Patient Safety in Obstetrics and Gynecology: Improving Outcomes, Reducing Risks, An Issue of Obstetrics and Gynecology Clinics (The Clinics: Internal Medicine)

162 Pages·2008·3.34 MB·English

by  Paul Gluck

ObstetGynecolClinNAm
35(2008)xiii–xiv
Foreword
WilliamF.Rayburn,MD,MBA
ConsultingEditor
Thedisciplineofobstetricsandgynecologyhasalongtraditionofleader-
ship in quality assessment and accompanying patient safety. The quest for
patientsafetyisanongoing,continuouslyrefinedprocess,incorporatingin-
formation sharing and collaboration into daily practice. Quality improve-
ment efforts have shifted from a punitive approach to an educational
process to assist all providers.
ThisissueoftheObstetricsandGynecologyClinicsofNorthAmerica,edi-
ted by Paul Gluck, MD, brings together leading advocates for improving
patientsafetyingeneral,andinobstetricsandgynecologyspecifically,toin-
creaseourunderstandingandtosuggestsolutions.Practicalsuggestionsare
offeredtoreduceerrorsintheoffice,duringsurgery,andinlaboranddeliv-
ery. Depending on the setting and type of practice, certain solutions men-
tioned in these articles can be implemented rapidly while others require
incremental change.
Effortstoimprovequalityandsafetyaremorelikelytoachieveconsensus
if changes come from within the departments. These changes include work-
ingcollaboratively in teams, improving communication,and increasing uti-
lization of information technology. As described in this issue, examples
of ways to reduce errors include (1) using electronic medical records and
e-prescribing, (2) working collaboratively in multidisciplinary teams, and
(3)usinghigh-fidelitysimulationsforlearningandforassessingcompetence
andcredentialing.Disclosinganymedicalerror,especiallytoaninjuredpa-
tientortoagrievingrelative,isoneofthemostdifficultbutmostimportant
tasks.
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xiv FOREWORD
Most medical errors should be handled in a nonpunitive environment to
improvereportingandtogainanunderstandingofthebreadthofproblems
inhealthcaresystems.Toimprovepatientsafety,physiciansshoulddisclose
errors and near misses openly and encourage their colleagues to do the
same. Thisopennesswillpromoteandincrease error reporting,identify po-
tentiallyhiddenproblems,andmotivateproviderstofindandresolvesystem
problems.
Involving patients in decisions about their own medical care is good for
their health, not only because it is a protection against treatment that pa-
tients might consider harmful, but because it contributes positively to their
well-being. Patients are to be encouraged to ask questions about medical
procedures, the medications they are taking, and any other aspect of their
care. Patient education materials developed by the America College of Ob-
stetricians and Gynecologists and other organizations are available.
Thisissuedescribesindetailthestepsnecessarytodevelop aprogramto
monitor the quality of care in a typical department of obstetrics and gyne-
cology.Emphasizingcompassion,communication,andpatient-focusedcare
will aid in creating a culture of excellence.
Ithanktheauthorsfortheirtimelycontributionstothisimportanttopic
of interest to all of our readers.
William F. Rayburn, MD, MBA
Department of Obstetrics and Gynecology
University of New Mexico School of Medicine
MSC10 5580
1 University of New Mexico
Albuquerque, NM 87131-0001, USA
E-mail address: [email protected]
ObstetGynecolClinNAm
35(2008)xv–xvii
Preface
PaulA.Gluck,MD
GuestEditor
Medicine usedto be simple, ineffective and relativelysafe. Now it is com-
plex, effective andpotentially dangerous.
dCyril Chantler
LewisThomas,inhissemi-autobiographicalbookTheYoungestScience:
NotesofaMedicine-Watcher,reminiscedabouthisfather,aninternistinthe
earlytwentiethcenturywhowouldsitbyhispatient,holdinghishandwhile
nature affected the cure. There was little else he could offer. Now, after
almost100years,wehavecrossedvastfrontiersinmedicine,fromhormones
to the immune system to unlocking the promise of genomics. We have
relegated diseases such as erythroblastosis to the history books and trans-
formedAIDSfromadeathsentencetoachronicillness.Yeteachnewtreat-
ment modality brings with it more complexity and greater risk for medical
error. According to Robert Wachter and Kaveh Shojania, in their book
Internal Bleeding, deaths from medical errors are the collateral damage of
ourwarondisease.Manymorepatientsaredyingnotfromtheirunderlying
illness but from well-intentioned but erroneously applied treatment.
Medical errors can now be counted among the leading causes of death
along with cancer, heart disease, and accidents. We must approach this
epidemic oferrors with education, research,and system changes. This issue
of the Obstetrics and Gynecology Clinics of North America brings together
some of the leading advocates for improving patient safety in general and
in obstetrics and gynecology specifically to increase our understanding
and suggest solutions.
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doi:10.1016/j.ogc.2007.12.009 obgyn.theclinics.com
xvi PREFACE
Lucian Leape was one of the first to raise the alarm about the unaccept-
ably high number of patients who are harmed and even die as a result of
medicalerrors.Not surprisingly,hiswarnings were met withdenialby pro-
viders who questioned everything from the methodology to the significance
of his findings. Now, some 16 years later, most physicians believe that
Leape’s original numbers regarding deaths from medical error are underes-
timates. From his unique perspective, Leape looks back on his 20-year
journey working to improve patient safety.
I next discuss error theory as applied to medicine. Understanding the
cause of disease will lead to better diagnosis and treatment. Through an
understanding of why mistakes happen, we can better prevent errors and
help mitigate the harmful effects of those that still occur.
Translatingtheoryintopractice,PaulStumpf,pastchairoftheAmerican
College of Obstetricians and Gynecologists’ Patient Safety and Quality
ImprovementCommittee,providespracticalsuggestionsthatcanberapidly
implemented to reduce errors in the office, in surgery, and in labor and
delivery.
Medicationerrorsaccountforthelargestnumberoferrorsinhealthcare.
Over the years, the group at Brigham and Women’s Hospital has led the
way in determining the scope of this problem. Carol Keohane and David
Bates put this problem into perspective and outline strategies to improve
medication safety in the hospital and ambulatory settings.
When patients suffer harm or die as a result of medical errors, it is our
ethicalandmoralobligationtoprovideatruthfulandcompassionateexpla-
nation as well as an apology if appropriate. Yet disclosing medical error to
aninjuredpatientoragrievingrelativeisoneofthemostdifficulttasksany
ofuswillface.PatriceWeiss,whotrainedattheBayerInstituteforHealth-
care Communication, outlines a practical approach for disclosing adverse
outcomes.
Comparedwithotherindustries,healthcarespendsthesmallestpercent-
age for information technology. Yet electronic health records and
e-prescriptionsholdthepromiseofimprovingsafety,increasingefficiencies,
and reducing costs. Caitlin Cusack lays out the promises as well as the pit-
falls for those moving toward implementation of a robust, fully integrated
electronic health record.
Working collaboratively in multidisciplinary teams has significantly
transformed other high-risk industries. Teamwork has the potential to im-
proveefficiency,reducerisks,andincreasepatientandprovidersatisfaction.
Peter Nielsen and Susan Mann discuss team training principles and the
impact they have on reducing adverse outcomes in labor and delivery.
Withimprovedtechnology,high-fidelitysimulationsarebecomingavalu-
able tool for perfecting technical skills and practicing team behaviors in
medical emergencies. Roxanne Gardner and Dan Raemer, leaders in this
field from the Center for Medical Simulation, outline the remarkable
technical advances in the field. Simulation is being incorporated into
PREFACE xvii
training programs and postgraduate education, not only for learning but
also for assessment of competence and credentialing.
Looking beyond the individual practitioner and at the systems of care,
Joseph Gambone and Robert Reiter discuss the critical elements needed
for a successful, sustainable departmental quality improvement program.
Efforts to improve quality and safety will be much more likely to achieve
consensus if changes come from within the department as opposed to
regulations from outside.
Finally,AbrahamLichtmakerreviewstheworkoftheVoluntaryReview
for Quality of Care Program of the American College of Obstetricians and
Gynecologists. This unique consultative service has reviewed 236 obstetrics
and gynecology departments from a diverse cohort of institutions. The
problemsencounteredinthesehospitalsweresurprisinglysimilar.Suggested
solutions may be helpful to other institutions encountering similar
problems.
Progress is achieved both through incremental steps and giant strides.
Thecontributorstothisissuehopethatreaderswillbeabletorapidlyadopt
some incremental changes to improve patient safety in any setting and in
any type of practice. Beyond that, we hope that readers will see the value
of addressing some of the long-term, transformational changes in health
care systems that will result in quantum improvements in patient safety.
Examples of these changes include collaborative teamwork, improved
communication, and increased use of health information technology. Only
through these and other changes can we substantially reduce the number
of patients harmed by well-intentioned providers who struggle every day
to care for patients in a flawed medical system.
Paul A. Gluck, MD
Associate Clinical Professor
University of Miami Miller School of Medicine
8950 North Kendall Drive, Suite 507
Miami, FL 33176, USA
E-mail address: [email protected]
ObstetGynecolClinNAm
35(2008)1–10
Scope of Problem and History
of Patient Safety
Lucian L. Leape, MD
HarvardSchoolofPublicHealth,677HuntingtonAvenue,Boston,MA02115,USA
Scope
How much of a problem is patient safety? The unsettling fact is that no
one knows. What we ‘‘know’’ depends on how we gather information, on
howandwhodeterminesthatapatienthasbeeninjuredbyanerrororother
lapse in care. However, because we have traditionally punished people for
making errors, caregivers, not surprisingly, often do not report errors they
can hide. Add to that the fact that many errors are not recognized, even
when they cause harm, and it is clear that obtaining a reliable estimate of
errors is difficult.
According to the National Academy of Sciences’ Institute of Medicine
(IOM),thedefinitionofsafetyis‘‘freedomfromaccidentalinjury,’’notfree-
dom from errors [1]. (Our safest industry, commercial aviation, still has
many errors, but few crashes.) Thus, many experts believe that it is more
feasible and productive to focus on the number of injuries that occur, not
the errors. However, even counting injuries proves to be a challenge. For
example, the estimates of the annual number of preventable adverse events
(AE)sufferedbyhospitalizedpatientsintheUnitedStatesvarybyanorder
of magnitude of 1.3 million [2] to 15 million [3].
Some of this discrepancy is definitional. That is, the Medical Practice
Study (MPS) measuredonly ‘‘disabling’’ injuries: those prolonginghospital
stay or resulting in a disability at discharge (including death). The Institute
for Healthcare Improvement (IHI) attempts to identify all injuries suffered
byhospitalizedpatients,including,forexample,nauseaandvomitingresult-
ing from a medication dosage error.
Anevengreatercauseofdiscrepanciesisthemethodusedtocollectdata
onadverseevents.Traditionally,wehavereliedonvoluntaryreporting.But
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2 LEAPE
studieshaveshownthat the vast majorityof events are notreported [4].As
a result, modern studies usually rely on collecting data from record review
(itselffraughtwitherrors),analysisoflaboratorydata,andinvestigationor
observation. Costs of data collection increase accordingly. But no method
yet devised has been shown to identify all adverse events, much less errors.
There is no ‘‘gold standard’’ to follow in this area of investigation.
Moderncounting began withthe MPS findings from record reviewsthat
3.7% of hospitalized patients suffered AEs, two thirds of which were pre-
ventableand14%ofwhichwerefatal[5,6].Whenextrapolatedtothecoun-
try as a whole by the IOM in 1999, the resulting estimate of 98,000
preventable deaths was greeted with skepticism by many physicians and
spawned a burst of rebuttals. The MPS study was subsequently replicated
insevenothercountrieswithcomparablehealthcaretrainingandstandards
(Australia, New Zealand, the United Kingdom, Denmark, France, the
Netherlands, and Canada) [7,8], with injury rates ranging from 7.5% to
15%.Theinternationalconsensusnowisthatapproximately10%ofhospi-
talized patients experience a treatment-caused injury and at least half of
these are preventable.
When specific types of AE are investigated, the figures are stunning.
Adverse drug events (ADE) have been studied the most extensively. An
early study of ADE found that 6.5% of hospitalized patients had an injury
related to use of a medication, of which 28% were preventable [9]. In nurs-
ing homes, the ADE rate is 227 per 1,000 resident-years [10]. A study of
ADEinofficepracticerevealedarateof25%[11].Basedontheseandother
studies, the IOM estimates that 1.5 million patients in the United States
experience an adverse drug event each year [12].
The problem of hospital-acquired infections has recently received
increased public scrutiny, particularly the incidence of antibiotic-resistant
infections.TheCentersforDiseaseControlandPrevention(CDC)estimates
that each year 1.7 million hospitalized patients acquire an infection, of
which 126,000 are caused by resistant staphylococci, and 99,000 are fatal
[13]. Most are preventable with current best practices and, indeed, there
have been some stunning successes in prevention of central line infections
and ventilator-associated pneumonia.
In obstetrics, Mann and colleagues [14,15] found that team training in
laboranddeliverysubstantiallyreducedthecomplicationssalienttodelivery.
AbouthalfoftheAEsinpatientsintheMPSwereassociatedwithasurgical
operation [6]. Subsequent studies suggest as many as 3.5 million patients
suffera postoperative AE.
Recently, the IHI reported the results of the use of its ‘‘trigger tool’’ to
identify AE. These are indicators (such as a high international normalized
ratio or the use of naloxone) that suggest a mishap. The record is then
reviewedtodetermineifaninjuryhasinfactoccurred.Datafromanumber
of hospitals using the trigger tool show that 40% of patients, or 15 million
Americans per year, have an adverse event while hospitalized [16].
SCOPEOFPROBLEMANDHISTORYOFPATIENTSAFETY 3
History
The beginnings
Itisprobablyfairtosaythatthemodernpatientsafetymovementbegan
withthepublicationoftheresultsoftheHarvardMedicalPracticeStudyin
the New England Journal of Medicine in February, 1991 [5,6]. The study
examined a random sample of medical records of 30,000 patients hospital-
ized inacutecarehospitalsin NewYork Statein 1984. Although theimpe-
tus for the study was the contemporary medical malpractice crisis, the
investigators expanded the focus to obtain a population-based estimate of
the extent of all medical injury, its preventability, and its consequences,
both in human terms and economically.
The MPS found that 3.7% of hospitalized patients suffered an adverse
event,definedasaninjurycausedbymedicaltreatment(incontrasttocom-
plicationsofdisease),whicheitherdelayeddischargeorcausedameasurable
disability. Of these injuries, 14% were fatal.
In more than two-thirds (69%) of adverse events identified in the MPS,
errors or other failures in treatment were identified that led physicians
who reviewed the records to conclude they were preventable, and nearly
half of those (1% of patients) were judged to meet the definition of negli-
gence:failuretomeetthestandardofcare.Aboutone-halfofadverseevents
occurred in surgical patients, and nearly one in five were related to use or
misuse of medications.
Interviews with patients or next of kin 5 years after injury identified the
long-term consequences of these injuries, from which the economic burden
of medical injury was calculated. It was estimated that the total cost of
adverse events suffered by patients in New York was approximately $4 bil-
lion (in 1989 dollars), of which one-fourth was out-of-pocket expense [17].
Fewerthan2%ofpatientswithpresumednegligentinjurieseverfiledasuit.
Although the study was published in the New England Journal of
Medicineandranasafront-pagearticleintheNewYorkTimes,thefindings
were essentially ignored. The state medical society rejoiced in the finding
that negligence accounted for injuries to ‘‘only’’ 1% of patients. Based on
the findings of the study, the investigators made a single recommendation:
that the State of New York implement a no-fault compensation plan for
medicalinjuries.TheHealthCommissioneragreedandproposedlegislation,
but his subsequent serious illness and a fiscal downturn led to it being
ignored.
Early days
The finding that a substantial majority of adverse events was caused by
errors ledtoasearch formethods toreduce errors and,thus,tothediscov-
ery of lessons from cognitive psychology and human factors engineering.
These insights, the most important of which is that errors can be reduced
4 LEAPE
by redesigning systems, led to dramatic reductions in accidents and injuries
inotherhazardousindustries,suchasaviationandnuclearpower.Manyof
these concepts seemed applicable in health care as well [18].
1995 was a pivotal year for patient safety. It began with a series of egre-
giouseventsthatputtheissueofmedicalerrorsonthefrontpagesofpapers
across the country: amputation of the wrong leg, removal of the wrong
breast,operationonthewrongsideofthebrain.Perhapsthemostgripping
was the death of a health reporter in Boston from a fourfold overdose of
chemotherapy. The public wanted to know: What was medicine going to
do about it?
By summer, the first studies appeared, applying the systems analysis
approach in health care [9,19]. The American Medical Association
(AMA), prodded by its legal counsel, Martin Hatlie, decided to establish
a foundation of stakeholders to promote patient safety, while the new
head of the Veteran’s Health Administration (VA), Ken Kizer, decided to
make safety a system priority.
In 1996, the AMA and the Joint Commission for the Accreditation of
Healthcare Organizations (JCAHO) joined the American Association for
theAdvancementofScienceandtheAnnenbergFoundationtohostthefirst
multidisciplinary conference on medical errors at the Annenberg Center in
California. At this meeting, the AMA announced the formation of the
National Patient Safety Foundation, and the JCAHO announced that it
was making its reporting system nonpunitive. But the memorable events
of the conference were Diane Vaughan’s recounting of events leading to
the Challenger disaster and Martin Memorial Hospital’s presentation of
full and open disclosure of a fatal medication error in a child.
Over the next several years, more evidence appeared on the efficacy of
systemschanges,largelyinthemedicationsystem:useofcomputerizedphy-
sician order entry [20], use of bar coding to prevent medication administra-
tion errors [21], having a pharmacist participate in rounds in the intensive
careunit[22],andtheroleofsimulation[23,24].Studiesexaminedthecosts
of adverse drug events [25,26] and the effect of sleep deprivation [27,28].
Replication of the Medical Practice Study in Australia produced a rude
shock: an adverse event rate of 13%, three times that found in the MPS
[7]. Meanwhile, the IHI began to train multidisciplinary hospital teams
how to change systems and implement new safe practices in a series of
collaborations [29,30].
The IOM report
Still, patient safety was not a major concern for most hospitals or doc-
tors, nor for the public, until November of 1999 when the IOM released
its report, ‘‘To Err is Human’’ [1]. Extrapolating from the MPS study of
a decade earlier, and a later study in Colorado and Utah, the IOM pro-
claimed that medical errors caused 44,000 to 98,000 of preventable deaths