How to develop an effective obstetric checklist

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    Reviews www.AJOG.orgread and performed by a single indi-vidual. Published oxytocin adminis-tration checklists and those govern-ing the use of anesthetic equipmentare examples of this approach.3,16

    2. Static sequential checklists with verifi-

    tection of premature infants and themanagement of hypertensive crisis inobstetrics (Figure 2).2,20 Checklistscurrently being developed for themanagement of category II fetal heart

    United States Air Force, the Department offense, or the United States Government.

    authors report no conflicts of interest.

    2-9378/$36.00blished by Mosby, Inc.TIENT SAFETY SERIES

    ow to develop an effl M. Bardett Fausett, MD, USAF, MC; Cjor Karin Van Doren, MSN, USAF, NC;

    n recent years, the use of protocolsand checklists to guide care in select,tical situations has become a major fo-s of efforts to improve patient safety inth medical and nonmedical profes-nal endeavors.1-6 We present in thisdy a review of general principles of

    ecklist development, and an examplethe process as implemented in a mod-te sized health care systemtheited States Air Force Medical Corps.

    As early as 1999, the use of checklistss advocated by the Institute of Medi-e as an integral part of a larger effort tovent medical error in the US healthe system.7,8 The Institute of Medicine

    s stated that the standardization of keycesses with the use of checklists andtocols is a key to the prevention of

    ors in health care systems and listeddefinition of standards of practice as a

    mary role professional organizationsuld take in creating a culture of

    ety.7 Many specialties have adoptedse recommendationsFigure 1 de-

    ls the exponential growth of publica-ns indexed by PubMed under safetyecklist in the past 3 decades.

    m the Wilford Hall Medical Center (Colsett, MD), Lackland AFB, TX;iformed Services University of the Healthences (Col Propst, MD), Bethesda, MD;iano Air Base (Major Van Doren),iano, Italy; McGuire Air Force Baseaptain Clark), Lakehurst, NJ.

    ceived Feb. 14, 2011; revised May 19,1; accepted June 2, 2011.

    prints not available from the authors.

    opinions expressed on this document arei: 10.1016/j.ajog.2011.06.003ctive obstetric checknthony Propst, MD, USAF, MC;ptain Benjamin T. Clark, USAF, JAGC

    The use of checklists has been demon-ated to be effective in improving out-mes in a variety of clinical settings, in-ding the prevention of central-lineociated infection, reduction in venti-or associated pneumonia in adultsd children, improved compliance withnical recommendations for the man-ment of acute myocardial infarction

    d stroke, the administration of generalesthesia, diabetes care, and improvedcision making in the diagnosis of brainath.1,2,9-16 General acceptance of theed for checklist-guided care in obstet-s has been slower, and largely limitedthe past few years. Most efforts haveen modeled after the groundbreaking

    grams developed by the Hospitalrporation of America to standardize

    monitoring and administration ofytocin, misoprostol, and magnesiumfate, and the documentation of thenagement of shoulder dystocia.3,4

    ese approaches have been shown tonificantly decrease both adverse out-mes and obstetric litigation in the na-ns largest obstetric health care deliv-system.4

    Checklists adopted by high-reliabilityanizations typically take 1 of the fol-ing 4 forms2,17:

    Checklists to guide critical procedures are bmedical practice. These tools have proved eof medical settings, including obstetrics. In thsuccessful checklist creation and implementatdevelopment in a worldwide, multiinstitutiona

    Key words: checklists, obstetric emergency,(USAF)cation involve a challenge and re-

    SEPTEMBER 2011 Americist

    sponse approach in which one in-dividual reads a list and a secondverifies completion of the requisitetasks. Many aircraft safety check-lists, as well as those used for centralline insertion and the administrationof blood products are examples of thistype of checklist.2,10,18

    Static sequential checklists with verifi-cation and confirmation are typicallyused in larger team settings in con-trast to a team of 2 as above. Suchchecklists are typically read by oneteam member with verification oftask completion by multiple addi-tional team members. Comprehen-sive operative room time outs oftenuse this approach, which may also beapplied to the management of shoul-der dystocia (Figure 1).2,19

    Dynamic checklists generally take theform of flow charts to guide clinicaldecision making. Flow charts lend toa visual display that is particularlyuseful when dichotomous decisionsfollow to different subsequent check-list items. Such checklists have beenused to guide the intubation of pa-tients with difficult airways, and morerecently to assist in clinical decisionmaking regarding the administration

    ming an increasingly important part oftive in improving outcome in a varietyeview, we outline essential principles ofand review our experience with checklistalth care delivery system.

    ient safety, United States Air Forcerate tracings will also likely take thisform.

    an Journal of Obstetrics& Gynecology 165

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    Reviews Patient Safety Series www.AJOG.org

    16Despite the evident importance ofecklists to patient safety and qualityprovement, no universally acceptedcesses exist for the effective develop-nt of medical checklists. Publishedommendations regarding checklist

    velopment tend to suggest the impor-ce of several key areas of checklist de-opment.1,2,4,11,15 This approach mayoutlined as follows:Choose your clinical processes care-fully. Not all medical conditions orprocedures are amenable to manage-ment by checklist. In selecting pro-cesses or procedures for checklistdevelopment we suggest followingclosely the requirements set forth bythe National Quality Forum forquality metric development.21 Thefollowing questions should be criti-cally addressed for each potentialchecklist topic:a. Is the topic of high importance? Is

    it currently associated with signif-icant numbers of poor outcomes?Is there a gap between recom-mended and actual performancein your facility or community?

    b. Is there a scientifically acceptableapproach to effective diagnosisor treatment of the condition inquestion? Although the manage-ment of shoulder dystocia meetsthis criterion for checklist devel-

    FIGURE 1PubMed safety checklist articles

    sett. How to develop an effective obstetric checklist. Am J Obsopment, the management of am-niotic fluid embolism does not.

    6 American Journal of Obstetrics& Gynecology SEc. Does the development and im-plementation of a checklist havethe enthusiastic support of se-nior and respected departmentmedical and administrative lead-ership? Without such support,change will be slow, painful, andineffective.

    d. How intrusive will such a protocolbe in the overall scheme of patientcare? Will its implementation in-terfere with other, more criticalprocesses? Will resource use bematched by expected clinical ben-efit? Does implementation of thechecklist run the risk of devaluingother, more important checklists,and the development among clini-cians of checklist fatigue.

    Processes are ideally developed byrepresentatives of all groups (physi-cians and nurses) expected to imple-ment the checklists. Often, an arbi-trary initial straw man protocolwill serve as an effective templatefor effective and efficient discussionand modification. Efforts of suchworking groups must be supportedby strong clinical and administra-tive leadership.Checklists should be short and unam-biguous. It is better to break a com-plex process into several short, spe-cific checklists rather than deal with a

    ynecol 2011.single cumbersome process.resto

    PTEMBER 2011Leave room for clinical judgment inexceptional cases. With a properly se-lected topic and a properly con-structed checklist, such exceptionswill be rare, and should be routinelysubject to peer review.Checklists should be reviewed fre-quently to assure ongoing compli-ance with new data and changingstandards of care.

    Incorporation of a checklist-basedtocol approach to high-risk obstetric

    nditions seemed especially well suitedpatient safety efforts of the US Airrce Medical Corps for several reasons.First, military aviation was the birth-ce of the checklist-based approachreducing error in critical and com-x situations, and is commonly cited

    the inspiration for such practices ad-ted by other high-reliability organi-ions.1,2,4,18,22,23 This concept wasrn out of the experience of the USmy Air Corp with the B-17 bomber inorld War II. After the crash in 1935 oforiginal prototype during an initialht demonstration, the B-17 was

    emed too much plane for one man to.24 This realization led to the devel-ment of an entirely new approach toing in which most critical portions of

    operation were guided by uniformecklists; pilot autonomy was purpose-ly made subordinate to guidance bych protocols. In the next few years,

    B-17 went from an abject failure toworkhorse of the American war ef-

    t and was a major factor in the even-l Allied victory. Ever since this ex-

    rience, reliance on checklist-basedotocols has been a mainstay of mili-y and later commercial aviation. In-ed, even today, the aviation industryilitary and civilian) remains the

    ototypical high-reliability organiza-n against which all other such en-avors are compared.1,2,4,18,22-25

    Based on this flight experience, check-s and protocols have become vital

    mponents of virtually all complex mil-ry procedures from mechanical main-ance to weapons readiness and evenlitary law. Disciplinary charges of der-ction of duty across a wide variety ofponsibilities are often based on failure2.

    3.follow established protocols or check-

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    www.AJOG.org Patient Safety Series Reviewss.26 This approach has contributednificantly to the current status en-ed by the US military as the preemi-

    nt fighting force in the world.Finally, the realities of military medi-practice include great degrees of mo-

    ity and change. A physician or nursebe practicing in a military treatment

    ility in Alaska today, and in Italy to-rrow. Such conditions are not dis-ilar to those experienced in many

    ilian settings in which physicians,rses, or both may simultaneouslyactice in different hospitals with dif-ent cultures, patient populations, anddical teams. Thus changing teams andctice conditions would seem to makecess standardization vital in both

    litary medicine and in the civilianrld. The recent development of

    ecklists to guide critical process per-mance in US Air Force facilities pro-es a useful example of the above prin-les in practice.

    In 2008, the Air Force Medical Opera-ns Agency was established in San An-io, TX, to assist in the centralization

    personnel and policies across the USr Force Medical Corps. In concert withs process, the Air Force Surgeon Gen-ls Perinatal Nursing, Obstetrics, andnecology, and Maternal-Fetal Medi-e consultants began a united effort tong to the specialty of obstetrics the

    e type of process standardizationt has worked so well for other compo-

    nts of the military. This effort had sev-l aspects:The US Air Force Surgeon GeneralsMaternal-Fetal Medicine Consultantwas appointed to direct and overseestandardization efforts.A patient safety task force was assem-bled, consisting of a representativeobstetrician and/or maternal fetalmedicine specialist and experiencedobstetric nurses from each US AirForce medical facility with an obstet-rics unit. The task force was assistedby a civilian patient safety consultant.In consultation with these facilityrepresentatives, a list of 10 specifichigh priority situations in obstetricpractice was developed. These were

    situations that were deemed by theteam to pose particular challengeswith respect to patient safety and sys-tem error, based on existing medicalliterature and the experience of phy-sicians and nurses on the task force(Table 1).This list was prioritized, assisted bya comprehensive review of closedclaims from all US Air Force facili-ties over the previous 5 years. Weincluded the issues driving most ofthe claims suitable for potential in-tervention (Table 2).Over the ensuing 24 months, highly

    FIGURE 2Blood pressure management of seveor postpartum hypertension

    is document is intended as a guidelinode of practice for this procedure in t the contrary. Clinical situations exist re are in the patients best interest.

    e following protocol should be initiatedmHg OR the diastolic blood pressure is

    Notify obstetrician

    Administer labetalol, 20 mg IV over 2 m

    Repeat blood pressure in 10 minutes

    If either blood pressure threshold is stil over 2 minutes.

    Repeat blood pressure in 10 minutes

    If either blood pressure threshold is stil over 2 minutes and obtain emergency m

    edicine consultation.

    Repeat blood pressure in 10 minutes

    If either blood pressure criteria is still edrochloride 10 mg IV over 2 minutes.

    dditional medication per specific order

    Once above blood pressure thresholds ainutes for 1 hour, then q 15 minutes x 1 ood pressures q hour x 4 hours.

    Additional blood pressure timing per spntravenous.

    sett. How to develop an effective obstetric checklist. Am J Obsspecific protocols addressing the situ-ations outlined in Table 1 were devel-

    SEPTEMBER 2011 Americoped and refined by the committee.We began with a centrally developedsample protocol that was then modi-fied as necessary by the obstetric pa-tient safety task force. This work wasassisted by monthly audio and/or vid-eoconferencing using Department ofDefense electronic conferencing sys-tems. In most cases, parallel nursingoperating instructions (policy andprocedures) were also developed. Allof the work was performed by thenurse/physician task force thus

    intrapartum

    t should be used as the default absence of a specific provider order which alternative approaches to

    the systolic blood pressure is 160 0 mmHg.

    utes

    ceeded, administer labetalol, 40 mg

    ceeded, administer labetalol, 60 mg ernal-fetal medicine or internal

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    an Journal of Obstetrics& Gynecology 167

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    Reviews Patient Safety Series www.AJOG.org

    16specific as possible, and were devel-oped in checklist form whenever fea-sible. A checklist is merely a moreconcise, clinically useful form of pre-senting a protocol. Examples are out-lined in Figures 2 and 3. In somecases, we adopted or modified exist-

    TABLE 1Obstetric practice areas targetedfor standardization

    No. Practice area

    1. Oxytocin administration...........................................................................................................

    2. Magnesium sulfate infusion...........................................................................................................

    3. Misoprostol administration...........................................................................................................

    4. Use of magnesium sulfate forneuroprophylaxis

    ...........................................................................................................

    5. Management of hypertensive crisis...........................................................................................................

    6. Management of postpartumhemorrhage

    ...........................................................................................................

    7. Management of second stage labor...........................................................................................................

    8. Shoulder dystociamanagementand documentation

    ...........................................................................................................

    9. Operative vaginal delivery...........................................................................................................

    10. Management of eclampsia...........................................................................................................

    Fausett. How to develop an effective obstetricchecklist. Am J Obstet Gynecol 2011.

    TABLE 2Analysis of adverse outcomes

    Issue

    Failure to perform cesarean delivery forselect category II tracings, especiallywhen complicated by other issues (eg,amnionitis, failure to progress)...........................................................................................................

    Suboptimal documentation of indicationsprocedures used in conjunction withoperative vaginal delivery...........................................................................................................

    Supoptimal documentation of maneuversused to relieve shoulder dystocia............................................................................................................

    Failure to respond to oxytocin-inducedtachysystole even in the absence ofworrisome fetal heart rate changes...........................................................................................................

    Failure to adequately recognize andinterpret FHR changes and possible needfor cesarean delivery in cases ofattempted vaginal birth after cesarean...........................................................................................................

    Management of postpartum hemorrhage...........................................................................................................

    FHR, fetal heart rate.

    Fausett. How to develop an effective obstetric

    checklist. Am J Obstet Gynecol 2011.

    8 American Journal of Obstetrics& Gynecology SEing protocols. In other instances theprotocols were unique.Consensus was achieved by multidis-ciplinary discussion and agreementrather than military rank, title, or po-sition. Once consensus had beenachieved with respect to a specificprotocol, it was implemented as astandard in all US Air Force facilitiesby directive of the CommandingGeneral Officer of the Air Force Med-ical Operations Agency via a Note toAirmen (NOTAM). This documentdirected adoption of the checklistsand associated operating instruc-tions, assisted by the previously estab-lished team communications and

    FIGURE 3Management of shoulder dystocia

    sett. How to develop an effective obstetric checklist. Am J Obssimulator drills.

    PTEMBER 2011An ongoing internal audit processwas then put into place to documentcompliance with established proto-cols. Deviation from established pro-tocols with the use of alternativeapproaches is freely permitted in excep-tional circumstances. The guidance atthe top of the checklist suggests that op-timal care sometimes requires devia-tion from the checklist. For example, apatient already on high-dose labetalolfor chronic hypertension would clearlyneed a different approach to a hyper-tensive crisis than that outlined in Fig-ure 2. However, such cases are sub-jected to peer review.The checklists developed by the US Air

    ynecol 2011.7.

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    tet GForce have been published for use by

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    www.AJOG.org Patient Safety Series Reviewsour sister services, and are available, byrequest, for use in civilian facilities.fter development and implementa-

    n of these checklists according to theove process, we surveyed the physi-ns and nurses in the 12 facilities in-lved in this project regarding the effectthis process on patient safety. Thisvey involved 17 physician leaders (12stetrician/gynecologists and 5 mater-l-fetal medicine specialists) and 15rse leaders. Our questions were de-ned to mirror the criteria adopted byNational Quality Forum in the eval-

    tion of potential quality performancetrics (Table 3).27 However, in our sur-, 1 specific question was purposefullyed twice, using different languageestions 2 and 4, Table 3). As demon-

    ated in Table 3, participants rankedse protocols highly in terms of clinicalportance of the topic addressed, sci-tific validity of the protocol developed,d ability to be integrated into clinicalctice without undue burden on the

    nical team. When asked to rate the gaptween the specific respondents actualchecklist performance and ideal per-

    TABLE 3Mean scores in a postchecklist imple

    Variable

    Protocol addressesan area of highclinical importance

    Oxytocin 4.9.........................................................................................................................

    Magnesium sulfate 4.8.........................................................................................................................

    Misoprostol 4.7.........................................................................................................................

    Shoulder dystocia 5.0.........................................................................................................................

    Hypertensive crisis 5.0.........................................................................................................................

    Postpartumhemorrhage

    4.9

    .........................................................................................................................

    Neuroprophylaxis 4.8.........................................................................................................................

    Eclampsia 5.0.........................................................................................................................

    Second stagemanagement

    4.5

    .........................................................................................................................

    Operative vaginaldelivery

    4.8

    .........................................................................................................................

    Regarding the obstetric patient safety protocols, these statements

    Fausett. How to develop an effective obstetric checklist. Am J Omance, most clinicians thought thewas small; however, when asked

    aswhether the same checklist would belpful in a general sense in providingod care, respondents ranked the pro-ol highly. We found this differencecinating, as it highlights one obstaclethe widespread acceptance of a check--based approach to critical medicalcesses: even excellent clinicians tend

    be defensive when faced with the emo-nal challenge of standardizing theirn current practice, whereas the same

    nicians generally see the value of suchapproach when the question is asked

    the abstract, and applies to future careen by clinicians in general.

    ur efforts in practice standardizationre based on a central premise that ap-es to virtually all human endeavors re-iring team management. Even if sev-l approaches to a specific situation areividually equivalent in terms of pa-

    nt outcome, choosing 1 of these ap-aches and implementing it the same

    y every time will yield results superiorthose achieved by random use of var-s individually valid protocols.4,28,29 Acessful checklist does not have to be

    sed on a proven best practice (such

    entation questionnaire

    re is a significantbetween idealactual team

    formance in thisa

    Protocol is consistentwith the practiceof evidence-basedmedicine

    5........................................................................................................................

    4.0........................................................................................................................

    4.8........................................................................................................................

    4.8........................................................................................................................

    4.4........................................................................................................................

    4.8

    ........................................................................................................................

    4.9........................................................................................................................

    5.0........................................................................................................................

    4.9

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    e ranked from 1-5 (5 agree strongly, 1 disagree strongly).

    et Gynecol 2011.multiple randomized clinical trials)en the existence of such a proven best

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    SEPTEMBER 2011 Americctice is not present. Rather, develop-simply need to select one approacht is as good as any others, and thenure that it is used consistently andiformly by all team members. Unifor-ty alone will improve outcomes, com-red with the random use of multipletocols that are, in isolation, equally

    ective.Widespread acceptance across the USr Force Medical Service has been chal-ging despite the fact that the larger US

    r Force uses checklists frequently. Thedical Corp trains and functions simi-to the civilian medical community.

    us, even in the military this approachntrasts with traditional models ofdical care in which physician auton-y is a primary concern. Our educa-

    n efforts have focused on the conceptt although autonomy in some aspect

    reduced with the use of a disciplinedof uniform protocols, the checklists

    ilitate collaborative management ofse common obstetric challenges mag-ying physician autonomy to deal wither complex issues. Poor team prepa-

    ion and communication failures in

    rotocol will beelpful to ourlinical teamn providingood care

    Implementationof the protocoldoes not posean undue burdenon our clinical team

    5...........................................................................................................

    .9 4.3...........................................................................................................

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    .8 4.7...........................................................................................................

    .9 4.5...........................................................................................................

    .0 4.8

    ...........................................................................................................

    .9 4.7...........................................................................................................

    .0 4.8...........................................................................................................

    .2 4.7

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    an Journal of Obstetrics& Gynecology 169

  • litigation resulting in diminished auton-omy. Demands on physician time andattention, mandate the collaborative useof skilled nursing and other support staffmaking obstetrics a team sport.

    Obstetrics today remains a complexprocess that is, like military and com-mercial aircraft, too much plane for oneman to fly. Checklists are an integralpart of a safer medical system advocatedby the Institute of Medicine in whichretovidfulchoune

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    REF1. Hvelqua200

    2. Winters BD, Gurses AP, Lehman H, et al.Clinical review: checkliststranslating evi-dence into practice. Crit Care 2009;13:210-5.3. Clark SL, Belfort MA, Saade GA, et al. Imple-mentation of a conservative, checklist basedprotocol for oxytocin administration: maternaland fetal outcomes. Am J Obstet Gynecol2007;197:480.e1-5.4. Clark SL, Belfort MA, Meyers JA, et al. Im-proved outcomes, fewer cesarean deliveriesand reduced litigation: results of a new para-digm in patient safety. Am J Obstet Gynecol2008;199;105.e1-7.5. HsafregGy6. Fuse1977. TbuiemWa8. Titytion9. SetactAm10.al.blo20011.toopro12.ChJ N13.of sfortien14.aneAn15.Chdle

    periences BMC. Health Serv Res 2010;10:342-6.16. Kendall A, Barthram C. Revised checklistfor anesthetic machines. Anaesthesia 1998;53:887-90.17. Peleg M, Boxwala AA, Ogunyemi O, et al.GLIF 3: the evolution of a guideline representa-tion format. Proc AMIA Symp 2000:645-9.18. Degani A, Weiner EL. Cockpit checklists:concepts, design and use. Human Factors1993;35:28-43.19. Makary MA, Holzmueller CG, ThompsonDA, et al. Operating room briefings: working onthe20020.for20121.Elegesablasp22.abl23.pla24.Yo25.SecrahttMT26.blafreAcc27.darces28.heame29.FoxAm30.corfaaces

    Reviews Patient Safety Series www.AJOG.org

    17liance on memory and vigilance arebe avoided.7,8 Our experience pro-es a concrete example of the success-

    application of the principles forecklist development discussed previ-sly. Unlike all humans, the checklistver forgets.We are confident that our approach,th appropriate modifications, may

    vide a valuable guide to the imple-ntation of those types of systems

    ange advocated by the Institute ofdicine as essential to improvement of

    tient safety. With appropriate andmmitted leadership, the developmentd institution of checklists has becomell accepted across a geographicallyd demographically diverse populationthin the US Air Force. Our experiencegests that such efforts will require theenditure of considerable energy and

    ources, in addition to innovative lead-hip. However, a comparison of theety record of military and commercialation with that of American medicinegests that with respect to patient

    ety, such efforts are well worth it.30 f

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    How to develop an effective obstetric checklistReferences