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: 301-710-0267; 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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