SOW_for_RFP.pdf

Attachment 1

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.

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:

o Patient demographics o Patient medical history o Relevant family history o Patient occupational history o Patient lifestyle or behavioral factors o Other relevant exposure-related information

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

o Anatomical site o Pathologic results o Other relevant medical and surgical information o Treatment course details o Patient health status

• Provide NIOSH with an interim progress report

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

o Approach to identification and acquisition of patients, including timeliness o Patient acceptability o Clinical staff acceptability o Ability to collect necessary data o Adequacy of data for intended use o Clinician-patient information sharing, including access to treatments such as clinical trials o Appropriateness of allocated resources o Time requirements for data collection and management o Implementation challenges o 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

HHSAR Subpart 324.70—Health Insurance Portability and Accountability Act of 1996

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 9 - SPECIAL CONSIDERATIONS

The services contemplated under this purchase order are considered to be an Other Function as defined by the Office of Federal Procurement Policy in OFPP letter 11-01 and by HHS in Acquisition Policy Memorandum 2012-01.

All records generated under this award are the property of NIOSH and the contractor is required to submit all originals and copies to NIOSH or to handle as specified by the Project Officer and in accordance with HHS/OCIO’s policy on records management at http://www.hhs.gov/ocio/policy/2007-0004.001.html.

http://www.hhs.gov/ocio/policy/2007-0004.001.html

SECTION 10 – DELIVERABLES/REPORTING SCHEDULE

Deliverable number

Items Description Quantity or No.

of Copies

Delivery Date Deliver To

Patient risk factor and medical history questionnaire

Tool to collect demographic information, personal and family medical history, and exposure or risk factor history digital copy of questionnaire

Include as appendix to final report

NIOSH Project Officer

Clinical data collection instrument

Tool to be used by clinical staff for collecting patient clinical information, including pathologic results, treatment information, and health status digital copy of instrument

Include as appendix to final report

First Interim progress report

Concise report summarizing the Center’s questionnaire/tool development, implementation, and early patient enrollment experience digital copy 150 days after date of award

Second Interim progress report

Concise report summarizing the Center’s questionnaire/tool development, implementation, and patient enrollment experience digital copy 14 months after date of award

Final report Evaluation describing the Center’s experience with identifying and enrolling patients, collecting clinical and epidemiologic information, and linking patients with appropriate clinical resources digital copy of final report

By 07/31/2021 NIOSH Project

Invoicing will be permitted as follows: 30% of total award after submission of deliverable 3; 30% after submission of deliverable 4, and 40% after submission of deliverable 5.