Recent Developments in Patient Safety

and
Scope of Patient Safety Special Interest Group

Ali Rashidee, MD. MS.

Co-Chair, Patient Safety SIG
PATIENT SAFETY: Estimates of medical errors

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.

When extrapolated to 33.6 million admissions to US hospitals in 1997, the

results of a study in Colorado and Utah conducted by Thomas E J et al. imply
that at least 44,000 Americans die each year as a result of medical errors.
Another study by Leape L L et al.. at Harvard Medical Practice Study, 1991
suggests 98,000 deaths due to medical errors- AHA Hospital Statistics.
Burden of medical errors

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

IOM reports have consistently emphasized the need for enhancing

patient safety and healthcare quality:

Patient Safety: A New Standard for Care ( 2003)

Priority Areas for National Action: Transforming Healthcare
quality (2003)
Crossing the Quality Chasm (2001)
To Err is Human (2000)
Computer-based Patient Record (1991, 1997)
IOM Recommendations

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

Original IOM Errors report: An adverse event is

defined as an injury caused by medical management
[commission] rather than by the underlying disease
or condition of the patient.

Patient Safety definition: An adverse event results in

unintended harm to the patient by an act of
commission or omission rather than by the
underlying disease or condition of the patient.
 Some Current Patient Safety Indicators

Domain Abbreviated Definitions NQF JCAHO USDHHS Medical- State

(and alternative language when NQF, Event-Related Systems
JCAHO, and State definitions differ) Data Systems
Surgery Wrong site surgery X X FL, MA,, ME, OH,
PA, TN, UT, WA

Surgery on wrong patient X FL, MA, ME, OH,

PA, RI, TN, UT,
WA
Wrong surgical procedure performed on patient X FL, MA, RI, TN
Foreign object left in a patient after surgery X HCUP, NNIS FL, MA,
or other procedure TN
Intraoperative or immediately post-operative X X HCUP, BPD, CO, NJ
Death in an ASA Class I patient (NQF) MERS,MEDMARX,
NNIS
Anesthesia-related event (JCAHO) ASA Class I patient
designation unlikely
to be available
Death or near death for anesthesia and NJ
cardiac procedures (NJ)
[Intraoperative or Post-operative complication X HCUP Often not RI, TN
specific
Surgical repair or damage resulted from planned FL
surgical procedure where damage was not
disclosed or documented to the patient
Domain Abbreviated Definitions NQF JCAHO USDHHS Medical-Event- State
(and alternative language when NQF, Related Data Systems Systems
JCAHO, and State definitions differ)
Product Death or serious disability from use of X AERS, ARS, BPD, DSN,
or contaminated drugs, devices, or biologics MAUDE, MEDSUN,
Device by facility MEDWATCH, MERS,
Events MEDMARX, NNIS,
VAERS, VSD

Aspiration in non-intubated patient related TN

to conscious/moderate sedation

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)

Intravascular catheter related events (TN)

Death or serious disability from X AERS, ARS, DSN, CO

intravascular air embolism during care at a MAUDE, MEDSUN,
facility MEDWATCH, MERS,
MEDMARX, MPSMS

Ventilator death or injury X CO

Care Death or serious disability from medication error (e.g. wrong drug, X X HCUP, MEDSUN, MA, ME,
Manage- dose, patient, time, rate, preparation, or route (NQF) MEDWATCH, MERS, PA, TN
ment Medication error (JCAHO) MEDMARX, NNIS, VAERS
Events
Patient death or serious disability associated with a hemolytic reaction X X HCUP, BPD, DSN, CO, MA,
due to the administration of ABO-incompatible blood or blood MEDWATCH, MERS, ME, PA,
products (NQF) MEDMARX TN, WA
Transfusion error (JCAHO)
Maternal death or serious disability associated with labor or delivery X X HCUP, MAUDE, MEDSUN, MA
in a low- risk pregnancy while being cared for in a healthcare facility MEDWATCH, MERS,
(NQF) MEDMARX, NNIS
Maternal death (JCAHO)
Hysterectomy in a pregnant woman, ruptured uterus (TN) TN
Birth injury (RI) RI
Patient death or serious disability associated with hypoglycemia, the X HCUP, DSN, MAUDE,
onset of which occurs while the patient is being cared for in MEDSUN, MEDWATCH,
a healthcare facility MERS, MEDMARX

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

Environmental Events: Falls, Burns, Fire, Electric shock, Restraint

malfunction, etc.

Criminal Events: Impersonation, Physical assault, Poisoning, Accident,

Abuse, Negligence, etc.

Site-specific Outcomes: Brain injury, spinal cord injuries,

Fracture/dislocation of bones, Incident involving sight or hearing
impairment, etc.

General Outcomes: Death arising from unexplained cause/suspicious

circumstances, death due to unnatural causes, treatment for adverse incident,
transfer required due to adverse incidents, serious injury, impairment, death
or further treatment due to adverse incidents, etc.
Iceberg Model of Accidents and Errors

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

Care Coordination- Cross cutting

Self management/Health literacy- Cross Cutting
Asthma
Cancer Screening, esp. cervical and colorectal
Children with special healthcare needs (Chronic physical,
developmental, behavioral or emotional)
End of life with advanced organ system failure: CHF and COPD
 Priority Areas

Frailty associated with old age - preventing falls, pressure

ulcers, maximizing function and developing advanced care
plans
Hypertension- appropriate management of early disease
Immunization children and adults
Ischemic Heart Disease - prevention, reduction of recurrence,
optimization of functional capacity
Major Depression- screening and treatment
 Priority Areas

Medication Management - preventing medication errors and

overuse of antibiotics
Healthcare acquired Infection - prevention and surveillance
Pain control in advanced cancer
Pregnancy and childbirth- appropriate prenatal and
intrapartum care
Severe and persistent mental illness- focus on treatment in
public sector
Stroke- early intervention and rehabilitation
Tobacco dependence treatment in adults
Obesity (emerging priority)
Draft HL7 Patient Safety Inventory
Suzanne Bakken, RN. DNSc.
Columbia University

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
Arden Syntax Maintenance and further
development of the Arden Syntax
Arden Syntax Implementation Guide
Attachments Initial focus on NPRM attachments.
Future projects include, but are not
limited to, Home Health, Skilled
Nursing Facility, Durable Medical
Equipment (DME), End Stage Renal
Disease (ESRD), and Pre-
Authorization and Referrals.
CCOW Standard Context Management
Specification
Clinical Common Expression Language
Decision (GELLO)
Support
Decision Support Workbook
Decision Support HDF
vmR - DIM/RMIM specialized from
the RIM for decision support in EHR
Decision support aspects of EHR
specification
Relevance to Patient Safety
Arden Syntax provides a standard for representing and
sharing of clinical knowledge (decision support rules)
through Medical Logic Modules
Arden Syntax Implementation Guide supports standard
implementation of Arden Syntax and Medical Logic
Modules
Beyond their primary purpose related to insurance and e-
commerce, attachments such as those proposed in future
project are of relevance to coordination of care across
organizations and sites.
Provision of specified data (e.g., patient name, allergies)
across applications has the potential to decrease errors.
Common expression language for guideline representation
will improve the computability and sharing of guideline
knowledge
Decision Support Workbook supports standard
implementation.
Decision Support HDF enables creation of decision support
messages.
Decision support DIM/RMIM enables creation of decision
support messages.
Decision support is an essential capability of EHR
(Committee on Data Standards for Patient Safety, 2003a, b).
HL7 TC/SIG Activities
Clinical Creation of the standard for the communication
Guidelines of clinical practice guidelines to facilitate their
integration into health care systems, electronic
medical records, and a variety of applications.
Community Messaging needs of community based providers
Based Health such as home health, hospice, long term care and
Services mental health. Work items include messages
related to home health, telehealth, and referrals
Conformance This group supports the HL7 mission to create
and promote its standards by providing a
consistent mechanism to specify conformance for
HL7 Version 2.X and HL7 Version 3 messages
and provide a framework for facilitating
interoperability using the HL7 standard.
Electronic EHR architecture and functionality
Health Records
Imaging Collection, review, development and
Integration documentation of use cases, information
structures and message content related to
ordering and reporting of non-textual data and
associated information, including images
themselves.
Relevance to Patient Safety
Common expression language for
guideline representation will improve the
computability and sharing of guideline
knowledge
Information exchange between
community-based and acute care settings
is essential for coordination of care and
ensuring patient safety.
Mechanism for assessing conformance
with data standards is needed to facilitate
adoption of data standards that support
patient safety (Committee on Data
Standards for Patient Safety, 2003a).
EHR systems form an essential
component of NHII that supports patient
safety (Committee on Data Standards for
Patient Safety, 2003a, b).
Non-textual data such as images are
critical patient information. Data from
imaging systems, PACS, and associated
radiological oriented systems require
integration with other clinical
information.
HL7 TC/SIG Activities
Laboratory, Automated laboratory messages and (a)
Automated, and extension of the messages, triggers, and
Point of Care Testing segments to Point of Care Testing devices,
Home Testing devices, and data collection
and processing computers that support
these activities, (b) development of the
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
Records/Information
Management
Medication Representation of medication related
information and pharmacy D-MIM
Modeling and HL7 RIM and Modeling Methodology
Methodology
Relevance to Patient Safety
Communication among automated clinical
laboratory systems, instruments, devices
including point of care and home testing
devices, and clinical information systems
will improve the timeliness and accuracy
of the information exchange.
Medical-legal agreements such as consent
forms are necessary to ensure that the
patient is aware of the potential risks and
benefits associated with treatment
Medication-related events are most
frequently occurring adverse events across
care settings. Messages that support
accurate and appropriate prescribing,
dispensing, and administering of
medications are critical to patient safety.
Reference Information Model essential for
semantic interoperability and a necessary
component of NHII (Committee on Data
Standards for Patient Safety, 2003a).
HL7 TC/SIG Activities
Orders/ Orders communication (e.g.,
Observations medications, laboratory, nursing)
and observation reporting (e.g.,
laboratory, symptom assessments,
surgery reports) processing
requirements
Medical Device interfaces
Communication between
implantable device manager and
HIS
Patient Standards related to descriptions of
Administration persons, places, organizations, and
other demographic and
administrative entities
Patient Care Goals
Referrals
Relevance to Patient Safety
Orders communication and observation
reporting form the central core of
communication and information exchange
among members of the healthcare team.
Communication between medical devices
and other information systems will improve
the timeliness and accuracy of the
information exchange.
Communication between implantable device
manager and other information systems will
improve the timeliness and accuracy of the
information exchange.
Accurate identification of individuals is a
prerequisite for patient safety.
Goals are a significant aspect of evidence-
based practice.
Referrals are essential to coordination of
care.
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
including required terminology.
Personnel Professional's identity, his/her rights and
Management obligations, the
special domain and qualifications, and the
relationships to patients.
Regulated Messages, document structures, and
Clinical terminology to support the systems and
Research processes used in the collection, storage,
Information distribution, integration and analysis of
Management regulated clinical research information.
Product labeling
Regulatory reports related to adverse events
(see Individual Case Safety Report, Patient
Safety
Research protocol representation
instances (e.g., drug dosages by weight).
The information exchanged is needed for
the professional's authentication,
authorization, access control and
accountability for data and processes.
Regulated clinical research information is
represented differently by different
agencies. Efforts such as Consolidated
Health Informatics are aimed at
commonalities across agencies.
Accurate product labeling is a prerequisite
for safe product administration and timely
sharing of information about product-
related adverse events.
Individual Case Safety Report provides a
standard representation for adverse event
reporting to various federal agencies.
Standard research protocol representation
will support accuracy and timeliness of
protocol sharing.
HL7 TC/SIG Activities
Scheduling and Messages for the purpose of communicating
Logistics and supporting the various processes related to
the scheduling of appointments for services
and associated resources. Processes include the
functions of requesting, booking, notification,
and modification pertaining to appointments
and resources., sterilization message
Security and HL7 Security Service Framework
Accountability
Standard Guide for Implementing HL7 EDI
Communication Security
Structured Clinical Document Architecture (CDA)
Documents
Vocabulary Identification, organization and maintenance of
coded vocabulary terms used in HL7 messages.
Relevance to Patient Safety
Issues related to scheduling of services and
associated resources have the potential to
delay or prevent necessary treatment and
impede coordination of care.
Security service a required component of
NHII that supports patient safety
(Committee on Data Standards for Patient
Safety, 2003a).
Standard Guide supports implementation
of security service.
CDA will facilitate the extraction of
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).
Computable representations of terms are
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

Individual Case Safety Reporting (ICSR)

Drugs, Vaccines, Devices
Blood Product Deviations
subject matter and vocabulary needs

Healthcare-acquired Infection Reporting

National Patient Safety Agency-UK needs

Patient Safety incident: Any unintended or unexpected incident(s)

that could have or did lead to harm for one or more persons
receiving healthcare services

Patient Safety: The multidisciplinary approaches by which an

organisation reduces the risk and occurrence of harm to patients
as a result of their healthcare
 Top level incident categories

Access, admission, transfer, Implementation and ongoing

discharge monitoring/review
Clinical assessment (incl. diagnosis, Infrastructure (including staffing,
tests, assessments) facilities, environment)
Consent, communication, Medical device, equipment
confidentiality
Medication
Disruptive, aggressive behaviour
Patient abuse
Documentation (including records, Patient accident
identification)
Self harming behaviour
Infection control
Treatment, procedure
Other
 Proposed relationship with WHOs Patient Safety
Alliance

Recognise need for international representation

PSA recognises that

no single player has the expertise, funding or research and

delivery capabilities to tackle the full range of patient safety issues
on a worldwide scale. An international alliance would provide a
mechanism to decrease duplication of investment and activities
and benefit by economies of scale.

PSSIG should work with the PSA to:

Raise awareness of the groups activities
Disseminate key deliverables
Seek guidance
Ensure that needs of the international community are catered for
Australian Participation

Working with HL7 Australia

Multiple needs in different settings
Different groups have long-term experience, and have
developed methodologies and tools

Japanese Participation
Current thoughts on the Domain

Entry point

Patient Safety Domain

S I T O
M V D p n r T
e a e e f a H
d c v c e n E
i c i i c s R
c i c a t f
a n e l i u
t e s t o s
i s i n i
o e s o
n s n
s
Vision, Mission, Principles,
Charter, Decision Making
Process, Prioritization,
Interaction with other TCs
and SIGs, etc.
Interactions with other TCs and SIGs

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

Finding Natural Home for different topics

Coordination of efforts where overlaps are identified
Friday Q1 meeting with PC
Harmonization of domains and work products
Ensuring that the HL7 standard as a whole reflects the
patient safety perspectives