PR48007 Statement of Work.docx

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION

DIVISION OF CANCER PREVENTION AND CONTROL

EPIDEMIOLOGY AND APPLIED RESEARCH BRANCH

STATEMENT OF WORK

Examining Colonoscopy Quality

SECTION 1 – BACKGROUND

Colorectal cancer screening can be of little value if performed poorly. Problems with the implementation of colonoscopy are well-documented and include wide variation among endoscopists in the ability to detect adenomas, and recommended rescreening and surveillance intervals that do not comply with guidelines. Quality indicators have been defined for routine monitoring in clinical practice. There is a need to examine the current status of colonoscopy quality in the United States in order to determine if colonoscopy quality needs to be improved.

SECTION 2 – PURPOSE

The objective of this project is to purchase data analytic support to analyze existing data from a colonoscopy registry or database to assess the current status of colonoscopy quality in the United States.

SECTION 3 – SCOPE OF WORK

Using data from colonoscopies performed from 2016-2019, the contractor shall compute recommended indicators of colonoscopy quality overall and by endoscopist, for each participating endoscopist with more than a set minimum number of procedures. The minimum number of procedures shall be determined by CDC in consultation with the contractor. The following high priority indicators shall be computed for colonoscopies:

· Adenoma detection rate (ADR), by patient gender and procedure indication (screening, surveillance or diagnostic). Adjustment for patient age may be performed.

· Cecal intubation rate, including by bowel preparation quality

· Percentage with adequate bowel preparation quality

· Recommended follow-up interval to next colonoscopy, by the outcome (pathology) of the original colonoscopy and bowel preparation quality (in order to assess appropriateness of rescreening and surveillance recommendations).

The contractor shall provide CDC with the distribution of values for each of the quality indicators listed above. The contractor in consultation with CDC will estimate the number and percentage of endoscopists that fall below recommended levels for these quality indicators.

The contractor shall provide CDC with the frequency distribution of the following variables both overall and for each quality indicator, if there is adequate data: patient age, patient gender, patient state of residence, patient type (inpatient vs. outpatient), whether a fellow performed the procedure, physician specialty, endoscopy suite type (hospital, ambulatory surgery/endoscopy center, or physician office), colonoscopy indication (screening, surveillance, or diagnostic), and year of previous colonoscopy. Quality indicators may be examined stratified by patient and endoscopist factors such as those listed above. The categories for each variable will be determined by CDC in consultation with the contractor.

The analysis may include tables and bar graphs or figures. Percentages and confidence intervals shall be computed. The analysis plan will be finalized by CDC in consultation with the contractor after contract award.

In order to describe the study population in the manuscript, the contractor shall provide CDC with data that describes the population of participants in the colonoscopy database from 2016-2019 and compares it to the population of all practicing endoscopists in the United States. For descriptive purposes, the contractor shall also provide CDC with the number of exams by calendar year since the registry started.

In order to disseminate the project results, a manuscript will be prepared and submitted for publication. Contractor staff may be co-authors on the manuscript. The contractor will assist with writing the Methods section and with preparation of the tables and figures for the manuscript.

The contractor shall provide all labor, expertise, equipment, materials, and supplies, and perform all services required to carry out the work under this contract.

SECTION 4 – TASKS TO BE PERFORMED

Task 1. Analysis Plan.

Within 2 months of project award, the contractor shall work with CDC to prepare a draft analysis plan. The analysis plan shall include plans for the variables, tables and figures/graphs. The contractor shall work with CDC to refine the analysis plan as the analyses progress. A final analysis plan shall be developed within 3 months of the contract award.

Task 2. Data Analysis.

The contractor shall work with CDC to define and create the variables for the data analysis. The contractor shall provide CDC with frequencies and 95% confidence intervals for the quality indicators and other covariate variables described in the scope of work. The contractor shall work with CDC to refine the analyses and prepare the tables and figures needed for the manuscript. The tables and figures needed for the manuscript shall be finalized within 10 months of project award.

Task 3. Manuscript Preparation.

The contractor shall work with CDC to prepare a draft manuscript. The contractor shall provide CDC with information about analysis methods and the colonoscopy database that will be needed for the manuscript. Within 14 months of project award, the contractor shall work with CDC to finalize the manuscript and to submit it for review by the contractor’s organization and by CDC. The contractor shall assist in making any revisions to the tables, figures or text that are required by the review process at CDC or by the journal.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

N/A. There are no materials to be furnished by the government.

SECTION 6 – PERIOD OF PERFORMANCE

Period of Performance: 24 months from start of contract award.

SECTION 7 - DELIVERABLES/REPORTING SCHEDULE

Section 8 - SPECIAL CONSIDERATIONS

1. Minimum Vendor Qualifications And Level Of Effort.

The vendor shall have a clinical data registry with data on at least 1 million colonoscopies for the years 2016-2019 from most U.S. states. The vendor shall have a high quality registry and conduct audits and data checks.

2. 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 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 9 – EVALUATION FACTORS Technical factors will be more important than cost in this evaluation. Technical evaluations for this RFTP are as follows:

Technical evaluation factors are:

Criterion 1 – Technical Approach The contractor shall provide a discussion of their technical approach for providing the services required for this contract including assistance with development of the analysis plan, data analysis, and assistance with manuscript preparation. The contractor is to provide a detailed time line for the accomplishment of tasks.

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.

Criterion 2 – Staffing and Management The contractor is to provide (1) a staffing plan that demonstrates an understanding of the labor requirements for this contract; and (2) a management plan that describes the approach for managing the work.

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

Criterion 3 – Similar or Previous Experience The contractor is to provide information reflecting experience that is similar in complexity and size to the anticipated project.