and
Scope of Patient Safety Special Interest Group
The Harvard Medical Practice Study (Brennan TA et al. and Leape LL et al. Results of the
Harvard Medical Practice Study. New England Journal of Medicine 324(6):370-376, and 377-
384 respectively, 1991.
adverse events in 3.7% of hospitalization, and about 28% of these attributable to
negligence. Although about 71% of these caused disabling injuries that lasted less
than six months, 2.6% caused permanent disability and 13.6 percent lead to death.
The Colorado and Utah Hospital Discharge Study (Thomas EJ et al. Incidence and Types
of Adverse Events and Negligent Care in Utah and Colorado. Medical Care, Spring 2000)
adverse events in 2.9% of hospitalizations, and 6.6 % of these lead to death, and over
half assessed to be preventable.
Even when using the lower estimate, deaths due to medical errors exceed the number
attributable to the 8th leading cause of death. Death: Final data for 1997. CDC-National Vital
Statistics Reports. 47(19):27, 1999.
More people die in a given year as a result of medical errors than from motor vehicle
accidents (~44,000), breast cancer (~43,000) or AIDS(~16,500). Births and Deaths:
Preliminary data for 1998. CDC, National Vital Statistics Reports. 47(25):6, 1999.
Medication error along, occurring either in or out of hospitals, are estimated to account for
7000 deaths annually. Phillips DP et al. Increase in US medication error deaths between
1983 and 1993. The Lancet, 351:643-44, 1998.
Total national cost of preventable adverse events are estimated between 17 billion of which
health care costs represent one half. Thomas EJ et al. Cost of Medical Injuries in Utah and
Colorado. Inquiry 36:225-264, 1999 and Johnson WJ et al. The economic consequences of
medical injuries, JAMA. 267:2487-2492, 1992.
The Quality in Australian Health Care Study (Wilson RM et al. The Quality in Australian
Health Care Study. The Medical Journal of Australia. 163(9):458-71,1995
16.6 percent of hospital admissions involved adverse events, half of those
considered preventable. About 14 percent of adverse events were found to have
resulted in permanent disability, with 4.9 percent resulting in death.
IOM Reports
The future healthcare models need to actively pursue many key elements:
Consider care to be a continuous process
Knowledge is shared & information flows freely
Decision making is evidence-based, with protocols & process support
Safety is a system property
Transparency is a necessity
Care delivery is Team-based
Cooperation among the clinicians is a priority
Patient Safety will be of paramount importance as healthcare grows
exponentially complex, and the discipline needs to encompass entire
spectrum of healthcare.
Definitions
Death or serious disability from use or X X AERS, ARS, DSN, CO, MA,
function of a device in patient care, when MAUDE, CMS, MEDSUN, ME, NY,
other than intended (NQF) MEDWATCH, MERS, OH, TN
MEDMARX, NNIS
Medical equipment-related event (JCAHO)
Death or serious disability (kernicterus) associated with failure to X HCUP, MAUDE, MEDSUN,
identify and treat hyperbilirubinimia in neonates MEDWATCH, MERS,
MEDMARX, NNIS, VAERS
Perinatal death or loss of function X HCUP, MAUDE, MEDSUN,
MEDWATCH, MERS,
MEDMARX, NNIS, VAERS
Stage 3 or 4 pressure ulcers acquired after X HCUP, CMS, MEDSUN,
admission to a healthcare facility MEDWATCH
Patient death or serious disability due to spinal manipulative therapy X MAUDE, MEDSUN,
MEDWATCH
Delay in treatment X
Infestation by parasites or vectors (CA) CA
Death due to malnutrition, dehydration, or sepsis (PA) PA
More
Serious Events
Death/Severe Harm
Near Miss
Unwanted consequence
prevented because of recovery
No Harm Events
Priority Areas for National Action: Transforming
Healthcare Quality, IOM, 2003.
Priority Areas
In order to ascertain the extent of patient safety-related activities in HL7, the recent
documents of Technical Committees and Special Interest Groups on the HL7 web
page were reviewed. For the purposes of the inventory, patient safety was broadly
defined to include freedom from errors of commission (e.g., administering a drug to
which a patient is allergic) and errors of omission (e.g., providing care that is not
consistent with the best evidence). The inventory was limited to Technical
Committees and Special Interest Groups that identified patient safety activities in their
mission, minutes, or other documentation or provided infrastructure standards as
specified in the 2003 Institute of Medicine patient safety data standards report
(Committee on Data Standards for Patient Safety, 2003a).
HL7 TC/SIG Activities Relevance to Patient Safety
Arden Syntax Maintenance and further Arden Syntax provides a standard for representing and
development of the Arden Syntax sharing of clinical knowledge (decision support rules)
through Medical Logic Modules
Arden Syntax Implementation Guide Arden Syntax Implementation Guide supports standard
implementation of Arden Syntax and Medical Logic
Modules
Attachments Initial focus on NPRM attachments. Beyond their primary purpose related to insurance and e-
Future projects include, but are not commerce, attachments such as those proposed in future
limited to, Home Health, Skilled project are of relevance to coordination of care across
Nursing Facility, Durable Medical organizations and sites.
Equipment (DME), End Stage Renal
Disease (ESRD), and Pre-
Authorization and Referrals.
CCOW Standard Context Management Provision of specified data (e.g., patient name, allergies)
Specification across applications has the potential to decrease errors.
Clinical Common Expression Language Common expression language for guideline representation
Decision (GELLO) will improve the computability and sharing of guideline
Support knowledge
Decision Support Workbook Decision Support Workbook supports standard
implementation.
Decision Support HDF Decision Support HDF enables creation of decision support
messages.
vmR - DIM/RMIM specialized from Decision support DIM/RMIM enables creation of decision
the RIM for decision support in EHR support messages.
Decision support aspects of EHR Decision support is an essential capability of EHR
specification (Committee on Data Standards for Patient Safety, 2003a, b).
HL7 TC/SIG Activities Relevance to Patient Safety
Clinical Creation of the standard for the communication Common expression language for
Guidelines of clinical practice guidelines to facilitate their guideline representation will improve the
integration into health care systems, electronic computability and sharing of guideline
medical records, and a variety of applications. knowledge
Community Messaging needs of community based providers Information exchange between
Based Health such as home health, hospice, long term care and community-based and acute care settings
Services mental health. Work items include messages is essential for coordination of care and
related to home health, telehealth, and referrals ensuring patient safety.
Conformance This group supports the HL7 mission to create Mechanism for assessing conformance
and promote its standards by providing a with data standards is needed to facilitate
consistent mechanism to specify conformance for adoption of data standards that support
HL7 Version 2.X and HL7 Version 3 messages patient safety (Committee on Data
and provide a framework for facilitating Standards for Patient Safety, 2003a).
interoperability using the HL7 standard.
Electronic EHR architecture and functionality EHR systems form an essential
Health Records component of NHII that supports patient
safety (Committee on Data Standards for
Patient Safety, 2003a, b).
Imaging Collection, review, development and Non-textual data such as images are
Integration documentation of use cases, information critical patient information. Data from
structures and message content related to imaging systems, PACS, and associated
ordering and reporting of non-textual data and radiological oriented systems require
associated information, including images integration with other clinical
themselves. information.
HL7 TC/SIG Activities Relevance to Patient Safety
Laboratory, Automated laboratory messages and (a) Communication among automated clinical
Automated, and extension of the messages, triggers, and laboratory systems, instruments, devices
Point of Care Testing segments to Point of Care Testing devices, including point of care and home testing
Home Testing devices, and data collection devices, and clinical information systems
and processing computers that support will improve the timeliness and accuracy
these activities, (b) development of the of the information exchange.
aspects of the Reference Information
Model that relate to automated clinical
laboratory and point of care/home testing,
and (c) development of version 3 messages
for automated clinical laboratory and point
of care/home testing.
Medical Medical-legal agreements Medical-legal agreements such as consent
Records/Information forms are necessary to ensure that the
Management patient is aware of the potential risks and
benefits associated with treatment
Medication Representation of medication related Medication-related events are most
information and pharmacy D-MIM frequently occurring adverse events across
care settings. Messages that support
accurate and appropriate prescribing,
dispensing, and administering of
medications are critical to patient safety.
Modeling and HL7 RIM and Modeling Methodology Reference Information Model essential for
Methodology semantic interoperability and a necessary
component of NHII (Committee on Data
Standards for Patient Safety, 2003a).
HL7 TC/SIG Activities Relevance to Patient Safety
Pediatric Data Definition of pediatric data standards required Pediatric safety and quality of care have
Standards for interchange of standardized and comparable specialized requirements in some
national pediatric performance measurement instances (e.g., drug dosages by weight).
including required terminology.
Personnel Professional's identity, his/her rights and The information exchanged is needed for
Management obligations, the the professional's authentication,
special domain and qualifications, and the authorization, access control and
relationships to patients. accountability for data and processes.
Regulated Messages, document structures, and Regulated clinical research information is
Clinical terminology to support the systems and represented differently by different
Research processes used in the collection, storage, agencies. Efforts such as Consolidated
Information distribution, integration and analysis of Health Informatics are aimed at
Management regulated clinical research information. commonalities across agencies.
Product labeling Accurate product labeling is a prerequisite
for safe product administration and timely
sharing of information about product-
related adverse events.
Regulatory reports related to adverse events Individual Case Safety Report provides a
(see Individual Case Safety Report, Patient standard representation for adverse event
Safety reporting to various federal agencies.
Research protocol representation Standard research protocol representation
will support accuracy and timeliness of
protocol sharing.
HL7 TC/SIG Activities Relevance to Patient Safety
Scheduling and Messages for the purpose of communicating Issues related to scheduling of services and
Logistics and supporting the various processes related to associated resources have the potential to
the scheduling of appointments for services delay or prevent necessary treatment and
and associated resources. Processes include the impede coordination of care.
functions of requesting, booking, notification,
and modification pertaining to appointments
and resources., sterilization message
Security and HL7 Security Service Framework Security service a required component of
Accountability NHII that supports patient safety
(Committee on Data Standards for Patient
Safety, 2003a).
Standard Guide for Implementing HL7 EDI Standard Guide supports implementation
Communication Security of security service.
Structured Clinical Document Architecture (CDA) CDA will facilitate the extraction of
Documents context-specific patient safety-related data
that are structured and of non-structured
data (through natural language processing)
(Committee on Data Standards for Patient
Safety, 2003a).
Vocabulary Identification, organization and maintenance of Computable representations of terms are
coded vocabulary terms used in HL7 messages. essential to semantic interoperability and
required component of of NHII that
supports patient safety (Committee on Data
Standards for Patient Safety, 2003a).
Topics being addressed
Japanese Participation
Current thoughts on the Domain
Entry point
Patient Care TC to define settings and processes in medical care that effect patient safety
and the related clinical/other information needs
Electronic Health Record TC to identify and develop patient safety related functionalities
within electronic medical record environment
Pharmacy SIG to ensure proper medication usage (drug-drug interaction, contraindications,
drug concentration and dosing, dispensing, AE reporting etc.)
Structured Document TC to accommodate the patient safety related information needs
within structured technical documents
Clinical Decision Support TC to address patient safety needs at the point-of-care from
a evidence-based healthcare practice perspective, and
Vocabulary TC to improve patient safety related vocabularies (coding for HL7 internal
codes, diseases, drugs, vaccines, medical devices/procedures, blood products, clinical
terminology, regulatory terminology, etc.) and promote the usage of appropriate controlled
vocabularies.
PHER
CBHS
What is needed