Part I Overview Information


Department of Health and Human Services

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ) ( http://www.ahrq.gov)

Components of Participating Organizations
Center for Quality Improvement and Patient Safety
Center for Primary Care, Prevention, and Clinical Partnerships

Title:  Ambulatory Safety and Quality Program: Enabling Quality Measurement through Health IT (R18)

Note:  The policies, guidelines, terms and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-HS-07-002

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: December 6, 2006
Opening Date: January 13, 2007
Letters of Intent Receipt Date(s): January 19, 2007
Application Submission/Receipt Date(s): February 13, 2007
Peer Review Date(s): April/May, 2007
Earliest Anticipated Start Date(s): July, 2007
Technical Assistance Teleconference: January 4, 2007
Expiration Date: February 14, 2007

NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The Agency for Healthcare Research and Quality (AHRQ) announces the availability of funds to support the development of health information technology (health IT) to assist clinicians, practices and systems to measure the quality and safety of care in ambulatory care settings. This Funding Opportunity Announcement (FOA) solicits R18 grant applications from applicant organizations that propose to:

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Submission, Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to AHRQ
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

General Purpose of the Ambulatory Safety and Quality (ASQ) Program

The purpose of the Agency for Healthcare Research and Quality’s (AHRQ’s) Ambulatory Safety and Quality (ASQ) program is to improve the safety and quality of ambulatory health care in the United States. The program’s components, with the exception of the announcement on risk assessment, have an emphasis on the role of health information technology (health IT).  Emerging information about ambulatory care suggests that the patient safety crisis in hospitals is only the “tip of the iceberg.” The scope of ambulatory care has increased over the past decade, as the volume and complexity of interventions has burgeoned.  Safe, high quality ambulatory care requires complex information management and coordination across multiple settings, especially for patients with chronic illness(es).  The opportunity to turn the potential of health IT towards improving safety and quality in the ambulatory care setting, especially within care transitions, will form the cornerstone of this proposed Ambulatory Safety and Quality (ASQ) Program.

Specific Purpose of this FOA

AHRQ is interested in projects that investigate novel methods or evaluate existing strategies for the development of health IT to assist clinicians, practices and systems to measure the quality and safety of care in ambulatory care settings. Applicants are encouraged to develop new safety and quality measures, determine essential data elements for Institute of Medicine (IOM) priority areas, develop health IT systems to export measures, demonstrate the ability of health IT to provide measures, enable public reporting through health information exchange, and measure the efficiency of quality measurement.

Overview: Ambulatory Safety and Quality (ASQ) Program

The ASQ Program offers an integrated approach to improving ambulatory safety and quality of care.  While there are strategies that could improve the quality and safety of ambulatory care, there are unknown risks in ambulatory care and across transitions in care that need to be better understood and described before appropriate interventions can be developed.  Where effective strategies exist to drive ambulatory safety and quality, such as health IT, there is a need for research to demonstrate value, as well as best approaches to broader diffusion, implementation and effective use. In particular, the high risk associated with medication use in ambulatory care and across transitions in care provides some urgency for targeted risk assessment and health services interventions related to medication management.  Finally, effective strategies to improve ambulatory care will be limited by the capacity of current electronic health systems to measure and report on ambulatory safety and quality. 

To achieve measurable improvements, the four funding opportunity announcements (FOAs) that comprise the ASQ Program address research needs that share a common focus on ambulatory care clinicians, patients, and information technology.  This funding opportunity is one of the four in the ASQ program, as described below:

I.                   ASQ: Risk Assessment in Ambulatory Care:  This announcement has a broad view on ambulatory care that includes the ambulatory care clinician, as well as the patient cared for in ambulatory settings and across high risk transitions in care.  Research will focus on assessing the risks associated with ambulatory care that have not yet been fully elucidated.  Unlike the rest of the ASQ program, this announcement does not include a primary focus on health information technology.

II.                ASQ: Improving Quality through Clinician Use of Health IT: This announcement has a primary focus on the ambulatory care clinician.  Research will focus on strategies to improve medication management and the delivery of evidence to the point-of-care resulting in improved clinical decision-making and clinical quality for priority conditions.  Issues to be addressed include the relationship between health IT and workflow redesign, systemic barriers to health IT adoption, care for patients with multiple chronic conditions, enhanced patient-centered models of care delivery, and improved use of effective alert strategies for decision support.

III.             ASQ: Enabling Patient-Centered Care through Health IT: This announcement has a primary focus on patients and their interaction with the ambulatory health care system.  Research will focus on strategies to improve the patient experience of care through the use of health IT.  It will include work to improve the delivery of patient-centered health information to ensure patients and clinicians have the information they need to make better health care decisions.  Specific topics to be addressed include shared decision-making and patient-clinician communication, personal health records, integration of patient information across transitions in care, and patient self-management of chronic conditions.

IV.               ASQ: Enabling Patient Safety and Quality Measurement through Health IT: This announcement has a primary focus on integrating patient safety and quality measurement with information technology.  Research will focus on strategies to improve transparency for patients in ambulatory care through the development, deployment and export of quality measures from electronic health record systems.  Issues to be addressed include measure development across episodes of care, clinical data needs for quality measurement export and reporting, and the reporting of quality data for improvement.

The research themes within these announcements were developed through expert consultation, new and emerging areas of federal and State focus, including the breakthroughs of the American Health Information Community and the work of federal partners, such as the Centers for Medicare and Medicaid Services, Indian Health Service, and the Health Resources and Services Administration.  The July 2006 release of the Institute of Medicine (IOM) report entitled “Preventing Medication Errors: Quality Chasm Series” offered important insights into risks of medication use in the ambulatory setting and across transitions in care, as well as potential strategies for improvement in need of demonstration projects.  The recent series of three IOM reports on the status of emergency services in the United States also confirmed the importance of emergency departments as high risk ambulatory care sites.  Finally, the IOM report entitled “Priority Areas for National Action: Transforming Health Care Quality (2003)” provided focus for the ASQ program on the ambulatory care priority areas identified for the nation, including care coordination, asthma, cancer screening, diabetes, children with special health care needs, hypertension, immunizations, ischemic heart disease, and frailty associated with old age. 

Definition of Ambulatory Care

For the purpose of the ASQ program, ambulatory care refers to all types of health services provided by healthcare professionals on an outpatient basis, in contrast to services provided in the home or to persons who are inpatients. While many inpatients may be ambulatory, the term ambulatory care usually implies that the patient must travel to a location to receive services which do not require an overnight stay. This program will specifically focus on the following ambulatory care settings: health care clinician offices; large and small practices, outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory care surgery centers.  Though not usually considered an ambulatory care setting, home care entities are also encouraged to apply. 

For the purpose of the ASQ program, health care transitions will refer to the movement of patients between healthcare providers and settings as their conditions and care needs change during the course of a chronic or acute illness (Coleman and Berenson, 2004; see also http://www.caretransitions.org/definitions.asp).  Non-ambulatory care settings with a strong interest in fostering safe, high quality ambulatory care and transitions are welcome to apply in partnership with an ambulatory care organization.  In particular, a focus on transitions between ambulatory care settings and hospitals, home care, assisted living centers, and nursing homes are critical to the success of ambulatory care for many elderly and chronically ill populations.

Program Purpose and Evaluation

The goal of the ASQ program is to improve the quality and safety of health care. AHRQ will measure progress toward that goal by evaluating whether patients are receiving the appropriate care for prevention, treatment and management of the IOM's priority areas; whether patients are able to access reports of ambulatory care quality and safety for their providers; whether patients report satisfaction with their care.

Each project in the ASQ program will be required to have a robust evaluation plan that addresses one or more of these goals.  In order to facilitate comparisons across ASQ projects, AHRQ suggests evaluation measures and instruments in these FOAs.  We encourage the use of these measures whenever possible and scientifically appropriate.

Researchers are encouraged to propose projects in low resourced rural and urban safety net settings where health IT diffusion is likely low, as well as projects that seek to improve the care provided to priority populations.  AHRQ is strongly committed to supporting research in priority populations, which include women, children, elderly, minority, rural, urban, and low-income populations, as well as patients with special health care needs and disabilities. AHRQ encourages the development of strong public and private partnerships that may include the health IT vendor community.

Background: Measuring Quality and Patient Safety

An essential component of improving health care quality is the measurement of services provided and clinical outcomes. Although quality measurement has been the focus for healthcare organizations, such as accreditation by the Joint Commission (see http://www.jcaho.org), participation in the Hospital Quality Alliance (HQA) (see http://www.aha.org/aha_app/issues/HQA) or Ambulatory Quality Alliance (AQA) (see http://www.aqaalliance.org), and the Centers for Medicare and Medicaid Services (CMS) demonstrations of hospital quality (see http://www.cms.hhs.gov/HospitalQualityInits/35_HospitalPremier.asp), such capabilities are not yet broadly employed in this nation’s health care system, particularly in ambulatory care settings and across transitions in care. Significant effort has been devoted to advancing quality measurement and achieving harmonization on high impact, cost-effective measure sets, through organizations such as the Healthcare Quality Alliance (HQA), American Quality Alliance (AQA), the National Quality Forum (NQF), the National Committee for Quality Assurance (NCQA), among others. These initiatives are often linked to incentives for improving quality, through emerging pay-for-performance programs. The impact of such programs on clinical outcomes remains nascent (McNamara, 2005; Premier, 2006) but the proliferation of demonstration projects clearly speaks to the interest of policy makers, payers, employers, and provider organizations to improving quality through incentives. There is a healthy debate about which metrics are significant, collectible without significant burden, and demonstrate an impact on clinical outcomes. There has also been a limited focus of quality measures for certain populations, such as children and patients with multiple co-morbid conditions.  Measures of clinical services provided do not always correlate with good outcomes (Bradley et al, 2006) but are used because more robust metrics may be much more difficult to collect (Jha, 2006). Current safety/quality measurement and reporting efforts are often forced to rely on the collection of data from paper-based sources because of the absence or inaccessibility of electronic health record data. Resource-intensive paper chart abstraction, manual quality reporting, and reliance on claims-based data hinders widespread measurement. Health IT systems have the potential both to ease current safety and quality measurement efforts and enable extensive, novel approaches to monitoring quality and providing feedback.  All of the issues surrounding quality measurement apply equally to the measurement of patient safety. In the domain of patient safety, measure development is even less mature, and fewer consensus measures are available.

The IOM report Patient Safety: Achieving a New Standard for Care (IOM, 2004), specifically addresses the issue of electronically enabled patient safety and quality measures and urges AHRQ to support such efforts. Conventional approaches to identifying and measuring patient safety events (i.e., that harm or have the potential to harm patients) such as individual chart audits, incident reports, or voluntary administrative reporting, have often been less successful in improving the detection of patient safety events. As a result, a new method of measurement—the trigger tool—has been developed in patient safety. For example, Resar, Rozich, and Classen (Reza et al, 2003) describe the trigger method and its application in measuring patient safety events in their 2003 article in Quality and Safety in Health Care.  This approach has been in use for quite some time to identify patient safety issues such as adverse medication events, hospital acquired infections, and pressure ulcers. However, there has been limited development and use of electronically enabled triggers/measures in the ambulatory care setting.

Health IT systems such as an electronic health record (EHR) can include the capacity to generate a complete record of patient encounters, as well as supporting other care-related activities including evidence-based decision support, quality measurement, and outcomes reporting (Bates and Gawande, 2003). Decision support systems in EHRs have the potential to bring feedback to the provider in a timely fashion at the point of care, allowing the provider to understand their individual quality history in the context of the next patient they are treating. Although there are many who have a stake in understanding the quality of care, providing individual feedback to the provider is one of the most important goals of quality measurement, as well as one of the key points of influence for improving the delivery of high quality, appropriate care. For quality measurement, reporting, and feedback, EHRs have the key benefit of being able to electronically capture structured, coded clinical data. Structured data can be used to measure the safety and quality of delivered care, and can be compared easily and automatically across patients and providers, and mapped directly to pre-defined quality metrics.   In addition, there is an opportunity to enhance available data from EHRs through linkage to electronic claims, laboratory, and radiology data. 

Enabling safety and quality measurement has gained new urgency as a priority in improving health care and reducing errors.  One cornerstone of the Department of Health and Human Services’ Transparency Initiative (see http://www.hhs.gov/transparency/) is transparency in quality. The initiative includes demonstration pilots in six cities to measure and report quality outcomes. This work is complemented by the creation of a new workgroup of the American Health Information Community (AHIC), the Quality Workgroup, with a charge to make recommendations regarding how health IT can provide the data needed for the development and implementation of quality measures that are useful to patients and others in the health care industry, automate the measurement and reporting of a comprehensive current and future set of quality measures, and accelerate the use of clinical decision support that can improve performance on those quality measures. The infrastructure for sharing and aggregating quality data continues to improve through certification, standardization, and the creation of health information exchanges. There is thus an urgent need to develop safety and quality measures in ambulatory care settings, determine essential data elements for IOM priority areas, use health IT systems to capture, provide, export and aggregate data on measures, enable public reporting and feedback through health information exchange, and measure the efficiency of quality measurement.  The projects funded by this FOA will be complementary to the specific charge to the AHIC Quality Workgroup, by demonstrating the use of health IT in quality measurement.

AHRQ’s Health IT Portfolio

Health IT has the potential to deliver evidence-based information to the point-of-care; expand the range and data collection for potential electronic health record (EHR)-based quality measures; and improve the value and quality of healthcare. AHRQ has funded over 30 years of research in the use of health IT to improve quality (Fitzmaurice et al, 2002).  The projects span the research and development spectrum, from innovations in health IT, planning for adoption, implementation, evaluation of outcomes, and taking the systems to scale through participation in regional and statewide health information exchange.  AHRQ’s projects have historically addressed issues of knowledge representation, delivery of tailored evidence, quality feedback, workflow and systems changes, and new approaches to care, including delivery in non-traditional settings.

One major component of AHRQ’s health IT portfolio is the National Resource Center (NRC) for Health IT.  The NRC captures the lessons learned in health IT adoption, and documents the progress of the portfolio grants.  Collective learning from the health IT portfolio pointed to some major lessons:

More information about AHRQ’s health IT portfolio can be found at http://healthit.ahrq.gov.

Objective: Enabling Patient Safety and Quality Measurement through Health IT

A barrier to widespread health care safety and quality measurement is the effort required to extract the requisite data from paper-based records or electronic records with free-text information.  While health IT has demonstrated improvement in health care safety and quality in several large healthcare delivery systems, there has been limited diffusion of electronic data systems capable of providing automated quality measurement and reporting. There is a need to address how widespread quality measures are represented and meaningfully extracted from electronic health records. There has also been limited focus on the quality and safety of ambulatory care across episodes of care and transitions in care.  There is also a need for more scalable applications of existing measures.  There is a need for greater functionality within electronic health records, enhanced by other electronic claims and clinical data, for aggregating, reporting, and providing feedback on quality.

This FOA will encourage applicants to develop safety and quality measures in ambulatory care settings, automate quality measurement, demonstrate the ability of electronic data systems (such as EHRs or claims data merged with EHR data) to expand potential safety and quality measures, and demonstrate improved ability to export measures for reporting and improvement.  Projects that explore the roles of health information exchange in support of public reporting of quality measures and emerging transparency initiatives are also encouraged.

To improve safety and quality measurement through health IT, AHRQ seeks to support projects in the following areas:

Project Requirements

Applicants are expected to:

The applicant must address the following project requirements in the Research Plan portion of the application.

In the Specific Aims section:

The applicant must specify an intervention (or new measure to be developed), the type of ambulatory care settings in which the intervention will be applied or the new measure developed, the health professional groups involved (note that interdisciplinary teams are encouraged whenever possible), and the patient populations included in the intervention or new measure developed.  It is expected that some aspect of the intervention will include the use of some form of health IT, or in the case of new measure development, that the new measure will rely on electronic coded data from EHRs or claims merged with EHRs.

In the Background and Significance section:

The applicant must demonstrate an understanding of the nature of the ambulatory care, the current challenges to quality measurement, and how health IT can enable better quality measurement.   The narrative should include a brief review of the salient literature with respect to the focus area and the anticipated benefits, limitations, and scientific, clinical or performance-based significance of the proposed research, the purpose and expected impact of the intervention or new measure developed, objectives or hypotheses to be evaluated, the supporting theoretical or conceptual framework, underlying assumptions, and scope or boundary conditions of the proposed demonstration.

In the Research Design and Methods section:

Given the project objectives, and taking into account practical constraints, the applicant must describe the research design or methodology that will best enable the research objectives to be realized.  The design must include a timeline with specific milestones, covering all major phases of the project. For those projects focused primarily on the development of measures, applicants must provide information on the evidence base from which the measure(s) are derived, any consensus development efforts included in the project, and the applicant’s proposed methods for validating and testing the measure(s) for clinical appropriateness, validity, reliability, sensitivity, and specificity. When possible, any health IT intervention should conform to interoperability standards and use certified products (see http://www.hitsp.org and http://www.cchit.org). Applicants must also provide convincing evidence of their organizational capacity to immediately commence work upon announcement of funding.

Applicants must specify the project’s primary and secondary outcome measures.  These may include health outcome, patient satisfaction, process measures, costs, and measures of patient safety and quality. (Please refer to the next two sections below for AHRQ’s recommendations for outcome measures.) The narrative must also include data collection plans, instruments and tools to be used, and a well-developed analysis plan.  To the extent possible, applicants should discuss any anticipated limitations or cautions needing to be exercised in generalizing results.

The applicant must describe how the intervention could be integrated into the delivery of ambulatory care throughout the applicant organization(s) and potentially into sites across the nation. The applicant should discuss the future sustainability of the intervention by their organization after the grant funded period has ended. The applicant must also present a project dissemination plan, including a proposal for widespread dissemination should the project results be generalizable and meritorious.  While AHRQ plans to offer additional funding through limited competition to further the dissemination of important findings and activities that result from these projects, these dissemination supplements will only be considered should future funds become available.  Applicants must include a project dissemination plan within the project plan and budget. The dissemination plan may include activities in cooperation with AHRQ's National Resource Center on Health IT, http://healthit.ahrq.gov.

The applicant must describe how, in the development and implementation of the intervention, privacy and security issues related to the exchange of sensitive health information will be identified and addressed.  Keeping health information in electronic format introduces new risks, real and perceived, to the privacy and security of health information.  New concerns arise, such as who has access to and use of electronic data, disclosure to patients regarding the collection and use of the data, patient consent requirements, the ability of patients to decline participation in electronic data collection, patient access to audit records, what happens to data after research is completed, and informing patients of any security breaches. 

Developers of electronic health information systems have promulgated policies for consideration with participating consumers and patients in order to assure patient awareness of, comfort with, and participation in electronic data collection and use.    While privacy and security solutions are not intended to be the focus of projects under this announcement, interventions should be designed to incorporate emerging privacy and security principles that may be applicable (see http://healthit.ahrq.gov/hiepolicyissues). Applicants should describe the resources and processes they will use to assure that these privacy and security concerns are being met throughout the project period.  These could include the inclusion of participating patients in periodic reviews in order to solicit their input and consultation with knowledgeable professionals over the course of the project, as well as a description of any existing privacy or security practices and technology consistent with those policies that will be incorporated into the project and reviewed for compliance on a regular basis.

Outcome metrics

In order to facilitate evaluation across projects in AHRQ's portfolio, AHRQ requires applicants to measure and report on the following outcomes when appropriate to the project aims:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the R18 Research Demonstration award mechanism.

The individual researcher sponsored by each organizational awardee will be solely responsible for planning, directing, and executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process.  Applications submitted in modular format will be returned without review.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

AHRQ intends to commit approximately $6.8 million dollars in FY 2007 to fund 12-24 applications. Should additional funds become available, AHRQ may fund additional meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years.  Although the size of award may vary with the scope of research proposed, it is expected that applications will range from $250,000 to $500,000 in total costs per year.  Total costs are limited to $1 million over a two-year period, with no more than $500,000 in total costs allowed in any single year.  Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.  

AHRQ intends to award at least $1.8 million from patient safety funds to projects that include a focus on patient safety and quality measurement projects that do not directly involve health IT.

Applications requesting more than $500,000 in total costs in any one year, more that $1 million over 2 years, or longer than 24 months of support will be returned to the applicant without review.

AHRQ plans to offer additional funding through limited competition to further the dissemination of important findings and activities that result from these projects.  Dissemination supplements will only be considered should future funds become available.

At this time, it is not known if competing renewal applications will be accepted and/or if this FOA will be reissued.

AHRQ grants policies as described in the PHS Grants Policy Statement (see http://grants.nih.gov/grants/policy/gps/index.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your domestic organization is a:

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations.  For-profit organizations may participate in projects as members of consortia or as subcontractors only. For-profit organizations that produce health IT systems are encouraged to apply in partnership with a non-profit organization. Because this FOA is principally intended to increase the quality of health care delivery in the U.S., foreign institutions are not eligible to apply. Foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations and foreign institutions will be returned without review.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his or her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs.

The Project Director/Principal Investigator should devote at least 20% time to the project over the course of the award. If the Project Director/Principal Investigator devotes less than 20% time to the project, an explicit justification must be provided.

Because of the nature of the project, expertise in evaluation is also a critical need that can be met through the requisite experience of the PD/PI or another member of the project team.

2. Cost Sharing or Matching

AHRQ does not require cost sharing for applications in response to this FOA.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and their collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.  

3. Other-Special Eligibility Criteria

Funding Preferences

A substantial portion of this FOA focuses on improving patient safety and quality measurement through the use of health IT.   Notably, $1.8 million has been set aside for projects with a substantial focus on quality and patient safety, and that may not directly involve health IT.  These projects should fulfill the objectives of improving quality measurement in ambulatory care settings and across settings of care, and may lead to health IT interventions.   Applicants may request to be considered for funding preference in the area of quality and patient safety that may not directly involve health IT.  Applicants requesting such consideration are exempt from the health IT requirements and health IT aspects of the review criteria of the FOA, but all other requirements and criteria apply.  Applicants may request to be considered for this funding preference in Appendix 1.  Appendix 1 should be titled “Qualifications for funding preferences," and should be used to justify the project's focus on patient safety considerations. If no funding preferences are requested, Appendix 1 should state “No funding preferences requested.”

Applicants may submit more than one application, provided each application is scientifically distinct.  However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an AHRQ peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only.  These are different than any DUNS number and CCR registration used by an applicant organization.  Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more.  Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons.  AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ.  There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID).  Agency-specific instructions for such fields are clearly identified in the Application Guide.  For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional.  The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional.  A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related BudgetPHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: AHRQ uses ONLY the detailed Research & Related Budget.  Do not use the PHS 398 Modular Budget.  Applications submitted in modular budget format will be returned without review.

Technical Assistance

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. The conference call will take place on January 4th at 12:00 p.m. EDT. To register to participate in the conference call, please send an e-mail request to Ms. Angela Lavanderos (QualityMeasurement@ahrq.hhs.gov) by January 2ndAll registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB January 3rd. Potential applicants are encouraged to contact AHRQ staff with any questions (see WHERE TO SEND INQUIRIES, below).

The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying.  Participants are encouraged to submit questions via email prior to the conference call.  Please submit up to five questions with your name and the name of your institution to Ms. Lavanderos by January 2nd.  Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.  Notes from the conference call will be sent to all participants via e-mail by January 17th.  If interested applicants are not able to participate in the call, please send requests for a copy of the notes to QualityMeasurement@ahrq.hhs.gov.

3. Submission Dates and Times

See (Section IV.3.A) for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: January 13, 2007
Letter of Intent Receipt Date(s): January 19, 2007
Application Submission Date(s): February 13 , 2007
Peer Review Date(s): April/May, 2007
Technical Assistance Teleconference: January 4, 2007
Earliest Anticipated Start Date(s): July, 2007

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants are asked to submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions.  Please include the name and email address of the Principal Investigator.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application.  However, these letters are administratively very helpful, as indicated above.  To be most useful, the letter of intent is to be sent by the date listed above and at the beginning to this document.

The letter of intent can be sent electronically, and should be sent to:

Angela Lavanderos
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road, 6000
Rockville, MD 20850
Telephone: (301) 427-1505
FAX: (301)427-1597
Email: QualityMeasurement@ahrq.hhs.gov

3.B. Sending an Application to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be evaluated for completeness and responsiveness by the Center for Scientific Review and AHRQ.

Incomplete or non-responsive applications will be returned without review.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

o Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the “Research Design and Methods” section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research.  In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data.  This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ's confidentiality statute, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of the CMS data in the budget.  In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap. 

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions
For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principals, and other considerations described in the HHS Grants Policy Statement.   The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

6. Other Submission Requirements

The Principal Investigator/Project Director and at least one key program staff member from the project are required to attend at least three days of an annual AHRQ grantee meeting in the Washington DC area.   Travel to the annual meeting must be included in the project’s budget.

AHRQ requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used. 

Specific Instructions for Modular Grant applications.

AHRQ is not using the Modular Grant Application and Award Process.   Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R).  Applications submitted in the Modular format will be returned without review.

Application Characteristics

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for this FOA applications:

Research Plan:

Use of Standards

Use of ANSI HITSP standards, where they exist, are required (see http://www.hitsp.org).  Applications that do not provide appropriate documentation of inclusion of existing ANSI HITSP standards will be returned without review.  Partnership with a vendor of CCHIT-certified health IT is encouraged (see http://www.cchit.org). In applications that employ existing measures of quality, use of AHRQ-developed, AQA- or HQA-approved standards is encouraged (see http://www.aqaalliance.org and http://www.aha.org/aha_app/issues/HQA).

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.  All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used. 

Note: Please refer to Project Requirements (see section I.1 above) for details about required elements of the Research Plan section.

Appendices:

Appendix 1 should be titled “Qualifications for Funding Preferences” and follow the guidelines discussed in section III.3.

Additional appendices may be used for:

a)       Preliminary data referred to in Preliminary Study section of Research Plan

b)       Surveys, questionnaires, data collection instruments, clinical protocols, informed consent documents, and product snapshots

c)       Up to five publications, manuscripts, abstracts, or other materials directly relevant to the proposed project.

d)       Letters of support

Applicants are cautioned not to use the Appendix to circumvent the page limitations of the Research Plan.

Budget:

Applications in response to this FOA will use the Research & Related budget components, with a maximum allowable request of up to $1 million in total costs over two years and a maximum of $500,000 in any one year.  Provide a narrative justification for each proposed personnel position, including role and proposed level of effort.  All other budgeted costs should also be justified.

The budget must include funding to allow at least two members of the project team to attend at least three days of an annual AHRQ grantee meeting in the Washington DC area. 

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the PHS Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.  This authority is also found at 42 USC 299.  To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).  Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ supported activities are accepted for publication in the professional literature.  Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff.  The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers.  This is critical when outreach to the general and trade press is involved.  Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions.  In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized.  An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, the AHRQ may request information essential to an assessment of the effectiveness of Agency research programs.  Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research.  Applicants are to agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

o   HCUP & MEPS

Applicants are encouraged to make use of AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS).  HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership.  HCUP inpatient databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data.  HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place.  HCUP databases include:  the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of approximately 1,000 hospitals, the Kids’ Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory care surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states.  More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, noninstitutionalized population.  MEPS is comprised of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC).  The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample.  The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees.  More information on the MEPS is available at http://www.meps.ahrq.gov.

This does not preclude the use of secondary data sources or primary data collection.

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

Not Applicable

Section V. Application Review Information


1. Criteria

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria are described in Section V.2 below.  The review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will be returned to the applicant without further consideration. 

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance and Impact: Does this study address an important problem in the measurement of quality and safety of care? Does it advance our knowledge of how safety and quality measurement changes and improves care delivery, and address transitions in care in the IOM’s priority areas? Does it have a novel design of a health IT system? If the aims of the application are achieved, will it demonstrate how quality measurement, reporting, and feedback can be integrated into health care delivery and workflow? Will the project, if successful, result in meaningful improvements in patient safety, health outcomes, and/or satisfaction for its target population? Does the application focus on how interoperable health IT can improve quality measurement? 

Usefulness and generalizability: Does the study demonstrate the application of an intervention across multiple settings or institutions? How feasible is it for others to implement this intervention or the measures developed?  Will the lessons learned in this study be applicable to other types of ambulatory care settings, patient populations, and/or clinical conditions? Does the study advance our ability to achieve widespread implementation and dissemination of positive gains? Are the core aspects of the intervention dependent on study resources that can not reasonably be expected to exist in health care settings outside of the study? If measure development is the focus of the project, will they be valid and usable by various organizations? If measures are proposed, will they be able to be submitted to appropriate organizations for validation?

Approach: Does the applicant demonstrate understanding of current patient safety and quality measurement methodologies? Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the applicant address areas of interdependence outside of the project scope, and have a plan for integrating with existing organizational initiatives in health IT? Does the study measure outcomes of interest, including appropriate clinical outcomes? Where possible, does the applicant make maximum use of existing standards and measures? Is the evaluation plan sufficient to illuminate the effects of the intervention?

Investigators and partnerships: Are the investigators appropriately trained and well suited to carry out this work? Is the investigative team inter disciplinary? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is there evidence of institutional support, integration with existing health IT infrastructure, and is the timeline reasonable in the institutional context? Are there strong partnerships with organizations such as third-party providers of technology?

Study setting(s): Will the proposed study benefit from the unique features of the selected ambulatory care sites and patient populations?  Have the ambulatory care practices involved in the project demonstrated their interest in participating in this study? Does the intervention or do the measures foster interdisciplinary ambulatory care teams? Does the study involve critical roles, settings or patient populations where change would have a large impact? Does the applicant have the available resources and capacity to begin work immediately?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Degree of responsiveness:  How well does the application address the purpose and objectives of this FOA?  How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? Is the budget allocated toward health IT hardware, software, and support appropriate?

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Adequacy of attention to AHRQ priority populations (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Required Federal Citations, below.)

Protection of Human Subjects from Research Risk:  The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  (See item 7 of the Research Plan, component of the SF 424 (R&R)).

Privacy and Security Protections for Patients:  The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.  (See Section 6 under Project Requirements).

2.B. Additional Review Considerations

2.C. Sharing Research Data

Data Confidentiality

Pursuant to section 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data.  There are now civil monetary penalties for violation of this confidentiality statute 42 USC 299c-3(d).  In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected.  The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded.  Identifiable patient health information collected by grantees under this RFA will also be obtained and managed in accordance with 42 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers.  Thus, health care plans ordinarily will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators.  The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/

The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA websites in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes.  In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate 7 months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support and certification of IRB approval of the project's proposed use of human subjects.  For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A and are subject to the requirements of the HHS Grants Policy Statement that are applicable to you based on your recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary, Terms and Conditions will be incorporated into the award statement.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the Public Health Service (PHS) Grants Policy Statement, found at http://grants.nih.gov/grants/policy/gps/index.html.

The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions. 

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ will provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs.  This report must be submitted for each budget period no later than 90 days after the close of the budget period.  A hard copy of the report should be submitted to the assigned grants management specialist.

A final Progress Report and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

Projects funded under this announcement are considered part of the AHRQ’s Patient Safety and Health IT Initiatives. AHRQ has established a Patient Safety Research Coordination Center (PSRCC) and the National Resource Center (NRC) for Health IT to support activities of the AHRQ Patient Safety and Health IT Initiatives. When appropriate and feasible, AHRQ expects awardees to work with each other in collaborative opportunities that can contribute to the success of their projects and AHRQ’s portfolio initiatives. These collaborative relationships may be facilitated by the AHRQ resource centers, and awardees will be expected to cooperate with AHRQ’s Centers.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.  Inquiries may fall into three areas, scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Direct your questions about general FOA issues, including information on the Inclusion of Women, Minorities and Children, and other priority populations to:

Angela Lavanderos
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1505
Email: QualityMeasurement@ahrq.hhs.gov

or

Marge Keyes, MA
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville , MD 20850
Telephone: (301) 427-1333
Email: QualityMeasurement@ahrq.hhs.gov

2. Peer Review Contacts:

Direct your questions about peer review issues to:  

Kishena C Wadhwani, Ph.D., M.P.H.
Director, Division of Scientific Review
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road, Room 2032
Rockville, MD 20850
Phone: (301) 427-1556
Fax: (301) 427-1562
Email: Kishena.Wadhwani@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct your questions about financial or grant management matters to:

Al Deal
Grants Management
Office of Performance, Accountability, Resources and Technology
540 Gaither Road
Rockville, MD  20850
Telephone: (301) 427-1806
FAX: (301) 427-1462
Email:  Al.Deal@ahrq.hhs.gov

Section VIII. Other Information


Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate: e.g., because of the lack of connection between the study and the health of women or particular minorities.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html.  AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations 45 CFR 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge  gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
 
Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information.  It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory.  Decisions about applicability and implementation of the Privacy Rule reside with covered entities.  Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) in certain circumstances.   Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal action is taken, having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement.  Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study, statutorily protected under 42 U.S.C. Section 299c-3(c), is exempted from disclosure under "the (b)(3) exemption” in FOIA.  It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support.  Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if they constitute trade secrets or commercial information.  NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ-supported projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of 42 USC 299 et seq. and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92 and applicable authorizing statutes and regulations.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

References

Bates DW and Gawande AA. "Improving safety with information technology." NEJM. 2003 348(25): 2526-34.

Bradley EH, Herrin J, Elbel B, McNamara RL, Magid DJ, Nallamothu BK, Wang Y, Normand SL, Spertus JA, Krumholz HM. “Hospital quality for acute myocardial infarction: correlation among process measures and relationship with short-term mortality.” JAMA. 2006 Jul 5;296(1):72-8. 

Coleman EA, Berenson RA. "Lost in transition: challenges and opportunities for improving the quality of transitional care." Ann Intern Med. 2004 Oct 5;141(7):533-6.

Corrigan, J. M, Greiner, A., & Erickson, S. M.  (2002). Fostering rapid advances in health care.  Washington, DC: National Academies Press.

Fitzmaurice JM, Adams K, Eisenberg JM. "Three decades of research on computer applications in health care: medical informatics support at the Agency for Healthcare Research and Quality." J Am Med Inform Assoc. 2002 Mar-Apr;9(2):144-60.

Institute of Medicine, Preventing Medical Errors: Quality Chasm Series. Washington, DC: National Academy Press, 2006.

Institute of Medicine, Patient Safety - Achieving a New Standard for care. Washington, DC: National Academy Press, 2004.

Institute of Medicine, Crossing the Quality Chasm: A New Health System for the Twenty-first Century. Washington, DC: National Academy Press, 2001.

Jha AK. “Measuring hospital quality: what physicians do? How patients fare? Or both?” JAMA. 2006 Jul 5;296(1):95-7.

Kohn LT, Corrigan JM, Donaldson MS (Institute of Medicine). To err is human: building a safer health system. Washington, DC: National Academy Press, 2000.

McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, Kerr EA. "The quality of health care delivered to adults in the United States." N Engl J Med. 2003 Jun 26;348(26):2635-45.

McNamara P. “Quality-based payment: six case examples.” Int J Qual Health Care. 2005 Aug;17(4):357-62.

National Quality Forum (NQF).  (2004).  Improving the Quality of Ambulatory Care Quality: Workgroup Meeting Summary.  Washington, DC: NQF.  Available at www.qualityforum.org/members/ambulatoryCare_docs/txmtgsummaryambulatoryFinalcolor.pdf

Premier, Inc. (2006). Centers for Medicare and Medicaid Services (CMS) / Premier Hospital Quality Incentive Demonstration Project: Findings from Year One. Charlotte, NC.

Resar RK, Rozich JD, Classen D. “Methodology and rationale for the measurement of harm with trigger tools.” Qual Saf Health Care. 2003 Dec;12 Suppl 2:ii39-45.

Wachter RM. "Expected and unanticipated consequences of the quality and information technology revolutions." JAMA. 2006 Jun 21;295(23):2780-3.


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