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Patient Safety Issues


in 1993 medication errors are estimated to have accounted for ... Medication-related errors occur frequently in hospitals; not ... on medication-related ... – PowerPoint PPT presentation

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Title: Patient Safety Issues

Patient Safety Issues
  • Where Does the Lab Professional Fit In?

Mary Ann McLane, PhD, CLS(NCA)
Region II Director

The patient must come first!
  • At the conclusion of this seminar, the
    participant will be able to
  • Describe the components of the Institute of
    Medicines 1999 To Err Is Human document which
    relate to the clinical lab.
  • Compare and contrast the programs offered by
    JCAHOs Speak Up initiative.
  • List at least 5 examples of errors involving
    patient safety and pre-analytical/post-analytical

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

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
  • 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
  • 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
  • 44,000 to 98,000 Americans die in hospitals each
    year as a result of medical errors
  • exceed the number attributable to the 8th-leading
    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
  • about 2.8 million annually for a 700-bed
    teaching hospital.

  • Medication-related errors
  • not all result in actual harm
  • those that do are costly
  • Preventable 2 billion for the nation as a

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

  • Adverse event
  • injury caused by medical management rather than
    the underlying condition of the patient.
  • Preventable adverse event
  • adverse event attributable to error

  • 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)

  • 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 medication-related error?
  • One of the most common types of error
  • Substantial numbers of individuals are affected
  • Accounts for a sizable increase in health care

Why focus on medication-related error?
  • 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!
  • 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. How frequently do errors occur?
  • 2. What factors contribute to errors?
  • 3. What are the costs of errors?
  • 4. Are public perceptions of safety in health
    care consistent with the evidence?

Harvard Medical Practice Study
  • 30,000 randomly selected discharges
  • 51 randomly selected hospitals in New York State
    in 1984
  • 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
  • 13.6 resulted in death
  • 2.6 caused permanently disabling injuries
  • Type of adverse event
  • drug complications 19
  • wound infections 14
  • technical complications 13

First instinct?
  • Blame someone! However…
  • 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
  • which recognizes people working in health care
    are among the most educated and dedicated
    workforce in any industry

What would work better?
  • The problem is not bad people
  • The problem is that the system needs to be made

Hindsight bias
  • things that were not seen or understood at the
    time of the accident seem obvious in retrospect
  • 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
  • information about an accident is spread over many
  • 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
  • action conducted is not what was intended
  • observable
  • Mistakes
  • the planned action is wrong

More definitions
  • Slips
  • physician chooses an appropriate medication,
    writes 10 mg when the intention was to write 1
  • Mistakes
  • selecting the wrong drug because the diagnosis is
  • 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
  • physician chooses an appropriate medication,
    writes 10 mg when the intention was to write 1
  • Mistakes (the planned action is wrong)

Safety absence of errors?
  • More!
  • Multiple dimensions
  • an outlook health care is complex and risky and
    solutions are found in the broader systems
  • 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
  • from the patient's perspective, the primary
    safety goal is to prevent accidental injuries
  • Safe environment low risk of accidents
  • 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
  • occur at the level of the frontline operator
  • their effects are felt almost immediately
  • Latent errors
  • 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
  • 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
  • errors may be hidden
  • in the design of routine processes in computer
  • in the structure or management of the
  • people become accustomed to design defects and
    learn to work around them, so they are often not

Active vs. latent error
  • Latent error
  • "normalization of deviance"
  • small changes in behavior became the norm
  • additional deviations became acceptable
  • the potential for errors is created
  • signals are overlooked or misinterpreted
  • signals accumulate without being noticed

Active vs. latent lab error
  • 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
  • punitive response may be appropriate in some
    cases (e.g., deliberate malfeasance)
  • it is not an effective way to prevent recurrence

First instinct?
  • Large system failures
  • latent failures coming together in unexpected
  • 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
  • lets the latent failures remain in the system
  • their accumulation actually makes the system more
    prone to future failure

Focus on latent errors
  • 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

High reliability theory
  • accidents can be prevented through good
    organizational design and management
  • an organizational commitment to safety
  • high levels of redundancy in personnel and safety
  • 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
  • complex and tightly coupled systems can "spring
    nasty surprises.
  • Guess what type of system healthcare is????!!!

Two cases of success
  • Aviation
  • Occupational health
  • growing awareness of safety concerns and the need
    to improve performance
  • comprehensive strategies
  • creation of a national focal point for
  • development of a knowledge base
  • dissemination of information throughout the

Two cases of success
  • Aviation
  • Occupational health
  • designated government agency with regulatory
    responsibility for safety
  • carefully constructed research agenda
  • substantial resources devoted to these

Third case of success?
  • Healthcare
  • no cohesive effort to improve safety in health
  • 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
  • provide leadership for safety improvements
    throughout the industry
  • establish goals and track progress in achieving
  • expand the knowledge base for improving safety in
    health care
  • provide visibility to safety concerns

Role of professionals
  • 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…
  • 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

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
  • 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
  • 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

630-792-5800, option 5
So whats happened since 1999?
  • 2001
  • Congress 50E6 for safety research
  • IOM The Quality Chasm
  • 2004
  • Congress named Agency for Healthcare Research and
  • Center for Quality Improvement and Safety
  • Education, training, dissemination, setting

  • Health and Human Services
  • 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
  • CAHPSConsumer 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
  • WebMM 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
  • TalkingQuality Communicating with consumers
    health care report cards

2005 JAMA (Lucian Leape, Donald Berwick)
  • Computerized prescribing
  • Including pharmacists on rounds
  • Standardizing medication practices
  • Errors 80
  • Preventable adverse events down 78
  • Adverse events down 60

Am J Clin Pathol
  • Volume 120, 18-26, 2003
  • Classifying laboratory incident reports to
    identify problems that jeopardize patient safety
  • 129 incidents
  • 95 potential adverse events
  • 73 preventable
  • 71 preanalytical, 18 analytical, , 11
  • 30 involved cognitive error (incorrect choices
    caused by insufficient knowledge)
  • 73 involved noncognitive error (lapses in
    expected automatic behavior)

  • 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
  • 68.2 of these specimen collection
  • Note…we usually havent a clue if its been drawn
    correctly unless its in the wrong tube…

Comment on the Clin Chem paper
  • 1998, Volume 44 1066-67, Witte et al.
  • Analyzed 219,353 clin chem results and found 98
  • 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
  • Falsely increases glucose levels in patients
    receiving parenteral products containing maltose,
    galactose, d-xylose
  • Peritoneal dialysis
  • Immune globulin

Our turn!