Index

A

AAMI. See Association for the Advancement of Medical Instrumentation

Academic institutions, terminologies of, 104–106

Accountability versus learning

case study, 262–263

concept of preventability, 268–269

implications for patient safety data systems, 269–273

Scherkenbach’s cycle of fear, 265–268

selection of measures, 263–265

understanding the continuum, 252–254, 262–273

Accredited Standards Committee (ASC), 335

ASC X12N, 99, 115

ACP Journal Club, 110

Acronyms, 24–25, 335–339

Acute myocardial infarction (AMI), 335

ADA. See American Dental Association

ADEs. See Adverse drug events

Administrative processes, 446–447, 458–459

Adverse drug events (ADEs), 73–75, 335

frequency by cause, 183

major causes of, 187

preventing, 185–187

scenario for interoperability demonstration project, 74–75

triggers for, 205

Adverse Event Reporting System (AERS), 215–221, 335

functional requirements, 215–216

implications for data standards, 217–221

Adverse events (AEs), 30, 327, 335

addressing errors of omission, 216

analysis, 171, 200–225

detection of, 185–187, 202–215

future detection approaches, 221–224

hazard analysis and systems approach to, 490–491

implications for data standards, 217–221

prevention, 185–187

sources of data, 202–203

triggers for, 205, 208, 221–222, 327

understanding, 215–216

verifying, 196



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Patient Safety: Achieving a New Standard for Care Index A AAMI. See Association for the Advancement of Medical Instrumentation Academic institutions, terminologies of, 104–106 Accountability versus learning case study, 262–263 concept of preventability, 268–269 implications for patient safety data systems, 269–273 Scherkenbach’s cycle of fear, 265–268 selection of measures, 263–265 understanding the continuum, 252–254, 262–273 Accredited Standards Committee (ASC), 335 ASC X12N, 99, 115 ACP Journal Club, 110 Acronyms, 24–25, 335–339 Acute myocardial infarction (AMI), 335 ADA. See American Dental Association ADEs. See Adverse drug events Administrative processes, 446–447, 458–459 Adverse drug events (ADEs), 73–75, 335 frequency by cause, 183 major causes of, 187 preventing, 185–187 scenario for interoperability demonstration project, 74–75 triggers for, 205 Adverse Event Reporting System (AERS), 215–221, 335 functional requirements, 215–216 implications for data standards, 217–221 Adverse events (AEs), 30, 327, 335 addressing errors of omission, 216 analysis, 171, 200–225 detection of, 185–187, 202–215 future detection approaches, 221–224 hazard analysis and systems approach to, 490–491 implications for data standards, 217–221 prevention, 185–187 sources of data, 202–203 triggers for, 205, 208, 221–222, 327 understanding, 215–216 verifying, 196

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Patient Safety: Achieving a New Standard for Care AERS. See Adverse Event Reporting System AEs. See Adverse events Agency for Healthcare Research and Quality (AHRQ), 9, 11, 19, 23, 25, 32, 48, 109, 335 overarching coordination, 121–123 AHRQ. See Agency for Healthcare Research and Quality AIMS. See Australian Incident Monitoring System AIMS Risk Assessment Index (RAI), 294 Alert message, 327 Alertness, 230 Alternative Summary Reporting-Medical Devices (ASR), 335 AMA. See American Medical Association American Dental Association (ADA), 99 American Hospital Association, 117–118 American Medical Association (AMA), 106 American National Standards Institute (ANSI), 97, 137, 335 American Society for Testing and Materials (ASTM), 100, 335 AMI. See Acute myocardial infarction Ancillary information, 219 ANSI. See American National Standards Institute Applications, continuum of, 252–254 Applied research agenda, 192–197 dissemination, 196–197 knowledge generation, 192–195 tool development, 195–197 Applied Strategies for Improving Patient Safety, 157 ASC. See Accredited Standards Committee ASR. See Alternative Summary Reporting-Medical Devices Assertional knowledge, 327 Association for the Advancement of Medical Instrumentation (AAMI), 137 ASTM. See American Society for Testing and Materials Audit procedures, 196–197 Australian Incident Monitoring System (AIMS), 335 Risk Assessment Index, 294 taxonomy from, 509–510 Authentication, 327 Automated surveillance, rules for detecting possible adverse drug events using, 207 Automated triggers for adverse events, 327 for chart review, 205 increasing importance of, 221–222 for outpatient adverse events, 208 B Blood Product Deviation Reporting System (BPD), 335 BPD. See Blood Product Deviation Reporting System C Case-based reasoning, 327 Case studies, 184–192, 262–263, 492–507 continuous quality improvement (CQI), 492–493 detected ADE rates, 187 detecting and preventing adverse drug events, 185–187 failure mode and effect analysis (FMEA), 496–497 hazard analyis and critical control points (HACCP), 493–494 hazard and operability studies (HAZOP), 494–495 healthcare failure mode and effect analysis (HFMEA), 498–499 major causes of adverse drug events, 187 postoperative infections, 188–190 probabilistic risk assessment (PRA), 499–501 root-cause analysis (RCA), 501–503 Six Sigma, 503–505 Toyota Production System (TPS), 505–507

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Patient Safety: Achieving a New Standard for Care Causal analysis, 293, 295–301, 333 Eindhoven classification model, medical version, 297, 300–301 generic reference model diagram, 297 Causal continuum assumption, 230–231, 327 Cause-and-effect diagram of preventable adverse drug events, 182 CDA. See Clinical Document Architecture CDC. See Centers for Disease Control and Prevention CDSS. See Clinical Decision Support System CEN. See Comité Européean Normalisation Center for Quality Improvement and Patient Safety (CQuIPS), 32, 335 Centers for Disease Control and Prevention (CDC), 73, 103, 335 example of federal patient safety/ health care reporting and surveillance systems, 346–357 Centers for Education and Research on Therapeutics (CERTs), 110 Centers for Medicare and Medicaid Service (CMS), 69, 111, 335 CERTs. See Centers for Education and Research on Therapeutics CHAI. See Child Health Accountability Initiative Chart review, 328 to detect adverse drug events, 205–206 CHF. See Congestive heart failure CHI. See Consolidated Health Informatics Child Health Accountability Initiative (CHAI), overview of, 312–313 Children’s Health Insurance Program (CHIP), 335 CHIP. See Children’s Health Insurance Program Chronic obstructive pulmonary disease (COPD), 335 Clinical data interchange standards, 16, 49 repository, 328 Clinical Decision Support System (CDSS), 58, 70, 78 Clinical Document Architecture (CDA), 66, 136, 328, 335 Clinical domains, 328 for patient safety, 427–429 Clinical event monitors, 328 and data repositories, 64–65 Clinical guideline representation model, 158–160 Clinical information systems, 72, 328, 335 Clinical performance data, 252–254 Clinical templates, 136–137 Clinical terminologies, 16–17, 50 Close calls, 328 CMS. See Centers for Medicare and Medicaid Services Cochrane Collaboration, 110, 161 Coding, 328 Comité Européean Normalisation (CEN), 335 Communication technologies, 69–71 Internet and private networks, 71 Comprehensive patient safety programs, 169–245 adverse event analysis, 171, 200–225 applied research agenda, 169–170, 192–197 case studies, 184–192 culture of safety, 174–177 establishment of, 169–171 in health care settings, 173–199 model for introducing safer care, 178–184 near-miss analysis, 171–172, 226–245 patient safety reporting systems and applications, 250–278 recommendations, 169–170 standardized reporting, 279–316 streamlining patient safety reporting, 247–249 Computer-based patient record system (CPRS), 35–36 Computerized patient records (CPRs), 79 Computerized physician order entry (CPOE), 328–329, 335 validation modules for prescribing medication, 214

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Patient Safety: Achieving a New Standard for Care Conceptual model of standards-based systems to support patient safety, 56–61, 329 integrated systems and large institutions, 58–59 integrated systems and office practice, 59–61 Congestive heart failure (CHF), 335 Connecting for Health initiative, 39 Consequence-driven investigations, a problem with data collection, 237 Consolidated Health Informatics (CHI) Initiative, 11, 17, 25, 38, 48, 108, 116, 119–121, 122–123, 335 domain areas, 146–147 Context variables, 233 Continuous quality improvement (CQI), 335 case studies, 492–493 COPD. See Chronic obstructive pulmonary disease CORAS. See Risk Assessment of Security Critical Systems Core functionalities for an electronic health record system, 442, 447–449 See Electronic health record Core terminology group, 148–158 drug terminologies, 152–153 Logical Observation Identifiers, Names and Codes (LOINC), 149, 152 mapping to supplemental terminologies, 154–155 medical device terminologies, 153–154 overview of core and supplemental terminologies, 150–151 Systemized Nomenclature for Human and Veterinary Medicine, Clinical Terms (SNOMED CT), 149 terminologies for further investigation and research, 155–158 Cost/benefit analysis of patient safety programs, 194 CPOE. See Computerized physician order entry CPRS. See Computer-based patient record system CPRs. See Computerized patient records CPT. See Current Procedural Terminology CQI. See Continuous quality improvement CQuIPS. See Center for Quality Improvement and Patient Safety Crossing the Quality Chasm: A New Health System for the 21st Century, 29, 36–37 Culture of safety, 174–177 a “just” culture, 177 open communication, 177 organizational commitment, 175–176 recruitment and training with patient safety in mind, 175 shared beliefs and values, 175 Current dental terminology, 151 Current Procedural Terminology (CPT), 106, 151, 335 Current standards-setting processing, 97–114 Consolidated Health Informatics (CHI) initiative, 116 data interchange standards, 97–102 federal and private sectors, 114–118 Integrating the Healthcare Enterprise initiative, 118 knowledge representation standards, 108–111 National Alliance for Health Information Technology, 117–118 National Committee on Vital and Health Statistics (NCVHS), 115 Public Health Data Standards Consortium, 116–117 reporting standards, 111–114 terminologies, 102–108 D DailyMed database, 162 Data acquisition, 329 methods and user interfaces, 61–62

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Patient Safety: Achieving a New Standard for Care Data elements, 329 Data filtering and cycle of fear, 267–268 Data interchange standards, 12–14, 48–49, 97–102, 128–129, 132–142, 329 clinical templates, 136–137 message format standards, 132–135 patient data linkage, 141–142 user interface, 137–141 Data management procedures, 85 clinical resource consumption quality assurance, 85 data validation, 85 data verification, 85 de-identification methods, 85 final reconciliation, 85 initial reconciliation, 85 manual data audit, 85 warehouse audit, 85 Data mining, 329 techniques for, 65–67 techniques for large patient safety databases, 196 Data repositories and clinical event monitors, 64–65 Data requirements for diabetes quality improvement project measures, 209, 210–213 Data requirements for adverse event detection, 204–206 automated surveillance, 206 chart review, 205–206 voluntary and mandatory reporting, 204 Data set, 329 Data standards, 63–64, 127–168, 214–215, 217, 221, 242–245 comprehensive list of data sources and reporting requirements, 130–131 data interchange formats, 12–14, 48–49, 128–129, 158–162 defining terms, 128–132, 217–218 definitions and models, 128–132, 242–243 design and operation of system components, 243–244 implementation, 163–164 knowledge representation, 13, 15, 49, 129 minimum datasets, 218–220 overview of, 127–132 recommendations, 163–164 relevance to patient safety systems, 63 setting standards, 98–99 sources, 130–131 standards development organizations, 102 technical review of health care data standards, 132–164 terminologies, 13–15, 49–50, 129, 142–158, 331, 442–443, 450–453 work plan, 15–17 Data system design, 270 Data types, 329 Data validation, 85 Data verification, 85 Data warehouse, 329 Davies award, winners of, 79 De-identification and data protection, 307–308 methods for, 85 Decision support systems, 330, 444–445, 454–455 Decision trees, 330 Default reasoning, 330 Definitions and models, data standards, 242–243 Dental terminology, current, 151 Department of Defense (DoD), 121, 335 Department of Health and Human Services (DHHS), 7, 11, 16, 25, 46–47, 89, 108, 123, 335 leadership strengthened for the NHII, 123 Detection of adverse events, 185–187 comparison of various approaches for, 203–204 data requirements for, 204–206 design and operation of system components, 243 general framework for processing near-miss reports, 240 implications for data standards, 214–215

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Patient Safety: Achieving a New Standard for Care monitoring the progress of patients, 206–214 multiple approaches, 202–215 sources of adverse event data, 202–203 using claims data, 222–223 DHHS. See Department of Health and Human Services Diabetes Quality Improvement Project (DQIP), 69, 207–218, 336 Diagnostic and Statistical Manual (DSM), 336 Diagnostic and Statistical Manual for Mental Disorders (DSM-IV), 151 Dialysis Surveillance Network (DSN), 336 DICOM. See Digital Imaging and Communications in Medicine Digital Imaging and Communications in Medicine (DICOM), 25, 99–100, 132, 335 Digital sources of evidence or knowledge, 67–69 Dissemination, 196–197 audit procedures, 196–197 knowledge dissemination, 196 R6, 20, 171 Document Ontology Task Force, 66 DoD. See Department of Defense Domains basic, 286–287 for a common patient safety reporting format, 303 completeness of, 330 DQIP. See Diabetes Quality Improvement Project Drug terminologies, 152–153 DSM. See Diagnostic and Statistical Manual DSM-IV. See Diagnostic and Statistical Manual for Mental Disorders DSN. See Dialysis Surveillance Network Dual pathways to system improvement, 231 E E-Codes. See External Causes and Injury Codes Early detection, 195 EHR. See Electronic health record Eindhoven classification model, medical version, 22, 297, 300–301 Electronic communication and connectivity, 445–446, 454–457 Electronic health record (EHR), 4, 7, 25, 46, 330, 442 administrative processes, 446–447, 458–459 background, 435–438 core functionalities, 442, 447–449 decision support, 444–445, 454–455 defining constructs for, 222 electronic communication and connectivity, 445–446, 454–457 framework for identifying core functionalities, 439–441 health information and data, 442–443, 450–453 implementation of, 78 letter report, 430–470 order entry/order management, 443–444, 452–453 patient support, 446, 456–457 project overview, 438–439 reporting and population health management, 447, 458–459 results management, 443, 452–453 system capabilities by time frame and site of care, 450–459 Encryption, 330 End-stage renal disease (ESRD), 336 EPC. See Evidence-based Practice Center Errors, 330 of commission, 31 of omission, 31, 216 ESRD. See End-stage renal disease Event-type taxonomy, 287–292 Evidence, levels of, 331–332 Evidence-based guidelines, 330

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Patient Safety: Achieving a New Standard for Care Evidence-based Practice Center (EPC), 336 Explicit data collection processes, 221 Explicit relationships, 330 Extensible markup language (XML), 111, 113, 330–331, 339 External Causes and Injury Codes (E-Codes), 22, 336 F FACCT. See Foundation for Accountability Failure mode and effect analysis (FMEA), 180, 336 case studies, 496–497 proactive hazard analysis, 481–482 Failure root causes, 233 FDA. See Food and Drug Administration Federal leadership need for leadership, 119–123 public-private partnerships, 96–126 standards activities, 114–118 standards-setting processing, 97–114 Federal reporting systems, 342–381 analysis of serious events, 344–345 examples, 346–357 format for reporting, 344 method of reporting, 344 reportable events, 343 surveillance or reporting systems, 342–343 tabular information, 345 terminologies for, 103–106 Financial incentives, 88–90 Florida state annual report, 400 Code 15 report, 401 reportable events, 399 FMEA. See Failure mode and effect analysis Food and Drug Administration (FDA), 73, 104, 336 example of federal patient safety/ health care reporting and surveillance systems, 358–373 Format for reporting, 382–383 in federal reporting systems, 344 in private-sector reporting systems, 404 Fostering Rapid Advances in Health Care: Learning from System Demonstrations, 39 Foundation for Accountability (FACCT), 113–114, 336 Free text uses, 233 Frequency of adverse drug events by cause, 183 G GELLO. See Guideline Expression Language, Object-Oriented Generic Reference Model (GRM), 336 diagram of, 297 GLIF. See Guideline Interchange Format Global Patient Index, 55 Glossary, 327–335 GRM. See Generic Reference Model Guideline Expression Language, Object-Oriented (GELLO), 160, 336 Guideline Interchange Format (GLIF), 159, 336 H HACCP. See Hazard analysis and critical control points Hazard analysis and critical control points (HACCP), 180, 336 case studies, 493–494 proactive hazard analysis, 482–483 Hazard and operability studies (HAZOP), 339 case studies, 494–495 proactive hazard analysis, 484 HAZOP. See Hazard and operability studies HCFA. See Health Care Financing Administration HCPCS. See Health Care Financing Administration Common Procedure Coding System

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Patient Safety: Achieving a New Standard for Care Health care data standards. See Data standards Health Care Financing Administration (HCFA), 336 Health Care Financing Administration Common Procedure Coding System (HCPCS), 151, 339 Health Insurance Portability and Accountability Act of 1996 (HIPAA), 16, 25, 38, 60, 90, 336 Health Level Seven (HL7), 25, 72, 99–100, 135–136, 336 Clinical Document Architecture (CDA) of, 74 context manager, 140 demonstration project, 76–77 reference information model, 135 Health Plan Employer Data and Information (HEDIS), 112 Health Resources and Services Administration, 89 Healthcare failure mode and effect analysis (HFMEA), 336 case studies, 498–499 proactive hazard analysis, 481–482 Healthcare Informatics Standards Board (HISB), 101–102 Healthcare Information Management Systems Society (HIMSS), 72, 336 HEDIS. See Health Plan Employer Data and Information HFMEA. See Healthcare failure mode and effect analysis HHCC. See Home Health Care Classification High-risk issues, 176 High-risk patients, 192 HIMSS. See Healthcare Information Management Systems Society HIPAA. See Health Insurance Portability and Accountability Act of 1996 HIPAA Security Rule, 70 HISB. See Healthcare Informatics Standards Board HL7. See Health Level Seven Home Health Care Classification (HHCC), 336 Human factors engineering, HE74 standard, 138 I Iatrogenic injury, 331 ICD. See International Classification of Diseases ICD-9 CM. See International Classification of Diseases, Ninth Edition, Clinical Modification ICD-10. See International Classification of Diseases, Tenth Edition ICD-O. See International Classification of Diseases, Oncology ICF. See International Classification of Functioning, Disability and Health ICNP. See International Classification of Nursing Practice ICPC. See International Classification of Primary Care IEEE. See Institute of Electrical and Electronics Engineers IHE. See Integrating the Healthcare Enterprise Implementation of adverse event systems, 183–184 of the common report format, 304–307 of data standards, 163–164 of near miss systems, 237–240 of NHII, 78–91 Incident causation model, 228 Information infrastructure, components of clinical information systems, 72 communication technologies, 69–71 data acquisition methods and user interfaces, 61–62 data mining techniques, 65–67 data repositories and clinical event monitors, 64–65 digital sources of evidence or knowledge, 67–69 health care data standards, 63–64

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Patient Safety: Achieving a New Standard for Care Information management in an electronic health record system, 81 Information technology (IT), 337 role in designing a safer health care system, 34–36 Injury detection, 178–180 deployment and implementation, 183–184 epidemiologic analyses, hypotheses for change generation, and prioritization, 180–181 holding the gains, 184 rapid-cycle testing, 181–183 use of standardized data for, 179 Institute for Safe Medication Practice (ISMP), 337 Institute of Electrical and Electronics Engineers (IEEE), 25, 99, 336 Integrating the Healthcare Enterprise (IHE) initiative, 118, 336 Integration with adverse event systems, 239–240 of individual human error/recovery models with team-based error/ recovery models, 193 with other systems, 234 of retrospective and prospective techniques, 193–194 International Classification of Diseases (ICD), 25 Ninth Edition, Clinical Modification (ICD-9 CM), 22, 336 Oncology (ICD-O), 336 Tenth Edition (ICD-10), 336 International Classification of Functioning, Disability and Health (ICF), 103, 151, 339 International Classification of Nursing Practice (ICNP), 336 International Classification of Primary Care (ICPC), 103, 151, 336 International Organization for Standardization (ISO), 97–98, 133, 337 IOM-Health Level Seven demonstration project, 72–78 final ADE scenario for interoperability demonstration project, 74–75 patient scenario data standards, 76–77 ISMP. See Institute for Safe Medication Practice ISO. See International Organization for Standardization IT. See Information technology J JAMIA. See Journal of American Informatics Association JCAHO. See Joint Commission on Accreditation of Healthcare Organizations Joint Commission on Accreditation of Healthcare Organizations (JCAHO), 5, 25, 337 Sentinel Event Policy, 418–423 Journal of American Informatics Association (JAMIA), 337 “Just” culture, 177 K Kaiser Permanente of Ohio, 80–82 Key Capabilities of an Electronic Health Record System, 7, 46 Knowledge representation, 13, 15, 17, 49, 50, 129, 158–162, 331 formalism in, 331 language of, 331 standards for, 64, 108–111 L Learning approaches need to invest more resources in, 273 Logical Observation Identifiers, Names and Codes (LOINC), 149–150, 152, 337 LOINC. See Logical Observation Identifiers, Names and Codes

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Patient Safety: Achieving a New Standard for Care M Magnetic resonance imaging (MRI), 337 Magnitude of the problem, 30–32 health care errors in the U.S., 31 Mandatory reporting, 204, 332 Manual data audit, 85 Manufacture and User Data Experience-Medical Devices (MAUDE), 337 Mapping terminologies, 154–155 Markle Foundation, Connecting for Health initiative, 39, 73 MAUDE. See Manufacture and User Data Experience-Medical Devices Mayo Clinic, 156 MDS. See Minimum Data Set for Nursing Home Care MEDCIN. See Medicomp Systems Incorporated MedDRA. See Medical Dictionary for Drug Regulatory Affairs Medical device terminologies, 153–154 Medical Dictionary for Drug Regulatory Affairs (MedDRA), 150, 337 Medical Event Reporting System for Transfusion Medicine (MERS TM), 337, 406–417 risk assessment index, 294 Medical literature representation of, 161–162 Medical Product Surveillance Network (MedSun), 337 Medical Subject Headings (MeSH), 337 Medicare Patient Safety Monitoring System (MPSMS), 337 Medication Errors Reporting (MER), 337 Medicomp Systems Incorporated (MEDCIN), 150 MedSun. See Medical Product Surveillance Network MER. See Medication Errors Reporting MERS TM. See Medical Event Reporting System for Transfusion Medicine MeSH. See Medical Subject Headings Message format standards, 132–135 HL7 reference information model, 135 MHS PSP. See Military Health System Patient Safety Program Military Health System Patient Safety Program (MHS PSP), 80, 337 Mindfulness, 230 Minimum Data Set for Nursing Home Care (MDS), 337 Minimum datasets, 218–220 ancillary information, 219 detailed analysis, 219 the discovery, 219 the event itself, 219 results, 220 Model for safer care, 178–184 Monitoring for adverse effects, 206–214 computerized physician order entry and medication prescribing, 214 rules for detecting possible adverse drug events using automated surveillance, 207 triggers for outpatient adverse drug events, 208 MPSMS. See Medicare Patient Safety Monitoring System MRI. See Magnetic resonance imaging N NANDA. See North American Nursing Diagnosis Association NASA. See National Aeronautics and Space Administration NaSH. See National Surveillance System for Health Care Workers NASHP. See National Academy for State Health Policy National Academy for State Health Policy (NASHP), 337 National Aeronautics and Space Administration (NASA), 337 National Alliance for Health Information Technology, 117–118 National Center for Health Statistics (NCHS), 116, 337 National Center for Patient Safety (NCPS), 337

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Patient Safety: Achieving a New Standard for Care National Committee for Quality Assurance (NCQA), 108, 113, 272, 337 National Committee on Vital and Health Statistics (NCVHS), 6, 10, 25, 46, 78, 107, 115, 119–121, 143, 145–146, 337 terminologies, 17 National Council for Prescription Drug Programs (NCPDP), 25, 99, 132, 337 National Drug Codes (NDCs), 104, 151, 337 National Drug File Clinical Drug Reference Terminology (NDF RT), 337 National Electronic Disease Surveillance System (NEDSS), 337 National Equipment Manufacturers Association (NEMA), 337 National Guideline Clearinghouse, 158 National Health Information Infrastructure (NHII), 37, 53, 88–90, 123, 332, 337 agenda for data standards, 48 building, 45–168 challenges to implementation, 86–91 components of, 46–47, 52–95 conceptual model of standards-based, integrated data systems to support patient safety, 56–61 dimensions of, 54 elements of, 6–8 enforcement of privacy and security, 90 federal leadership and public-private partnerships, 96–126 financial incentives, 88–90 health care data standards, 127–168 implementing the systems, 72–78, 86–91 informatics components, 61–72 organizational leadership, 86–88 practical approaches to moving forward, 78–86 recommendations, 6–8, 45, 47 technical assistance, 90 National Healthcare Safety Network (NHSN), 337 National Institute of Standards and Technology (NIST), 101 National Library of Medicine (NLM), 16–17, 107, 119–121, 337 National Nosocomial Infections Surveillance (NNIS), 338 National Patient Safety Foundation (NPSF), 338 National Quality Forum (NQF), 338 National Research Council (NRC), 338 National Surveillance System for Health Care Workers (NaSH), 337 National Uniform Billing Committee, 99 Natural language processing (NLP), 196, 332, 337 NCHS. See National Center for Health Statistics NCPDP. See National Council for Prescription Drug Programs NCPS. See National Center for Patient Safety NCQA. See National Committee for Quality Assurance NCVHS. See National Committee on Vital and Health Statistics NDCs. See National Drug Codes NDF RT. See National Drug File Clinical Drug Reference Terminology Near-miss analysis, 30, 171–172, 226–245, 332, 338 causal continuum assumption, 230–231 data collection, 237–238 design and operation of system components, 244 framework for processing near-miss reports, 240–242 functional aspects, 215–216 functional requirements of near-miss systems, 234–236 fundamental aspects of near-miss systems, 232–233 gaps between ideal and current systems, 242

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Patient Safety: Achieving a New Standard for Care general framework for processing reports, 241–242 goals for near-miss systems, 229–230 implementation and operational considerations, 236–240 implications for data standards, 242–245 incident causation model, 228 integration with adverse events systems, 239–240 mindfulness/alertness, 230 modeling for qualitative insight, 229 reporting and analysis, 229–232 role of the patient, 231–232 testing assumptions of, 192–193 trending for quantitative insight, 229–230 NEDSS. See National Electronic Disease Surveillance System Negative predictive value (NPV), 338 NEHEN. See New England Healthcare Electronic Data Interchange Network NEMA. See National Equipment Manufacturers Association Neural networks, 332 New England Healthcare Electronic Data Interchange Network (NEHEN), 55 New York Patient Occurrence Reporting and Tracking System (NYPORTS), 33, 248, 338 medication supplement, 398 reportable events, 394–396 root-cause analysis form, 397 short form, 397 NHII. See National Health Information Infrastructure NHSN. See National Healthcare Safety Network NIC. See Nursing Intervention Classification Nicholas E. Davies award winners, 79 NIST. See National Institute of Standards and Technology NLM. See National Library of Medicine NLP. See Natural language processing NMHS. See North Mississippi Health Services NNIS. See National Nosocomial Infections Surveillance NOC. See Nursing Outcomes Classifications Normalized notations for clinical drugs (RxNORM), 150, 338 North American Nursing Diagnosis Association (NANDA), 337 North Mississippi Health Services (NMHS), 83 NPSF. See National Patient Safety Foundation NPV. See Negative predictive value NQF. See National Quality Forum NRC. See National Research Council Nursing Intervention Classification (NIC), 337 Nursing Outcomes Classifications (NOC), 338 NYPORTS. See New York Patient Occurrence Reporting and Tracking System O OASIS. See Outcome and Assessment Information Set for Home Care Omission, addressing errors of, 216 Open communication, 177 Order entry/order management, 443–444, 452–453 Organizational commitment to detect patient injuries and near misses, 175–176 high-risk areas that deserve special attention, 176 Organizational leadership, 86–88 Organizational learning, as a system focus, 234–235 ORYX initiative, 113 Outcome and Assessment Information Set for Home Care (OASIS), 338

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Patient Safety: Achieving a New Standard for Care P Parameters of a medical event reporting system desirable, 285 Partnerships among CHI initiative, NCVHS, and NLM, 119–122 PATH. See Program for Appropriate Technology in Health Patient Care Data Set (PCDS), 338 Patient data linkage, 141–142 Patient medical record information (PMRI), 115, 338 Patient roles, 194 engaging patients and their families more in patient safety, 190–192 Patient safety data applications of, 247 audits of, 271–273 possible uses and mechanisms of action for, 253 Patient safety data standards (PSDS), 40, 338 Patient Safety Institute (PSI), 141 Patient safety reporting standards, 40–41 Patient safety reporting system (PSRS), 250–278, 338 and accountability, 252–254 versus learning, understanding the continuum, 262–273 need to invest more resources in learning approaches, 273 Patient safety systems, 269–273 acceptability of the scheme to all personnel, 237 cost/benefit analysis of programs for, 194 data system design, 270 design and operation of system components, 244 in health care settings, 17–20 IOM-Health Level Seven demonstration project, 72–78 level of help provided for collecting and analyzing the data, 236 nature of the information collected, 236 nature of the organization of the reporting scheme, 236–237 patient safety data audits, 271–273 recommendations, 19, 20–23 reporting, 20–23 selection of measures for, 263–265 design and operation of system components, 243 general framework for processing near-miss reports, 240 sources of variation in measured outcomes, 264 standardized data, 270–271 PBRNs. See Practice-based research networks PCDS. See Patient Care Data Set Perioperative Nursing Data Set (PNDS), 338 PHA. See Proactive hazard analysis Pharmacy knowledge bases, 151 PMRI. See Patient medical record information PNDS. See Perioperative Nursing Data Set Positive predictive value (PPV), 338 Postoperative infections, 188–190 PPV. See Positive predictive value PQI. See Prevention quality indicator PRA. See Probabilistic risk assessment Practical approaches to data systems, 78–86 data management procedures, 85 information management, 81 Kaiser Permanente of Ohio, 82 Nicholas E. Davies award winners, 79 North Mississippi Health Services (NMHS), 83 Perspective Online, 85 Practice-based research networks (PBRNs), 109 President’s Information Technology Advisory Committee, 6 Preventability concept of, 268–269 Preventing adverse drug events, 185–187 Prevention quality indicator (PQI), 338

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Patient Safety: Achieving a New Standard for Care Primary and secondary uses of report data, 308–310 Primary standards development organizations in the U.S., 99 American Dental Association, 99 American Society for Testing and Materials, 335 ASC X12N, 99 Digital Imaging and Communications in Medicine, 99 Health Level Seven, 99 Institute of Electrical and Electronics Engineers, 99 National Council for Prescription Drug Programs, 99 Priority Areas for National Action: Transforming Health Care Quality, 9, 38, 147 Privacy, enforcement of, 90 Private networks, representative applications conducted over, 71 Proactive hazard analysis (PHA), 338, 481–485 features common to all approaches, 486 features unique to specific tools, 487 FMEA/HFMEA, 481–482 HACCP, 482–483 HAZOP, 484 PHA, 484–485 quality improvement tools, 476–477 RCA, 485 Probabilistic risk assessment (PRA), 338 case studies, 499–501 Professional associations terminologies of, 104–106 Program for Appropriate Technology in Health (PATH), 338 Proof theory, 333 PS. See Patient safety PSDS. See Patient safety data standards PSI. See Patient Safety Institute PSRS. See Patient safety reporting system Public and private partnership to set standards, 8–12, 47–48, 120 recommendations, 8–12, 47–48 Public Health Data Standards Consortium, 116–117 Q QIPS. See Quality indicators for patient safety Quality improvement and proactive hazard analysis models, 471–508 applicability to adverse event prevention, 490–491 case studies, 492–507 common features to all QI tools, 486 conceptual and methodological considerations, 488–489 data requirements and measurement tools, 491–492 essential features of health care quality, 473 features unique to specific QI tools, 487 key common principles and attributes of methodologies, 486–489 overview of existing models, 473–485 proactive hazard analysis, 481–485 of QI/PHA methodologies, 486–489 quality improvement tools, 473–481 unique features to specific PHA tools, 487 Quality improvement tools, 473–481 proactive hazard analysis approaches, 476–477 quality improvement approaches, 474–475 Six Sigma, 480–481 TPS, 479–480 TQM/CQI, 478–479 Quality in Australian Health Care Study, 30 Quality indicators for patient safety (QIPS), 338 Quality Interagency Coordination Task Force (QuIC), 10, 32, 112–113, 338 QuIC. See Quality Interagency Coordination Task Force R R-Demo. See Reporting demonstration Radiological Society of North America (RSNA), 338

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Patient Safety: Achieving a New Standard for Care RAI. See AIMS risk assessment index RCA. See Root-cause analysis Recommendations, 6–8, 15–17, 45, 47–48, 49–50 clinical data interchange standards, 16, 49 clinical terminologies, 16–17, 50 elements of a health information infrastructure, 6–8 establishment of comprehensive patient safety programs, 169–170 knowledge representation, 17, 50 patient safety reporting, 22–23 patient safety systems in health care settings, 19 standardized reporting, 248–249 Recovery root causes, 233 Recovery taxonomy testing a suitable, 193 Reference Information Model (RIM), 338 Reference terminology, 333 Regulated Clinical Research Information Management, 305 Reportable events, 382 in federal reporting systems, 343 in private-sector reporting systems, 403 Reporting and population health management, 447, 458–459 Reporting demonstration (R-Demo), 338 Reporting formats, 333 Reporting methods, 383 in federal reporting systems, 344 in private-sector reporting systems, 404 Reporting standards, 111–114 Research agenda, 192–197 developing a recovery taxonomy, 195 dissemination, 196–197 knowledge generation, 192–195 tool development, 195–197 RIM. See Reference Information Model Risk assessment index, 292–295 AIMS risk assessment index (RAI), 294 MERS TM risk assessment index, 294 Risk Assessment of Security Critical Systems (CORAS), 335 Root-cause analysis (RCA), 333, 338 case studies, 501–503 proactive hazard analysis, 485 Root-cause taxonomies context variables, 233 failure root causes, 233 free text, 233 need for, 233 recovery root causes, 233 RSNA. See Radiological Society of North America RxNORM. See Normalized notations for clinical drugs S SAC. See Safety Assessment Code Safe care, 334 Safety Assessment Code (SAC), 292–293, 338 Safety data using for accountability, licensing, or legal action, 255 using for selection, 256 Scherkenbach’s cycle of fear, 265–268 SDO. See Standards development organizations Securities and Exchange Act of 1934, 114 Security, enforcement of, 90 Semantics, 334 Serious events analysis of, 384 in federal reporting systems, 344–345 in private-sector reporting systems, 404–405 Setting standards for the exchange of health care data in the U.S., 98 Seven-module framework for processing, general framework for processing near-miss reports, 241 Shared beliefs and values, 175 Six Sigma, 503–505 case studies, 503–505 quality improvement tools, 480–481 Six Sigma anticoagulation improvements at Virtua Health, 504–505

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Patient Safety: Achieving a New Standard for Care SNAEMS. See Special Nutritionals Adverse Event Monitoring System SNOMED CT. See Systemized Nomenclature for Human and Veterinary Medicine, Clinical Terms SPARCS. See Statewide Planning and Research Cooperative System Special Nutritionals Adverse Event Monitoring System (SNAEMS), 338 Standardized mappings of terminologies, 105, 107–108 Standardized report format basic domains, 286–287 causal analysis, 293, 295–301 desirable parameters of a medical event reporting system, 285 essential elements of, 283–304 event-type taxonomy, 287–292 lessons learned, 302 need for, 280–283 risk assessment index, 292–295 summary of domain areas for a common report format, 302–304 Standardized reporting, 247–249, 279–316 de-identification and data protection, 307–308 essential elements of, 283–304 implementation of, 304–307 need for, 280–283 overview of CHAI, 312–313 primary and secondary uses of, 308–310 recommendations, 248–249 Standards activities in the federal and private sectors, 114–118 CHI initiative, 116 Integrating the Healthcare Enterprise initiative, 118 National Alliance for Health Information Technology, 117–118 National Committee on Vital and Health Statistics (NCVHS), 115 Public Health Data Standards Consortium, 116–117 Standards development organizations (SDO) overlap of work by major, 97 terminologies, 105–107 Standards-setting processing, 97–114 data interchange standards, 97–102 knowledge representation standards, 108–111 reporting standards, 111–114 terminologies, 102–108 State reporting systems, 382–401 analysis of serious events, 384 examples from the New York and Florida reporting system, 386–393 Florida state annual report, 400 Florida state Code 15 report, 401 Florida state reportable events, 399 format for reporting, 382–383 method of reporting, 383 New York Patient Occurrence Reporting and Tracking System (NYPORTS) medication supplement, 398 NYPORTS reportable events, 394–396 NYPORTS root-cause analysis form, 397 NYPORTS short form, 397 reportable events, 382 tabular information, 385 Statewide Planning and Research Cooperative System (SPARCS), 338 Streamlining patient safety reporting, 247–249 patient safety data applications, 247 standardized reporting, 247–249 Supplemental terminologies, overview of, 150–151 Surveillance. See Automated surveillance Surveillance of clinical data, 334 automated, 206 in federal reporting systems, 342–343 Syntactic aspect of knowledge representation language, 334

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Patient Safety: Achieving a New Standard for Care Systemized Nomenclature for Human and Veterinary Medicine, Clinical Terms (SNOMED CT), 25, 33, 106, 149–150, 338 T Taxonomies data standards for, 243 Terminology, 13–15, 49–50, 102–108, 129, 142–158, 334 academic institutions, 104–106 clinical domain areas of the CHI initiative, 146–147 defining, 217–218 evolution and development of new, 147–148 federal government, 103–106 for further investigation and research, 155–158 international organizations, 103–104 knowledge representation standards, 108–111 professional associations, 104–106 representation of clinical domains, 143–146 selection of the core terminology group, 145, 148–158 standardized mappings of, 105, 107–108 standards development organizations, 105–107 technical criteria and representation of clinical domains, 143–146 To Err Is Human, 2, 30–31, 33 response to, 32–34 Tool development, 195–197 data mining of patient safety databases, 196 early detection, 195 natural language processing, 196 prevention capabilities, 195 R6, 20, 170 verifying adverse events, 196 Total quality management (TQM), 339 and quality improvement tools, 478–479 Toyota Production System (TPS), 339 case studies, 505–507 quality improvement tools, 479–480 TPS. See Toyota Production System TQM. See Total quality management U UCSF. See University of California, San Francisco UHI. See Universal health identifier UMDNS. See Universal Medical Device Nomenclature System UMLS. See Unified Medical Language System Unified Medical Language System (UMLS), 108, 121, 339 Unique Ingredient Identifier (UNII), 150 United States Pharmacopeial Convention, Inc. (USP), 339 Universal health identifier (UHI), 14, 25, 339 Universal Medical Device Nomenclature System (UMDNS), 150, 291, 339 University of California, San Francisco (UCSF), 339 User interfaces, 137–141, 334 HL7 context manager, 140 human factors engineering process governing the HE74 standard, 138 USP. See United States Pharmacopeial Convention, Inc. V Vaccine Adverse Event Reporting System (VAERS), 339 Vaccine Safety Datalink (VSD), 339 VAERS. See Vaccine Adverse Event Reporting System Veterans Health Administration (VHA), 80, 85, 339 example of federal patient safety/ health care reporting and surveillance systems, 374–381

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Patient Safety: Achieving a New Standard for Care Veterans Health Integration System and Technology Architecture (VISTA), 89 VHA. See Veterans Health Administration VISTA. See Veterans Health Integration System and Technology Architecture Voluntary reporting, 204, 335 VSD. See Vaccine Safety Datalink W WEDI. See Workgroup on Electronic Data Interchange WHO. See World Health Organization Willingness to report patient safety events, 237–238 WONCA. See World Organization of National Colleges, Academies, and Academic Associations of General Practitioners and Family Physicians Workgroup on Electronic Data Interchange (WEDI), 163 World Health Organization (WHO), 103 World Organization of National Colleges, Academies, and Academic Associations of General Practitioners and Family Physicians (WONCA), 103, 156, 339 X XML. See Extensible markup language