identify gaps in current treatment options; and rapidly identify and track patients, treatment and outcomes.

SECTION 2 – PURPOSE

A national mesothelioma registry does not exist. State registries do not routinely collect risk factor information or include functionalities for connecting patients with treatment resources, and the reporting interval (time lapse between diagnosis and data availability) is generally one to two years. This reporting interval is too long for a registry to provide services to patients, since about half of those diagnosed with mesothelioma die within the first year. A national registry could address these gaps through systematic collection of exposure and clinical data and secure web-based data sharing, but methods for rapid identification and enrollment of mesothelioma patients following diagnosis have not been developed or tested in the United States.

To respond to the Congressional mandate in a timely manner, a funded comprehensive mesothelioma center will assess the feasibility, materials, and specifications needed for rapidly identifying mesothelioma patients and collecting clinical and demographic information. Through engagement with its regional patient population, the funded center will create and pilot test a questionnaire for mesothelioma patients to assess demographics and potential risk factors, and assess data collection methods for clinicians to provide information about diagnosis, treatment, and clinical outcomes. A resulting methodological evaluation will enable NIOSH to assess the acceptability and utility of data collection tools to inform its registry feasibility study.

SECTION 3 – SCOPE OF WORK

The funded center will create and pilot test a questionnaire for mesothelioma patients, and a data collection tool to be used by clinical staff. The questionnaire will be structured to collect information on patient demographics and familial information, medical history, occupational history, lifestyle/behavioral factors, and other exposure-related information. The data collection tool for clinicians will gather information on anatomical site, pathologic results, other relevant medical and surgical information, treatment course details, and health status, and will include functionalities that allow for periodic updates related to treatment and survival follow-up. The center will also assess approaches for clinician-patient information sharing, including methods for expediting access to specific treatments earlier in the disease course (e.g. clinical trials). Prior to administering the questionnaire or tool to patients, the center will obtain relevant institutional permissions such as a certificate of confidentiality and institutional review board approval, and will adhere to relevant Health Insurance Portability and Accountability Act of 1996 (HIPAA) requirements (see Section 10: Reference Materials). In addition, the center will work with NIOSH to obtain required approvals from the Office of Management and Budget as required under the Paperwork Reduction Act. By a specified date, the center will draft and submit to NIOSH a report evaluating their experience. The report will address: patient acceptability, clinical staff acceptability, data adequacy, appropriateness of allocated resources, time requirements, unforeseen implementation challenges, and potential for registry scalability.

SECTION 4 – TASKS TO BE PERFORMED

To meet objectives, the funded center will perform the following tasks:

· Meet with NIOSH staff for orientation to the Congressional mandate and to discuss general expectations

· Obtain all appropriate human subjects-related determinations through its institutional review board

· Collaborate with NIOSH to help obtain approval for data collection from the Office of Management and Budget, as required under the Paperwork Reduction Act

· Develop a mesothelioma patient questionnaire that captures information including:

· Patient demographics

· Patient medical history

· Relevant family history

· Patient occupational history

· Patient lifestyle or behavioral factors

· Other relevant exposure-related information

· Develop a clinician-oriented data collection tool that captures mesothelioma patient information including:

· Anatomical site

· Pathologic results

· Other relevant medical and surgical information

· Treatment course details

· Patient health status

· Provide NIOSH with an interim progress report

· Submit to NIOSH a final evaluation report addressing elements including:

· Approach to identification and acquisition of patients, including timeliness

· Patient acceptability

· Clinical staff acceptability

· Ability to collect necessary data

· Adequacy of data for intended use

· Clinician-patient information sharing, including access to treatments such as clinical trials

· Appropriateness of allocated resources

· Time requirements for data collection and management

· Implementation challenges

· Assessment of the potential for registry scalability

SECTION 5 – SPECIAL REQUIREMENTS

HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

SECTION 6 – REFERENCE MATERIALS

Subpart 324.70—Health Insurance Portability and Accountability Act of 1996

324.7000 Scope of subpart.

All individually identifiable health information that is Protected Health Information (PHI), as defined in 45 CFR 160.103 shall be administered in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) implementing regulations at 45 CFR parts 160 and 164 (the HIPAA Privacy, Security, and Breach Notification Rules). The term “HIPAA” is used in this part to refer to title II, subtitle F of the HIPAA statute, at part C of title XI of the Social Security Act, 42 U.S.C. 1320d et seq., section 264 of HIPAA, subtitle D of title XIII of the American Recovery and Reinvestment Act of 2009, and regulations under such provisions.

SECTION 7 – PLACE AND PERIOD OF PERFORMANCE (POP)

Work will be performed at the contractor’s facility, and the period of performance is expected to be 8/1/2019 – 7/31/2021.

SECTION 8 – GOVERNMENT FURNISHED EQUIPMENT

None

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Note: Interim payments will be allowed and a payment schedule will be included in the final award.