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TRANSFORMING HEALTHCARE QUALITY THROUGH INFORMATION TECHNOLOGY (THQIT) –
IMPLEMENTATION GRANTS
RELEASE DATE: November 20, 2003
RFA Number: RFA-HS-04-011
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
Agency for Healthcare Research and Quality (AHRQ)
(http://www.ahrq.gov)
National Institutes of Health
(http://www.nih.gov/)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Library of Medicine (NLM)
(http://www.nlm.nih.gov)
NOTE: The policies, guidelines, terms, and conditions stated in this
announcement may differ from those used by NIH.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.226, 93.879
LETTER OF INTENT RECEIPT DATE: February 6, 2004
APPLICATION RECEIPT DATE: April 22, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION:
o Purpose of the RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
o References
PURPOSE
The Agency for Healthcare Research and Quality (AHRQ) announces the
availability of implementation grants to evaluate the effects of health
information technology (HIT) on improving patient safety and quality of
healthcare. 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.
Projects presented for consideration under this RFA should comply with the
Agency’s policy regarding the inclusion of priority populations
(http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Further
information on the requirements is listed in the special requirements section
of this RFA.
This RFA is one in a series of solicitations to be issued by AHRQ in FY‘04 on
the use of HIT to improve patient safety and quality of care. The
solicitations form an integrated set of activities designed to explore
strategies for successful organizational and community-wide planning and
implementation of HIT solutions and to demonstrate the value of HIT in
patient safety and quality of care. The FY ’04 HIT initiative will place
particular emphasis on the challenges facing rural and small communities in
integrating HIT into their healthcare delivery systems. In addition to this
RFA, other grants and contracts to be released as part of this program
include:
1. Transforming Healthcare Quality Through Information Technology (THQIT)
Planning Grants - a series of planning grants to provide organizations and
communities with the resources needed to develop their capacity to compete
for AHRQ (and other funding agencies) implementation grants and further
develop their HIT capabilities for improving patient safety and quality of
care. Planning grants will enable these entities to begin planning and
developing their HIT infrastructure and data sharing capacity among clinical
provider organizations in their communities.
2. Demonstrating the Value of Health Information Technology - This RFA will
focus on the value derived from the adoption and utilization of HIT to
improve patient safety, cost, and overall quality of care. This RFA will
solicit proposals to elucidate the value of HIT to providers, patients,
purchasers, payers, policymakers, and other important stakeholders. Research
resulting from this RFA should provide important information on the direct
and indirect benefits of HIT and inform decision makers about facilitators
and barriers to HIT adoption, including various forms of incentives and
disincentives.
3. Health Information Technology Resource Center - The center will provide
technical assistance to grantees; serve as a repository for best practice
assimilation and diffusion; help develop, maintain and export executable
knowledge for clinicians and patients; offer expert HIT support for providers
and communities; perform and sponsor educational activities; and develop and
disseminate tools to help providers and organizations utilize HIT to improve
patient safety and quality of care.
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, increasing time constraints placed on
health care providers, and mounting pressures to contain costs. This
complexity, coupled with poorly designed 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 plagued 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 21st 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 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 accurate data are not available,
it is estimated that less than 10% of facilities across the United States
have comprehensive HIT systems in place and use them regularly to provide
clinical care. Reasons for this paucity of investment in HIT are manyfold,
including the lack of financial incentives for HIT investment, lack of
reimbursement based on quality for clinical services, effects on clinical
workflow, 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
for more research on the impact of HIT on important health-related outcomes;
more research on HIT in diverse healthcare settings; the need to support
local and regional HIT collaborative projects that would lead to standards-
based data sharing across healthcare delivery sites, 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.
As part of the Agency’s FY 2004 patient safety activities, AHRQ is investing
$50 million in a portfolio of grants and contracts to study how HIT can
improve patient safety and quality of care. Of this amount, $26 million is
earmarked for implementing proven technologies in rural and small hospitals,
where HIT penetration has been particularly low. The remaining $24 million is
targeted for implementation and evaluation of new and innovative technologies
to improve patient safety and quality of care in diverse healthcare settings.
The objective of this RFA is to support implementation and diffusion grants
which employ HIT in diverse health care delivery settings and assess the
extent to which HIT contributes to measurable and sustainable improvements in
patient safety and quality of care. Results from this 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.
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 support of
efficient processes for health care delivery.
Clinical decision support systems (CDSS) are defined as computer applications
that assist clinicians in the management of their patients at the point-of-
care by integrating medical knowledge with patient characteristics and
generating patient-specific recommendations. CDSS can take the form of
computerized reminders, alerts, guidelines, order sets or other such tools.
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.
o Financial benefits include cost reduction, revenue enhancement and
productivity gains.
o Clinical benefits include advances in care processes, improved patient
outcomes (improvements in safety and quality), and better monitoring of
diseases and other health risks.
o Organizational benefits include improvements in organizational
effectiveness – as evidenced in work and quality 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.
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 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 to 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).
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.
httphttp://www.ers.usda.gov/briefing/Rurality/RuralUrbanCommutingAreas/
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
facilities, medical staff and all necessary personnel to provide diagnosis,
care and treatment of a wide range of acute conditions, including injuries.
Partnerships - are defined as a collaborative working relationship between
three or more organizations formalized through one or more written agreements
that contain at a minimum the following elements: 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.
AHRQ is seeking application from partnerships (as described above) involving
at least three or more organizations that are interested in obtaining grant
funding to help develop and implement collaborative adoption and utilization
of HIT in their organizations and communities. Proposals must include
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. Applicants
may use these funds for the development and sharing of important
infrastructure components including, but not limited to, community-wide
collaborative organizations, information-sharing agreements, business and
financial plans, information architecture, health information access and
exchange systems, computer networks, hardware, software, personnel, 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 or software.
In order to be considered for funding, projects must include a robust
evaluation to assess the nature and extent 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 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 how HIT implementation in their institutions changes
clinical and administrative practices, clinical workflow, staff deployment,
patient relations, or other important organizational and cultural factors.
Proposals should also 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 of successfully completing a multi-institutional planning
process that 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.
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
a formal partnerships (see definition) comprised of three or more
institutional partners. Evidence may include memorandum of understanding or
similar documentation among the partners. Selection 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.
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 should consider the following in developing their proposals:
o Importance of the implementation project in addressing our understanding
of the unique role HIT serves in improving the safety, quality and efficiency
of care.
o Focus on implementation projects that will lead to measurable
improvements in important patient safety outcomes (i.e. # of adverse drug
events identified, reported and/or prevented).
o 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.
o Barriers to HIT implementation and proposed strategies to overcome them.
o 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.
o Clear plan for HIT implementation, including a project management plan
with clear objectives, timelines, and deliverables.
o Clear plans for addressing organizational and cultural issues in HIT
implementation at the participating institutions.
o Effective and efficient use of project expenditures, including
reasonableness of the budget.
o Development of collaborative partnerships that will increase the
opportunity for data sharing across clinical care sites and increase the
generalizability of the project findings.
o Specific mechanisms to ensure the long-term sustainability of the project
beyond the duration of the grant.
o Inclusion of priority patient populations.
o Adequacy of human subjects’ protection.
o 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.
MECHANISM OF SUPPORT
This RFA will use the U01 Cooperative Agreement award mechanism, in which the
Principal Investigator from either a nonprofit or for-profit organization
retains the primary responsibility and dominant role for planning, directing,
and executing the proposed project, with AHRQ staff being substantially
involved in the monitoring and evaluation of these projects and serving as a
partner with the Principal Investigator, as described under the section
"Cooperative Agreement Terms and Conditions of Award." There is a cost
sharing requirement of a minimum of 50% of total costs allocated to the
project. This RFA is a one-time solicitation. Future unsolicited, competing
continuation applications based on this project will compete with all
investigator-initiated applications and will be reviewed according to the
customary peer review process. The anticipated award date is September 2004.
AHRQ is not using the Modular Grant Application and Award Process.
Applications submitted in modular format will be returned without review.
FUNDS AVAILABLE
AHRQ intends to commit up to $24 million in FY 2004 to fund up to 48 new
implementation grants in response to this RFA, with up to $14 million
earmarked for rural and small hospitals. An applicant may request a project
period of up to three years and a budget of up to $3.0 million in total costs
(not to exceed $1,000,000 per year in total combined federal and nonfederal
costs) of which AHRQ will provide up to 50% of the project total 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 grants will
ensure that facilities are committed 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 cost sharing portion is a minimum with
no maximum. In other words, an organization must, at a minimum, match 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 two additional budgets, the first documenting the cost-
sharing component (non-Federal; i.e., their own contributions) and the second
documenting 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% of the Federal grant funds (maximum of $100,000/yr) in any
one year may be used for purchasing hardware or software.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has one or more of the
following characteristics: (Individuals are not eligible applicants under
this RFA. Awards are granted to institutions rather than individuals)
o Domestic institutions
o For-profit organizations
o Public and private non-profit institutions
o Units of State and local governments
o Tribes and Tribal governments
o Faith-based organizations/institutions
Under recently enacted reauthorization legislation, AHRQ is authorized to
enter into cooperative agreements with for-profit organizations as well as
with public and not-for-profit entities. Thus, for-profit organizations are
eligible to respond to this notice with research applications for cooperative
agreements. Such applications will be administered in accordance with
Subpart E of 45 CFR Part 74 and 42 CFR Part 67 Subpart A. The latter
regulation has not yet been amended to reflect these changes in Agency name
and authority. (See December 6, 1999, AHRQ reauthorization at
http://www.ahrq.gov (under the section "Budget and Mission").
Organizations described in sections 501(c) 4 of the Internal Revenue Code
that engage in lobbying are not eligible.
Because this RFA is principally intended to increase the availability of HIT
in the US, no awards will be made to foreign institutions. Foreign
organizations may participate in projects as members of consortia or as
subcontractors.
Practice-based research networks, such as Integrated Delivery Systems
Research Networks (ISDRNs) and Primary Care Practice-Based Research Networks
(PBRNs) are eligible and encouraged to apply. The ISDRNs are a model of
field-based research that links the health care researchers with large health
care systems to conduct research on cutting-edge issues in health care on an
accelerated timetable. A PBRN is a group of practices devoted to the primary
care of patients to investigate questions related to community-based
practice.
Institutions and partnerships which provide a substantial amount of safety
net care to uninsured and Medicaid patients are encouraged to apply.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop and submit an application. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for AHRQ programs.
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%).
SPECIAL REQUIREMENTS
AHRQ is committed to supporting public-private partnerships that will result
in interoperable, standards-based data sharing across multiple care sites and
lead to measurable, generalizable and sustainable improvements in patient
safety and quality of care. Where applicable, investigators are 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 Secretary of Health and Human
Services. 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. The first set of CHI
standards were adopted by Secretary Tommy Thompson on March 21, 2003 and
include: Health Level 7 (HL7) messaging standards; Logical Observation
Identifier Name Codes (LOINC) to standardize the electronic exchange of
clinical laboratory results; National Council on Prescription Drug Programs
(NCDCP) standards for retail pharmacy transactions; Institute of Electrical
and Electronics Engineers 1073 (IEEE1073) standards that allow for health
care providers to plug medical devices into information and computer systems;
Digital Imaging Communications in Medicine (DICOM) standards that enable
retrieval and transfer of images and associated diagnostic information. More
information on 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
The Project director and at least one key program staff member from the
project are required to attend an annual grantee meeting. Travel to the
annual meeting should be included in the project’s budget.
This RFA is being issued as a challenge grant with the government providing
no more than 50% 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; 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 two additional budgets, the first documenting the cost-
sharing (non-Federal) component and the second documenting the federal (non-
cost sharing) component.
Cooperative Agreement: Terms and Conditions of the Award
These special Terms of Award are in addition to and not in lieu of otherwise
applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92, 42 CFR Part 67 Subpart A, and other
HHS, PHS grants administration policy statements. Applicants should be
familiar with the AHRQ's grant regulations, 42
CFR Part 67 Subpart A, and particularly sections 67.18-67.22.
The administrative and funding instrument to be used for this program will be
a cooperative agreement (U01), an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial AHRQ scientific and/or
programmatic involvement with the awardee is anticipated during performance
of the activity. Under this cooperative agreement, the Agency’s purpose is
to support and/or stimulate the recipient's activity by involvement in and
otherwise working jointly with the award recipient in a partnership role, but
it is not to assume direction, prime responsibility, or a dominant role in
the activity. Consistent with this concept, the dominant role and prime
responsibility for the project activities resides with the awardee(s) for the
project as a whole, although specific tasks and activities in carrying out
the studies will be shared among the awardees and the AHRQ Program
Official(s).
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. (See 42 CFR 67.21 and Rights in Data section below.)
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). 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. AHRQ Staff Responsibility
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 HIT 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.
3. Health Information Technology Resource Center
Projects funded under this RFA are considered part of the AHRQ HIT portfolio.
As part of its FY 2004 HIT initiatives, AHRQ intends to establish a Health
Information Technology Resource Center (HITRC). The HITRC will provide a
variety of services, including coordinating the activities of awardees across
all of the HIT patient safety RFAs. All awardees under this RFA are expected
to participate in the activities of the HITRC, including participation in
periodic conference calls and an annual meeting of all awardees in the
Washington, D.C. area.
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 AHRQs 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. Agreeing to full cooperation with the
RAND.
5. Arbitration
Any disagreements that may arise on scientific/programmatic matters (within
the scope of the award) between award recipients and AHRQ may be brought to
arbitration. An arbitration panel will be composed of three members: one
selected by the individual awardee, a second member selected by AHRQ, and the
third member selected by the two prior selected members. This special
arbitration procedure in no way affects the awardees right to appeal an
adverse action that is otherwise appealable in accordance with the PHS
regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part
16.
PRIORITY POPULATIONS
The Healthcare Research and Quality Act of 1999 (See
http://www.ahrq.gov/hrqa99a.htm) reauthorized the AHRQ and directed the
Agency, 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 who seek funding from AHRQ should address the
requirements of including priority populations as specified in the Notice.
Publication Transmittal: General AHRQ Requirements
In keeping with the Agency’s efforts to translate the results of AHRQ-funded
research into practice and policy, grantees and/or contractors are to inform
the Office of Communications and Knowledge Transfer (OCKT) when articles from
their studies are accepted for publication in the professional literature.
Grantees and contractors should also discuss any ideas about other
dissemination and marketing efforts with OCKT staff. The goal is to ensure
that efforts to disseminate research findings are coordinated with other
Agency activities to maximize awareness and application of the research by
potential users, including clinicians, patients, healthcare systems,
purchasers and policymakers. This is critical when outreach to the general
and trade press is involved. Contact with the media will take place in close
coordination with OCKT and the press offices of the grantee’s or contractor’s
institutions. In cases when products are created (such as annual or final
reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to
submit to OCKT a brief plan describing how the product will be publicized.
An OCKT staff person will be assigned to each product and will coordinate the
implementation of the plan, especially issues related to printing and
electronic dissemination, and outreach to the media.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions regarding scientific/research/technical issues,
including information on the inclusion of women, minorities, and children in
study populations to:
Scott Young, M.D.
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1580
FAX: (301) 427-1597
Email: SYOUNG@AHRQ.GOV
o Direct your questions about peer review issues to:
Patricia Thompson, Ph.D.
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
FAX: (301) 427-1562
Email: pthompso@AHRQ.gov
o Direct your questions about financial or grant management matters to:
Joan Metcalfe
Grants Management Officer
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1450
FAX: (301) 427-1462
Email: jmetcalf@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
o Direct your questions about NLM financial or grants management
matters to:
Dwight Mowery
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301, 6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX: (301) 402-0421
Email: moweryd@mail.nlm.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of the other key personnel
o Participating institutions
o Number and title of this RFA
o Declaration, if applicable, of status as either a small community or
rural.
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 AHRQ 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:
Scott Young, M.D.
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1580
FAX: (301) 427-1597
Email: SYOUNG@AHRQ.GOV
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a DUN and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714,
Email: GrantsInfo@nih.gov.
To ensure equity among applicants, however, applicants using the Form PHS 398
must observe page number and font size requirements specified in the form.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SUPPLEMENTARY INSTRUCTIONS:
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 supercede the PHS 398
instructions.
1) Under “Performance Sites” (page 2), list only the official name and
address of the lead partner. A complete listing of the other partners should
be attached to the application as an appendix.
2) Detailed Budget. In general, allowable budget items for these planning
and development grants are limited to a portion of the salaries of the
planning director, consultation fees, key administrative and clerical support
personnel, as allowed by the appropriate cost principals, travel and per diem
expenses for outside consultants/advisors, and supplies. The budget should
include travel and per diem expenses for the planning director and/or other
key personnel to be attend one meeting in Washington, D.C. with AHRQ and
HITRC staff.
3) Biographical Sketches. Include in this section a biographical sketch of
the project director (equivalent of Principal Investigator) and other key
personnel to be involved in the planning effort.
4) Resources available to the partnership should be described once, either
in a separate section following the biographical sketches or included in the
narrative text (see below).
Research Plan. This narrative part of the application should contain the
following elements:
Section I. Partnerships
a) Description of the existing or planned partnership. Describe the
organizations and their role in the partnership. Discuss the contribution of
resources from each organization in the partnership. Include as an attachment
any memorandum of understanding (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.
Section II. 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.
Section III. 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 22, 2004.
An application received after the deadline may be acceptable if it carries a
legible proof-of-mailing date, assigned by the carrier, and the proof-of-
mailing is not later than one week prior to the deadline date. If an
application is received after that date, it will be returned to the applicant
without review.
The application must provide a set of long-term outcome goals and explicitly
state how the project will support the achievement of these goals. For
example, AHRQ’s long-term goals for the overall HIT initiative include the
following:
o Successfully deploy or enable the deployment of hospital HIT practices
that reduce medical errors and improve overall patient safety;
o Increase the identification and reporting of medical errors and adverse
events;
o Decrease in the number of actual errors and adverse events;
o Increase the number of hospitals utilizing CPOE with CDSS to reduce
medication errors; and,
o Increase the number of non-hospital providers utilizing CPOE with CDSS
and EHRs
In addition, the application must address how the applicant will monitor
their progress toward the goal(s) they specify and how those goals further
the accomplishment of the agency goals.
Other Instructions
Applicants are encouraged to make use of AHRQ’S Healthcare Cost and
Utilization Program (HCUP). The HCUP includes databases covering 1988-1997,
with 1998 and 1999 data available in 2001. These all-payer databases were
created through a Federal- State-industry partnership to build a multistate
healthcare data system. The main HCUP databases contain discharge-level
information for inpatient hospital stays in a uniform format with privacy
protections. The Nationwide Inpatient Sample (NIS) is a nationwide
probability sample of about 1000 hospitals. The State Inpatient Databases
(SID) contain inpatient records for all community hospitals in 22 states.
Other HCUP databases contain ambulatory surgery data from nine states. These
databases can be directly linked to county-level data form the Health
Resources and Services Administration’s Area Resource File and to hospital-
level data from the Annual Survey of the American Hospital Association.
This does not preclude the use of secondary data sources or primary data
collection.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:
AHRQ is not using the Modular Grant Application and Award Process.
Applicants for funding from AHRQ should ignore application instructions
concerning the Modular Grant Application and Award Process, and prepare
applications according to instructions provided in form PHS 398.
Applications submitted in the Modular format will be returned without review.
SENDING AN APPLICATION TO AHRQ: Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
(20817 for express/courier service)
At the time of submission, two additional copies of the application must also
be sent to:
Scott Young, M.D.
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1580
FAX: (301) 427-1597
Email: SYOUNG@AHRQ.GOV
APPLICATION PROCESSING
Applications must be received by the receipt dates listed in the heading of
this RFA. If an application is received after that date, it will be returned
to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is, the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes from the
previous unfunded version of the application.
Although there is no immediate acknowledgment of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
Applicants are encouraged to read all PHS Form 398 instructions prior to
preparing an application in response to this RFA. The PHS 398 type size
requirements (p.6) will be enforced rigorously and non-compliant applications
will be returned. State and local government applicants may use PHS 5161-1,
Application for Federal Assistance (rev. 5/96), and follow those requirements
for copy submission. It is very important to note that limitations on
number of pages and size of font must be observed; applications violating
these requirements will be returned without review.
Institutional Review Board (IRB) approval of human subjects is not required
prior to peer review of an AHRQ application. The “AHRQ Revised Policy for
IRB Review of Human Subjects Protocols in Grant Applications” was published
in the NIH Guide on September 27, 2000.
http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html
The RFA is also available on AHRQ’s Web site, http://www.AHRQ.gov, (see under
Funding Opportunities).
Application Preparation (for Using CMS Data)
Purchase of CMS public-use data, if required, should be discussed in the
application narrative and included in the budget. Projects will ordinarily
not use CMS (Medicare or Medicaid) data involving individual identifiers.
However, for applications that propose to use Medicare or Medicaid data that
are individually identifiable, applicants should state explicitly in the
“Research Design and Methods” section of the Research Plan (form 398) the
specific files, time periods, and cohorts proposed for the research. In
consultation with Center for Medicare and Medicaid Services (CMS), previously
called Health Care Financing Administration (HCFA), AHRQ will use this
information to develop a cost estimate for obtaining the data. This estimate
will be included in the estimated total cost of the grant at the time funding
decisions are made.
Applicants should be aware that for individually identifiable Medicare and
Medicaid data, Principal Investigators and their grantee institutions will be
required to enter into a Data Use Agreement (DUA) with CMS to protect the
confidentiality of data in accordance with AHRQ’s confidentiality statue, 42
USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable,
and standards set out in OMB Circular A-130, Appendix III–Security of Federal
Automated Information Systems. The use of the data will be restricted to the
purposes and time period specified in the DUA. At the end of this time
period, the grantee will be required to return the data to CMS or certify
that the data have been destroyed.
Unless AHRQ is able to negotiate exceptional arrangements included in the DUA
is the requirement that the User agrees to submit to CMS, a copy of all
findings within 30 days of making such findings, for the sole purpose of
assuring CMS that data confidentiality is maintained. The user further
agrees not to submit these findings to any third party (including but not
limited to any manuscript to be submitted for publication) until receiving
CMS’s approval to do so.
In developing research plans, applicants should allow time for refining,
obtaining approval, and processing of their CMS data requests. Requests may
take 6 months from the time they are submitted to complete. Applications
proposing to contact beneficiaries or their providers require the approval of
the CMS Director and may require meeting(s) with CMS staff.
CMS data are provided on IBM mainframe tapes using the record and data
formats commonly employed on these computers. Applicants should either have
the capability to process these tapes and formats or plan to make
arrangements to securely convert them to other media and formats.
Questions regarding CMS data should be directed to the AHRQ program official
listed under INQUIRIES.
Assessment of AHRQ Grant Programs
In carrying out its stewardship of research programs, the AHRQ may request
information essential to an assessment of the effectiveness of Agency
research programs. Accordingly, grant recipients are hereby notified that
they may be contacted after the completion of awards for periodic updates on
publications resulting from AHRQ grant awards, and other information helpful
in evaluating the impact of AHRQ-sponsored research.
AHRQ expects grant recipients to keep the Agency informed of publications as
well as the known uses and impact of their Agency-sponsored research.
Applicants are to agree to notify AHRQ immediately when a manuscript based on
research supported by the grant is accepted for publication, and to provide
the expected date of publication as soon as it is known, regardless of
whether or not the grant award is still active.
To receive an award, applicants must agree to submit an original and 2 copies
of an abstract, executive summary, and full report of the research results in
the format prescribed by AHRQ no later than 90 days after the end of the
project period. The executive summary should be sent at the same time on a
computer disk which specifies on the label the format used (Word Perfect, or
Word, or ASCII format).
The past cooperation of applicants with regard to the submissions described
in this section may be considered in the application review to assess
applicants’ potential for responsible stewardship of awarded funds.
TECHNICAL ASSISTANCE
AHRQ encourages applicants to take advantage of a technical assistance
conference call sponsored by AHRQ program staff. This two hour conference
call will provide potential applicants with background information and
respond to questions about the preparation of an application in response to
this RFA. Participants are encouraged to submit questions via email prior to
the conference call. Please submit up to five questions with your name and
the name of your institution to HITImplementationRFA@AHRQ.gov by January 27,
2004. Questions of a similar topic and nature may be grouped at the sole
discretion of AHRQ staff. The conference call is open to any individual or
organization intending to apply. Participation is not a prerequisite to
applying. The conference call will take place on January 29, 2004 at 1:00
EST and last approximately 2 ½ hrs. The last hour of the call will be
reserved exclusively for issues relevant to small community and rural
applicants. To register to participate in the call, please send your request
to HITImplementationRFA@AHRQ.gov by January 27, 2004.
Transcripts of the conference call will be available seven business days
after the call. Please send your request for a copy of the transcripts to
HITImplementationRFA@AHRQ.gov.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness and
responsiveness to the RFA. Incomplete and/or non-responsive applications or
applications not following instructions given in this RFA will be returned to
the applicant without further consideration. An appropriate peer review
group convened in accordance with standard AHRQ Special Emphasis Panel (SEP)
peer review procedures will evaluate 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.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened in accordance with standard AHRQ peer review procedures.
As part of the merit review, all applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit will be discussed and assigned a priority score.
o Receive a written critique
REVIEW CRITERIA
In the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of AHRQ-
supported research goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
o Budget
The scientific review group will address and consider each of these criteria
in assigning your application’s overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have a major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) 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?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? 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?
(3) 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?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry
out this work? Is the work proposed appropriate to your experience level as
the principal investigator 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?
(5) ENVIRONMENT: Does the environment in which your work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
(6) 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 share of the challenge grant. 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
PROTECTIONS: The adequacy of the proposed protection for humans or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
INCLUSION: The adequacy of plans to address the need of both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
aims of the project. Adequacy of attention to other populations of special
priority to AHRQ (see discussion on Priority Populations in the section on
Special Requirements, above, and Inclusion Criteria included in the section
on Agency Policies and Requirements, 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
active participation, resource allocation form partners toward the project
and commitment to sustain the project after completion of the grant. Ability
to demonstrate broad community commitment to the 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 already
completed 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;
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) The adequacy of evaluation of success of the implementation process.
2. The potential of the organization to implement and sustain its HIT plan:
a) Adequacy of the commitment of the members of the collaborative to
implement HIT, as evidenced by previous work in HIT implementation, letters
of support, or success with similar projects;
b) Adequacy of the organization to address the healthcare of priority
populations, especially the needs of small/rural healthcare providers and
communities;
c) Adequacy and stability of the organization’s administrative,
organizational and management capabilities;
d) 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;
e) 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
f) The 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.
ADDITIONAL CONSIDERATIONS
DATA SHARING:
Data Confidentiality
Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c-
3(c)), information obtained in the course of any AHRQ supported-study that
identifies an individual or entity must be treated as confidential in
accordance with any explicit or implicit promises made regarding the possible
uses and disclosures of such data. There are now civil monetary penalties for
violation of this confidentiality statute [42 U.S.C.299c-3(d)). In the Human
Subjects section of the application, applicants must describe procedures for
ensuring the confidentiality of the identifying information to be collected.
The description of the procedures should include a discussion of who will be
permitted access to the information, both raw data and machine readable
files, and how personal identifiers and other identifying or identifiable
data will be restricted and safeguarded. Identifiable patient health
information collected by grantees under this RFA will also be managed in
accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to
the privacy of protected health information. These privacy regulations,
developed by the Department of Health and Human Services pursuant to the
Health Insurance Portability and Accountability Act of 1996 (HIPAA) became
mandatory for covered entities on April 14, 2003. These regulations serve to
limit the disclosure of personally identifiable patient information by
covered entities and define when and how such information can be disclosed
e.g., to researchers. Thus, for example, health care plans, will require
either patient authorization of disclosures of identifiable information to be
made to researchers or waivers of such authorizations obtained from an IRB or
Privacy Board (defined in the regulations) satisfied that any identifiable
health information will be appropriately safeguarded by the investigators.
The HHS Office of Civil Rights is the enforcement body for this regulation.
Additional information about the regulations, their implementation, and
alternative methods of permissible disclosures to researchers (limited data
sets with data use agreements, de-identified data sets, data about deceased
persons, and data use to develop protocols) can be obtained from:
http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/
The awardee should ensure that computer systems containing confidential data
have a level and scope of security that equals or exceeds those established
by the Office of Management and Budget (OMB) in OMB Circular No. A-130,
Appendix III - Security of Federal Automated Information Systems. The
National Institute of Standards and Technology (NIST) has published several
implementation guides for this circular. They are: An Introduction to
Computer Security: The NIST Handbook; Generally Accepted Principals and
Practices for Securing Information Technology Systems; and Guide for
Developing Security Plans for Information Technology Systems. The circular
and guides are available on the web at
http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and
intended means of applying these confidentiality and security standards to
subcontractors and vendors, if any, should be addressed in the application.
Rights in Data
AHRQ grantees may copyright, unless otherwise provided in grant awards, or
seek patents, as appropriate, for final and interim products and materials
including, but not limited to, methodological tools, measures, software with
documentation, literature searches, and analyses, which are developed in
whole or in part with AHRQ funds. Such copyrights and patents are subject to
a worldwide irrevocable Federal government license to use and permit others
to use these products and materials for government purposes. In accordance
with its legislative dissemination mandate, AHRQ purposes may include,
subject to statutory confidentiality protections, making project materials,
databases, results, and algorithms available for verification or replication
by other researchers; and subject to AHRQ budget constraints, final products
may be made available to the health care community and the public by AHRQ or
its agents, if such distribution would significantly increase access to a
product and thereby produce substantial or valuable public health benefits.
Ordinarily, to accomplish distribution, AHRQ publicizes research findings but
relies on grantees to publish research results in peer-reviewed journals and
to market grant-supported products. AHRQ's Office of Health Care Information
wishes to be consulted in advance of publication in order to coordinate these
issuances with other AHRQ dissemination activities. Important legal rights
and requirements applicable to AHRQ grantees are set out or referenced in the
AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries
and from the GPO's website http://www.gpoaccess.gov/cfr/index.html).
RECEIPT AND REVIEW SCHEDULE
Technical Assistance Call: January 29, 2004
Letter of Intent Receipt Date: February 6, 2004
Application Receipt Date: April 22, 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS:
It is the policy of AHRQ that women and members of minority groups be
included in all AHRQ-supported research projects involving human subjects,
unless a clear and compelling rationale and justification are provided that
inclusion is inappropriate with respect to the health of the subjects or the
purpose of the research.
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects
in Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html).
A complete copy of the updated Guidelines is available at:
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the
extent possible, AHRQ requires adherence to these NIH Guidelines.
Investigators may obtain copies from the above sources or from the AHRQ
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web
site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may
also provide additional information concerning these policies (see
INQUIRIES).
AHRQ also encourages investigators to consider including children in study
populations, as appropriate.
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 website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a
set of decision tools that may be used to determine whether a researcher is a
staff of a covered entity. Project Officers will assist grantees in
resolving questions about the applicability of HIPAA requirements.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting health improvement
priorities for the United States. AHRQ encourages applicants to submit grant
applications with relevance to the specific objectives of this initiative.
Potential applicants may obtain a copy of "Healthy People 2010" at:
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance, Number 93.226. Awards are made under Title IX
of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-
129 (1999). Awards are administered under the PHS Grants Policy Statement
and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92.
This program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
REFERENCES
o McGlynn EA, et al. The quality of health care delivered to adults in the
United States. N Engl J Med. 2003;348:2635-45.
o Kohn LT, Corrigan JM, Donaldson MS, Eds. To err is human: building a
safer health system. Washington, D.C. National Academy Press, 1999.
o Corrigan JM, Donaldson MS, Kohn LT, Eds. Crossing the quality chasm: a
new health system for the 21st century. Washington, D.C. National Academy
Press, 2001.
o 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.
o 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.
o Overhage JM, Tierney WM, Zhou XH, McDonald CJ. A randomized trial of
“corollary orders” to prevent errors of omission. JAMIA. 1997;4:364-75.
o 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.
o 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.
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