Part I Overview Information

Department of Health and Human Services (DHHS)

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

Catalog of Federal Domestic Assistance Number(s): 93.226

Key Dates

Release Date: September 24, 2004
Letters Of Intent Receipt Date(s): December 19, 2004
Application Receipt Dates(s): January 19, 2005
Peer Review Date(s): May 2005
Earliest Anticipated Start Date: June 2005
Expiration Date: January 20, 2005

The partnerships in implementing patient safety grants are to assist health care institutions in implementing safe practice interventions that show evidence of eliminating or reducing medical errors, risks, hazards, and harms associated with the process of care. These implementation projects will inform AHRQ, providers, patients, payers, policy makers, and the public about how safe practice interventions can be successfully implemented in diverse health care settings and lead to safer and better health care for all Americans.

The RFA will use the Cooperative Agreement U18 award mechanism. In FY 05, AHRQ intends to commit up to $3 million in total costs to fund up to 10-15 new grants. Because the nature and scope of the projects will vary from application to application, it is anticipated that the size and duration of each award will also vary. Applications can be up to 24 months in duration with a budget supported by AHRQ not to exceed $300,000 per year in total costs to the government.

Awards are granted to institutions; therefore, individuals are not eligible applicants under this RFA. One application may be submitted by each institution. Applications may be submitted if the institution has any of the following characteristics: for-profit or non-profit organizations; domestic; eligible federal agencies; public and private non-profit institutions, such as universities, clinics, colleges, and hospitals; units of State and local governments; faith-based or community-based organizations; and tribes and tribal organizations.

Because this RFA is principally intended to increase the implementation of safe practice interventions in the U.S., foreign institutions are not eligible to apply for grants. However, foreign organizations may participate in projects as members of consortia or as subcontractors. The PI should be an experienced senior level individual familiar with implementing change in health care settings. This individual should devote a considerable portion of his/her time to the project (at least 15% through the project duration). Any individual with the skills, knowledge, and resources necessary to carry out the implementation of safe practices is invited to work with their colleagues and institution to develop an application for support.

Further description regarding AHRQ’s authorizing statute and the regulations under which these grants fall is described in Section VIII below. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

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
3. Other - Special Eligibility Criteria

Section IV. Application and Submission and Instructions
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
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
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Awardee Rights and Responsibilities
2. AHRQ Staff Responsibilities
3. AHRQ Contractors Supporting the Patient Safety Initiative
4. Collaborative Responsibilities
5. Arbitration
3. Award Criteria
4. 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

The Agency for Healthcare Research and Quality (AHRQ) announces the availability of grants for partnerships in implementing patient safety. The objective of this Request for Applications (RFA) is to assist health care institutions in implementing safe practice interventions that show evidence of eliminating or reducing medical errors, risks, hazards, and harms associated with the process of care. Applicant institutions are expected to identify the medical errors, risks, hazards or harms that are to be addressed by the safe practice intervention; develop a complete implementation plan for the safe practice intervention; describe the projected impact of the safe practice intervention on the process of care; and provide an evaluation plan to determine whether the safe practice intervention is effective as adopted within the institution. These implementation projects will inform AHRQ, providers, patients, payers, policy makers, and the public about how safe practice interventions can be successfully implemented in diverse health care settings and lead to safer and better health care for all Americans.

The determination of the safe practice intervention may be drawn from a variety of sources including: published recommendations of safe practices such as ARHQ’s Evidence Report/Technology Assessment Number 43, Making Health Care Safer: A Critical Analysis of Patient Safety Practices (See ref. 1); the National Quality Forum’s (NQF) Safe Practices for Better Health Care (See ref. 2); Joint Commission on Accreditation of Healthcare Organizations (JCAHO) ten patient safety goals (See ref. 3); and ongoing research findings from patient safety grants and projects funded by AHRQ (See Research Objectives, below).

AHRQ encourages implementation projects which focus on diverse settings of care, safe practices, and patient populations including priority populations. Projects presented for consideration under this RFA should comply with the Agency’s policy regarding the inclusion of priority populations (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Further information on the requirements is listed in the special requirements section of this RFA.

Authorities and regulations under which these grants will be funded are described in Section VIII.

In FY 2004, AHRQ issued three RFAs focused on the use of computing, information and communication technology to improve quality, safety, efficiency, and effectiveness of care. Due to AHRQ’s substantial commitment in this area, this RFA is focusing on safe practice interventions that do not focus solely on the use of health information technology (HIT)[e.g., electronic health records, personal health records, e-mail communication, clinical alerts and reminders, computerized provider order entry, computerized decision support systems, hand-held computers, information resources, and electronic monitoring systems]. For example, a solely HIT intervention would be the development of a computerized scheduling system to increase use of perioperative beta-blockers. However, interventions which utilize HIT in a secondary capacity would be allowable under this RFA. For example, an intervention which redesigns workflow and staffing to increase perioperative beta-blocker use which has e-mail reminders as a secondary component would not be considered a primarily HIT intervention. If there is any question about proposed safe practice interventions, potential applicants are encouraged to contact Ms. Hogan or Ms. Queenan with any questions (See Where to Send Inquiries, below).

AHRQ believes that ultimately patient safety is a local issue that must be addressed by each health care organization at the point of care. As partners, AHRQ wants to help local health care organizations meet the challenge of implementing safe practice interventions to improve patient safety. There are no cost sharing requirements in this RFA. AHRQ encourages applicant institutions to provide significant institutional support for the proposed project. The applicant institutions, including any collaborators, are encouraged to devote substantial resources to this effort. This RFA provides a mechanism for collaboration between and among the grantees and AHRQ to develop safe practice interventions and improve patient safety. These partnerships will facilitate opportunities for collaboration and coordinated efforts in response to new, emerging or ongoing issues related to patient safety.

AHRQ will support projects that focus on safe practice interventions that can be generalized to other settings of care and for use by those who wish to adapt and/or adopt the safe practices interventions to improve patient safety. At the end of the grant period, the intent of this RFA is that awardees will have developed tools, including a comprehensive implementation toolkit. The toolkit should focus on documenting the impact of the safe practice intervention on patient care and the manner in which barriers to implementation and adoption were overcome. AHRQ will widely disseminate the tools from the grants, including the implementation toolkits, for adaptation and/or adoption by other institutions.

In its November 1999 report To Err is Human: Building a Safer Health System (See ref. 4), the Institute of Medicine (IOM) estimated that between 44,000 and 98,000 Americans die each year as a result of medical errors. The IOM report quickly elevated awareness of patient safety. The majority of these medical errors are a result of systemic problems rather than poor performance by individual providers. Although the United States provides some of the best health care in the world, the number of patients that are being harmed as a result of the process of health care is unacceptably high.

In January 2000, within weeks of the IOM report's release, the Senate Committee on Appropriations (Committee) began hearings on medical errors and patient safety issues. As a result of those hearings, the Committee directed AHRQ to lead the national effort to combat medical errors and improve patient safety. The Committee urged AHRQ to prepare and submit an interim report to Congress concerning the results of this medical error reduction program within 2 years of the commencement of the projects (See ref. 5). Additionally, in Senate Report 107-84, dated October 11, 2001, the Committee requested that AHRQ describe how it was responding to applicable recommendations in the IOM's report, To Err is Human (See ref. 6).

In FY 2001, AHRQ received a $50 million appropriation, which enabled the Agency to implement a broad and diversified patient safety initiative. Through a portfolio of grants and contracts, the initiative stimulates research and demonstrations in patient safety and medical error reduction. Collectively, the funded projects form an integrated set of activities that design and test best practices for reducing errors in multiple settings of care. Moreover, the funded projects develop the science base to inform those who must implement programs and policies regarding the most effective approach to take. AHRQ received continued appropriations of $55 million in FY 2002 and $60 million in FY 2003 to carry out its patient safety initiative. The current effort continues the Agency's activities to reduce errors and improve the delivery of safe health care in a purposeful and coordinated manner.

During FY 2001 2003, the patient safety initiative with respect to grants focused, in large measure, on six program areas of research that included:

Centers of Excellence for Patient Safety Research and Practice: to support established cross cutting teams of researchers, health care facilities, and organizations in geographically diverse locations. The Centers of Excellence currently help determine the causes of medical errors and develop new knowledge as well as support the work of others such as those who have received grants to develop reporting systems (also referred to as demonstrations). Multiple projects are funded under three Centers of Excellence grants.

Developmental Centers for Evaluation and Research in Patient Safety (DCERPS): to develop new multidisciplinary research teams to improve the nation's capacity in patient safety research, to expand the patient safety knowledge base, and to establish mechanisms to assure that new knowledge is incorporated into actual practice and that its impact is assessed. Eighteen developmental centers were funded to establish additional capacity and expertise to identify threats to patient safety.

Improving Patient Safety. Health System Reporting, Analysis, and Safety Improvement Research Demonstrations: to support large demonstrations in States, health care systems, and networks of providers to test both mandatory and voluntary reporting strategies. AHRQ funded sixteen medical error reporting systems grants.

Clinical Informatics to Promote Patient Safety (CLIPS): to develop and test the use of innovative technologies, such as hand-held electronic medication and decision support systems, training simulators for medical education, computerized bar-coding, patient bracelets, and smart cards. Eleven clinical informatics grants were awarded.

Effect of Working Conditions on Quality of Care and Patient Safety: to develop an understanding of how the environment of care impacts the ability of providers to improve safety and how interactions with the physical and organizational environment impact workflow and provision of safe care. Twenty-one working conditions grants were funded.

Patient Safety Research Dissemination and Education: to fund researchers and organizations to develop, demonstrate, and evaluate new approaches to improving provider education in order to reduce errors, such as incorporating new knowledge on patient safety in the development of curricula, Web-based materials, and continuing education. Six grants were awarded in this area.

Also included in the patient safety initiative are a few patient safety grants that were awarded non-solicited applications. Most of the above grants, with the exception of the Centers of Excellence grants, are three-year efforts with the current fiscal year serving as the final year.

Towards the close of FY 2003, AHRQ undertook a new patient safety activity, referred to as the Patient Safety Challenge Grants. These grants are for healthcare organizations to conduct either risk assessment or patient safety implementation projects. In awarding the challenge grants, AHRQ provided 50% of the costs and the awardees matched 50% of the costs. Thirteen Challenge Grants were awarded in September of 2003.

For a more detailed summary of the AHRQ patient safety grants funded in FY 2001 2003, potential applicants are encouraged to send an e-mail to PSImplement@ahrq.gov requesting the summary.

In December 2003, AHRQ submitted an interim report Building Foundations, Reducing Risk which focused on a status update of AHRQ's Patient Safety Initiative. The goal of AHRQ’s Patient Safety Initiative is to identify, understand, and reduce the medical errors, risks, hazards, and harms associated with health care system-related problems. To support its initiative, AHRQ developed a long-term plan that includes four distinct elements. The plan requires sustained effort, and many projects underway span more than one element of activity. The four elements of activity are listed below:

Element 1: Identifying threats to patient safety. Identify medical errors and causes of patient injury associated with the delivery of health care.

Element 2: Identifying and evaluating effective patient safety practices. Identify, design, and evaluate practices that eliminate or mitigate the effects of medical errors and system-related risks and hazards which compromise patient safety.

Element 3: Teaching, disseminating, and implementing effective patient safety practices. Educate health care providers, purchasers, and patients; disseminate information to a variety of users; implement patient safety best-practices; raise awareness that patients are at risk for health care associated injury and harm; and adopt a positive patient safety culture.

Element 4: Maintaining vigilance. Continually monitor and evaluate threats to patient safety to ensure that a positive safety culture is maintained and a safe environment continues.

Because AHRQ’s Patient Safety Initiative began less than 3 years ago, most activity is focused on elements one through three. Even though efforts to improve the safety of health care delivered to Americans are well on their way, it is crucial to recognize that optimizing the safe delivery of health care is a multi-year endeavor and there is still much work to be done. Furthermore, AHRQ’s efforts must be combined with those of others within the Department of Health and Human Services (DHHS), other Federal agencies, and the private sector.

As part of the Patient Safety Initiative, AHRQ commissioned a systematic review of patient safety practices; a total of 79 practices were reviewed. The resulting report has served as a starting point for determining what safe practices institutions might wish to consider for adoption (See ref. 1). The National Quality Forum has also established recommendations for patient safety practices for which there is indication for adoption (See ref. 2). In July 2004, the Joint Commission's Board of Commissioners approved the Joint Commission 2005 National Patient Safety Goals. JCAHO established goals to help accredited organizations address specific areas of concern in regards to patient safety. Each goal includes no more than two succinct, evidence- or expert-based recommendations (See ref. 3). Building on these reports and recommendations, AHRQ has developed this Partnerships in Implementing Patient Safety RFA to assist institutions in implementation of safe practice interventions to eliminate or reduce medical errors, risks, hazards, and harms from the process of health care.

Project Objectives

Each applicant must select an evidence-based safe practice intervention to implement in their institution at the time of grant award. As described above, this RFA excludes projects in which the primary safe practice intervention is an HIT intervention. Applications with safe practice interventions focused solely on HIT will be returned without review.

For the selected safe practice intervention, the applicant must have already completed a risk assessment which documents the medical errors, risks, hazards, and harms to be addressed. Applicants must provide an implementation plan for introducing the safe practice intervention into their health care delivery system. In addition to the plan, the applicant must be able to document and assess the impact of the intervention on the process of care and the patient population. For their institution, the applicants must assess the level of adoption and acceptance of the safe practice intervention by health care professionals. Finally, the applicants must be able to describe the tools resulting from their project including a well developed implementation toolkit. These applicant institutions will be able to use the tools from the grants for future implementation projects in their institution. As part of AHRQ’s overall dissemination efforts, AHRQ will widely disseminate the tools resulting from these grants.

The overall goal is for institutions to work in collaboration with AHRQ to implement safe practice interventions to improve patient safety. As partners, AHRQ encourages applicant institutions to make a substantial commitment of support by providing resources to the projects. Through collaboration, AHRQ and the institutions will be able to improve patient safety through the reduction of medical errors, risks, hazards and harms in the health care system.

The funding opportunity will use the U18 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on funded projects may be submitted as R18 applications and will compete with all unsolicited applications. These applications will be reviewed according to the Agency peer review procedures. The earliest anticipated award date is June 2005.

The U18 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator (PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with AHRQ staff being substantially involved as a partner with the PI, as described under the section VI.2. Administrative and National Policy Requirements, Cooperative Agreement Terms and Conditions of Award.

AHRQ intends to commit up to $3 million in total costs in FY 05 to fund up to 10-15 new grants in response to this RFA. Because the nature and scope of the projects will vary from application to application, it is anticipated that the size and duration of each award will also vary. If additional funds become available in FY 2005, AHRQ reserves the option to fund additional applications submitted in response to this RFA.

Applications can be up to 24 months in duration with a budget supported by AHRQ not to exceed $300,000 per year in total costs, both direct and indirect, to the government. Applications with project periods that exceed 24 months or budgets that exceed $300,000 total costs will be returned without review.

Although the financial plans of AHRQ provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Funding beyond the initial budget period will depend upon the site visits, annual progress reviews by AHRQ, and availability of funds.

Section III. Eligibility Information

Awards are granted to institutions, therefore individuals are not eligible applicants under this RFA. Applications may be submitted if the institution has any of the following characteristics:

• For-profit or Non-profit organizations
• Domestic
• Eligible federal agencies
• Public and private non-profit institutions, such as universities, clinics, colleges, and hospitals
• Units of State and local governments
• Faith-based or community-based organizations
• Tribes and tribal organizations

Under the most recently enacted reauthorization legislation, AHRQ is authorized to enter into cooperative agreements with for-profit organizations, as well as with public and not-for-profit entities. Thus, for-profit organizations are eligible to respond to this notice with research applications for cooperative agreements. Such applications will be administered in accordance with Subpart E of 45 CFR Part 74 and 42 CFR Part 67 Subpart A. The latter regulation has not yet been amended to reflect these changes in Agency name and authority. (See December 6, 1999, AHRQ reauthorization at http://www.ahrq.gov/hrqa99a.htm). Organizations described in sections 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

Because this RFA is principally intended to increase the implementation of safe practice interventions in the U.S., foreign institutions are not eligible to apply for grants. No awards will be made to foreign institutions. Applications from foreign institutions will be returned without review. Foreign organizations may participate in projects as members of consortia or as subcontractors.

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 PI should be an experienced senior level individual familiar with implementing change in health care settings. This individual should devote a considerable portion of his/her time to the project (at least 15% through the project duration).

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

Because the RFA is intended to support the introduction of safe practices in the delivery of health care, organizational entities that are not health care provider organizations must have a provider organization which is actively engaged in the delivery of health care as a participating partner in the proposed project. For purposes of this RFA a health care provider organization is defined as any organization engaged in the direct delivery of care to patients in any setting including but not limited to: in-patient, out-patient or ambulatory centers, community health centers, emergency medical services, laboratories, diagnostic centers, pharmacies, blood centers, long term care, and/or home care.

The applicant must address the following eight project requirements in the narrative portion of the application. Applications that do not address all eight project requirements will be returned without review.

Partnerships in Implementing Patient Safety Project Requirements

1. The applicant, or its partner, must be a health care provider organization. The applicant must specify the safe practice to be introduced and justify its selection as an intervention to eliminate or mitigate the errors, risks, and hazards identified. The application must provide supporting evidence that the intervention to be introduced is a safe practice. The safe practice intervention can not be solely focused on HIT.

2. Because implementation projects are intended to introduce established or known safe practices, the safe practice intervention selected must be able to be implemented at the beginning of the award of the grant.

3. The applicant must have already completed a risk assessment and be able to document the medical errors, risks, hazards, and harms that are to be addressed with the implementation of a specific safe practice. The applicant must document how the risk and hazards were identified and the priority for the organization established. The applicant must identify the patient population impacted by the risks and hazards and outline the expected benefit from the implementation of the safe practice.

4. The applicant must provide an implementation plan including a time line for introducing the safe practice intervention into the health care delivery process. This plan should include the identification of barriers and problems to be overcome in introducing the safe practice intervention. The plan should discuss the costs and benefits to the institutions of implementing the safe practice intervention

5. The applicant must be able to anticipate the level of adoption and acceptance of the safe practice intervention by health care professionals in their institution. The applicant should describe potential barriers to adoption and how these barriers can be overcome.

6. The applicant must describe the tools resulting from their project. The applicant should specify projected impact and generalizability of any tools developed. One tool should be a well developed implementation toolkit. The toolkit should document the lessons learned during the implementation process, and identify any resources and other tools that facilitate adaptation and/or adoption of the safe practice intervention. The plan and process for the development of the implementation toolkit will be worked on collaboratively by the awardees and AHRQ.

7. The applicant must submit an evaluation plan. The plan should focus on the performance of the implementation of the safe practice intervention. The applicant should describe how safe practice intervention and its outcomes will be evaluated and assessed. In addition, the evaluation plan should also focus on assessing the generalizability of the intervention and the resource implications.

8. The applicant must submit a dissemination plan. The plan should be developed to document and assess the impact of the safe practice intervention on the process of care and the patient population being addressed by the safe practice within the applicant institution and any partner organizations as applicable.

Section IV. Application Submission Instructions

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsections III.3 Other Special Eligibility Criteria and VI.2 Administrative and National Policy Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

To ensure equity among applicants, however, applicants using the Form PHS 398 must observe page number and font size requirements specified in the form.

Supplementary Instructions:

Institutional Support:

There are no cost sharing requirements included in this RFA. These grants are seen as partnerships and as facilitating opportunities for collaboration and coordinated efforts in response to new, emerging, or ongoing issues related to patient safety. AHRQ encourages applicant institutions, including any collaborating institutions, to devote substantial amounts of their own resources to this effort. A strong 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 actual dollars, donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicateinstitutional 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.

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 RFA. The conference call will take place on October 6, 2004 at a time to be determined and will last approximately 1-2 hrs. To register to participate in the conference call, please send an e-mail request to PSImplement@ahrq.gov by October 4, 2004. All registrants will be sent an e-mail reply which will contain information on the call, including time and call-in information, by October 1, 2004. Potential applicants are encouraged to contact Ms. Hogan or Ms. Queenan with any questions (see Where to Send Inquiries, above).

The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying. All 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 PSImplement@ahrq.gov by October 4, 2004. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the conference call will be available October 18, 2004. Please send requests for a copy of the notes to PSImplement@ahrq.gov.

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

James Burgdorf
Center for Quality Improvement and Patient safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1801
FAX: (301) 427-1341
E-mail Address: PSImplement@ahrq.gov

James Burgdorf
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1801
FAX: (301) 427-1341
E-mail Address: PSImplement@ahrq.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. It is very important to note that limitations on number of pages and size of font must be observed; applications violating these requirements will be returned without review.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an AHRQ application. The AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

The RFA is also available on AHRQ’s Web site, http://www.AHRQ.gov, (see under Funding Opportunities).

This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

o Priority Populations

The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) reauthorized the Agency and 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. To implement this directive, 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 RFA should address the requirements of including priority populations as specified in the Notice.

o 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 and/or contractors are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors 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. Contact with the media will take place in close coordination with OCKT and the press offices of the grantee’s or contractor’s institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors 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.

o HCUPS & 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 over 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 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 comprises three component surveys: the Household Component (HC), the Medical Provider Component (MPC), andthe 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.

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, previously called Health Care Financing Administration (HCFA), 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 statue, 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 INQUIRIES.

o 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.

To receive an award, applicants must agree to submit an original and two copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (Word Perfect, or Word, or ASCII format).

The past cooperation of applicants with regard to the submissions described in this section may be considered in the application review to assess applicants potential for responsible stewardship of awarded funds.

Specific Instructions for Modular Grant applications.

Section V. Application Review Information

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness. Merit Review Criteria are described in section V.3 below.

2. Review and Selection Process

3. Merit Review Criteria

As part of the merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score.
• Receive a written critique

In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application.

• Significance
• Approach
• Innovation
• Investigator
• Environment
• Inclusion of Priority Populations
• Budget

The application does not need to be strong in all categories to be judged likely to have a 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: Does the proposed project address an important patient safety problem? Will the proposed safe practice intervention make a difference in patient care and improved patient safety? If the aims of the project are achieved, how do they advance the diffusion and adoption of effective safe practice interventions into practice? What are the overall benefits to patients and society of implementing the safe practice intervention?

Approach: Does the application adequately demonstrate the completion of a risk assessment for the safe practice intervention? Is there a clear plan for implementation including a project management plan, clear objectives, timelines, and deliverables? Does the project plan have clear and well-reasoned goals consistent with those stated by AHRQ in this RFA? Does the application acknowledge potential problem areas and consider alternative tactics? Are the barriers to adoption and difficulties in implementation adequately addressed?

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project develop new methods for implementation? Is the safe practice intervention one that has not widely been implemented and for which implementation tools are not already available?

Investigators: What are the qualifications of the PI to lead the implementation effort for the safe practice intervention? Does the PI provide an appropriate level of commitment to the project (at least 15%)? What are the qualifications of the key personnel designated to assist the PI? Has the project included outside resources or partners that have expertise in implementing safe practice interventions if they are not present in the organization?

Environment: Does the organizational climate support the improvement of patient safety? Is there a positive safety culture within the organization in which will contribute to the probability of success? Does the proposed project take advantage of unique features of the organizational environment or employ useful collaborative arrangements?

Budget: How reasonable is proposed project budget and the requested period of support in relation to the proposed safe practice intervention? Are dedicated grantee resources sufficient to ensure commitment on the part of key personnel? Is there effective and efficient use of project resources? Is there specific evidence of the nature and extent of the applicant institution resource contribution?

Responsiveness. How well does the application address the purpose and objectives of this RFA? Is this application focused on a critical patient safety issue for their organization? How responsive is the application to the eight project requirements for partnerships in implementing patient safety?

Evaluation and Assessment of Impact. Does the application include an evaluation plan for assessing the implementation of the safe practice intervention and documenting its impact on the institution and the target patient population at risk? Does the application include a dissemination plan and an assessment of the level of adoption and acceptance of the safe practice intervention? What is the potential of the applicant institution to develop an implementation toolkit on the safe practice interventions and share this toolkit to ARHQ for dissemination?

Generalizability. How generalizable would the safe practice intervention be to other settings of care and other institutions? Can the implementation toolkit for the safe practice intervention resulting from the project be adapted and/or adopted by other parts of the applicant institutions and other institutions? How generalizable would the proposed project findings and tools be to other institutions implementing patient safety improvements?

Institutional Support and Commitment. Does the application provide evidence that the institution has sufficient influence, experience, and resources to carry out the proposed interventions? Is there a substantial level of institutional support? Is there thorough and convincing evidence and documentation of the commitment of institution? Is the type and extent of the institutions resource commitment an appropriate commitment to patient safety? Is this effort part of an ongoing effort to improve patient safety, or is there other evidence that the institution has a history of successful efforts in patient safety? Is there evidence of institutional support and commitment to sustaining and institutionalizing the safe practice intervention once the funding has been completed?

Protection: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application.

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Adequacy of attention to other populations of special priority to AHRQ (see discussion on Priority Populations in the section on Other Submission Requirements, above, and in the section on Required Federal Citations, below.)

3.B. Additional Review Considerations

3.C. Sharing Research Data

Data Confidentiality

Pursuant to section 924(c) of the Public Health Service Act (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 U.S.C.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 the 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 managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of protected health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) became mandatory for covered entities on April 14, 2003. 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, for example, health care plans, 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) satisfied that any identifiable health information will be appropriately safeguarded by the investigators. The HHS 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 those 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.

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 Federal government 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 these issuances 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).

Section VI. Award Administration Information

After the peer review of the application is completed, the Principal Investigator will receive a written critique called a Summary Statement.

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Notification will be made electronically to the designated administrative/institutional official.

All AHRQ grant and cooperative agreement awards are subject to the terms and conditions of the Public Health Service (PHS) Grants Policy Statement as part of the notice of grant award, found at http://grants1.nih.gov/grants/policy/gps/index.html. For terms of the award, see http://grants1.nih.gov/grants/policy/gps/5award.htm#terms, and see http://grants1.nih.gov/grants/policy/gps/5award.htm#fund for the award and funding process.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator, as well as to the appropriate institutional official, at the time of award.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U18), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial AHRQ programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the AHRQ as defined above.

Awardees will have primary and lead responsibilities for the project as a whole, including research design and protocol development, participant recruitment and follow-up, data collection, quality control, preparation of publications exclusively about the data collection, analysis, information dissemination and testing of safe practice interventions to improve patient safety.

The awardees are expected to meet the requirements for the bi-monthly conference calls, quarterly progress reports, and site visits. In addition, the awardees must participate in the annual patient safety meeting sponsored or supported by AHRQ.

Awardees should collaborate with AHRQ on the development of the implementation toolkits for the safe practice intervention and the dissemination of the implementation toolkits to other institutions who may wish to adopt and/or adapt the safe practice intervention. In addition, awardees must fully participate in AHRQ Patient Safety Initiative dissemination activities as described in RFA HS 05-012.

Awardees will be responsible for cooperating and collaborating with other AHRQ awardees working on patient safety improvements with assistance from the AHRQ program officials. In addition, awardees are required to cooperate with AHRQ contractors to assist with Patient Safety Initiative activities.

Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current DHHS, Public Health Services (PHS), and AHRQ policies.

The AHRQ Program Officials for this program include project officers (POs) for the funded cooperative agreements and staff working on AHRQ’s Patient Safety Initiative. They will have substantial programmatic involvement in guiding grant activities toaddress priority issues regarding implementing safe practice interventions to improve patient safety.

For these cooperative agreements, AHRQ program officials are responsible for convening and participating in bi-monthly conference calls, reviewing quarterly progress reports and providing input as needed, conducting site visits and preparing site visit reports, participating in the progress evaluation meeting, and attending an annual AHRQ patient safety meeting.

Under the cooperative agreement, AHRQ’s purpose is to support and stimulate the recipient's activity by involvement in and otherwise working jointly with the grantees in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Cooperative activities are intended to strengthen individual projects and at the same time generate collaboration across projects. Specific cooperative tasks and activities in carrying out individual projects may be shared among the awardees and the AHRQ program officials. AHRQ program officials may also provide expertise/technical assistance to the awardees and assist them with their project activities or in coordinating the activities of different grantees (e.g. author or co-author articles that compare two or more of the safe practice interventions). AHRQ program officials, individually and in partnership with awardee staff, may publish analyses and syntheses of aggregated findings from the partnerships in implementing patient safety projects.

Projects funded under the Partnerships in Implementing Patient Safety RFA are considered part of the AHRQ’s Patient Safety Initiative. Using the contract mechanism, AHRQ has established a Patient Safety Research Coordination Center (PSRCC) and a Patient Safety Program Evaluation Center (Evaluation Center) to support activities of the AHRQ Patient Safety Initiative.

AHRQ’s PSRCC provides a variety of services and technical support to patient safety grantees including a variety of communication linkages and resources. AHRQ’s PSRCC has a Steering Committee which provides advice to the PSRCC contractor as to how it can best serve the needs of the PIs and their teams and how to best disseminate and move towards implementation of the findings and products resulting from AHRQ’s Patient Safety Initiative. The Steering Committee is composed of up to 13 members chosen from the PIs of Agency-wide patient safety projects as well as federal partners, international partners, and external stakeholders and customers. The Steering Committee will meet periodically and also will participate in additional activities as needed. All grantees under this RFA are expected to participate in the activities coordinated by AHRQ’s PSRCC.

AHRQ’s Evaluation Center provides support to AHRQ by facilitating the documentation and evaluation of the impact of the entire patient safety portfolio. AHRQ’s Evaluation Center is not intended to evaluate the specific performance of individual patient safety projects but rather to provide an objective, comprehensive, and longitudinal view of AHRQ’s Patient Safety Initiative. As needed, AHRQ’s Evaluation Center will conduct interviews with the PIs and other key personnel of the grants to learn more about safe practice interventions being developed and implemented. Awardees under this RFA are required to fully cooperate with the AHRQ’s Evaluation Center. The existence of AHRQ’s Evaluation Center does not eliminate the need for individual projects to have an evaluation component within the project itself.

When appropriate and feasible, AHRQ expects awardees to work with each other to identify collaborative opportunities that can contribute to the overall success of their projects and the overall success of AHRQ’s Patient Safety Initiative. These collaborative relationships may be facilitated by AHRQ’s POs, program officials, and contractors; instigated by the grantees through self-identified opportunities, or developed via other mechanisms during the life of the project.

Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and AHRQ may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the individual awardee in the event of an individual disagreement, a second member selected by AHRQ, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee’s right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16.

Award criteria that will be used to make award decisions include:

• Scientific merit (as determined by peer review)
• Availability of funds
• Responsiveness to goals and objectives of the RFA
• Demonstration and evidence of substantial applicant institutional commitment and support
• Programmatic balance of both the type of applicant institutions (system or individual) and geographic location
• Potential impact and generalizability of the safe practice intervention (numbers of patients or size of population) and the implementation toolkit
• Portfolio balance within AHRQ’s Patient Safety Initiative and DHHS patient safety activities

Project Monitoring Requirements

Progress Reports. All awardees will be required to submit quarterly progress reports to communicate grant progress to AHRQ. The progress report will follow a format to be prescribed by AHRQ, but will include not only completed activities but plans for the remainder of that year and any changes foreseen in the future. At a minimum, the progress reports will include information on progress to date measured against project aims, methodological changes implemented, key preliminary findings, significant problems and resolutions, inclusion of priority populations, and related publications and presentations. AHRQ, in consultation with the awardees, will prescribe the timetable, format, and content for these progress reports.

Site Visits. During the first 9 months of the grant award period, each grantee will have a site visit conducted by the AHRQ project officer (PO) and other appropriate AHRQ program officials (e.g., grants management, financial, subject area staff). The purpose of the site visit is to review the progress of the implementation of the safe practice intervention and to assess the level of institutional support and commitment. In addition, the site visit serves as an opportunity for an active dialogue between the grantee partner and AHRQ. The site visit will follow a format to be prescribed by AHRQ after grant award. After the visit, each grantee will be provided a short report from the AHRQ PO providing input on the grant activities, progress and level of institutional support.

Annual Meeting. All grantees are required to participate in an annual patient safety meeting sponsored or supported by AHRQ. The date and location of the meeting will be communicated to the grantees after grant award. The PI and at least one program staff member from the project are required to attend the annual meeting. Therefore, applicants must include an allocation of projected travel funding for attendance at this meeting in the project budget.

Progress Meeting. Each grantee will submit a non-competing continuation application for funding for a second year. After receipt of these applications, AHRQ program officials will meet to review the applications, evaluate the progress of each grantee, and discuss the continuation of funding for the projects. In addition to the continuation applications, ARHQ will also review the progress and site visit reports and discuss the fulfillment of Awardee Rights and Responsibilities (see below). While there is no plan to reduce the number of grantees for the second year, the expectation is that grantees will have made substantial progress in carrying out the project.

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:

Eileen M. Hogan, M.P.A.
Project Officer
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1307
FAX: (301) 427-1341
Email: PSImplement@ahrq.gov

Or

Deborah Queenan, M.S.W.
Project Officer
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1330
FAX: (301) 427-1341
Email: PSImplement@ahrq.gov

Direct your questions about peer review issues to:

Michele Hindi Alexander
Health Scientist Administrator
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1547
FAX: (301) 427-1347
Email: mhindi@ahrq.gov

Direct your questions about financial or grant management matters to:

Dianna N. Bailey
Grants Management Specialist
Agency for Healthcare Research and Quality
OPART/GM, 4^th Floor
540 Gaither Road
Rockville, MD 20850
Telephone: (301)427-1454
FAX: (301)427-1462
Email: dbailey@ahrq.gov

It is the policy of AHRQ that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.

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 AHRQ Publications Clearinghouse, listed under INQUIRIES, 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 INQUIRIES).

AHRQ also encourages investigators to consider including children in study populations, as appropriate.

The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some 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 act is taken, having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data is not subject to this disclosure requirement. Furthermore, even if a Federal regulation action is taken in reliance on AHRQ-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." 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 it constituted trade secrets or commercial information collected. 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 RFA 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.

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) issued the last modification the "Standards for Privacy of Individually Identifiable Health Information", was mandated by the "Privacy Rule," on August 14, 2002. This 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). Mandatory compliance with the Privacy Rule (for those classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply).

Decisions about applicability and implementation of the Privacy Rule reside with covered entities. 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. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

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/, Number 93.226. Awards are made under Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92.

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

1. Wachter RM, McDonald KM. Making health care safer: a critical analysis of patient safety practices. Evidence Report/Technology Assessment Number 43. Rockville, MD., AHRQ 2001.

2. National Quality Forum. Safe Practices for Better Health Care. Washington, DC, National Quality Forum, 2003.

3. Joint Commission on Accreditation of Healthcare Organizations Patient Safety Goals found a www.jcaho.org.

4. Kohn, L.T., Corrigan, J.M., Donalson, M.S. eds. To Err is human: building a safer health system. Washington: National Academy Press, 1999.

5. Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Committee Appropriation Bill, 2001. Report 106-293 (May 12, 2000), p. 195-198. Available at: http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.21&filename=sr293.106&directory=/disk2/wais/data/106_cong_reports. Accessed July 7, 2003.

6. Harkin T. Committee on Appropriations, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 2002. Report 107-84 (Oct 11, 2001). Available at: http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.21&filename=sr084.107&directory=/diskb/wais/data/107_cong_reports. Accessed July 7, 2003.

7. AHRQ’s Patient Safety Initiative: Building Foundations, Reducing Risk. Interim Report to the Senate Committee on Appropriations, AHRQ Publication No. 04-RG005, December 2003. Agency for Healthcare Research and Quality, Rockville,MD, http://www.ahrq.gov/qual/pscongrpt/

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