3
Federal Leadership and Public–Private Partnerships

CHAPTER SUMMARY

Common clinical data standards are critical to establishing a national health information infrastructure that can support patient safety. While progress is being made in selecting core groups of these clinical data standards for national adoption, issues remain with the different standards development, approval, and maintenance processes currently employed by the multitude of organizations that produce data interchange and terminology standards. Delays in the ability of health care organizations to implement data standards will likely slow investment in information technology and necessitate sizable reworking of the information technology systems that currently exist to enable connectivity. Successful transition to and operation of the national health information infrastructure will require a more efficient, streamlined mechanism for standards development and implementation processes that can be achieved only through strong federal leadership and effective public–private partnerships. This chapter reviews current standards development and implementation processes and presents the committee’s recommendations for leveraging existing organizations and standards initiatives to build and sustain the informatics infrastructure envisioned in this report.

Development and implementation of data standards for the national health information infrastructure (NHII) will require the participation of



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Patient Safety: Achieving a New Standard for Care 3 Federal Leadership and Public–Private Partnerships CHAPTER SUMMARY Common clinical data standards are critical to establishing a national health information infrastructure that can support patient safety. While progress is being made in selecting core groups of these clinical data standards for national adoption, issues remain with the different standards development, approval, and maintenance processes currently employed by the multitude of organizations that produce data interchange and terminology standards. Delays in the ability of health care organizations to implement data standards will likely slow investment in information technology and necessitate sizable reworking of the information technology systems that currently exist to enable connectivity. Successful transition to and operation of the national health information infrastructure will require a more efficient, streamlined mechanism for standards development and implementation processes that can be achieved only through strong federal leadership and effective public–private partnerships. This chapter reviews current standards development and implementation processes and presents the committee’s recommendations for leveraging existing organizations and standards initiatives to build and sustain the informatics infrastructure envisioned in this report. Development and implementation of data standards for the national health information infrastructure (NHII) will require the participation of

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Patient Safety: Achieving a New Standard for Care both industry and government to create an optimal set of specifications that meet compatibility and interoperability needs, enable regulatory requirements, and allow for continued innovation and technology advancement by a variety of vendors. The organizations associated with the development of the three types of standards required—data interchange, terminologies, and knowledge representation—have differing methods for developing and implementing those standards. Both standards and methods have remained rather uncoordinated to date, resulting in overlaps and gaps in the comprehensive set of data standards needed for full operation of the national health information infrastructure. This chapter describes current processes for setting each type of standard; reviews current standards activities in the federal and private sectors; and presents the committee’s recommendations for how the standards development, implementation, and dissemination process can be streamlined and coordinated for greater usefulness and efficiency. CURRENT STANDARDS-SETTING PROCESSING Data Interchange Standards Data interchange standards are developed by three means—federal mandate by legislation or regulation, voluntary consensus through balloting of an industry professional group or sector, or de facto as the result of dominance in the commercial marketplace (see Figure 3-1). Once standards have been developed and approved, an integral part of their utilization is the conformity assessment process used to evaluate the compliance of products and processes with particular standards. Most technical standards in the health sector and other industries are developed at the national and international levels through the voluntary consensus process, with the participation of industry members of standards development organizations (SDOs) and government representatives having an interest in the use of the standard. More recently, these three pathways have converged, primarily as a result of the administrative simplification provisions of the Health Insurance Portability and Accountability Act (HIPAA), which require that standards for transactions be selected from those developed through the voluntary consensus process and/or those available because of marketplace dominance, rather than from government-unique standards. The American National Standards Institute (ANSI) bears the responsibility for endorsing consensus standards in the United States and for representing U.S. interests internationally in the International Organization for

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Patient Safety: Achieving a New Standard for Care FIGURE 3-1 Overview of processes used to set standards for the exchange of health care data in the United States. NOTE: AAMI = American Association of Medical Instrumentation; ASC = Accredited Standards Committee; ASTM = American Society for Testing and Materials; DICOM = Digital Imaging and Communication in Medicine; HL7 = Health Level Seven; IEEE = Institute for Electrical and Electronics Engineers; NCPDP = National Council for Prescription Drug Programs; NIST = National Institute of Standards and Technology.

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Patient Safety: Achieving a New Standard for Care Standardization (ISO). ANSI does not produce standards itself but functions as an accreditor of SDOs through its Accredited Standards Committee (ASC). ANSI primarily ensures that SDOs adhere to the principles of openness, balance of interests, due process, and an appeals process and approves standards that could become U.S. national standards. ANSI does not perform quality checks on the data interchange standards developed or distribute standards interpretation and implementation guides for consistency. Several primary SDOs in the United States develop the various types of data interchange standards required for health care data (see Box 3-1). Other independent groups are involved indirectly. They include the National Uniform Billing Committee, which develops a single billing form and standard dataset to be used nationwide by institutional providers and payers for handling health care claims, and the National Uniform Claims Committee, which develops a standardized dataset for use by the noninstitutional health care community in transmitting claim and encounter information to and from all third-party payers. BOX 3-1 Primary Standards Development Organizations Setting Standards for Data Interchange in the United States ASC X12N—the ANSI committee responsible for developing health care–related electronic data interchange (EDI) standards for administrative and financial transactions. Health Level Seven (HL7)—chief developer of clinical data exchange, vocabulary, and document architecture standards. Institute for Electrical and Electronics Engineers (IEEE)—developer of medical device transmission and vocabulary specifications. American Society for Testing and Materials (ASTM)—developer of standards for medical and surgical materials and devices, emergency medical services, and health information systems. Digital Imaging and Communication in Medicine (DICOM)—developer of transmission and vocabulary standards for radiological images; created jointly by the American College of Radiology and the National Equipment Manufacturers Association and now is an international organization. American Dental Association (ADA)—developer of all standards relating to dentistry. National Council for Prescription Drug Programs (NCPDP)—developer of transmission standards for documents related to prescription drugs.

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Patient Safety: Achieving a New Standard for Care As the chief endorser of U.S. standards, ANSI recognizes SDOs and their standards through three methods: ANSI determines that a U.S. national standard is needed, but there is no work in this area. An organization to develop the needed standard is either created or contracted from existing sources. ASC then recognizes and oversees the standards development process. An SDO independently develops standards following ANSI-prescribed rules and processes (i.e., balloting) for consensus standards. An SDO submits an independently developed standard to ANSI for endorsement as a national standard, after canvassing the sector for objections and comments. In the consensus balloting process (used by Health Level Seven [HL7], the Institute of Electrical and Electronics Engineers [IEEE], and the National Council for Prescription Drug Programs [NCPDP]), a draft standard is circulated to the SDO members and other interested parties for comment over a 6-week period. Care is taken to ensure balance among voters, with no more than 50 percent being vendors. All comments are considered, and negative ballots must be specifically addressed. If a negative ballot is persuasive, the standard is modified and must be reballoted, particularly if the changes are significant. If a negative ballot is not persuasive, the SDO requests its removal. If neither of these situations occurs, comments are sent to the entire balloting group for consideration. The resulting vote determines the content of the standard; for health care data interchange standards, over 90 percent agreement among the parties is usually required for a standard to be approved (American National Standards Institute, 2002). In fact, some SDOs, such as HL7, also have a preliminary approval process by a technical committee before a new or revised standard is presented for open balloting by ANSI rules (Health Level Seven, 2002). For the canvassing process (used by the American Society for Testing and Materials [ASTM] and Digital Imaging and Communication in Medicine [DICOM]), a notice of a proposed standard is published in an official registry, and interested persons may provide objections and/or comments. In the absence of negative comments, the standard is approved. This process is generally not preferred over the consensus process because public notices are often ignored as the result of a lack of immediate need for interoperability, use of other data standards, or other reasons, resulting in a much less open or scientifically rigid process for achieving standardization.

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Patient Safety: Achieving a New Standard for Care Once data interchange standards have been approved by ANSI, they become American national standards, and the SDOs and ANSI can sell them to vendors. The standards must then be reviewed at least every 5 years for currency and appropriateness. Implementing the standards is another challenge. A process is required for ensuring that vendor products comply with the standards. Conformity assessment is the comprehensive term for measures taken by manufacturers, their customers, regulatory authorities, and independent third parties to evaluate and determine whether products and processes conform to particular standards (National Research Council, 1995). Conformity is critical in ensuring standards compliance and quality of products for buyers, users, and regulators. In addition, the organizations that conduct conformity assessments are themselves accredited by consumer and/or regulatory authorities. Accreditors can be either public (e.g., the National Voluntary Laboratory Accreditation Program operated by the National Institute of Standards and Technology [NIST]) or private (e.g., the American Association for Laboratory Accreditation). Accreditation may involve the review of technical procedures used, staff qualifications, product sampling, test equipment calibration and maintenance, quality control, independence, and financial stability (National Research Council, 1995). The government is then involved in assessing the competence of programs that accredit conformity assessment organizations. Government acceptance or recognition has the effect of confirming official approval of the methods used by the accreditation organizations (National Research Council, 1995). Most primary SDOs have signed memoranda of understanding with ANSI and with each other to define their areas of responsibility. Also, there is a strong drive toward harmonization of standards at the international level with the Comité Européen de Normalisation (CEN—the chief SDO for Europe, similar to ANSI) and ISO. Despite these efforts, significant overlap in the standards being developed by the SDOs still contributes to problems in their interpretation and implementation (see Table 3-1). Often the standards are further modified at the local level to accommodate personal preferences, which can directly affect vendors’ ability to compete effectively in the marketplace. The consequence has been a continued lack of interoperability. ANSI’s Healthcare Informatics Standards Board (HISB) has recently made some efforts to encourage cooperation across the various standards-setting bodies. Two major issues have impeded the implementation of standards to support increased data comparability and system interoperability: (1) wide variation in the maturity and ease of implementation of ANSI voluntary consensus standards, and (2) the fact that even where mature, usable

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Patient Safety: Achieving a New Standard for Care TABLE 3-1 Overlap of Work by the Major Standards Development Organizations Category ASTM DICOM HL7 NCPDP X12N IEEE CEN ISOa Clinical laboratory X   X       X X Data interchange X X X X X X   X Vocabulary X X X X X X X X Object modeling X X X   X   X X Security X X X X X   X   Patient information X X X X X   X X Accounting     X X X       XMLb X   X   X   X X Electronic health records (EHR) X   X       X X Medical devices           X   X Templates X X X       X   aISO documents are generally derived from standards originally developed by CEN, DICOM, HL7, and/or IEEE. bExtensible markup language. standards exist, terminologies have not been agreed upon for all the important domain areas (e.g., laboratory, devices). The committee believes that stronger leadership and coordination can position the ANSI HISB to address these issues. Another important issue in standards development and implementation is financial support. Producing a standard is expensive in terms of both time and money. In the United States, vendors and users must be willing to support the hours of work involved (usually on “company time”), the travel expenses, and the costs of documentation and distribution. In contrast, most European and Asian (e.g., Japanese, Australian, and Korean) standards are developed and entirely funded by a government agency, then designated for widespread adoption. Terminologies The process for developing and updating terminologies is highly variable. Currently, there are well over 150 terminology systems in use to describe various medical domains. Other than the HIPAA-mandated standards, there has been little agreement on or implementation of common clinical terminologies across institutions and settings. Many of the terminologies that are used are either locally developed and maintained and exchangeable with other entities only at great effort; developed by proprietary

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Patient Safety: Achieving a New Standard for Care vendors for specific system implementations; or broad international terminologies (e.g., the International Classification of Diseases [ICD]) that are often modified at the local level. Thus, one laboratory system has not been able to communicate with another without great difficulty. This “custom” approach incurs high costs and inhibits efforts to reuse clinical data to understand and prevent patient safety events. For computer interoperability, data must be recorded in a terminology that is recognized and understood by the receiving computer; local terms are not interoperable. Adoption of a set of core terminologies for use in clinical information systems will accomplish this task, and such terminologies are in the process of being selected through public–private partnerships. Vendor compliance with the standards will ensure the interoperability of products for buyers, users, and regulators. Box 3-2 and the following subsections provide a brief overview of the processes used by these organizations to develop their terminology data standards. International Organizations Some international organizations (i.e., World Health Organization [WHO] for ICD codes and International Classification of Functioning, Disability and Health [ICF], and the World Organization of National Colleges, Academies and Academic General Practice and Family Physicians for the International Classification of Primary Care [ICPC]) engage in terminology development through a relatively formalized consensus process that requires approval by a governing oversight or steering committee (Institute of Electrical and Electronics Engineers, 2001; World Health Organization, 1999). For WHO terminologies, submissions for changes are accepted by the heads of the WHO collaborating centers established around the world. If accepted by the WHO regional office, they are then circulated to the other centers no later than 6 months in advance of the official WHO annual meeting, where they may receive final approval upon consensus of the group. Federal Government Development of clinical modifications for the ICD codes is accomplished through the National Center for Health Statistics at the Centers for Disease Control and Prevention (CDC) using an open and formal process that accepts suggestions by the public and private sectors and is managed by the Coordination and Maintenance Committee. Proposals for a new code must include a description of the code, why it is needed, and supporting

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Patient Safety: Achieving a New Standard for Care BOX 3-2 Types of Terminology Development Organizations and Examples of Specific Terminology Developers International Organizations World Health Organization (WHO)—developed the International Classification of Diseases (ICD)-9; ICD-10; the International Classification of Functioning, Disability, and Health (ICF); and ICD-O for oncology. International Conference on Harmonization (ICH)—developed the Medical Dictionary for Drug Regulatory Affairs (MedDRA). World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (WONCA)—developed the International Classification of Primary Care (ICPC). Federal Government Department of Health and Human Services (DHHS) Centers for Medicare and Medicaid Services (CMS)—developed the ICD-9 Clinical Modifications (CM) Volume 3 (procedures) and the ICD-10 Procedure Coding System (PCS) and the Healthcare Financing Administration Common Procedure Coding System (HCPCS). National Committee for Health Statistics—developed the ICD-9 CM Volumes 1 and 2 (diagnoses) and ICD-10 CM (diagnoses). Food and Drug Administration (FDA)—responsible for National Drug Codes (NDCs) and developed the Orange Book. Joint effort by the Veterans Health Administration (VHA), National Library of Medicine (NLM), and Health Level Seven (HL7) to develop the clinical drug terminology RxNORM. Professional Associations/Academic Institutions Nursing groups, including professional associations and academic research references and literature. Final decisions are made by the director of the National Committee on Health Statistics and the administrator of the Coordination and Maintenance Committee (National Center for Health Statistics and Centers for Disease Control and Prevention, 2003). The Food and Drug Administration’s (FDA) process for incorporating new National Drug Codes (NDCs) has been highly informal; new codes are

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Patient Safety: Achieving a New Standard for Care ers—developed many terminologies;1 other efforts focus on integrating nursing terminologies into the Systemized Nomenclature of Human and Veterinary Medicine (SNOMED) Clinical Terms (CT) and Logical Observation Identifiers, Names, and Codes (LOINC). College of American Pathologists (CAP)—developed SNOMED (RT—reference terminology); developed SNOMED CT through a collaboration with the National Health Service of the United Kingdom. Regenstrief Institute—developed LOINC. American Medical Association (AMA)—developed Current Procedural Terminology (CPT). American Psychiatric Association (APA)—developed the Diagnostic and Statistical Manual of Mental Disorders (DSM). Emergency Care Research Institute (ECRI)—developed the Universal Medical Device Nomenclature System (UMDNS). National Cancer Institute (NCI)—developed genetics-related terminologies Standards Development Organizations Health Level Seven (HL7)—registers existing controlled terminologies and defines required terminologies for which no controlled terminologies exist. Institute of Electrical and Electronics Engineers (IEEE)—developed medical device terminologies. Other Private Entities Medicomp Systems Incorporated—developed Medcin®, which is not a standard terminology but a vendor-developed set of coordinated terms used locally by some health care organizations. Standardized Mappings of Terminologies National Library of Medicine (NLM)—developed the Unified Medical Language System (UMLS), which can store and cross-reference existing terminologies, and the Medical Subject Headings (MeSH) 1   Nursing terminologies include: HHCC—Home Health Care Classification; ICNP—International Classification of Nursing Practice; NANDA—North American Nursing Diagnosis Association classification; NIC—Nursing Intervention Classifications; NOC—Nursing Outcomes Classifications; Omaha System; PCDS—Patient Care Data Set; and PNDS—Perioperative Nursing Data Set. submitted by the manufacturer, reviewed by the FDA for redundancy or overlap, and added to the set of codes. However, this procedure has been associated with several issues. One such issue is that drug codes for pharmaceuticals that are considered obsolete are often reused by the manufacturer, a practice that contributes to problems in tracking medication usage and potential drug interactions or contraindications. A second issue is the lack

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Patient Safety: Achieving a New Standard for Care of a single standard for chemical names, ingredient listings, and dosage sizes associated with NDCs, resulting in variation from one organization to another. Professional Associations and Academic Institutions Many terminologies in use are developed by professional associations and academic institutions. The processes for terminology development vary, generally depending on the size of the organization and the purpose of the standard. Organizations such as the College of American Pathologists (which produces the Systemized Nomenclature of Human and Veterinary Medicine [SNOMED]) and the American Medical Association (which produces Current Procedural Terminology [CPT]) have relatively formal sets of processes for developing and refining terminology concepts that rely on an editorial board for final approval. SNOMED technical subgroups evaluate and model terminology and then advise the editorial board regarding scope of coverage, creation of hierarchies, semantic definitions, and scientific accuracy (SNOMED International, 2000). Because CPT codes are used for reimbursement, new codes are not based on technical criteria but on the need to code new medical procedures. These updates are incorporated quarterly once approved by the American Medical Association editorial board. Processes used by other terminology development organizations, such as nursing groups, are very informal, with general group approval occurring annually. Standards Development Organizations and Other Private Entities IEEE has a highly formal approach to developing standards based on due process, openness, consensus, balance, and right of appeal. The membership of working groups is defined. Three-quarters of the members of a group must vote on ballots of official documents, and of those who vote, three-quarters must support the document for it to be accepted. The HL7 process for obtaining consensus on terminologies is not as formal as that for data interchange standards since HL7 is not actually a terminology developer per se but maps registered terminologies for encoding in its messaging formats. Participants in the HL7 terminology special interest group agree to the additions, mappings, and technical specifications. However, sign-off by the HL7 steering committee is still required. Private companies developing terminologies, such as Medicomp, create new terms at will without a formal or open process and as required by cli-

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Patient Safety: Achieving a New Standard for Care Consolidated Health Informatics Initiative NCVHS is also serving as the primary advisory body to the CHI initiative, established in October 2001 as the first of the 24 Office of Management and Budget eGOV initiatives to streamline and consolidate government programs among like sectors (Office of Management and Budget, 2003). DHHS was designated as the managing partner for the CHI initiative, with CMS in the lead. Other members of CHI include the VHA, the Department of Defense, the Indian Health Service, the U.S. Department of Agriculture, Environmental Protection Agency, and the FDA. CHI’s mission is to articulate and execute a coherent vision and strategy for the adoption of federal interoperability standards for health care information while providing technical support to selected projects. As noted earlier in this report, in March 2003 the secretary of DHHS announced that DHHS, the Department of Defense, and VHA would be adopting an initial set of clinical data interchange standards recommended to the secretary by NCVHS, including HL7, NCPDP, IEEE 1073, DICOM, and the Logical Observation Identifiers, Names, and Codes (LOINC) for laboratory tests and results (usually referred to as Laboratory LOINC). This announcement was based directly on the recommendations of CHI for standards that should be adopted government-wide. CHI is also continuing to identify standardized terminologies for the clinical domain areas associated with the EHR for use among federal agencies. The organizations are expected to announce their selection of the core group of standard terminologies in fall 2003. Given the sizable purchasing power (more than 40 percent of health care expenditures) and regulatory authority of the federal government, incorporation of these data standards into government programs is a powerful and effective approach to establishing national standards. However, CHI still lacks a clear mandate to establish standards that will be applied by all government programs. The CHI initiative also would benefit from greater participation of private-sector stakeholders and standards-setting bodies and from more clearly defined linkages with AHRQ’s evidence synthesis program and QuIC’s performance measurements standardization program. Public Health Data Standards Consortium In the public sector, in addition to CHI’s activities, an organization that is involved in the promotion of national data standards is the Public Health Data Standards Consortium, which is coordinated by the National Center for Health Statistics. It was developed to organize the public health and

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Patient Safety: Achieving a New Standard for Care health services research communities on data standards issues. This consortium serves as a mechanism for ongoing representation of public health and health services research interests in HIPAA implementation and other data standards–setting processes. Its membership comprises a variety of state-based public health data organizations, health services research organizations, federal public health representatives (e.g., CDC, AHRQ, and CMS), managed care organizations, business coalitions, and consumer groups. The consortium’s tasks have included an ad hoc work group on External Causes of Injury Codes (E-Codes), which will evaluate current practices in E-Codes collection and propose next steps to improve E-Codes reporting in discharge data systems and electronic reporting standards. Two other consortium work groups recently developed a standardized format as a guide for reporting health care service data. This guide is compatible with the health claim transaction set standards identified by HIPAA. It is intended to provide assistance in developing and executing the electronic transfer of health care systems data for reporting purposes to local, state, and federal agencies that use the data for monitoring utilization rates, assessing patterns of health care quality and access, and other purposes required by legislative and regulatory mandates. Given the past difficulties and financial constraints of state-based public health organizations, the consortium could serve as one of the key facilitators helping states to implement national data standards for the NHII and guiding implementation of the common format for reporting to the AHRQ national patient safety database. In addition to the efforts of NCVHS, other activities to promotion and implement data standards are being conducted in the private sector. The Markle Foundation’s Connecting for Health initiative is focusing on building consensus around and accelerating the development of clinical data standards. In June 2003, this initiative released the results of a 9-month collaborative effort focused on key aspects of the adoption of clinical data standards, which included identifying strategies and solutions for the secure and private transmission of medical information and actively working to understand what consumers will need and expect from an interconnected electronic health system. National Alliance for Health Information Technology Another recent private-sector effort in the area of promotion and implementation of data standards is the National Alliance for Health Information Technology, founded in June 2002 by the American Hospital Associa-

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Patient Safety: Achieving a New Standard for Care tion and other interested organizations (The National Alliance for Health Information Technology, 2002). Its membership currently includes provider organizations, such as hospitals, health systems, medical groups, and professional associations; technology companies and vendors; and other stakeholders, such as standards groups, the government, and payers. The purpose of the alliance is to develop and promote interoperability standards for health care information technology systems in order to improve patient outcomes and increase patient safety. In the near term, the alliance is focusing on standardized bar codes for products used by health care organizations. Plans for the longer term are to focus on connectivity and communications technology, automated order entry, electronic medical records, and standardized nomenclatures. Integrating the Healthcare Enterprise A third effort in the private sector was initiated by the Healthcare Information and Management Systems Society and the Radiological Society of North America in November 1998. The Integrating the Healthcare Enterprise initiative is working to facilitate the adoption of existing standards for communicating clinical and operational data by specifying how to apply such standards to real-world scenarios and integration problems (HIMSS, 2003). The initiative process consists of four steps: (1) identification of common integration problems and needs by clinicians and information technology experts, represented by their professional societies; (2) specification of the existing health care or other general information technology standards that address the identified needs; (3) participation by vendors in an open testing process; and (4) publication of Initiative Integration Statements documenting the integration profiles, which can be accessed by users to assist in the vendor selection process (HIMSS, 2003). To date, Integrating the Healthcare Enterprise has introduced several integration profiles—12 for radiology and 5 for information technology infrastructure—which were published in August 2003 (HIMSS, 2003). Despite these activities, the absence of national leadership in the establishment of standards for the collection, coding, and classification of data means that the information and communications systems built over the coming decade will provide inadequate support for the delivery of safe and effective care, will be unable to share information among all of a patient’s caregivers, and will require costly rework to respond to external reporting requirements.

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Patient Safety: Achieving a New Standard for Care NEED FOR MORE FORMALIZED LEADERSHIP If the NHII is to be realized, more formalized leadership in the establishment of data standards will be required. The committee’s recommendations to this end center on a principal partnership among CHI, NCVHS, and NLM; overarching coordination; and strengthened leadership on the part of DHHS. Principal Partnership: Consolidated Health Informatics, National Committee on Vital and Health Statistics, and National Library of Medicine It is critical that Congress provide clear direction, enabling authority, and financial support for the establishment of national data standards to support patient safety. DHHS should be given the lead role in establishing and maintaining a public–private partnership for the promulgation of national standards for data interchange, terminologies, knowledge representation, and reporting (see Figure 3-2). Central to this public–private partnership is the CHI initiative, which should work collaboratively with NCVHS to identify data standards appropriate for national adoption as well as gaps in existing standards that need to be filled. Although NCVHS has already become a primary advisory body to CHI, this relationship needs to be formalized to ensure adequate representation of all stakeholders in the decision-making process. As a federal body that is subject to the Federal Advisory Committee Act, CHI cannot have private-sector members, but the viewpoints of many interested parties outside of the federal government should be considered. NCVHS is in a strong position to provide that input, as it is already designated as a private-sector advisory body to DHHS. The current membership of NCVHS includes individuals from health plans, universities, and other private organizations and associations with backgrounds in health statistics, electronic interchange of health care information, privacy and security of electronic information, population-based public health, purchasing or financing of health care services, integrated computerized health information systems, health services research, consumer interests in health information, health data standards, epidemiology, and the provision of health services (National Committee on Vital and Health Statistics, 2001). The membership of NCVHS should continue to be broad and diverse with adequate representation of all stakeholders, including consumers, state governments, professional groups, and standards-setting bodies.

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Patient Safety: Achieving a New Standard for Care FIGURE 3-2 Proposed public-private partnership to establish national standards. NOTE: AHRQ = Agency for Healthcare Research and Quality; CHI = Consolidated Health Informatics; DHHS = Department of Health and Human Services; DOD = Department of Defense; JCAHO = Joint Commission on Accreditation of Healthcare Organizations; NCQA = National Committee for Quality Assurance; NCVHS = National Committee on Vital and Health Statistics; NLM = National Library of Medicine; NQF = National Quality Forum; OPM = Office of Personnel Management; QuIC = Quality Interagency Coordinating Task Force; VHA = Veterans Health Administration.

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Patient Safety: Achieving a New Standard for Care One of the most powerful roles played by the federal government in the U.S. health care sector is that of regulator, and the government has historically used this role to address quality and patient safety concerns. Regulatory requirements (e.g., Medicare conditions of participation) generally focus on institutional providers, clinicians, and health plans that seek to receive payment from or deliver care under an identified program; however, these responsibilities can also be exercised by state governments that administer the programs. Therefore, once CHI and NCVHS have identified national data standards, those standards should be incorporated into the contractual and regulatory requirements of the major federal government health care programs, including those operated or sponsored by DHHS, VHA, and the Department of Defense. Broad stakeholder input into the data standards selection process should facilitate such incorporation, which will aid in rapid adoption of the identified data standards nationwide. NLM also will need to assume new responsibilities for ensuring the establishment of national data standards for patient safety. As noted earlier in this chapter, NLM has worked to develop standardized mappings from one terminology to another through the UMLS and is therefore ideally positioned to become the primary oversight body for maintenance of the core terminology group to be established by CHI and associated patient safety data standards. The committee also recommends that NLM be designated as the responsible entity for the distribution of all national clinical terminologies related to patient safety and for assuring the quality of terminology mappings. NLM should work closely with the terminology developers to establish a more formalized development process and serve as a primary information source for CHI–NCVHS regarding available terminologies and areas in which terminologies are still needed. Overarching Coordination In addition to the need to strengthen the partnership and leadership of CHI, NCVHS, and NLM, the committee believes that AHRQ is an agency positioned to provide overarching coordination among all public- and private-sector organizations involved in the development, implementation, and dissemination of data standards, evidence-based guidelines, and patient safety and quality improvement programs. AHRQ is already the chief agency leading efforts in two of the three areas—evidence-based guidelines and patient safety and quality improvement programs—and as such has well-established core competencies in these areas, public–private networks, and relationships with the provider community that are critical to the suc-

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Patient Safety: Achieving a New Standard for Care cessful development of the NHII. The committee believes it is important to build on AHRQ’s expertise and capabilities by extending that agency’s role in overarching coordination for the implementation and dissemination of data standards that support the agency’s programs in clinical guidelines, patient safety data, and quality measures, as well as public health and the NHII. Additionally, AHRQ is playing a key role with providers and public health entities in addressing the challenges of building the NHII and has allocated $50 million of its $84 million fiscal year 2004 budget to support health information technology initiatives ($24 million for safety- and quality-related projects and $26 million for community and rural projects); $10 million of the budget has been allocated for standards adoption projects (Agency for Healthcare Research and Quality, 2003b). AHRQ also has the breadth and depth of resources to support the overarching coordination needed for widespread development of the NHII. The committee recognizes that the costs to support the corresponding programs and initiatives that would fall within the scope of AHRQ’s coordinating activities would be significant. Because of AHRQ’s historical, extensive experience in critical areas that directly relate to the NHII, it is best placed to provide a detailed cost estimate for development, implementation, and dissemination activities. AHRQ can support the work of CHI–NCVHS in several ways. AHRQ should: Provide financial support for standards development activities as necessary to fill the standards gaps identified by CHI–NCVHS. Work with SDOs to ensure the development of implementation guides (which provide the specifications and instructions for how to implement a standard (Federal Register, 2000), certification procedures, and conformance testing for all data standards to facilitate their adoption by vendors and users. Additional information on the standards implementation process is presented in Chapter 4. Coordinate activities and maintain a clearinghouse of information in support of national data standards and their implementation to improve patient safety. Move forward with the establishment of a national patient safety database that utilizes a common report format and associated data standards as recommended by the IOM (2000). Take on a chief role in the development of a robust agenda for applied research in patient safety, focused on enhancing knowledge, developing information technology tools, and disseminating research findings as outlined in Chapter 5.

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Patient Safety: Achieving a New Standard for Care Build on its track record in funding the synthesis and dissemination of clinical knowledge and assume a lead coordinating role in working with health professions leadership, specialty societies, academic institutions, and others to translate clinical knowledge into best-practice care processes, which in turn will inform the CHI–NCVHS decision-making process regarding national knowledge representation standards. Strengthened Department of Health and Human Services Leadership for the National Health Information Infrastructure The NCVHS report Information for Health provides a high-level strategy for building the NHII (National Committee on Vital and Health Statistics, 2001). It includes as one of its chief recommendations the establishment of a new and separate office to handle policy, coordination, and strategic oversight for NHII initiatives and projects, led by a senior officer reporting directly to the secretary of DHHS. Since the report was issued, the NHII office has been established in the Office of Science and Data Policy within the Office of the Assistant Secretary for Planning and Evaluation. The NCVHS recommendations empowered the Office of Science and Data Policy with broad responsibilities, including coordination with all relevant stakeholders, the strategic planning for NHII development, management of the NHII budget, promotion of effective training methods in health informatics, and assurance that all population groups will share in the activities and benefits of information technology integration. The office is now beginning to exercise leadership and held its first NHII conference to develop specific goals and a strategic plan for the key areas of the infrastructure’s operation: architecture, standards and vocabulary, safety and quality, financial incentives, consumer health, homeland security, privacy and security, and research and population health. The committee fully supports the NCVHS recommendations and the NHII activities conducted to date. At the same time, the committee believes that the NHII office must step forward more aggressively with stronger leadership and an accelerated approach to the integration of information technology into the health care delivery system. REFERENCES Agency for Healthcare Research and Quality. 2001. Primary Care Practice-Based Research Networks: Fact Sheet. Online. Available: http://www.ahcpr.gov/research/pbrnfact.htm [accessed September 5, 2003].

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