PARTNERSHIPS FOR QUALITY RELEASE DATE: May 10, 2002 RFA: HS-02-010 Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) LETTER OF INTENT RECEIPT DATE: June 20, 2002 APPLICATION RECEIPT DATE: July 17, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Project Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators o Special Requirements o Where to send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations o References PURPOSE OF THIS RFA The Agency for Healthcare Research and Quality (AHRQ) invites applications designed to accelerate the pace with which research findings are translated into improved quality of care and the health care system"s ability to deliver that care. The recent Institute of Medicine report on quality of health care (1), is one of numerous calls for using available knowledge to more quickly close the gap between the level of quality that is possible and that which is currently achieved. Systematic reviews have shown that new scientific knowledge does not automatically lead to improved patient care, that knowledge must be linked with supportive environments and incentives for change, and systemic approaches are required for improved health care services (2, 3). In recent years, the Agency expanded its research portfolio beyond studies of what works best in medical practice, health care organization and payment to include evaluation of the effectiveness of alternative strategies for using this knowledge to improve health care. The Agency"s portfolio now includes multiple studies that evaluate the effectiveness of improvement strategies, and a growing body of scientific literature has emerged (4, 5). The Partnerships for Quality RFA provides a mechanism for collaboration between and among the member organizations of the Partnership, including AHRQ, to translate research findings into practice and policy. The unifying goal is a strong commitment to the improvement of health care services and their security, safety, outcomes, quality, effectiveness, and cost-effectiveness. Member organizations, including AHRQ, will utilize the cooperative agreement mechanism to: o identify and prioritize aims for improvement based on member need and existing evidence of effectiveness, o translate, disseminate, and implement research findings with a strong preference for findings that have resulted from prior Agency-sponsored research, o annually identify, create and expand opportunities for collaboration and coordinated efforts in response to new, emerging or ongoing issues related to the security, safety, quality, effectiveness or outcomes of care, and o estimate the impact of the implementation effort on policies, processes, and/or outcomes as well as key stakeholders in the care process being addressed, and facilitate AHRQ"s understanding of the health services research needs and concerns held by policy and decision makers representing Partnership member organizations. In addition, supplemental funds are expected to be available to improve the security of the United States population by improving the readiness of the healthcare system to respond to bioterrorism. Agency funds are anticipated to support multi-year projects, with additional set-aside funds to support partnership projects that focus on improving the quality of the health care system"s preparedness in the event of a bioterrorist event. The purpose of the Partnerships program is to support models or prototypes of change led by organizations or groups with the immediate capacity to influence the organization and delivery of health care as well as measure and evaluate the impact of their improvement efforts. Such organizations could include, but are not limited to, health care professional organizations, accrediting and certifying bodies, provider groups, practice networks, disease-specific advocacy groups, health insurers, and employer coalitions or purchaser collaboratives (including coalitions of State or public purchasers or other State or local organizations). Also encouraged as applicants are consortia of such organizations or others whose influence or potential impact working alone would be relatively modest (for example, a collaboration among Quality Improvement Organizations working with nursing homes, or a coalition of State Medicaid agencies or health departments). A consortium may include organizations of more than one of the types mentioned. Recognizing the diversity and complexity of health care delivery arrangements, the Agency wishes to establish partnerships among a variety of organizations or groups and their stakeholders, to target evidence-based change in care to a range of settings delivering care to a large number of people over a very wide geographic area. Through these partnerships, AHRQ seeks opportunities to accelerate current or proposed improvement initiatives, including empirical assessment of their impact. Developing or strengthening partnerships may be one of the aims of the application. While there are no specific matching requirements, the Agency expects that since these are partnerships, the grantee organization will devote substantial resources to this effort. The partnerships are primarily focused on improvements in the delivery and outcomes of health care, through a focus on priority health conditions, such as diabetes and heart disease, and priority health issues, such as long term care and bioterrorism. (Targets are discussed in greater detail in this section below.) Partnerships may choose to focus on evidence-based improvement in bioterrorism preparedness using specific set-aside funds. Maximal system responsiveness to bioterrorism will require effective linkages between the health care system and the public health infrastructure. Using available evidence-based information, such as AHRQ"s evidence reports on effective training models for bioterrorism preparedness and the role of decision support systems for improved responsiveness to bioterrorism (see summary at http://www.ahrq.gov/clinic/epcsums/biotrsum.htm), partners will be expected to evaluate and disseminate vital health care information, models of effective health care delivery, and results of research to their members. Applicants choosing to include a project on bioterrorism preparedness will be required to clearly delineate this project from other proposed projects and include a request for supplemental resources for the bioterrorism preparedness effort as part of the overall budget in order to qualify for the set-aside funds. PROJECT OBJECTIVES The ultimate objectives of this program are to design, support and facilitate change that, according to evidence, is likely to lead to documented improvements in health care security, safety, and quality, ensure that these improvements become part of the ongoing practice of health care providers and clinicians, and disseminate improvements beyond targeted selected population groups. Achieving these objectives will require the capability to assess current practice, select targets in terms of health care settings, conditions, populations, and/or elements of the care process, plan and institute changes in organizations, incentives, and individual clinical practices that will motivate and support the desired changes, document the effects, determine the resource implications, and institutionalize the process. Documentation of results must include benefits to patients and also costs and benefits to individual providers and to the organizations that are likely to have a bearing on long-term adoption and sustainability of the changes. In other words, it is desirable to (1) institute policy, organizational, or operational efforts that will motivate and support changes in practice to improve quality, and (2) provide evidence that the changes in quality are cost-beneficial to the relevant participants so that they can be expected to continue, independent of this or other grant funding. The Partnership grants are intended to use a phased approach an initial planning phase of one year (Phase I) and continued implementation during Phase II, which may comprise up to three additional years. Phase I of the grant is intended to allow the applicant to (1) conduct planning, testing, and organizational development and preparation that will further the overall aims to be addressed, as well as preliminary evidence of implementation, (2) demonstrate by the end of month 6 that the aims can be accomplished if further funding is awarded, and (3) present, also by the end of month 6, full baseline information if not included in the application. Phase I may be used to create or expand partnership arrangements with stakeholders or collaborators. Funding for Phase II will be determined by the progress achieved during Phase I. Thus it is desirable that Phase I be designed to have stand-alone outcomes that are useful in promoting quality improvement by the applicant and its partners and have potential informational value for others, even without further funding for Phase II. Projects are expected to adopt one of three models: one type of project would be short-term, having a single, relatively limited target. These projects would be expected to have relatively modest budgets and short durations (two years or less). A second model might have a complex plan of multiple targets requiring a sequence of interventions over a longer period (up to 4 years). A third project model would expand over time, adding additional targets or partners in a planned sequence over a period not to exceed 4 years. The project models would support the inclusion of information technology (IT) as a tool to transmit evidence-based information, provide decision support for patients and providers, and support quality improvement initiatives in health care settings. AHRQ is interested in projects from partner(s) who will disseminate and translate IT interventions with known efficacy into clinical practice. Projects requesting bioterrorism funds should address how the core partnership will be supplemented by set-aside funds in order to work with their members to improve health system preparedness for bioterrorism. Partnership projects may target specific conditions or diseases, specific population or patient groups (for example, see Special Requirements, below), specific processes, specific care sites, specific components of quality or a combination of these. Improvement grants may focus on priority health conditions, including cancer, diabetes, heart disease, chronic kidney disease, or respiratory disease, as well as priority health issues, including maternal and child health, mental health, long-term care and bioterrorism. Some of these priority conditions and priority issues will fall within the categories that will be addressed by the National Health Care Quality Report currently under development. The selection of these targets was conceptualized in a matrix presented in "Envisioning the National Health Care Quality Report." The matrix includes specific components of health care quality adopted from the "Crossing the Quality Chasm" report including safety, effectiveness, patient-centeredness, and timeliness. The matrix also includes consumer perspectives on health care needs, adapted from a variety of sources. Consumer perspectives are categorized to include staying healthy, getting better, living with illness or disability, or coping with the end of life (6). Applicants wishing to include projects related to bioterrorism preparedness should clearly identify the specific processes and settings that are being addressed as well as the populations under study. Targeted population groups must be justified, with specific reference to the scientific literature, the IOM Chasm Report, or a similar foundation, such as analysis of data in the public domain. Analysis of proprietary data not available for verification by others may be useful for planning, but would not be considered sufficiently robust, in the absence of other evidence, to justify selection of a target. Justification should address the importance of the target as well as the evidence base supporting the relationship to outcome of the quality measure proposed, such as set out in the Guide to Clinical Preventive Services (7). The interventions to be employed or tested must be selected and justified on the basis of published evidence of their success in analogous health care settings and with attention to what is known of the process of translation of research into practice. The literature includes many discussions of these issues (for example, references 8 and 9). Specific desired results of the interventions must be identified, together with a description of how results will be used to effect or consolidate changes in infrastructure, operations, and/or policy. A rationale must be presented for the entire project that indicates exactly how the results are expected to occur that is, relating the selected targets and interventions to the results in a logical way, incorporating available evidence. Baseline measures must be provided or convincingly projected to be available in a reasonable time period, and the capability to measure results must be demonstrated. The planning phase (Phase I) is expected to produce a detailed strategy for evaluation of the interventions in terms of their success and their long-term viability in the organization, and full baseline information if not provided in the application. AHRQ wishes to draw from these projects evaluative information as to the context of the project (that is, the baseline or antecedent condition prior to the activities implemented to improve care, also referred to as "the intervention"). For supplemental projects to the core partnership, intended for the bioterrorism set-aside, a number of resources exist to design effective strategies to improve preparedness. Using available evidence for improvement, such as AHRQ"s evidence reports on best methods for training clinicians and the role of information systems and decision support, as well as evidence from other Department of Health and Human Services initiatives, the Partners would be expected to improve clinical readiness for bioterrorism preparedness through collaborative activities, including: o evaluating and adapting models of effective training for front-line clinical staff, evaluation of regional models for system preparedness, o reinforcing effective linkages between the health care system and the public health infrastructure to detect and respond to a bioterrorist event, examining health care system preparedness issues, such as surge capacity and workforce projections to meet needs, and o evaluating the role of information technology for providing critical real- time clinical decision support information for front-line physicians and nurses. The Agency considers Partnership projects to require attention to the use of methods to motivate, recognize, reward, and support quality, broad participation in planning and evaluation efforts on the part of those directly or indirectly affected, sensitivity to local context (such as barriers at the micro level), collaborative work to identify and align the needs and capabilities of stakeholders, and system changes to sustain quality improvements. Incentives based on payment policies are extensively discussed in the IOM Chasm Report (10). The use of specific tools or measures developed by AHRQ, or with AHRQ support, is strongly encouraged. For example, to the extent that benchmarking and feedback are employed, AHRQ recommends consideration of the use of Achievable Benchmarks of Care (11). Other examples are evidence reports, information available from the National Quality Measures Clearinghouse, AHRQ quality indicators (Prevention Quality Indicators, Inpatient Quality Indicators, and Patient Safety Indicators), or CAHPS. For information about these tools, applicants may consult the AHRQ Web site (see above) or contact AHRQ for programmatic assistance (see Where to Send Inquiries, below). Project Organization. Applicants must demonstrate sufficient organizational and technical capability and other resources and sufficient influence over practice to provide reasonable likelihood of succeeding in their stated aims and sustaining this success beyond the period of the grant. Planned or ongoing efforts to improve quality of care must be described fully in terms of their current organizational underpinnings, committed resources, and changes envisioned under the grant. The potential impact sought from a Partnership is significant improvement in quality of care for a substantial part of the population of the United States. AHRQ is seeking projects that will, in aggregate, affect the quality of care of patients numbering in the hundreds of millions. Prospective applicants should consider this aggregate aim in terms of what contribution they might make to that number as one of ten projects. Evaluation, Reporting and Dissemination: AHRQ intends that funded projects be models, and as such yield information that may be useful to other organizations. Evaluation relevant to an individual project must be a part of all plans, with an emphasis on acquiring information that will permit assessment and reporting of progress against approved aims as well as internal decisionmaking by the grantee and consortium members. Cost and other resource dimensions must be addressed in evaluation at this level. The application should also provide for cooperation with the coordinating committee in evaluation of the entire program. Otherwise, planning and conducting evaluation at the programmatic level is an AHRQ activity and is not part of the responsibilities of the projects, though advice and consultation will be sought from projects. Dimensions to be addressed in evaluation at that level will be context (antecedent or baseline conditions), input (intentions and interests considered, including legislative mandates), process (implementation activities and the changes they themselves produced), and products, including unanticipated consequences. AHRQ staff will be responsible for designing and steering that process, working with the projects as part of the Agency"s programmatic responsibilities. This in no way reduces the rights and responsibilities of grantees with respect to their individual projects. Information provided in the application and in progress reports that is designated as proprietary and damaging to the organization if publicly released will be protected, but an approach must be outlined for sharing information with other grantees in the course of the projects, collaborative activities with other projects with overlapping targets or similar interventions, and dissemination of useful information to the general public and to clinical and administrative decisionmakers in analogous circumstances. There must also be provisions for sharing with researchers sufficient data to verify published findings. Timetable. In each year of the grant, the Agency will require a progress report on January 15. Except in the final year of funding, a continuation request including a cumulative progress report will be due each June 1, and a third progress report will be required September 30. (In the final year of funding, the June 1 submission will be a progress report but no continuation application, and no progress report will be due September 30, but a final report will be due 90 days after termination.) 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 future year plans. Projects that include set-aside bioterrorism funds will require a separate section of each progress report related to bioterrorism preparedness activities. The continuation application submitted during Phase I for Phase II funding will be subjected to peer review to determine if adequate progress has been made toward achieving Phase I aims, as approved in the original application, or acceptable revisions of these aims (such revisions to be evaluated based on the review criteria published in this announcement, as applicable). Progress evaluation will include fulfillment of Awardee Rights and Responsibilities (see Special Requirements, below). Reviews may or may not include site visits. It is anticipated that not all Phase I awards may receive Phase II continuation awards, but continuation applications are noncompetitive, and there is no plan to reduce the number of Phase II grantees. No continuation award will be denied without a site visit. Phase II awards may be denied for inadequate progress in Phase I or if reduction or reallocation of resources is found by the Agency to be necessary. Phase I grantees who do not receive Phase II awards will be invited to continue attending grantee meetings and may continue to receive technical assistance through Agency arrangements, depending on availability of resources. During Phase II, the second progress report of each year (due June 1) is part of the continuation application. It will summarize all progress for the year to date and provide updated and detailed plans for the next year. It will be reviewed for progress against original or revised project aims and for cooperation in joint activities with the Agency and other Partners, such as attendance at meetings (see Awardee Rights and Responsibilities, under Special Requirements below). As is the case in Phase I, these reviews will be noncompetitive, there is no plan to reduce the number of projects. Unlike Phase I progress reports, Phase II progress reports will emphasize implementation rather than planning. Formats for progress reports will be specified by AHRQ with assistance from such experts as it may choose and in consultation with the Principal Investigators. If a project is terminated after Phase I, a final report will be required, but the grantee will be invited to continue to take part in meetings and receive technical assistance, subject to resource limitations. Budget and Related Issues. Although no specific matching requirements are included in this RFA, these grants are seen as partnerships and as furthering and facilitating efforts already underway or in advanced stages of planning. Therefore it is expected that grantee organizations and consortia will devote substantial amounts of their own resources to this effort. Collection of new data must be supported from these resources, though grant funds may be used for planning, instrument development, and analysis. A coordinating committee, including the grantees, will meet approximately twice annually (see Special Requirements, below). Dates and times will be established as far ahead as possible, and in consultation with PIs. Budgets must take into account the obligation to attend these meetings, and provide the means for the grantee to host, at least one time in the course of the project, a one- and-one-half day coordinating committee meeting. Applications that include a project under the bioterrorism set-aside should also include in that budget the cost of attending one meeting of all bioterrorism project grantees. MECHANISM OF SUPPORT This RFA will use the cooperative agreement (U18) award mechanism under which the Principal Investigator 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 Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." This RFA is a one-time solicitation. FUNDS AVAILABLE Partnerships: The total amount requested in Phase I of an application may not exceed $100,000 for the Partnership (see below re supplemental funding for bioterrorism preparedness). Up to 10 applications will be funded. Phase II requests may be for an additional 1-3 years, with a suggested budget of $200,000 to $400,000 per year, depending on the scope of the project. For example, an application that would correspond with the first of the three project models discussed above (under Project Objectives) would be expected to requested in the range of 2 years" total support, at a maximum of $100,000 for the first year, and $200,000 for the second. Continuation awards for subsequent years will be contingent on performance as reviewed each year. Because the nature and scope of the proposed projects 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 for support of this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. There are no plans to reissue this RFA. Bioterrorism Preparedness Supplements: Up to $1 million per year total costs will be set aside for Partnership supplements to enhance health system responsiveness to bioterrorism. If the Partnership includes projects specifically related to bioterrorism preparedness, applicants may be eligible for $100,000 in Phase I funding through the set-aside funds. Subsequent years of funding for the bioterrorism-related projects is anticipated to be $100,000 per year. ELIGIBLE INSTITUTIONS Your institution may submit an application if it has any of the following characteristics: (Individuals are not eligible applicants under this RFA.) o Domestic o Public or private institutions o For-profit or not-for-profit o Faith-based organizations It is AHRQ"s intention in funding these cooperative agreements to assist grantees in influencing directly the behavior of organizations and clinicians delivering health care to large numbers of patients. For this reason, individual academic institutions are ineligible to be primary grantees, though they may serve as partners or as valuable members of consortia, including a consortium of academic medical centers providing health care to large numbers of people. An important aim is to bring change to geographic areas larger than that of any single State, therefore, units of individual State or local governments may not apply except as members of consortia. Examples of the kinds of organizations AHRQ anticipates as applicants are given under Purpose, above. Important Note: Under 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 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). Although eligible, for-profit organizations considering submission of an application should read carefully the Special Requirements section below concerning responsiveness and competitiveness, below. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed project is invited to develop and submit application for support on behalf of an eligible applicant organization with which he or she is affiliated. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs. SPECIAL REQUIREMENTS Responsiveness and Competitiveness Although for-profit organizations are eligible to apply, in order to maximize numbers of patients affected, individual entities, the Agency encourages applications from consortia of insurers, employers, hospitals, or integrated delivery systems, rather than from individual entities, in order to maximize numbers of patients affected. Also responsive might be organizations such as pharmacy benefit managers or provider alliances handling such functions as purchasing and quality improvement, if they are influential and have strong and close affiliations with substantial numbers of care providers serving large numbers of patients. The Agency discourages commercial vendors, such as those purveying IT systems or continuing education, from applying except as members of consortia. Terms and Conditions These 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, 42 CFR Part 67 Subpart A, and other HHS, PHS grants administration policy statements. Applicants should be familiar with the Agency""s grant regulations, 42 CFR Part 67 Subpart A, and particularly sections 67.18-67.22. Awardee Rights and Responsibilities The awardee will conduct activities in accordance with the terms and conditions of the Notice of Grant Award, and cooperate with other key parties, including designated AHRQ program staff. An overall coordinating committee will be formed, composed of PIs and AHRQ staff, with a subcommittee for projects that include bioterrorism preparedness. The purpose of the coordinating committee is discussed in this section below. Meetings of the coordinating committee will be held approximately twice each year (with the possible exception of year 1). Time and place of meetings will be determined by AHRQ, consulting with and providing adequate notice to grantees. PIs are required to attend these meetings, substitutes are not acceptable. Meeting attendance and cooperation in collaborative efforts is an important measure of performance. The meetings will be hosted either by AHRQ or by a grantee. AHRQ may include in these meetings additional experts or staff of AHRQ or other Federal programs. Grantees may request additional attendance by other key staff or collaborators. Expenses for grantee meeting attendance will be paid from grant funds. Telephone conferences with subsets of the coordinating committee may also be required from time to time. In working with the coordinating committee, PIs will actively participate in the formulation of plans to promote collaboration across projects and to respond as appropriate to new developments and findings from AHRQ activities. Other principles, rules, and organizational structure of the committee will be established by AHRQ in consultation with the grantees. Within limits of available resources, AHRQ intends to provide for technical assistance regarding methods, tools, and strategies for use in planning, implementing, or evaluating the interventions, selecting additional targets or collaborators, or disseminating results. From time to time, developments and findings from other AHRQ activities may offer opportunities for amending project plans to incorporate new or different activities, either within an individual project or collaboratively between two or more projects. AHRQ will work with grantees to effect such amendments. The responsibility for planning, carrying out, and reporting on the activity resides with the awardee, but AHRQ Program Officials will be kept informed during the intervals between required progress reports when events of significance occur. They will also be kept apprized of and, on request, invited to attend all planned project meetings as observers and resource people, provided with minutes of all such meetings, and notified of all changes in project plans, together with the underlying rationales. AHRQ may also wish to conduct an evaluation of the program as a whole, or to disseminate information on the combined experience of the several projects. Awardees are required to cooperate in such efforts even after completion of the grants. To the extent that such cooperation has financial implications, suitable arrangements will be made by AHRQ. Progress reports will be required January 15, June 1, and September 30 of each year, if the date falls on a Sunday, the due date will be the extended to Monday. AHRQ, in consultation with the projects, will prescribe the format for progress reports. The report due June 1 will be part of the annual continuation application, except in the final year of the project period. The final report of the final year of the project will be due within 90 days of termination, instructions and format for that report will be provided during the project"s final year. Based on periodic review of grantee progress, awards may be terminated in cases of documented under-performance, lack of participation in collaborative activities (such as nonattendance at meetings), or human subject ethical issues where the awardee has been given adequate notification about performance and failed to take corrective actions. AHRQ Staff Responsibilities The cooperative agreement (U18) is an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial AHRQ scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the AHRQ purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient 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. AHRQ involvement will include an advisory and technical assistance role in prioritization of targets and choice of interventions. In addition to monitoring performance of the projects and providing technical assistance, one AHRQ staff aim will be to bring about uniformity in measurement and definitions, where there are similarities among project targets. Another will be to encourage and facilitate incorporation of new AHRQ findings and tools into project activities, when appropriate. An additional aim will be to synthesize, through project reporting and results and through interaction with project staff at coordinating committee meetings and on other occasions, a broad set of evaluative findings and "lessons learned" to guide future work. Annual meetings, as discussed under Awardee Rights and Responsibilities above, will be designed to further such aims. Coordinating Committee The purpose of the coordinating committee is to facilitate collaboration among projects. Among other activities, it is intended to develop uniformity in measures among projects with similar targets or interventions, share information about barriers and successes, facilitate technical assistance, and further evaluation within and across projects. As discussed above, details of structure and process not specified in this RFA will be worked out among participants during Phase I of the projects. Arbitration 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, a second member selected by AHRQ, and the third member selected by the two prior selected 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 the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. Priority Populations The Agency"s authorizing legislation (refer to http://www.ahrq.gov/hrqa99a.htm) directs special attention in Agency programs to populations of inner-city areas and rural areas (including frontier areas), 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. Applications under this RFA should address attention to and potential benefits for these priority populations. 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 Health Care Information (OHCI) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss other dissemination and marketing efforts with staff of the Agency"s Office of Health Care Information. The intent is by no means to discourage or delay such efforts, but to facilitate their coordination with other Agency activities. The Agency wishes to maximize awareness and application of the results 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 should take place in close coordination with OHCI and the press offices of the grantee"s or contractor"s institutions. In cases when products are created (such as Web- based tools, CD-ROMs, "best practices," or "lessons learned"), grantees and contractors may be asked to submit to OHCI a brief plan describing how the product will be publicized. Agency staff may elect to have a cooperative role in furthering and coordinating these plans. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into four areas: programmatic, programmatic involving bioterrorism readiness, peer review, and financial or grants management issues: o Direct your questions regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Mary Cummings Center for Outcomes and Effectiveness Research Agency for Healthcare Research and Quality 6010 Executive Boulevard, Room 300 Rockville, MD 20852 Telephone: 301, 594-2417 Fax: 301, 594-3211 email: mcumming@ahrq.gov OR Margaret Coopey Center for Practice and Technology Assessment Agency for Healthcare Research and Quality 6010 Executive Boulevard, Room 300 Rockville, MD 20852 Telephone: (301) 594-4022 FAX: (301) 594-4027 Email: mcoopey@ahrq.gov OR Marge Keyes Center for Quality Improvement and Patient Safety 6011 Executive Boulevard, Room 200 Rockville, MD 20852 Telephone: (301) 594-1824 FAX: (301) 594-2155 Email: mkeyes@ahrq.gov (Alternate for Marge Keyes: Elinor Walker, CquIPS, telephone: (301) 594-2049, Fax: (301) 594-2155, Email: ewalker@ahrq.gov) o Direct your questions about programmatic issues having to do with bioterrorism readiness to: Sally Phillips, RN, PhD Center for Primary Care Research Agency for Healthcare Research and Quality 6010 Executive Boulevard, Room 200 Rockville, MD 20852 Telephone: (301) 594-6491 FAX: (301) 594-3721 Email: sphillip@ahrq.gov o Direct your questions about programmatic issues having to do with incentives to: Michael Hagan, PhD Center for Organization and Delivery Services Agency for Healthcare Research and Quality 2101 E. Jefferson St. Rockville, MD 20852 Telephone: (301) 594-6818 FAX: 301, 594-2314 Email: mhagan@ahrq.gov o Direct your questions about peer review issues to: Joan Hurley, MHS, JD Office of Research Review, Education and Policy Agency for Healthcare Research and Quality Suite 400 Rockville, MD 20852 Telephone: (301) 594-6075 FAX: (301) 594-0154 Email: jhurley@AHRQ.gov o Direct your questions about financial or grant management matters to: Al Deal Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1843 FAX: (301) 594-3210 Email: adeal@AHRQ.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 Agency 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: Pat Thompson, PhD Director, Division of Scientific Review Agency for Healthcare Research and Quality 2101 East Jefferson Street, Room 400 Rockville, MD 20852 Telephone: (301) 594-1404 FAX: (301) 594-0154 Email: pthompso@AHRQ.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and form (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. State and local government entities applying as members of consortia with other organizations, are entitled to use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. To ensure equity among applicants, however, applicants using this form must observe page number and font size requirements specified in the Form PHS 398. AHRQ encourages use of Form PHS 398 in preference to Form 5161-1. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form 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. SUPPLEMENTAL INSTRUCTIONS: Applicants are encouraged to make use of AHRQ"S Healthcare Cost and Utilization Program. The HCUP includes databases covering 1988-1997, with 1998 and 1999 data available in 2001. These all- payer databases were created through a Federal- State-industry partnership to build a multistate healthcare data system. The main HCUP databases contain discharge-level information for inpatient hospital stays in a uniform format with privacy protections. The Nationwide Inpatient Sample (NIS) is a nationwide probability sample for about 1000 hospitals. The State Inpatient Databases (SID) contain inpatient records for all community hospitals in 22 states. Other HCUP databases contain ambulatory surgery data from nine states. These databases can be directly linked to county-level data from the Health Resources and Services Administration"s Area Resource File and to hospital-level data from the Annual Survey of the American Hospital Association. Format of the Application Narrative. Standard instructions for Form PHS 398, which refer to a "research plan," should be disregarded. The sections of an application narrative for these projects are as follows: (1) Background, Significance and Rationale, addressing the problem or target to be addressed, its importance, and the logic of the proposal, with reference to scientific evidence as appropriate, a brief statement of the methods to be used to bring about improvement, and evidence supporting selection of these methods, with use of diagrams if appropriate, (2) Specific Aims, in which the aims, approach, and rationale are presented, (3) Methods and Timeline, expanding on the Specific Aims, indicating what will be done and in what sequence, barriers anticipated and plans for overcoming them, a timetable for the project indicating activities to take place in Phase I and subsequent phase(s) and results anticipated, keyed to reporting intervals, (4) Project Organization, indicating the qualifications of the organizations, discussion of past or ongoing quality improvement initiatives, future plans for creating, strengthening, or expanding partnerships, the way in which participants (organizations and individuals) will interact, and how decisions will be made, (5) Inclusion of Minority, Female, and Other AHRQ Priority Populations, as discussed in Special Requirements, above, (6) Human Subjects, addressing the protections that will be instituted to preserve privacy of patients and confidentiality of their medical information, to disclose to patients any deviation from standard care that may confer risk, and to guard patients from consequent injury or harm. SENDING AN APPLICATION TO NIH & AHRQ: Submit a signed original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) At the time of submission, two additional copies of the application, labeled "Advance Copy" must also be sent to: Marge Keyes Center for Quality Improvement and Patient Safety 6011 Executive Boulevard, Room 200 Rockville, MD 20852 Telephone: (301) 594-1824 FAX: (301) 594-2155 Email: mkeyes@ahrq.gov APPLICATION PROCESSING: Applications must be received by the receipt dates listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The CSR and AHRQ will not accept any application in response to this RFA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR and AHRQ will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. 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. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. 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. Beginning with applications for AHRQ submitted for the February 1, 2001 receipt date, Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application unless otherwise indicated by the Agency (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html.) However, given the nature of this project and the speed with which successful applicants will need to begin work, IRB approval prior to review will facilitate subsequent processing of awards to successful projects and avoid delays in beginning project activities. All applicants should pay particular attention to the instructions in the form PHS 398 regarding human subject involvement. The RFA is also available on AHRQ"s Web site, http://www.AHRQ.gov, (under Funding Opportunities) and through AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594-6344. In carrying out its stewardship of funded programs, the AHRQ may request information essential to an assessment of the effectiveness of Agency programs. Accordingly, grant recipients are hereby notified that they will be asked for periodic updates on publications resulting from AHRQ grant awards, and other information AHRQ requires in order to evaluate the impact of AHRQ- sponsored projects. AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency-sponsored work. Applicants are to agree to notify AHRQ immediately when a manuscript based on work 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 2 copies of an abstract, executive summary, and full report of the 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 (WP5.1 or WP6.0 is preferable). CMS Data Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. Purchase of CMS public-use data, if required, should be discussed in the application narrative and included in the budget. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness to the RFA. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration. Applications that fail to observe instructions in Form PHS 398 as to numbers of pages and font size will be returned in this way. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. As part of the merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest technical merit, generally the top half of the applications under review, will be discussed and assigned a priority score. REVIEW CRITERIA The goals of this RFA are to improve quality of care for large numbers of people in a measurable, broad, and lasting way, and to establish and assess models for achieving further improvements. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed project will have a substantial impact on the pursuit of these goals: o Significance o Approach o Organizational Strength and Commitment o Project Leadership and Staff o Environment o Budget The technical review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have a major impact and thus to deserve a high priority score. (1) SIGNIFICANCE: Does the application target an important problem? If the aims of the application are achieved, do they have the potential to effect improvement in quality of care? What will be the effect of this work on other aspects of quality of care for other diseases, conditions, settings, or populations? To what extent will this work result in improved outcomes for important diseases or conditions and/or improved safety, quality, security and health status for a large proportion of the U.S. population? In terms of the AHRQ aim for this program of affecting health care for hundreds of millions of people, will this project as one of ten funded contribute a reasonable share to that aggregate number. For supplemental bioterrorism projects, is the proposed work likely to result in enhanced preparedness for a significant sector of the health care system? (2) APPROACH: Are targeted conditions/populations well defined and selected? Are the rationale, preliminary plans, interventions, evaluation, and dissemination plans or preliminary plans adequately described, suitably evidence-based, technically sound, well integrated, and appropriate to the aims of the project? Does the application acknowledge potential problem areas and consider alternative tactics? Do the interventions make sense from the perspective of the interests and motivations of stakeholders? Are incentives (monetary or nonmonetary) appropriately aligned to achieve the aims? (3) ORGANIZATIONAL STRENGTH AND COMMITMENT: Does the application provide evidence that the applicant has sufficient influence, experience, and resources to carry out the proposed interventions? Is there thorough and convincing documentation of the commitment of Partnership members to perform the roles indicated in the application? Are the resources proposed for investment in the effort by the applicant organization sufficient to show serious commitment? If multiple organizations or groups are involved, is there a history of similar collaborative activities among these organizations, or between these organizations and others? If development of partnerships with other organizations is among the aims of the project, are realistic plans described to accomplish this intent? Is this effort part of an ongoing effort to improve health care quality, or is there other evidence that the organization or consortium has a history of successful efforts in quality improvement? Are there adequate provisions and capabilities to involve all stakeholder groups in planning, implementation, and evaluation of these efforts? Are adequate mechanisms in place or proposed to conduct studies of costs and benefits that will affect sustainability and institutionalization of the effort? For supplemental bioterrorism projects, can the organization(s) demonstrate a prior commitment to improving bioterrorism preparedness? How will the organizations use their organizational strength and commitment to improve preparedness for bioterrorism? (4) PROJECT LEADERSHIP AND STAFF: Are the Principal Investigator and other designated staff appropriately trained and experienced and well suited to carry out the proposed work? Is the Principal Investigator in a strong position to influence the policies and activities of the applicant organization? Is an appropriate array of skills represented for all the aims and for evaluation and dissemination? Are time commitments sufficient to accomplish the aims? Are roles clearly delineated and complementary? (5) ENVIRONMENT: Will the health care environment in which the proposed work will be done contribute to the probability of success? Do the proposed interventions take advantage of unique features of the health care and medical practice environment or employ useful collaborative arrangements? Is there evidence of institutional support? Are participant organizations investing their own resources sufficiently to show commitment and the likelihood of sustained improvement? Are stakeholders, including institutions, clinicians, patients, and the wider community, adequately involved in planning, carrying out, and evaluating the quality improvement activities proposed? For supplemental bioterrorism projects, the partners should demonstrate how their work will complement ongoing state and federal initiatives to improve preparedness. (6) BUDGET: Is the budget appropriate to the work proposed? Are suitable amounts included for travel to attend two Rockville meetings per year (and to host one meeting in one year)? Are data collection activities apportioned according to instructions, with the grant to support only planning, development, and analysis? Are dedicated grantee resources sufficient to ensure commitment on the part of key participants? For supplemental bioterrorism projects, can the partners justify the additional use of resources for a focused activity related to bioterrorism preparedness that is distinct from other core partnership activities? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, in terms of protecting privacy, disclosing risk, obtaining informed consent, and guarding against harm or injury. If applicable, the adequacy of protection for the environment, to the extent it may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to address the needs of both genders, all 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 sec6tion on Special Requirements, above, and Inclusion Criteria included in the section on Agency policies and Requirements, below.) DATA SHARING 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 patient-related 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), are scheduled to be effective and enforceable in April 2003. These regulations serve to limit the disclosure of personally identifiable patient information and define when and how such information can be disclosed. Thus, for example, health care plans and providers will require either patient authorization of disclosures of identifiable information to be made to researchers who are not their health care providers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) upon being satisfied that any identifiable health information will be appropriately safeguarded by the investigators. Additional information about the regulations and their implementation can be obtained from: http://www.aspe.hhs.gov/admnsimp/ 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, data bases, 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 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 Health Care Information 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.access.gpo.gov/nara/cfr/index.html). RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 20, 2002 Application Receipt Date: July 17, 2002 Peer Review Date: September 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA In making decisions about awards, AHRQ will take into account funds available, technical merit as determined by scientific peer review, potential impact (numbers of patients or size of population, disease burden reduced, breadth of geographic area), geographic balance, and balance in targets, types of approaches, or change agents. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN STUDY POPULATIONS: It is the policy of AHRQ that women and members of minority groups be included in all AHRQ- supported 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 project. All applicants proposing projects 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. Applicants 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 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 and under FOIA, 5 USC 552(b), disclosure of 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. However, courts have generally not regarded a researcher"s interest in "his" data as proprietary. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. 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 think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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, 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. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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. Institute of Medicine, 2000. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy of Sciences. 2. Davis DA, Thomson MA, Oxman AD, Haynes RB (1995, Sep 6). Changing physician performance. A systematic review of the effect of continuing medical education strategies. JAMA. 274(9):700-5. 3. Eisenberg JM (2001). The Agency for Healthcare Research and Quality and the U.S. Preventive Services Task Force. Public support for translating evidence into prevention practice and policy. American Journal of Preventive Medicine, 20 (3S): 1-2. 4. Thomas MA, Oxman AD, Davis DA, Haynes RB (1998). Audit and feedback to improve health professional practice and health care outcomes (Parts I and II): The Cochrane Library. 5. Soumerai SB, McLaughlin TJ, Gurwitz JH, and others (1998). Effect of local medical opinion leaders on quality of care for acute myocardial infarction: a randomized controlled trial. JAMA 179 17:1358-63. 6. Institute of Medicine (2001). Envisioning the National Health Care Quality Report. Washington, D.C.: National Academy of Sciences, pages 58 and 61). 7. U.S. Preventive Services Task Force (1996). Guide to Clinical Preventive Services, Second Edition. Washington, D.C.: U.S. Department of Health and Human Services, available on the Web at http://www.ahrq.gov/clinic/uspstfix.htm#review). 8. Grol R (2001). Improving the Quality of Medical Care: Building Bridges Among Professional Pride, Payer Profit, and Patient Satisfaction, 2001 November, JAMA 286(20): 2578-2691. 9. Rogers, EM (1983). Diffusion of Innovations, New York, The Free Press. 10. IOM, Crossing the Quality Chasm, Chapter 8, pp. 193-219. 11. Allison J, Kiefe CI, Weissman NW (1999, Jan.). Can data-driven benchmarks be used to set the goals of Healthy People 2010? Am J Public Health, 89(1):61-5. See also, on the Website for Healthy People 2010, the ABC toolkit: http://www.health.gov/healthypeople/state/toolkit.

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