Healthcare Informatics Standards Activities of Selected Federal Agencies (A Compendium)

09/01/1996

Sponsored by
Center for Information Technology
Agency for Health Care Policy and Research

Prepared by
Moshman Associates, Inc.
Bethesda, Maryland

Contract No. 290-90-0031


Introduction

The Center for Information Technology, Agency for Health Care Policy and Research (AHCPR), is producing this pilot report to compile health care informatic standards activities voluntarily reported by selected federal agencies.

The AHCPR has undertaken this initiative to assist the Department of Health and Human Services (DHHS) Data Council and the White House Information Infrastructure Task Force (IITF), Committee on Applications and Technology (CAT), Health Information Applications Workgroup (HIAWG) in meeting the goals of the Administration to promote the widespread use of the National Information Infrastructure (NII)in health care. The report will also provide information to assist DHHS in responding to a request of Vice President Gore to improve the coordination of federal activities in health care data standards development.

As part of its work plan, the Data Council has chosen to start this federal coordination through its Committee on Health Data Standards by documenting existing federal health data standards activities. This report complements a current review, also produced by the AHCPR's Center for Information Technology, of the activities of the major private sector standards development organizations: "Current Activities of Selected Health Care Informatics Standards Organizations (A Compilation), Revised, June, 1996.

The information presented in this report has been solicited from federal agencies that are among the most active in drafting and promulgating standards for health care data collection and reporting. Each of these organizations was contacted and asked to provide information for the following eight areas: (1) a contact person, (2) data related programs, (3) standards employed, (4) purpose of the standards, (5) subject areas covered, (6) standards activities, (7) data dictionaries, and (8) publications and other disseminations. This was followed-up with onsite interviews and agency opportunities to revise the information provided prior to publication of this document. In this pilot study, it is not possible to include all federal agencies and all their health care data standards activities. The AHCPR intends to update this report on a regular basis.

Information received from organizations after the publication date for this report will be included in the next report. The report will be available on the AHCPR's web page located at http://www.ahcpr.gov and the DHHS Data Council's web page located at http://aspe.hhs.gov/datacncl. Information on the activities of DHHS agencies can be found on the DHHS web page located at http://www.hhs.gov. Information on the NII and the HIAWG is available on the NII web page located at http://nii.nist.gov/.

The collection and compilation of this information in this document was carried out by Moshman Associates, Inc., under the direction of J. Michael Fitzmaurice, Ph.D. and the management of Stanley E. Edinger, Ph.D. The diligent work of Doug Samuelson, Ph.D., and Jack Moshman, Ph.D., both of Moshman Associates, Inc., is greatly appreciated. Suggestions for improvements or revisions are welcome and may be made to AHCPR by contacting:

J. Michael Fitzmaurice, Ph.D.
Director
Center for Information Technology
Agency for Health Care Policy and Research
2101 E. Jefferson Street
Rockville, MD 20852
Fax 301-594-2333

or

Stanley Edinger, Ph.D.
Senior Science Advisor
Center for Information Technology
Agency for Health Care Policy and Research
2101 E. Jefferson Street
Rockville, MD 20852
Phone 301-594-1483
Fax: 301-594-2333

Email address: CITNEWS@po5.ahcpr.gov


TABLE OF CONTENTS


Agency:

U. S. Department of Defense

Contact:

Capt. Medhat Ashamalla, M.D.
Office of the Assistant Secretary of Defense (Health Affairs)
Medical Function Integration Management
Skyline 6 / Suite 817
5109 Leesburg Pike
Falls Church, VA 22041
Phone 703-681-5614 Fax 703-681-8845

Data-related programs:

OASD(HA) is participating in DoD's data standardization program by developing standards needed to support the projected business of the Military Health Services System (MHSS). These include data to support such activities as medical readiness, managed care, immunization, and credentialing. It is also a tri-service activity including the Army, Navy and Air Force health/medical communities.

Standards Employed:

Approximately 1300 of the DoD approved data standards relate to the MHSS. These standards are model based. There are approximately 1700 more that are currently identified and in a developmental state. More are being identified as they are implemented into the selected migration systems and as other health industry standards are incorporated and used by the MHSS. Health industry standards are reviewed and to influence models and DoD standards. For example, HL7, the American Standards Committee (ASC) X12 series, DICOM, and other health industry standards are used.

Purpose of Standards:

The standards will be used in MHSS migration systems to achieve better sharing of data and interoperability of systems, both within the MHSS and among the other DoD and civilian systems.

Subject Areas Covered:

The subject areas covered by the data standardization effort include all aspects of medical readiness and managed care. It includes data needed to provide and manage clinical services, to provide resources, to provide medical logistics support and to make executive decisions.

Standards Activities:

Standards activities include developing new standards and coordinating them across the three services, with other DoD functional areas, and with industry. These activities also include assisting developers to implement the standards in the MHSS migration system.

Data Dictionaries:

OASD(HA) registers the Military Health Services System (MHSS) migration systems' data dictionaries, as well as the DoD-approved standard data elements, in the Defense Data Dictionary System (DDDS). Both approved and developmental data elements for the MHSS are recorded in the MHSS Functional Area Model - Data (FAM-D).

Publications and Other Dissemination:

These standards are promulgated by numerous publications, magnetic media, and World Wide Web dissemination. The WWW address is http://www.hirs.af.mil. Current versions are MHSS FAM-D, Version 6 and MHSS FAM-A, Version 3.


Agency:

Department of Health and Human Services
Agency for Health Care Policy and Research

Contact:

J. Michael Fitzmaurice, Ph.D.
Director, Center for Information Technology
Agency for Health Care Policy and Research
Suite 602
2101 E. Jefferson Street
Rockville, MD 20852
Phone 301-594-1483 Fax 301-594-2333
Email: MFitzmau@po5.ahcpr.gov

Data-related programs:

AHCPR undertakes the Medical Expenditure Panel Survey which collects data on the specific health services that Americans use, how frequently they use them, the cost of these services, and how they are paid, as well as data on the cost, scope, and breadth of private health insurance held by and available to the U.S. population. The Agency, under the Health Cost and Utilization Program (HCUP), maintains information on inpatient hospital stays. AHCPR and the National Library of Medicine (NLM) are in partnership to support eight cooperative agreements on applications of the electronic medical record: for example, defining laboratory and imaging standards, and developing and testing common medical terminology for the electronic patient record. AHCPR is funding a program studying the use of clinical practice guidelines as content in computerized clinical decision support systems. The agency also collects uniform data to provide information about the cost impact of its guideline programs.

Standards Employed:

The data standards used in data collected by AHCPR are based on those employed by the Census Bureau, the American Hospital Association, the Health Resources and Services Administration (Area Resource File), the National Center for Health Statistics, and codes for clinical diagnosis and procedures such as ICD-9, ICD-9-CM, and CPT-4.

Purpose of Standards:

The standards AHCPR uses are intended to facilitate data analysis and use by ensuring comparability, quality and interoperability. Further, by promoting uniform, accurate, and automated health care data, AHCPR advances medical research (including medical effectiveness and cost effectiveness research) and improves the efficiency of the private sector health care delivery system and quality improvement measurement.

Subject Areas Covered:

The standards cover data including: demographic, employment, economic, health status and other characteristics of survey respondents; the use and cost of services provided by various health care providers; laboratory and imaging standards; and general clinical and administrative data for use in computer-based patient record systems.

Standards Activities:

AHCPR promotes the coordination of health care data standards nationally by supporting the meetings of the American National Standards Institute (ANSI), Healthcare Informatics Standards Board (HISB) in Washington, D.C., and by participating in standards meetings as resources permit; and internationally by sponsoring meetings of standards experts (primarily U.S., European, and Japanese, but also including Canadian and Australian), coordinated through HISB, and by exchanges of information about current standards activities through research and government liaison.

The agency sponsors research conferences to advance the development and use of data standards in electronic medical patient records and health services research. AHCPR staff Serve on a number of DHHS and national standards organizations and committees including the International Medical Informatics Association, Computerized Patient Record Institute, ASTM, ANSI, HISB, the White House Information Infrastructure Task Force - Committee on Applications and Technology - Health Information Applications Working Group - Standards Subcommittee, the Global Information Infrastructure - G7 Enabling Mechanism Sub-project, and the OMB Interagency Committee for the Review of Racial and Ethnicity (Data) Standards.

Data Dictionaries:

The agency uses a number of generally available standard data dictionaries, formats, and coding systems, in developing its data surveys and other standards activities. These include ICD-9, CPT-4, NLM's Metathesaurus, and the U.S. Census Bureau's dictionaries.

Publications and Other Dissemination:

Descriptions of these standards activities and uses are contained in various publications and in World Wide Web dissemination. The ACHPR Clearinghouse's phone number is 1-800-358-9295. AHCPR's WWW address is http://www.ahcpr.gov .


Agency:

Department of Health and Human Services

Centers for Disease Control and Prevention and Agency for Toxic Substance and Disease Registry (CDC/ATSDR)

Contact:

Ronald R. Fichtner, Ph.D.
Chief, Office of Prevention Informatics
National Center for HIV, STD, and TB Prevention
1600 Clifton Rd., N.E. (MS E08)
Atlanta, GA 30333
404-639-8040
FAX: 404-639-8603
E-MAIL: RRF1 @ CPSOD1.EM.CDC.GOV

Data-related programs:

CDC is the nation's prevention agency, responsible for preventing disease, injury, and disability, and, thereby promoting health and quality of life. In collaboration with public health partners and others, it focuses on the prevention of infectious diseases, chronic diseases, injuries, workplace hazards, birth defects and disabilities, and environmental hazards.

CDC is challenged by the ongoing need to provide timely, useful, and epidemiologically-sound information to assist the public health community in developing prevention programs and interventions. A broad variety of data collection methods and systems is in place to help meet this challenge.

At least seven categories of information are needed by CDC: a) reports of health events affecting individuals; b) vital statistics on the entire population; c) information on the health status, risk behaviors, and experiences of populations; d) information on potential exposure to environmental agents; e) information useful to public health but obtained by non-public sources; f) information on existing public health programs; and g) information on the health care system and its overall effects on health.

Standards employed:

CDC has begun an overall process of identifying where relevant surveillance and information systems need standards, and deciding what those standards should be. However, a few CDC programs have begun formal consideration of standards in selected areas.

For example, the National Immunization Program is awaiting approval from HL7 for transmission messages that will be instrumental in the development and implementation of a planned national immunization registry. This system will ultimately provide ongoing measurement of immunization coverage at national, state, and local levels.

Elsewhere, the National Center for Injury Prevention and Control is initiating a broad-based, public-private effort to develop a set of uniform data elements for voluntary use in 24-hour, hospital-based emergency departments in the U.S. The goals of this effort are to identify routinely recorded emergency department data elements that have multiple, productive uses, and to recommend data definitions, data entry formats, and other specifications for the identified data elements. The effort will attempt to incorporate existing data standards to the fullest extent possible, particularly standards for computer-based patient records, such as HL7 electronic data interchange standards and ASTM standards for the content and structure of computer-based records.

Purpose of standards:

CDC supports standards because they are seen as critical to the creation of integrated public health surveillance and health information systems, recently identified by strategic planning as CDC's highest priority.

Subject Areas Covered:

Areas to be considered for standards development may include: common data elements/standard core variables, software development, transmission, data access, and confidentiality/security. It is intended that standards will eventually influence key areas necessary for integrated surveillance and information systems, potentially affecting the broad array of these systems supported by CDC.

Standards Activity:

In order to serve the purpose, "to formulate and enact policy concerning the planning, development, maintenance, and use of integrated public health information and surveillance systems," CDC has formed the Health Information and SurveillanceSystems Board (HISSB). CDC's principal organizations are represented on the HISSB, which has major subcommittees devoted to general standards and liaison with standards bodies, standards related to Internet applications, and coordination of surveillance activities. A pre-existing committee of CDC information resource managers, responsible for setting standards in related areas such as computing platforms, connectivity, and information dissemination, is represented on the HISSB.

Links with Other Agencies:

Strong internal linkages exist with CDC's National Center for Health Statistics. External linkages are being developed through participation on the DHHS Data Council's Committee on Health Data Standards, and, with organizations that maintain or have access to data on health care services and utilization, such as those involved in delivering managed care.

Publications and Other Disseminations:

CDC has numerous publications including the Morbidity and Mortality Weekly Report (MMWR) and Emerging Infectious Diseases (EID), both of which are available via Internet. Integrating Public Health Information and Surveillance Systems, which describes the basic considerations for formation of the HISSB, is available upon request. These reports are available on the CDC web page located at http://www.cdc.gov..

Comments:

The HISSB will oversee the formulation of policy related to standards by instituting and orchestrating a process which will facilitate discussion, develop consensus, and legitimize outcomes. Organizational liaisons with standards bodies have begun and are seen as critical to these bodies developing standards that are informed by the future needs of the public health community.


Agency:

Department of Health and Human Services
Centers for Disease Control and Prevention
National Center for Health Statistics

Contact:

Marjorie Greenberg
DHHS / CDC / NCHS
6525 Belcrest Road, Room 1100
Hyattsville, MD 20782
Phone 301-436-4253 Fax (301) 436-4233
E-mail: msg1@nch11a.em.cdc.gov

Data-related programs:

The agency serves as the World Health Organization (WHO) Collaborating Center for the Classification of Diseases for North America. The agency is also responsible for coordination of all official disease classification activities in the U.S. relating to the International Classification of Diseases (ICD) and its use, interpretation, and periodic revision. This includes maintenance of the ICD-9 for mortality and the clinical modification of ICD-9 (ICD-9-CM) for morbidity. NCHS will also be responsible for the implementation of ICD-10 in 1998 for mortality and the planned Year 2000 implementation of ICD-10-CM for morbidity. The Collaborating Center is also responsible in North America for the International Classification of Impairments, Disabilities and Handicaps (ICIDH), which is currently under revision with strong North American input.

NCHS continues to work with the states to develop standard certificates for vital events, which include births, deaths, fetal deaths, marriages, divorces and abortions. These certificates are revised approximately every 10 years. NCHS also develops with state participation a model law for state registration systems. The standard certificates and model law are the principal means of implementing standardization in the national vital statistics system. Currently, a National Steering Committee convened by NCHS is developing minimum content and transmission standards for the electronic death certificate.

NCHS also participates in developing a number of core health data sets in conjunction with interagency task forces and the National Committee on Vital and Health Statistics (NCVHS). The NCVHS is the external advisory committee to the Department of HHS; NCHS serves as Executive Secretary to the Committee. The two most prominent core data sets are the Uniform Hospital Discharge Data Set (UHDDS), which is the basis of the hospital discharge data systems in 34 states, and the Uniform Ambulatory Care Data Set (UACDS). Uniform bills, the UB-92 and HCFA 1500, respectively, are a major vehicle for collecting the UHDDS and UACDS.

The agency is responsible for numerous national surveys, including the National Health Interview Survey (NHIS), the National Health and Nutrition Examination Survey (NHANES), and national provider surveys. The NHIS is serving as the sampling frame for the Medical Expenditure Panel Survey and, under the Department's integrated survey plan, will serve as the core sampling frame for several Departmental surveys. Through this and related mechanisms, NCHS is trying to promote standardized reporting and coding in NCHS surveys and, by example, in similar surveys conducted elsewhere.

Standards Employed:

The ICD is the official medical classification for disease reporting in the U.S. The standard certificates for vital records are adopted by all registration areas in the U.S. Of the core data sets, only the UHDDS has been officially promulgated by DHHS.

Purpose of Standards:

The standards are intended to facilitate data collection and analysis by ensuring comparability across geographic areas and sites of care and enhancing data quality.

Subject Areas Covered:

Subject areas are the classification of diseases, causes of death, vital events, and reporting of morbidity data, health events, and other health-related information from individuals, providers and households.

Standards Activities:

Agency personnel participate in activities of the WHO Collaborating Centers for the Classification of Diseases and in development and revision of international classification standards under WHO. Agency personnel also function as one of the four cooperating parties in the United States for development of standard morbidity coding guidelines and, with HCFA, as co-chair of the ICD-9-CM Coordination and Maintenance Committee.

Links with Other Agencies:

These activities are coordinated extensively within DHHS, as well as with a broad range of public and private sector organizations.

Data Dictionaries:

The automated systems used in mortality classification are referred to as "dictionaries," translating from medical terms into medical codes. The definitions developed for data elements in the core data sets also represent a type of data dictionary.

Publications and Other Dissemination:

The agency publishes numerous reports, professional papers by staff members, coding instructions for disease classifications, and World Wide Web documents. The annual update of the ICD-9-CM and coding guidelines are made available on CD-ROM. Guidelines are also published in conjunction with private sector organizations, such as the American Hospital Association. The NCHS report, Health, United States, is published annually and contains trend data on health status, health care resources, health care expenditures, and utilization of health resources. Natality and mortality data are published in annual volumes and through monthly reports and recently have been included on the NCHS Home Page located on the web at http://www.cdc.gov/nchswww/nchshome.htm.


Agency:

Department of Health and Human Services
Food and Drug Administration

Contacts:

Gary Green
Strategic Systems Staff, OIRM, OC
FDA, Mail Code HF-21 Room 16-B-45, HF-21
Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Phone 301-594-6491 Fax 301-594-0829

Charles S. Furfine, Ph.D.
FDA/CDRH, Mail Code HFZ-143
12720 Twinbrook Parkway
Rockville, MD 20857
Phone 301-443-2536, ext. 16 Fax 301-443-9101

Data-Related Programs:

The Food and Drug Administration (FDA) is responsible for ensuring that foods are safe, wholesome, and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; and cosmetics and electronic products that emit radiation are safe. As a regulatory agency the work of the FDA requires high quality, timely decisions. These decisions must be based on information that is complete, accurate, and readily available whenever and wherever it is needed. While many factors that influence the FDA's environment will continue to change; one thing will not change: the agency is and will continue to be an information-intensive organization. The FDA must collect, analyze, and maintain significant amounts of data collected from pre-market approval and post-market surveillance of regulated products.

Standards Employed:

FDA currently utilizes standards in multiple ways. Guidelines such as the Good Laboratory Practice (GLP) guideline and Good Manufacturing Practice (GMP) guidelines set standards for the testing and manufacturing of regulated products. The current use of terminology standards is primarily confined to the post marketing product surveillance portions of the regulatory process. Examples include the utilization of the Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) developed and maintained by the FDA's Center for Drug Evaluation and Research; World Health Organization Adverse Reaction Terminology (WHO-ART), developed and maintained by the WHO; and the Classification Names for Medical Devices and In-Vitro Diagnostic Products and the Health Effects coding conventions within the Instruction for Completion Form 3500A Specific for Medical Device Reporting developed and maintained by the Center for Device and Evaluation and Radiological Health.

Purpose of Standards:

The use of standards such as the terminologies used in the coding of post marketing adverse event information allows the Agency to perform safety evaluations based on population, product classification, concurrent illness or medical product use for the products it regulates. This is a major part of FDA's mission.

Subject Areas Covered:

The subject areas covered are all aspects of the product development life cycle for ethical pharmaceuticals, from pre-clinical toxicology and pathology through manufacturing and post-marketing surveillance. The agency emphasizes prescribing content, not format standards; but it does set guidelines for reporting and requirements for submission for marketing approval, and these guidelines affect providers and their vendors.

Affected activities include the development, marketing and effects reporting by pharmaceutical companies, plus their service and software providers, information technology and telecommunications organizations, and other companies somehow involved in marketing drugs or medical devices. The companies affected number in the tens of thousands.

Measures the agency takes to enforce or encourage compliance with these standards:

Currently, the FDA encourages and in some case requires the utilization of GMP and GLP practices in the development, testing, and manufacturing of the products it regulates. These guidelines were developed and reviewed by all parties and felt to be the gold standards upon which other nations have based their guidelines. In areas of terminology, industry is encourages to utilize the various terminologies via policy statements.

Measures the agency takes to assess the effects of these standards:

The Agency assesses the effects of standards through its ability to make effective, efficient, and reproducible decisions regarding the safety and efficacy of the products it regulates.

Comments:

Many of the FDA's medical, scientific, information science and regulatory staff participate in standard settings bodies as either representative of their professional organizations or as representatives of the FDA. Participation varies as to the level of participation and potential impact on either a program area within the Agency or the Agency as a whole.

Currently, the FDA is participating in multiple international groups made up of regulators and regulated industry to begin the identification, evaluation expansion and implementation of standards to facilitate information sharing, data analysis, and data retrieval between and among the various parties world-wide. Two such groups are the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) ---under which the International Medical Terminology, originally based upon the Medical Dictionary for Drug Regulatory Affairs (MEDRRA) terminology is being developed; and the Global Harmonization Task Force which is focusing on devices. Both groups are moving aggressively to provide implementable solutions to support regulatory communication.


Agency:

Department of Health and Human Services
Health Care Financing Administration

Contact:

Robert Moore
Bureau of Data Management Strategy (BDMS) / OSM
Health Care Financing Administration
7000 Security Boulevard
Baltimore, MD 21207
Phone 410-786-0950 Fax 410-786-1810

Data-related programs:

HCFA is working with the managed care industry to develop the Healthplan Employer Data and Information Set (HEDIS), which includes quality measures as well as financial indicators, measures of beneficiary satisfaction, and measures of access to care. HCFA also collects data on quality of care through the Peer Review Organization (PRO) program--Clinical Data Abstraction Data Centers (CDACs). The agency is seeking to provide more global and comparable data from these reviews. The agency maintains data bases for the Medicare and Medicaid programs.

Standards Employed:

HCFA employs standards developed by Health Level 7 (HL7), American Standards Committee (ASC) X12N, and a number of other external standards (including ICD-9, ICD-9cm andCPT-4 codes); the agency also setsits own requirements for claims data.

Purpose of Standards:

The standards are used as part of HCFA's reimbursement process, as mandated by the authorization acts for the agency. To enforce or encourage compliance with these standards, the agency regularly reviews submitted data and the procedures used by submitters; non-payment of non-compliant submitters is the primary means of enforcement.

Subject Areas Covered:

These standards cover all aspects of medical care and health status for Medicare beneficiaries. Activities covered include all claims and the claim-relevant treatment data from medical providers who are paid by HCFA, and selected submissions under states' Medicaid claims. Users include 1.2 million Medicare providers and their agents and vendors. There are about 70 vendors/contractors supplying data services.

Standards Activities:

Agency personnel participate in ASC X12, HL7, ICD-10-PCS (Provider Coding System). ICD-9-CM committee (with NCHS), CPT-4 (HCPCS-Health Care Financing Administration Common Procedure Coding System), and numerous other bodies to set standards.

Links with Other Agencies:

Standards are coordinated extensively within DHHS, by formal policy-setting processes, and with other agencies, states, insurers, providers and vendors.

Publications and Other Dissemination:

These standards are promulgated by numerous publications, magnetic media, and World Wide Web dissemination, for example, http://www.hcfa.gov.

Assessment of Effects:

To assess the effects of standards, the agency conducts analyses of the data and reviews of the submitters' procedures.

Comments:

Most of this agency's data interchange is electronic. HCFA implements more ASC X12N standards than any other health care organization.

Standards specify what data elements are included, but not order and formats. These are in the implementation guide; different coding systems may be used. The industry needs one agreement to standardize these aspects. As it is, a given field may contain varying contents -- for example, date formats may vary considerably.


Agency:

Department of Health and Human Services
Health Resources and Services Administration (HRSA)

Contacts:

Mike Millman
Office of Planning, Evaluation and Legislation
Health Resources Services Administration
Room 14-33, Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Phone 301-443-0368 Fax 301-443-9270

Trish Royston
Office of Planning, Evaluation and Legislation
Health Resources Services Administration
Room 14-36, Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Phone 301-443-1129 Fax 301-443-9270

Data-related programs:

HRSA promotes primary care and other services to vulnerable populations, principally through grants to States, localities, academic institutions, and community-based organizations. Grantees report aggregate data on clients served and services provided.

HRSA sponsors the Area Resource File (ARF), a county specific health resources information system. The existing data elements from the externally provided data sources are used and include geographic descriptors, health professions information Iincluding training), health facilities information, utilization levels for hospitals, health care expenditures, and population characteristics and economic data. HRSA also maintains the Practitioner Data Bank established by Congress to direct discrete inquiries into and scrutiny of specific areas of a practitioner's license, professional society memberships, Medical malpractice payment history, and record of clinical priviliges.

HRSA is very interested in the current work on standardizing encounter and enrollment data, which will facilitate monitoring access to care. HRSA has participated as a commenter on a number of data standardization initiatives including the Healthplan Employers Data and Information Set (HEDIS) indicators; the identification of a consensus-based set of ICD-9 codes that can be used to measure inadequate primary care; and the current DHHS study of state and local public health expenditures and capacity for personal health services.

Standards Employed:

HRSA is a user but not a setter of data standards. In the developmentof grantee reporting requirements and other data systems, HRSA reviews coding schemes and adopts them as appropriate. For example, the National Practitioner Data Bank uses the Harvard University Foundation Allegation of Negligence coding scheme. In reviewing and selecting existing coding systems. HRSA consults widely with relevant parties before implementing reporting formats.


Agency:

Department of Health and Human Services
Indian Health Service

Contacts:

Jim Garvie, Acting Director
Office of Information Resources Management
Indian Health Service
Parklawn Building, Room 5-A-21
5600 Fishers Lane
Rockville, MD 20857
Phone 301-443-0750 Fax 301-443-7279

Tony d'Angelo
Office of Information Resources Management
Indian Health Service
Parklawn Building, Room 5-A-21
5600 Fishers Lane
Rockville, MD 20857
Phone 301-443-1180

Data-related programs:

IHS has a number of efforts in progress to develop health status and care indicators, which it then encourages tribes to adopt.

Standards Employed:

The agency generally follows DHHS standards (e.g. departmental ambulatory medical data and discharge data setsort and molds its forms and processes to follow HCFA's model in most cases. Tribes are encouraged but not required to use the core data set IHS has adopted. Tribes have considerable flexibility and variability in what services they receive, how they pay, and how they report.

Computer software and systems developed by or for the agency are increasingly driven by standards activity elsewhere, but no one in the agency is formally assigned to follow such activity.

Purpose of Standards:

The standards developed by the agency are used as part of the agency's usual processing and related functions. External standards are applied as deemed useful. The legislative and regulatory mandates for this activity are the authorization acts for the agency, but this legislation does not mention standards; it simply directs the agency to provide services.

Subject Areas Covered:

The subject areas covered are various aspects of health status of, and medical care provided to, members of Indian tribes, either directly by this agency or under contract by private providers and insurers. Community health and infrastructure are affected as well as clinical care.

Standards Activities:

Agency personnel do not participate in standards-setting bodies. IHS generally tries to follow standards and guidelines developed elsewhere, especially within DHHS.

Data Dictionaries:

None. IHS has developed a core data set which tribes are encouraged but not required to use.

Publications and Other Dissemination:

The standards are promulgated by publication in the Federal Register, by inclusion in manuals, and by less formal communication with providers and tribal leaders. To promote the use of standards or guidelines by tribes, the agency holds meetings with tribes and usually sends out letters to tribes and regional officials soliciting review and comment. Such solicitations are generally published in the Federal Register as well. Information on the health care data systems is available on the world-wide web at htttp://www.ihs.gov/.

Measures the agency takes to enforce or encourage compliance with these standards:

IHS enforces compliance with standards by declining requests for contract renewal from providers and vendors who do not follow the agency's requirements. There is a current Notice of Proposed Rule-Making on draft regulations concerning requirements for contractors and criteria for acceptance.

Measures the agency takes to assess the effects of these standards:

The agency assesses the effects of standards by developing baseline measures and performance indicators and encouraging their adoption by IHS providers and by contractors with tribes. These measures include health status, health practices, community involvement, some financial elements, some Healthy People 2000 objectives, some HEDIS indicators, and some community-specific elements.

Comments:

The agency's Office of Health Programs has focused more on NCHS reporting than on HCFA reporting; much payment data HCFA would collect is not collected for IHS beneficiaries.


Agency:

Department of Health and Human Services
National Institutes of Health
National Cancer Institute
International Cancer Information Center

Contact:

Susan M. Hubbard
Director, Inter International Cancer Information Center
9030 Old Georgetown Road
Bethesda, Maryland 20814
Phone: 301 496-1773
Email: su@icic.nci.nih.gov

Data Related Programs:

The International Cancer Information Center's (ICIC) mission is to effectively disseminate state-of-the-art information about cancer treatment and research worldwide. The major long term goal of the ICIC is to provide appropriate information about cancer treatment and research to all persons and organizations with a need for the information. Strategies for achieving the program goals include removing technological, cost and language barriers to obtaining ICIC information products; defining the universe of potential users of information about cancer treatment and research and the needs of groups within that universe; and developing a plan for reaching groups within that universe.

Towards this end, the ICIC disseminates the Journal of the National Cancer Institute bimonthly and provides two databases containing information about cancer research and treatment, the Physician Data Query (PDQ) database and the CANCERLIT database. ICIC provides electronic access to this data in a variety of ways including online access, facsimile access, and access via the Internet. ICIC is currently building a universal database server that will contain and disseminate all scientific information collected by or created in the ICIC.

Standards Employed:

Medical data standards are not used in creating the ICIC information collection, but are useful in accessing that collection. They include a wide variety of standards such as ICD-9, CPT-4, Snomed, ACR/NEMA, HL7, etc.

Purpose of Standards:

Standards described above, and others, will allow individual users or automated medical information systems to interface directly to ICIC data using native nomenclatures.

Subject Areas Covered:

The standards cover data including health status, the use and cost of health services, laboratory and imaging standards, and general clinical data for use in computer-based patient record systems.

Standards Activities:

ICIC staff monitor standards activities through the Health Information Standards Planning Panel, the White House Information Infrastructure Task Force - Health Information Applications Working Group, and through G7 activities.

Data Dictionaries:

The ICIC universal database will support retrieval using a wide range of standard nomenclatures as stored in the National Library of Medicine's Unified Medical Language System (UMLS).


Agency:

Department of Health and Human Services
National Institutes of Health
National Library of Medicine

Contact:

Betsy L. Humphreys, M.L.S.
National Library of Medicine
8600 Rockville Pike
Bethesda, MD 20894
Phone 301-496-6921Fax 301-496-6923
E-mail: blh@nlm.nih.gov

Data-related Programs:

Although its basic services are focused on acquisition, organization, preservation, and access to the published literature, NLM also has several programs related to biomedical and health data:

(1) NLM's National Center for Biotechnology Information builds and maintains GenBank, a huge data base of molecular sequence data, and develops information systems that allow researchers to contribute to the data base, to use it to aid their research, and to link it to related biological information sources.

(2) The Library collaborates with other Federal agencies to build and make available data banks on the toxicological and environmental effects of chemicals and on AIDS clinical trials and experimental drugs.

(3) The Visible Human project has created high resolution volumetric data sets for entire human male and female cadavers.

(4) The Unified Medical Language System (UMLS) project has developed a Metathesaurus that integrates concepts and terms from 30 different health-related vocabularies and classifications in a single data base format. Developers of health data systems can use the Metathesaurus as a convenient and uniform source of controlled vocabulary for data creation applications.

(5) NLM's Extramural Grants program has a 25-year history of funding research related to the development of clinical information systems and automated patient data. More recently, as a participant in the multi-agency High Performance Computing and Communications (HPCC) program, the Library has funded research and development regarding health-related applications of the National Information Infrastructure, including patient record systems, the transfer of data between the health care and public health systems, and ensuring the confidentiality of electronic health data.

Standards Employed:

NLM uses a wide range of national and international standards for bibliographic and publication data, including SGML (Standard Generalized Mark-up Language), standards for bibliographic references, cataloging records, holdings data, and abbreviations of titles of journal articles.

The Library also uses the Abstract Syntax Notation 1 (ASN-1) in the distribution of molecular biology data, and the UMLS Knowledge Sources.

Purpose of Standards:

NLM employs standards to facilitate the integration of the Library's bibliographic, molecular biology, and vocabulary data into information systems throughout the world and the incorporation of information generated elsewhere into the Library's systems and services.

Subject Areas Covered:

Standards apply to published literature; molecular biology data; chemical, toxicological, and environmental health data; and biomedical and health-related nomenclature.

Standards Activities:

NLM is a voting member of the National Information Standards Organization and from time to time chairs or participates in committees developing specific library and information science-related standards.

NLM currently chairs the DHHS Data Council Working Group on International Health Data Collaboration: G7 Nations and represents NIH on the DHHS Data Council's Committee on Health Data Standards and Interdepartmental Health Privacy Working Group.

NLM provides support for the development and extension of the DICOM standard and related work on aligning HL7 and DICOM.

NLM participated in the ANSI HISPP (Health Informatics Standards Planning Panel) Vocabularies and Codes Working Group.

NLM and AHCPR are currently sponsoring a Large-Scale Vocabulary Test to determine the extent to which a set of controlled vocabularies cover the concepts and terms needed in health care and public health applications. The test set includes the 30 vocabularies in the 1996 edition of the UMLS Metathesaurus, plus the remainder of SNOMED International, LOINC (Logical Observations: Identifiers, Names, and Codes), and the Read Clinical Classification, Version 3.1.

Links with Other Agencies:

As indicated above, NLM collaborates with many other agencies in building data bases, in the HPCC Program, in DHHS Data Council Activities, and in other efforts.

Data Dictionaries:

NLM maintains data dictionaries for its bibliographic, thesaurus, molecular biology, and chemistry and toxicology data.

Publications and Other Dissemination:

Information about the Library's programs, services, and machine-readable data is available on the NLM Web site (www.nlm.nih.gov). NLM staff report regularly at professional meetings and in the published literature.


Agency:

Department of Health and Human Services
Substance Abuse and Mental Health Administration (SAMHSA)

Contacts:

Ronald Manderscheid, M.D.
Office of Survey Analysis
SAMHSA
Room 15-C-04, Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Phone 301-443-3343 Fax 301-443-7926

Nancy Pearce
Office of Applied Studies
SAMHSA
Room 16-C-18, Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Phone 301-443-7978 Fax 301-443-9847

Data-related programs:

SAMHSA provides leadership in improving and standardizing client data in substance abuse. The agency is working with representatives of states and national organizations tosupport development and improvement of what is now called the Treatment Episode Data Set (TEDS), formerly the Client Data Set (CDS) and CODAP before that. SAMHSA also conducts the annual Uniform Facilities Data Survey (UFDS) of providers.

The Office of Survey Analysis is launching the Mental Health Statistics Improvement Program, a new effort which includes some elements of standardization.

Standards Employed:

SAMHSA employs the Diagnostic and Statistical Manual (DSM) for classification of mental disorders and has developed a number of internal standards and data conventions as well. A data dictionary is currently in draft, including items and definitions, character and field lengths, and edit quality checks.

Comments:

Until about two years ago, the focus in substance abuse data collection was on admissions. Recently, there has been more emphasis on improving discharge data.


Agency:

U. S. Department of Transportation
Office of Emergency Medical Services

Contact:

Susan Ryan
Chief, Emergency Medical Services Division
U. S. Department of Transportation
Room 5119
400 - 7th Street S.W.
Washington, DC 20590
Phone 202-366-9794 Fax 202-366-7721

Commander Garry Criddle
Emergency Medical Services Division
U. S. Department of Transportation
Room 5119
400 - 7th Street S.W.
Washington, DC 20590
Phone 202-366-9794 Fax 202-366-7721

Data-related programs:

The agency supports nationwide training of emergency medical personnel and the CODES project (pilot, now in seven states) to link police, ambulance, emergency room, and hospital reports on one data sheet (using ICD-9 codes)

Standards Employed:

This agency is specifically prohibited from imposing standards. Voluntary guidelines, developed in cooperation with states and localities, are incorporated in training materials.

Purpose of Guidelines:

The guidelines are intended to improve the quality of emergency medical care by incorporating best practices into training materials.

DOT is the only agency which has a Congressional mandate regarding emergency medical services (PL 89-564, 1966).

Subject Areas Covered:

All aspects of emergency medical care, especially first responders, ambulance services, and paramedics.

Standards Activities:

Agency personnel do participate in standards-setting bodies such as the ASTM, F30 committee on emergency medical standards.

Links with Other Agencies:

Agency staff participate in the Federal Interagency Committee on Emergency Medical Services (FICEMS), chaired by the Federal Emergency Management Administration, to develop improved responses to disasters, pursuant to the Federal Response Plan (FEMA-229(1), 1993). Coordination is mostly with state medical directors, primarily through their national association.

The Centers for Disease Control and Prevention (CDC) is developing voluntary standards for what information should be included in an emergency room report.

Data Dictionaries:

None. The agency does disseminate a recommended standard-form ambulance run sheet.

Publications and Other Dissemination:

The agency's most significant guidelines-related publications are training manuals and related materials for emergency medical service staff. The agency also publishes a newsletter, which will soon be on-line; it has a home page and publishes a periodic liaison report.

The agency also disseminates guidelines and related information through special mailings to state medical directors and their professional associations.

Assessment of Effects:

The agency relies on feedback from states, localities and providers. The agency sends expert teams (not Federal employees) to help states determine what works and develop five-year plans for improvements.

The agency is very interested in outcomes research to assess whether emergency medical services work as intended but does not have resources to support this research.


Agency:

Department of Veterans Affairs

Contacts:

Dr. Robert Kolodner
Department of Veterans Affairs
Mail Code 19
810 Vermont Avenue, N.W.
Washington, DC 20420
Phone 202-273-8663-7441 Fax 202-273-9386

Steve Wagner
Office of the Chief Information Officer
Veterans Health Administration
Department of Veterans Affairs, Mail Code 003
718 Smyth Road
Manchester, NH 03104
Phone 603-624-4366 x6780 Fax 603-624-6578
E-mail: steve.wagner@forum.va.gov

Daniel Maloney
Technology Service
Department of Veterans Affairs
8403 Colesville Road, Suite 200
Silver Spring, MD 20910
Phone 301-427-3701 Fax 301-427-3711

Data-related programs:

Virtually all program areas in the Veterans Health Administration (VHA) are supported by information system applications. Almost all of these applications are written in the M (formerly MUMPS) standard computer language and are based on a single data dictionary which implements a standard set of data elements and data values. VHA has also implemented a standard clinical lexicon, based on the Uniform Medical Language System (UMLS), for use in all applications.

Standards Employed:

VHA uses the M computer language for developing most of its applications and for implementing a standard data dictionary for all applications. VHA uses the ASC X12, HL7 and DICOM III standards for exchanging health care information between health care facilities and among applications. VHA uses a number of standard coding schemes for data consistency and uses the UMLS as the basis for its standard clinical lexicon. VHA is considering implementing the national provider and payer identification systems that are being developed by HCFA.

Purpose of Standards:

The standards are implemented in VHA software applications and specified in applicable contracts for commercial products and services in order to ensure consistent representation of data and in order to facilitate the exchange of data between health care facilities.

Subject Areas Covered:

The subject areas covered include virtually all aspects of health care and health status, such as electronic medical records; exchange of clinical information; ancillary tests and procedures; instrument interfaces; demographic, financial and eligibility information; scheduling information, privacy, confidentiality and security.

Standards Activities:

VHA personnel participate in a large number of standards groups, including the ANSI Health-care Informatics Standards Board (HISB), HL7, ASTM (E31 committee), ASC X12 (X12N insurance subcommittee), DICOM III, and IEEE. VHA is also participating in HCFA's efforts to create national provider and payer identifiers. VHA personnel attend standards meetings, propose improvements to existing standards, identify new standards that are needed, and review and comment on ballots of proposed standards. VHA also develops internal standards when external standards are not available or not applicable.

Links with Other Agencies:

VHA maintains contact with a number of other Federal agencies, including DoD, HHS, AHCPR, IHS, CDC, NLM and NIH, concerning standards activities.

Data Dictionaries:

The M programming language and the VA FileMan data dictionary provide an internal standard for representing data in VHA applications. VHA also uses ICD for diagnostic coding, CPT for ambulatory coding and SNOMED for laboratory coding. VHA is participating in the LOINC coding system for representing laboratory tests and procedures. A clinical lexicon based on the UMLS is being used to standardize clinical terminology.

Publications and Other Dissemination:

Internal standards are disseminated through policy and other manuals. These manuals are distributed in both printed and electronic form; the latter through a VA Web page (http://www.va.gov), electronic mail and a bulletin board. VHA has made an arrangement with the HL7 Committee to distribute the HL7 standard electronically throughout VHA. Other external standards activities are reported and distributed through e-mail.

Measures the agency takes to enforce or encourage compliance with these standards:

To enforce or encourage compliance with these standards, VHA relies on policy manuals, programming standards and conventions, peer reviews of software applications, and software tool sets that can be used by all software developers.

Measures the agency takes to assess the effects of these standards:

VHA assesses the effects of standards by testing applications at multiple facilities, conducting follow-up surveys, and providing formal mechanisms to report problems and request enhancements. VHA also uses multidisciplinary expert panels to review application areas and provide feedback.

Comments:

Unique patient identification is an unmet need. Even though VHA has military identification information on its patients, there are still problems with missing or duplicate Social Security numbers (the primary identifier) and other identifying data.

There is a need for a standard clinical terminology, especially in areas such as mental health.

Proposed legislation concerning privacy, confidentiality and security of information will, if enacted, significantly affect VHA.


Agency:

Federal Emergency Management Administration

Contact:

Jean Adams
National Fire Administration
Federal Emergency Management Administration
16825 S. Seton Avenue
Emmitsburg, MD 21727
Phone 301-447-1402 Fax 301-447-1213

Data-related programs:

The agency attempts to determine what data elements need to be captured to support efforts to analyze the effectiveness of emergency medical services. This effort encompasses data about both victims (patients) and providers. A particular interest is exposure to hazardous materials, which generates a need for long-term monitoring of both patients and providers to assess effects.

The agency's current effort to improve the health and safety of female firefighters includes a task to improve data describing injuries. This includes considering such questions as whether injuries resulted from or were made worse by job-related stress, or by equipment which fit poorly because it was designed for men.

Standards Employed:

None for health data; ANSI 1500, 1582, 1583 for standards and specifications for protective clothing and equipment for firefighters.

Purpose of Standards:

The health data are included in the injury and incident reports emanating from the agency's emergency response activities. These data, among other considerations, motivate the agency's policies and participation in setting standards for protective clothing and equipment.

Subject Areas Covered:

Subject areas are primarily the medical effects of emergencies, especially fires, and the role of protective clothing and equipment in preventing or mitigating these effects.

Standards Activities:

Agency personnel participate in ANSI committees to set standards for protective clothing and equipment.

Links with Other Agencies:

Emergency procedures are coordinated extensively with other agencies, states, and emergency service providers, primarily through the Federal Interagency Committee on Emergency Medical Services (FICEMS), which FEMA/NFA chairs.

Data Dictionaries:

None.

Publications and Other Dissemination:

The agency published a report of a conference in sponsored in early 1995 on data needs for evaluation of emergency medical services.


Agency:

Office of Personnel Management

Contacts:

Lucretia F. Meyers
Office of Personnel Management
1900 E Street NW
Washington, DC 20044
Phone 202-606-0770

Nancy Kichak
Office of Personnel Management
1900 E Street NW
Washington, DC 20044
Phone 202-606-0722 Fax 202-606-2922

Abby Block
Office of Personnel Management
1900 E Street NW
Washington, DC 20044
Phone 202-606-0004 Fax 202-606-0633

Data-related programs:

OPM is expanding its requirements and requests for data from the insurers who serve Federal employees. The agency now collects samples of claims from the five biggest carriers. OPM expects to "piggyback" on HEDIS and other indicators.

The agency is moving toward requiring all carriers to be able to receive enrollment data PC-to-PC. It is OPM's policy that by September 1996, carriers will reject all claims submitted for manual processing on forms other than the HCFA 1500 form. OPM also expects that by the year 2000, the majority of provider claims will be submitted electronically.

OPM has an initiative to require transmittal of valid CPT4 procedure codes, and place of service, for Medicare to process Part B claims from Federal retirees.

Standards Employed:

OPM uses some HCFA standards and works with carriers to help them develop standard formats for transmission of data to OPM.

Purpose of Standards:

The agency encourages the use of standards such as those used by HCFA to improve the quality and completeness of data that carriers submit. OPM's decisions regarding pricing of plans to be offered to Federal employees and retirees are based on these data.

Subject Areas Covered:

The data and standards cover enrollment and claims information for Federal employees and retirees.

Standards Activities:

The agency does not participate in standards setting organizations. It occasionally collaborates with other agencies, such as HCFA, to promote standardization and improvement of data.

Data Dictionaries:

None.

Publications and Other Dissemination:

Most dissemination of the agency's guidelines is through direct communication with the carriers.

Comments:

The growing number of HMOs and the consequent pressure on the agency to develop guidelines for them raise a concern, as the rest of the industry will probably follow any standard OPM mandates. The agency does not want to create such a requirement without coordination with other agencies.