Source: http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-05-013.html
Timestamp: 2014-12-19 02:26:00
Document Index: 322571964

Matched Legal Cases: ['arts 160', 'arts 160', 'art 67', 'arts 74', 'art 92', 'art 67', 'art 50', 'art 16', 'arts 74']

RFA-HS-05-013: Limited Competition for AHRQ Transforming Healthcare Quality through Information Technology – Implementation Grants
Limited Competition for AHRQ Transforming Healthcare Quality through Information Technology – Implementation Grants RFA Number: RFA-HS-05-013 Part I Overview Information Department of Health and Human Services (DHHS) Participating Organizations
Center for Primary Care, Prevention, and Clinical Partnerships, (http://www.ahrq.gov)
National Library of Medicine (NLM), (http://www.nlm.nih.gov) Announcement Type
93.226, 93.879 Key Dates Release Date: November 24, 2004 Letters Of Intent Receipt Date(s): March 14, 2005
Application Receipt Dates(s): April 14, 2005
Peer Review Date(s): June, 2005
Earliest Anticipated Start Date: July, 2005
Expiration Date: April 15, 2005 Due Dates for E.O. 12372
Not Applicable Executive Summary The Transforming Healthcare Quality Through Information Technology (THQIT) program is aimed at improving health care quality and patient safety by promoting the development, adoption, and diffusion of health IT in a variety of important health care settings. This initiative will include a special focus on small and rural hospitals. This RFA will use the Cooperative Agreement (UC1) award mechanism. AHRQ intends to commit up to $7 million in FY 2005 to fund up to fourteen new grants in response to this RFA. This solicitation is the second announcement of the availability of implementation grants to evaluate the effects of health information technology (HIT) on improving patient safety and quality of healthcare initiated by the Agency for Healthcare Research and Quality in 2003, and applicants are limited to the current recipients of the initial THQIT planning grants( RFA-HS-04-010). Eligible project directors are individuals with the skills, knowledge and resources necessary to carry out the proposed implementation project and evaluation program. The objective of this Request for Applications (RFA) is to support organizational and community-wide implementation and diffusion of HIT and to assess the extent to which HIT contributes to measurable and sustainable improvements in patient safety, cost and overall quality of care. Research resulting from this RFA should inform AHRQ, providers, patients, payers, policy makers, and the public about how HIT can be successfully implemented in small and rural hospitals and other providers and lead to safer and better health for all Americans. Importance in this new competitive solicitation will be placed on HS-04-010 planning grant accomplishments and demonstration of the need for the continued support to carry out the Health IT Implementation Plan. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001; 9/2004 version after May 10). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Table of Contents Part I Overview Information Part II Full Text of Announcement Section I. Funding Opportunity Description 1. Research Objectives Section II. Award Information 1. Mechanism(s) of Support 2. Funds Available Section III. Eligibility Information 1. Eligible Applicants A. Eligible Institutions B. Eligible Individuals 2. Cost Sharing 3. Other - Special Eligibility Criteria Section IV. Application and Submission Information 1. Address to Request Application Information 2. Content and Form of Application Submission 3. Submission Dates A. Receipt and Review and Anticipated Start Dates 1. Letter of Intent B. Sending an Application to the NIH C. Application Processing 4. Intergovernmental Review 5. Funding Restrictions 6. Other Submission Requirements Section V. Application Review Information 1. Criteria
2. Review and Selection Process 3. Merit Review Criteria A. Additional Review Criteria B. Additional Review Considerations C. Sharing Research Data D. Sharing Research Resources Section VI. Award Administration Information 1. Award Notices
2. AHRQ Staff Responsibilities
3. Health Information Technology Resource Center
3. Award Criteria 4. Reporting Section VII. Agency Contact(s) 1. Scientific/Research Contact(s) 2. Peer Review Contact(s) 3. Financial/ Grants Management Contact(s) Section VIII. Other Information - Required Federal Citations Part II - Full Text of Announcement Section I. Funding Opportunity Description This solicitation is the second announcement of the availability of implementation grants to evaluate the effects of health information technology (HIT) on improving patient safety and quality of healthcare initiated by the Agency for Healthcare Research and Quality in 2003. Applications will only be accepted from current recipients of the initial Transforming Health Care Quality Through Information Technology (THQIT) planning grants (RFA-HS-04-010). The objective of this Request for Applications (RFA) is to support organizational and community-wide implementation and diffusion of HIT and to assess the extent to which HIT contributes to measurable and sustainable improvements in patient safety, cost and overall quality of care. Research resulting from this RFA should inform AHRQ, providers, patients, payers, policy makers, and the public about how HIT can be successfully implemented in diverse health care settings and lead to safer and better health for all Americans. From the THQIT planning grant solicitation (RFA-HS-04-010), released in Nov. 2003, 38 awards were made that cover a range of technologies and geography. Importance in this new competitive solicitation will be placed on HS-04-010 planning grant accomplishments and a demonstration of the need for the continued support to carry out the Health IT Implementation Plan.
Projects presented for consideration under this RFA should comply with the Agency's policy regarding the inclusion of priority populations in health services research (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). AHRQ priority populations include those who live in inner-city 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. 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 this RFA is one in a series of solicitations issued by AHRQ on the use of HIT to improve patient safety and quality of care, especially in small and rural health care settings. The solicitations form an integrated set of activities designed to explore strategies for successful organizational and community-wide planning and implementation of HIT solutions and to demonstrate the value of HIT in patient safety and quality of care. This RFA allows AHRQ to continue its investment in a subset of health care organizations and their partners to realize their plans for HIT implementation, as well as, to learn replicable lessons from this group of grantees. This RFA will continue to place particular emphasis on the challenges facing rural and small communities in integrating HIT into their healthcare delivery systems. Authorities and regulations under which these grants will be funded are described in Section VIII.
1. Research Objectives The complexity of modern medicine has increased tremendously as a result of the explosion in biomedical knowledge, rapid growth of pharmaceuticals, medical technology, and genetics, multiple demands on the time health care providers spend with patients, and mounting pressures to contain costs. This complexity, coupled with poorly designed and outdated healthcare delivery systems, has made it difficult for clinicians to provide safe, high-quality care on a consistent basis and has resulted in a healthcare system beset by medical errors, inappropriate practice variation, and suboptimal care. For example, in a recent RAND study [1], investigators found that only 55% of participants in a large random sample of the U.S. population received recommended care and led the authors to conclude, “The deficits we have identified in adherence to recommended processes for basic care pose serious threats to the health of the American public.” Similarly, in 1998 the Committee on the Quality of Health Care in America, established within the Institute of Medicine (IOM), was charged with identifying strategies for achieving substantial improvement in the quality of health care in America. The committee's first report, To Err is Human: Building a Safer Health System, was released in November 1999 and focused on issues relating to patient safety [2]. The study found that 44,000 to 98,000 people die in U.S. hospitals each year as a result of medical errors. In March 2001, the Committee released a follow-up report, Crossing the Quality Chasm: A New Health System for the 21 st Century, which addressed a broader range of quality issues and provided a strategic direction for redesigning the healthcare delivery system [3]. They reported that the U.S. healthcare system is plagued by serious quality problems resulting from an outmoded and inadequate delivery system, which is incapable of providing high-quality care to its population in a consistent manner. The Committee went so far as to state, “In its current form, habits, and environment, American healthcare is incapable of providing the public with the quality healthcare it expects and deserves.” In particular, HIT was identified as one of the four critical forces that could significantly improve healthcare quality. The Committee specifically said, “There must be 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.” In particular, HIT was identified as a critical environmental force that could significantly improve healthcare quality. In 2003 AHRQ sponsored the Institute of Medicine, Committee on Data Standards for Patient Safety to build on the IOM reports To Err Is Human and Crossing the Quality Chasm, and in November 2003, the IOM released Patient Safety: Achieving a New Standard for Care. Patient Safety puts forward a road map for the development and adoption of key health care data standards to support both information exchange and the reporting and analysis of patient safety data. They reported that to significantly reduce the tens of thousands of deaths and injuries caused by medical errors every year, health care organizations must adopt information technology systems that are capable of collecting and sharing essential health information on patients and their care. These systems should operate seamlessly as part of a national network of health information that is accessible by all health care organizations and that includes electronic records of patients' care, secure platforms for the exchange of information among providers and patients, and data standards that will make health information uniform and understandable to all. In recent years attention has increasingly 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 patients' 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 in healthcare settings. Although data are not available, it is estimated that less than 10% of facilities across the United States have comprehensive HIT systems in place or use them regularly to provide clinical care. Reasons for this paucity of investment in HIT are many fold, including the lack of financial incentives for HIT investment, lack of reimbursement based on quality outcomes for clinical services, clinical workflow delays, cultural barriers, and competing priorities. In July 2003, AHRQ convened a diverse group of approximately 50 experts who helped the Agency 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 to support local and regional HIT collaborative projects that would lead to standards-based data sharing across healthcare delivery sites, i.e., interoperable systems within communities; 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 by providers, organizations, and communities in order to implement HIT successfully in their environment; and the need to develop 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, like the Office for Rural Health Programs (OHRP) at the Health Resources and Services Administration (HRSA) and the Center for Medicare and Medicaid Services, 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. The objective of this limited competition RFA is to support implementation and diffusion grants which employ HIT in diverse health care delivery settings (including rural and small community) and assess the extent to which HIT contributes to measurable and sustainable improvements in patient safety and quality of care among the grantees of the initial THQIT planning grants (RFA-HS-04-010). As anticipated in the FY04 THQIT grant competition, the FY05 limited competition awards allow those planning grantees that have been able to substantially and successfully plot out their systems redesign efforts around HIT, to compete in fiscal year 2005 for funds to assist them to successfully implement HIT in their organizations and measure its impact. The specific minimum planning accomplishments required are listed in the Research Plan section of this announcement. Results from this implementation RFA should inform AHRQ, providers, patients, payers, policy makers, and the public about how HIT can be successfully implemented in these healthcare settings and lead to safer and better health for all Americans. As a co-sponsor, 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 the purposes of this RFA, the following definitions will apply: Health Information Technology is broadly defined as the use of computing, 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. 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 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 health care delivery. Clinical decision support systems (CDSS) are defined as computer applications that assist clinicians in the treatment and management for 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. Health Information Technology Value is defined as clinical, organizational, financial, or other benefits derived from the adoption, diffusion, and utilization of HIT – less the costs of achieving these benefits. Clinical benefits include advances in care processes, improved patient outcomes (improvements in safety and quality), and better monitoring of diseases and other health risks. Organizational benefits include improvements in organizational effectiveness – as evidenced in work and quality improvement processes; communication among individuals, groups and organizations; satisfaction of needs and expectations of patients, providers, and other stakeholders; capacity to adapt to changing technical and operating conditions, such as fluctuations in patient load, acuity, and emergency conditions; and organizational risk mitigation. Financial benefits include cost reduction, revenue enhancement and productivity gains. Patient Safety refers to the absence or reduction of injury associated with healthcare delivery to patients. Patient safety can result from the avoidance of medical errors as well as from taking action to prevent errors from causing injury. Essentially patient safety improvement is the reduction of the probability of an adverse event resulting from health care. 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. 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 identified aim. Medical errors can result from an action that is taken (error of commission) or an action that is not taken (error of omission). Medication Error is defined as preventable inappropriate use of medication including prescribing, dispensing, and administering. 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 of communicating it to the clinician. Preventable Injury is defined as harm that could be avoided through reasonable planning or proper execution of an action. 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. It means striking the right balance in the provision of health services by avoiding overuse (e.g., getting unnecessary tests or procedures), under use (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). 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). Equipment as it pertains to this RFA there is a 20% budget cap on equipment purchases, this includes: the establishment of the Information System and all costs associated with that system, i.e., development, installation, maintenance costs, purchasing hardware, software, equipment or software development costs Rural Hospitals are defined as acute care hospitals physically located in a rural or non-metro area within the borders and confines of any State or U.S. territory. Rural and/or non-metro 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 non-metro 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). Non-metro areas will be defined by a RUCA code of between 4 and 10. http://www.ers.usda.gov/briefing/rurality/RuralUrbCon/
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. Acute Care Hospitals are defined as short-term hospitals with the medical facilities, medical staff and all necessary personnel to provide diagnosis, care and treatment of a wide range of acute conditions, including injuries. Memorandum of Understanding (MOU) An agreement of cooperation between organizations defining the roles and responsibilities of each organization in relation to the other or others with respect to an issue over which the organizations have concurrent jurisdiction. Partnerships are defined as a collaborative working relationship between three or more independent organizations AND formalized through one or more written agreements that contain at a minimum the following elements: 1) substantial and meaningful contributions of personnel, expertise, money, equipment, facilities or other important resources to and from each of the partners; and 2) sharing of clinical and research data across healthcare delivery sites. If there is any question that the partner organizations are separate entities, the applicant should detail the characteristics of the organizations to justify consideration of them as discrete organizations. Indicators of discrete organizations could be separate Boards of Directors, individual IRS recognition (EIN numbers are separate), local operational autonomy, or separate management and financial systems. AHRQ is seeking applications from partnerships (as described above) involving at least three or more organizations, one of which has been identified as the primary applicant organization from a FY04 AHRQ THQIT planning grant and are interested in obtaining grant funding to help implement collaborative adoption and utilization of HIT in their organizations and communities through the successful completion of their HIT implementation plan. 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) and various healthcare settings (e.g., hospital inpatient, ambulatory care, long-term care, home health care). Applicants are required to present evidence of formal partnerships (see definition) comprised of three or more institutional partners. Evidence may include memorandum of understanding or similar documentation among the partners. Funding preference will be given to applicants who can demonstrate that the proposed IT implementation will be integrated across healthcare delivery sites. For qualifying rural and small organizations, the lead partner will usually be an acute care hospital. However, in rural regions where there is no hospital (or only a very small facility) another entity such as a home health agency, long term care facility or ambulatory facility (e.g., a Rural Health Clinic or a Federally Qualified Community Health Center) may be the most appropriate lead applicant. In such instances, the regional referral hospital could be a partner to the application. Proposals must include both, a summary of accomplishments, highlighting achievements as well as problems encountered and how they were resolved, AND an evaluation of the impact of their HIT implementation on patient safety, costs, and overall quality of care. AHRQ is interested in proposals that involve a variety of healthcare settings, including primary care, ambulatory care, long-term care, home health, and hospital inpatient 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. Applicants may use these funds for 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, project management, and research capacity. However, no more than 20% of the Federal grant funds in any one year may be used for purchasing hardware, software, equipment or software development costs.
In order to be considered for funding, projects must include a robust evaluation plan to assess the penetration and accomplishments of their HIT implementation and its impact on important patient safety/quality processes and outcomes within the demonstration sites. For example, investigators might choose to evaluate the impact of HIT implementation on patient level outcomes such as reducing medication errors or preventable adverse events; improving adherence to recommended clinical care guidelines; increasing the use of recommended preventive services; decreasing the number of patients who develop renal failure due to inappropriate medication use; decreasing the number of patients who develop nosocomial infections; or decreasing the number of elderly patients who are injured by falls. As a component of their research proposal, applicants are also encouraged to submit evaluations of system level outcomes such as how HIT implementation in their institutions changes clinical and administrative practices, clinical workflow, staff deployment, patient relations, or other important organizational and cultural factors. Findings from these evaluations should provide new knowledge and capture lessons learned about factors that lead to successful implementation of HIT solutions, including financial, technical, organizational, personnel, cultural and procedural barriers, as well as ways to overcome them. Implementation efforts revolving around the integration of patient-centered HIT in a variety of settings is encouraged. In order to be considered for funding, applicants must provide evidence in their application that the work plan timeline as submitted and approved by AHRQ for the HS-04-010 Planning grant has been adhered to and progress outlined in this proposal. This progress must demonstrate how it has adequately prepared them to successfully implement HIT in their organizations and communities. The proposal must describe the planning process, what was learned from the planning process, and how these lessons were incorporated into the implementation plan. Applicants should consider the following in developing their proposals: Importance of the implementation project in addressing our understanding of the unique role HIT serves in improving the safety, quality and efficiency of care. Focus on implementation projects that will lead to measurable improvements in important patient safety outcomes (i.e., number of adverse drug events identified, reported and/or prevented). Evaluation of the impact of HIT on the efficiency, safety and quality of care at the implementation sites, as well as the strength of the evaluation methods. Barriers to HIT implementation and proposed strategies to overcome them. Quality of the research project teams, including project lead/investigator, co-lead/investigator, and participating institutions; ability of the team to successfully complete the project in a timely manner; and evidence of commitment of and by the participating institutions. Clear plan for HIT implementation, including a project management plan with clear objectives, timelines, and deliverables. Clear plans for addressing organizational and cultural issues in HIT implementation at the participating institutions. Effective and efficient use of project expenditures, including reasonableness of the budget. Development of collaborative partnerships that will increase the opportunity for data sharing across clinical care sites and increase the generalizability of the project findings. Specific mechanisms to ensure the long-term sustainability of the project beyond the duration of the grant. Inclusion of priority patient populations. Adequacy of human subjects' protection. Overall impact on improving the nation's health through improved patient safety, quality of care, and effectiveness and efficiency of healthcare delivery. A cost sharing of a minimum of 50% of total costs is a condition of award for all recipients of funding from this solicitation. Cost sharing refers to a situation where the recipient shares in the costs of the project. Cost sharing is a requirement for funding because projects funded under this solicitation will have a greater degree of likelihood of success if the recipient contributes to the cost of project. Section II. Award Information 1. Mechanism(s) of Support The funding opportunity will use the U01 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. The U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator (PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with AHRQ staff being substantially involved as a partner with the PI, as described under the Section VI.2.A. Administrative Requirements, “Cooperative Agreement Terms and Conditions of Award.” AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review. 2. Funds Available AHRQ intends to commit up to $7 million in FY05 to fund up to 14 new implementation grants in response to this RFA with up to $5 million of these funds reserved for efforts involving rural and small community hospitals as the lead entity. If additional funds become available in FY 2005, AHRQ reserves the option to fund additional applications submitted in response to this RFA. An applicant may request a project period of up to three years and a Federal contribution to the budget of up to $1.5 million in total project period costs (not to exceed $500,000 per year in total Federal costs, including direct and indirect costs). Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will vary. Grants funded in response to this RFA will be administered as cost sharing grants. The use of cost sharing will ensure that facilities are c ommitted to their HIT investments and help to ensure the long-term sustainability of these projects after the grant program has expired. Continuation awards for subsequent years will be contingent on performance as reviewed each year. Although the financial plans of AHRQ provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of scientifically meritorious applications. AHRQ will provide matching funds not to exceed $500,000 per year in total costs . Cost sharing between the requesting organization and the federal government will be at a 1:1 ratio. The applicant's cost sharing portion is a minimum with no maximum. In other words, an organization must, at a minimum, match the request for AHRQ's funding contribution to the project. However, applicants can spend more than this amount using their own funds or resources. Applications must clearly delineate the methods used by the organizations to calculate how they will match AHRQ's contributions. Organizations must be able to document their actual contributions to the project and provide assurances that the organization is committed to providing funds and resources for its share of the project throughout the duration of the project. Matching contributions from the participating organizations can be comprised of actual dollars, in-kind contributions, or other resource investments, as long as the methods used to calculate the organizations' contributions are explicit, transparent, and comply with general accounting principals. Applicants must submit budgets that clearly document the total costs as well as the federal and institutional (non-Federal) components of the budget. A total project budget should be included in the budget section of the PHS 398 with an attachment of spreadsheets documenting the cost-sharing component (non-Federal; i.e., their own contributions) and the federal component (non-cost sharing). Cost sharing applies to all budget periods of the project. Any application which fails to adequately document the cost sharing requirement as specified in this RFA will be returned without review. Awardees who fail to demonstrate that continued cost sharing is actually part of the program activity may have their grants terminated. No more than 20 percent of the Federal grant funds (maximum of $100,000 per year for a $500,000 per year total grant funds) in any one year may be used for purchasing hardware, software, equipment, and software development. Section III. Eligibility Information 1. Eligible Applicants 1.A. Eligible Institutions In 2004, AHRQ awarded 38 THQIT planning grants (P20s) under RFA-HS-04-010 for planning activities. Support was provided for planning activities related to the development of their HIT capabilities for improving patient safety and quality of care. This RFA is a competitive continuation that extends these activities and only current recipients of the initial THQIT planning grants are eligible to apply. The purpose of these awards is to allow these grantees to build on their current work in progress and to build their HIT infrastructure and data sharing capacity among clinical provider organizations in their communities. Because the existing THQIT recipients possess the implementation project objectives to enable them to build on the existing work and because continuity in the project is required, this is a limited competition. At least 2 of the required minimum of 3 partner institutions which are participants in the AHRQ THQIT planning grant must remain in the current application. In addition, ongoing evaluation of the THQIT program requires a longer period of funding be in place for the current awardees in order to determine the appropriate structure for future Agency programs of a similar nature. Because this RFA is intended to increase the availability of HIT in the US, no awards will be made to foreign institutions. Foreign institutions may participate in projects as members of consortia or as subcontractors only. Organizations described in sections 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible. (See December 6, 1999, AHRQ reauthorization at http://www.ahrq.gov/hrqa99a.htm. The following eligible institutions/partnership configurations are acceptable for this RFA: 1. The 38 THQIT Planning Grant institutions that received grants in response to RFA HS-04-010, or 2. Partnership configurations in which the original partners participating in the original THQIT grant change. This option requires that the original grantee institution remain a member of the applicant team. Also, as noted above, at least 2 of the 3 original partner institutions must remain. Eligible institutions may propose a change in Principal Investigator/Program Director. Justification for such changes must be provided. 1.B. Eligible Individuals Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with eligible institutions to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs. The Project Director (or Principal Investigator) should be an experienced senior level person familiar with managing organizational change and IT program implementation. This person should devote a considerable portion of his/her time to this project (at least 25%). The required 25% may not be split between more than one individual PI at any given time. 2. Cost Sharing Cost sharing is required for applicants responding to this RFA. The government will provide no more than 50 percent of the total costs of the project. Institutions (or partnerships) must be able to document their actual contributions to the project and provide assurances that the organization(s) are committed to providing the funds and resources for their share of the project. Cost sharing may be provided to offset direct and/or indirect costs. However, if a cost category, such as salaries, is treated as an indirect cost for purposes of the organization's indirect cost rate, then contributions to a grant in these categories cannot be treated as a direct cost contribution – they must be treated as indirect costs. Third party in-kind contributions received by the participating institutions may satisfy the cost sharing requirement only if such goods or services would be a required for project completion and constitute an allowable cost. Volunteer services may be counted as cost sharing if they provide an integral and necessary part of an approved program or project and if payment for them would constitute an allowable cost if the recipient had to pay for them. The total costs for these projects, including the organization's contribution to cost sharing, does not have an upper limit; only the Federal government's portion of the grant has an upper limit. Generally cost sharing requirements may not be met from the following sources: a) costs borne by another Federal grant or sub award; b) costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds; and c) cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient). Applicants must submit budgets that clearly document the total costs as well as the Federal and Institutional (non-Federal) components of the budget. A total project budget should be included in the budget section of the PHS 398 with an attachment of spreadsheet(s) documenting the cost-sharing (non-Federal) component and the federal (non-cost sharing) component. 3. Other-Special Eligibility Criteria 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, investigators are strongly encouraged to comply with 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 DHHS Secretary. The NCVHS is a federal advisory committee to the Secretary on health data and information policy. The CHI is a collaborative effort between the Department of Health and Human Services, 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. By the completion of the project period, AHRQ requires that all awardees comply with the CHI-adopted Federal Health Information interoperability standards, or give a detailed explanation why these standards were considered but rejected.
The first set of CHI standards were adopted by the DHHS 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 . On May 6, 2004, the Departments of Health and Human Services, Defense, and Veterans Affairs announced the adoption of 15 additional standards to allow for electronic exchange of clinical information across the federal government. These new standards include: Health Level 7® (HL7®) vocabulary standards for demographic information, units of measure, immunizations, and clinical encounters, and HL7®'s Clinical Document Architecture standard for text based reports; Laboratory Logical Observation Identifier Name Codes® (LOINC®) to standardize the electronic exchange of laboratory test orders and drug label section headers; and the College of American Pathologists Systematized Nomenclature of Medicine Clinical Terms® (SNOMED CT®) for laboratory result contents, non-laboratory interventions and procedures, anatomy, diagnosis and problems, and nursing. HHS is making SNOMED-CT® available for use in the U.S. at no charge to users. The Health Insurance Portability and Accountability Act (HIPAA) transactions and code sets for electronic exchange of health related information to perform billing or administrative functions. These are the same standards now required under HIPAA for health plans, health care clearinghouses and those health care providers who engage in certain electronic transactions. A set of federal terminologies related to medications, including the Food and Drug Administration's names and codes for ingredients, manufactured dosage forms, drug products and medication packages, the National Library of Medicine's RxNORM for describing clinical drugs, and the Veterans Administration's National Drug File Reference Terminology (NDF-RT) for specific drug classifications. The Human Gene Nomenclature (HUGN) for exchanging information regarding the role of genes in biomedical research in the federal health sector. The Environmental Protection Agency's Substance Registry System for non- medicinal chemicals of importance to health care. More information on the CHI can be found at: http://www.whitehouse.gov/omb/egov/gtob/health_informatics.htm Information of NCVHS may be found at http://www.ncvhs.hhs.gov.
Section IV. Application and Submission Information 1. Address to Request Application Information The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. Telecommunications for the hearing impaired: TTY 301-451-5936. 2. Content and Form of Application Submission Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001; 9/2004 version after May 10). 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com. The D&B number should be entered on line 11 of the face page of the PHS 398 form. See also Sections III.3 and VI.2 for additional information. The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked. To ensure equity among applicants, however, applicants using the Form PHS 398 must observe page number and font size requirements specified in the form. Supplementary Instructions:
Application Preparation Complete information about the proposed implementation project 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 supplement 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 addendum to the face page. 2) Detailed Budget. The budget should include travel and per diem expenses for the planning director and/or other key personnel to attend one 2-day meeting in Washington, D.C. with AHRQ and HITRC staff. 3) 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. Follow the instructions in the PHS 398 for the format of the research plan, but this narrative part of the application should contain the following information: I. Planning Efforts (as was described in the THQIT Planning RFA(HS-04-010) to be detailed at a minimum: a) Specify clinical and organizational needs that can be met through HIT: a. Identify partnership organizational goals and needs that can be met by HIT.
b. Explain how HIT will meet these needs and enable the accomplishment of objectives (show causal linkages between HIT and desired improvements).
c. Discuss the factors that indicate the partnership organization is prepared to take the steps necessary to achieve its HIT implementation goals. b) Assess feasibility of HIT implementation and develop an implementation plan: a. Define resources available to support implementation.
b. Identify potential barriers to implementation and ways to address them.
i. Financialii. Organizationaliii. Personnel (knowledge, skills, language, readiness and attitudes toward HIT)iv. Procedural (rules, payment procedures, regulations)
c. Define and establish new organizational entities required, including appropriate multi-institutional governance mechanisms
d. Assign tasks, responsibilities, and performance standards for implementing and sustaining HIT
e. Discuss planned intent to comply with the CHI-adopted Federal Health information interoperability standards
f. Develop detailed budget and timeline for implementation c) Define basic project parameters: a. Specify desired outcomes of adopting HIT
b. Specify clinical and organizational practices that will change with introduction of HIT; explain how they will change and lead to desired outcomes
Indicate how people, units, and organizations will be involved
d. Assign responsibilities and discuss available resources for implementation activities
e. Describe anticipated funding of implementation and subsequent operation of HIT
f. Identify expertise needed to support HIT implementation and maintain long-term sustainability
Specify time frame for main stages of the project (planning, transition, full implementation) d) Specify procedures for ongoing project evaluation and feedback: a. 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
b. Designate an individual (or committee) to monitor project progress and evaluate its success II. 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 (MOU) 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, 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 or implementation activities completed to date, including a summary of decisions and their underlying rationale. III. The Proposed Implementation Effort a) Description of the project director and his/her responsibilities and authority to carry out the project. Discuss the selection of this individual as project 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 project committee. If an internal committee is being proposed, list and discuss the membership. List any external consultants to the project committee. c) Description of other key personnel and their duties. Discuss the selection and duties of the key personnel supporting the project director and committee. d) Description of issues that will need to be resolved through the implementation process and strategies to overcome them. Discuss the issues/obstacles that must be considered and overcome. e) Detailed description of the implementation project. Include discussions of the proposed approach to implementation activities/project, basic project parameters, milestones and timelines. f) Discussion of partnership's future plans to sustain and evaluate HIT activities. IV. Rural and Small Community Projects a) If self-designated as either a rural or small community site describe the basis for this self declaration and supply documentation. b) Designate and describe the lead partner including the partner's corporate structure and operational sites. Describe the location of the lead partner's corporate headquarters. Describe the nature of the relationship between the lead partner and the other partners and the link to the small/rural community, c) Describe any HIT implementation barriers unique to the specific community, hospital or partnership that will be overcome by this project. d) Describe the specific community served by the partnership include demographics, economic measures and measure of rurality. Describe the health status of the community. Describe how the project will improve the community's health status as well as improve the safety, quality and efficiency of health care delivered to the community. Applications submitted under this RFA must be received by April 14, 2005. 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 date 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. 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: Successfully deploy or enable the deployment of hospital HIT practices that reduce medical errors and improve overall patient safety; Increase the identification and reporting of medical errors and adverse events; Decrease in the number of actual errors and adverse events; Increase the number of hospitals utilizing CPOE with CDSS to reduce medication errors; and, 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. Technical Assistance
AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ staff. This two and a half 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 HITImplementationRFA@AHRQ.gov by January 7, 2005. 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 14, 2005 at 1:00 EST and last approximately 2 ½ hrs. To register to participate in the call, please send your request to HITImplementationRFA@AHRQ.gov by January 7, 2005. 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 HITImplementationRFA@AHRQ.gov. 3. Submission Dates 3.A. Receipt, Review and Anticipated Start Dates
Technical Assistance Conference Call: January 14, 2005 Letters Of Intent Receipt Date(s): March 14, 2005
Peer Review Date(s): June 2005
Earliest Anticipated Start Date: July, 2005 3.A.1. Letter of Intent Prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed research Name, address, and telephone number of the Principal Investigator Names of other key personnel Participating institutions Number and title of this funding opportunity Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Lisa Dolan-Branton, RN
Telephone: (301) 427-1588
Email: Lisa.Dolan@AHRQ.GOV 3.B. Sending an Application to the NIH Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 (U.S. Postal Service Express or regular mail) Bethesda, MD 20817 (for express/courier service; non-USPS service) At the time of submission, two additional copies of the application and all appendix materials must be sent to: Lisa Dolan-Branton, RN
Email: Lisa.Dolan@AHRQ.GOV Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. 3.C. Application Processing Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by AHRQ. Incomplete and/or non-responsive applications will not be reviewed. The NIH & AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks. 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). 4. Intergovernmental Review
This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 5. Funding Restrictions All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm (See also Section VI.3. Award Criteria.) 6. Other Submission Requirements 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 AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will take place in close coordination with OCKT and the press offices of the grantee's or contractor's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media. HCUPS & MEPS Applicants are encouraged to make use of AHRQ'S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP inpatient databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP databases include: the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of over 1,000 hospitals, the Kids' Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states. More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp. The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, noninstitutionalized population. MEPS comprises three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov. This does not preclude the use of secondary data sources or primary data collection. Use of CMS Data Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the “Research Design and Methods” section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. In consultation with CMS, previously called Health Care Financing Administration (HCFA), AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ's confidentiality statue, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed. Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so. In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff. CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats. Questions regarding CMS data should be directed to the AHRQ program official listed under INQUIRIES. Assessment of AHRQ Grant Programs In carrying out its stewardship of research programs, the AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency-sponsored research. Applicants are to agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active. To receive an award, applicants must agree to submit an original and two copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (Word Perfect, or Word, or ASCII format). The past cooperation of applicants with regard to the submissions described in this section may be considered in the application review to assess applicants' potential for responsible stewardship of awarded funds. Specific Instructions for Modular Grant applications. 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. Applications submitted in the Modular format will be returned without review. Section V. Application Review Information 1. Criteria 2 . Review and Selection Process 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 3. Merit Review Criteria As part of the merit review, all applications will: Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. Receive a written critique In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. Significance Approach Innovation Investigator Environment Budget The application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Significance: Does your study address an important gap or problem in patient safety and quality of care? 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 these studies on the concepts or methods that drive this field? If applicable, does the study address and affect the unique challenges facing rural and small community hospitals in integrating and utilizing HIT and/or EHR's? To what extent will the proposed implementation activity involve populations of providers or patients most in need of HIT innovations? Did the proposal demonstrate the compelling need for continued support by AHRQ to carry out their HIT Implementation Plan? Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Did the proposal demonstrate the need for continued support to carry out the partner's HIT Implementation Plan? Do you acknowledge potential problem areas and consider alternative tactics? Where applicable, will the unique needs of small and rural providers be incorporated into the project?
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? Where applicable, will the proposed work develop research capacity in HIT in small and rural communities? Investigators: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the project director/principal investigator and to that of other researchers? Where applicable, does the proposal offer an opportunity to adequately examine unique features of HIT implementation in small and rural communities? If the same Project Director is proposed as in the THQIT Planning grant, did the project director exhibit the adequate leadership and other appropriate skills to the accomplish the planning project goals(or make significant progress toward the goals)? Environment: Does the environment in which your work will be done contribute to the probability of success? Did the environment contribute to the success of the THQIT planning efforts progress? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of multi-institutional support ? Budget: The reasonableness of the proposed project budget and the requested period of support in relation to the proposed research, including documentation of the institutions cost sharing contribution. Is the documentation adequate to determine that the institution can meet the 50% contribution to the project? Is the type and extent of cost sharing appropriate and a representation of organizational commitment to the project?
3.A. Additional Review Criteria: Protection: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Adequacy of attention to other populations of special priority to AHRQ (see discussion on Priority Populations in the section on Other Submission Requirements, above, and in the section on Required Federal Citations, below.) Partnerships: The formation of partnerships across various components of the health care delivery system, including traditional and non-traditional partners, State and local governments, educational institutions, payers, providers, community organizations, not-for-profit and for-profit entities. Strength of the above mentioned associations, with particular emphasis on the operations of the partnership during the THQIT planning grant period, progress toward concrete accomplishments, active participation, resource allocation from partners toward the project, and commitment to sustain the project after completion of the grant. Ability to demonstrate broad community commitment and need related to the HIT implementation plan would be viewed favorably. Finally, applications will be assessed in two additional areas: 1) technical merit of the proposed implementation process; and 2) potential of the new and existing organizations to implement and sustain the HIT project. 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 implementation process: a) Clarity and appropriateness of the goals and objectives; b) Extent to which the application appropriately defines an ongoing planning process including listing of barriers and strategies to overcome them; c) Extent to which the project plan has clear, unambiguous and well reasoned goals consistent with those stated by AHRQ's in this RFA and met the minimum required elements as defined by HS-04-010; d) Qualifications of the project director to lead the implementation effort and his/her leadership experience, administrative skills and research/evaluation background; e) Qualifications of the key personnel designated to assist the project director; f) Strength of the partnership as exhibited in either memorandum of understanding and/or previous projects; and g) Extent to which the application discusses intent to comply with the CHI-adopted Federal Health information interoperability standards over the project period; h) Adequacy of plans to evaluate success of the implementation process. 2. The potential of the organization to implement and sustain its HIT plan: a) Extent to which the work plan timeline as submitted and approved by AHRQ for the HS-04-010 Planning grant is adhered to and progress outlined in this proposal. b) Adequacy of the commitment of the members of the collaborative to implement HIT, as evidenced by previous work in THQIT planning efforts and other HIT implementation efforts, letters of support, or success with similar projects; c) Adequacy of the organization to address the healthcare of priority populations, especially the needs of small/rural healthcare providers and communities; d) Adequacy and stability of the organization's administrative, organizational and management capabilities; e) Extent to which the award of grant funds will enhance the ability of the organization to plan future activities to sustain the implementation of HIT systems; f) In the case of self-designated rural or small-community sites, the extent to which the awardee proposes to implement HIT systems in regions with low HIT penetration due to unique or significant barriers to implementation; and g) Extent to which lessons learned from this implementation effort can help to increase diffusion of effective HIT tools into practice, especially in healthcare sites with underdeveloped HIT systems. 3.B. Additional Review Considerations
Not Applicable 3.C. Sharing Research Data Data Confidentiality Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute [42 U.S.C.299c-3(d)). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this RFA will also be managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of protected health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) became mandatory for covered entities on April 14, 2003. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, for example, health care plans, will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) satisfied that any identifiable health information will be appropriately safeguarded by the investigators. The HHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/ The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application. 3.D. Sharing Research Resources Rights in Data AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's web site http://www.gpoaccess.gov/cfr/index.html). Section VI. Award Administration Information 1. Award Notices After the peer review of the application is completed, the Principal Investigator will receive a written critique called a summary statement. A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. Notification will be made electronically to the designated administrative/institutional official. 2. Administrative Requirements All AHRQ grant and cooperative agreement awards are subject to the terms and conditions of the Public Health Service (PHS) Grants Policy Statement as part of the notice of grant award, found at httphttp://grants1.nih.gov/archive/grants/policy/nihgps_2003/index.htm. For terms of the award, see http://grants1.nih.gov/grants/policy/gps/5award.htm#terms, and see http://grants1.nih.gov/grants/policy/gps/5award.htm#fund for the award and funding process. The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator, as well as to the appropriate institutional official, at the time of award. 2. A. Cooperative Agreement Terms and Conditions of Award The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and PHS grant administration policy statements. Applicants should be familiar with the AHRQ's grant regulations, 42 CFR Part 67 Subpart A, and particularly sections 67.18-67.22. The administrative and funding instrument used for this program will be the cooperative agreement ( UC1 ), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial AHRQ programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the AHRQ as defined above. 2.A.1. Awardee Rights and Responsibilities Awardee will have primary and lead responsibilities for the respective project, including project design and protocol development, participant recruitment, development of measures, data collection, quality control, evaluation, and preparation of presentations and publications related to their projects. During the course of the project period, awardees are expected to meet the requirement of compliance with the CHI-adopted Federal Health information interoperability standards, or this is not met, provide a detailed explanation as to why it was not. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to government rights of access and use consistent with current Department of Health and Human Services, Public Health Services, and AHRQ policies.
Awardees will be responsible for cooperating and collaborating with other awardees working on AHRQ's HIT or patient safety initiatives with assistance from AHRQ program officials and the Health Information Technology Resource Center (HITRC - described below). All awardees under this RFA are expected to participate in the activities of the HITRC, including participation in periodic conference calls and an annual 2 day meeting of all awardees in the Washington, D.C. area. In addition, awardees are required to cooperate with any future contractors that may be assessing various aspects of the Agency's HIT or patient safety portfolio. 2.A.2. AHRQ Staff Responsibilities AHRQ Program Officials will have substantial scientific and programmatic involvement in guiding grant activities to address priority issues of AHRQ, the Department of Health and Human Services, or the Federal Government regarding the use of Health Information Technology to improve patient safety and quality of care. Specific cooperative tasks and activities in carrying out individual projects may be shared among the awardees and AHRQ Program Officials. AHRQ staff may also provide expertise/technical assistance to the awardees and assist them with their project activities or in coordinating the activities of different grantees. However, as indicated above, the dominant role and prime responsibility for project activities will reside with the awardees.
2.A.3 Health Information Technology Resource Center Projects funded under this RFA are considered part of the AHRQ Health Information Technology portfolio. As part of its FY 2004 Health IT initiatives, AHRQ intends to establish a Health Information Technology Resource Center (HITRC). The HITRC will provide a variety of services, including coordinating the activities of awardees across all of the Health IT patient safety RFAs. All awardees under RFA-HS-05-013 are expected to participate in the activities of the HITRC, including participation in periodic conference calls and an annual 2 day meeting of all awardees in the Washington, D.C. area. 2.A.4. Collaborative Responsibilities When appropriate and feasible, AHRQ expects awardees to work with each other to identify collaborative opportunities that can contribute to the overall success of their projects and the overall success of AHRQ's HIT and patient safety initiative. These collaborative relationships may be facilitated through the HITRC, instigated by the awardees through self-identified opportunities, or developed via other mechanisms 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 initiatives. This work is being accomplished by characterizing AHRQ's (1) progress in achieving its goals, (2) effects of patient safety interventions undertaken within the patient safety initiative on important health-related outcomes, and (3) diffusion of new knowledge and practices beyond patient safety initiative participants. The RAND team will conduct interviews with the principal investigators, project directors, and other key personnel that are responsible for each of the patient safety grants and will conduct occasional site visits to learn more about new interventions and tools being developed and implemented. All awardees under RFA-HS-05-013 are encouraged to cooperate fully with the RAND. 2.A.5. 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 in the event of an individual disagreement, a second member selected by AHRQ, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16.
Award criteria that will be used to make award decisions include: Scientific merit (as determined by peer review) Availability of funds Responsiveness to goals and objectives of the RFA Programmatic priorities Program and geographic balance 4. Reporting Project Monitoring Requirements: The Project Director and at least one key program staff member from the project are required to attend an annual 2 day grantee meeting in the Washington DC area. Travel to the annual meeting should be included in the project's budget.
Section VII. Agency Contacts We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: 1. Scientific/Research Contacts: Direct your questions about scientific/research issues, including information on the inclusion of women, minorities, and children, and other priority populations in the study to: Direct your questions about AHRQ scientific/research interests to: Lisa Dolan-Branton, RN
Email: Lisa.Dolan@AHRQ.GOV 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 2. Peer Review Contacts: Direct your questions about peer review issues to: Scott Andres, PhD
Telephone: (301) 427-1551
Email: scott.andres@ahrq.gov 3. Financial or Grants Management Contacts:
Direct your questions about AHRQ financial or grant management matters to: George Gardner
Telephone: (301) 427-1453
FAX: (301) 427-1464
Email: george.gardner@AHRQ.gov 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 Section VIII. Other Information 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 justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). AHRQ also encourages investigators to consider including children in study populations, as appropriate. 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 AHRQ-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if it constituted trade secrets or commercial information collected. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities. Should applicants wish to place data collected under this RFA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted. Standards for Privacy of Individually Identifiable Health Information: The Department of Health and Human Services (DHHS) issued the last modification the "Standards for Privacy of Individually Identifiable Health Information", was mandated by the "Privacy Rule," on August 14, 2002. This regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). Mandatory compliance with the Privacy Rule (for those classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with covered entities. The OCR web site (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 at http://www.cfda.gov/, Number 93.226. Awards are made under Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References McGlynn EA, et al. The quality of health care delivered to adults in the United States. N Engl J Med. 2003;348:2635-45. Kohn LT, Corrigan JM, Donaldson MS, Eds. To err is human: building a safer health system. Washington, D.C. National Academy Press, 1999 . Corrigan JM, Donaldson MS, Kohn LT, Eds. Crossing the quality chasm: a new health system for the 21 st century. Washington, D.C. National Academy Press, 2001. Philip Aspden, Janet M. Corrigan, Julie Wolcott, Shari M. Erickson, Eds. Patient Safety: Achieving a New Standard for Care. Washington, D.C. National Academy Press, 2003. Evans RS, Classen DC, Pestotnik SL, Clemmer TP, Weaver LK, Burke JP. A decision support tool for antibiotic therapy. In: Gardner RM, ed. Proceedings from the Nineteenth Annual Symposium on Computer Applications in Medical Care. Philadelphia, PA: Hanley and Belfus; 1995:651-55. Evans RS, Pestotnik SL, Classen DC, Clemmer TP, Weaver LK, Orme JF, et al. A computer-assisted management program for antibiotics and other antiinfective agents. N Engl J Med. 1998;338:232-38. Overhage JM, Tierney WM, Zhou XH, McDonald CJ. A randomized trial of “corollary orders” to prevent errors of omission. JAMIA. 1997;4:364-75. Bates DW, Leape LL, Cullen DJ, Laird N, Peterson LA, Teich JM, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998;280:1311-16. Hunt DL, Haynes RB, Hanna SE, Smith K. Effects of computer-based clinical decision support systems on physician performance and patient outcomes. JAMA. 1998;280:1339-45. Weekly TOC for this Announcement