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
ACP Journal Club, 110
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
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
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
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
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
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
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
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
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
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
ESRD. See End-stage renal disease
Event-type taxonomy, 287–292
Evidence, levels of, 331–332
Evidence-based guidelines, 330
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
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
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
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
M
Magnetic resonance imaging (MRI), 337
Magnitude of the problem, 30–32
health care errors in the U.S., 31
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Veterans Health Integration System and Technology Architecture (VISTA), 89
VHA. See Veterans Health Administration
VISTA. See Veterans Health Integration System and Technology Architecture
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