Draft Statement of Work-Assessing Capacity to Expand Hepatitis C Testing and Treatment in United States Carceral Settings.pdf

Statement of Work-Draft

Title: Assessing Capacity to Expand Hepatitis C Testing and Treatment in United States Carceral Settings

SECTION 1 – BACKGROUND

Hepatitis C virus (HCV) is the most common bloodborne infection in the United States. Approximately 30% of persons with HCV infection rotate in and out of the United States carceral system each year. The prevalence of HCV is estimated to be 10-20 times higher in carceral settings as compared to the general population. Since 2013, direct acting antivirals (DAAs) have simplified hepatitis C treatment and have cure rates of >95%.

Improving hepatitis C elimination in carceral settings is essential to achieving national hepatitis C elimination targets.

Treating HCV infection is cost effective at both the individual and community levels. Hepatitis C treatment not only prevents further health complications such as liver damage, hepatocellular carcinoma, and cirrhosis, but it also reduces the burden of paying for care as it relates to those complications. Successfully treating individuals for their HCV infection prior to being released back into their communities helps mitigate further transmission.

There has been steady progress towards hepatitis C elimination in carceral systems as the costs of DAAs have declined, simplified treatment algorithms have been developed, and lawsuits led by incarcerated people have led to rulings or settlements that increase funds allocated for hepatitis C treatment. However, progress towards hepatitis C elimination in carceral settings has been uneven, with many states not adopting best practices and employing strategies to lower DAA costs to facilitate broader treatment of their population.

CDC wishes to expand hepatitis C testing and treatment in carceral settings but lacks the knowledge of which carceral facilities have implemented best practices to eliminate hepatitis C and which facilities have high numbers of people with hepatitis C that pass through their systems. This includes both state Departments of Correction (DOCs) as well as larger jails which may have the capacity to both diagnose and treat hepatitis C while an individual is incarcerated. To increase CDC’s effectiveness in advancing hepatitis C elimination in carceral settings, CDC aims to characterize hepatitis C burden of disease as well as prevention, testing, and treatment policies at carceral facilities nationally.

Actionable point prevalence data allows for appropriate allocations of resources to support state DOCs and larger jails in their efforts to eliminate hepatitis C in carceral settings. The importance of this task is monumental in that carceral health is public health which benefits the community and keeps the rate of new hepatitis C infections low. The goal of this contract is to survey all 50-state DOCs, the district of Columbia, and a number of large jails to understand the point prevalence of hepatitis C, patient characteristics, clinical management, harm reduction techniques, as well as successes and challenges to implementation.

SECTION 2 – PURPOSE

The purpose of the contract is for CDC to receive a data file from the Contractor that details the prevalence of hepatitis C virus, testing methodologies, and treatment practices in state DOCs and large jails. This will aid in understanding where the most need is to move the needle on Division of Viral Hepatitis goals towards hepatitis C elimination. Carceral settings pose a unique challenge to Hepatitis C elimination in that data, as it relates to HCV testing and treatment, is not readily available for analysis to understand the burden of disease within this environment. To our knowledge, CDC does not have a repository of data specifically directed towards hepatitis C within state DOCs. This contract will provide CDC the opportunity to collaborate with a well-respected community partner that has built trust among state DOCs and larger jails. The Contractor will administer a survey that will advance the Division of Viral Hepatitis 2025 Strategic Plan to eliminate viral hepatitis in the U.S.

• Goal 1: Reduce new viral hepatitis infections

• Goal 2: Reduce viral hepatitis-related morbidity and mortality

• Goal 3: Reduce viral hepatitis-related disparities

SECTION 3 – SCOPE OF WORK

For the purposes of this contract, carceral settings are defined as facilities that house people who are incarcerated, detained and/or awaiting sentencing to include prisons and jails.

The Contractor shall work with and report to the COR at CDC. The Contractor shall submit an outline of the approach to writing up the report and a modified initial timeline for the deliverables prior to/or within 30 days of the first meeting (see additional details outlined in Section 4 below). The document(s) will be reviewed by CDC and modified by joint agreement between CDC and the Contractor of what is feasible in the 12-month contract period. As the Contractor progresses through the development of the deliverable, CDC and the Contractor will participate in monthly calls to monitor progress towards developing the deliverables and implementing adjustments to the timeline as necessary. By the final closeout meeting, the Contractor shall present a final data file with all of survey responses.

SECTION 4 – TASKS TO BE PERFORMED

The Contractor shall perform the following tasks:

Task 1: Administer survey to the carceral facilities

The Contractor shall administer the survey to 50-state DOCs and the District of Columbia prisons and large jails to include: screening and rescreening practices, HCV diagnostics, strategies to reduce DAA costs, provider training and patient education, use of hepatitis C data to assess elimination progress, and prevention strategies such as viral hepatitis immunization, provision of medications for opioid use disorder (MOUD), or harm reduction activities.

The survey will be administered through an instrument of choice by the Contractor.

Task 2: Analysis of the survey responses

The Contractor may perform a basic statistical analysis of the data collected from survey. The variables to include but are not limited to: demographics, point prevalence estimates, policies related to HCV testing and treatment, successes, challenges, and barriers to implementation.

Task 3: Progress Calls/Mid-Term Meeting

The Contractor shall coordinate with the contracting officer’s representative (COR) for all project-related communications. The Contractor shall maintain regular communications with the COR involved with the project. The chief means of communication will be via progress calls that will be scheduled monthly at an interval jointly agreed on by the COR and the Contractor that ensures timely resolution of outstanding issues or challenges. Additional calls may be scheduled as needed to facilitate project success. All meetings shall be held virtually via MS Teams, Zoom, or another platform that all parties have access to. The Contractor shall provide an agenda and minutes for each call. All progress calls shall be scheduled and administered by the Contractor.

The Contractor shall respond to all emails and telephone communications from the COR within three working days.

The Contractor shall coordinate a mid-term meeting with the COR where they will meet with the CDC Project Officer and other relevant CDC staff to discuss mid-term progress for the project. The mid-term meeting shall be held virtually via MS Teams, Zoom, or another platform that all parties have access to. The Contractor shall provide an agenda and minutes for the mid-term meeting.

Task 4: Submitting Deliverables and Final Meeting

The Contractor shall submit a finalized data file of all survey responses to the administered survey. The degree of de-identification of the dataset is as outline in the Data Management Plan below. At the final closeout meeting, the Contractor shall present on the deliverable and report any work planned but not accomplished during the contract period, if applicable.

In addition to this file, the Contractor may provide a summary of their findings after their initial analysis of the survey responses.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

No Government material will be furnished.

SECTION 6 – PERIOD OF PERFORMANCE

The period of performance shall be 12 months (base period only – no options): September 5, 2024 – September 4, 2025

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Task Deliverable Quantity Delivery Date Deliver To

1 Survey administration 1 data file of all survey responses

Final file within the last month of the contract

COR

2 Analysis 1 brief report

At least 5 business days before the final closeout meeting

3 Progress Calls

Mid-term Meeting

1 Agenda per Meeting

1 Meeting

At least 3 business days before meeting

6 months into the contract period +/- 1 month)

COR

4 Final Meeting 1 Meeting Within the last month of the contract

SECTION 8 – REFERENCE MATERIALS

N/A

SECTION 9 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is:

Michtta Jean-Louis Centers for Disease Control and Prevention 1600 Clifton Rd NE Atlanta, Georgia 30324 Telephone Number: 954-232-2801 E-mail Address: qdy2@cdc.gov Preferred method of communication: Email

SECTION 10 – PAYMENT TERMS

N/A

SECTION 11 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

Refer to Section 12 Evaluation Factors below.

SECTION 12 – EVALUATION FACTORS

The following technical evaluation criteria will be used to evaluate proposals and will be weighted as indicated below for all technical proposals submitted.

Similar Experience

The offeror’s proposal shall provide the general background, experience, and qualifications of the organization related in scope, magnitude, and complexity. The offeror’s plan shall provide a general background of the work performed and describe how the work is related to the requirements of the Statement of Work.

The Contractor must have extensive experience in carceral healthcare as well as connections to DOC leadership through collaborations that encompass custody, operations, facility design, and carceral leadership thereby ensuring that the content of the deliverables reflects a holistic understanding of the constraints and challenges of hepatitis C elimination in carceral settings. Further, the Contractor must have established connections and history of collaboration with the leadership of all the state DOCs to ensure that the content and recommendations for carceral settings strategies for hepatitis C elimination are relevant in these settings.

The Contractor must have prior experience evaluating the landscape of opportunities and challenges for hepatitis C elimination in carceral settings. The requirement for prior experience relating to the deliverable is to minimize start up time required and ensure timely completion of the deliverable within the contract period.

The proposal shall be further evaluated on the offeror’s demonstrated experience of managing projects relevant to the content and complexity of this requirement. This criterion will be evaluated to determine appropriate experience of assigned personnel and of the organization.

Technical Approach

The offeror is to provide a technical approach for delivering the services required for this contract. The offeror is to provide a detailed and comprehensive statement of the problem, scope, and purpose of the project to demonstrate a complete understanding of the intent and requirements of the contract and potential challenges that may be encountered. The description of the technical approach shall be in the Contractor’s own words, not a restatement of the listed requirements.

This criterion will be evaluated according to the soundness, practicality, and feasibility of the Contractor’s technical approach for providing the services required for this contract.

Staffing and Management Plan

The offeror’s proposal shall describe in detail the current staff capacity of the vendor to complete proposed activities and provide a detailed statement of staffing and management approach for managing the work outlined in the statement of work. This shall include any plans to subcontract work with the name of the subcontractor, if known. The offeror should include the percent time each staff person is expected to put towards this project so that CDC can adequately evaluate whether the staffing plan is adequate. Additionally, the management plan should include clear lines of responsibility to ensure it is clear how staff member will be organized in a management structure.

The offeror shall demonstrate their understanding of the labor requirements by proposing appropriate staff and including (a) resumes for key personnel outlining the credentials and background of key management, professional, and technical personnel to be used for this requirement, including the percent time on this and other projects; (b) a detailed plan that describes current staff available for this task order, percent time that all staff will dedicate to this requirement, and how the team will interface with CDC, and (c) a clear delineation of staff authorities and line of responsibility with special emphasis on relationships with subcontractors, if any.

This criterion will be evaluated according to the soundness, practicality, and feasibility of the Offeror’s staffing and management plans for this contract.

Price/Cost Evaluation: A price analysis of the cost proposal will be conducted to determine the reasonableness of the Contractor’s cost proposal.

Special Considerations

(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-aboard.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

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 an 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 is 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.

Data Management Plan

Type of date to be collected: The following quantitative and qualitative data will be collected from the Contractor and will be made available in a raw format for further analysis. The data transmitted will not contain any personally identifiable information. In order to maintain confidentiality of survey respondents, the data shared will be at an aggregate level.

The format of the dataset will be in a form that is easy for data manipulation and analysis. Upon completion of the survey administration, the Contractor will provide CDC with access to aggregate level data that will maintain confidentiality of all survey respondents before the end of the performance period.

Type of data collected:

• Number of persons tested for HCV upon intake and the general population

• Number of persons testing positive for hepatitis C antibody and/or RNA upon intake and the general population

• Demographic data (race/ethnicity, and age)

• Number of persons diagnosed with hepatitis C virus

• Number of persons waiting to be treated for hepatitis C virus

Institutional clinical practice:

• Presence of clinical practice guidelines

• Treatment prioritization

• Testing modalities

• Testing algorithm

Data preparation for transfer, preservation and sharing

The Contractor will collect and maintain the data including carceral facility identifiers. The Contractor will provide CDC a deidentified dataset to include: geographic description that includes ‘region’ for DOCs and ‘state’ for jails. The transfer of information will be performed using a secure application as identified in the Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action (cdc.gov). If the Contractor requires access to CDC databases and/or network we will follow the “Data Security and Confidentiality Guidelines” above.

CDC will perform an analysis that describes national, regional, and state (for jails) stratifications, but will not have access to direct identifiers. When CDC identifies facilities in need of support, the Contractor will approach the facility with CDC’s request to engage at which point the facility can decide whether to self-identify or remain anonymous. This approach gives the facilities control over whether to share their data with CDC.

The Contractor will be provided with CDC guidance on the collection, storage, and use of data while maintaining confidentiality as outlined here: Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action (cdc.gov) https://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf https://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf https://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf