SYSTEMS-RELATED BEST PRACTICES TO IMPROVE PATIENT SAFETY

Release Date:  December 16, 1999

RFA:  HS-00-007

Agency for Healthcare Research and Quality (formerly AHCPR)
 
Letter of Intent Receipt Date: March 10, 2000
Application Receipt Date: April 27, 2000
 
PURPOSE

The Agency for Healthcare Research and Quality (AHRQ), formerly known as 
the Agency for Health Care Policy and Research (AHCPR), announces the 
availability of cooperative agreements to test the effectiveness of the 
transfer and application of best practices (i.e., techniques or 
interventions) to improve patient safety through the reduction of 
preventable systems-related medical errors with high prevalence and severe 
consequences.  Medical error is defined as the failure of a planned action 
to be completed as intended (i.e., error of execution) or the use of a 
wrong plan to achieve an aim (error of planning).  Safety is defined as 
freedom from accidental injury (Kohn, et al, 1999).  These projects should 
use a research design to detect tangible and measurable improvements in 
patient safety which may result from the use of those best practices.  Each 
project should be capable of making conclusions that are generalizable to 
other sites and settings.  The projects undertaken as a result of this 
request for applications (RFA) will (1) expand the conceptual and 
methodological basis for identifying and understanding preventable systems-
related errors, and (2) produce relevant and feasible best practices for 
improving patient safety across a variety of health care settings and 
institutions.  To complement current efforts underway in the field, 
development of best practices for populations, groups, or settings where 
these are most lacking will be given a high priority.  This RFA does not 
include projects on the safety of health care workers.

Applicants are encouraged to form partnerships or consortia that provide 
the technical capabilities to develop best practices that reduce avoidable 
medical error and improve safety across a variety of institutions and 
settings.  Such consortia could  include partnerships between academic, 
public, and private delivery organizations that provide the ability to 
apply a rigorous application of scientific methods to improve patient 
safety with a suitable Alaboratory@  in which to conduct the evaluation.  
These partnerships, research teams, and consortia participants should 
include multidisciplinary expertise (e.g., clinical care, human factors, 
informatics, patient safety, and quality measurement.) 

HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2000," 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 2000" (Full Report:  Stock 
No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 
017-001-00473-1) through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 
 
ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic or foreign, public or private 
organizations, including universities, clinics, units of State and Local 
governments, and eligible agencies of the Federal Government.  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 
invited 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 will be amended in the near future to reflect this 
change in agency name and authority.

AHRQ encourages investigators who are women, members of minority groups, 
and persons with disabilities to apply as Principal Investigators.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will 
be a cooperative agreement (U18), an assistance mechanism (rather than an 
Aacquisition@ mechanism), in which substantial AHRQ scientific and/or 
programmatic involvement with the awardee is anticipated during the 
performance of the activity.  Under the cooperative agreement, the AHRQ 
purpose is to support and/or stimulate the recipient=s activities 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.  Details of the responsibilities, 
relationships, and governance of the study to be funded under cooperative 
agreements are discussed later in this document under the section ATerms 
and Conditions of Award.@  

The total project period for applications submitted in response to the 
present RFA may not exceed 3 years.  This RFA is a one-time solicitation.  
The anticipated award date is September 30, 2000.  AHRQ has not determined 
whether or how this solicitation will be continued beyond the present RFA.
 
FUNDS AVAILABLE

The AHRQ expects to award up to $2 million in Fiscal Year 2000 to support 4 
to 6 projects under this RFA.  

The actual number of applications funded is dependent on the number of high 
quality applications and their individual budget requirements.  It is not 
the intent of AHRQ that the awards be equal in size.

Although this program is provided for in the financial plans of AHRQ, 
awards pursuant to this RFA are contingent upon the availability of funds 
for this purpose.  Funding beyond the initial budget period will depend 
upon annual progress reviews by AHRQ and the availability of funds.

Definitions

For the purpose of this document, medical error is defined as an unintended 
act, either of  omission or commission; the definition excludes an act that 
does not achieve its intended outcome.  Patient safety is defined as a 
process that guards against any adverse condition in a patient occurring as 
a result of testing or treatment by care giver(s).

RESEARCH OBJECTIVES

Background

Delivering the right care to the right patient at the right time in the 
right way is a historical challenge that has been appreciably exacerbated 
by modern medicine=s complexities.   They involve sophisticated treatment 
technology; an explosion of available medications and therapeutic agents, 
many of which have narrow margins of effectiveness and safety; and the 
changing settings in which complex care is delivered.  One researcher 
(David Eddy) notes that AThe complexity of modern medicine exceeds the 
inherent limitations of the unaided human mind@  (Millenson, 1997).  Other 
researchers note that Aerror in medicine is real and common@ (Leape, et al, 
1998), and another researcher (David Nash) notes that A.... we commit 
thousands of errors every week nationally@ (Gerlin, 1999).  A recent report 
by the Institute of Medicine synthesized the available evidence on patient 
safety and concluded that health care is not as safe as it should be.  It 
went further to note that medical errors are a leading cause of death and 
injury (Kohn, et al, 1999).

Studies such as the Harvard Medical Practice Study, which was designed to 
develop more current and reliable estimates of the incidence of adverse 
events and negligence in hospitalized patients, have shown that there is a 
significant amount of injury to patients caused by the delivery of medical 
care.  For example, the Harvard study found that almost 4 percent of the 
30,195 sampled hospital admissions in New York State in 1984, reflected an 
injury that increased the length of hospital stay.  Fourteen percent of 
these injuries were fatal (Brennen, et al, 1991; Leape, et al, 1991).  
Sixty-nine percent of the iatrogenic injuries studied were due to medical 
error, not negligence.  In this study, error was defined as an unintended 
act, either of omission or commission, or an act that does not achieve its 
intended outcome (Leape, 1994).  As defined, most of these errors are 
preventable.  When the President=s Advisory Commission on Consumer 
Protection and Quality in the Health Care Industry presented its Final 
Report to the President of the United States, Quality First: Better Health 
Care for All Americans (1998), reduction of medical errors was listed as 
one of its top priorities. The Institute of Medicine report on medical 
errors and patient safety called for Aa comprehensive and strong response 
to this most urgent issue facing the American people@ (Kohn, et al, 1999). 
 In addition to researchers, policy makers and the general public have an 
increased awareness of medical error and patient safety because they are 
topics reported on with increasing frequency by the popular press including 
television networks, newspapers, professional and lay journals, and so 
forth.

Some industries and groups have successfully addressed errors by 
identifying, reporting, and examining their causes, many of which are 
attributed to system failures.  In addition, those industries and groups 
have vigorously endorsed and supported the application of quality 
principles.  For example, Motorola and General Electric have committed 
themselves to a six sigma level of quality that allows less than 3.4 
defects per million  (Chassin, 1998).  The aviation industry, once fraught 
with accidents, has successfully reduced its level of error.  Surgical 
anesthesia, once with an error rate of 25 to 50 per million, has 
effectively reduced its error rate nearly seven-fold, to 5.4 per million 
(Orkin, 1993).  These groups acknowledge that humans are imperfect and 
error prone.  They have employed measures that examine the systems in which 
the errors occur, and to improve safety, they have developed systems 
approaches to compensate for  humans= propensity to err.  As one researcher 
noted, systems that rely on error-free performance by humans are doomed to 
failure (Leape, 1994).

Organizations successful in improving patient safety have designed systems 
to protect against human shortcomings.  They have made major strides in 
improving safety through the use of system approaches such as automation, 
simplification, and standardization of functions and equipment; practice 
guidelines or protocols; and  teamwork that includes checks and balances.  
Furthermore, error reduction and improved safety have become 
Ainstitutionalized.@  That is, these industries and groups share a vision 
of reduced error and improved safety, and it is a philosophy embraced 
throughout the organization from top to bottom.  

To improve safety in the modern health care system, similar philosophies 
must be embraced and similar changes must be made.  It is the knowledge 
that both opportunity and potential for improvement exist in the health 
care system that leads to a call for rigorous research focused on 
preventable system errors and improved patient safety.

Like the industries and groups mentioned above, if the technically complex 
system of health care is not properly designed to protect against errors, 
there are many opportunities for them to occur.  One study on adverse drug 
events showed that 78 percent of adverse drug events were due to system 
failures such as lack of knowledge about a drug, lack of information about 
a patient, failure to follow accepted and well-established procedures, 
transcription errors, faulty drug identification and checking, faulty dose 
checking, inadequate monitoring, preparation errors, drug stocking and 
delivery problems, and lack of standardization (Leape, et al, 1995).

Health care practitioners are increasingly placed in situations wherein 
errors are bound to occur.  For example, inexperience and poor training can 
lead to inaccurate diagnosing and treatment and a higher rate of human 
error (Leape, 1994, Bruining, et al, 1987).  Inadequate staffing levels 
have been linked to an increase of adverse events (Blegen, Goode, Reed, 
1998; Kovner, Gergen, 1999).  Overwork and fatigue have been shown to cause 
a significant decrease in alertness and concentration leading to errors ( 
Leonard, et al, 1998).  Reliance on memory, which is fallible, can also 
lead to compromised patient safety (Leape, 1994).

Medical errors are costly.   A recent study found that for an average 700-
bed teaching hospital, costs associated with dangerous reactions to 
medication totaled about $5.6 million per year or about $8,000 per bed per 
year (Bates et al, 1997).  Another study identified excess costs associated 
with adverse drug events.  These researchers noted that adverse drug events 
caused 1.74 extra hospital days per admission at an excess cost of $2,013 
per discharge (Classen et al, 1997).  The excess mortality associated with 
adverse drug events was nearly two fold. 

Even with such startling evidence of the need for change, most health care 
organizations continue with their historical approaches to error.  These 
mechanisms typically employ blame and punishment (Leape, 1994).   Moving 
away from the Aname, blame, and shame@ approach has afforded great success 
to the aviation industry in improving safety.  This approach, however, has 
not been and is not well-accepted in current-day medical community culture 
and where tort and contract law provide significant resistance to blame-
free reporting (Liang, 1999).  If preventable medical errors are to be 
identified, analyzed, understood, and eliminated, the core culture of the 
entire health delivery system needs to change.

Objectives and Scope  

This RFA focuses on improving the safety of health care through the 
identification and prevention of avoidable system errors.  This 
solicitation seeks applications for studies that use rigorous research 
methods and designs to test the effectiveness of the transfer and 
application of best practices (i.e., techniques or interventions) for 
improved patient safety.  The techniques and interventions, when applied to 
frequent, severe systems-related preventable medical errors, should result 
in tangible, measurable, sustainable, and portable improvements in patient 
safety.  System failures are likely to include issues such as problems in 
the physical environment, organization, coordination, communication, 
scheduling, training, supervision, or management of health care.

The topic of this RFA requires researchers representing a broad, 
interdisciplinary approach and the development of working partnerships to 
facilitate access to relevant data, resources, and expertise to test the 
effectiveness of the transfer and application of best practices that reduce 
system-related medical errors and improve patient safety.  Studies focused 
on all types of settings will be accepted, although results are expected to 
be generalizable across settings and institutions.  This research will help 
to identify high-risk patients or patient groups, providers, processes, and 
settings; measure, monitor, and analyze preventable errors and injuries; 
expand the understanding of the impact of changes in the health care system 
on preventing avoidable errors and injuries; and develop generalizable, 
transportable, effective best practices for the prevention or reduction of 
errors and injuries and the improvement of patient safety.

System-based best practices to prevent avoidable errors can be selected 
from among a wide range of prevention and improvement efforts.  They should 
answer the following types of research questions:

o  What physical conditions, clinical situations, and events expose 
patients to system-related significant avoidable errors and what best 
practices can be used to successfully address them?

o  What methods can be developed and implemented to predict and prevent 
avoidable errors and diminished patient safety?

o  What error reduction and improved safety concepts from other industries 
can be successfully implemented or adapted and applied in health care 
systems and what is their cost-benefit?

o  What successful best practices can be implemented to reduce avoidable 
errors in high-risk populations or high-risk situations?

o  What effective, practical methods can be implemented to collect, 
validate, analyze, and understand errors, and what information systems are 
required to support these methods?

o  What non-punitive methods can be developed and implemented to 
effectively report and communicate error and patient safety information to 
health care providers, managers, and administrators that will produce 
improved performance?

In addition, the methods for capturing the costs of the patient safety 
improvement strategy, such as those associated with development, 
implementation, and maintenance of the effort,  should be included in the 
application.

Research Methods

All proposed studies are expected to use rigorous research designs and 
methods that optimize the validity, reliability, utility, and 
generalizability (i.e., across institutions, settings, patient and provider 
groups) of findings.  The research should have a clear theoretical 
framework, demonstrate familiarity with the pertinent literature, and make 
use of data collection and analysis strategies that yield valid, reliable, 
implementable, and transportable findings and conclusions.  Rigorous 
research methods are the preferred approach and can include quantitative 
and qualitative approaches.

Applications should include a detailed plan outlining the dissemination 
strategy for results from the project, including specific plans to promote 
the adoption of successful avoidable error reduction and safety improvement 
strategies in non-study organizations and settings.

SPECIAL REQUIREMENTS
 
Collaborative activities are intended to strengthen individual studies and, 
at the same time, produce generalizable results across study sites, patient 
groups, provider groups, etc.  To maximize the utility and generalizability 
of work under this RFA, awardees will be expected to participate in annual 
1-day meetings with other grantees and AHRQ staff.  The annual meetings 
will be held in Rockville, Maryland and will be chaired by AHRQ staff with 
input from the grantees.  Each grantee will be expected to have its 
Principal Investigator attend the annual meeting.  At the discretion of the 
grantee, up to 2 additional members of the research team may attend the 
annual meetings.  Funds to attend these meetings should be included in each 
applicant=s budget.  Investigators will be encouraged to participate in 
collaborative work, as developed in these meetings, that promotes the 
commonality of research methods, shared measures of impact, and 
generalizability.  These collaborative activities may include a focus on 
the generic characteristics of intervention strategies and best practices, 
institutions, and populations that lead to measurable avoidable error 
reduction and improved patient safety.  In addition, the collaborative 
activities may be used to evaluate the cost-effectiveness and cost-benefit 
of various strategies and interventions and examine the sustainability and 
portability of the avoidable error reduction interventions and safety 
improvement techniques.  AHRQ, with the help of grantees, will produce 
reports of these meetings.  They will be distributed to all participating 
grantees and relevant Agency staff within approximately one month after 
each meeting.  Applicants should include in the application a statement 
reflecting its willingness to participate in these annual meetings, and 
each applicant=s budget should include such plans in its budget request.

Documentation of Partnership Arrangements

Applicants are required to include documentation of partnerships, which 
should include letters of collaboration or copies of memoranda of 
understanding.  In-kind support for the project from partners should be 
noted in the documentation and must be submitted in the application 
package.

Project Organization

If a partnership or consortium of institutions responds to this RFA, the 
application should describe a practical structure for its decision-making 
and governance, and the mechanisms designed to ensure that effective 
collaboration will occur among sites.  Unanticipated disagreements about 
methods, resource allocations, standardization, authorship, etc., may arise 
during the course of any project.  A partnership or consortium must be able 
to make unified decisions on the merits of these issues without dissolving 
or routinely relying upon outside arbitration.

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.
 
Consistent with the U18 concept defined under Mechanism of Support, 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 may be shared among the awardees and 
the AHRQ Program Official(s).
  
1.  Awardee Rights and Responsibilities
 
o  Awardees have primary authorities and responsibilities to define 
objectives and approaches, and to plan, conduct, analyze, and publish 
results, interpretations, and conclusions of their studies.

o  Awardees have the responsibility to participate in periodic (e.g., 
quarterly) conference calls, attend annual meetings, and develop a 
dissemination strategy for any results of the project, including specific 
plans to promote the adoption of successful best practices for error 
reduction and improved safety.  

o  Awardees will retain custody of and have primary rights to the data 
developed under these awards, subject to Agency rights to use the data for 
Agency purposes, consistent with HHS, PHS, and AHRQ policies.
 
2.  AHRQ Responsibilities

The AHRQ Program Official(s) will have substantial scientific programmatic 
involvement during the conduct of this activity, through technical 
assistance, advice, and coordination above and beyond normal program 
stewardship for grants, as described below.

o  Provide collaboration with and information from other relevant Federal 
agencies and programs.

o  Chair, coordinate, or participate in strategy sessions to review 
progress, for example, quarterly conference calls and annual meetings of 
grantees.

o  Provide logistical support to the organization of periodic discussions 
between principal investigators including, but not limited to, quarterly 
conference calls and annual meetings of grantees.

o  Review and approve interim and final reports.

o  Disseminate research findings as they become available.

o  Participate in the drafting and review of publications resulting from 
the joint activities under this cooperative agreement as deemed appropriate 
by the principal investigators.

The AHRQ reserves the right to terminate or curtail the study in the event 
of:

o  Insufficient progress toward completion of study goals within an agreed-
upon timeframe.

o  Inability to work in a collaborative manner with other necessary 
organizations on joint projects.

o  Inability to successfully address key methodological issues.

3.  Collaborative Responsibilities
 
At a minimum, Principal Investigators will participate in meetings once a 
year and, if necessary, periodic (e.g., quarterly or more often as needed) 
general collaborative conference calls.  Other members of the research 
teams may participate in these calls as deemed appropriate by each 
Principal Investigator.

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 individual grantee 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.

Data Privacy

Pursuant to section 903(c) of the Public Health Service Act (42 USC 299a-
1(c)), information obtained in the course of any AHRQ-study that identifies 
an individual or entity must be treated as confidential in accordance with 
any promises made or implied regarding the use and purposes of the data 
collection, unless a consent for disclosure or another use is obtained.  In 
the Human Subjects section of the application, a description of procedures 
for ensuring the confidentiality of such  identifying information 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 safeguarded.

The grantee 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 
Principles 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/handbook.pdf.  The application of 
these standards to subcontractors and vendors should be addressed as 
necessary.

Important legal rights and requirements applicable to AHRQ grantees are set 
out or referenced in the Agency=s grants regulations at 42 CFR 67, Subpart 
A.

Rights in Data

AHRQ grantees may copyright 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 Federal government 
license to use and permit others to use these products and materials for 
AHRQ purposes.  In accordance with its legislative dissemination mandate, 
AHRQ purposes may include, subject to statutory confidentiality 
protections, making research materials, data bases, 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 in 
peer-reviewed journals and to market grant-supported products.

Important legal rights and requirements applicable to AHRQ grantees are set 
out or referenced in the AHRQ=s grants regulation at 42 CFR Part 67, 
Subpart A (Available in libraries and from the GPO=s website 
http://www.access.gpo.gov/nara/cfr/index.html).
  
INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH INVOLVING STUDY 
POPULATIONS
 
It is the policy of the 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 is provided that 
inclusion is inappropriate with respect to the health of the subjects or 
the purpose of the research.  When included, analyses relevant to women and 
minority groups should be part of the analytic plan as scientifically and 
ethically appropriate.
 
All investigators proposing research involving human subjects should read 
the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in 
Clinical Research," which have been published in the Federal Register of 
March 28, 1994 and in the NIH Guide for Grants and Contracts of March 18, 
1994.  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 
Website http://grants.nih.gov/grants/guide/index.html.

AHRQ also encourages investigators to consider including children in study 
populations, as appropriate.  AHRQ announced in the NIH Guide of May 9, 
1997, that it is developing a policy and implementation plan on the 
inclusion of children in health services research.  This Notice is 
available through the AHRQ Website http://www.AHRQ.gov (Funding 
Opportunities) and InstantFAX (see instructions under INQUIRIES).

AHRQ Program staff may also provide additional information concerning these 
policies (see INQUIRIES). 

LETTER OF INTENT

Prospective applicants are asked to submit, by March 10, 2000, a letter of 
intent that includes a descriptive title of the proposed research proposal, 
name, address, and telephone number of the Principal Investigator, the 
identities of other key personnel and participating institutions, and 
number and title of the RFA in response to which the application may be 
submitted.
 
Although a letter of intent is not required, is not binding, and does not 
enter into consideration of any subsequent applications, the information 
allows AHRQ staff to estimate the potential review workload and to avoid 
conflict of interest in the review.  AHRQ will not provide responses to 
letters of intent.
 
The Letter of Intent is to be sent to Lisa Krever (see address under 
Application Procedures).

APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  State and local government applicants may use 
PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow 
those requirements for copy submission.  Applicants are encouraged to read 
all PHS Form 398 instructions prior to preparing an application in response 
to this RFA. 

Applications kits are available at most institutional offices of sponsored 
research.  They may also be obtained from the Division of Extramural 
Outreach and Information Resources, National Institutes of Health, 6701 
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, 
E-mail/Internet:grantsInfo@nih.gov.
 
AHRQ applicants are encouraged to obtain application materials  from the 
AHRQ Publications Clearinghouse  (see INQUIRIES).

The RFA label and line 2 of the application form (rev. 4/98) should both 
indicate the RFA number.  The RFA label must be affixed to the bottom of 
the face page.  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 and the YES box must be marked.    The 
sample RFA label available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified 
to allow for this change.  Please note this is in pdf format.

The PHS 398 type size requirements (p.6) will be enforced rigorously and 
non-compliant applications will be returned.

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
Bethesda, MD  (20817 for express/courier service)
 
At the time of submission, two additional copies of the application, 
labeled AAdvanced Copy(s)@  must be sent to:

Lisa Krever
Center for Quality Measurement and Improvement
Agency for Healthcare Research and Quality
2101 E. Jefferson St., Suite 502
Rockville, MD  20852
Telephone:  (301) 594-6625 

Applications must be received by April 27, 2000.  An application received 
after that 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 1 week prior to the deadline date.  If an application is 
received after that date, it will be returned to the applicant without 
review.  

Application Preparation (for Using HCFA Data) 

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 PHS 398) the 
specific files, time periods, and cohorts proposed for the research.  In 
consultation with the 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 AHRQ cost of funding 
the grant and may affect the fundability of the application.  To avoid 
double counting, applicants should not include the cost of the data in the 
budget.  

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 HCFA to protect 
the confidentiality of data in accordance with standards set out in OMB 
Circular A-130, Appendix IIIBSecurity of Federal Automated Information 
Systems.  The use of the data is restricted to the purposes and time period 
specified in the DUA.  At the end of this time period, the grantee is 
required to return the data to HCFA or certify that the data have been 
destroyed.  

Grantees must also comply with the confidentiality requirements of Section 
903(c) of the PHS Act.  See the Data Privacy Section above regarding 
details on these requirements as well as references to Circular A-130 and 
its implementation guides from the National Institute of Standards and 
Technology.

In developing research plans, applicants should allow time for refining, 
approving, and processing their data requests.  Requests may take 6 months 
to complete from the time they are submitted.  Applications proposing to 
contact beneficiaries or their provider require the approval of the HCFA 
Administrator and may require meeting(s) with HCFA staff.

HCFA 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 HCFA data should be directed to the AHRQ program 
official listed under INQUIRIES.

REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness and 
responsiveness.  Incomplete applications will be returned to the applicant 
without further consideration.  Applications that are complete but not 
responsive to the RFA will be returned to the applicant without further 
consideration, applicants may submit these applications as investigator- 
initiated R01 grant applications to AHRQ to compete with other unsolicited 
applications at the next review cycle. The resubmitted application should 
be revised to meet R01 requirements.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the AHRQ in accordance with the review criteria stated below.

As part of the merit review, all applications will receive a written 
critique, and also may undergo a process in which only those applications 
deemed to have the highest scientific merit will be discussed and assigned 
a priority score. 

All applications will be judged on the basis of the scientific merit of the 
proposed project and the documented ability of the investigators to meet 
the RESEARCH OBJECTIVES of the RFA.  Although the technical merit of the 
proposed project is important, it will not be the sole criterion for 
evaluation of a study.  Other considerations, such as importance and 
timeliness of the proposed study and access to patients/data will be part 
of the evaluation criteria.

General Review Criteria
 
The goals of AHRQ-supported research are to enhance the quality, 
appropriateness, and effectiveness of health care services, and access to 
such services.  The reviewers will comment on the following aspects of the 
application in their written critiques in order to judge the likelihood 
that the proposed research will have a substantial impact on the pursuit of 
these goals.  Each of these criteria will be addressed and considered by 
the reviewers in assigning the overall score weighting them as appropriate 
for each application.  Note that the application does not need to be strong 
in all categories to be judged likely to have a major scientific impact and 
thus deserve a high priority score.  For example, an investigator may 
propose to carry out important work that by its nature is not innovative 
but is essential to move a field forward.
 
1.  Significance.  Does this study address a problem that is important from 
a scientific and technical viewpoint?  Is the problem addressed both severe 
and frequent?  If the aims of the application are achieved, will scientific 
knowledge be advanced?  Will this study drive the field of reduced medical 
error and improved patient safety?
 
2.  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Are the proposed data sources appropriate and adequate?  Does the 
applicant acknowledge potential problem areas and describe alternatives?  
Are women, minorities, and children (as appropriate and where applicable) 
adequately represented in study populations?  Is there adequate means for 
protecting human subjects?
 
3.  Investigator.  Do the investigator and other involved researchers have 
the appropriate experience and training to carry out this work?
 
4.  Environment.  Does the environment in which the work will be carried 
out contribute to the probability of success?  Is there evidence of 
institutional support with an appropriate administrative structure in place 
that will enable the applicant to complete the projects on time and with 
full accountability for funds?  Does the proposed study take advantage of 
unique features of the scientific environment or employ useful 
collaborative arrangements?  

6. Budget: Is the budget, as proposed, reasonable?

The initial review group will also examine: the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders, 
children, and minorities and their subgroups as appropriate for the 
scientific goals of the research and plans for the recruitment and 
retention of subjects; the provisions for the protection of human and 
animal subjects; and the safety of the research environment.

Special Review Criteria

In addition to the general criteria above, the reviewers will assess the 
applications responsiveness to the RFA and other critical aspects such as:

o  Appropriateness of methods and demonstrated willingness to work as part 
of a cooperative study with the AHRQ Program Official(s).

o  Development of applications incorporating two or more sites which will 
help ensure generalizability, portability, and utility of findings.

o  Access to relevant data on errors and patient safety as evidenced by 
letters of commitment from organization(s) supplying the data.

o  Ability of the project to measure the impact of the best practices for 
error reduction and improved patient safety.

o  Demonstrated evidence of ability to conduct economic analyses of best 
practices to reduce error and improve safety.

o  Development of a dissemination strategy for any results of the project, 
including specific plans to promote the adoption of successful error 
reduction and safety improvement best practices.

AWARD CRITERIA
 
Applications will compete for available funds with all other applications 
under this RFA.  The following will be considered in making funding 
decisions: 1) use of rigorous research methods and overall quality of the 
proposed project as determined by peer review, 2) availability of funds, 3) 
program balance including balance across settings and best practices, 4) 
policy relevance, and 5) inclusion of best practices for populations, 
groups, or settings where these are most lacking.

INQUIRIES
 
Copies of the RFA are available from:

AHRQ Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD 20907-8547
Telephone: 1-800-358-9295


The RFA is available on AHRQ=s Web site, http://www.AHRQ.gov, and through 
AHRQ InstantFAX at (301) 594-2800.  To use InstantFAX, you must call from a 
facsimile (FAX) machine with a telephone handset.  Follow the voice prompt 
to obtain a copy of the table of contents, which has the document order 
number (not the same as the RFA number).  The RFA will be sent at the end 
of the ordering process.  AHRQ InstantFAX operates 24 hours a day, 7 days a 
week.  For comments or problems concerning AHRQ InstantFAX, please call at 
(301) 594-6344.

AHRQ welcomes the opportunity to clarify any issues or questions from 
potential applicants who have read the RFA.  Written and telephone 
inquiries concerning this RFA are encouraged.   Direct inquiries regarding 
programmatic issues, including information on the inclusion of women, 
minorities, and children in study populations to:

Marge Keyes
Center for Quality Measurement and Improvement
Agency for Healthcare Research and Quality
2101 E. Jefferson St., Suite 502
Rockville, MD  20852
Telephone:  (301) 594-1824
FAX: (301) 594-2155
Email: mkeyes@ahcpr.gov

Direct inquiries regarding fiscal matters to:
 
Al Deal
Grants Management Specialist
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone: (301) 594-1843
FAX: (301) 594-3210
Email: adeal@ahcpr.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance No. 
93.226.  Awards are made under authorization of Title IX of the Public 
Health Service Act (42 USC 299-299c-6).  Awards are administered under the 
PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A,  
and 45 CFR Parts 74 and 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

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Brennan TA, Leape LL, Laird NM, et al.  Incidence of Adverse Events and 
Negligence in Hospitalized Patients B Results of the Harvard Medical 
Practice Study I. ANew England Journal of Medicine.@ 324: 370-376, 1991.

Bruining HA, Birkenhager JC, Ong GL, et al.  Causes of Failure in 
Operations for Hyperparathyroidism. ASurgery.@ 101(5):562-5, 1987.

Chassin M.  Is Health Care Ready for Six Sigma Quality?  AMilbank 
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Classen DC, Pestonik SL, Evans RS, et al.  Adverse Drug Events in 
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Gerlin A.  For a Systematic Problem, No Easy Fix.  APhiladelphia 
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Kohn LT, Corrigan JM, Donaldson MS (editors).  To Err Is Human: Building a 
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Healthcare in America:  National Academy Press, 1999.  
  
Kovner C, Gergen PJ.  Nurse Staffing Levels and Adverse Events Following 
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Leape LL. Error in medicine.  AJournal of the American Medical 
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Leape LL, Bates DW, Cullen DJ, et al.  Systems Analysis of Adverse Drug 
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Leape LL, Brennan TA,  Laird NM, et al.  The Nature of Adverse Events in 
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Leape LL, Woods DD, Hatlie MJ, et al.  Promoting Patient Safety by 
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280:  1444-1447, 1998.

Leonard C, Fanning N, Attwood J, et al.  The Effect of Fatigue, Sleep 
Deprivation and Onerous Working Hours on the Physical and Mental Wellbeing 
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Liang BA.  Error in Medicine: Legal Impediments to U.S. Reform.  AJournal 
of Health Politics, Policy and Law.@ 24(1): 27-58, 1999.

Millenson, M.  Demanding Medical Excellence: Doctors and Accountability in 
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Orkin FW.  Patient Monitoring During Anesthesia as an Exercise in 
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Saidman and NT Smith.  London, United Kingdom: Butterworth-Heineman, 1993.


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