Project to Develop the International Patient Safety Event Taxonomy: Updated Review of the Literature 2003-2005

The WHO World Health Organization Alliance for Patient Safety

September 2005 Prepared by: Heather Sherman, PhD, Jerod Loeb, PhD Joint Commission on Accreditation of Healthcare Organizations WHO Consultants

FINAL REPORT

WHO Project Officer: Mr. Martin Fletcher Performance Manager WHO World Alliance for Patient Safety 20, Avenue Appia CH-1211 Geneva 27 Switzerland

INTRODUCTION Patient safety, the freedom from accidental or unnecessary harm caused by adverse events made in any health care setting, directly affects quality of care. Adverse events can be avoided by integrating the concepts of patient safety into the operational systems that affect the provision of care. Patient safety monitoring and reporting systems are intended to act as surveillance systems that identify adverse events and provide early warnings of potential failure. In order for a monitoring or reporting system to be effective, it must be based on a standardized patient safety event classification that can yield information about the epidemiology of adverse events. Analysis of these data draws attention to trends and patterns in the incidence rates, type, severity, causes and consequences of adverse events. Once these have been identified, strategies to prevent or mitigate effects of adverse events can be developed, ultimately creating safer health care environments and improving quality of care. The World Health Organization (WHO) recognizes patient safety as a basic tenet of overall patient care and a crucial component of the quality of care provided. The Fifty-fifth World Health Assembly (the Assembly) passed resolution WHA55.18 in May 2002 calling upon Member States to pay the closest possible attention to the problem of patient safety and to establish and strengthen sciencebased systems necessary for improving patients safety and quality of care.1 The Assembly urged the WHO to develop global norms for the definition, measurement and reporting of adverse events and near misses in health care based on Member State experiences with crafting patient safety programs.1 In response to the Assemblys recommendation, the WHO requested the United States Joint Commission on Accreditation of Healthcare Organizations (the Joint Commission) to review the available literature on patient safety event classification and incident reporting systems worldwide, to propose a preliminary method of assessing these systems, and to prepare an accompanying glossary of existing patient safety terms to assist the WHOs working group on patient safety. The Joint Commissions work culminated in a two part report entitled, Towards an International Patient Safety Taxonomy: A review of the Literature on Existing Classification Schemes for Adverse Events and Near Misses and a Draft Framework to Analyze Patient Safety Classifications and A Draft Comparative Glossary of Patient Safety

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Terms (collectively the 2003 Background Paper).2 The WHOs working group on patient safety convened a panel of technical experts in October 2003 to consider the 2003 Background Paper and to lay the groundwork for the development of an international patient safety event taxonomy. In May 2004, The Fifty-Seventh World Health Assembly proposed the formation of an international alliance for improving patient safety. The following October, the WHO launched the World Alliance for Patient Safety (the Alliance) to assist Member States in addressing patient safety issues. One of the Alliances six program goals is to support the development of an international patient safety event taxonomy. The Alliance, with the assistance of classification and patient safety experts representing a wide variety of health care systems, is building upon the work initiated in October 2003. The preparation of this document is one step in that process. LITERATURE REVIEW 2003 - 2005 A thorough review of the literature was undertaken to account for developments in the realm of patient safety classifications since the publication of the 2003 Background Paper. A similar search strategy to that utilized in the 2003 Background Paper was employed to perform this search.2 The following MeSH (Medical Subject Headings) terms were used to search Medline, EBM (Evidence Based Medicine) Cochrane Database of Systematic Reviews, CINAHL (Cumulative Index to Nursing and Allied Health Literature), EMBASE Drugs and Pharmacology, ERIC (Education Resources Information Center) and PsycINFO: medical errors, safety management, safety, nomenclature, terminology, classification, accident prevention, risk management and sentinel events. These databases plus Entrez Life Sciences, Web of Science (general and related references), the Dissertation Abstract Database and Google were searched with key words including taxonomy, patient safety, adverse event, near miss, classification, glossary and error. Articles were excluded based on four criteria: (1) not relevant to the field of patient safety; (2) relevant to the field of patient safety but lack sufficient information to describe critical components of the classification; (3) outdated descriptions of classifications; and (4) unpublished classifications. The search was limited to human subject studies published between November 2003 and

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August 31, 2005. It should be noted that although this search was extensive, it may have failed to reveal classifications which merit inclusion, particularly those in the unpublished and grey literature. While there is a plethora of information providing general overviews of patient safety classifications, there is a dearth of information describing the actual structural and functional characteristics. The overview of each of the 17 classifications that met the criteria to be included in this report is a compilation of information that could be gleaned from the literature. Eleven classifications were developed to classify a defined patient safety issue (i.e., diagnoses, procedures, laboratory and test results, medication issues, or a combination of these). Six were developed specifically for use with particular reporting systems. For the purpose of this document, the words classification and taxonomy are used interchangeably. The International Organization for Standardizations definition of classification is applied to both terms. By that definition, a classification is an arrangement of concepts into classes and their subdivisions to express the semantic relations between them.3 Classifications of Defined Subject Areas
1.

Applied Strategies for Improving Patient Safety (ASIPS) Taxonomy4 The Victoroff/ASIPS Taxonomy was developed in collaboration with the Colorado Physicians Insurers Association of America to identify, study and ameliorate medical errors in primary care.4 The taxonomy is designed to highlight the complexity of patient safety issues in primary care and to facilitate learning. It has a multi-axial, hierarchical and relational structure and is capable of mapping to several currently existing classification systems through the Victoroff taxonomy.5 Taxonomic categories include the participants involved and their contribution to the event, the course of the event, the outcome, and observations by the originator or discoverer of the event.

2.

Edinburgh Incident Classification6,7 The Edinburgh Incident Classification was developed to categorize critical incidents relating to anesthesia in the intensive care unit. The classification is theoretically based upon Reasons model for error causation.8 Incidents are categorized according to

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either performance shaping factors or domain/environment/task-specific factors. Narrative data about the incident can also be captured.
3.

International Classification of Diseases, Tenth Version (ICD-10)3 The International Classification of Diseases has a long history. First developed by the International Statistical Institute as the International List of Causes of Death in 1893, the ICD is now maintained by the World Health Organization and provides a standardized classification for causes of both morbidity and mortality. It promotes international comparability of patient safety information by serving as a common reference point for reporting and statistical use.3 The ICD is based upon sound scientific and taxonomic principles.3 The classification categories are clearly defined into 22 primary chapters describing the basic parameters of health.3 The structure is hierarchical and scaleable.

4.

International Classification of Primary Care (ICPC)10,11 ICPC, developed by the World Organizations of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians, allows simultaneous classification of three elements related to an encounter in primary care: the process of care, the reason for the encounter, and the health problem diagnosed.11 ICPC uses ICPC-2 as an ordering principle (based on the high prevalence of common diagnoses in family practice) and ICD-10 as a nomenclature (based on the wide range of known diagnoses).10 The ICPC bi-axial organizational structure categorizes encounters into 26 chapters and seven components.

5.

Logical Observation Identifiers Names and Codes (LOINC)11,12 LOINC, developed by the Regenstrief Institute, provides a set of universal names and numeric identifier codes for laboratory and clinical observations and measurements.11 The laboratory section classifies data according to biomedical categories (i.e., chemistry, microbiology, toxicology); the clinical section classifies data based on clinical findings and results (i.e., vital signs, ultrasound, imaging). Each data element contains a formal 6-part name, a unique name for tests identifying code with check digit, synonyms, and other useful information.12

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6.

Medical Dictionary for Drug Regulatory Affairs (MedDRA)11,13,14 The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use sponsored the development of MedDRA. MedDRA offers a comprehensive vocabulary and coding system [for] safety-related events and adverse drug reactions.11 Terms are classified into three high level categories: (1) equivalence grouping of synonymous terms; (2) hierarchical vertical links between super-ordinate and subordinate descriptors; and (3) associative hierarchical links between terms which are neither equivalent nor hierarchically related but related by sign, symptom, disease, and diagnosis.14 MedDRA is capable of incorporating new terms provided the terms are unambiguous, within the scope of the terminology, medically valid and internationally acceptable by an international panel of medical personnel.14

7.

National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP)2,13,15 The NCC-MERP taxonomy is a tool to categorize reports of medication errors.15 The taxonomy is comprehensive and descriptive. Data categories include patient information, description of the event, patient outcome, product information, personnel involved, type of error, causes for the error, and contributing factors. It has a hierarchical structure and is scaleable.

8.

Patient Safety Event Taxonomy-Version 1.0 (PSET-v1.0)2,7 The PSET-v1.0, developed by the Joint Commission, was endorsed by the United States National Quality Forum, through its consensus development process, as the US national standard in August 2005. It is designed to generate standardized patient safety data which can be used to understand the variables and relationship between variables in adverse events and near misses. It is theoretically based upon Reasons model of error causation8 and Rasmussens theories on human-system interactions9. The taxonomy has five root nodes (impact, type, domain, cause, and prevention and mitigation) and is able to capture narrative data. PSET-v1.0 is capable of ordering complex information in a logical and reproducible fashion, has a hierarchical structure, is scaleable and enables knowledge discovery.

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9.

Systemized Nomenclature of Human and Veterinary medicine Clinical Terms (SNOMED-CT)11,13,16 Developed by the College of American Pathologists in conjunction with the United Kingdoms National Health Services, SNOMED CT is a concept-oriented reference terminology.11 The classification consists of a concept table containing codes with unique meanings and formal logicbased definitions; a description table comprised of synonyms for flexibility in expressing clinical concepts; a relationship table with semantic relationships to enable robust reliability and consistency of data retrieval; and a list of attributes which are useful, understandable, and reproducible.16 SNOMED CT is capable of being cross mapped to other medical classifications, such as ICD and LOINC.16 It is hierarchically organized and can be modified to incorporate new information.

10. The International Taxonomy of Medical Errors in Primary Care17 The International Taxonomy of

Medical Errors in Primary Care was developed to code and classify the medical errors reported by family physicians and general practitioners in research undertaken by the American Academy of Family Physicians.17 Primary classifications were derived from qualitative analysis of comments made by these family and general practitioners. The categories are type of error, action taken, consequences, severity of harm, contributing factors, and prevention strategies.
11. Unified Medical Language System (UMLS)11,18 UMLS was developed and is maintained by the

National Library of Medicine. It is a metathesaurus, comprised of existing classifications including SNOMED CT, LOINC, and ICD, that links similar concepts by organizing the various source classification data elements by concept or meaning. Its scope is determined by the combined scope of its source vocabularies.18 UMLS preserves the organizational structures, components and relational connections of the source vocabularies while providing a consistent categorization of all concepts represented.18

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Classifications Developed Specifically for Use with a Particular Incident Reporting System The classifications are discussed following an overview of their corresponding reporting systems. 1. The Australian Incident Monitoring System (AIMS), the Generic Occurrence Classification (GOC) and the Generic Reference Model (GRF)2,7,19,20,21 The Australian Patient Safety Foundation (APSF) originally developed the Australian Incident Monitoring System in 1987 to monitor adverse events in anesthesia. In 1993 (AIMS-Generic) and again in 2000 (AIMS-2), the APSF broadened the scope of AIMS to serve as a methodology for reporting, analysis, and monitoring all patient safety events.21 The expanded monitoring system is specifically designed to (1) be used across the entire spectrum of a national healthcare system by staff, patients and relatives, (2) be sufficiently flexible to meet the requirements of specialty based units and generic reporting, (3) allow web based reporting and rapid feedback and analysis, and (4) be suitable for both local and national data collection.20 The first classification scheme designed to support AIMS was the Generic Occurrence Classification. The GOC was later replaced by the Generic Reference Model. The Generic Occurrence Classification was developed in 1994. It used natural categories and natural mapping to generate a multi-axial framework into which all iatrogenic events could be classified.20 It was constructed to obtain pertinent information about an event, place the event in its proper context, and record system and/or human based factors contributing to the event. The classification categorized events from various patient safety data sources, was scaleable and allowed for analysis at various levels of detail. The GOC, however, proved to be too complex to use at [the] health unit level.19 As a result, the APSF developed the Generic Reference Model. The GRM maintains the basic characteristics of the GOC, but utilizes the Healthcare Incident Types Classification (HIT Classification) to extract salient information about an event through a series of user-friendly, cascading, natural language questions.19 The GRM is based on Reasons theory of error causation8 and its organizational structure is scaleable.

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2. The Eindhoven Classification Model for System Failure (ECM) and The Prevention and Recovery Information System for Monitoring and Analysis Medical (PRISMA)11,13,22,23 PRISMA, developed by the Faculty of Technology Management at Eindhoven University of Technology, is both a patient safety surveillance system and a process by which to perform root cause analyses. The system has three components a causal tree, the Eindhoven Classification Model, and a classification/action matrix. The framework consists of modules system inputs (detection, selection, and description), input processing (classification, computation, and interpretation and implementation), and output evaluation. The Eindhoven Classification Model, also developed by the Faculty of Technology Management at Eindhoven University of Technology, was originally designed as an event reporting system for the chemical industry. In 1997, ECM was expanded to be applicable in health care. It is predicated upon the theories promulgated by Reason and Rasmussen.8,9,23 Errors are classified by: (1) latent errors/technical factors, such as equipment, design, construction, materials, or external factors; (2) organizational factors such as transfer of knowledge issues, protocols, procedures, management priorities, or cultural issues; (3) active errors, including knowledge-based, rule-based, and skill-based errors; and (4) other factors such as patient related factors or unclassified issues. Recovery factors are also captured. These are categorized as human, technical, organizational, patient-related or unclassified. The classification/action matrix aggregates the data categorized by ECM to produce a PRISMA profile, a graphical representation of the root causes of all incidents or of a certain type of incident, which can then be used to develop preventive strategies.23 Data are coded by classes of actions technology/equipment, procedures, information/communication, training, motivation, escalation, and reflection.23

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3. The Medical Event Reporting System Total HealthSystem (MERS-TH) and the MERS-TH Taxonomy24,25 MERS-TH, developed by faculty at Columbia University, is designed to capture both near misses and adverse events in health care. The reporting system is web-based and allows for standardized reporting across inpatient and ambulatory health care systems. Both the Eindhoven Classification Model and the MERS-TH taxonomy are embedded within MERS-TH. The Eindhoven Classification Model is used to categorize causal relationships. The MERS-TH taxonomy is used to code adverse events, and their corresponding discovery and antecedent events, through a four-tiered system which classifies data by service description, event type, event description and contributing factors. Contributing factors include logistical or process oriented factors, institutional or managerial issues, communication and documentation issues, environmental factors, staff related factors, delay in or premature provision of care, and patient issues. It also has the ability to capture narrative data. 4. The National Reporting and Learning System (NRLS) and the NRLS Classification26 In 2004, the United Kingdoms National Patient Safety Agency (NPSA) implemented the National Reporting and Learning System. NRLS is the primary mechanism to collect information on patient safety incidents, including near misses that occur within National Health Services-funded healthcare systems.26 It is designed to operate in acute care and general hospitals and pharmacies, as well as with mental health, disability, community nursing, general practice, ambulance, dental and optometry services. The information is analyzed to identify trends, provide feedback, develop health care priorities and to promote learning. A customized classification system, the NRLS Classification, is embedded within the NRLS. Patient safety data is categorized into six nodes (1) incident details (i.e., type, location, specialty area, outcome); (2) patient details (i.e., demographic and pertinent clinical information); (3) medication; (4) medical devices; (5) staff details; and (6) contributing factors. Contributing factors include those related to the patient, the task, team or social dynamics, the environment,

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communication, education and training, equipment and resources, medication, and/or organizational structure. 5. the Uppsala Monitoring Centre (UMC), the WHO Data Dictionary (WHO-DD) and the Terminology for Coding Adverse Reactions (WHO-ART)28,29 In 1968, the WHO established the International Drug Monitoring Programme to collect data on adverse drug reactions and to issue public warnings when warranted. The WHO transferred the administration of this program from Geneva, Switzerland to a WHO Collaborating Center in Uppsala, Sweden in 1978. Now referred to as the Uppsala Monitoring Center, the program continues to collect and monitor drug reaction data and to publish international alerts through pharmacovigilance (drug safety surveillance).28 Reports produced by the UMC are based upon data generated from three classifications WHODD, WHO-ART and MedDRA. Each of these classifications has a scaleable hierarchical structure, is able to incorporate new knowledge and is able to aggregate data at various levels. The WHO-DD categorizes drug product information at four levels: (1) the Anatomical-Therapeutic-Chemical (ATC) level denoting the main indication for which a medicinal product is used; (2) the generic level describing the ingredient or combination of ingredients; (3) the pharmaceutical product level indicating the combination of ingredients, form [and] strength; and (4) the medicinal product level referring to the named product marketed and sold in a particular country.28 Herbal products are also classified using a unique classification based on the ATC, which links to internally accepted botanical names and synonyms.28 the UMC simultaneously uses WHO-ART, the adverse drug reaction coding system developed specifically for the UMC, and MedDRA. WHO-ART consists of two group levels preferred terms and lower level terms and is a subset of MedDRA.28 Narrative descriptions of adverse reactions are also collected. This information is linked to lexicon tables which contain predefined, allowed values, expressed as formatted text or codes28 Data captured by a lexicon table can be standardized and translated into various languages.

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6. The VA/NASA Patient Safety Reporting System (PSRS) and the Patient Safety Information System (PSIS)11,27,30,31 The United States Department of Veterans Administration (VA) and the National Aeronautics and Space Administration (NASA) jointly developed the Patient Safety Reporting System in 2000. The reporting system is fashioned after NASAs successful Aviation Safety Reporting System constructed for the United States Federal Aviation Administration. NASA was selected to externally maintain PSRS because it is an independent, respected research organization without regulatory or enforcement responsibilities.30 PSRS is designed to identify broad system vulnerabilities within the VA healthcare system. It complements, not replaces, existing VA internal patient safety initiatives.30 PSRS uses the Patient Safety Information System to classify adverse events and near misses by (1) the description of the event; (2) the type of event; (3) the location of the event; (4) environmental factors; (5) the actions taken; and (6) other or unclassified factors. Free text data is also captured. PSRS organizational structure is scaleable. Characteristics of a Patient Safety Classification The 2003 Background Paper identified several principles and criteria that a patient safety classification must meet in order to be useful for standardizing, aggregating and comparing data across disparate systems. The review of the patient safety literature published subsequent to 2003 further emphasized the need to adhere to these principles and structural and functional criteria. I. Principles2,7,13,32-35 A classification should:

be based upon sound taxonomic and error reduction/prevention theory; have a clear organizing principle to ensure elements are logically related; be able to classify information in a comprehensive manner that enables knowledge discovery in addition to data warehousing (i.e., allow for the development of hypotheses by explicitly elucidating relationships amongst the data elements);

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provide a method to represent the features of adverse events and/or near misses along as many dimensions as possible;13

be useful to a variety of users (such as policy makers, health care providers, administrators, researchers);

have a stable core framework; and be generally accepted within the health care community.

II. Structural Criteria2,7,13,32-35 A classification should:

use a standardized coding system with an associated terminology that is descriptive within the patient safety domain;

use primary classification modules that can be applied in any health care delivery setting, in any health care specialty and toward any adverse event or near miss;

be scaleable (i.e., able to incorporate new or different knowledge without threatening the integrity of its organizational structure); and

be multidimensional.

III. Functional Criteria2,7,13,32-35 A classification should:

use an unambiguous, common terminology for patient safety events (i.e., avoid any term that has the potential to cause confusion or misunderstanding);

ideally be compatible with existing reporting systems so as to facilitate adoption; facilitate data aggregation at multiple levels; be minimally disruptive (i.e., lessen the reporting burden on health care organizations without extensive reengineering of existing systems); and

generate reproducible results (i.e., different users should be able to classify the same problem in the same way).33

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CONCLUSION Little progress has been made to resolve the considerable variation in the quality and sophistication of existing patient safety classification systems since the 2003 Background Paper was issued.2 The ad hoc approaches used to develop many of these classifications, the dissimilar methods used to categorize data, and the assortment of definitions for a single term render it difficult, if not impossible, to reconcile the asymmetries. It is equally as arduous to aggregate and compare data across the incongruent classifications. As a result, the information yielded is of limited value outside the specified purpose for initially developing the classification. There is a need for international standardization of terminology in definition, common methods for measurement, and compatible reporting of adverse events.35 Standardization would enable comparison of research findings, better benchmarking across healthcare organizations, [and] the development of reliable reporting.33 Conclusions drawn from national and international data would therefore provide a broader, more meaningful picture of individual [and] population health.11

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REFERENCES 1. Fifty-Fifth World Health Assembly. Res. WHA55.18. 18 May 2002. 2. World Health Organization, Patient Safety: Reduction of Adverse Events through Common Understand and Common Reporting Tools. (2003, June) Towards an International Patient Safety Taxonomy: A Review of the Literature on Existing Classification Schemes for Adverse Events and Near Misses, A Draft Framework to Analyze Patient Safety Classifications, and a Draft Comparative Glossary of Patient Safety Terms. Geneva, Switzerland: J. Loeb and A. Chang. 3. World Health Organization. (2004). Family of International Classifications. Geneva, Switzerland. 4. Pace W. (2004, October) Perspectives on Creating a Taxonomy for Medical Errors and Dimensions of Patient Safety: A Taxonomy. Presentation at the Institute of Medicine Patient Safety Data Standards: Fifth Meeting, Washington DC. 5. Pace W, Staton E., Higgins G, Main D, West D, Harris D. Database Design to Ensure Anonymous Study of Medical Errors: A Report from the ASIPS Collaborative. J Am Med Inform Assoc 2003;10:531-540. 6. Busse DK, Wright DJ. Classification and analysis of incidents in complex medical environments. Top Health Inf Manage 2000; 20(4):1-11. 7. Chang A, Schyve P, Croteau R, OLeary D, Loeb J. The JCAHO patient safety event taxonomy: a standardized terminology and classification schema for near misses and adverse events. Int J Qual Health Care 2005;17(2):95-105. 8. Reason J. (1990) Human Error. Cambridge: Cambridge University Press. 9. Rasmussen J. (1986). Information Processing and Human-Machine Interaction: An Approach to Cognitive Engineering. New York: North-Holland. 10. Okkes IM, Oskam SK, Lamberts H. (2005) ICPC in the Amsterdam Transition Project. Amsterdam: University of Amsterdam Academic Medical Center, Department of Family Medicine. 11. Institute of Medicine, Committee on Data Standards, Board on Health Care Services. Patient Safety: Achieving a New Standard for Care. Washington DC: National Academies of Science. 2004. 12. Logical Observation Identifiers Names and Codes. [www.regenstrief.org/loinc/]. Accessed 18 August 2005. 13. Boxwala A, Dierks M, Keenan M, Jackson S, Hanscom R, Bates D. Organization and Representation of Patient Safety Data: Current Status and Issues around Generalizability and Scalability. J Am Med Inform Assoc 2004;11:468-478. 14. MedDRA - The Medical Dictionary for Regulator Activities Terminologies, [www.meddramsso.com]. Accessed 22 August 2005. MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations.

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15. National Coordinating Council for Medication Error Reporting and Prevention. [www.nccmerp.org]. Accessed 15 August 2005. 16. SNOMED International. [www.snomed.org]. Accessed 18 August 2005. 17. The Linnaeus Corporation. (2002). International Taxonomy of Medical Errors in Primary Care Version 2. Washington DC: The Robert Graham Center. 18. Unified Medical Language System (UMLS). [www.nlm.nih.gov/research/umls]. Accessed 18 August 2005. 19. Runciman WB (2004, October) History of the APSF Taxonomy. Proceedings from the International Taxonomy Conference, Orlando, FL. 20. Runciman WB. Lessons from the Australian Patient Safety Foundation: Setting up a national patient safety surveillance system is this the right model? Qual Saf Health Care 2002;11:246-251. 21. Spigelman A, Swan J. Review of the Australian Incident Monitoring System. ANZ J. Surg 2005;75:657-661. 22. Battles JB, Kaplan HS, Van der Schaaf TW, Schea C. The attributes of medical event-reporting systems: experience with a prototype medical event-reporting system for transfusion medicine. Arch Pathol Lab Med 1998; 122(3):231-8. 23. Van der Schaaf, Tjerk (2005). PRISMA-Medical: A brief description. Eindhoven, The Netherlands: Eindhoven University of Technology. 24. Medical Event Reporting System Total HealthSystem. [www.ahrq.gov]. Accessed 18 August 2005. 25. Medical Event Reporting System Transfusion Medicine. [www.mers-tm.net/about.html]. Accessed 16 August 2005. 26. National Patient Safety Agency. Building a memory: preventing harm, reducing risks and improving patient safety. London. 2005. 27. Heget JR, Bagian JP, Lee CZ, Gosbee JW. System Innovation: Veterans Health Administration National Center for Patient Safety. Jt Comm J Qual Improv 2002;28(12):660-665. 28. The Uppsala Monitoring Centre. The WHO Adverse Reaction Database (2004) [www.who-umc.org]. Accessed 31 August 2005. 29. The Uppsala Monitoring Centre. About the UMC [www.who-umc.org.aboutumc.html]. Accessed 31 August 2005. 30. Department of Veterans Affairs - Patient Safety Reporting System. [http://psrs.arc.nasa.gov/faq.html]. Accessed 17 August 2005. 31. Department of Veterans Affairs, Veterans Health Administration. VHA National Patient Safety Improvement Handbook. 2002. Washington DC. [www.patientsafety.gov/ncpshb.pdf].

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32. Altman, I. (1968). Choicepoints in the Classification of Scientific Knowledge. In BP Indik & FK Berrien (Eds.), People, Groups, and Organizations (p. 47-69). New York: Teachers College Press. 33. Weingart S. Beyond Babble: prospects for a universal patient safety taxonomy. Int J Qual Health Care 2005;17(2):93-94. 34. Zhang J, Patel V, Johnson T, Shortliffe E. A cognitive taxonomy of medical errors. J Biomed Inform 2004;37(3):193-204. 35. World Health Organization, Fifty-Fifth World Health Assembly. (2002). Quality of care: patient safety. Report by the Secretariat. Geneva: Switzerland.

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