Transcript Patient Safety Issues

Patient Safety Issues
Where Does the Lab Professional
Fit In?
Mary Ann McLane, PhD, CLS(NCA)
Region II Director
Objectives
At the conclusion of this seminar, the participant
will be able to:
 Describe the components of the Institute of
Medicine’s 1999 “To Err Is Human” document
which relate to the clinical lab.
 Compare and contrast the programs offered
by JCAHO’s Speak Up” initiative.
 List at least 5 examples of errors involving
patient safety and pre-analytical/postanalytical error.
Unsafe acts are like
mosquitoes…
You can try to swat them one at a time, but
there will always be others to take their
place. The only effective remedy is to
drain the swamps in which they breed. In
the case of errors and violations, the
"swamps" are equipment designs that
promote operator error, bad
communications, high workloads,
budgetary and commercial pressures…
Unsafe acts are like
mosquitoes…
…procedures that necessitate their violation in
order to get the job done, inadequate
organization, missing barriers, and safeguards
. . . the list is potentially long but all of these
latent factors are, in theory, detectable and
correctable before a mishap occurs.
James Reason,
To Err Is Human
Americans harmed by
medical error

Two studies of large samples of hospital admissions
 New York using 1984 data
 Colorado and Utah using 1992 data
 adverse event (injuries caused by medical
management) were 2.9 and 3.7 percent
respectively
 adverse events attributable to errors (i.e.,
preventable adverse events) was 58 percent in
New York, and 53 percent in Colorado and Utah

extrapolated to the over 33.6 million
admissions to U.S. hospitals in 1997

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44,000 to 98,000 Americans die in
hospitals each year as a result of medical
errors
exceed the number attributable to the 8thleading cause of death
exceed the deaths attributable to motor
vehicle accidents (43,458), breast cancer
(42,297) or AIDS (16,516)
Total national costs

lost income, lost household production,
disability, health care costs


$37.6 billion to $50 billion for adverse
events
$17 billion to $29 billion for preventable
adverse events

slightly higher than the direct and indirect costs
of caring for people with HIV and AIDS.
Lives lost


more than 6,000 Americans die from
workplace injuries every year
in 1993 medication errors are estimated
to have accounted for about 7,000
deaths


one out of 131 outpatient deaths
one out of 854 inpatient deaths

Medication-related errors occur
frequently in hospitals; not all result in
actual harm, but those that do are
costly.

2% admissions at two large hospitals:
preventable adverse drug event


average increased hospital costs of $4,700 per
admission
about $2.8 million annually for a 700-bed
teaching hospital.

Medication-related errors

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not all result in actual harm
those that do are costly
Preventable: $2 billion for the nation as a
whole.
Not just hospital patients

In 1998: ~2.5 billion prescriptions were
dispensed by U.S. pharmacies at a cost
of about $92 billion.

errors in



prescribing medications
dispensing by pharmacists
unintentional nonadherence on the part of the
patient.
Definitions

Adverse event


injury caused by medical management
rather than the underlying condition of the
patient.
Preventable adverse event

adverse event attributable to error
Definitions

Error


the failure of a planned action to be
completed as intended (i.e., error of
execution)
the use of a wrong plan to achieve an aim
(i.e., error of planning)
Definitions

Negligent adverse event

the care provided failed to meet the
standard of care reasonably expected of an
average physician qualified to take care of
the patient
Discussion point: expected of an “average physician” only?
Why focus on medicationrelated error?


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One of the most common types of error
Substantial numbers of individuals are
affected
Accounts for a sizable increase in health
care costs
Why focus on medicationrelated error?

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Easy to identify an adequate sample of
patients who experience adverse drug events
The drug prescribing process provides good
documentation of medical decisions, residing
in automated, easily accessible databases


Case of Comfort and Caring, Inc
Deaths attributable to medication errors are
recorded on death certificates.
Important note!

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“There are probably other areas of
health care delivery that have been
studied to a lesser degree but may offer
equal or greater opportunity for
improvement in safety.”
That is us!!
What the literature shows
1.
2.
3.
4.
How frequently do errors occur?
What factors contribute to errors?
What are the costs of errors?
Are public perceptions of safety in health
care consistent with the evidence?
Harvard Medical
Practice Study

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>30,000 randomly selected discharges
51 randomly selected hospitals in New
York State in 1984

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Adverse events, manifest by prolonged
hospitalization or disability at the time of
discharge or both = 3.7%
Preventable adverse events = 58%
Negligence = 27.6%
Harvard Medical
Practice Study

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13.6% resulted in death
2.6% caused permanently disabling
injuries
Type of adverse event
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drug complications = 19%
wound infections = 14%
technical complications = 13%
First instinct?

Blame someone!
However…

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due most often to the
convergence of multiple
contributing factors
blaming an individual does
not change these factors
and the same error is likely
to recur

Case of Charles Thompson, deathrow inmate from TX
What would work better?

Preventing errors and improving safety for
patients requires a systems approach
 to modify the conditions that contribute to
errors
 which recognizes people working in health
care are among the most educated and
dedicated workforce in any industry
What would work better?

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The problem is not bad people
The problem is that the system needs to
be made safer.
Hindsight bias
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things that were not seen or
understood at the time of the accident
seem obvious in retrospect

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misleads a reviewer into simplifying the
causes of an accident
highlighting a single element as the cause
overlooking multiple contributing factors
Hindsight bias

things that were not seen or
understood at the time of the accident
seem obvious in retrospect

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information about an accident is spread
over many participants
no one may have complete information
easy to arrive at a simple solution or to
blame an individual, but difficult to
determine what really went wrong.
More definitions

Slips
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action conducted is not what was intended
observable
Mistakes
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the planned action is wrong
More definitions

Slips
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Mistakes

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physician chooses an appropriate medication,
writes 10 mg when the intention was to write 1
mg
selecting the wrong drug because the diagnosis is
wrong
Important not to equate slip with "minor."
Patients can die from slips as well as
mistakes.
Lab definitions?

Slips
(action conducted is not what was intended)
physician chooses an appropriate medication, writes
10 mg when the intention was to write 1
mgaaaaaaaaaaaaaaaaaaaaaaaaaaaa

Mistakes
(the planned action is wrong)
Safety = absence of errors?

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More!
Multiple dimensions

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an outlook: health care is complex and risky and
solutions are found in the broader systems
context;
a set of processes: identify, evaluate, and
minimize hazards and continuously improve
an outcome: manifested by fewer medical errors
and minimized risk or hazard
Safety definition

Freedom from accidental injury
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from the patient's perspective, the primary
safety goal is to prevent accidental injuries
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Safe environment = low risk of accidents

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reduce defects in the process or departures from the
way things should have been done
establish operational systems and processes that
increase the reliability of patient care.
Active vs. latent error

Active errors
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occur at the level of the frontline operator
their effects are felt almost immediately
Latent errors

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removed from the direct control of the
operator
poor design, incorrect installation, faulty
maintenance, bad management decisions,
and poorly structured organizations
Active vs. latent error

Active errors


the pilot crashed the plane
Latent errors

a previously undiscovered design
malfunction caused the plane to roll
unexpectedly in a way the pilot could not
control and the plane crashed
Active vs. latent error

Latent error

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greatest threat to safety in a complex
system
often unrecognized
have the capacity to result in multiple
types of active errors.
Challenger accident traced contributing
events back nine years
Three Mile Island accident, latent errors
were traced back two years
Active vs. latent error

Latent error

difficult for the people working in the
system to notice

errors may be hidden
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in the design of routine processes in computer
programs
in the structure or management of the organization
people become accustomed to design defects
and learn to work around them, so they are
often not recognized
Active vs. latent error

Latent error

"normalization of deviance"

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small changes in behavior became the norm
additional deviations became acceptable
the potential for errors is created

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signals are overlooked or misinterpreted
signals accumulate without being noticed
Active vs. latent lab error
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Active errors

Latent errors
First instinct?


focus on the active errors by punishing
individuals (e.g., firing or suing them)
retraining or other responses aimed at
preventing recurrence of the active
error

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punitive response may be appropriate in
some cases (e.g., deliberate malfeasance)
it is not an effective way to prevent
recurrence
First instinct?
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Large system failures
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latent failures coming together in
unexpected ways
appear to be unique in retrospect
Same mix of factors is unlikely to occur
again

efforts to prevent specific active errors are
not likely to make the system any safer
Focus on active errors

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lets the latent failures remain in the
system
their accumulation actually makes the
system more prone to future failure
Focus on latent errors

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Discovering and fixing latent failures,
and decreasing their duration, are likely
to have a greater effect on building
safer systems than efforts to minimize
active errors at the point at which they
occur
likely to have a greater effect on
building safer systems
High reliability theory

accidents can be prevented through
good organizational design and
management

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an organizational commitment to safety
high levels of redundancy in personnel and
safety measures
strong organizational culture for continuous
learning and willingness to change
Correct performance and error

"two sides of the same coin”
Complexity and tight-coupling

Systems that are more complex and
tightly coupled are more prone to
accidents and have to be made more
reliable
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complex and tightly coupled systems can
"spring nasty surprises.“
Guess what type of system healthcare
is????!!!
Two cases of success
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Aviation
Occupational health
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growing awareness of safety concerns and
the need to improve performance
comprehensive strategies
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creation of a national focal point for leadership
development of a knowledge base
dissemination of information throughout the
industry
Two cases of success
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Aviation
Occupational health
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designated government agency with
regulatory responsibility for safety
carefully constructed research agenda
substantial resources devoted to these
initiatives
Third case of success?
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Healthcare

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no cohesive effort to improve safety in
health care
resources devoted to enhancing and
disseminating the knowledge base are
wholly inadequate
“health care is not likely to make significant
safety improvements without a more
comprehensive, coordinated approach.“
Center for Patient Safety
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provide leadership for safety
improvements throughout the industry
establish goals and track progress in
achieving results
expand the knowledge base for
improving safety in health care
provide visibility to safety
concerns
Role of professionals
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Become active leaders in encouraging and
demanding improvements in patient safety.
Setting standards, convening and
communicating with members about safety
Incorporating attention to patient safety into
training programs
Collaborating across disciplines
Contribute to creating a culture of safety. As
patient advocates, health care professionals
owe their patients nothing less.
Center for Patient Safety
should…
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4. Define feasible prototype systems
(best practices) and tools for safety in
key processes, including both clinical
and managerial support systems for…

management of diagnostic tests, screening,
and information…
Improve Access to Accurate,
Timely Information

Information about the patient,
medications, and other therapies should
be available at the point of patient care,
whether they are routinely or rarely
used. Examples of ways to make such
information available are the following
Improve Access to Accurate,
Timely Information
• Have a pharmacist available on nursing units
and on rounds.
(why just a pharmacist? Commercial minute for the
professional DLM doctorate…)
• Use computerized lab data that alert clinicians
to abnormal lab values.
• Place lab reports and medication records at
the patient's bedside.
• Place protocols in the patient's chart.
Improve Access to Accurate,
Timely Information
• Color-code wristbands to alert of allergies.
• Track errors and near misses and report them
regularly.
• Accelerate laboratory turn around time.
…also noted the importance of involving the
patient in their own care…commercial about
the ASCLS consumer webpage
Joint Commission on Accreditation of
Healthcare Organizations

Speak Up: Help Prevent Errors In Your Care
Brochures and Poster
Speak Up Poster
Hospitals (English)
Ambulatory Care
Hospitals (Spanish)
Behavioral Health Care
Laboratory Services
Health Care Networks
Long Term Care
Home Care
http://www.jcaho.org/general+public/gp+speak+up/speak+up_bro.htm
630-792-5800, option 5
So what’s happened since 1999?
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2001
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Congress: $50E6 for safety research
IOM: The Quality Chasm
2004
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Congress named Agency for Healthcare
Research and Quality
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Center for Quality Improvement and Safety
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Education, training, dissemination, setting standards
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Health and Human Services
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Agency for Healthcare Research and Quality
Quality & Patient Safety
Health Information Technology
Electronic health records — innovation — privacy — international standards — data sources —
clinical vocabulary
National Quality Measures Clearinghouse™
Evaluate health care quality — online database — process — outcome — access — patient
experience
CAHPS®—Consumer Assessment of Health Plans
Consumer feedback — survey and report tools — fact sheet — impact
Measuring Healthcare Quality
Studies and projects — standardized methods — performance measures
Medical Errors & Patient Safety
Scope of problem — reducing errors — research program — patient tips
WebM&M: Morbidity & Mortality Rounds
Patient safety forum— learning modules — analysis of medical errors
Quality Indicators
Hospital quality measures — prevention — inpatient — patient safety
Quality Information & Improvement
Employer experience — consumer information — case studies — glossary
TalkingQuality
Communicating with consumers — health care report cards
2005 JAMA (Lucian Leape, Donald Berwick)

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Computerized
prescribing
Including
pharmacists on
rounds
Standardizing
medication practices

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Errors 80%
Preventable adverse
events down 78%
Adverse events
down 60%
Am J Clin Pathol
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Volume 120, 18-26, 2003
Classifying laboratory incident reports to
identify problems that jeopardize patient
safety
129 incidents

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95% potential adverse events
73% preventable

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71% preanalytical, 18% analytical, , 11% postanalytical
30% involved cognitive error (incorrect choices caused
by insufficient knowledge)
73% involved noncognitive error (lapses in expected
automatic behavior)
ADVANCE for MLP
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11/7/05
Quashing errors
Streamlining… the lab professionals getting
involved in the training of nurses…
Cited Clin Chem 1997 paper (Plebani et al)

46% lab errors = preanalytical phase
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68.2% of these = specimen collection
Note…we usually haven’t a clue if it’s been drawn
correctly unless it’s in the wrong tube…
Comment on the Clin Chem paper
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1998, Volume 44: 1066-67, Witte et al.
Analyzed 219,353 clin chem results and
found 98 errors
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447 ppm
Anesthesia errors = 2.5 ppm
Aviation errors = 0.18 ppm
We have a ways to go!!
And then there are the blood glucose meters…

11/9/05

Glucose readings done using stix having glucose
dehydrogenase pyrroloquinolinequinone
(GDH-PQQ) as the method
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Falsely increases glucose levels in patients receiving
parenteral products containing maltose, galactose, dxylose
Peritoneal dialysis
Immune globulin
Our turn!