RFP_AHRQ-17-10004_Amendment_4.pdf

Request for Proposal No. AHRQ-17-10004 Amendment 4

The following RFP sections are revised as a part of Amendment 4:

C. Description/Specification/Work Statement F.2 Deliverable Schedule L.7 Technical Proposal Instructions L.9 Business Proposal Instructions M. Evaluation Factors for Award

All deletions have been struck through and highlighted in yellow. All additions have been highlighted in yellow.

Note to offerors: Please review the Statement of Work (SOW) carefully and pay special attention to the business assumptions. The SOW revisions reflect substantial reductions in volume and activity that AHRQ expects to experience during the period of performance of this contract.

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Request for Proposal No. AHRQ-17-10004

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

Date Issued: January 25, 2017 Date Questions Due: February 8, 2017 Please Note: All questions and inquires will be processed on a non-attribution basis.

Date Notice of Intent Due: February 24, 2017 Date Proposals Due: April 19, 2017 at 11:00 AM, EST

You are invited to submit a proposal to the Agency for Healthcare Research and Quality (AHRQ) for Request for Proposal (RFP) No. AHRQ-17-10004 entitled “Evidence-based Practice Center (EPC) Program Scientific Resource Center III.” Your proposal must be developed and submitted in accordance with the requirements and instructions of this RFP.

Please note: Conflict of Interest: A significant organizational conflict of interest has been identified for this solicitation. See section L herein for additional information.

Solicitation Information: Please review the table of contents and refer to the appropriate section of this RFP for requirements, proposal instructions and evaluation information. The Government intends to award this contract without negotiations, so it is imperative that all questions are addressed during the solicitation phase, and that all proposals submitted include the required information and accept the terms and conditions as stated. Failure to comply with proposal instructions or submit required information may result in the removal of a proposal from consideration for award. Please review Section L carefully.

Proposal Intent: If you intend to submit a proposal in response to this solicitation, please inform the Contracting Officer of your intent by completing the Proposal Intent Response Form (See section L.10 and Attachment A) and send it to the Contracting Officer no later than February 24, 2017. You may mail it to the address below; fax it to 301-427-1740, Attention: Sarah Chace, Contract Specialist or email it to sarah.chace@ahrq.hhs.gov.

Questions: All Questions regarding this solicitation shall be received in this office no later than the date shown above. All questions shall be submitted electronically by e-mail to Sarah Chace, Contract Specialist, at the following email address: sarah.chace@ahrq.hhs.gov. Subject line shall read: Proposal Questions RFP No. AHRQ-17-10004. Answers to questions and all solicitation amendments will be posted to the Federal Business Opportunities web page:

www.fbo.gov. It is your responsibility to monitor the website.

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http://www.fbo.gov/

Additional Information:

a. A cost plus fixed fee contract is contemplated for a period of one year, with four one-year options.

b. The Government anticipates awarding one contract from this solicitation on or about

August 15, 2017.

c. Proposals submitted in response to this solicitation must state that they are valid for a period of at least 120 days (reference FAR clause 52.215-1 in Section L of this document).

d. The NAICS code for this requirement is 541990 with a size standard of $15,000,000.

Proposal Submission: The proposal shall be signed by an authorized official to bind your organization and must be received by the due date specified above. The proposal must be submitted to the following address:

Agency for Healthcare Research and Quality (AHRQ)* Division of Contracts Management* 5600 Fishers Lane* Mail Stop 06N34B* Rockville, Maryland 20857* Attn: Sarah Chace, (301) 427-1010*

*All boxes must be clearly labeled with this information.

Please read this section carefully. Some mail and package delivery procedures have changed due to security controls. All mail and packages are screened at a local offsite facility before being delivered to 5600 Fishers Lane.

The U.S. Postal Service’s “Express Mail” does not deliver to our Rockville, Maryland address.

Please do not use this means of delivery for proposal submission.

Proposals delivered by commercial package delivery company (example: Fedex, UPS, DHL, etc.): Submit and label as instructed above. These companies are familiar with the delivery procedures at 5600 Fishers Lane.

Hand carried or hand carry courier service: The 5600 Fishers Lane building security does not allow packages to be delivered directly to the building. Hand carried or courier delivered proposals should be labeled as instructed above, however they must be delivered directly to the offsite screening facility at 12225 Wilkins Avenue Rockville MD 20852. Please note that anyone who arrives at the Fishers Lane location with a delivery will be directed to the screening facility, however this will cause delay. Packages will be accepted and date/time stamped at the screening facility. Please allow ample time as proposals cannot be date/time stamped until they

Request for Proposal v. Jan-17; FAC 93 Evidence-based Practice Center (EPC) Program Scientific Resource Center III have gone through security.

System for Award Management: In accordance with Federal Acquisition Regulation, all contractors must be registered in the System for Award Management (SAM) database in order to conduct business with the government [See Section I - FAR clause 52.204-7 System for Award Management]. Access the System for Award Management (SAM) at http://www.sam.gov.

Reminder: The Procurement Integrity Act prohibits the unauthorized disclosure of, inquiry about, or acceptance of procurement information. Communications with any other individual outside the AHRQ contracting office may result in rejection of an offeror’s proposal. All requests for any information concerning this RFP should be referred to Sarah Chace, (301) 427-1010 or e-mail: sarah.chace@ahrq.hhs.gov. Please note e-mail requests should state subject as RFP

AHRQ-17-10004.

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Amendment 4 http://www.sam.gov/ mailto:sarah.chace@ahrq.hhs.gov

Table of Contents

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

SECTION D - PACKAGING AND MARKING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II – CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

PART III- LIST OF DOCUMENTS, EXHIBITS AND ATTACHMENTS

SECTION J – SOLICITATION LIST OF ATTACHMENTS

PART IV– REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

SECTION M- EVALUATION FACTORS FOR AWARD

Evidence-based Practice Center (EPC) Program Scientific Resource Center III

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

“Evidence-based Practice Center (EPC) Program Scientific Resource Center III”. See Section C for a complete description.

B.2 ESTIMATED COST AND FIXED FEE

a. The Estimated Cost (exclusive of fees) for performance of the work under the base period of this contract, including direct and indirect costs is $ To Be Determined (TBD).

b. The Fixed Fee for the base period of this contract is $TBD. The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the Clause ALLOWABLE COST AND PAYMENT and FIXED FEE incorporated herein.

c. The total contract value, represented by the sum of the estimated cost plus the fixed fee for the base period is $TBD.

Period of Performance

Services Estimated Cost Fixed Fee Total

Base Period Severable $ $ $

B.3 OPTION COSTS

If the Government exercises its option(s) pursuant to the option article in Section H of this contract, the Government’s total contract amount represented by the sum of the estimated cost and fixed fee will be revised as follows:

Period of Performance

Services Estimated Cost Fixed Fee Total

Option Period 1 Severable $ $ $

Option Period 2 Severable $ $ $ Option Period 3 Severable $ $ $ Option Period 4 Severable $ $ $

The base period and each option are separate and distinct from one another for accumulation of costs and billing purposes.

B.4 PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, Request for Proposal v. Jan-17; FAC 93 Evidence-based Practice Center (EPC) Program Scientific Resource Center III incorporated into this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

(1) Acquisition, by purchase or lease, of any interest in real property;

(2) Rearrangement or alteration of facilities;

(3) Purchase or lease of any item of general purpose-office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

(4) Accountable Government property;

(5) Travel to attend general scientific meetings;

(6) Foreign Travel;

(7) Any costs incurred prior to the contract's effective date;

(8) Rental of meeting rooms not otherwise expressly paid for by the contract;

(9) Any formal subcontract arrangements not otherwise expressly provided for in the contract;

(10) Consultant fees;

(11) Information Technology hardware or software;

(12) Food and Beverages; and

Note: Food and Beverages are unallowable costs. Contracting Officer Authorization for Food and Beverages will be only made as specifically authorized by statute, which is extremely rare. The contractor shall not provide food or beverages of any type. The contractor shall not accept food or beverages, even if included in, or provided ‘free’ as part of a meeting/conference ‘package’.

b. Travel Costs

This contract is subject to the provisions of Public Law (P.L.) 99-234 which amends the

Office of Federal Procurement Policy Act to provide that contractor costs for travel, including lodging, other subsistence, and incidental expenses, shall be allowable only to the extent that they do not exceed the amount allowed for Federal employees. The Contractor, therefore, shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.

The following applies to Educational Institutions: The Contractor shall invoice and be

Request for Proposal v. Jan-17; FAC 93 Evidence-based Practice Center (EPC) Program Scientific Resource Center III reimbursed for all travel costs in accordance with OMB Circular A-21 - "Cost Principles for Educational Institutions."

No funding or expenditures will be authorized under this contract for travel or meeting expenses of any person that is not an employee of the contractor or approved subcontractor in accordance with the terms of the contract. See 31 USC § 1345 for appropriations restrictions.

B.5 CONTRACTING OFFICER AUTHORIZATION

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.

To Be Determined

Evidence-based Practice Center (EPC) Program Scientific Resource Center III

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work as follows:

Statement of Work

Unless otherwise noted under a specific task, this Statement of Work applies to the base period and all options (if exercised).

A. Background Information The Agency for Healthcare Research and Quality

The Agency for Healthcare Research and Quality (AHRQ) was established in 1989 as the Agency for Health Care Policy and Research. Its reauthorizing legislation (42 U.S.C. 299 et seq;

“Healthcare Research and Quality Act of 1999”) renamed the Agency for Healthcare Research and Quality (AHRQ) and established it as the lead Federal agency for enhancing the quality, appropriateness, and effectiveness of health services and access to such services.

The Agency mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. To achieve this mission, AHRQ conducts and supports a broad base of scientific research and promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. AHRQ sponsors and conducts research that develops and presents evidence-based information on healthcare outcomes, quality, patient safety, cost, use and access.

Included in AHRQ’s mandate is support of synthesis and dissemination of available scientific evidence, including dissemination research and analytic methods or systems for rating the strength of scientific evidence. AHRQ sponsors and conducts research on existing as well as innovative technologies and care delivery approaches, and conducts research on methods for measuring quality and strategies for improving quality. AHRQ also recognizes that a number of populations experience persistent disparities in health status, access to care, quality of care, and poor health outcomes. To address these disparities, AHRQ encourages research projects to include special populations such as low-income groups, racial and ethnic minority groups, women, children, the elderly, and individuals with disabilities and chronic health conditions.

AHRQ work in Patient Centered Outcomes Research

Under Section 937 of the Affordable Care Act (ACA) passed in 2011 (42 USC 299b-37), AHRQ is mandated to disseminate research findings published by PCORI and other government-funded research relevant to comparative clinical effectiveness research to physicians, healthcare providers, patient, payers and policy makers. In support of this mandate AHRQ is investing in disseminating and implementing high-value patient-centered outcome research findings to promote evidence-based practice, and improve health outcomes (http://www.ahrq.gov/pcor/index.html). Significant investments include EvidenceNOW, Health IT Clinical Decision Support, and the PCOR Dissemination and Implementation Initiative.

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The AHRQ Evidence-based Practice Centers (EPCs) synthesize scientific evidence, which is the first step in dissemination and implementation of evidence into practice. The John M Eisenberg Clinical Decisions and Communications Science Center and other grant or Knowledge Transfer contract work further translate scientific findings for different audiences for further dissemination to patients and healthcare providers.

John M. Eisenberg Clinical Decisions and Communications Science Center

The John M. Eisenberg Clinical Decisions and Communications Science Center, also referred to as the Eisenberg Center, takes a systematic approach to translate scientific knowledge about effective health care into understandable, actionable language for all decision-makers. As scientific evidence about effectiveness is synthesized by the EPC program, the Eisenberg Center then translates the scientific knowledge into targeted products for stakeholders – including patients, providers, and policy-makers. Stakeholders can use this knowledge to maximize benefits from their health care, minimize harm, and optimize the use of health care resources. An important function of the Eisenberg Center is to present the often complex scientific information in a format that stakeholders and the public can easily understand.

As a part of the Eisenberg Center’s role in interfacing with external stakeholders, they manage the Effective Health Care public-facing website (http://www.effectivehealthcare.ahrq.gov/). The Effective Health Care website is a public repository for EPC products, including systematic reviews, technical briefs, methods papers and methods guidance, and translation products based on EPC products; houses the portal for nominations from the public for proposed systematic review topics; and manages the public comment portals for EPC reports.

Evidence-based Practice Centers (EPC) Program

The Evidence-based Practice Centers Program was created in 1997 to synthesize existing scientific literature about important health care topics and promote evidence-based practice and decision-making. These reviews use the research methodology of systematic review to systematically and critically appraise existing research and synthesize knowledge on a particular topic. These are systematic reviews based on rigorous, comprehensive methods, emphasizing explicitly detailed documentation of methods rationale and assumptions. EPCs also use a systematic approach to synthesizing relevant evidence for new technologies or other healthcare interventions, tests, or care delivery approaches and produce other evidence reports such as technical briefs or technology assessments.

The ultimate goal of EPC work is to present the “state of the science” on a given topic in a manner that can be directly applied to decisions made by users of health care information.

These users include clinicians, patients, policy-makers, payers, and healthcare organization representatives. Specifically, evidence reports have been used as a scientific foundation for development and implementation of clinical practice guidelines, clinical pathways, decision aids, review criteria, performance measures and other clinical quality improvements tools, individual treatment decisions, coverage or reimbursement policies, and to develop research agendas.

With funding from a variety of sources, each with a different program goal, EPCs work with various partners and stakeholders to review a variety of health care delivery and clinical areas of focus. Clinical areas may focus on traditional therapeutics as well as complementary, alternative, and nutritional interventions. An increasingly important stakeholder group is healthcare delivery organizations and health systems, with an interest in a variety of nonclinical

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http://www.effectivehealthcare.ahrq.gov/ topics such models of care, healthcare delivery interventions, implementation strategies to promote evidence-based practice, and quality improvement.

As the first step in dissemination of patient-centered outcomes research efforts, EPCs engage directly with stakeholders such as guideline development groups, patients, providers, policy-makers, healthcare delivery organizations, and other consumers of evidence reports, including researchers and funders of research to determine the questions that patients, providers, and policy-makers ask prior to the actual systematic review process. EPCs continue to be involved in development of dissemination materials such as those produced by the Eisenberg Center to ensure that key messages are accurately portrayed. In addition to various stakeholders, EPCs also continue to engage technical experts to provide input while developing the protocol in order to ensure that the review shall be comprehensive and relevant. Additional information on the EPC program descriptions of processes and derivative products in disseminating patient-centered outcomes research can be found at:

http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/; and http://www.ahrq.gov/research/findings/evidence-based-reports/index.html.

In addition to working with a variety of external partners, EPCs conduct reviews for a variety of other Federal programs, including the US Preventive Services Task Force (USPSTF), the Technology Assessment (TA) Program, and other Federal agencies, such as individual centers within National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (DHHS), or other Federal branches of government.

Through the Technology Assessment (TA) Program, EPCs conduct abbreviated, focused technology assessments on behalf of the Centers for Medicare and Medicaid Services (CMS) through the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to inform its national coverage decisions for the Medicare program as well as provide information to Medicare carriers. Examples of Technology Assessments can be found at:

http://www.ahrq.gov/research/findings/ta/index.html. The U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984, and since 1998 supported by AHRQ, is the leading independent panel of private-sector experts in prevention and primary care. The USPSTF reviews the scientific evidence for the effectiveness of a broad range of clinical preventive services, including screening tests, counseling services, and preventive medications to determine the balance of benefits and harms for specific groups of people based on age, gender, and other risk factors for disease. Based on that evidence review, the USPSTF makes recommendations to primary care providers about which clinical preventive health care services to offer their patients and how often.

The work of the USPSTF is supported by Evidence-based Practice Centers (EPCs), which conduct rigorous, impartial assessments of the scientific evidence on specific topics in clinical prevention that serve as the scientific basis for USPSTF recommendations. The EPCs also provide consultation to the Task Force on developing its recommendations and translating them for multiple target audiences. For a detailed explanation of the USPSTF's methods, go to http://www.uspreventiveservicestaskforce.org/Page/Name/methods-and-processes. To access a current list of released topics and a list of topics in progress visit www.uspreventiveservicestaskforce.org.

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To improve the scientific rigor, transparency, and consistency of reviews, the EPC program has collaborated to improve the methods used by developing guidance to the program as well as instituting processes to uphold the quality of the methods of reports. EPCs are on the forefront and lead the field by developing guidance on cutting edge systematic review methods issues. The Methods Guide for Effectiveness and Comparative Effectiveness Reviews (Methods Guide, January 2014) is an ongoing, collaborative process by the EPC workgroups to provide guidance on how to handle the most difficult methodological issues in conducting systematic reviews. Recent methods investments include assessment of risk of bias;

prioritization of harms; systematic reviews of complex interventions; and rapid reviews. This work has led to other activities including collaboration with other organizations such as GRADE and WHO for further development of systematic review methods; and development of a reporting guideline for systematic reviews of complex interventions. This EPC Methods Guide (Methods Guide, January 2014) was a cornerstone for the development of the IOM Standards for Systematic Review (IOM, 2011). Training modules are also provided which help new EPC investigators implement the methods guide and can be found as downloadable slides or CME (http://www.effectivehealthcare.ahrq.gov/trainingmodules.cfm). In addition to reference and teaching materials, the EPC program has a rigorous editorial and peer review process to ensure the production of quality, unbiased reports. A panel of associate editors and peer reviewers are selected to provide unbiased expert feedback to authors (http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-evidence-based-practice-centers-epcs/epc-center-editorial-review-process/).

The Systematic Review Data Repository (SRDR) is an online software tool and database that EPCs may use in development of the systematic review, and is used to deposit Systematic review data for all EPC reviews at the end of a project to improve transparency and the process for future updates. The SRDR is available at: http://srdr.ahrq.gov/.

The Scientific Resource Center

The Scientific Resource Center (SRC) was conceived in 2007 to promote efficiency, rigor, consistency, and quality across the Evidence-based Practice Centers (EPCs). The SRC supports the scientific rigor of the EPC Program through leadership, organization and handling of the editorial and peer review process for EPC reports; through organization, development, leadership and authorship of methodological papers, tools, and materials to promote consistency across EPCs and for the scientific field; through development and maintenance of tools and identification and development of opportunities to promote learning opportunities, coordination, collaboration, and sharing of information; and through tracking and assessment of topics for evidence review and update by the EPCs. The SRC’s scientific expertise and experience is essential to effectively lead and convene innovative methods work by experts in research and systematic review; to ensure and maintain excellence and rigor in each of its centralized activities on behalf of the program; and to promote and improve the impact of the EPC program and its products.

Statement of Work Attachments

EPC-SRC Technical Overview – Please see Section J

HHS Enterprise Lifecycle Framework (EPLC) – Please see Section J

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Amendment 4 http://www.effectivehealthcare.ahrq.gov/trainingmodules.cfm http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-evidence-based-practice-centers-epcs/epc-center-editorial-review-process/ http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-evidence-based-practice-centers-epcs/epc-center-editorial-review-process/ http://srdr.ahrq.gov/

B. Objectives

The Scientific Resource Center (SRC) shall support and coordinate many of the cross-cutting functions of the EPC program, including:

1. Develop, lead and coordinate methodological work to maintain utility, scientific rigor, and consistency of EPC products.

a. The SRC shall engage EPCs to maintain, develop, and implement consistent guidance for the systematic review methods used by the EPC program.

b. The SRC shall convene and lead regular meetings to discuss coordination, consistency, rigor and utility of EPC products and methodological approaches.

2. Provide scientific and technical leadership and support to protect and ensure scientific credibility and independence of EPC Program Products

a. The SRC shall coordinate and track EPC reports for peer review.

b. The SRC shall lead and coordinate an editorial and peer review process to optimize the scientific rigor of draft and final reports. The SRC shall participate as associate editors and statistical or methodological peer reviewers. The SRC shall identify and provide resources for associate editors to optimize consistency and rigor in reviewing reports. The SRC shall schedule, set agendas for, and lead regular associate editor calls and meetings for coordination purposes.

c. The SRC shall invite peer reviewers and collate comments for EPC reports.

d. The SRC shall coordinate the solicitation and receipt of supplementary evidence and data for systematic reviews from study sponsors and other stakeholders.

3. Develop topic nominations and manage selection and surveillance processes

a. The SRC shall work with stakeholders, particularly those from health systems, to identify, develop and refine questions that would improve patient care and outcomes, and identify methods and options for addressing those questions.

b. The SRC shall develop and evaluate topic nominations by established selection criteria following an algorithm to efficiently triage topics to those that are most viable for EPC Program evidence review. The SRC shall produce a report (“topic brief”) on each topic nomination for greater transparency and prioritization.

c. The SRC shall lead and manage the EPC Program topic selection process through the support of communications and calls approximately quarterly.

The SRC shall engage the topic selection group members for comment through email and through discussion at meetings when needed.

c. d. The SRC shall gather and track topic nominations

d. The SRC shall assess EPC systematic reviews by an established surveillance process to determine the currency of its conclusions.

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d. The SRC shall provide medical librarian support for AHRQ and EPC topic development efforts.

4. Promote program collaboration, communication and learning through development, maintenance and updating of EPC program resources.

a. The SRC shall maintain and update software tools and documents, such as ScholarOne, for greater consistency among EPC products, for smooth functioning among the different parts of the EPC program, and for improved adherence to EPC policies and procedures.

b. The SRC shall adhere to AHRQ policies and requirements for Federal Information Systems, including security and privacy concerns.

c. The SRC shall identify, coordinate, and support activities and resources for mutual learning and collaboration within the EPC program, including through maintenance of methods library, development of webinars and other methods of communication or learning opportunities.

C. Tasks C.1. Develop, lead and coordinate methodological work to maintain utility, scientific rigor, and consistency of EPC products.

C.1.1. The SRC shall engage EPC input on methodological priorities through assembly of, and communication with, and support of an EPC Methods Steering Group. Through at least quarterly teleconference calls of this Steering Group, the SRC shall update the Steering Group on the status of EPC methods work,; identify topics and speakers and plan an annual cross- EPC in-person meeting and at least quarterly cross-EPC virtual meetings or webinars with the goal of improving consistency, utility, and scientific rigor of EPC program products; and identify areas of methodological priorities for EPC workgroup projects and other methods work, taking into consideration the priorities and future directions of AHRQ and the EPC Program. The SRC shall work with this group to consider current EPC Program resources and needs, external methodological efforts, and prioritize EPC methodological efforts to improve utility, quality and consistency of EPC products. The SRC shall provide administrative support for such conference calls, including scheduling calls, developing agendas for calls, facilitating calls, and sending materials prior to calls.

C.1.2. The SRC shall lead, organize and support methodological work, such as cross-EPC workgroups, addressing areas as determined by engagement with the EPC Methods Steering group (C.1.1). The SRC shall be responsible for organizing calls with EPC workgroup members, setting agendas, keeping notes, tracking resources, clarifying roles and responsibilities, and encouraging timely completion of tasks for each workgroup. The SRC shall contribute scientifically to workgroups, and may also take a leadership role.

The SRC shall work with each group to:

• Develop and refine the scope of prioritized methods work

• Develop and refine a timeline, workplan, abstract and protocol for and conduct work on the highest priority need or needs. These projects may include projects or papers to:

o Update EPC Methods Guide for Effectiveness and Comparative Effectiveness Reviews (EPC Methods Guide, Request for Proposal v. Jan-17; FAC 93 Evidence-based Practice Center (EPC) Program Scientific Resource Center III https://www.effectivehealthcare.ahrq.gov/ehc/products/60/318/CER-Methods- Guide-140109.pdf) o Improve implementation of methods guidance o Lay the groundwork for development of an EPC approach on methodological issues (and subsequent Methods guide chapter)

• Present summary of projects to EPCs.

• Support, organize, and author (if relevant) papers based on EPC program-funded methods work. The SRC shall support and organize the development of methods papers consistent with the procedures outlined in the EPC Program Procedures Guide included at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html.

C.1.3 The SRC shall convene two one in-person 2 day meetings yearly in addition to at least quarterly virtual meetings to discuss coordination and consistency of EPC products and methodological approaches to optimize rigor and utility of EPC products. To achieve these objectives, the SRC shall participate in and develop a steering committee engage the Methods Steering Committee, set the meeting agenda, invite speakers, develop learning objectives for productive sessions, collate materials for distribution, and arrange and handle logistics of meeting participants prior to and during the meeting. These in-person meetings shall be held in the Washington DC or Rockville, MD areas.

C.2. Provide scientific and technical leadership and support to protect and ensure scientific credibility and independence of EPC Program Products C.2.1. Lead and provide editorial leadership and independent scientific review to optimize scientific rigor of EPC products.

The SRC shall lead and manage the assembly, coordination, and training of associate editors (AE) for EPC products. See the EPC Program Procedures Guide included at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html for more information about the timing and role of AE in EPC products. The SRC shall participate in the editorial process as associate editors. The SRC shall identify issues for improving the editorial and review process and convene quarterly calls with AEs to discuss issues to improve consistency and efficiency in AE review as well as identify areas for quality improvement within the program, such as areas where methods guidance may improve quality or consistency; or templates, guidance, workshops, or other venues may improve clarity of reports and the presentation of evidence (see the Associate Editor Guidance for Reviewing EPC reports located at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html). The SRC shall provide administrative support for such conference calls, including scheduling calls, developing agendas for calls, facilitating calls, and sending materials prior to calls. The SRC shall also manage the assignment of reports to AEs.

C.2.2. Manage and provide statistical or methodological peer review.

Using appropriate software such as ScholarOne software, the SRC shall manage a peer review process for EPC products. See the EPC Program Procedures Guide located at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html for more information about the description and timing of the peer review process in EPC products. The SRC shall maintain and refine peer review processes to enhance efficient, quality, and unbiased review of each EPC report by the appropriate respective associate editor, AHRQ Task Order Officer (TOO), and peer reviewers; and ensure the scientific credibility of EPC products by recognizing threats and proactively develop safeguards. The SRC shall provide or ensure adequate statistical or

Request for Proposal v. Jan-17; FAC 93 Evidence-based Practice Center (EPC) Program Scientific Resource Center III

AHRQ-17-10004

Amendment 4 https://www.ahrq.gov/funding/contracts/rfp-17-10004.html https://www.ahrq.gov/funding/contracts/rfp-17-10004.html https://www.ahrq.gov/funding/contracts/rfp-17-10004.html methodological review of EPC products. The SRC shall make peer review comments available to the COR and TOO. The SRC shall receive public comments on draft reports submitted through a public portal such as the one on the EHC website from the Eisenberg Center staff and provide them to the COR and TOO.

The SRC shall provide data on timeliness of EPC product milestones to the COR twice a year to assist with AHRQ’s preparation of an annual report; and to EPCs, AEs, and AHRQ TOOs for informational and Program quality improvement purposes.

The SRC shall also develop an annual letter acknowledging the contribution of AEs and peer reviewers who reviewed EPC reports that year and send to the named AEs and peer reviewers, and to the COR for public posting on the EHC website.

C.2.3. Maintain and refine process for requests of information from stakeholders, including Supplemental Evidence and Data for Systematic Reviews (SEADS).

The SRC shall maintain, refine, and manage the processes for requests to stakeholders, such as manufacturers or industry to provide any unpublished information, including SEADS for each EPC review, at the time of protocol posting as described in the EPC Procedures Guide.

See the EPC Program Procedures Guide located at https://www.ahrq.gov/funding/contracts/rfp- 17-10004.html for more information about the timing and description of the SEADS process in EPC products.

The SRC shall also prepare a memo for posting on the Federal Register website (https://www.federalregister.gov/), notifying the public of the opportunity to submit unpublished data on the topic of the EPC review.

C.2.4. C.2.3. Ensure appropriate statistical review upon request of AHRQ COR.

The SRC shall ensure that reviewers with appropriate statistical expertise are available to review EPC reports with meta-analysis, network meta-analysis, or other statistical methods such as qualitative comparative analysis.

C.2.5. C.2.4. Provide methodological support.

The SRC shall assist provide consultation and assist EPC authors AHRQ in methodological issues or processes such as searches of the FDA site, clinicaltrials.gov site, or relevant registries or other data sources.

C.3. Develop topic nominations and manage selection and surveillance process.

C.3.1. Develop topic nominations and manage EPC Program Topic Selection and Surveillance Processes.

• The SRC shall maintain and refine the topic development process to enhance efficient, quality, and unbiased assessment of each topic nomination. The contractor shall develop topic nominations and manage the topic selection process in accordance with the EPC Program Procedures Guide located at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html.

• The SRC shall identify and engage stakeholders in new areas for the EPC Program, particularly those representing health systems, in the nomination process to identify and develop relevant questions for new nominations, and methods for addressing these questions

• The SRC shall receive nominated topics from the Eisenberg Center (EC) by

Request for Proposal v. Jan-17; FAC 93 Evidence-based Practice Center (EPC) Program Scientific Resource Center III

AHRQ-17-10004

Amendment 4 https://www.ahrq.gov/funding/contracts/rfp-17-10004.html https://www.ahrq.gov/funding/contracts/rfp-17-10004.html https://www.federalregister.gov/ email or through delivery via secure EPC Program website.

• The SRC shall manage the receipt, initial assessment, processing, and tracking of all topic nominations received.

• The SRC shall develop assigned topic nominations using established EPC

Program selection criteria (see the Topic brief template and selection criteria table for EPC Program Topic Selection Process for more information located at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html), using an algorithm to triage them appropriately and efficiently. The SRC shall produce a report on each assigned topic nomination (“topic brief”) for greater transparency and prioritization.

• The SRC shall engage stakeholders to clarify nominations and identify methods and options to address nominations, to ensure relevance and usefulness

• These evaluations of nominations shall occur on an ongoing basis be assigned by the COR and the SRC shall provide assessments (or EPC Program “topic briefs”, See the Topic brief template and selection criteria table for EPC Program Topic Selection Process for more information located at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html) to the AHRQ COR for approval monthly, and discuss and revise as needed. For topics that meet these established selection criteria, the SRC shall assess the estimated scope and size of the review (i.e. how many studies are estimated to be relevant to the topic).

• The SRC shall solicit input from a topic selection group identified by AHRQ via monthly email notification after approval by the AHRQ COR. If active discussion is requested by the AHRQ COR, the SRC shall schedule and host a call with appropriate topic selection group members. The SRC shall provide administrative support for such conference calls, including scheduling calls, developing agendas for calls, facilitating calls, and posting materials on the secure EPC Program website prior to calls.

• The SRC shall convene and lead meetings to prioritize topic nominations which meet EPC Program topic selection criteria, and select those for evidence review development via teleconference two to three times once per year. The SRC shall develop the agenda, develop briefing materials and lead calls, as well as provide administrative support such as scheduling calls and sending materials prior to calls.

• The SRC shall provide medical librarian support for AHRQ or EPC topic development efforts. A medical librarian shall assist in developing and performing searches of the published literature, and provide consultation as requested for refining search strategies.

• The SRC shall develop and apply an algorithm for selecting five high impact completed EPC reports per year for surveillance.

• The SRC shall assess the currency of no more than five high impact completed EPC reports per year through a surveillance process. The SRC shall document the results of assessments, and the assessments shall be posted on the public EHC website after AHRQ COR approval (see the Surveillance template located at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html).

C.3.2. Provide Transparency to Topic Selection Process and Surveillance Process.

• The SRC shall keep current materials describing the selection of topics within the

EPC Program. As the topic selection processes are being updated, the SRC

Request for Proposal v. Jan-17; FAC 93 Evidence-based Practice Center (EPC) Program Scientific Resource Center III

AHRQ-17-10004

Amendment 4 https://www.ahrq.gov/funding/contracts/rfp-17-10004.html shall update the topic selection criteria and simple description of selection process on public EHC website as needed.

• The SRC shall finalize each topic brief with the coded decision with supporting documentation to provide feedback to every its nominator who provides contact information and to be posted on the public EHC Program website after AHRQ approval.

• The SRC shall prepare a prioritized list of topics selected with estimated sizes of review and post on the EPC Program secure website.

• The SRC shall develop and maintain processes to obtain input on proposed review questions.

• The SRC shall keep current materials describing the surveillance process for the EPC Program. As the processes are updated the SRC shall update the description of the surveillance process on the public EHC website as needed.

C.4. Promote program collaboration, communication, and learning through development, maintenance, and updating of EPC program resources.

C.4.1. Maintain and develop methods library.

The SRC shall maintain a continuously updated library of methods articles relevant to the conduct of systematic reviews and make the library available and accessible to EPC investigators.

C.4.2. Develop and maintain documents for EPC program. This includes, in collaboration with the COR, updating and maintaining templates for the Topic Briefs and Surveillance Reports.

The SRC shall maintain templates, procedures, and instructions for use of peer review software, such as Scholar One, for authors, AE, AHRQ staff, and peer reviewers; peer review processes; SEAD; topic development templates and process (see the Topic brief template and selection criteria table for EPC Program Topic Selection Process located at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html); surveillance template and process (see the surveillance template located at https://www.ahrq.gov/funding/contracts/rfp-17- 10004.html); and AE guidance (see the Associate Editor Guidance for Reviewing EPC reports located at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html). The SRC shall document a history of changes with each updated version.

C.4.3. Maintain databases for EPC program including for topics, peer reviewers, and stakeholders (Databases are described in the SRC-managed Databases, Tools and Resources document located at https://www.ahrq.gov/funding/contracts/rfp-17-10004.html).

The SRC shall maintain a searchable Topics Database with tracking and reporting capabilities so the status of each topic can be followed (by date) and reported on an ongoing basis. The database shall be available on a secure EPC Program website for use by AHRQ.

Each topic in the database shall be assigned unique identifying information (e.g., number, title, key words) so that if the topic is developed into a report, it can be added to and tracked in the database of EPC Products. For each topic, information such as the source of the nomination, priority condition to which it belongs, and final disposition shall be included. The SRC shall maintain and adapt the Topics Database.

The SRC shall maintain a searchable database of EPC reports and peer reviewers to track and manage peer reviewer recruitment and review of EPC reports. The database shall include

Request for Proposal v. Jan-17; FAC 93 Evidence-based Practice Center (EPC) Program Scientific Resource Center III

AHRQ-17-10004

Amendment 4 https://www.ahrq.gov/funding/contracts/rfp-17-10004.html https://www.ahrq.gov/funding/contracts/rfp-17-10004.html https://www.ahrq.gov/funding/contracts/rfp-17-10004.html communications with peer reviewers, and peer review comments.

The SRC shall maintain a searchable database of EPC Program stakeholders to track and manage contacts and outreach with contacts. The database shall be available on an EPC Program secure website for use by AHRQ, and the EPCs, and Eisenberg Center. The database shall include communications with stakeholders.

C.4.4. Support of EPC learning through bi-monthly webinars.

The SRC shall identify learning needs and opportunities to improve the scientific rigor of EPC Program products. The SRC shall identify topics and speakers, set agendas and learning objectives, and coordinate calls or webinars.

C.4.5. C.4.4 Maintain an EPC Program Secure website for maintaining and sharing program resource documents for the EPC program.

The SRC shall maintain and keep up-to-date a EPC Program secure 508-compliant website in the AHRQ environment for coordination of EPC Program activities among the SRC, AHRQ, and EPCs and the EC (see EPC-SRC Technical Overview attachment located in Section J), and develop a plan for migrating development and maintenance of the secure site after the completion of this contract or to meet Program needs. The security categorization of the EPC Program secure website is low. As part of its maintenance and support the SRC shall provide:

• Technical support in use of and access to the site.

• Maintenance and support for user logins and passwords.

• The SRC shall provide for near-full time availability to ensure system uptime for user operations including updates. Any hardware or software failure shall not result in a loss of more than 24 hours of current data, any software failure shall not result in more than 72 hours of downtime, any hardware failure shall not result in more than 72 hours of downtime, and any Internet connectivity failure shall not result in more than 48 hours of downtime. The SRC shall test the backup/restore process at least monthly and report any failures to the Contracting Officer Representative.

• System operation and maintenance for the length of the contract in accordance with all the Federal and Department of Health and Human Services requirements in laws, policies, and directives for information technology, capital planning and investment, and information management and the security of Agency information and systems. This includes security and privacy concerns, and 508-compliance.

Processes should be consistent with the…