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BSTETRICS

mpact of a comprehensive patient safetytrategy on obstetric adverse events

hristian M. Pettker, MD; Stephen F. Thung, MD; Errol R. Norwitz, MD, PhD; Catalin S. Buhimschi, MD;heryl A. Raab, RNC; Joshua A. Copel, MD; Edward Kuczynski, MA; Charles J. Lockwood, MD; Edmund F. Funai, MD

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BJECTIVE: We implemented a comprehensive strategy to track andeduce adverse events.

TUDY DESIGN: We incrementally introduced multiple patient safety inter-entions from September 2004 through November 2006 at a university-basedbstetrics service. This initiative included outside expert review, protocol stan-ardization, the creation of a patient safety nurse position and patient safetyommittee, and training in team skills and fetal heart monitoring interpretation.e prospectively tracked 10 obstetrics-specific outcome. The Adverse Out-

ome Index, an expression of the number of deliveries with at least 1 of the 10

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see Table of Contents

92.e1 American Journal of Obstetrics & Gynecology MAY 2009

ESULTS: Our interventions significantly reduced the Adverse Out-ome Index (linear regression, r2 � 0.50; P � .01) (overall mean,.50%). Concurrent with these improvements, we saw clinically signif-

cant improvements in safety climate as measured by validated safetyttitude surveys.

ONCLUSION: A systematic strategy to decrease obstetric adversevents can have a significant impact on patient safety.

ey words: crew resource management, medical errors, obstetric
dverse outcomes per total deliveries, was analyzed for trend. adverse outcomes, patient safety
ite this article as: Pettker CM, Thung SF, Norwitz ER, et al. Impact of a comprehensive patient safety strategy on obstetric adverse events. Am J Obstet Gynecol

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n September 1999, the Institute ofMedicine (Washington, DC) assessed

he prevalence and impact of medical er-ors in the United States, estimating thatstaggering 44,000-98,000 patients die

rom the Department of Obstetrics,ynecology, and Reproductive Science, Yaleniversity School of Medicine (Drs Pettker,hung, Norwitz, Buhimschi, Copel,ockwood, and Funai and Mr Kuczynski),nd Yale–New Haven Hospital (Ms Raab),ew Haven, CT.

resented at the 28th Annual Meeting of theociety for Maternal–Fetal Medicine, Dallas,X, Jan. 28-Feb. 2, 2008.

eceived Sept. 27, 2008; revised Nov. 14,008; accepted Jan. 19, 2009.

orrespondence: Christian M. Pettker, MD,epartment of Obstetrics, Gynecology, andeproductive Sciences, Yale University Schoolf Medicine, 333 Cedar St., PO Box 208063,ew Haven, CT [email protected].

CIC Vermont, Inc (New York, NY) providedartial financial support for this project as auality assurance activity.

002-9378/free2009 Mosby, Inc. All rights reserved.

oi: 10.1016/j.ajog.2009.01.022

For Editors’ Commentary,

ach year as a result of medical errors.1

oncluding that a majority of medicalrrors are caused by correctable faults,his report was a “call to arms” to deliverare more safely. Since then, improve-ents in safety have been documented in

ardiology,2 critical care,3 and anesthe-ia,4 although there is a relative paucityf literature regarding monitoring andreventing obstetric adverse events. This

s notable given that childbirth accountsor 4 million hospitalizations each year,anking second only to cardiovascularisease, and obstetrics is considered to be

n a liability crisis.5 The individual im-act of an obstetric adverse outcome isonsiderable: 2 patients are often injuredmother and neonate) and neonatal in-ult may result in significant long-termonsequences for families, including theffort and cost of lifelong care. In obstet-ics, good outcomes are expected whiledverse outcomes are often considerednavoidable because trends and causesay be difficult to discern without a for-al tracking program.With the hypothesis that a multifaceted

pproach to enhance the overall safety cli-ate would reduce the rate of adverse out-

with our hospital c

Yale–New Haven Hospital [YNHH],ew Haven, CT) and our malpractice car-

ier (MCIC Vermont Inc, New York, NY)Appendix A) to assess and improve ourafety climate. The goal of this programas to improve patient safety, decrease pa-

ient injury, and decrease liability losseshrough a program that identified and ini-iated specific risk-reduction clinical prac-ices and created a comprehensive culturef safety.

ATERIALS AND METHODSNHH is a tertiary-level academic center

erving a diverse urban and suburban pop-lation and is the predominant referralenter within a 50-mile radius. Our serviceverages approximately 5500 obstetric ad-issions per year, of which 4650 are for

elivery. The mean age of the women de-ivering at YNHH is 29.5 years (SD � 6.2)nd our obstetric population is 53% white,9% African American, 19% Hispanic,nd 6% Asian. Community providers careor approximately two-thirds of all pa-ients; the remainder are the responsibilityf the full-time faculty of Yale Universitychool of Medicine, New Haven, CT. Ded-cated obstetric anesthesiologists are avail-ble 24 hours a day and our nursery is des-gnated as a level 3C newborn intensive
are unit (ICU).
mailto:[email protected]

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www.AJOG.org Obstetrics Research

ntroduction of a patientafety programhis program was initiated as a qualityssessment and improvement activitynd consisted of an initial independentssessment of the service, followed by aeries of interventions.

utside expert reviewe began with a review of our obstetric

ervices by 2 independent consultants (aaternal-fetal medicine physician and a

urse specialist/leader), both experts inerinatal risk assessment and manage-ent and unaffiliated with Yale Univer-

ity or Yale-New Haven Hospital.6 Theireview consisted of a 3-day visit (Decem-er 2002) to assess organizational risknd patient safety issues. They inter-iewed staff from all professional catego-ies (physicians, nursing, administra-ion) and used a triangulation method toesolve differences in perspectives, re-orting only those findings repeated in at

east 2 of 3 domains.7,8 They also re-iewed hospital policies and protocolsnd compared them with national stan-ards. The review and recommenda-ions—focused on principles of patientafety, evidence-based practice, and con-istency with the standards of profes-ional and governing bodies—providedn outline with specific observations andecommendations for improvement.eneral weaknesses were found in: (1) a

ack of institutional guidelines (eg, forisoprostol inductions and oxytocin ad-inistration); (2) ineffective communi-

ation practices; (3) poor knowledge ofhain of command; and (4) the absencef a quality assurance mechanism.

rotocols and guidelinesn response to this review, we developedseries of protocols and guidelines de-

ineating practice standards. These pro-ocols were directed at the organizationf patient care (eg, admission criteria toifferent units and appropriate disposi-ion of high-risk cases) and practicesonsidered at greatest risk for misman-gement and highest yield for correctioneg, induction criteria and administra-ion of oxytocin, prostaglandin, and

agnesium sulfate).9-11 These protocols
nd guidelines aimed to codify and stan- f
ardize existing practices (eg, clarify theppropriate dosing of oxytocin). Somerotocols were in place before the con-ultant review; formal revision and im-lementation of these began in the firstuarter of 2004. Further protocols andolicies—37 in total (Appendix B)—ave been developed by our patientafety committee (see below) since thatime.

bstetric safety nurseo assist in data collection and facilitatelanned interventions, we created theosition of patient safety nurse in June004. This position has been described inetail previously.12 This nurse’s main re-ponsibility was to provide a formal

ethod of evaluating clinical care andutcomes for our obstetrics services. To

dentify cases complicated by adverseutcomes and system weaknesses, theurse led our anonymous event report-

ng system and on a daily basis reviewedriage, labor, and neonatal logs; met withharge nurses; and attended residentorning report. This nurse’s methods of

ase ascertainment were consistenthroughout the period of this project.his nurse then initiated investigations

nto adverse and sentinel events throughoot-cause analysis, presenting a qualityssurance document for review by theatient safety committee. Beginning ineptember 2004, data were collectedrospectively— on an occurrence ba-is—for an adverse event database ofrespecified outcomes measures (mater-al death, maternal ICU admission, ma-

ernal return to operating department,n-hospital fetal demise �24 weeks, term-minute Apgar score � 7, umbilicalord pH � 7.0, postpartum hemorrhageesulting in hysterectomy/transfusion/terine artery ligation/uterine artery em-olization, shoulder dystocia, uterineupture or dehiscence, fetal traumaticirth injury, or unexpected term admis-ion to newborn ICU). Assessments wereeported to the patient safety committee,ocal hospital leaders, and MCIC Ver-

ont, Inc obstetric leadership. In addi-ion, this nurse initiated and directed ourrograms in team training and electronic

etal monitoring (EFM) certification. p

MAY 2009 Americ

nonymous event reportinge activated a computerized tool for

nonymous event reporting (Peminicnc, Princeton, NJ), allowing any mem-er of the hospital staff to anonymouslyeport medication errors, device-relatedvents, falls, or other events that in thepinion of the staff member may haveaused harm to a patient or visitor. Ouratient safety nurse directed its applica-ion specifically to reporting obstetricvents in July 2004 and continually edu-ated staff on its use.

he obstetric hospitalist—ale On-Call Attendinghe role of the Yale On-Call Attending

YOCA) and the description of YOCAuties were initiated in July 2003 (ex-anded August 2005) to provide a con-istent system of inpatient coverage andesident supervision. Before YOCA,ommunity physicians provided sub-tantial resident coverage, including su-ervision of the care of resident clinic pa-ients. However, these supervisoryesponsibilities were not clearly delin-ated and could vary by provider. Ini-ially, the YOCA was a type of obstetricospitalist (or laborist) covering all in-atients within the resident and univer-ity practices. An expansion of this roleccurred in August 2005, so that theOCA has responsibility for the qualityf care of the entire obstetric service byroviding services to patients within theniversity practices and emergencyackup and consultation for all commu-ity physicians. In-house on-call attend-

ng services are provided 24 hours a day,days a week by the members of our ma-

ernal-fetal medicine section.

bstetric patient safety committeehis committee was formed in the fall of005 to define and track adverse events.

ith the assistance of the patient safetyurse, specific events were reviewed on aase-by-case basis. Based on these re-iews, the committee addressed needsor protocols and policies. Examples ofnterventions included a shoulder dysto-ia documentation form, relabeling ofagnesium and oxytocin intravenous

uids, and a standardized form for labor
rogress documentation.
an Journal of Obstetrics & Gynecology 492.e2

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4

afety attitudes survey/questionnairee implemented the Safety Attitudesuestionnaire (SAQ), a tool adapted

rom the aviation field and used for thessessment of health care employee per-eption of teamwork and safety. An SAQpecific to obstetrics has been developednd validated by Sexton et al.13,14 Thisnonymous survey helps detect per-eived systemic weaknesses and differ-nces of opinion over time or betweenmployee groups (eg, staff, nursing, phy-icians) that result from being trained inontrasting styles. The survey consists ofseries of statements to which the re-

pondent is able to answer with agree-ent or disagreement, using a 5-point

ikert scale. Differences of � 10%, overime or between groups, are consideredlinically significant; overall scoreshowing 80% agreement that the team-ork climate is favorable are considered

he target for change. The questionnaireas distributed to all medical staff and

mployees involved in obstetric care ini-ially in April through May 2004 and re-eated in May 2006 and September 2007o assess the progress of the patient safetynitiative.

eam trainingur initial safety review highlightedeaknesses in the coordination and

ommunication of the various membersf the obstetric teams (eg, nurses, obste-ricians, anesthesiologists, neonatolo-ists, and administration and ancillaryervices). This is a common finding inealth care: physicians, midwives,urses, and staff train in isolated silos,ith differing languages and contrastingerspectives, yet are expected to work ineams.1 We initiated a team training pro-ram based on crew resource manage-ent programs initiated and tested by

he airline and defense industries in July005.15 Similar interventions haveelped improve teamwork—althoughot necessarily outcomes—in medicinend obstetrics.16-19 Led by our patientafety nurse, these 4-hour seminars in-luded videos, lectures, and role playing,nd always integrated a mix of individu-ls within the obstetric team. Attendeesere familiarized with the concept of the

hared mental model for communica- i

92.e3 American Journal of Obstetrics & Gynecolo

ion: an organized way for team mem-ers to conceptualize how a team worksnd to predict and understand how theiream members will behave to improveverall team performance.20,21 Otherpecific concepts and techniques coveredncluded structured communication/de-riefing techniques (situation, back-round, assessment, recommendation),22

ommunication key words (“concerned,”uncomfortable,” “scared”),23 the 2-chal-enge rule (a quick conflict resolutionechnique where a team member mayuestion an action 2 times and, if a suf-cient answer is not provided, may halt

hat action),24 the chain of command,nd elements of an effective hand off ofare.25 Completion of the seminars was aondition for employment and/or clini-al privileges. The target group of 289eople completed team training at thend of October 2006; this representedhe entire complement of physicians andurses as well as a majority of the ancil-

ary staff.

FM certificationo standardize EFM interpretation, ouratient safety nurse initiated an institu-ional education program that includedissemination and review of Nationalnstitute of Child Health and Humanevelopment (NICHD) guidelines,26 re-

iew of tracings, allocation of studyuides,27,28 and voluntary review ses-ions. This training culminated in anxamination offered by National Certifi-ation Corp (http://www.nccnet.org;hicago, IL), a nonprofit group that of-

ers training and testing of fetal monitor-ng standards based on the 1997 NICHDriteria. All medical staff and employeesesponsible for fetal monitoring inter-retation (resident and attending obste-ricians, midwives, and labor room andntepartum nurses) were obligated toake this examination within 1 year ofmployment and pass within 18 months.he first series of examinations were of-

ered in January through February 2006,nd the target group of 211 individualsompleted testing at the end of Novem-er 2006.During the study period there were no

ignificant hospital-based patient safety
nitiatives that included the obstetrics s
gy MAY 2009

ervice. Data collection was performedor surveillance purposes and was incor-orated into a research protocol as a sec-ndary effort. A waiver of consent wasbtained from the Human Investiga-ions Committee at Yale Universitychool of Medicine, which, after review,esignated this a quality improvementctivity and not human subjects re-earch. This project was performed inonjunction with our liability insurancearrier, MCIC Vermont, Inc, which pro-ided financial support for our patientafety nurse. MCIC Vermont, Inc is aisk retention group, which providesedical professional and general liability

nsurance coverage to its academicedical center shareholders, their vari-

us affiliated entities, employees, andhysicians.

valuation of the patientafety programhe effectiveness of these initiatives wasssessed through the comparison of in-ividual and composite adverse eventsver time. These events were compiledn a monthly basis from September 2004hrough August 2007, when an initialnalysis on the data was performed andubmitted for presentation in a prelimi-ary report. We determined a 3-year du-ation for this work was appropriate torovide adequate time for the trainingnd testing initiatives and time for devel-pment and maturing of the culture ofafety. Cases were collected as describedbove (see “Obstetric safety nurse” sec-ion); after case identification, the pa-ient safety nurse (C.A.R.) reviewed the

edical chart, created a summary narra-ive that was reviewed by the principalnvestigator (E.F.F.), and then presentedhe finalized findings to the safety com-

ittee. On this review, cases were classi-ed only according to their worstutcome.For the purposes of this article, cases

nderwent a second review for valida-ion and coding by a second physicianC.M.P.). During this audit the originalutcomes of interest listed above (seeObstetric safety nurse” section) wereodified to correspond to those of other

ublished reports (Table), as a consen-
us of obstetric adverse events (Adverse
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TABLEAdverse OutcomeIndex indicators27

Indicator..............................................................................................................

Blood transfusion..............................................................................................................

Maternal death..............................................................................................................

Maternal ICU admission..............................................................................................................

Maternal return to OR or labor and delivery..............................................................................................................

Uterine rupture..............................................................................................................

Third- or fourth-degree laceration..............................................................................................................

Apgar score � 7 at 5 min..............................................................................................................

Fetal traumatic birth injury..............................................................................................................

Intrapartum or neonatal death � 2500 g..............................................................................................................

Unexpected admission to neonatal ICU� 2500 g and for � 24 h...........................................................................................................

ICU, intensive care unit; OR, operating room.Pettker. Impact of a comprehensive patient safetystrategy on obstetric adverse events. Am J ObstetGynecol 2009.

ively through review of our birth logshat record the types of lacerations forach delivery. This review also accountedor all applicable outcome categories forach patient; 1 patient could have multi-le adverse events and all of these wereecorded.

Compliance to the various initiativesas not officially tracked, although theatient safety nurse performed routinehart audits and addressed issues ofompliance directly with the involvednits and caregivers.The main outcome of interest was the

uarterly composite adverse event rate,xpressed as the number of deliveriesmothers) with associated adverse eventser total deliveries for that 3-month pe-iod. A multiple gestation was consid-red as a single delivery. The individualvents comprising the composite eventotal are listed in the Table and are theasis of the obstetric AOI proposed byann et al.29 Fetal traumatic birth injury

ncludes any injury deemed directly re-ated to the obstetric care or birth eventeg, head trauma, fracture, neurologic

r2 = 0.50P = .01

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MAY 2009 Americ

njury such as Erb palsy, hemorrhage, oraceration). Unexpected admissions tour neonatal care unit and perinataleaths include only cases where a preex-

sting antepartum maternal (eg, Rh iso-mmunization) or fetal (eg, prematurityr anomaly) complication independentf the delivery was not present.Beyond the components of the AOI,e also assessed other process variables

aspects of care related to quality, such asesarean delivery and episiotomy rates)nd reviewed each case of shoulder dys-ocia. Finally, we assessed results for ourFM training and changes in workplaceafety perception based on the SAQ dur-ng the study period.

tatistical analysisata were analyzed by pregnancy, withultiple gestations classified as 1 deliv-

ry. Simple linear regression was used tovaluate the significance of the trend inuarterly AOI, cesarean delivery rate,nd episiotomy rate. Student t test (2-ailed) and �2 testing was performedhere appropriate. A P value of � .05as considered significant. All analysisas performed with software (SPSS 16.0;PSS Inc, Chicago, IL).

ESULTStotal of 13,622 deliveries occurred in

he 36-month period from September004 through August 2007, with a meanuarterly delivery number of 1135 (SD

59).The mean quarterly AOI during this

eriod was 2.50% (SD � 0.72%; range,.55-3.75%). When calculated monthly,ean AOI was 2.49% (SD � 0.86%;

ange, 0.75-4.58%). The change in theuarterly AOI during the study time pe-iod is shown in Figure 1; a statisticallyignificant decrease in the AOI was seenuring the study period (r2 � 0.50, P �

011). This trend was still significanthen the AOI was calculated on aonthly basis (r2 � 0.33, P � .001). Theean quarterly AOI for the first half of

he initiative (2.90 � 0.64%) was alsoignificantly different than that for theecond half (2.09 � 0.57%) (Student test, P � .04).

Variations in most individual patient

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ould not be meaningfully assessed be-ause of their rare occurrence rates, al-hough there was no statistically signifi-ant change. For the most commonarker, third- and fourth-degree lacera-

ions (quarterly mean, 18; SD � 4.2),here was no statistically significanthange over time (r2 � 0.11, P � .30). Noutcome of the AOI was seen to increasever time. With respect to major obstet-ic quality measures not included in theOI, our mean cesarean delivery rateas 35.1% (SD � 2.1%) and episiotomy

ate was 10.9% (SD � 1.5%). Of note,he cesarean delivery rate showed a sig-ificant increase over time (r2 � 0.50, P

.01) and the episiotomy rate showed aignificant decrease over time (r2 � 0.50,� .01) (Figure 2). We had a total of 81

pisodes of shoulder dystocia, with a ratef 5.95/1000 deliveries (SD � 2.3); thereas no statistically significant change in

his rate over time.During 2006, our overall pass rate for

FM certification was 97% (213/219).ix persons failed the first time, with 1ailing a second time, requiring transferff the antepartum service. All providersaking the examination in 2007 (n � 38)assed on the first attempt. No physi-ians or midwives failed the examinationn the first attempt.From 2004 through 2007, the percent-

ge of respondents reporting a “goodeamwork climate” and a “good safetylimate,” as assessed by the SAQ, im-roved from 38.5% to 55.4% and 33.3%o 55.4%, respectively. During this sameime period, perceptions among nursesnd physicians of a “good teamwork cli-ate” improved from 16.4% to 88.7%

nd 39.5% to 72.7%, respectively. Thesehanges are considered clinically signifi-ant by those who designed theuestionnaire.11

OMMENThere exist few published models for the

eduction of obstetric adverse outcomes.ne limited example is the Institute ofealthcare Improvement’s Idealized De-

ign of Perinatal Care, which presents 2erinatal care bundles proposed as poli-ies for the induction and augmentation
f labor.30 Moreover, there is no stan- a

ard for assessing the rates of adversevents in perinatal care. Some triggersmeant to capture events for further re-iew) and outcome measures have beenroposed, although none have beendopted universally.29,31 We report aovel way to describe a diverse array ofatient safety interventions, with evi-ence of success at reducing adversevents, using an adverse outcomes as-essment tool (the AOI). Our initialomposite adverse event rate was com-arable with, if not lower than, previouseports.31

We believe a combination of evidence-ased standardization, enhancements inommunication, and a dedicated patientafety nurse are the integral componentsf this effort. We are unaware of anyodels that would easily identify which,

f any, individual interventions had thereatest impact and which were of noalue at all. The project may have beennhanced by a more programmatic andtepwise introduction of our interven-ions, although this would have in-reased the time required for implemen-ation. Our objective was not to conduct

randomized trial–although we agreehat may be the gold standard— butather, timely quality improvement. Inact, as recently suggested by Berwick,32

he type of study design we describe may

FIGURE 2Cesarean delivery and episiotomy r

ettker. Impact of a comprehensive patient safety strategy on

rguably be the most feasible, if not most t

gy MAY 2009

ppropriate, for studying the “complex,nstable, [and] nonlinear social change”haracterized by quality improvementnitiatives. A clinical trial would requireuspending all other quality improve-

ent activities for our service during aubstantial period of time; this wouldot be practical in today’s setting oftringent government oversight and highatient expectations. A rigorous applica-ion of methods of ascertainment and ahoughtful approach to meaningful in-erventions to influence behavior andulture can nonetheless yield importantnd valid results. The reporting of suchethods and results is critical for com-

rehensive nationwide improvement inatient safety.Because this is a descriptive article, itay be inherently prone to bias. Our

ase- and event-identification methodsay not have identified all adverse out-

omes. However, these were collectedrospectively on an occurrence basis andhe methodology was unchanged overime. Importantly, our results were notffected by the biases inherent in reliancen coding or discharge diagnosis data. Inddition, we were unable to control foronfounding factors in the practice envi-onment such as changes in staff or workours, or improvements in other educa-ional or skills sets, that were not a part of

tric adverse events. Am J Obstet Gynecol 2009.

ate

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his project. Although we endeavored to

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ive a comprehensive accounting of allubstantive changes to our service dur-ng the reporting period, we may haveailed to include some other importanthange that affected safety. Further-ore, we did not track compliance to the

uidelines and protocols, although weelieve adherence improved over time ase created a culture that promoted their

ntegration. It is additionally worthoting that we did not implement any

nitiatives related to the cesarean deliveryr episiotomy rate, which did showhanges.

Our work adopted the AOI as the mea-ure for tracking adverse events and val-dates its use and adoption for othertudies.16,33 We also tracked other out-omes and safety measures not includedn the AOI such as shoulder dystocia, ce-arean delivery, and episiotomy rates.he incidence of shoulder dystocia atur institution falls at the lower range ofational estimates (0.6-1.5%)34 and weere unable to demonstrate any signifi-

ant change over time. Generally, casesf shoulder dystocia are not consideredredictable. The value of monitoringhese events may lie as a process measure,n assessing the quality of documenta-ion and the conduct of appropriatemergency responses.

We noted a significant increase in ce-arean delivery rate during the period ofur initiative, potentially confoundinghe statistically significant decrease indverse events. This study design cannotetermine whether or how this changeffected the overall change in AOI. Ourate of increase (1.7 percentage pointsnnually) mirrors the national trend inesarean rate (1.5 percentage point an-ual increase from 2000-2005).35 Sur-eys have indicated that physicians feelressured to increase their cesarean ratesnd lower their vaginal birth after cesar-an rates in response to mounting pro-essional liability insurance costs36; thiss also supported by vital statistics analy-is demonstrating an increase in primaryesarean rate associated with increasingiability premiums in Illinois.37 Further,he national decline in vaginal birth afteresarean has impacted overall cesareanates.35 Although there are few studies,
e are not aware of any published work a
emonstrating that obstetric care in thenited States is appreciably safer since

he cesarean rate began its latest increasen 1997. As a result, we believe that ourwn increase in cesarean rate is more

ikely related to the forces affecting na-ional trends and did not materially con-ribute to our results. We cannot con-lude whether this should be consideredn improvement or a step backward.

We also note a significant decrease inpisiotomy rate during the 3 years of thetudy. Overall, our episiotomy rate was0.9%, which is low compared with theational rate (in 2005) of 19% and is

ikely influenced by a significant intra-artum midwifery presence at Yale.5

one of our initiatives, including ourrotocols and guidelines, was meant topecifically address the rate or practice ofpisiotomy. We speculate that our epi-iotomy rate decreased as our institutionecame more familiar with the accumu-

ating evidence regarding the appropri-te use of and indications for episiotomy.iven that episiotomy is a major risk fac-

or for the most frequent outcome of theOI, and is frequently overused, we be-

ieve it is a valuable indicator for track-ng. Despite the decrease in episiotomyate, there was no change in our third-nd fourth-degree laceration rate, andhus we do not feel the change in episiot-my rate significantly impacted ourverall AOI improvement.We acknowledge that our comprehen-

ive approach may not be applicable inll settings. YNHH is a large academicenter with sufficient resources to sup-ort many simultaneous interventions,ome of which are relatively costly. Our

alpractice liability carrier supportedhe cost of the outside expert review, ouratient safety nurse, her initial training

n crew resource management trainingducation, the SAQ, and the EFM exam-nation. Initial costs of the program arestimated at $210,000, with ongoingearly costs of $150,000. This investments dwarfed by the average payment$500,000-1,900,000) for just 1 obstetriciability claim.38

Our efforts at performance improve-ent are still nascent, and we acknowl-

dge that our service is still subject to
dverse outcomes. We believe that con- a
MAY 2009 Americ

inued application of these and similartrategies can have a further impact onafety. More work is necessary to estab-ish benchmarks and best practices forbstetric care. This article is one of thearly steps in this process. f

CKNOWLEDGMENTSe thank the nurses, physicians, and staff of

ale–New Haven Hospital Obstetrics Depart-ent and the fellows and attendings of the Sec-

ion of Maternal-Fetal Medicine; without theirontributions, this multidisciplinary effort wouldot have been possible. We would also like tocknowledge MCIC Vermont Inc, its leadership,nd the individual hospitals of MCIC Vermont

nc that contributed with similar patient safetynitiatives at their own institutions.

EFERENCES. Kohn L, Corrigan J, Donaldson M. To err isuman: building a safer health system. Wash-

ngton, DC: National Academy Press; 2000.. Williams SC, Schmaltz SP, Morton DJ, KossG, Loeb JM. Quality of care in US hospitals as

eflected by standardized measures, 2002-004. N Engl J Med 2005;353:255-64.. Berenholtz SM, Pronovost PJ. Monitoringatient safety. Crit Care Clin 2007;23:659-73.. Bion JF, Heffner JE. Challenges in the care ofhe acutely ill. Lancet 2004;363:970-7.. DeFrances C, Cullen K, Kozak L. Nationalospital discharge survey: 2005 annual sum-ary with detailed diagnosis and procedureata; National Center for Health Statistics. Vitalealth Stat 13. 2007;165:1-209.. Simpson KR, Knox GE. Adverse perinatalutcomes: recognizing, understanding andreventing common accidents. AWHONN Life-

ines 2003;7:224-35.. Erzberger C, Prein G. Triangulation: validitynd empirically based hypothesis construction.uality and Quantity 1997;31:141-54.. Farmer T, Robinson K, Elliott SJ, Eyles J. De-eloping and implementing a triangulation pro-ocol for qualitative health research. Qual Healthes 2006;16:377-94.. Cohen WR, Schifrin BS. Medical negligence

awsuits relating to labor and delivery. Clin Peri-atol 2007;34:345-60.0. Simpson KR, Knox GE. Obstetrical acci-ents involving intravenous magnesium sulfate:ecommendations to promote patient safety.CN Am J Matern Child Nurs 2004;29:161-71.1. Grunebaum A. Error reduction and qualityssurance in obstetrics. Clin Perinatol007;34:489-502.2. Will SB, Hennicke KP, Jacobs LS, O’NeillM, Raab CA. The perinatal patient safetyurse: a new role to promote safe care for moth-rs and babies. J Obstet Gynecol Neonatalurs 2006;35:417-23.3. Sexton JB, Helmreich RL, Neilands TB, et
l. The safety attitudes questionnaire: psycho-

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etric properties, benchmarking data, andmerging research. BMC Health Serv Res006;6:44.4. Sexton JB, Holzmueller CG, Pronovost PJ,t al. Variation in caregiver perceptions of team-ork climate in labor and delivery units. J Peri-atol 2006;26:463-70.5. Helmreich RL, Merritt AC, Wilhelm JA. Thevolution of crew resource management train-

ng in commercial aviation. Int J Aviat Psychol999;9:19-32.6. Nielsen PE, Goldman MB, Mann S, et al.ffects of teamwork training on adverse out-omes and process of care in labor and deliv-ry: a randomized controlled trial. Obstet Gy-ecol 2007;109:48-55.7. Grogan EL, Stiles RA, France DJ, et al. The

mpact of aviation-based teamwork training onhe attitudes of health-care professionals. J Amoll Surg 2004;199:843-8.8. Ellis D, Crofts JF, Hunt LP, Read M, Fox R,ames M. Hospital, simulation center, andeamwork training for eclampsia management:

randomized controlled trial. Obstet Gynecol008;111:723-31.9. Crofts JF, Ellis D, Draycott TJ, Winter C,unt LP, Akande VA. Change in knowledge ofidwives and obstetricians following obstetric

mergency training: a randomized controlledrial of local hospital, simulation center andeamwork training. BJOG 2007;114:1534-41.0. Jones PE, Roelofsma PH. The potentialor social contextual and group biases in team
ecision-making: biases, conditions and psy- q

hological mechanisms. Ergonomics 2000;3:1129-52.1. Paris CR, Salas E, Cannon-Bowers JA.eamwork in multi-person systems: a reviewnd analysis. Ergonomics 2000;43:1052-75.2. Haig KM, Sutton S, Whittington J. SBAR: ahared mental model for improving communi-ation between clinicians. Jt Comm J Qual Pa-ient Saf 2006;32:167-75.3. Leonard M, Graham S, Bonacum D. Theuman factor: the critical importance of effec-ive teamwork and communication in providingafe care. Qual Saf Health Care 2004;13Suppl1):i85-90.4. Macready N. Two-challenge rule averts er-ors, improves safety. OR Manager 1999;15:2.5. Alonso A, Baker D, Holtzman A, et al. Re-ucing medical error in the military health sys-em: how can team training help? Hum Re-ource Manage Rev 2006;16:396-415.6. Parer JT. Electronic fetal heart rate monitor-

ng: research guidelines for interpretation; Na-ional Institute of Child Health and Human De-elopment research planning workshop. Am Jbstet Gynecol 1997;177:1385-90.7. Brucker MC, Jones M, Weekly S. EFM caseook. Chicago: Center for Certification Prepa-ation and Review; 1999.8. Brucker MC, Jones M, Weekly S. EFM caseook II. Chicago: Center for Certification Prep-ration and Review; 2002.9. Mann S, Pratt S, Gluck P, et al. Assessing
uality in obstetrical care: development of stan- 2
gy MAY 2009

ardized measures. Jt Comm J Qual Patientaf 2006;32:497-505.0. Cherouny P, Federico F, Haraden C, Leavittullo S, Resar R. Idealized design of perinatalare. IHI innovation series. Cambridge, MA: In-titute for Healthcare Improvement; 2005.1. Forster AJ, Fung I, Caughey S, et al. Ad-erse events detected by clinical surveillance onn obstetric service. Obstet Gynecol 2006;108:073-83.2. Berwick D. The science of improvement.AMA 2008;299:1182-4.3. Nicholson JM, Parry S, Caughey AB, Rosen, Keen A, Macones GA. The impact of thective management of risk in pregnancy at termn birth outcomes: a randomized clinical trial.m J Obstet Gynecol 2008;198:511.e1-15.4. American College of Obstetricians and Gy-ecologists. Shoulder dystocia: ACOG practiceulletin No. 40. Obstet Gynecol 2002;00:1045-50.5. Martin J, Hamilton B, Sutton P, et al. Births:nal data for 2005; national vital statistics re-orts. Vol 56. Hyattsville, MD: National Center

or Health Statistics; 2007.6. Chervenak JL. Overview of professional lia-ility. Clin Perinatol 2007;34:227-32.7. Murthy K, Grobman WA, Lee TA, Holl JL.ssociation between rising professional liability

nsurance premiums and primary cesarean de-ivery rates. Obstet Gynecol 2007;110:1264-9.8. Barbieri RL. Professional liability payments

n obstetrics and gynecology. Obstet Gynecol
006;107:578-81.
PPENDIXppendix: ACIC Vermont, Inc is a risk retention group that provides medical professional and general liability insurance coverage to its

cademic medical center shareholders, their various affiliated entities, employees, and physicians. The shareholders of MCICermont, Inc are New York-Presbyterian Hospital (New York, NY), Cornell University (New York, NY), Columbia University

New York, NY), The University of Rochester/Strong Memorial Hospital (Rochester, NY), The Johns Hopkins Hospital and Theohns Hopkins University (Baltimore, MD), and Yale–New Haven Hospital and Yale University (New Haven, CT). Additionalffiliated hospitals include Bridgeport Hospital (Bridgeport, CT), Greenwich Hospital (Greenwich, CT), Howard County Gen-ral Hospital (Columbia, MD), Highland Hospital (Rochester, NY), and Johns Hopkins Bayview Medical Center (Baltimore,

D).


APPENDIX BYale–New Haven Hospital, New Haven,CT, obstetric protocols and guidelinesAdvanced maternal age and antenatal fetal testing.............................................................................................................................................................................................................................................

Assessment of fetal lung maturity.............................................................................................................................................................................................................................................

Assessment of labor.............................................................................................................................................................................................................................................

Assessment of shoulder dystocia risk.............................................................................................................................................................................................................................................

Care of the obese gravida.............................................................................................................................................................................................................................................

Care of the previable infant.............................................................................................................................................................................................................................................

Cesarean delivery.............................................................................................................................................................................................................................................

Complicated cesarean delivery.............................................................................................................................................................................................................................................

Considerations for assisted reproductive technology pregnancies.............................................................................................................................................................................................................................................

Emergency department care of pregnant patients.............................................................................................................................................................................................................................................

Epidural in labor.............................................................................................................................................................................................................................................

Group B streptococcus prophylaxis.............................................................................................................................................................................................................................................

Induction of labor.............................................................................................................................................................................................................................................

Intermittent auscultation.............................................................................................................................................................................................................................................

Magnesium sulfate for preeclampsia.............................................................................................................................................................................................................................................

Magnesium sulfate for preterm labor.............................................................................................................................................................................................................................................

Management of gestational and pregestational diabetes.............................................................................................................................................................................................................................................

Management of hypertension in pregnancy.............................................................................................................................................................................................................................................

Management of intrapartum HIV and the newborn.............................................................................................................................................................................................................................................

Management of preterm labor.............................................................................................................................................................................................................................................

Management of preterm premature rupture of membranes.............................................................................................................................................................................................................................................

Maternal and fetal monitoring for nonobstetric surgery.............................................................................................................................................................................................................................................

Maternal special care unit “red zone”.............................................................................................................................................................................................................................................

Newborn special care unit circumcision.............................................................................................................................................................................................................................................

Opiate detoxification in pregnancy.............................................................................................................................................................................................................................................

Oxytocin for induction and augmentation of labor.............................................................................................................................................................................................................................................

Photography in labor and birth.............................................................................................................................................................................................................................................

Resident documentation.............................................................................................................................................................................................................................................

Resident and fellow communication.............................................................................................................................................................................................................................................

Time-out after vaginal delivery.............................................................................................................................................................................................................................................

Thromboembolism prophylaxis.............................................................................................................................................................................................................................................

Use of intravenous insulin in labor.............................................................................................................................................................................................................................................

Use of misoprostol for preinduction cervical ripening.............................................................................................................................................................................................................................................

Use of prostaglandin gel for preinduction cervical ripening.............................................................................................................................................................................................................................................

Vaginal birth after cesarean delivery.............................................................................................................................................................................................................................................

Visitation in labor and birth.............................................................................................................................................................................................................................................

Yale On-Call Attending (YOCA)..............................................................................................................................................................................................................................................

HIV, human immunodeficiency virus.Pettker. Impact of a comprehensive patient safety strategy on obstetric adverse events. Am J Obstet Gynecol 2009.

MAY 2009 American Journal of Obstetrics & Gynecology 492.e8

impact of a comprehensive patient safety strategy on obstetric adverse events

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