Research (OER)
9000 Rockville Pike
Bethesda, Maryland 20892
and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.
SAFE PRACTICES IMPLEMENTATION CHALLENGE GRANTS
RELEASE DATE: April 4, 2003
RFA: HS-03-005
Agency for Healthcare Research and Quality (AHRQ)
(http://www.ahrq.gov)
Centers for Disease Control and Prevention (CDC)
(http://www.cdc.gov)
Centers for Medicare and Medicaid Services (CMS)
(http://www.cms.gov)
Food and Drug Administration (FDA)
(http://www.fda.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER(S): 93.226
LETTER OF INTENT RECEIPT DATE: June 15, 2003
APPLICATION RECEIPT DATE: July 15, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION:
o Purpose of the RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Agencies
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
o References
PURPOSE OF THE RFA
The Secretary of the U.S. Department of Health and Human Services
(DHHS) has established the Patient Safety Task Force (PSTF) with the
mission to coordinate research and analysis efforts across the
Department, and to collaborate on reducing the occurrence of injuries
that result from medical error. The PSTF brings together the Agency for
Healthcare Research and Quality (AHRQ), the Centers for Disease Control
and Prevention (CDC), the Centers for Medicare and Medicaid Services
(CMS) and the Food and Drug Administration (FDA) to integrate and
coordinate their activities related to patient safety and the reduction
of medical errors.
AHRQ and PSTF announce the availability of funds to assist health care
institutions to: (1) assess risks and known hazards to patients in the
process of care leading to preventable injuries or harm, and devise
intervention strategies; and (2) implement safe practices that show
evidence of eliminating or reducing the known risks and hazard
associated with the process of care. A cost sharing of a minimum of 50
percent 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 likelihood of success if the recipient
contributes to the costs of the project. Eligible institutions must
demonstrate evidence of commitment to reducing the potential for harm
from preventable medical error and improving patient safety through the
identification of risks and hazards and eliminating them by
implementing safe practices. Two type of projects are requested in the
RFA with approximately half the total number of awards being funded in
each category.
Risk assessment and intervention planning projects are intended for
organizations that are in process of identifying risk areas. These
planning projects are for those identified areas that represent a
significant threat to patient safety for which further assessments are
needed to identify the specific target risks and hazards with the risk
area to be eliminated or reduced and to make the process of care safer.
The use of established assessment and analytic approaches, including
root cause analysis, process mapping, failure mode and effects analysis
(FMEA), and probabilistic risk assessment (PRA), are strongly
suggested. Once specific target risks are identified, then
intervention strategies for the target risks can be designed. These
risk assessment planning grants will be no more than 12 months in
duration.
Patient Safety Implementation projects - Organizations and provider
networks wishing to introduce safe practices, to minimize or eliminate
the potential for risks of injury or harm to patients from the process
of care, may submit a second type of application for implementation
project. The determination of the safe practice may be from published
recommendation of safe practices such as ARHQ's Evidence
Report/Technology Assessment Number 43, Making Health Care Safer: A
Critical Analysis of Patient Safety Practices (See ref.1); the National
Quality Forum's (NQF) Safe Practices for Better Health Care (See
ref.2); and Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) (See ref.3) six patient safety priorities. Safe
practices may be derived from ongoing research findings from patient
safety grants and projects funded by AHRQ and/or other funding
agencies. Organizations are expected to identify the target risk that
is to be addressed by the safe practice, develop a complete
implementation plan for introducing the safe practice intervention, and
provide an evaluation plan to determine whether the safe practice did,
indeed, eliminate the target risk, was the practice adopted by health
care professions within the organization and what was the impact of the
practice on the process of care. The implementation projects can be up
to 24 months in duration. Currently funded AHRQ safety improvement
projects that are poised to build upon and expand initial results to
additional settings or populations are also eligible to apply under
this RFA.. All implementation projects are expected to identify
anticipated outcomes prospectively.
AHRQ seeks to support projects that can be generalized to other
settings for use by those who wish to assess risks and devise
intervention strategies, or adopt safe practices to eliminate or
minimize the risk of harm to patients from the process of care. These
cooperative agreements are intended to capitalize on advances in
knowledge about medical errors and translate established strategies to
reduce medical errors into the adoption of proven safe practices.
RESEARCH OBJECTIVES
Definitions
For purposes of this RFA, these terms have been defined and may not be
wholly consistent with other organizations' use of the terms:
o The goal of patient safety is to reduce the risk of injury and harm
from preventable medical errors. This goal can be accomplished by
removing or minimizing hazards, which are known to increase the risk of
injury to patients.
o Errors are actions or inactions that lead to deviations from
intentions or expectations. Errors can include problems in practice,
products, procedures, and systems.
o Active failures are errors and violations committed by those in
direct contact with the human-system interface. (See ref. 3)
o Sharp end individuals are in direct contact with the human-system
interface. In health care, sharp end individuals administer care to
patients. Their actions and decisions may result in active failures.
(See ref. 3)
o Latent conditions are the delayed consequences of technical and
organizational actions and decisions. These underlying conditions may
predispose sharp end individuals to fail.
o Blunt end individuals take actions and/or make decisions that
affect technical and organization policy and procedures and allocate
resources. Their actions and decisions may result in latent
conditions. Examples of such decisions include those related to
staffing and resource allocation.
o Knowledge-based behavior involves the conscious application of
existing knowledge to manage novel situations. (See ref. 4)
o Rule-based behavior is decision making involving the application of
existing rules or schemas to manage familiar situations. (See ref. 4)
o Skill-based behavior refers to automatic tasks requiring limited or
no cognitive attention during execution. (See ref. 4)
o Slips are inadvertent skill-based failures of commission (doing
the wrong thing).
o Lapses are skill-based failures of knowing what to do but failing
to do it, omitting a step or losing one's place in a process; failures
of omission. (See ref. 3)
o Fumbles are skill-based failure of whole body movement such as
dropping something. (See ref. 3)
o Mistakes are rule based failures of planned actions/rules to be
completed as intended or selecting the wrong rule to achieve an aim.
(See ref. 3)
o Risk is the possibility/probability of occurrence or recurrence of
an event multiplied by the severity of the event. (See ref. 5)
o Hazard is anything that can cause harm. (See ref. 5)
o Events are deviations in activities or technologies which lead
towards unwanted negative consequences. (See ref. 6) Events can be
classified in three different categories. (See ref. 7)
o Adverse event/misadventures are occurrences during clinical care
that result in physical or psychological injury or harm to a patient or
harm to the mission of the organization.
o Sentinel events are events in which death or serious harm to a
patient has occurred.
o No-harm events are events that have occurred but result in no
actual harm although the potential for harm may have been present.
Lack of harm may be due to the robust nature of human physiology or
pure luck. An example of such, a no-harm event would be the issuing of
an ABO incompatible unit of blood for a patient, but the unit was not
transfused and was returned to the blood bank.
o Near misses are defined as events in which the unwanted
consequences were prevented because there was a recovery by
identification and correction of the failure, either planned or
unplanned. (See ref. 8)
o Dangerous situations are where both human and latent failure exist
that create a hazard increasing the risk of harm. Information may be
collected from individuals familiar with the process of care in
organizations about conditions that are highly likely to cause an
injury to a patient or patients.
o Safe practices are those practices for which there is evidence that
they reduce the risk of adverse events related to exposure to medical
care across a range of diagnoses or conditions. (See ref. 1)
Background
Patient safety is a top priority in the Nation today. The Institute of
Medicine (IOM) report entitled "To Err is Human", (in ref. 9) estimated
that between 44,000 and 98,000 people die each year in hospitals from
medical errors. The majority of these errors are a result of systemic
problems rather than poor performance by individual providers.
Although, the United States provides some of the best health care in
the world, the number of patients that are being harmed as a result of
the process of health care is unacceptably high. In response to the
IOM report, the Quality Interagency Coordination Task Force (QuIC),
which is composed of Federal members representing the Departments of
Health and Human Services (DHHS), Labor (DoL), Defense (DoD), Veterans
Affairs (VA), and Commerce; Office of Management and Budget (OMB);
Office of Personnel Management (OPM); U.S. Coast Guard, Federal Bureau
of Prisons (BoP); National Highway Transportation and Safety
Administration; and the Federal Trade Commission (FTC), issued a report
in February 2000 "Doing What Counts for Patient Safety, Federal Action
to Reduce Medical Errors and Their Impact". (See ref. 10)
The QuIC's report laid out a road map for action comprising more than
100 activities. The goals of these actions are to: 1) create a
national focus on reducing errors; 2) develop a knowledge base for
learning about errors' causes and effective error prevention; 3)
ensure accountability for safe health care delivery; and 4) guarantee
that patient safety practices are implemented.
AHRQ's reauthorization in 1999 specified that the Director of the AHRQ
"shall conduct and support research and build private-public
partnerships to 1) identify the causes of preventable health care
errors and patient injury in health care delivery; 2) develop,
demonstrate, and evaluate strategies for reducing errors and improving
patient safety; and 3) disseminate such effective strategies throughout
the health care industry."
John Eisenberg, the late director of AHRQ, declared that medical error
was an "epidemic of worldwide portions" and called for a "war on
medical error." (See ref. 11) This medical error epidemic has three
stages of action to ensure that the "epidemic" is contained. These
stages are:
Stage One: Assessment and Evaluation
o Identify the causes of preventable errors and the hazards that
increase the risk of injury to patients.
o Raise the awareness that patients are at risk for iatrogenic injury
and harm.
o Build the capacity for research and development.
Stage Two: Patient Safety Improvement
o Implement patient safety practices that eliminate known hazards and
reduce the risk of injury to patients.
o Design, test and implement practices and processes that eliminate
hazards and reduce the risk of iatrogenic injury.
o Develop a positive patient safety culture.
Stage Three: Sustaining Improvements
o Maintain vigilance to ensure that a safe environment continues and
positive safety cultures are maintained.
This epidemic model is AHRQ's paradigm for the long range plan for
patient safety. AHRQ has approached improving patient safety through
an integrated set of activities to address each of the stages of this
model. Examples of these activities include the design and testing of
best practices for reducing errors in multiple settings of care;
developing the science base to inform reduction of medical error, as
well as improving provider training in the reduction of errors; using
advances in information technology to translate proven effective
strategies into widespread practice; and building the capacity to
further reduce the opportunity for errors in the future. AHRQ and its
partner members of the PSTF have also been supporting ways to identify
risk and hazards with various reporting systems and the development of
patient safety and quality indicators to identify, evaluate, and
monitor the incidence of adverse events using readily available
administrative data. AHRQ's activities complement related efforts in
other DHHS components, to produce desired improvements in quality and
safety. It is through the cooperative efforts of AHRQ, CDC, CMS, and
FDA that comprise the PSTF that this RFA has been developed.
The majority of research and programmatic efforts are currently at
stage one in the epidemic cycle, with the primary focus on the
identification of risks and hazards to patients from iatrogenic injury
and building the capacity for patient safety research. This initiative
is intended to enhance efforts in improving patient safety (stage two).
The IOM report "To Error is Human" addressed much of its
recommendations to what should be done at a national level by the
government and other regulatory bodies to deal with issues at stage one
of the epidemic model. However, its last recommendation was directed
at implementing safety systems in heath care organizations. Based on
insights from other industries, patient safety programs should:
o provide strong, clear and visible attention to safety;
o incorporate well-understood safety principles, such as
standardizing and simplifying equipment, supplies, and precesses;
interdisciplinary team training programs for providers that incorporate
proven methods of team training, such as simulation; and
o implement proven medical safety practices. (See ref. 9 p.14)
The IOM indicated that designing safe systems requires an understanding
of the causes of errors and how to use safety design concepts to
minimize these errors which allow detection before harm occurs. There
are two main classifications of error (i.e., failure) – active and
latent. (See ref. 3) Active failures are errors and violations
committed by those in direct contact with the human-system interface
and are what we commonly refer to as human errors. Rasmussen (See ref.
4) has provided a useful human behavioral taxonomy for active errors.
His classification begins with knowledge-based decision making at the
top of a hierarchy of actions or decisions. Knowledge-based behavior
involves the conscious application of existing knowledge to manage
novel situations. In contrast, rule-based decision making involves the
application of existing rules or schemes to manage familiar situations.
Prolonged, active processing is not required, simply the selection and
application of the appropriate rule. Latent conditions, or system
failures are the delayed consequences of technical design or
organizational issues and decisions. Reason (See ref. 3) refers to
these latent conditions or system failures as "organizational
pathogens," that lie in wait for the right opportunity to become
active. Accidents (as defined in the human-error literature) and
adverse events happen when latent conditions or system failures,
combine with active human failures. Reason stresses studying the
latent conditions because they may well set up humans for failure.
Thus, safety researchers stress the importance of examining both active
human failures and looking at underlying latent conditions and system
issues that contribute to the potential for injury and harm. Van der
Schaaf (See ref. 8) emphasizes that it is important to document how
health professionals identify errors and recover from combinations of
active and latent conditions, thus preventing events from having
adverse consequences.
Donabedian's structure - process - outcome model (See ref. 12) has
served as a conceptual framework for health services research for over
30 years. In the case of patient safety, there is concern that risks
and hazards that are embedded within the structure and process of care
have the potential for causing injury and or harm to patients. Within
the process of care is the potential for active failure from individual
actions of members of the health care team. "Organizational
pathogens", latent conditions within both the process and structure of
care -- can set up the sharp-end health care providers for failure.
Thus, to achieve the outcome of safe care, both the structure and
processes of care must be modified before these latent conditions
become active and cause unintended and avoidable patient harm. Van der
Schaaf has indicated that accurate identification of the root causes of
events must precede identification and implementation of appropriate
interventions. Moreover, solutions for active failures such as skill
based failures are different from rule-based, and are associated with
different latent failures in organizational process and structure. The
use of sophisticated risk assessment techniques including process
mapping, FMEA, and PRA can be used to identify at which point
previously defined interventions are most appropriate.
In health care, most instances of patient harm are attributed to
individuals at the sharp end of the care process. Both Morey (See ref.
13) and Van Cott (See ref. 14) point out that the prevention of these
active or sharp end failures require systems that are designed for
safety - that is a system in which the sources of active failure are
systematically recognized and minimized. Norman (See ref. 15) has
championed user-centered design using human factors or cognitive
engineering principles. He stresses, making things visible,
simplifying the structure of tasks, use of process mapping, forcing
functions to guide the uses, assuming that things will fail and plan
for recovery, and avoid recycling previous failure prone designs.
There is a growing trend to improve processes using mistake proofing
techniques which design out active failures. Mistake proofing often
involves relatively inexpensive changes to systems that can have high
returns on investment. (See ref. 16) Shigeo Shingo, (See ref. 17)
Toyota's quality control expert has used the term poka-yoke for devices
to eliminate active failures. Poka-yoke's or mistake proofing
approaches are essential for system improvements and making the health
care process safer for patients. An example of mistake proofing would
be the connectors on anesthesia equipment that will not allow the
switching of different gases or the blood lock which prevents the
transfusion of a unit of blood without the correct patient
identification code.
The IOM report also stressed the importance of automating repetitive,
time-consuming, and error-prone tasks through the use of technology.
(See ref. 9) The use of technology to eliminate skill- and rule-
based human error has been an important theme in the patient safety
movement. Skill-based behavior refers to "automatic" tasks requiring
little or no conscious attention during execution whereas rule-based
behavior involves the application of existing convention, policy, or
schemes to manage familiar situations. The IOM's recommendation is
based in part on the experience in high-risk industries such as nuclear
power and aviation where technology has been introduced as a means of
improving human performance.
Despite the promise of improved safety through technology, a number of
safety experts note that there are limits to technology. Billings (See
ref. 18) stresses that there is an important human-centered aspect
related to the ways in which individuals interact with technology.
Cook emphasizes that future failures of automated systems cannot be
forestalled by providing simply another layer of defense against
failure. "Rather, safe equipment design and use depends on a chain of
involvement and commitment that begins with the manufacturer and
continues with careful attention to the vulnerabilities of a new device
or system" in a real-world environment. (See ref. 19) Despite
designers' best intentions, the IOM report committee emphasized that
"All technology introduces new errors, even when its sole purpose is to
prevent errors." Consequently as change occurs, health systems should
anticipate and prevent trouble. (See ref. 9, pg. 175)
Kukla et. al. (See ref. 20) lists four design criteria or system
requirements for technology-based systems. It must be: 1) technically
efficient (i.e., reduce costs, increase ease of operation, or increase
productivity of the process); 2) easy to use (i.e., users must be able
to focus on their work rather than on the technology); 3) a better way
for operators to do their job (or at least as good as current methods);
and 4) adaptable to shifting constraints and priorities of changing
business conditions.
Corbett (See ref. 21) has indicated that as many as 75 percent of
companies have achieved less than their expected benefit from advanced
manufacturing technology primarily because of unanticipated problems
with human-machine interaction. He identified five points that define
the design issues relating to the interface: 1) allocation of functions
between humans and machines, 2) configuration of the architecture of
the system, 3) control characteristics of the human-machine interface,
4) informational characteristics of the human-machine interface, and 5)
allocation of responsibilities among users such as operating and
support personnel.
Weiner (See ref. 22) has addressed the issue of reliability of
technology indicating that as systems become more and more reliable,
overconfidence may develop on the part of both operators and managers
in the system's infallibility creating the situation that, "nothing
recedes like success." He addresses three issues relating to the
influences of automation: 1) situation awareness, 2) defining the
optimum level of technology, and 3) appropriate level of trust in the
system's reliability. To the degree that technology may cause the
operator to be "out of the loop," there may be a loss of awareness of
the system's immediate (present) state and less capability of the
operator to intervene when needed. The challenge for system designers
is to sufficiently engage the operator without sacrificing the benefits
of automation. A correlate of this concern relates to trust. Because
no system operates with absolute reliability, too high a level of trust
may be problematic. Two major components, accuracy/precision and
availability, define the reliability of an automated system. Both are
critical in the successful operation of a system. However,
paradoxically, if reliability of the system is very high, operator
vigilance is likely to decrease so that early signs of system change
are less likely to be detected. Additionally, confidence in
availability may decrease the probability of system redundancy and
backup. Skills for backup or crisis mode operation are then less
likely to be well–practiced, and the risk of error becomes greater when
unplanned, unpracticed changes are performed under pressure.
Operational complacency remains problematic unless process control and
an external quality assurance function help adjust the degree of trust
to more appropriate levels. A lesson can be learned from Xerox when
they moved from technical reliability to perceived reliability. (See
ref. 23) Instead of focusing exclusively on failure proof systems,
Xerox designed for ease of use and provided learning experiences for
the operators, "when users learn how to recover from paper jams
effortlessly, then paper jams became much less of a usability problem."
When users or operators of technology-based systems are aware of
potential failures and understand recovery, they are more mindful and
alert.
The important lesson learned from aviation and other industries is that
when new technology-based systems are introduced into an existing
process, there is an important interaction between human behavior,
organizational procedures, policies, and culture. It is within this
nested context and under actual operational conditions that a new
technology needs to be studied to examine actual and potential failure
points. It is not only the technology itself (technical design) that
must be studied, but also the organizational and human factor aspects
of its actual working environment. It is through the observation of
system operations and a review of reported failures and near misses
associated with the entire work flow process that information can be
gained on potential errors and possible failures.
While technology-based solutions can address some active failures,
latent conditions may not be able to be addressed with a technical
intervention. Organizational changes and the restructuring of the work
or care process are equally important. Many risks and hazards are
contained within less than optimal processes of care which do not lend
themselves to technical solutions but rather require changes to the
process and structure of care. The actual conditions of health care
work may well need significant modification or change to reduce the
potential from patient harm.
Both AHRQ and the PSTF believe that ultimately patient safety is a
local issue that must be addressed by each heath care organization at
the point of care. However, the Federal government can and is willing
to help local health care organizations meet the challenge of patient
safety. As part of its long range plan for patient safety, AHRQ has
established the following goals related to this RFA:
1) Performance Goal: Accelerate the implementation by local health
care organizations of evidence based "safe practices" that eliminate
identified hazards and/or reduce the risk of harm to patients.
2) Indicator: Health care institutions are willing and able to
successfully implement safe practices which have reduced actual or
potential harm to patients.
As part of the identification process in stage one, AHRQ commissioned a
systematic review of patient safety practices; a total of 79 practices
were reviewed. The resulting report has served as a starting point for
determining what safe practices institutions might wish to consider for
adoption (See ref. 1). The National Quality Forum has also established
recommendation for patient safety practices for which there is
indication for adoption (See ref. 2). In July 2002, the Joint
Commission's Board of Commissioners approved the Joint Commission 2003
National Patient Safety Goals. JCAHO established goals to help
accredited organizations address specific areas of concern in regards
to patient safety. Each goal includes no more than two succinct,
evidence- or expert-based recommendations. To ensure a greater focus
on priority safe practices, no more than six goals are established for
any given year (See ref. 3). Another source for safe practices is the
"Pathways for Medication Safety" developed by the American Hospital
Association, the Research and Educational Trust and the Institute for
Safe Medical Practice with the support from the Commonwealth Fund.
Building on these reports and recommendations, AHRQ and the PSTF have
developed the Safe Practices Challenge Grants RFA to assist
institutions to move from stage one of the epidemic process to stage
two, actual implementation of interventions to eliminate or reduce the
risk of injury and harm to patients from the process of care they
receive.
The anticipated objectives of risk assessment projects are to be well
documented risk assessment reports and suggested approaches to
eliminate the identified risk.
The anticipated goal of the patient safety practice implementation
projects would be a well developed case study documenting the impact of
the safe practice on patient care and the manner in which barriers to
adoption and implementation were overcome.
MECHANISM OF SUPPORT
This RFA will use the Cooperative Agreement U18 award mechanism because
the agency will have substantial involvement in the monitoring and
evaluation of these projects. There is a cost sharing requirement of a
minimum 50 percent of total costs allocated to the project.
Applicants, will be solely responsibility for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation.
Future unsolicited, competing continuation applications based on
projects will compete with all investigator-initiated applications
(R18) and will be reviewed according to the customary peer review
procedures. Cost sharing will be required of any continuation proposal
for challenge grant activities as outlined in this RFA. The anticipated
award date is September 30, 2003.
AHRQ is not using the Modular Grant Application and Award Process.
The U18 is a cooperative agreement award mechanism in which the
Principal Investigator retains the primary responsibility and dominant
role for planning, directing, and executing the proposed project, with
AHRQ staff being substantially involved as a partner with the Principal
Investigator, as described under the section "Cooperative Agreement
Terms and Conditions of Award."
FUNDS AVAILABLE
The AHRQ and the PSTF intend to commit approximately $ 3 million in
total costs in FY 03 to fund five to ten new grants in response to this
RFA. It is anticipated that half of the grant awards will be for risk
assessment projects and half for implementation projects. Because of
the nature and scope of the challenge projects will vary from
application to application, it is anticipated that the size and
duration of each award will also vary.
Application for risk assessment projects can be up to 12 months in
length with a total budget supported by AHRQ not to exceed $200,000 in
total costs to the government. The cost sharing portion is a minimum
with no maximum. A 12 month period of time for the risk assessment
process is considered adequate for a well developed project. An
example of institutional contributions for risk assessment projects
could be internal personnel resources with grant funding being applied
to external consultants. Applications for implementation projects can
be up to 24 months in duration with a total budget supported by AHRQ
not to exceed $500,000 per year in total costs to the government.
Again, the cost sharing portion is a minimum with no maximum. An
example for implementation grants could the use of grant funds for
resource procurement while internal funding could be for personnel and
used for implementation. The total cost for these projects including
the organization's contribution to cost sharing does not have an upper
limit, only the governments portion of the challenge has an upper
limit. Although the financial plans of AHRQ and the PSTF provide
support for this program, awards pursuant to this RFA are contingent
upon the availability of funds and the receipt of a sufficient number
of meritorious applications. Funding beyond the initial budget period
will depend upon annual progress reviews by AHRQ and availability of funds.
ELIGIBLE INSTITUTIONS
Eligible institutions are those that have any of the following
characteristics:
o For-profit or non-profit organizations
o Domestic and foreign
o Public and private non-profit institutions, such as universities,
clinics, colleges, and hospitals
o Units of State and local governments
o Faith-based or community-based organizations
o Tribes and tribal organizations
Practice-based networks, such as Integrated Delivery System Research
Networks (ISDRN) and Primary Care Based Research Networks (PBRN) are
encouraged to apply.
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 section 501(c)4 of the internal revenue code
that engage in lobbying are not eligible.
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 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.
SPECIAL REQUIREMENTS
Since the RFA is intended to support the introduction of safe practices
in the delivery of health care, organizational entities that are not
health care provider organizations must have a provider organization
which is actively engaged in the delivery of health care as a
participating partner in the proposed project. For purposes of this RFA
a health care provider organization is defined as any organization
engaged in the direct delivery of care to patients in any setting
including in-patient, out patient or ambulatory, long term care, and/or
home care. Also included under this definition of health care provider
organizations are those organizations that dispense or directly collect
specimens, or engage in diagnostic processes (i.e., blood and urine
collection, blood centers, laboratories or organizations such as
pharmacies that dispense therapeutics).
This RFA is being issued as a challenge grant with the government
providing no more than 50 percent of the total costs of the project.
Institutions must be able to document their actual contribution to the
project and provide assurances that the organization is committed to
provide the funds and resources for its share of the challenge project.
Cost sharing may be provided in the form of direct and/or indirect
costs. As a result, if a category of cost, such as rent or executive
salaries, is treated as an indirect cost for purposes of the
organizations's indirect cost rate, then contributions to a grant in
these categories cannot be treated as a direct cost contribution.
Third party in-kind contributions may satisfy the cost sharing
requirement only when payment for them would be an allowable cost if
the party receiving the contributions were to pay for them. Volunteer
services may be furnished by professionals or technical personnel,
consultants, or other skilled or unskilled labor. Volunteered 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 the recipient had to pay for
them.
Generally cost sharing requirements may not be met from the following
sources: a) costs borne by another Federal grant or subaward; 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 subrecipient).
Cost sharing applies to all budget periods of the project. Applicants
must submit three separate budgets; the first budget documenting the
Federal share (non-cost sharing) dollars being requested. A second
budget must be provided documenting the cost sharing (non-Federal)
dollars that constitute the cost sharing requirement. A third budget
must be submitted which is a composite budget documenting the Federal
and cost sharing dollars. By providing separate budget presentations,
AHRQ and the PSTF will be clear on what dollars are being employed as
cost sharing. 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.
There are two types of projects that will be supported under this RFA,
(1) assess risks and known hazards to patients in the process of care
leading to preventable injuries or harm and devise intervention
strategies and (2) implement safe practices that show evidence of
eliminating or reducing the known risks and hazards associated with the
process of care. It is expected that no organization ready for
implementation will require nor apply for resources for risk assessment
projects. Therefore, an organization may only apply for one type of
project, either a risk assessment or an implementation project, but not
both.
Risk Assessment Projects
1. The applicant must identify a priority risk area to be assessed
such as hospital acquired infection, use of medical devices,
transfusion process, medication process, transitions of care from one
area to another, emergency care, intensive care, long term care,
ambulatory care, and the actual conditions of clinical work. The
application must be able to describe the manner in which the risk area
was identified and how it was established as a priority for the
organization. The information on the risk area should come from an
organization's event reporting, auditing or other risk
identification/management process and be specific to the organization
itself rather than a generic risk to health care in general.
Applicants are strongly encouraged to consider the AHRQ Patient Safety
Indicator at http://www.qualityindicators.ahrq.gov. in their risk assessment
process.
2. The applicant must describe the risk assessment methodology (i.e.,
FMEA, PRA) or combination of methods to be used and describe the
experience level in using these approaches. Applicants who have
limited experience in using risk assessment techniques are encouraged
to partner with individuals or organizations who possess such expertise
such as consultants, colleges of engineering, business, management, or
social sciences, DoE National Laboratories, or other appropriate
entities.
3. The applicant must develop a plan for selecting interventions that
will eliminate or reduce the target risk area that has been identified
in the risk assessment process. The plan should include how and in
what way different intervention strategies are to be assessed to
determine the most appropriate for dealing with the targeted risks.
Implementation Projects
1. The applicant must be able to document the risks and hazards that
are to be addressed with the implementation of a specific safe
practice. The applicant must document how these risk and hazards were
identified and the priority for the organization established. The
applicant must identify the patient population impacted by the risks
and hazards and outline the expected benefit from the implementation of
the safe practice.
2. The applicant must specify the safe practice to be introduced and
justify its selection as an intervention to eliminate or minimize the
risks and hazards identified. The application must reference the
evidence that supports the intervention to be introduced is a safe
practice.
3. The applicant must provide an implementation plan including a time
line for introducing the safe practice into the health care delivery
process. This plan should include the identification of barrier and
problems to be overcome in introducing the intervention.
4. Since implementation projects are intended to introduce
established or known safe practices, the safe practice selected must be
able to be implemented at least at the pilot stage within six months of
the award of the challenge grant.
5. Implementation projects that build upon or expand currently funded
AHRQ patient safety improvement projects must include clear budget for
additional expansions and anticipated outcomes.
6. The applicant must be able to assess the level of adoption and
acceptance of the innovation represented by the safe practice by health
care professionals who are to use the intervention.
7. The applicant must be able to document and assess the impact of the
safe practice on the process of care and the patient population being
addressed by the safe practice.
Cooperative Agreement Terms and Conditions of 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 Agency'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 (U18), an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial AHRQ
scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity. Under the cooperative
agreement, the AHRQ purpose is to support and/or stimulate the recipient's
activity by involvement in and otherwise working jointly with the award
recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity. Consistent with this
concept, the dominant role and prime responsibility for the activity 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:
Awardees will have primary and lead responsibilities for the project as
a whole, including research design and protocol development,
participant recruitment and follow-up, data collection, quality
control, preparation of publications exclusively about the data
collection, analysis, information dissemination and testing of
interventions to improve safety within their demonstration project.
They will be responsible for cooperating and collaborating with other
AHRQ awardees working on patient safety improvement with assistance
from the AHRQ Program Official(s)and the coordinating center (described
below). In addition, awardees are required to cooperate with AHRQ's
evaluation contractor that is assessing the relative effectiveness of
the different implementation projects funded under this program.
Awardees will retain custody of and have primary rights to the data
developed under these awards, subject to Government rights of access
consistent with current Department of Health and Human Services, Public
Health Services, and AHRQ policies.
Awardees must work with AHRQ and the coordinating center to disseminate
the case study description of the project implementation process for
other institutions who may wish to adopt safe practices.
2. AHRQ Staff Responsibilities
The AHRQ Program Officials for this program include the Director of the
Center for Quality Improvement and Patient Safety (CQuIPS) and the
project officers for the funded cooperative agreements. They will have
substantial scientific-programmatic involvement in all matters related
to developing common vocabulary, common evaluation methods, and data
collection that will enable collaboration and comparisons of the
relative strengths and weaknesses of each funded reporting system. The
dominant role and prime responsibility for the activity 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 Officials. AHRQ program officials may
participate in the analysis of data and author or co-author articles
that compare two or more of the awardees reporting systems or the
interventions to improve patient safety.
AHRQ expects award recipients to work with each other to test the
effectiveness of various methods of identify risk and risk assessment
process, adoption and implementation strategies for safe practices. To
enable these comparisons, AHRQ also expects awardees to work to enhance
the ability of an independent evaluator to review the projects and
synthesize information from the demonstrations about which methods for
risk assessment, implementation of safe practices, and communication
are most effective in improving patient safety or reducing risks to
patients.
Specifically, the (CQuIPS) within AHRQ will promote collaboration and
comparison of risk assessment approaches and implementation strategies.
AHRQ will contract with a coordinating center to facilitate the sharing
of information and to facilitate collaborations among recipient
demonstration projects. In addition, the AHRQ-supported coordinating
center will facilitate communication and sharing of ideas between the
safe practice projects and the Agency's funded patient safety project.
In addition, AHRQ contacted with RAND to conduct an evaluation of the
demonstration projects. RAND is responsible for assessing the
strengths and weaknesses of each approach to reporting. AHRQ will work
with the demonstration projects to ensure they are collecting
information that is necessary for the evaluation. AHRQ expects that
all funded patient safety projects will cooperate with the evaluation
contractor to provide needed information.
3. Steering Committee
A Steering Committee, composed of the principal investigator of each
grant, the director of the Coordinating Center, and AHRQ Program
Officials will be the main governing board of the study and will have
primary responsibility for developing common vocabulary, research
designs, facilitating the monitoring of studies, and reporting results
of comparisons between and among the demonstration projects (including
the interventions that are tested). The principal investigator from
each grant and the Coordinating Center, and the AHRQ Program Officials
will each have one vote.
Awardees will be required to accept and implement the common protocols
and procedures approved by the Steering Committee.
Principal Investigators will participate in Steering Committee meetings
three times per year and general collaborative conference calls on a
schedule as determined by the Steering Committee.
4. 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 Steering Committee (with the AHRQ
members not voting) or 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 selected members. This special
arbitration procedure in no way affects the awardee's right to appeal
an adverse action that is otherwise appealable in accordance with the
PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45
CFR Part 16.
These special Terms of Award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines. HHS grants
administration regulations at 45 CFR Part 74 and 92, 42 CFR Part 67
Subpart A, and other HHS, PHS grants administration policy statements.
Applicants should be familiar with the Agency's grant regulations, 42
CFR Part 67 Subpart A, and particularly section 67.18-67.22.
o Coordinating Center
Projects funded under the Safe Practices RFA are considered part of the
AHRQ and Patient Safety Research Portfolio. AHRQ has established a
Patient Safety Research Coordination Center (PSRCC) currently under
contract to Westat. The PSRCC provides a variety of services and
technical support to patient safety grantees including a variety of
communication linkages and resources. All grantee under this RFA are
expected to participate in the activities of the PSRCC including
participating in quarterly conference calls and an annual meeting of
all patient safety grantees held in March of each year in the
Washington DC area. The Principal Investigator and at least one
program staff member from the project are required to attend the annual
meeting. Therefore, in the preparation of the proposal an allocation
of travel funding for this meeting needs to be included in the budget
for the project.
o Patient Safety Program Evaluation Center
In addition to the PSRCC, AHRQ has created a program evaluation center
to document the impact of the entire patient safety portfolio. RAND
currently has the contract to operate the evaluation center as an
independent evaluator for the agency. Grantees under this RFA are
required to provide information and make themselves available for
potential site visits and respond to requests for information from the
evaluation center as needed and required. The existence of the
evaluation center does not eliminate the need for individual projects
to have an evaluation component within the project itself.
o Priority Populations
The Agency's authorizing legislation (refer to
http://www.ahrq.gov/hrqa99a.htm) directs special attention in Agency
programs to populations of inner-city areas and rural areas (including
frontier areas); low income groups; minority groups; women; children;
the elderly; and individuals with special health care needs, including
individuals with disabilities and individuals who need chronic care or
end-of-life health care. Applications under this RFA should address
attention to and potential benefits for these priority populations.
o Publication Transmittal: General AHRQ Requirements
In keeping with the Agency's efforts to translate the results of AHRQ-
funded research into practice and policy, grantees and/or contractors
are to inform the Office of Health Care Information (OHCI) when
articles from their studies are accepted for publication in the
professional literature. Grantees and contractors should also discuss
any ideas about other dissemination and marketing efforts with OHCI
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 OHCI 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 OHCI a brief plan describing how
the product will be publicized. An OHCI 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 programmatic issues, including
information on the inclusion of women, minorities, and children in
study populations to:
James B. Battles, Ph.D.
Senior Service Fellow for Patient Safety
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
6011 Executive Blvd. Suite 200
Rockville, MD 20852
Telephone: (301) 594-9892
FAX: (301) 594-2155
Email: jbattles@AHRQ.gov
o Direct your questions about peer review issues to:
Michele Hindi-Alexander
Health Scientist Administrator
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Room 401
Rockville, MD 20852
Telephone: (301) 594-6057
FAX: (301) 594-0154
Email: mhindi@AHRQ.gov
Direct your questions about financial or grant management matters to:
Joan Metcalfe
Grants Management Specialist
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD 20852
Telephone: (301) 594-1841
FAX: (301) 594-3210
Email: jmetcalf@ahrq.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows 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:
Lisa Krever
Center for Quality Improvement and Patient safety
Agency for Healthcare Research and Quality
6011 Executive Blvd. Suite 200
Rockville, MD 20852
Telephone: (301) 594-1783
FAX: (301) 594-2155
E-mail Address: lkrever@AHRQ.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and form (rev. 5/2001). The PHS 398 is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact Grants Info,
Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
State and local government applicants may use PHS 5161-1, Application
for Federal Assistance (rev. 5/96), and follow those requirements for
copy submission. To ensure equity among applicants, however,
applicants using this form must observe page number and font size
requirements specified in the Form PHS 398. AHRQ encourages use of
Form PHS 398 in preference to Form 5161-1.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: AHRQ is not
using the Modular Grant Application and Award Process. Applicants for
funding from AHRQ should ignore application instructions concerning the
Modular Grant Application and Award Process, and prepare applications
according to instructions provided in form PHS 398. Applications
submitted in the Modular format will be returned without review.
SENDING AN APPLICATION TO THE NIH and AHRQ: Submit a signed,
typewritten original of the application, including the checklist, and
three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
(20817 for express/courier service)
At the time of submission, two additional hard copies and one
electronic copy (Word or Word Perfect format) of the application,
labeled "Advanced Copy(s)" must also be sent to:
Lisa Krever
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
6011 Executive Blvd. Suite 200
Rockville, MD 20852
Telephone: (301) 594-1783
FAX: (301) 594-2155
E-mail Address: lkrever@AHRQ.gov
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date 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) and AHRQ will not accept any
application in response to this RFA that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to 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. While the investigator may
still benefit from the previous review, the RFA application is not to
state explicitly how.
Although there is no immediate acknowledgement 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 Forms 398 instructions prior
to preparing an application in response to this RFA. The PHS 398 type
size requirements (p.6) will be enforced rigorously and non-compliant
applications will be returned. State and local government applicants
may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and
follow those requirements for copy submission. It is very important to
note that limitations on number of pages and size of font must be
observed; applications violating these requirements will be returned
without review.
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) and through AHRQ InstantFAX at (301) 594-
2800. To use InstantFAX, you must call from a facsimile (FAX) machine
with a telephone handset. Follow the voice prompt to obtain a copy of
the table of contents, which has the document order number (not the
same as the PA number). The RFA will be sent at the end of the
ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a
week. For comments or problems concerning AHRQ InstantFax, please call
(301) 594-6344.
In carrying out its stewardship of funded programs, the AHRQ may
request information essential to an assessment of the effectiveness of
the Agency programs. Accordingly, grant recipients are hereby notified
that they will be asked for periodic updates on publications resulting
from AHRQ grant awards, and other information AHRQ requires in order to
evaluate the impact of AHRQ-sponsored projects.
AHRQ expects grant recipients to keep the Agency informed of
publications as well as the known uses and impact of their Agency-
sponsored work. Applicants are to agree to notify AHRQ immediately
when a manuscript based on work supported by the grant is accepted for
publication, and to provide the expected date of publication as soon as
it is known, regardless of whether or not the grant award is still
active.
To receive an award, applicants must agree to submit an original and 2
copies of an abstract, executive summary, and full report of the
results in the format prescribed by AHRQ no later tan 90 days after the
end of the project period. The executive summary should be sent at the
same time on a computer disk which specifies on the label the format
uses (WP8.0 or WP9.0 is preferable).
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.
At this stage a technical review of the cost sharing requirements
outlined in the RFA will be performed. Applications which fail to
demonstrate the minimum 50 percent cost sharing requirement will be
returned 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.
As part of the merit review, all applications will:
1. Receive a written critique
2. Undergo a process in which only those applications deemed to have
the highest scientific merit will be discussed and assigned a priority
score.
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 these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
o Evaluation and Assessment of Impact
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. Since there are
two types of projects requested under this RFA, two sets of review
criteria will be used, one for each type of project.
Risk Assessment Projects
(1) SIGNIFICANCE: Does your study address an important patient
safety problem? Has the risk area been identified and to what extent
is there a major threat to patient safety? If the aims of your
application are achieved, how do they advance scientific knowledge in
patient safety? What will be the effect of these studies on the
concepts or methods that drive the field of patient safety?
(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? Does the project use accepted approaches
to risk assessment such as FMEA or PRA? Do those responsible for
carrying out the approach have appropriate experience and skills in the
approach?
(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? Does your project employ accepted safety research
methods and approaches from disciplines outside of the health care
field?
(4) INVESTIGATOR: Are you appropriately trained and well suited to
carry out a patient safety project? Is the work proposed appropriate
to your experience level as the principal investigator and to that of
other researchers (if any)?
Project personnel. Are there qualified patient safety personnel
associated with the project. Has the project included outside
resources or partners that have expertise in assessing risks if they
are not present in the organization itself?
(5) ENVIRONMENT: Does the organizational climate support the
improvement of patient safety? Is there a positive safety culture
within the organization in which your work will be done which will
contribute to the probability of success? Does the proposed project
take advantage of unique features of the organizational environment or
employ useful collaborative arrangements? Is there evidence of
institutional support and commitment to maintaining taking action based
upon the successful risk assessment?
(6) EVALUATION and ASSESSMENT of IMPACT: Does the application
outline an evaluation plan for assessing the risk assessment process
and documenting the impact of the process to the organization?
(7) BUDGET: The reasonableness of the proposed project budget and
the requested period of support in relation to the proposed project,
including documentation of institution share of the challenge grant.
Is the documentation adequate (3 budget presentations) 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 patient safety?
Patient Safety Practices Implementation
(1) SIGNIFICANCE: Does your study address an important patient
safety problem? Will the prosed patient safety practice make a
difference in patient care and improved patient safety? If the aims of
your application are achieved, how do they advance scientific knowledge
in the field of patient safety? What will be the effect of these
studies on the concepts or methods that drive the field of patient
safety?
(2) APPROACH: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Is the approach documented with appropriate
references demonstrating an understanding of the literature of safe
practices and patient safety? Do you acknowledge potential problem
areas and consider alternative tactics? Are the barriers to adoption
and difficulties in implementation been adequately addressed?
(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? Does your project employ accepted safety research
methods and approaches from disciplines out side of the health care
field?
(4) INVESTIGATOR: Are you appropriately trained and well suited to
carry out a patient safety project? Is the work proposed appropriate
to your experience level as the principal investigator and to that of
other researchers (if any)?
Project personnel. Are there qualified patient safety personnel
associated with the project. Has the project included outside
resources or partners that have expertise in implementing safety
interventions if they are not present in the organization?
(5) ENVIRONMENT: Does the organizational climate support the
improvement of patient safety? Is there a positive safety culture
within the organization in which your work will be done which will
contribute to the probability of success? Does the proposed project
take advantage of unique features of the organizational environment or
employ useful collaborative arrangements? Is there evidence of
institutional support and commitment to maintaining the intervention
once the funding has been completed?
(6) EVALUATION and ASSESSMENT of IMPACT: Does the application
outline an evaluation plan for assessing the implementation process and
documenting the impact of the process to the organization and the
target patient population at risk ?
(7) BUDGET: The reasonableness of the proposed project budget and the
requested period of support in relation to the proposed project,
including documentation of institution share of the challenge grant.
Is the documentation adequate (3 budget presentations) to determine 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 patient safety?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans
and the environment, to the extent they may be adversely affected by
the project proposed in the application.
o INCLUSION: The adequacy of plans to address the need of both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the aims of the project. Adequacy of attention to
other populations of special priority to AHRQ (see discussion on
Priority Populations in the section on Special Requirements, above, and
Inclusion Criteria included in the section on Agency policies and
Requirements, below.)
DATA SHARING:
Data Confidentiality
Pursuant to section 924(c) of the Public Health Service Act (42 USC
299c- 3(c)), information obtained in the course of any AHRQ supported-
study that identifies an individual or entity must be treated as
confidential in accordance with any explicit or implicit promises made
regarding the possible uses and disclosures of such data. There are now
civil monetary penalties for violation of this confidentiality statute.
(42 U.S.C.299c-3(d)) In the Human Subjects section of the application,
applicants must describe procedures for ensuring the confidentiality of
the identifying information to be collected. The description of the
procedures should include a discussion of who will be permitted access
to the information, both raw data and machine readable files, and how
personal identifiers and other identifying or identifiable data will be
restricted and safeguarded. Identifiable patient health information
collected by grantees under this RFA will also be managed in accordance
with 42 CFR Parts 160 and 164, federal regulations pertaining to the
privacy of patient-related health information. These privacy
regulations, developed by the Department of Health and Human Services
pursuant to the Health Insurance Portability and Accountability Act of
1996 (HIPAA), are scheduled to be effective and enforceable in April
2003. These regulations serve to limit the disclosure of personally
identifiable patient information and define when and how such
information can be disclosed. Thus, for example, health care plans and
providers will require either patient authorization of disclosures of
identifiable information to be made to researchers who are not their
health care providers or waivers of such authorizations obtained from
an IRB or Privacy Board (defined in the regulations) upon being
satisfied that any identifiable health information will be
appropriately safeguarded by the investigators. Additional information
about the regulations and their implementation can be obtained from:
http://www.aspe.hhs.gov/admnsimp/.
The awardee should ensure that computer systems containing confidential
data have a level and scope of security that equals or exceeds those
established by the Office of Management and Budget (OMB) in OMB
Circular No. A-130, Appendix III - Security of Federal Automated
Information Systems. The National Institute of Standards and Technology
(NIST) has published several implementation guides for this circular.
They are: An Introduction to Computer Security: The NIST Handbook;
Generally Accepted Principals and Practices for Securing Information
Technology Systems; and Guide for Developing Security Plans for
Information Technology Systems. The circular and guides are available
on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The
applicability and intended means of applying these confidentiality and
security standards to subcontractors and vendors, if any, should be
addressed in the application.
Rights in Data
AHRQ grantees may copyright unless otherwise provided in grant awards,
or seek patents, as appropriate, for final and interim products and
materials including, but not limited to, methodological tools,
measures, software with documentation, literature searches, and
analyses, which are developed in whole or in part with AHRQ funds.
Such copyrights and patents are subject to a worldwide irrevocable
Federal government license to use and permit others to use these
products and materials for government purposes. In accordance with its
legislative dissemination mandate, AHRQ purposes may include, subject
to statutory confidentiality protections, making project materials,
data bases, results, and algorithms available for verification or
replication by other researchers; and subject to AHRQ budget
constraints, final products may be made available to the health care
community and the public by AHRQ or its agents, if such distribution
would significantly increase access to a product and thereby produce
public health benefits. Ordinarily, to accomplish distribution, AHRQ
publicizes research findings but relies on grantees to publish research
results in peer-reviewed journals and to market grant-supported products.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 15, 2003
Technical Assistance Workshop and Conference Call: June 12, 2003
Application Receipt Date: July 15, 2003
Peer Review Date: August 2003
Earliest Anticipated Start Date: September 26, 2003
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 including systems rather than individual
institutions and geographic distribution may be special consideration
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. Also, disclosure of identifiable data from any AHRQ-
supported-study is exempted from FOIA disclosures under "the (b)(3)
exemption.", unless the identifiable subjects or provider(s) of data
consent to such disclosures. It is important for applicants to
understand the scope of this requirement and its limited potential
impact on data collected with AHRQ support. Proprietary data might also
be exempted from FOIA disclosure requirements under "the (b)(4)
exemption", for example, if it constituted trade secrets or commercial
information. However, courts have generally not regarded a
researcher's interest in "his" data as proprietary. NIH has provided
guidance for researchers on the requirements of A-110.36
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Should applicants wish to place data collected under this RFA in a
public archive, which can provide protections for the data (e.g., as
required by the confidentiality statute applicable to AHRQ supported
projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non-
identifiable data for an indefinite period of time, they may. The
application should include a description of any archiving plan in the
study design and include information about this in the budget
justification section of the application. In addition, applicants
should consider how to structure informed consent statements or other
human subjects 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 final
modification to the "Standards for Privacy of Individually Identifiable
Health Information", the "Privacy Rule," on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (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 the researcher and his/her institution. 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 on "Am
I a covered entity?" Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-03-025.html.
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 Part 67, Subpart
A, and 45 CFR Parts 74 or 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products. In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education, library,
day care, health care or early childhood development services are
provided to children. This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.
REFERENCES
1. Wachter RM, McDonald KM. Making health care safer: a critical
analysis of patient safety practices. Evidence Report/Technology
Assessment Number 43. Rockville, MD., AHRQ 2001.
2. National Quality Forum. Safe practices for better health Care.
Washington, DC, National Quality Forum, 2003.
3. Joint Commission on Accreditation of Healthcare Organizations
Patient safety priorities found a www.jcaho.org.
4. Reason J. Human error. New York, Cambridge University Press; 1990:175.
5. Rasmussen, J. Outlines of a Hybrid Model of the Process Operator.
In: Sheridan, T.B., and Johannsen, G. eds. Monitoring behavior and
supervisory control. New York: Plenum Press, 1976.
6. An organization with a memory; a report to the chief medical officer
of the National Health Service. London, Department of health, 2001.
7. Freitag M, Hale A. Structure of event analysis. In: Hale A,
Wilpert B, Freitag M (eds0. After the event: from accident to
organization learning. New York: Elsevier. 1997;11-22.
8. Battles JB, Shea CE. A system of analyzing medical errors to
improve GME curricula and programs. Acad Med 2001: 76:2;125-1339.
9. Van der Schaaf, T.W. Near miss reporting in the chemical process
industry. Ph.D. Thesis, Eindhoven, NL: Eindhoven University of
Technology, 1992.
10. Kohn, L.T., Corrigan, J.M., Donalson, M.S. eds. To Err is human:
building a safer health system. Washington: National Academy Press, 1999.
11. Quality Interagency Coordination Task Force. Doing what counts for
patient safety: federal actions to reduce medical errors and their
impact, 2000.
12. Eisenberg JM. Medical errors as an epidemic. A presentation at
the national Summit on medical errors and patient safety research.
Washington DC, QuIC; September 2000.
13. Donabedian A. Explorations in quality assessment and monitoring:
the definition of quality and approaches ti its assessment, Vol I. Ann
Arbor, MI; Health Administration press, 1980.
14. Moray N. Error reduction as a systems problem. in Human error in
medicine. Bogner MS (ed). Hillsdale, NJ: Lawrence Erlbaum, 1994.
15. Van Cott H. Human error: their causes and reduction. in Human
error in medicine. Bogner MS (ed). Hillsdale, NJ: Lawrence Erlbaum, 1994.
16. Norman DA The design of everyday things. New York: Doubleday, 1988.
17. Hinckley CM. Make no mistake: an outcome-based approach to
mistake-proofing. Portland, OR; Productivity Press, 2001.
18. Shingo S. Zero quality control: source inspection and the poka-
yoke system. Portland, OR; Productivity Press, 1985.
19. Billings, CE Aviation automation: the search for a human
centered approach (human factors in transportation). Hillsdale, NJ,
Lawrence Erlbaum Associates; 1996.
20. Cook, RI. Two years before the mast: learning how to learn about
patient safety. In: Enhancing patient safety and reducing errors in
health care. Rancho Mirage CA, Annenberg Center; 1998.
21. Kukla CD, et. al. Designing effective systems: a tool approach. In
Adler P, Winograd T, eds. Usability: turning technology into tools.
New York, Oxford University Press; 1992:144.
22. Corbett JM. Work at the interface: advanced technology and job
design. In Adler P, Winograd T, eds. Usability: turning technology
into tools. New York, Oxford University Press; 1992.
23. Weimer J. Research techniques in human engineering: New Jersey,
Prentice Hall; 1995:120-24. Rheinfrank JJ. Design for usability:
crafting a strategy for the design of a new generation of Xerox
copiers. In Adler P, Winograd T, eds. Usability: turning technology
into tools. New York: Oxford University Press; 1992:39.
Return to NIH Guide Main Index
|
|
Office of Extramural Research (OER) |
|
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
|
Department of Health and Human Services (HHS) |
|
||||
|
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files. |
||||||||||