overview of progress in patient safety
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ATIENT SAFETY SERIES
verview of progress in patient safety
eter J. Pronovost, MD, PhD; Christine G. Holzmueller, BLA; Christopher S. Ennen, MD; Harold E. Fox, MD, MSch1ontcnt1w21mn5d
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he tipping point for the patientsafety movement occurred in late
999 when the Institute of Medicine re-orted ubiquitous problems with theuality and safety of patient care in thenited States.1 Although their findingsere based on several studies that hadeen done in the previous decade,2-4 thenstitute of Medicine report finallyrabbed the health care community andublic attention. Since then, a flurry ofuality improvement and patient safetyfforts have been made on a local, na-ional, and global scale. Nonetheless,rogress has been slow.5 This sluggishrogress stems from the complexity ofur health care system and culture6 androm an immature science of safety anduality that makes measurement andvaluation of progress difficult.7
Obstetrics and gynecology in thenited States has made some improve-ents in patient outcomes. The fetalortality rate has declined by an average
f 1.4% annually from 1990-2003 but
rom the Departments of Anesthesiologynd Critical Care Medicine, Quality & Safetyesearch Group (Dr Pronovost and Msolzmueller), Surgery (Dr Pronovost),ynecology and Obstetrics, Maternal andetal Medicine (Drs Ennen and Fox), Schoolf Medicine; and the Department of Healtholicy and Management, Bloomberg Schoolf Public Health (Dr Pronovost), Johnsopkins University, Baltimore, MD.
eceived Sept. 20, 2010; revised Oct. 19,010; accepted Nov. 1, 2010.
eprints: Peter J. Pronovost, MD, PhD, Johnsopkins University, Quality & Safety Researchroup, 1909 Thames St., 2nd Floor, Baltimore,D 21231. [email protected].
uthorship and contribution to the article isimited to the 4 authors indicated. There waso outside funding or technical assistance withhe production of this article.
002-9378/$36.002011 Published by Mosby, Inc.
oi: 10.1016/j.ajog.2010.11.001
oSee related editorial, page 1
as leveled off with 6.22 fetal deaths per000 live births in 2004 and 2005.8 Hem-rrhage-related deaths during preg-ancy are also declining; however, ma-
ernal deaths from preexisting medicalonditions (eg, cardiovascular, pulmo-ary, neurologic) are rising.9 Moreover,
he maternal mortality rate in 2006 was3.3 deaths per 100,000 live births,10
hich is far from the Healthy People010 projected goal of �3.3 deaths per00,000 live births.9 Nevertheless, severeorbidity from complications and preg-
ancy-related conditions is reportedly0 times more common than maternaleath.11
Although the field has made progress,he benefits to patients from the publicnvestment in biomedical research fallar short of what is possible. This isargely because health care has grosslynderinvested in the science of healthare delivery. For every dollar the Unitedtates spends finding new genes and newrugs, it spends 2 pennies ensuring thatatients actually receive those thera-ies.12,13 The delivery of health care isiewed too often solely as an art ratherhan also as a science. Most academic
edical centers abound with basic andlinical researchers; few centers haveimilar experts in the science of healthare delivery (particularly rare are hu-an factors and systems engineers, soci-
In the 11 years since the Institute of Medicinand safety of patient care in the United StatObstetrics and gynecology has made someof health care, progress has been slow. Thecare system and culture and an immaturmeasurement and evaluation of progress dhave been made in obstetrics and gynecoloto adverse outcomes, to develop measuresments. It also offers a framework to help oment. Finally, this article offers ways the Acologists can organize and support future w
Key words: gynecology, obstetrics, patient
logists, psychologists, anthropologists, a
JANUARY 2011 A
nd health services researchers). Patientstill experience preventable harm fromiagnostic errors, procedure-relatedistakes, teamwork failures, and our
ailure to deliver recommended thera-ies. For example, studies estimate thatnly 80% of patients who are at risk forreterm birth receive the recommendedourse of antenatal corticosteroids.14
The field of obstetrics and gynecologys cognizant of the need to improve qual-ty and patient safety and is engaged ac-ively in improvement efforts. Themerican College of Obstetricians andynecologists (ACOG) published aanual a decade ago about quality im-
rovement in women’s health care.15 Ef-orts have been made to identify prevent-ble obstetric errors and the causes ofortality and morbidity and to offer in-
icators of patient safety. Some studiesuggest that between 28% and 50% of
aternal deaths are preventable.16-18
he science of how to measure prevent-ble harm, however, is still immaturend should be a research priority. Be-ause much maternal morbidity andeath occurs in patients with preexistingedical problems and because preg-
ancy is preventable and approximatelyne-half of pregnancies are unplanned,aternal and infant morbidity and mor-
ality rates may be reduced with im-roved access to desired contraception
ported ubiquitous problems with the qualityefforts been made to improve health care.rovements; however, similar to other areasjor deterrents are complexities in our healthcience of safety and quality that makescult. This article describes the efforts thato identify causes or factors that contributequality and safety, and to make improve-nize patient safety research and improve-ican Congress of Obstetricians and Gyne-.
ety, quality, quality improvement
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lightly more than one-half of womenho request postpartum tubal ligation
ctually have the procedure performeduring their hospital stay.19
A wide range of causes or factors thatontribute to adverse patient outcomesave been identified. One study foundhat hemorrhage, hypertension, pulmo-ary or amniotic fluid embolisms, infec-
ion, and preexisting chronic conditionsere the leading causes of death amongregnant women between 1991 and997.18 Moreover, the most commonreventable errors described in the studyy Clark et al17 were failure to controlypertensive patient blood pressure, toiagnose and treat pulmonary embolismdequately in women with preeclampsia,nd to monitor vital signs and hemor-hage adequately after cesarean sectionelivery. Many of these errors result
rom teamwork and communicationailures and correspond with the causesf death that were described in the studyy Berg et al.18 Importantly, hemorrhageuring labor and delivery is a majorause of maternal morbidity and death;ulmonary embolism is 1 of the top 3auses of postpartum death amongothers.20
Perinatal death or permanent disabil-ty remains on The Joint Commission’sist of top 10 sentinel event types for008.21 In a 2004 alert, they identified aariety of causes for the 47 perinataleaths or permanent disabilities thatere reported between 1996 and 2003,hich is likely a significant under report-
TABLE 1Complications/emergencies duringto process measurement as indica
Maternal Fetal
Placental abruption Indeterminate oror abnormal feta
...................................................................................................................
Uterine rupture Prolapsed umbil...................................................................................................................
Magnesium sulfate toxicity Uterine tachysys...................................................................................................................
Eclampsia Second-stage fe...................................................................................................................
Amniotic fluid embolism Shoulder dystoc...................................................................................................................
Postpartum hemorrhage Emergent cesare...................................................................................................................
Adapted, with permission, from Simpson.23
Pronovost. Progress in patient safety. Am J Obstet Gyneco
ng.22 Communication problems were t
American Journal of Obstetrics & Gynecology JA
he main causes in 72% of cases, with or-anizational culture (eg, hierarchy/in-imidation, poor teamwork) noted as aarrier to effective communication in5% of cases. Staff competency (47%),rientation and training (40%), inade-uate fetal monitoring (34%), unavail-bility of monitoring equipment orrugs (30%) or prenatal information11%), credentialing/privileging/super-ising issues for physicians and nurseidwives (30%), and staffing (25%)ere other causes that were identified by
he Joint Commission.Providers, government agencies, pro-
essional societies, and regulators haveroposed or established measures or in-icators of quality and safety. Table 1ives a list of maternal and fetal compli-ations or emergencies that occur duringabor and delivery in which process mea-ures could be developed.23 The Agencyor Healthcare Research and Quality alsoas a list of hospital-level patient safety
ndicators with a portion of them appli-able to perinatal and neonatal care (Ta-le 2).24 Finally, the Joint Commissionas transitioned their patient safety goalf recognizing and responding tohanges in a patient’s condition to theevel of a standard in 2010 (PC.02.01.19)or critical access and other hospitals.25
his standard requires hospitals to havewritten protocol/process that describes
he early warning signs of a change oreterioration in a patient’s conditionmade specific to a clinical area), when toeek assistance, and how to provide pa-
bor and delivery amenables of failure to rescue
normal fetal heart rate pattern/indeterminateatus..................................................................................................................
cord..................................................................................................................
..................................................................................................................
ntolerance to pushing..................................................................................................................
..................................................................................................................
birth for nonreassuring fetal status..................................................................................................................
1.
ients and families with a name and con- N
NUARY 2011
act information should they have con-erns about a patient’s condition. Like allelds, obstetrics and gynecology needseasures that are valid and reliable,eaningful to clinicians, and feasible to
ollect. This requires that physicians de-elop skills in measuring quality and leadfforts to develop measures. Too often,linicians believe measures are thrust onhem. When measures are not valid, cli-icians should push back, but theyhould also work to develop better mea-ures, measures that reflect clinical excel-ence and quality of care.
Recently, the ACOG published up-ated patient safety objectives that ob-tetrician-gynecologists should considerhen practicing medicine.25 These in-
lude establishing a culture of patientafety, implementing recommended safe
edication practices, reducing the like-ihood of surgical errors, improvingommunication with health care provid-rs and with patients, partnering withatients to improve safety, and makingafety a priority during clinical practice.lthough appropriate, these objectivesre general and require further research,ocus, and direction to be achieved. Ob-tetrics must develop clinicians who
ake patient safety the focus of theircholarly work.
If all of this seems confusing and atimes disjointed, it is. To help organizeatient safety efforts, we developed a
ramework for patient safety researchnd improvement.26 This framework isased on the idea that different safetyroblems require different solutions.he relevant components include devel-ping performance measures to evaluaterogress, translating evidence into prac-ice, assessing and improving safety cul-ure, identifying and mitigating hazards,rganizing for patient safety, and reduc-
ng diagnostic errors.It is important to evaluate progress in
atient safety using measures that clini-ians believe are valid. Simpson23 has ar-iculated failure to rescue indicators inhich process measures could be devel-ped to measure and evaluate progressTable 1) and has proposed a list of ob-tetric “never events” that included those
easures that have been described by the
lator
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ical.........
tole.........
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ia.........
an.........
ational Quality Forum.27 Failure to res-
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ue is defined as the “failure to prevent alinically important deterioration (eg,eath or permanent disability) from aomplication of an underlying illnesseg, maternal death in an obese patientith hypertensive disorder) or medical
are (eg, magnesium sulfate toxicity in areeclamptic patient).28 “Never events,”s originally established by the Nationaluality Forum, are serious adverse
vents that are largely preventable.29
iven the limited resources for patientafety research, researchers and clini-ians should prioritize and pick indica-ors of greatest importance to clinicians,hereby ensuring that the measures arecientifically sound, feasible, and usable.or too long, health care focused oneasures that were feasible yet often not
alid. If clinicians are to use performanceeasures to improve care, they must be-
ieve that those measures are valid.Equally important to measurement is
ranslating evidence-based therapiesnto clinical practice. When empiric evi-ence suggests that patients should re-eive a specific therapy, clinicians shouldnsure that they actually do need them.oo often, the patient does not. Al-
hough approaches such as evidence-ased medicine, clinical practice guide-
TABLE 2Perinatal- and neonatal-related ag
Indicator Defi
Complications of anesthesia Ane...................................................................................................................
Death in low-mortality diagnosis-related groups
In hcan
...................................................................................................................
Postoperative hemorrhage orhematoma
Poson scan
...................................................................................................................
Selected infections because ofmedical care
Excl
...................................................................................................................
Transfusion reaction Cas...................................................................................................................
Birth trauma: injury to neonate Cas...................................................................................................................
Obstetric trauma..........................................................................................................
Cesarean delivery Cas..........................................................................................................
Vaginal delivery with instrument Cas..........................................................................................................
Vaginal delivery without instrument Cas...................................................................................................................
Adapted, with permission, from Johnson.24
Pronovost. Progress in patient safety. Am J Obstet Gyneco
ines, and total quality management p
ttempt to increase a physician’s use ofhese therapies,30 delivery of care is aeam effort and occurs in unique con-exts and cultures. We developed a con-eptual model for translating evidencento practice that includes (1) summa-izing evidence into checklists, (2) iden-ifying and mitigating local barriers toomply with the checklist, (3) measuringnd providing feed-back, and (4) ensur-ng all patients receive the items on thehecklist by reorganizing work, improv-ng culture, and monitoring perfor-
ance.31 Given the resources that areequired to develop these types of pro-rams, it is likely more efficient and ef-ective for groups of hospitals to collab-rate. Indeed, performance measuresnd checklists can be developed by pro-essional societies or federal agencies; lo-al hospitals can implement the inter-entions by modifying them to fit theirocal context and resources. This modelas used virtually to eliminate central
ine–associated bloodstream infectionshroughout the state of Michigan.32
Safety culture includes individual androup values, perceptions, and behaviorshat drive the commitment and profi-iency of an organization’s health andafety management.32 Therefore, it is im-
y for health care research and quali
on
tic overdose, reaction, or endotracheal tube mis.........................................................................................................................
ital deaths of patients with �0.5% mortality ratepatients.........................................................................................................................
rative hemorrhage, postoperative hematoma, poe day or after principal procedure), or drainage opatients.........................................................................................................................
s immunocompromised or cancer patients
.........................................................................................................................
f transfusion reaction.........................................................................................................................
f birth trauma; excludes some preterm infants a.........................................................................................................................
.........................................................................................................................
f obstetric trauma (fourth-degree lacerations, ot.........................................................................................................................
f obstetric trauma (fourth-degree lacerations, ot.........................................................................................................................
f obstetric trauma (fourth-degree lacerations, ot.........................................................................................................................
1.
ortant to assess safety culture and to m
JANUARY 2011 A
mprove on it. Research demonstrateshat culture is localized by unit or clinicalrea rather than by hospital.33,34 Culturearies 6-fold more among units within aospital than among hospitals. Further,hese and other studies determined vari-tions by clinical discipline. Among la-or and delivery caregivers in 44 hospi-als, the specific role on the team affectedhe perceptions of teamwork climate.35
n this study, heeding nurse input, easen asking questions, conflict resolution,nd physician-nurse collaboration af-ected nurses’ poor and divergent per-eptions of teamwork, compared withhysicians. Accordingly, interventionshat work to improve teamwork, collab-ration, and communication should im-rove the safety culture. Simulation issed increasingly in the obstetric com-unity for team training.36 A systematic
eview of studies of multidisciplinaryeam training simulation to reduce ad-erse events during acute obstetric emer-encies found only 1 study that reportedn improvement of a clinical outcome,nd 7 studies that demonstrated im-rovements in knowledge, skills, com-unication, and team performance.37
his review and another of simulation asbest practice for training and assess-
patient safety indicators
cement..................................................................................................................
xcludes trauma, immunocompromised, and
..................................................................................................................
perative control for hemorrhage (must occurematoma; excludes immunocompromised or
..................................................................................................................
..................................................................................................................
..................................................................................................................
infants with osteogenic imperfecta..................................................................................................................
..................................................................................................................
obstetric lacerations)..................................................................................................................
obstetric lacerations) with instrument..................................................................................................................
obstetric lacerations) without instrument..................................................................................................................
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ent concluded that it is beneficial for
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ehearsing and improving performance,ut limited data supported improved pa-ient outcomes.38
For many safety hazards, health careacks empiric evidence regarding how tomprove outcomes. Unlike efforts toranslate evidence into practice (inhich we monitor performance as a
ate), these types of safety hazards gener-lly are not amenable to monitoringates, and clinicians must monitor thextent to which risks have been reduced.afety hazards must be identified anditigated or prevented to improve
afety. Hazards can be identified throughetrospective analysis of events or pro-pective examinations in real-time orimulated settings. Once hazards and theactors that cause them are identified,his information can be used to changeare processes and work systems. Ourrevious discussion clearly demon-trated that obstetrics and gynecologyas actively sought to identify hazardsnd their causes for several decades. Col-ectively, the list of hazards and causalactors is long and seemingly convoluteds new studies are done. For example, aeview of malpractice suits adds vaginalirth after cesarean delivery amongroader predictors of adverse out-omes.20 We are not implying that ob-tetric and gynecologic practitionerserform poorly. The practice of healthare (and often the medical condition ofatients) has become very complex.onsider obesity as an example. There isgreater prevalence of obesity among
regnant women with which comes aigher risk of adverse perinatal out-omes.39 Bariatric surgery is one of theewest answers to obesity, but side-ef-
ects from this procedure (eg, anemia)an cause complications during preg-ancy (eg, preterm delivery or low infantirthweight).40 Still, in most hospitals,rrors and adverse outcomes are investi-ated by people with limited time andraining in error investigation. Unfortu-ately, it is still rare to have someoneho is trained in human factors and sys-
ems engineers participate on an investi-ation team.One of the most widely spread and
obust interventions to improve safety
ulture and learn from mistakes is the dAmerican Journal of Obstetrics & Gynecology JA
omprehensive Unit-based Safety Pro-ram.41 This program establishes theoncept that culture is local and thateams in units need to be empowered todentify and reduce risks. Each unitorms an interdisciplinary Comprehen-ive Unit-based Safety Program teamnd interactively works through the fol-owing 5 components:. Train all staff members in the science
of safety; describe that safety is aproperty of a system in which safe sys-tems standardize work, implementindependent checks, learn whenthings go wrong, and include the di-verse and independent input of allteam members when making deci-sions.
. Ask all staff members how the nextpatient will be harmed on their unitand how it could be prevented.
. Partner a senior hospital leader withthe unit to help them prioritize safetyhazards and to provide resources toimplement interventions and to holdunit staff members accountable forlearning from defects.
. Use a structured tool to investigateand learn from defects.
. Implement tools to improve team-work and communication.
Research is also needed to determineow best to organize for patient safety.o improve quality of care, health careroviders must treat populations of pa-ients, but most units are still organizedo provide care to individual patients.atient care could be organized intonit-based teams. Although culture var-
es widely among units within hospitals,ursing and other staff members are or-anized at the unit level, and unit-leveleams have improved quality. The pa-ient care area could be viewed as the mi-rosystem for quality improvement ef-orts. Such unit-level approaches createocal ownership for the improvement ofatient safety.It is understandable that many hospi-
al-based quality improvement effortsmerged from the intensive care unit,mergency department, or hospitalistervice because there is unit-level physi-ian-nurse comanagement and a clearlyefined care team. Indeed, hospitals with
edicated intensive care unit physician pNUARY 2011
taffing have a 30% reduction in deaths,ompared with those hospitals withoutuch staffing. Most other areas of theospital lack a unit-level physician man-ger or a specified care team. For exam-le, labor and delivery units are orga-ized largely with physicians who care
or individual patients rather than a la-orist who manages the unit. As a result,
n most hospital units, multiple physi-ians care for their own patients, whichimits the ability for doctors and nurseso make rounds together, to developtandardized protocols, to improveuality, and to improve teamwork andommunication. The presence of a la-orist in the hospital at all times mayave benefits, such as decreasing physi-ian burnout, improving access to trial ofabor after previous cesarean delivery,upporting standardized practice anduality measurement, and improvingursing satisfaction; these are the bene-ts that may improve patient safety.42
ith these benefits, however, comeafety risks that must be overcome thatnclude increased patient handoffs andotential loss of skills by the nonla-orist.43 The impact of having dedicatedhysician unit leaders and/or laboristsn patient outcomes and satisfactionhould be studied. Finally, although di-gnostic errors are a significant problemn obstetrics, for instance, in the identi-cation of the fetus that is at risk for hy-oxic brain injury, the science of how toeasure and reduce diagnostic errors is
mmature.Obstetrics and gynecology has made
rogress, given that the field of patientafety research remains in virgin terri-ory. Progressing to even better patientutcomes will require advancement ofhe science; use of the framework that isescribed briefly in this article can help.he signs are hopeful that obstetricsnd gynecology can make significantrogress; this department is leading theeld in team training. A growing groupf academic physicians are making pa-ient safety their focus, obtaining formalegrees in public health, and pursuingrant funding. Academic promotionommittees increasingly are recognizingork that results in measurable im-
rovements in patient safety. Commu-
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ity physicians are becoming engagedore actively; in many places, the hospi-
al is providing financial support to im-rove patient safety. Finally, professionalocieties increasingly are focusing theirttention on patient safety.
By working interdependently ratherhan independently, by being coopera-ive rather than competitive, by focusingn science and robust measurement, wean make significant progress in patientafety. Imagine if the obstetrics and gy-ecology community agreed to partner
o focus on one of the many causes ofreventable harm. We have seen theower of such an approach in reducingentral line–associated bloodstream in-ections in the intensive care unit.32,44
ollaborative efforts have shown successn obstetrics and gynecology as well. Forxample, a statewide initiative in Ohiouccessfully reduced the number ofcheduled preterm births that lacked a
edical indication.45 The ACOG is mak-ng efforts to reduce barriers to a trial ofabor after a previous cesarean deliveryn an effort to decrease the morbidityhat is associated with repeat cesareanelivery.46 What area will obstetrics andynecology select next?The ACOG could take the lead and or-
anize future efforts. First, they couldork with patient safety researchers in
heir field to package programs that in-lude valid measures that are meaningfulo clinicians and important to patients,mprovement interventions (eg, check-ists), and strategies to remove barriers inhe implementation of these interven-ions. Second, learn from common mis-akes. Third, support current team train-ng efforts. And fourth, work withccreditation bodies to require compe-encies in patient safety, especially team-ork competency to supplement techni-
al competencies. f
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