Full Text LM-94-002

APPLIED RESEARCH RELEVANT TO AN ELECTRONIC MEDICAL RECORD

NIH GUIDE, Volume 23, Number 5, February 4, 1994

RFA:  LM-94-002

P.T. 34

Keywords: 
  0710078 
  Health Records 


National Library of Medicine

Letter of Intent Receipt Date:  March 28, 1994
Application Receipt Date:       April 27, 1994

PURPOSE

The National Library of Medicine (NLM) and the Agency for Health Care
Policy and Research (AHCPR) invite applications for cooperative
agreements for applied research and development projects relevant to
the development of an electronic medical record system (EMRS).  These
projects should be designed to address one or more of the key
elements of an EMRS with emphasis on work whose utility will be
tested in a computerized record system as part of the proposed
project.  The selection of a cooperative agreement mechanism in this
instance stems from the overall goal of facilitating a working EMRS
that is also capable of generating data useful in health services
research.  Ultimately, the outcome of the various projects to be
supported must be capable of incorporation into a system.  Creative
opportunism is highly valuable, but the Public Health Service must
ensure that such branching and deviation does not impede eventual
intermeshing of the various projects into a useful whole.  Standards
for interchanging data must be maintained, purely parochial or highly
proprietary solutions need interdiction, and test bed sites may need
to be increased to permit appropriate evaluation.  In addition, there
is much to be gained by ensuring that the awardees engaged in the
project have periodic exchange of progress reports and ideas.
Accordingly, applicants should understand that the Principal
Investigators (PI) in this request for applications (RFA) will
constitute an interactive group that will cooperate with Federal
staff to achieve the overall goal.

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 priority areas.  This RFA,
Applied Research Relevant to an Electronic Medical Record, is related
to the priority area of surveillance and data systems.  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
202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, non-profit organizations,
public and private, such as universities, colleges, hospitals,
laboratories, units of state and local governments, and eligible
agencies of the federal government.  Applications from minority
individuals and women are encouraged.  Only domestic organizations
are eligible to apply.  Domestic applications may not have
international components.  The NLM, but not the AHCPR, is also
authorized to award grants to domestic for-profit organizations.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program
will be a cooperative agreement (U01), an assistance mechanism
(rather than an acquisition mechanism) in which substantial PHS
scientific and/or programmatic involvement with the awardee is
anticipated during the performance of the activity.  Details of the
responsibilities, relationships, and governance of the study to be
funded under this cooperative agreement are discussed later in this
document under the section Terms and Conditions of Award.

The total project period for applications submitted in response to
this RFA may not exceed three years.  The anticipated award date is
September 1994.

Because the nature and scope of the research proposed in response to
this RFA may vary, the award size will vary also.  However, it is
anticipated that most of the awards made will have a total annual
cost between $250,000 and $500,000.

FUNDS AVAILABLE

Funds available for the first year of support for the RFA are
approximately $1,300,000; however, expenditure of this commitment
amount is conditional upon the receipt of applications of high
scientific merit.  Number of awards to be made are estimated to be
between three and six.  Although the PHS budget is expected to permit
support of these projects, funding of applications pursuant to this
RFA are contingent upon the availability of funds at the appropriate
time.

RESEARCH OBJECTIVES

Background

The 1993 NIH Revitalization Act established at the National Library
of Medicine a National Information Center of Health Services Research
and Health Care Technology.  The purpose of the National Information
Center is to improve the collection, storage, and dissemination of
information on health services research, clinical practice
guidelines, and health care technology assessments.  The
establishment of this center allows the NLM to build on programs that
were initiated in 1990 in response to the legislation that created
the Agency for Health Care Policy and Research and to implement fully
the recommendations in a 1991 Institute of Medicine (IOM) study of
information needs and access to information by creators and users of
health services research.  One of the IOM recommendations addressed
the need to expand the detailed clinical content in the unified
medical language system knowledge sources in order to improve their
utility in the creation of useful automated patient data systems and
in the extraction of data from these systems for use in health
services research, including outcomes research.

The importance of such vocabulary issues to health services research
is inextricably linked to the general problem of devising a
computerized patient record system, an imperative that has been
recognized by numerous authorities, including Congress and the IOM.

In legislation pertaining to the high performance computing and
communication initiative (HPCC), Congress recently directed the
National Institutes of Health, and particularly the National Library
of Medicine, to address a number of technology issues of importance
to health care, including "... Technology for storing, accessing, and
transmitting patients' medical records while protecting the accuracy
and privacy of those records," an issue that was also among the
topics of interest in NLM's recent Broad Agency Announcement of March
20, 1993.

In a 1991 report on patient records, the Institute of Medicine
described computerized patient records as a key infrastructural
requirement for support of the nation's health information management
needs.

Clearly, an electronic record system based on an appropriate
vocabulary can be of enormous utility in carrying out the goals of
Congress and the recommendations of the IOM.  With appropriate
abstracting and privacy safeguards a digital record system can
facilitate greatly the efforts of health care providers and health
services research workers, and can furnish vital information to
planners, evaluators, regulators, and payers.

Much work has been done on electronic patient records, but no fully
satisfactory complete system exists as yet.  This RFA is designed to
foster development of working systems suitable for both inpatient and
outpatient care, and capable of providing data useful in health
services research, including technology assessment and outcomes
research.

Objectives and Scope

Applications must be relevant to an electronic medical record system,
broadly defined, and should clearly recognize the interest of PHS in
testable solutions to one or more of the myriad problems associated
with development and implementation of a useful EMRS.  Because this
project is an element of the national HPCC initiative, great
importance is placed on widely-useful models, a goal that requires
attention to such features as the various sites in which care is
provided, open architecture, sensitivity to problems of
standardization, suitability for a broad variety of users, and
potential of proposed systems for eventual linkage into nationally
networked patient data pools.  Applicants should understand that this
RFA emphasizes projects that can be expected to have practical
application in the near term; applications are expected to include a
plan for demonstrating the practicality and utility of the proposed
work.

NLM has a particular interest in applications that address clinical
vocabulary issues relevant to an EMRS: vocabulary topics of interest
include, but are not limited to:

o  utility of vocabularies proposed as standards for an EMRS

o  feedback on the evolving clinical content of the Unified Medical
Language System (UMLS) metathesaurus and semantic network

o  the value of the UMLS knowledge sources in linking the EMRS to
clinical guidelines, to reference databases (such as MEDLINE), to
expert systems, and to other clinical data sources

o  development of mechanisms for extracting subsets of clinical data
for use in health services research.

The AHCPR has particular interest in applications that address
improvements in delivery of health services through the use of an
EMRS.  Such topics include, but are not limited to:

o  incorporation of guidelines, decision aids, expert systems, and
reminder systems

o  use of EMRS data for multiple purposes including patient care,
payment, research, utilization review, assessment of quality of care,
outcome analysis, and planning
o  data systems
o  data input issues
o  security/confidentiality/privacy issues
o  behavioral, interface and other issues related to user acceptance
o  data-retrieval
o  multi-media options
o  storage, transmission, and retrieval of images
o  cost/benefit evaluations
o  shareability and standards, including content, data-exchange, and
vocabulary issues
o  transmission of EMRS data among institutions

SPECIAL REQUIREMENTS

To help ensure that the various projects are compatible with each
other and potentially useful for a widely distributed EMRS, a number
of issues need to be addressed in the application:

The PI will be expected to attend and participate in two one-day
progress report and planning meetings per year as a member of the
steering committee. (See below).  The PI will be expected to present
the current status of the project, and to participate in discussions
about future directions of the work, including coordination with
other projects if appropriate.  Applicants are advised to assume such
meetings will be held in Bethesda, MD, and to include plans for such
travel in their budget request.  Each application must provide a
statement expressing willingness to participate as a member of the
projects' steering committee.

Applications should discuss the rationale for the choice of hardware,
software, protocols, and standards  in view of the emphasis PHS is
placing on intercompatibility of the projects carried out under this
RFA.

Applicants should discuss their plans for testing the project work in
a model or working system.  If no test bed is available at the home
institution, applicants should make arrangements to test projects at
other sites.

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 Part 74 and 92, and other HHS,
PHS, and NIH Grants Administration Policy Statements.

Under the cooperative agreement, the PHS 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 the
government will not 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 subject to
comments and advice from the project coordinator and the steering
committee.

Awardee Rights and Responsibilities

The Principal Investigator will have primary responsibility for the
development of the specific research approach, design, and
methodology, and for identifying the specific goals and measurable
objectives of the study.  After the award of the cooperative
agreement.  The Principal Investigator is responsible for all aspects
of the day-to-day conduct of the study, and will have primary
decision-making authority.

The Principal Investigator will retain custody of and primary rights
to data developed under this RFA, subject to government rights of
access, consistent with current HHS, PHS, AHCPR, and NIH policies.

NLM and AHCPR Responsibilities

To implement the cooperative agreements, NLM's Associate Director of
Extramural Programs will serve as the project's scientific
coordinator.  A steering committee, composed of all PIs funded under
this RFA, the scientific coordinator, and one other Federal staff
member will function as the governing board for the work done under
the RFA.  The steering committee will have two Federal members, one
from NLM (the scientific coordinator) and one from AHCPR.  Each
steering committee member will have one vote.  One of the PIs will be
selected by the committee members to serve as chairperson.  The
steering committee will develop common research designs as needed,
serve as a guide to maintaining the goals of the RFA as the work of
each grant progresses, and may provide advice about protocol
refinement, data analysis, interpretation, reporting, and
coordination among the projects.

PHS reserves the right to terminate or curtail an individual award in
the event of substantial shortfall in reporting of progress, major
breach of protocol, or significant failure to conform work with
overall goals of this RFA.

Collaborative Responsibilities

Awardees may be asked to collaborate with others, for example in
extending the number of test-bed sites.  Awardees are expected to
cooperate reasonably with the decisions of the steering committee.

Arbitration

Any disagreement that may arise on scientific/programmatic matters
within the scope of the award between award recipients and PHS may be
brought to arbitration.  An arbitration panel will be composed of
three members, one selected from among the PI members of the steering
committee (with the scientific coordinator absent during the
selection vote), one selected by PHS, 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 PHS Regulations at 42 CFR Part 50, Subpart D and HHS
Regulation at 45 CFR Part 16.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 28, 1994, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the principal
investigator, the identities of other key personnel and participating
institutions, and the 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 the review of subsequent applications, the information
that it contains allows PHS staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Mr. Peter Clepper
Division of Extramural Programs
National Library of Medicine
Building 38A, Room 5S-518
Bethesda, MD  20894
Telephone:  (301) 496-4221
FAX:  (301) 402-0421
E-mail:  clepper@nlm.nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these cooperative agreements.  These forms are
available at most institutional offices of sponsored research; from
the Office of Grants Information, Division of Research Grants,
National Institutes of Health, 5333 Westbard Avenue, Room 449,
Bethesda, MD 20892, telephone: 301-435-0714; and from the Division of
Extramural Programs, National Library of Medicine, Building 38A, Room
5S-518, Bethesda, MD 20894, telephone 301-496-4221.

Applicants are urged to note the special features described in the
SPECIAL REQUIREMENTS and Terms and Conditions of Award sections of
this RFA.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
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 2a of the face page of the application form, and the 'YES' box
must be marked.

Submit a signed, typewritten original of the application, including
the checklist, and three signed photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must be sent to:

Mr. Peter Clepper
Division of Extramural Programs
National Library of Medicine
Building 38A, Room 5S-518
Bethesda, MD  20894
Telephone:  (301) 496-4221
FAX:  (301) 402-0421
E-mail:  clepper@nlm.nih.gov

Applications must be received by April 27, 1993.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) 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.  The DRG will not accept
any application that is essentially the same as one already reviewed,
but will accept substantial revisions of applications already
reviewed with the understanding that such applications must include
an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

General Considerations

All applications will be judged on the basis of the scientific and
technical merit of the proposed research, and the degree to which
they address the research objectives of the RFA.

Review Method

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NLM and AHCPR.  Incomplete applications will be
returned to the applicant without further consideration.  Complete
applications will be evaluated in accordance with the criteria stated
below by an initial review group to be convened by NLM.  Second-level
review will be conducted by the Board of Regents of NLM and the
National Advisory Council of AHCPR in accordance with applicable
policies.

Applications may be subjected to triage if the number of applications
is large compared to the number of awards to be made.  If so, the NLM
and the AHCPR will withdraw from further competition those
applications judged to be non-competitive for an award and notify the
Principal Investigator and applicant institution.  Applications
judged to be competitive will undergo further review.

The factors to be used in judging each application are:

o  Responsiveness in general to the objectives of the RFA
o  potential for furthering progress toward the goal of a national
EMRS
o  compliance with the requirements noted in the SPECIAL REQUIREMENTS
and Terms and Conditions sections of this RFA
o  Scientific and technical merit and significance
o  appropriateness of the approach and methodology
o  qualifications and experience of the PI and others involved in the
project
o  availability of necessary resources
o  plans for demonstrating the utility of the project

Award Criteria

Decisions as to which applications will be funded will be based on
evaluation of the project in accordance with the criteria listed in
the Review Method section above.

Although the scientific/technical merit of the proposed protocol is
important, it will not be the sole criterion for selection of a
study.  Other considerations, such as the importance and timeliness
of the proposed study, and degree of complementarity to other
projects under consideration will be part of the evaluation criteria.

Applicants should be aware that in addition to scientific/technical
merit, consideration will be given to program priorities, program
balance, and total cost of the proposal when staff, the board of
regents, and the national advisory council make their funding
recommendations.

Schedule

Letter of Intent Receipt Date:  March 28, 1994
Application Receipt Date:       April 27, 1994
Scientific Merit Review:        June/July 1994
Second Level Review:            August/September 1994
Anticipated Award Date:         September 1994

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Milton Corn, M.D.
Division of Extramural Programs
National Library of Medicine
Building 38A, Room 5N505
Bethesda, MD  20894
Telephone:  (301) 496-4621
FAX:  (301) 402-0421
E-mail:  corn@lhc.nlm.nih.gov

James McAllister, M.P.H.
Center for General Health Service Extramural Research
Agency for Health Care Policy and Research
2101 E. Jefferson Street, Suite 501
Rockville, MD  20852
Telephone:  (301) 594-1439
FAX:  (301) 594-2155
E-mail:  jmcallis@po3.ahcpr.gov

Direct inquiries regarding fiscal matters to:

Mrs. Ruth Bortz
Division of Extramural Programs
National Library of Medicine
Building 38A, Room 5N507
Bethesda, MD  20892
Telephone:  (301) 496-4243
FAX:  (301) 402-0421
E-mail:  bortz@lhc.nlm.nih.gov

Mr. Ralph Sloat
Grants Management Branch
Agency for Health Care Policy and Research
2101 E. Jefferson Street
Rockville, MD  20852
Telephone:  (301) 594-1447
FAX:  (301) 594-3210
E-mail:  rsloat@po7.ahcpr.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.879, 93.180, and 93.226.  Awards are made under
authorization of the PHS Act, Title III, Part A, Section 301, Title
IV, Part D, Subpart 2, Sections 472-476, as amended, Public Law
100-607 and Title IX, as amended (Public Laws 101-239 and 102-410)
and administered under PHS grants policies and Federal Regulations 42
CFR 67, Subpart A and 45 CFR Part 74, (45 CFR Part 92 for State and
local Governments).  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

.

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