TRANSFORMING HEALTHCARE QUALITY THROUGH INFORMATION TECHNOLOGY (THQIT) PLANNING GRANTS RELEASE DATE: November 20, 2003 RFA Number: RFA-HS-04-010 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) National Institutes of Health (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Library of Medicine (NLM) (http://www.nlm.nih.gov) 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: 93.226, 93.879 LETTER OF INTENT RECEIPT DATE: February 6, 2004 APPLICATION RECEIPT DATE: April 22, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the RFA o Program 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 THE RFA The Agency for Healthcare Research and Quality (AHRQ) announces the availability of planning grants to assist healthcare systems and their partners in planning for activities that will lead to successful implementation of health information technology (HIT) to promote and improve patient safety and the quality of healthcare. The objective of this Request for Applications (RFA) is to support community-wide planning processes across multiple healthcare organizations within a local or regional area that will enable them to develop HIT infrastructure that provides for effective exchange of health information within the community. Successful planning efforts should also allow them to compete for future funding for implementation activities. Applicants may use these funds for planning development of important infrastructure components including, but not limited to, computer networks, hardware, software, personnel, project management, and quality improvement and research capacity. AHRQ is particularly interested in supporting community-wide collaborative partnerships that include acute care hospitals, clinics, health care providers, and other health delivery organization (e.g., public health) that will also help to provide effective HIT tools for immediate access to complete and timely health care information in diverse health care settings (e.g., ambulatory care, long-term care - including home health) that involve all AHRQ identified priority populations. Through this initiative, AHRQ seeks to support collaborative planning processes that will result in standards-based data sharing across multiple care sites and lead to measurable and sustainable improvements in patient safety and quality of care. 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. It is anticipated that after completion of these planning grants, recipients will be in a position to compete for subsequent AHRQ funding in Fiscal Year (FY) 2005 (contingent upon funding availability) that will assist them to implement HIT successfully in their organizations and measure its impact on patient safety and both the quality and costs of care. This RFA includes an area of special emphasis with a portion of the total funding specifically set aside for projects involving rural and small hospitals and communities. This RFA is one in a series of solicitations to be issued by AHRQ in FY 04 on the use of HIT to improve patient safety and quality of care. The solicitations form an integrated set of activities designed to explore strategies for successful planning and implementation of HIT solutions in communities and to demonstrate the value of HIT in patient safety and both quality and costs of care. The FY 04 HIT initiative will place particular emphasis on the challenges facing rural and small communities in integrating HIT into their healthcare delivery systems. In addition to this RFA, other grants and contracts to be released as part of this program include: 1. Transforming Healthcare Quality Through Information Technology (THQIT) Implementation Grants - a series of implementation grants to evaluate the effects of HIT on improving patient safety and both quality and cost of healthcare. The objective of this RFA is to support implementation and diffusion of HIT information exchange and sharing and to assess the extent to which HIT contributes to measurable and sustainable improvements in patient safety and both quality and costs of care. Research resulting from this RFA should inform AHRQ, providers, patients, payers, policy makers, and the public about how community-wide HIT can be successfully implemented in diverse health care settings and lead to safer and better health for all Americans. 2. Demonstrating the Value of Health Information Technology Grants - This RFA will focus on the value derived from the adoption and utilization of HIT to improve patient safety and quality of care. This RFA will solicit proposals to elucidate and quantify the value of HIT to providers, patients, purchasers, payers, policymakers, and other important stakeholders. Research resulting from this RFA should provide important information on the direct and indirect costs and benefits of HIT and inform decision makers about facilitators and barriers to HIT adoption, including various forms of incentives and disincentives. 3. Health Information Technology Resource Center - The center will provide technical assistance to grantees; serve as a repository for best practice assimilation and diffusion; help develop, maintain and export executable knowledge for clinicians and patients; offer expert HIT support for providers and communities; perform and sponsor educational activities; and develop and disseminate tools to help providers and organizations utilize HIT to improve patient safety and quality of care in their communities. PROGRAM OBJECTIVES Background In the Institute of Medicine’s report, Crossing the Quality Chasm (Institute of Medicine 2001), the members of the institute, among other things, recommend: Congress, the executive branch, leaders of health care organizations, public and private sector purchasers, and health informatics associations and vendors should make a renewed national commitment to building an information infrastructure to support health care delivery, consumer health, quality measurement and improvement, public accountability, clinical and health services research, and clinical education. This commitment should lead to the elimination of most handwritten clinical data by the end of the decade. In particular, HIT was identified as a critical environmental force that could significantly improve healthcare quality. Further the IOM, the National Committee on Vital and Health Statistics, and the President’s Information Technology Advisory Committee have also recommended the development of a National Health Information Infrastructure to assist other efforts in improving safety, reducing cost and enhancing the quality of healthcare. In July 2003, AHRQ convened a diverse group of approximately 50 experts who helped the Agency to identify gaps in knowledge relating to the use of HIT and provided recommendations on important thematic areas for AHRQ’s HIT initiatives in FY 2004. Among the panel’s many recommendations were the need for more research on the impact of HIT on important health-related outcomes; more research on HIT in diverse healthcare settings; the need to support local and regional HIT collaborative projects that would lead to standards- based data sharing across healthcare delivery sites; the need to demonstrate the value of HIT in improving patient safety and quality of care, including direct/indirect and tangible/intangible benefits; the need to study incentives and disincentives to the adoption and use of HIT; the need for technical assistance to providers, organizations, and communities in order to implement HIT successfully in their environment; and the need to develop and disseminate evidence-based, executable knowledge content and decision-support tools to support clinical decision-making. The panel also encouraged collaboration between AHRQ and other Federal agencies, such as the Office for Rural Health Policy (OHRP) and the Office for the Advancement of Telehealth at the Health Resources and Services Administration (HRSA) and the Center for Medicare and Medicaid Services (CMS), to leverage the resources, expertise, and experiences of these diverse federal agencies and increase the program’s success. Finally, the panel stressed the need for developing collaborative partnerships and HIT programs that are viable and sustainable. A summary of the proceedings is available on the AHRQ website at http://www.ahrq.gov/data/hitmeet.htm. As part of the Agency’s FY 2004 patient safety activities, AHRQ is investing $50 million to demonstrate HIT’s role in patient safety and quality of care in a portfolio of grants, contracts and other activities. Of this amount, $26 million is earmarked for planning and implementing effective technologies in rural and small hospitals, where HIT penetration has been low. The remaining $24 million is targeted for planning, implementation and evaluation of new and innovative technologies in communities and other settings to improve patient safety and quality of care in diverse healthcare settings. This RFA makes available $7 million of the total $50 million investment. As healthcare has become increasingly complex, attention has turned to the role of information and communication technology as a means to improve clinical decision-making, patient safety, and overall quality of care. Over the past 30 years, research has demonstrated that HIT can improve patient safety and quality of care. For example, at LDS Hospital in Salt Lake City, a computerized physician order entry (CPOE) system with decision support reduced the incidence of adverse drug events related to antibiotic administration by 75% [4]. It also significantly reduced orders for drugs for which patient’s records reported allergies and adverse effects that were caused by antibiotics [5]. At the Regenstrief Institute for Health Care in Indianapolis, researchers demonstrated that automated computerized reminders increased orders for recommended interventions from 22% to 46% [6]. At the Brigham and Women’s Hospital in Boston, use of a CPOE system with decision support led to increased use of appropriate medications for high-risk clinical situations, such as an increase in the use of subcutaneous heparin to prevent venous thromboembolism, from 24% to 47%. Medication errors were also reduced by 19% to 84% [7]. A 1998 systematic review of the literature that assessed the effects of 68 computer-based clinical decision support systems demonstrated a beneficial, though variable impact on physician performance in 43/65 studies (66%) and a beneficial effect on patient outcomes in 6/14 studies (43%) [8]. Despite these successes, penetration of HIT has grown at a disappointingly low rate, especially in the non-inpatient clinical setting. Although accurate data are not available, it is estimated that less than 10% of facilities across the United States have comprehensive HIT systems in place and use them regularly to provide clinical care. Healthcare organizations, providers and organizations face many challenges in adopting HIT, including the lack of financial incentives for HIT investment, a reimbursement system that does not reward improved outcomes and safe high- quality care, multiple competing priorities, effects on clinical workflow, medical or organizational traditions and other cultural barriers, lack of effective leadership, and lack of HIT standards and interoperable systems. In order to successfully implement HIT, organizations will have to address most of these barriers. Other barriers, such as the lack of standards or the lack of reimbursement for HIT infrastructure, may be beyond the immediate control of the organization or community, but these may change over time as a result of ongoing efforts such as the Federal initiatives to develop/adopt national standards for the exchange of health information, research and demonstration projects on the effects of financial incentives and additional research that demonstrates the beneficial effects of HIT at the provider, organizational, and community levels on patient safety and quality of care. The objective of this RFA is to support planning grants to assist healthcare provider organizations and their partners to plan for activities that will lead to successful implementation of HIT to improve patient safety and quality of care. This grant program will support community-wide planning processes across multiple healthcare organizations and delivery systems that will enable them to develop their HIT infrastructure and data sharing capacity with other provider organizations and allow them to compete for future Agency HIT implementation funding. The National Library of Medicine (NLM) provides grant support to health-related institutions and organizations for projects to plan, design, test and deploy systems and techniques for integrating data, information and knowledge resources into a comprehensive networked information management system. NLM supports these organizations in their efforts to build integrated advanced information managements systems (IAIMS). IAIMS are computer networks that link and relate the published biomedical knowledge base with individual and institutional databases and information files, within and external to an institution. The long-term goal of an IAIMS is a comprehensive and convenient information management system, one that brings useful, usable knowledge to action settings in health care, education and research, binding knowledge to effective action. Particular emphasis is placed on mechanisms that enable the easy flow of information between arenas of action, such as between health care and education, or between health-related organizations, such as from a community clinic to a hospital or public health department. Of particular interest to NLM are projects which focus on context-appropriate information to guide learning and decisions; standards based information management that employs standard vocabularies and information exchange protocols; and digital libraries. Definitions For purposes of this RFA, the following definitions will apply: 1) Health Information Technology is broadly defined as the use of information and communication technology in healthcare and includes, but is not limited to, 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. 2) Electronic Health Record Systems are defined by the Institute of Medicine’s Letter Report on the Key Capabilities of an Electronic Health Record System http://www.iom.edu/report.asp?id=14391. EHR systems will include the ability to collect longitudinal data for and about a person in an electronic format; immediate electronic access to person and population level information by authorized users; provision of knowledge and decision-support tools that enhance the safety, quality and efficiency of health care; and support of efficient processes for health care delivery. 3) Clinical decision support systems (CDSS) are defined as computer applications that assist clinicians in the management of their patients at the point-of-care by integrating medical knowledge with patient characteristics and generating patient-specific recommendations. CDSS can take the form of computerized reminders, alerts, guidelines, order sets or other such tools. 4) Health Information Technology Value is defined as the sum of financial, clinical, and organizational advantages or benefits derived from the adoption, diffusion, and utilization of HIT less the costs of achieving these benefits. o Financial Benefits include cost reduction, revenue enhancement and productivity gains. o Clinical Benefits include advances in care processes, improved patient outcomes (improvements in safety and quality), and better monitoring of diseases and other health risks. o Organizational Benefits include improvements in organizational effectiveness as evidenced in work and quality assurance/improvement processes, communication among individuals, groups and organizations; satisfaction of needs and expectations of patients, providers, and stakeholders; capacity to adapt to changing technical and operating conditions, such as fluctuations in patient load, acuity, and emergency conditions; and organizational risk mitigation. 1) Patient Safety refers to the absence of the potential for, or occurrence of, healthcare associated injury to patients. Patient safety can result from the avoidance of medical errors as well as taking action to prevent errors from causing injury. AHRQ patient safety activities involve four major components: identifying threats; identifying and evaluating effective practices; education dissemination, and implementation interventions that enhance patient safety; and maintaining vigilance. 2) Medical Errors are defined as mistakes made in the process of care that result in, or have the potential to, result in harm to patients. Mistakes include the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Medical errors can result from an action that is taken (error of commission) or an action that is not taken (error of omission). 3) Medication Error is defined as preventable inappropriate use of medication including prescribing, dispensing, and administering. 4) Adverse Event is defined as an untoward, unintended (usually), and unanticipated (usually) outcome that occurs in association with health care. Preventable adverse events are a subset of adverse events that are judged to have been avoidable if appropriate and reasonable steps had been taken. For example, an anaphylactic reaction to penicillin is an adverse event. It is a preventable adverse event if the patient’s allergy to penicillin is noted in his or her chart or if the patient knows of his or her history of penicillin reactions and is capable to communicating it to the clinician. 5) Preventable Injury is defined as harm that could be avoided through reasonable planning or proper execution of an action. 6) Quality is defined as doing the right thing, at the right time, in the right way, for the right person, and having the best possible results. Quality of care should strike the right balance in the provision of health services by avoiding overuse (e.g., getting unnecessary tests or procedures), underuse (e.g., not being screened for high blood pressure or not being treated with a beta-blocker when clinically indicated), or misuse (e.g., being prescribed drugs that have dangerous interactions or being given the wrong dose of a medication). 7) Healthcare Environment is defined as the structures and processes employed to provide healthcare. They reflect the characteristics of the facility (e.g., size, location, specialty, licensure, certification, equipment, working conditions); and the organization (e.g., personnel mix and experience, lines of authority, leadership, policies and procedures, governance, culture). 8) Rural Hospitals are defined as acute care hospitals physically located in a rural or nonmetro area within the borders and confines of any state or U.S. territory. 9) Rural and/or nonmetro areas are defined as geographic regions that either: Reside within a county or area not designated by the Office of Management and Budget as a Metropolitan Statistical Area (MSA) or Metropolitan New England City or Town Area (MNECTA). http://www.census.gov/population/estimates/metro-city/03msa.txt or Reside within a nonmetro region of an MSA or MNECTA designated county or area as defined by the Economic Research Service (ERS) of the United States Department of Agriculture (USDA) Rural-Urban Commuting Area codes (RUCA). Nonmetro areas will be defined by a RUCA code of between 4 and 10. http://www.ers.usda.gov/briefing/Rurality/RuralUrbanCommutingAreas/ 1) Small Hospitals are defined as acute care hospitals containing no more than 100 licensed beds or fewer than 6,000 inpatient admissions in the most recent 12-month period. 2) Acute Care Hospitals are defined as short-term hospitals with the facilities, medical staff and all necessary personnel to provide diagnosis, care and treatment of a wide range of acute conditions, including injuries. 3) Partnerships are defined as a collaborative working relationship between three or more organizations formalized through one or more written agreements that contain at a minimum the following elements: a) substantial and meaningful contributions of personnel, expertise, money, equipment, facilities or other important resources to and from each of the partners; and b) sharing of clinical and research data across healthcare delivery sites. AHRQ is seeking applications from partnerships (as described above) involving three or more organizations that are interested in obtaining grant funding to help them develop and implement a formal and detailed plan for the adoption of HIT in their organizations and the community. AHRQ is specifically interested in supporting local or regional collaborative partnerships involving multiple organizations (e.g., community hospitals, academic hospitals, local public health department, outpatient clinics, community health centers) and various healthcare settings (e.g., hospital inpatient, ambulatory care, long-term care, home health care). The Agency encourages HIT research that incorporates training and educational settings. HIT has been implemented in a variety of educational settings such as rural residency training sites and many healthcare professional trainees are being introduced to HIT in a variety of clinical settings. This type of educational exposure and adoption may have a substantial lasting impact on these trainees and may demonstrate even greater value in healthcare quality improvement. For organizations that qualify as rural or small hospitals or communities, the lead partner must be an acute care hospital. For all other applications, an acute care hospital must be included as one of the partners. The long- term objective of each partnership should be to develop a viable and sustainable plan for HIT implementation within eighteen months of receiving the award. Applicants may use these funds for the planning and prototype development of important infrastructure components including, but not limited to, community-wide collaborative organizations, information-sharing agreements, business and financial plans, information architecture, health information access and exchange systems, computer networks, hardware, software, personnel dedicated to grant activities, project management, and research capacity. However, no more than 20% (or a maximum of $40,000) of the Federal grant funds may be used for purchasing hardware or software. During the planning period, each award recipient will be required to develop a plan for HIT implementation that includes the following (at a minimum): 1. Specification of clinical and organizational needs that can be met through HIT. 2. Assessment of feasibility of HIT implementation including identifying barriers and ways to address them. 3. Defining basic project parameters. 4. Development of implementation plan, including organizational, governance, and financial components. 5. Specify procedures for ongoing program evaluation and feedback. Specific required planning activities to be accomplished with funding through this RFA are listed below, by the areas of focus: 1. Specification of clinical and organizational needs that can be met through HIT: o Identify partnership organizational goals and needs that can be met by HIT. o Explain how HIT will meet these needs and enable the accomplishment of objectives (show causal linkages between HIT and desired improvements). o Discuss the factors that indicate the partnership organization is prepared to take the steps necessary to achieve its HIT implementation goals. 2. Assessment of feasibility of HIT implementation including identifying barriers and ways to address them: o Define resources available to support implementation. o Identify potential barriers to implementation and ways to address them. - Financial - Technical - Organizational - Personnel (knowledge, skills, language, readiness and attitudes toward HIT) - Procedural (rules, payment procedures, regulations) 3. Define basic project parameters: o Specify desired outcomes of adopting HIT o Specify clinical and organizational practices that will change with introduction of HIT; explain how they will change and lead to desired outcomes o Indicate how people, units, and organizations will be involved o Assign responsibilities and discuss available resources for implementation activities o Describe anticipated funding of implementation and subsequent operation of HIT o Identify expertise needed to support HIT implementation and maintain long-term sustainability o Specify time frame for main stages of the project (planning, transition, full implementation) 4. Development of implementation plan o Assign tasks, responsibilities, and performance standards for implementing and sustaining HIT o Define and establish new organizational entities required, including appropriate multi-institutional governance mechanisms o Develop detailed budget o Set timeline for implementation 5. Specify procedures for ongoing project evaluation and feedback o Develop a formal plan for the ongoing monitoring and evaluation of the projects progress throughout the duration of the grant including identification of specific timelines and milestones. o Designate an individual (or committee) to monitor project progress and evaluate its success. The responsibility for directing the planning and development effort should be assigned to an experienced senior level person familiar with managing organizational change and program implementation. This person should devote a significant proportion (30% or more) of his/her time to this endeavor. The collaborative may also choose to have an internal planning committee to assist the planning director. The committee will at a minimum be comprised of at least one representative from each of participating organizations. The director/planning committee should evaluate the current strengths and weaknesses in the key areas needed for successful HIT implementation and consider all available resources in the planning process. Appropriate consultants may be called upon to assist. The total project period for an application submitted in response to this RFA may not exceed 12 months. It is anticipated that after successful completion of these planning grants, awardees will be in a position to compete for subsequent implementation grants from the Agency, contingent upon the availability of funds. The application must provide a set of long-term outcome goals and explicitly state how the project will support the achievement of these goals. For example, AHRQ’s long-term goals for the overall HIT initiative include the following: o Successfully deploy or enable the deployment of hospital HIT practices that reduce medical errors and improve overall patient safety; o Increase the identification and reporting of medical errors and adverse events; o Decrease in the number of actual errors and adverse events; o Increase the number of hospitals utilizing CPOE with CDSS to reduce medication errors; o Increase the number of non-hospital providers utilizing CPOE with CDSS and EHRs. In addition, the application must address how the applicant will monitor their progress toward the goal(s) they specify and how those goals further the accomplishment of the agency goals. MECHANISM OF SUPPORT This RFA will use the P20 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 this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award start date is September 30, 2004. AHRQ is not using the Modular Grant Application and Award Process. Projects funded under this RFA are considered part of the AHRQ HIT portfolio. As part of its FY 2004 HIT initiatives, AHRQ intends to establish a Health Information Technology Resource Center (HITRC). The HITRC will provide awardees with technical assistance to help them with their planning and implementation strategies, including an evaluation of the outcomes resulting from the planning process. FUNDS AVAILABLE AHRQ intends to commit up to $7 million in FY 04 to fund up to 35 new grants in response to this RFA. It is anticipated that up to $5 million of these funds will be used to support applicants from rural and small communities. An applicant may request a project period of up to 12 months and a budget of up to $200,000 in total costs. Awards will be made in a single funding cycle spanning up to 12 months. Because the nature and scope of the proposed project will vary from application to application, it is anticipated that the size and duration of each award will vary. No more than 20% (or a maximum of $40,000) of the Federal grant funds may be used for purchasing hardware or software. ELIGIBLE INSTITUTIONS Institutions are eligible to submit applications if they are domestic, non- profit and included in any one of the following categories: o Domestic institutions o Public and private non-profit institutions o Units of State and local governments o Tribes and Tribal governments o Foreign institutions are not eligible to apply o Faith-based organizations For the purpose of this RFA, AHRQ will award grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors. Organizations described in sections 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. Practice-based research networks, such as Integrated Delivery Systems Research Networks (IDSRNs) and Primary Care Practice-Based Research Networks (PBRNs) are eligible and encouraged to apply. The ISDRNs are a model of field-based research that links the health care researchers with large health care systems to conduct research on cutting-edge issues in health care on an accelerated timetable. A PBRN is a group of practices devoted to the primary care of patients to investigate questions related to community-based practice. Institutions and partnerships which provide a substantial amount of safety net care to uninsured and Medicaid patients are encouraged to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed planning activities is invited to work with their institution to develop and submit an application. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs. SPECIAL REQUIREMENTS AHRQ is committed to supporting public-private partnerships that will result in interoperable, standards-based data sharing across multiple care sites and lead to measurable, generalizable and sustainable improvements in patient safety and quality of care. Where applicable, Planning Directors are encouraged to use federal health information interoperability standards that have been proposed by the Federal Government’s Consolidated Health Informatics (CHI) Initiative and the National Committee on Vital and Health Statistics (NCVHS), and adopted by the Secretary of the U.S. Department of Health and Human Services (HHS). NCVHS is a federal advisory committee to the Secretary on health data and information policy. CHI is a collaborative effort between the HHS, the Veterans Affairs/Veterans Health Administration, the Department of Defense, and other Federal agencies to adopt government- wide health information standards for implementation into the Federal IT architecture. The first set of CHI standards were adopted by the HHS Secretary on March 21, 2003 and include: Health Level 7 (HL7) messaging standards; Logical Observation Identifier Name Codes (LOINC) to standardize the electronic exchange of clinical laboratory results; National Council on Prescription Drug Programs (NCDCP) standards for retail pharmacy transactions; Institute of Electrical and Electronics Engineers 1073 (IEEE1073) standards that allow for health care providers to plug medical devices into information and computer systems; Digital Imaging Communications in Medicine (DICOM) standards that enable retrieval and transfer of images and associated diagnostic information. More information on CHI can be found at: http://www.whitehouse.gov/omb/egov/gtob/health_informatics.htm. Information on NCVHS may be found at http://www.ncvhs.hhs.gov. Projects funded under this RFA are considered part of the AHRQ HIT portfolio. As part of its FY 2004 HIT initiatives, AHRQ intends to establish a Health Information Technology Resource Center (HITRC). The HITRC will provide awardees a variety of services, including coordinating the activities of awardees across all of the HIT patient safety RFAs. All awardees under this RFA are expected to participate in the activities of the HITRC, including participation in periodic conference calls and an annual meeting of all awardees in the Washington, D.C. area. The Principal Investigator and at least one key program staff member from the project are required to attend the annual meeting. Travel to the annual meeting should be included in the project’s budget. 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 AHRQs HIT and patient safety initiative. These collaborative relationships can be either self- initiated by the awardee, in conjunction with the HITRC or via mechanisms developed during the life of the project. RAND is under contract to AHRQ to serve as its Patient Safety Evaluation Center. RAND’s evaluation contract activity 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. This work is being accomplished by characterizing AHRQ’s (1) progress in achieving its goals, (2) effects on clinical outcomes of patient safety interventions undertaken within the patient safety initiative, and (3) diffusion of new knowledge and practices beyond AHRQ patient safety initiative participants. The RAND team will conduct interviews with all researchers directing the funded patient safety grants and will conduct site visits to a few projects that are field testing new interventions. Full cooperation with the RAND evaluation team is a requirement for receiving AHRQ HIT patient safety grant support. Arbitration Any disagreements 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 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 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. 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 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, 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. 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 the original and 2 copies of an abstract, executive summary, and full report of the results in the format prescribed by AHRQ no later tan 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 uses (WP5.1 or WP6.0 is preferable). 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 three areas: scientific/research, 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: Lisa Dolan-Branton, R.N. Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: 301-427-1588 FAX: 301-427-1595 Email: ldolan@ahrq.gov o Direct your questions about peer review issues to: Patricia Thompson Office of Research Review, Education, and Policy Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1556 FAX: (301) 427-1561 Email: pthompson@ahrq.gov o Direct your questions about financial or grant management matters to: George Skip Moyer Grants Management Specialist Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1452 FAX: (301) 427-1464 Email: smoyer@ahrq.gov o Direct your questions about NLM scientific/research interests to: Valerie Florance, PhD Extramural Programs National Library of Medicine 6705 Rockledge Drive, Suite 301 Bethesda, MD 20892 Telephone: (301) 594-4882 FAX: 301 402-2952 Email: floranv@mail.nlm.nih.gov o Direct your questions about NLM financial or grants management matters to: Dwight Mowery Extramural Programs National Library of Medicine Rockledge 1, Suite 301, 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 496-4221 FAX: (301) 402-0421 Email: moweryd@mail.nlm.nih.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 project o Name, address, and telephone number of the Principal Investigator o Names of the other key personnel o Participating institutions o Number and title of this RFA Although the 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 AHRQ and IC staff to estimate the potential review workload and plan for 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: Lisa Dolan-Branton, R.N. Agency for Healthcare Research and Quality CP3, Room 6103 540 Gaither Road Rockville, MD 20850 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 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. To ensure equity among applicants, however, applicants using this form must observe page number and font size requirements specified in the Form PHS 398. 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. SUPPLEMENTARY INSTRUCTIONS Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Program (HCUP). 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 of about 1000 hospitals. The State Inpatient Databases (SID) contains 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 form the Health Resources and Services Administration’s Area Resource File and to hospital- level data from the Annual Survey of the American Hospital Association. This does not preclude the use of secondary data sources or primary data collection. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications according to instructions provided in form PHS 398. Applications submitted in the Modular format will be returned without review. SENDING AN APPLICATION TO THE NIH and AHRQ: Submit a signed, typewritten 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 "Advanced Copy" must also be sent to: Lisa Dolan-Branton, R.N. Agency for Healthcare Research and Quality CP3, Room 6103 540 Gaither Road Rockville, MD 20850 Telephone: 301-427-1588 FAX: 301-427-1597 Email: ldolan@ahrq.gov SPECIAL APPLICATION REQUIREMENTS: Application Preparation Complete information about the proposed planning effort must be submitted with the application. The narrative portions of the application, described below under Research Plan, should be limited to twenty-five pages of text. The application should be a complete document that includes all essential information necessary for its evaluation. While additional explanatory material may be submitted as appendices, such appendices should not be used to bypass page limitations in the application because only selected reviewers will receive copies of the appendices. Since the form PHS 398 was developed for research grant applications, the following supplemental instructions should be used as a guide in the preparation of the application. The following supercede the PHS 398 instructions. 1) Under Performance Sites (page 2), list only the official name and address of the lead partner. A complete listing of the other partners should be attached to the application as an appendix. 2) Detailed Budget. In general, allowable budget items for these planning and development grants are limited to a portion of the salaries of the planning director, consultation fees, key administrative and clerical support personnel, as allowed by the appropriate Federal cost principals, travel and per diem expenses for outside consultants/advisors, and supplies. The budget should include travel and per diem expenses for the planning director and/or other key personnel to be attend one meeting in Washington, D.C. with AHRQ and HITRC staff. The level of effort of personnel should reflect the commitment of the individual to the planning process. The purchase of equipment, including computer hardware and software, is limited to 20% of the total grant. All budget requests should be well justified. Budget requests submitted under this part of the RFA should not exceed $200,000 in total costs. Applications submitted with budget requests that exceed $200,000 in total cost will be returned without review. Cost sharing or matching are not required of applications submitted in response to this RFA. 3) Biographical Sketches. Include in this section a biographical sketch of the planning director (equivalent of Principal Investigator) and other key personnel to be involved in the planning effort. 4) Resources available to the partnership should be described once, either in a separate section following the biographical sketches or included in the narrative text (see below). Research Plan. This narrative part of the application should contain the following elements: Section I. Partnerships a) Description of the existing or planned partnership. Describe the organizations and their role in the partnership. Discuss the contribution of resources from each organization in the partnership. Include as an attachment any memorandum of understanding or agreement (MOU/A) between the partners. b) Current or proposed infrastructure supporting the partnership. Describe and discuss the existing or planned infrastructure that supports the implementation effort. This discussion (which may alternatively be included in the Resources section of the application) should include details of any computer-based or other information systems currently in use (or planned). The current, or proposed, director and any support staff should be identified, including a description of their qualifications and source of salary support (if any). Senior officials of participating organizations should, in addition to the above mentioned MOU/A, provide a letter documenting support for the proposed planning and development process. These and other letters of support should be included as an appendix and referenced in this section of the application. c) Progress to date in developing HIT infrastructure. Include a summary of other HIT planning activities completed to date, including a summary of decisions and their underlying rationale. Applicants should also include discussions of the partnership’s current status for each of the Areas of Focus. Section II. The Proposed Planning Effort a) Description of the planning director and his/her responsibilities and authority to carry out the proposed planning process. Discuss the selection of this individual as planning director (equivalent of principal investigator) and his/her future role in the partnership. This section should present an adequate description of his/her qualifications and administrative experience. b) Description of the planning committee. If an internal planning committee is being proposed, list and discuss the membership. List any external consultants to the planning committee. c) Description of other key personnel and their duties. Discuss the selection and duties of the key personnel supporting the planning director and planning committee. d) Description of issues that will need to be resolved through the planning and development process and strategies to overcome them. Discuss the issues/obstacles that must be considered in the planning and development process. e) Detailed description of the planning proposed. Include discussions of the proposed approach to planning activities and basic project parameters for each of the Areas of Focus. f) Discussion of partnership’s future plans to implement and evaluate HIT activities. Applications submitted under this RFA must be received by April 22, 2004. An application received after the deadline may be acceptable if it carries a legible proof-of-mailing date, assigned by the carrier, and the proof-of- mailing is not later than one week prior to the deadline date. If an application is received after that date, it will be returned to the applicant without review. APPLICATION PROCESSING Applications must be received on or before the application 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made and the text must not be marked to indicate the changes from the previous unfunded version of the application. 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). Application Preparation (for Using CMS Data) Purchase of 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 Center for Medicare and Medicaid Services (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. 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 2 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. TECHNICAL ASSISTANCE: AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. This two hour conference call will provide potential applicants with background information and respond to questions about the preparation of an application in response to this RFA. 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 HITPlanningRFA@AHRQ.gov by January 20, 2004. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying. The conference call will take place on January 22, 20043 at 1:00 p.m. EST and last approximately 2 hrs. The last hour of the call will be reserved exclusively for issues relevant to small community and rural applicants. To register to participate in the call, please send your request to HITPlanningRFA@AHRQ.gov by January 20, 2004. Transcripts of the conference call will be available seven business days after the call. Please send your request for a copy of the transcripts to HITPlanningRFA@AHRQ.gov. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness by the Agency Referral Officer, program staff, and grants management staff. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant by the Agency Referral Officer without further consideration. 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 Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score o Receive a written critique REVIEW CRITERIA In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed project will have a substantial impact on the pursuit of the RFA’s goals: o Significance o Approach o Innovation o Planning Director o Environment o Budget The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does your project address an important gap or problem? If the aims of your application are achieved, how do they advance the general knowledge with regard to HIT diffusion and adoption? What will be the effect of your project on the concepts or methods that drive this field? To what extent will the proposed implementation activity involve populations of providers or patients most in need of HIT innovations? APPROACH: Are the conceptual framework, design, methods, and analysis adequately developed, well integrated to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? PLANNING DIRECTOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator? Does the study team contain appropriate experience? ENVIRONMENT: Does the environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the environment or employ useful collaborative arrangements? Is there evidence of institutional support? BUDGET: The proposed project budget and the requested period of support should be reasonable in relationship to the project. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: o PROTECTIONS: 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. o INCLUSION: The adequacy of plans to address the need 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 of Priority Populations in the section of Special Requirements, and Inclusion Criteria included in the section on Agency policies and Requirements, below). Finally, applications will be assessed in two additional areas: 1) technical merit of the proposed planning process; and 2) potential of the new or existing organization to implement its HIT plan. Peer reviewers will be asked to specifically comment in these two areas. The final priority scores will reflect the peer reviewer’s overall assessment based on their judgments of the two review areas. 1. The technical merit of the proposed planning process: a) Clarity and appropriateness of planning goals and objectives; b) Extent to which the application appropriately defines the problems that need to be resolved in the planning process; c) Extent to which the proposed detailed planning effort has clear and appropriate goals consistent with AHRQ’s stated goals and is of adequate scope with regard to the Areas of Focus; d) Qualifications of the proposed planning director to lead the planning and development effort and his/her leadership experience, administrative skills and research background; e) Qualifications and appropriateness of the key personnel designated to assist the planning director; f) Appropriateness of the membership and stated functions, as well as potential effectiveness, of the proposed internal planning committee (or advisors to the planning director), and, g) The adequacy of measuring the success of the planning process. 2. The potential of the organization to implement its HIT plan: a) Adequacy of the commitment of the members of the collaborative to implement HIT, as evidenced by previous work in HIT implementation or letters of support; b) Adequacy of the organization to address the healthcare of priority populations; c) Adequacy and stability of the organization’s administrative, organizational and management capabilities; and, d) Extent to which the award of grant funds will enhance the ability of the organization to plan future activities for implementing HIT. The reviewers will also examine the adequacy of the budget for the proposed project to achieve the projects goals. ADDITIONAL CONSIDERATIONS: 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 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. Thus, for example, health care plans, clearinghouses, and those providers who engage in HIPAA-covered electronic transactions 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. The HHS Office of Civil Rights (OCR) is the enforcement body for this regulation. 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 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). RECEIPT AND REVIEW SCHEDULE Technical Assistance Conference Call: January 22, 2004 Letter of Intent Receipt Date: February 6, 2004 Application Receipt Dates: April 22, 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS: 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 justifications 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). 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. Furthermore, even if a Federal regulation action is taken in reliance on such 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 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. 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. 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 Committee on Quality Health Care in America and Institute of Medicine (2001). Crossing the quality chasm: a new health system for the 21st century. Washington, DC, National Academy Press. Harrison, M. and A. Shirom (1999). Organizational Diagnosis and Assessment: Bridging Theory and Practice. Thousand Oaks, CA, Sage.

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