Effect of a comprehensive obstetric patient safety program on compensation payments and sentinel events Reviews www.AJOG.org P A T I E N T S A F E T Y S E R I E S Effect of a comprehensive obstetric patient safety program on compensation payments and sentinel events Amos Grunebaum, MD; Frank Chervenak, MD; Daniel Skupski, MD s M c m Improving patient safety has becomean important goal for hospitals, phy- sicians, patients, and insurers.1 Imple- menting patient safety measures and promoting an organized culture of safety, including the use of highly spe- cialized protocols, has been shown to de- crease adverse outcomes;2-5 however, it is less clear whether decreasing adverse outcomes also reduces compensation payments and sentinel events. Our objective is to describe compre- hensive changes to our obstetric patient safety program and to report their im- pact on actual spent compensation pay- ments (sum of indemnity and expenses paid) and sentinel events. Materials and Methods New York Presbyterian Hospital-Weill Cornell Medical Center is a tertiary aca- demic referral center with a level 3 neo- natal intensive care unit and serves as a New York State regional perinatal cen- ter. The labor and delivery unit performs about 5200 deliveries per year of which voluntary attending physicians manage approximately 25%, and 75% are man- aged by full-time faculty. The New York Weill Cornell Investi- gation Research Board approved this re- port as exempt research. Patient safety program In 2002, we began to implement in a step-wise fashion a comprehensive and From the Department of Obstetrics and Gynecology, New York Weill Cornell Medical Center, New York, NY. Received Aug. 9, 2010; revised Nov. 1, 2010; accepted Nov. 2, 2010. Reprints not available from the authors. 0002-9378/$36.00 © 2011 Mosby, Inc. All rights reserved. doi: 10.1016/j.ajog.2010.11.009 ongoing patient safety program. The date of implementation is included for each step. Consultant Review (2002) In 2002, as part of an obstetric initiative by our insurance carrier (MCIC Ver- mont, Inc, Burlington, VT), 2 indepen- dent consultants reviewed our depart- ment and assessed our institution’s obstetric service. This review resulted in specific recommendations and provided a general outline for making changes and improvements in patient safety. Building on these findings, we implemented a comprehensive obstetric patient safety program. Labor and delivery team training (2003) Poor communication is among the most cited reasons for malpractice suits,6 whereas improved nurse-physician com- munication can make labor and delivery afer.7 Consequently, the Institute of Medicine recommended interdiscipli- nary team training programs for provid- ers to incorporate proven methods of Our objective was to describe a compreh its effect on reducing compensation pa 2003 to 2009, we implemented a compr our institution with multiple integrated c pensation payments and sentinel events ments and sentinel events retrospectively through 2009. Average yearly compensat between 2003-2006 to $2,550,136 betw from 5 in 2000 to none in 2008 and 2 patient safety program decreased comp sulting in immediate and significant savin Key words: compensation payments, med patient safety, sentinel events team training as a way to improve efforts FEBRUARY 2011 Am and to empower every team member to speak up and intervene if an unsafe situ- ation may be occurring.8 Crew Resource anagement (CRM) can potentially de- rease medical malpractice litigation, ostly by improving communication,9 but studies have been less clear about its effect on adverse outcomes.10 In 2003, several of our labor and de- livery staff members including nurses, obstetricians, and anesthesiologists at- tended a “train the trainer” team-train- ing course. Subsequently, all staff work- ing on labor and delivery including clerical staff, nurses, attending obstetri- cians, neonatologists, anesthesiologists, and residents successfully attended a 4-hour team training session and team principles were introduced on labor and delivery. Since then, all new staff has been required to attend labor and deliv- ery team training sessions. The CRM program is performed regularly every 2-3 months. New staff, including nurses, attending, residents, and cleri- cal staff, are scheduled to undertake CRM at the next available time. At- tending physicians are instructed that ive obstetric patient safety program and nts and sentinel adverse events. From nsive obstetric patient safety program at ponents. To evaluate its effect on com- e gathered data on compensation pay- m 2003, when the program was initiated, payments decreased from $27,591,610 2007-2009, sentinel events decreased . Instituting a comprehensive obstetric ation payments and sentinel events re- . liability, obstetric adverse outcomes, ens yme ehe om , w fro ion een 009 ens gs ical credentialing/privileges will not be erican Journal of Obstetrics & Gynecology 97 h l t t a t r s p T u ( t m t i C l C c p p n t b c o n p c t T i n t i i b d e f s a D a A w s l b v t c t c g a fl L o f M m d m u h Reviews Patient Safety Series www.AJOG.org granted or renewed if CRM is not com- pleted and nursing staff and residents are informed that they must take the CRM program within a year after em- ployment begins. Electronic medical record charting (2003) Good medical record charting can help defend professional liability cases and may persuade potential plaintiffs to forego filing a suit11 and electronic ealth records on labor and delivery are ess likely to miss key clinical informa- ion.12 To facilitate communication and o improve patient safety, we were mong the first departments in our insti- FIGURE 1 Chain of communication Grunebaum. Obstetric patient safety measures and compensa ution to require electronic medical w 98 American Journal of Obstetrics & Gynecology F ecord charting with Eclipsys XA (Eclip- ys Corporation, Boca Raton, FL) for all atients on labor and delivery. OB racevue (Phillips, Andover, MA) is sed for electronic fetal monitoring EFM). All documentation occurs in hese electronic formats. Paper docu- entation is not allowed, except when he electronic format is temporarily ncapacitated. hain of communication for abor and delivery (2003) ommunication on labor and delivery is rucial to ensure patient safety and to rovide the best care for patients and revent errors,13 but there are times payments. Am J Obstet Gynecol 2011. hen physician’s orders and actions EBRUARY 2011 eed to be questioned. We believed that he most effective way for staff on the la- or and delivery unit to voice their con- erns is to establish and promote chain- f-communication policies. In 2004, a ew chief of labor and delivery was ap- ointed and a clear chain of communi- ation was established and supported by he departmental chairman (Figure 1). he chain of communication includes nvolvement of all staff beginning at the urse and junior resident level, then up o the chief resident, the inhouse attend- ng, the maternal-fetal medicine special- st on call, and finally the director of la- or and delivery and the chairman of the epartment. All staff are being empow- red to use the chain of communication requently and around the clock to en- ure a quick resolution to unresolved nd urgent issues. edicated gynecology ttending on call (2004) gynecology attending on call schedule as established separately from the ob- tetric coverage. Before this change, the abor and delivery attending covered oth the obstetric and gynecology ser- ices and there had been occasions when here were concurrent emergency gyne- ologic and obstetric cases. This situa- ion prevented the attending from suffi- iently covering both services. The added ynecology coverage allowed the labor nd delivery attending to cover the labor oor exclusively. imitation of misoprostol to induction f labor or cervical ripening or a nonviable fetus (2004) isoprostol is not US Federal Drug Ad- inistration (FDA) approved for use uring labor. There is evidence that isoprostol is not effective,14 and its se is associated with an increase in yperstimulation/tachysystole.15 Misoprostol has never been used at the medical center for a live fetus. After the warning from the Searle company dis- couraging its use in the year 2000, there was no incentive to begin using this med- ication at our institution, and our con- cern about potential adverse outcomes tion led us to conclude that misoprostol use s v p s www.AJOG.org Patient Safety Series Reviews should be limited to induction of labor and cervical ripening only in the nonvi- able fetus. Standardized oxytocin labor induction and stimulation protocol (2005) A standardized protocol enables the staff to become facile in handling the myriad of problems that occur on any busy unit, quickly and efficiently.16 In 2005, we im- plemented a standardized low-dose oxy- tocin labor induction and stimulation policy (Table 1) and a standardized or- der template was designed in the hospi- tal’s electronic ordering system (Eclip- sys, Atlanta, GA). No other method of using intrapartum oxytocin was permit- TABLE 1 Standardized protocol for induction Item Protocol a. Only a premixed oxytocin solu ................................................................................................................... b. The oxytocin infusion is limited ................................................................................................................... c. A buretrol infusion is used wit ................................................................................................................... d. The infusion is piggybacked in ................................................................................................................... e. A written attending order (elec ................................................................................................................... f. Before the start of oxytocin an cervical status, estimated feta ................................................................................................................... g. An attending must be available ................................................................................................................... h. Before initiation of oxytocin a ................................................................................................................... i. The oxytocin concentration is ................................................................................................................... j. The oxytocin infusion begins a ................................................................................................................... k. The infusion is increased by 1 ................................................................................................................... l. An attending must evaluate, d ................................................................................................................... m. The maximum oxytocin dosag ................................................................................................................... n. If the oxytocin infusion was di it was stopped for greater than ................................................................................................................... o. Only a nurse can titrate oxytoc this. ................................................................................................................... p. The oxytocin infusion must be than 2 minutes in frequency a elevated uterine resting tone; ................................................................................................................... q. The attending physician must or down titration of oxytocin. ................................................................................................................... r. Terbutaline may be given if sto hyperstimulation ................................................................................................................... s. Oxytocin should be discontinu ................................................................................................................... Grunebaum. Obstetric patient safety measures and compe ted. Highlights of this protocol included a premixed oxytocin solution, a required written attending order and note before starting the oxytocin infusion, a stan- dardized starting dosage and increases, and a “smart pump” (a pump that comes with an error reduction system and drug library capabilities). The protocol paid special attention to tachysystole and fetal heart rate concerns. If there was tachysy- tole, or there were concerns about the fetal heart rate, the oxytocin infusion had to be decreased or stopped. Premixed and safety color-coded labeled magnesium sulfate and oxytocin solutions (2005) Magnesium sulfate is among the most r augmentation with oxytocin is used ......................................................................................................................... intravenous route via an infusion pump ......................................................................................................................... “smart pump” (a pump that comes with error re ......................................................................................................................... he port most proximal to patient ......................................................................................................................... ic template) is required before the start of oxyto ......................................................................................................................... ending must document the plan of care includin ight, pelvic adequacy, and fetal heart rate asse ......................................................................................................................... the same floor as labor and delivery floor at all ......................................................................................................................... suring fetal heart rate must be present for a mi ......................................................................................................................... emixed solution of 30 U per 500 mL. No individ ......................................................................................................................... mU per minute. ......................................................................................................................... per minute no more frequently than every 15 m ......................................................................................................................... ment, and determine the plan of care if the oxyt ......................................................................................................................... nnot exceed 40 mU per minute ......................................................................................................................... tinued for 20 minutes or less, it may be restart minutes then it should be restarted at 1 mU pe ......................................................................................................................... The nurse can stop or titrate the oxytocin infusio ......................................................................................................................... pped or titrated for any of the following: uterine r lasting longer than 90 seconds and/or more t reassuring fetal heart rate tracing; presumed ute ......................................................................................................................... otified of any hyperstimulation/tachystole, abno ......................................................................................................................... ing oxytocin does not lead to a normalization of ......................................................................................................................... s soon as a cesarean delivery is planned ......................................................................................................................... ion payments. Am J Obstet Gynecol 2011. dangerous solutions used on labor and FEBRUARY 2011 Am delivery.17 More recently, in addition to eizure prophylaxis and tocolysis, pre- ention of cerebral palsy was added as a otential indication for giving magne- ium sulfate on labor and delivery.18,19 To improve the safe use of magnesium sulfate, we implemented several changes, including the use of premixed magne- sium sulfate and oxytocin solutions, color coded magnesium sulfate and oxyto- cin containers and intravenous lines, as well as using both with “smart pumps.” Electronic medical record templates for shoulder dystocia and operative deliveries (2005) Both shoulder dystocia and operative de- .................................................................................................................. .................................................................................................................. tion system and drug library capabilities) .................................................................................................................. .................................................................................................................. .................................................................................................................. dication, fetal presentation and station, ent. .................................................................................................................. es while the patient is on oxytocin .................................................................................................................. um of 20 minutes .................................................................................................................. mixing of solutions is permitted onsite. .................................................................................................................. .................................................................................................................. tes .................................................................................................................. dosage reaches 20 mU per minute .................................................................................................................. .................................................................................................................. t a lower rate than before discontinuation. If inute .................................................................................................................. indicated. The doctor must be notified of .................................................................................................................. erstimulation/tachysystole (contractions less 5 contractions in any 10 minute period); e rupture; water intoxication .................................................................................................................. l fetal heart rate changes and/or stoppage .................................................................................................................. l heart rate changes in the presence of .................................................................................................................. .................................................................................................................. o tion ......... ......... to ......... ......... h a duc ......... ......... to t ......... ......... tron cin ......... ......... att g in l we ssm ......... ......... on tim ......... ......... reas nim ......... ......... a pr ual ......... ......... t 1 ......... ......... mU inu ......... ......... ocu ocin ......... ......... e ca ......... ......... scon ed a 20 r m ......... ......... in. n if ......... ......... sto hyp nd/o han non rin ......... ......... be n rma ......... ......... pp feta ......... ......... ed a ......... ......... nsat liveries are associated with an increase in erican Journal of Obstetrics & Gynecology 99 d n o m s r c u o E o c O o i c i i w t t t e q O A i f T t s m a E w F b m s t a d v l i a o w p a t c a u nsat Reviews Patient Safety Series www.AJOG.org neonatal and maternal injury and conse- quently litigation.20 Making the correct iagnosis, performing the correct ma- euvers, time management, prevention f traction, and documenting manage- ent and maneuvers are therefore es- ential.21 We designed and implemented equired templates and electronic medi- al charting tools for several clinical sit- ations, including shoulder dystocia and perative delivery (Table 2). arly identification of potential bstetric professional liability ases (2005) ur medicolegal department met with ur department and decided that early dentification of adverse obstetric out- TABLE 2 Shoulder dystocia documentation t Shoulder dystocia note Head delivery (Spont/Forc/Vac): ................................................................................................................... Time head delivered (min/sec): ................................................................................................................... Time body delivered (min/sec): ................................................................................................................... Second stage (min): ................................................................................................................... Anterior shoulder (right/left): ................................................................................................................... Initial traction: gentle attempt at traction, assi ................................................................................................................... Oxytocin stopped: yes or no ................................................................................................................... Terbutaline given: yes or no ................................................................................................................... Any/all maneuvers that apply and the order in ................................................................................................................... McRoberts maneuver and by whom: ................................................................................................................... Suprapubic pressure and by whom: ................................................................................................................... Episiotomy (and by whom): ................................................................................................................... Rubin’s maneuver and by whom: ................................................................................................................... Woods maneuver and by whom: ................................................................................................................... Gaskin maneuver (all fours): ................................................................................................................... Posterior arm release and by whom: ................................................................................................................... Other (maneuvers list): ................................................................................................................... No Fundal pressure after the head delivered ................................................................................................................... The arm under the symphysis at the point the ................................................................................................................... Primary Care Provider(s) present: ................................................................................................................... Registered Nurse(s) present: ................................................................................................................... Pediatrician(s) present: ................................................................................................................... Others present: ................................................................................................................... Full disclosure given to patient: Yes/No ................................................................................................................... Grunebaum. Obstetric patient safety measures and compe omes and potential professional liabil- a 100 American Journal of Obstetrics & Gynecology ty cases and expedited reviews would be mplemented. If a clear medical error as identified, we planned to approach he patient with the goal of an early set- lement. Since the implementation of his program, 1 adverse outcome (an arly neonatal death) was identified and uickly settled. bstetric patient safety nurse (2005) s part of our patient safety efforts, our nsurance carrier (MCIC Vermont, Inc) unded an obstetric patient safety nurse. he patient safety nurse is employed full- ime by the hospital and is involved in taff education, team training, imple- entation of protocol changes on labor nd delivery, obstetric emergency drills, plate ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... by maternal expulsive forces ................................................................................................................... ................................................................................................................... ................................................................................................................... ich they were utilized. ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... d was delivered was: right OR left ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... .................................................................................................................. ion payments. Am J Obstet Gynecol 2011. nd collection of data. FEBRUARY 2011 lectronic online communication hiteboard (2006) or decades, the labor whiteboard has een the center of communications on any labor and delivery units. It usually erves as a hub for situational awareness o make all staff aware of events on labor nd delivery. However, the traditional ry erasable whiteboard has many disad- antages, including limited visibility, imited access, small size, no interactiv- ty, and inflexibility. We programmed nd implemented our own proprietary nline electronic whiteboard (http:// ww.LDTrack.com), a secure password- rotected and IP address-controlled site vailable through any internet browser hat has many interactive features, in- luding color-coded warning labels and utomatic mathematically supported pdates.22 Recruitment of physician’s assistants for labor and delivery (2006) Newly instituted resident work hours limit the extent of resident involvement and night calls in the hospital including the labor and delivery unit. Three new obstetric physician assistants were re- cruited to amplify the staff and help with the workload. The physicians’ assistants are assigned to labor and delivery triage and as assistants for cesarean deliveries and provide continuity and stability on the labor and delivery floor. Electronic fetal monitor interpretation certification (2006) Effective communication is essential when discussing and interpreting fetal heart rate and uterine activity and it re- quires a mutual understanding of termi- nology. We required that all staff in- volved in interpreting electronic fetal monitoring, including attendings, resi- dents, physician assistants, and nurses, become certified in electronic fetal monitoring by National Certification Corporation (NCC), a not-for-profit or- ganization that provides a national cre- dentialing program for nurses, physi- cians, and other licensed health care professionals. In addition, all staff are required to use the National Institute em ......... ......... ......... ......... ......... sted ......... ......... ......... wh ......... ......... ......... ......... ......... ......... ......... ......... ......... ......... hea ......... ......... ......... ......... ......... ......... of Child and Human Development http://www.LDTrack.com http://www.LDTrack.com t p a t c d O T t r h c p p w c f r o O W m d t i s P W t u c t v C N Y I a W p p t i r p r C a W o 2 s fi s e f p w a l c s f $ t s e i a s q e C s fi p r o j A m j p www.AJOG.org Patient Safety Series Reviews (NICHD) standardized language for fe- tal heart rate interpretation23 and tem- plates for documenting fetal heart rates based on the NICHD language were added in the electronic charting tools. Electronic antepartum medical records (2006) We implemented uniform antepartum medical record charting (Epic Systems Corporation) for all full-time faculty and staff patients (about 75% of all deliver- ies). The availability of electronic ante- partum charts on a 24-hour/7 day a week basis improves availability of data, such as laboratory results and helps in im- proving communication among the staff. Routine thromboembolism prophylaxis for all cesarean deliveries (2006) Pulmonary thromboembolism is among the leading causes of maternal deaths in the United States, and most events of ve- nous thromboembolism can be reduced with either medical or mechanical throm- boprophylaxis,24,25 and it has been sug- gested that a systematic reduction in ma- ternal death rate in the United States can be expected if all women undergoing ce- sarean delivery receive thromboembo- lism prophylaxis.5 Therefore, in addition o using pharmacologic anticoagulation rophylaxis for high-risk patients, we lso implemented the routine use of in- ermittent lower extremity pneumatic ompression devices for all cesarean eliveries. bstetric emergency drills (2006) he Joint Commission recommends hat obstetric departments consider pe- iodically conducting clinical drills to elp staff prepare for shoulder dystocia, onduct debriefings to evaluate team erformance, and identify areas for im- rovement.13 Such drills appear to im- prove recognition and management of shoulder dystocia and can improve phy- sician’s communication skills as well as reduce traction forces.26,27 Drills were instituted over time for maternal cardiac arrest, shoulder dystocia, emergency ce- sarean section, and maternal hemor- p rhage. Obstetricians, anesthesiologists, neonatologists, nurses, residents, fellows, and physician assistants participate in these drills. The shoulder dystocia and ma- ternal hemorrhage drills are performed with a maternal and fetal manikin and in small groups of 6-8 individuals so each can obtain practice in performing the neces- sary fetal manipulations. The main objectives of the shoulder dystocia drill are to diagnose shoulder dystocia, prevent injury by performing the correct maneuvers, time manage- ment, prevention of traction, and teach proper documentation. Recruitment of a laborist (2007) Inhouse oncall attending coverage is provided on a 24-hour basis by one of the full-time faculty attendings that have obstetric privileges. To address lifestyle and patient safety concerns, Weinstein recommended a practice of having hos- pitalists and laborists,28 Clark recom- mended a reassessment of group obstet- ric practice to improve patient safety,29 and a survey showed that laborists can have a high career satisfaction.30 In 2006, e hired a laborist to provide inhouse overage for the labor and delivery floor or nights and weekends and therefore educe inhouse oncall responsibilities of ther physicians. xytocin initiation checklist (2009) e implemented a checklist with the ost important elements of the stan- ardized oxytocin policy. Completion of he checklist is required by nurses before nitiation of oxytocin for induction or timulation of labor. ostpartum hemorrhage kit (2009) e made available a single hemorrhage kit hat includes the 4 most important drugs sed for postpartum hemorrhage (oxyto- in [Pitocin; King Pharmaceuticals, Bris- ol, TN], misoprostol [Methergine; No- artis Pharmaceuticals, Basel, Switzerland, ytotec; Bristol-Myers Squibb, Skillman, J], carboprost [Hemabate; Pfizer, New ork, NY]). nternet based required reading ssignments and testing (2009) e created an inhouse internet-based assword protected reading and testing FEBRUARY 2011 Am rogram (http://www.InPrep.com) for rotocols and other publications related o labor and delivery safety. All attend- ngs and residents have been required to egularly read assigned literature and ass a multiple choice test related to the eading material. ompensation payments nd sentinel events e performed a retrospective review of bstetric compensation payments from 003 to 2009 collected by the MCIC. Ob- tetric compensation payments were de- ned as all actual payments made as a um of indemnity paid plus medicolegal xpenses paid for by the hospital for de- ending the case. In New York City, most rofessional liability suits are initiated ithin 2-3 years after delivery, and they re often not settled until many years ater. Therefore, in addition to actual ompensation payments, we also as- essed new and ongoing significant pro- essional liability suits (expected at 1,000,000 and above) and potential fu- ure professional liability suits. Data on entinel events at our institution were valuated from 2000 to 2009 by analyz- ng data obtained from a sentinel event dverse outcome database that is pro- pectively recorded by the hospital’s uality assurance committee. Sentinel vents are determined by the Medical enter according to Joint Commission tandards. The Joint Commission de- nes a sentinel event as “. . . an unex- ected occurrence involving death or se- ious physical or psychological injury, r the risk thereof . . .” (http://www. ointcommission.org/SentinelEvents/). t our institution, sentinel events included aternal deaths, and serious newborn in- uries, including birth asphyxia and hy- oxic ischemic encephalopathy. Results Compensation payments Figure 2 shows the yearly obstetric com- pensation payment totals paid out from 2003 to 2009. The 2009 compensation payment total constituted a 99.1% drop from the average 2003-2006 payments (from $27,591,610 to $ 250,000). The av- erage yearly compensation payment in the 3 years from 2007 to 2009 was erican Journal of Obstetrics & Gynecology 101 http://www.InPrep.com http://www.jointcommission.org/SentinelEvents/ http://www.jointcommission.org/SentinelEvents/ c t a $ $ $ $ $ $ Reviews Patient Safety Series www.AJOG.org $2,550,136 as compared with an average of $27,591,610 in the previous 4 years (2003- 2006), a yearly saving of $25,041,475 (total: $75,124,424) during the last 3 years. The compensation payments between 2003 and 2008 included delivery dates before 2003. We also assessed potential future and pending professional liability suits through the early identification program. In 2006, we had 1 adverse out- come case that was identified through FIGURE 2 Compensation payments by year $30,464,590 $3,336, $50,940,309 $0 10,000,000 20,000,000 30,000,000 40,000,000 50,000,000 60,000,000 2003 2004 200 Grunebaum. Obstetric patient safety measures and compensa FIGURE 3 Sentinel events by year (per 1000 d 1.04 0.60 0.64 0.82 0.00 0.20 0.40 0.60 0.80 1.00 1.20 2000 2001 2002 2003 20 (N=5) (N=2) (N=3) (N=3) (N=4) Grunebaum. Obstetric patient safety measures and compensa 102 American Journal of Obstetrics & Gynecology our program for the early identification of potential professional liability cases, and the case was settled expeditiously. In 2008 and 2009, for the first time in this decade, there was no professional liabil- ity suit initiated involving a possibly brain-damaged infant. In addition, there is currently only 1 active professional li- ability suit exceeding a $1 million esti- mated loss for an obstetric case from 2005 onward. One of the 2 other cur- $25,624,937 $2,852,620 $4,547,787 $250,000 2006 2007 2008 2009 payments. Am J Obstet Gynecol 2011. veries) 0.000.00 0.19 0.210.21 8 2005 2006 2007 2008 2009 (N=1)(N=1)(N=1) payments. Am J Obstet Gynecol 2011. t FEBRUARY 2011 rently pending “baby damage” suits in- volves deliveries before 2003. Table 3 shows the average time it takes from the event to payment. There is an average of 6.9 years (range, 0.6 –17.1 years) between the event and the pay- ment. On average, it takes 3.2 years (range, 0 –10 years) between the event and the claim and another 3.7 years (range, 0.3–10.4 years) between the claim and the payment. Of all claims, 65% (26/40) were made within 3 years after the event and 49% of payments (20/ 41) were made within 6 years after the event. Sentinel events and adverse outcomes Figure 3 shows the yearly rate of sentinel events per 1000 deliveries. There was a steady decline of sentinel events over the years of the study, from 1.04 sentinel events per 1000 deliveries in the year 2000, to no sentinel events in both 2008 and 2009. For the last 6 years, there has been no maternal death on labor and de- livery (we had 1 postpartum maternal death 10 days after discharge from a ce- rebrovascular accident) and there has been no permanent Erb’s palsy since we began shoulder dystocia drills in 2008. Since 2007 there was only 1 infant born of a total of 15,932 deliveries with the di- agnosis of hypoxic ischemic encephalop- athy (HIE) for an incidence of 0.6 HIE of 10,000 deliveries. Subsequently, that in- fant had no moderate or severe neurode- velopment impairments. In 2009 there was no infant born with HIE. The definition of HIE included a se- verely depressed newborn with need for resuscitation in the delivery room, evi- dence of severe acidemia at birth based on cord blood gas values and early ab- normal findings on neurologic examina- tion and/or abnormal assessment of ce- rebral function.32 Comment In 1999, the Institute of Medicine pub- lished a report challenging the prevailing wisdom that all was well with the Amer- ican health care system.8 This report alled for a sweeping overhaul and stated hat “higher level of care cannot be chieved by further stressing current sys- 605 5 tion eli 0.3 04 tion ems of care. The current care systems u i c y p w i c m l i a b b t c e i a n c l nsat www.AJOG.org Patient Safety Series Reviews cannot do the job. Trying harder will not work. Changing systems of care will.” There also have been increasing con- cerns about the rise in malpractice costs and its effect of availability of health care.31 After an external review of our obstet- ric service, we undertook comprehensive system changes beginning in 2003, to improve patient safety on our service. Among these patient safety changes were significant eliminations in practice vari- ations as well as significant improve- ments in communication methods be- tween staff. The main goal of these changes was to improve patient safety and decrease adverse outcomes. We did not expect a rapid and significant effect on compensation payments. Our results show that implementing a comprehensive obstetric patient safety program not only decreases severe ad- verse outcomes but can also have an im- mediate impact on compensation pay- ments. Beginning with the fourth year of the program, compensation payments began to drop significantly. Yearly pay- ments for the most recent 3 years (2007- 2009) averaged $2,550,136 as compared with average yearly payments of $27,591,610 for the preceding 4 years (2003-2006). The $25,041,475 yearly savings in compensation payments for the last 3 years alone dwarf the incre- mental cost of the patient safety program and are well above those reported by Simpson et al.32 In our opinion the doc- mented success of our patient safety mprovement program in decreasing ompensation payments for the past ears understates the true long-term im- act of the program on patient safety, as e expect significant savings to continue nto the future. Our neonatal intensive care unit is a enter for “cool cap” treatments (treat- ent of infants with neonatal encepha- opathy with hypothermia helmets), and t regularly treats infants with HIE.33 Of the more than 50 infants with HIE who were treated in this program over the last 3 years, only 1 among our own 15,932 deliveries came from our institution (the only 2007 sentinel event). Our observed departmental incidence of 0.6 HIE of 10,000 deliveries in the last 3 years is well below the reported 25 of 10,000 deliver- ies.34 On follow-up, this infant had no moderate or severe neurodevelopment impairments and hence for the last 3 years there are presently no known HIE brain damaged infants “in the pipeline.” As the amount of compensation pay- ments for an infant with neurodevelop- ment impairments can be well in excess of $10 million in New York City, the pre- vention of each and every 1 of these cases is crucial to minimize such payments. The Institute for Safe Medication Practices (ISMP) has added oxytocin to its list of high alert medications.35 The use of oxytocin during labor has been found to be associated with malpractice claims.36 Using oxytocin during labor may have a negative impact on the prob- ability of successfully defending a pro- fessional liability case, and its misuse, especially its association with hyper- stimulation, has been alleged to be re- sponsible for many if not most of the ad- verse outcomes and professional liability litigation involving abnormal labor.37-40 The best defense against legal chal- lenges involving the misuse of oxytocin is to use the drug judiciously and in ac- cord with institutional policies.41 How- ever, despite reports that standardized and uniform practice patterns are known to have better outcomes than greater practice variations, medical prac- tice continues to be characterized by wide variations that have little basis in clinical science.16 This is especially true TABLE 3 Yearly compensation payments an Year Payments 2003 $50,940,309 ................................................................................................................... 2004 $30,464,590 ................................................................................................................... 2005 $3,336,605 ................................................................................................................... 2006 $25,624,937 ................................................................................................................... 2007 $2,852,620 ................................................................................................................... 2008 $4,547,787 ................................................................................................................... 2009 $250,000 ................................................................................................................... 2003-2009 $117,991,848 ................................................................................................................... Grunebaum. Obstetric patient safety measures and compe for oxytocin usage, which has many per- i FEBRUARY 2011 Am sistent variations even within the same institution.42 Clark et al41 concluded that physiologically sound and evidence- ased approach to oxytocin use is possi- le and explained that it may be difficult o effect change in practice when physi- ians so often see no untoward effects of xcessive uterine activity. It has been suggested that implement- ng a uniform oxytocin policy and using n oxytocin checklist may improve peri- atal outcomes.43-45 We also found that implementing a uniform oxytocin pro- tocol and checklist helped our staff make better use of oxytocin and allowed nurses to focus on better patient care instead of following protocols that varied from physician to physician. Implementing a uniform oxytocin protocol likely con- tributed to our improved patient safety and prevention of adverse outcomes. Our experience supports the recommen- dation that: “. . . Malpractice loss is best avoided by reduction in adverse out- comes and the development of unam- biguous practice guidelines.”5 Many pregnant women are given mi- soprostol “off-label” for cervical ripen- ing and labor induction even though this medication is not approved for use in la- bor and is associated with an increase in uterine hyperstimulation and resultant fetal asphyxia and uterine rupture, am- niotic fluid embolism, perinatal mortal- ity, and HIE in surviving infants.46 Be- ause of these concerns, we decided to imit the use of misoprostol in labor to vent-to-payment time Event-to-payment average (range), y 5.9 (1.1–10.3) .................................................................................................................. 10.5 (3.9–17.1) .................................................................................................................. 5.5 (1.2–9.5) .................................................................................................................. 8.2 (4.1–13.2) .................................................................................................................. 8.1 (5.0–12.0) .................................................................................................................. 4.7 (0.6–14.4) .................................................................................................................. 0.8 .................................................................................................................. 6.9 (0.6–17.1) .................................................................................................................. ion payments. Am J Obstet Gynecol 2011. d e ......... ......... ......... ......... ......... ......... ......... ......... nductions in a nonviable fetus. erican Journal of Obstetrics & Gynecology 103 i t e c l p e s a b s c c p t l c t Reviews Patient Safety Series www.AJOG.org Good teamwork promotes profes- sional integrity and is essential in deliv- ering optimal patient care,47 and failure n communication and teamwork is of- en cited as a common cause of adverse vents.6,48,49,50 We found that teamwork an be further improved in labor and de- ivery by maintaining an electronic com- rehensive communication board as the ssential hub for communications among taff. Sleep deprivation can impair safety, nd establishing a laborist program has een recommended to improve safety.28 The hiring of a laborist allowed our ob- stetricians to work reduced inhospital hours and likely contributed to the im- proved safety climate and improved out- comes at our institution. The traditional erasable labor and de- livery white board usually reflects situa- tional awareness, the state of knowing what is going on with patients and in the unit. Unfortunately, most obstetric units still use a dry erasable white board that has severe limitations, including accessi- bility and space limitations. We believe that the implementation of a centralized, internet-based comprehensive electronic “white board” with automatic alarms and color-coding18 significantly improved ituational awareness and thus may have ontributed in decreasing adverse out- omes and reducing compensation ayments. Historically, EFM tracings have been in- erpreted with wide variations among the abor and delivery staff, often leading to in- onsistent decision making in response to racing interpretation. MacEachin et al51 showed improved communication as well as improved safety perception by the staff with the use of a common EFM language after a multidisciplinary EFM training program. Our study is limited by its retrospective nature. There were numerous changes made over several years, so that the im- pact of any one change on a single out- come measure cannot be individually determined. It is possible, that because of the retrospective nature of this report, there may have been other unknown fac- tors that contributed to the reduction of compensation payments and sentinel events. 104 American Journal of Obstetrics & Gynecology To paraphrase Ralph Waldo Emerson (1803-1882) who said “Life is a journey not a destination,” we believe that achieving patient safety on labor and de- livery is a journey, not a destination. Improving patient safety requires ex- tensive and considerate changes, physi- cian and staff cooperation, constant vig- ilance, flexibility, and rapid adaption based on new experiences and it may take considerable time to reap financial benefits in the future. Making significant changes on a labor and delivery unit including such features as the implementation of a standardized oxytocin protocol, electronic charting, team training, and improving situational awareness through a central communi- cation system, should be considered by all obstetric services. As we have shown, these changes can increase pa- tient safety, decrease sentinel events, and, as a consequence, reduce compen- sation payments. f REFERENCES 1. Weinstein L. A multifaceted approach to im- prove patient safety, prevent medical errors and resolve the professional liability crisis. Am J Ob- stet Gynecol 2006;194:1160-5. 2. Wagner B, Meirowitz N, Cohen P, et al. Peri- natal safety initiative to reduce adverse obstetric events. Am J Obstet Gynecol 2009;201:S45. 3. Pettker CM, Thung SF, Norwitz ER, et al. Im- pact of a comprehensive patient safety strategy on obstetric adverse events. Am J Obstet Gy- necol 2009;200:492.e1-8. 4. Pettker C, Thung S, Raab C, Copel J, Funai J. A comprehensive OB patient safety program improves safety climate and culture. Am J Ob- stet Gynecol 2009;201:S202-3. 5. Clark SL, Belfort MA, Dildy GA, Herbst MA, Meyers JA, Hankins GD. Maternal death in the 21st century: causes, prevention, and relation- ship to cesarean delivery. Am J Obstet Gynecol 2008;199:36.e1-5. 6. Sutcliffe KM, Lewton E, Rosenthal MM. Communication failures: an insidious contribu- tor to medical mishaps. Acad Med 2004;79: 186-94. 7. Simpson KR, James DC, Knox GE. Nurse- physician communication during labor and birth: implications for patient safety. J Obstet Gynecol Neonatal Nurs 2006;35:547-56. 8. Kohn LT, Corrigan JM, Donaldson MS, eds. Committee on Quality of Health Care in Amer- ica, Institute of Medicine. To err is human: build- ing a safer health system. Washington, DC: Na- tional Academy Press; 1999:1-312. FEBRUARY 2011 9. Mann S, Pratt SD. Team approach to care in labor and delivery. Clin Obstet Gynecol 2008; 51:666-79. 10. Nielsen PE, Goldman MB, Mann S, et al. Effects of teamwork training on adverse out- comes and process of care in labor and deliv- ery: a randomized controlled trial. Obstet Gy- necol 2007;109:48-55. 11. Williams DG. Practice patterns to decrease the risk of a malpractice suit. Obstet Gynecol 2008;51:680-7. 12. Eden KB, Messina R, Li H, Osterweil P, Henderson CR, Guise JM. Examining the value of electronic health records on labor and deliv- ery. Am J Obstet Gynecol 2008;199: 307.e1-9. 13. Joint Commission on Accreditation of Healthcare Organizations: Sentinel event alert. Issue 30, July 21, 2004. Available at: www. jointcommission.org/SentinelEvents/Sentinel EventAlert/sea_30.html. Accessed July 1, 2010. 14. Fonseca L, Wood HC, Lucas MJ, et al. Ran- domized trial of preinduction cervical ripening: misoprostol vs oxytocin. Am J Obstet Gynecol 2008;199:305.e1-5. 15. Hofmeyr GJ, Gülmezoglu AM Vaginal miso- prostol for cervical ripening and induction of la- bour. Cochrane Database Syst Rev 2003; CD000494. 16. Wennberg JE. Unwarranted variations in healthcare delivery: implications for academic medical centres. BMJ 2002;325:961-4. 17. Simpson KR, Knox GE. Obstetrical acci- dents involving intravenous magnesium sulfate: recommendations to promote patient safety. MCN Am J Matern Child Nurs 2004;29:161-9. 18. Conde-Agudelo A, Romero R. Antenatal magnesium sulfate for the prevention of cere- bral palsy in preterm infants less than 34 weeks’ gestation: a systematic review and metaanaly- sis. Am J Obstet Gynecol 2009;200:595-609. 19. Rouse DJ. Magnesium sulfate for the pre- vention of cerebral palsy. Am J Obstet Gynecol 2009;200:610-2. 20. Mavroforou A, Koumantakis E, Micha- lodimitrakis E. Physicians’ liability in obstetric and gynecology practice. Med Law 2005; 24:1-9. 21. Deering S, Poggi S, Macedonia C, et al. Improving resident competency in the manage- ment of shoulder dystocia with simulation train- ing. Obstet Gynecol 2004;103:1224. 22. Grunebaum A, Langsenkamp C, Cherve- nak FA. An intelligent web-based board to im- prove patient safety and communication on la- bor and delivery. Am J Obstet Gynecol 2005: 193:S97. 23. Macones GA, Hankins GD, Spong CY, Hauth J, Moore T. The 2008 National Institute of Child Health and Human Development work- shop report on electronic fetal monitoring: up- date on definitions, interpretation, and research guidelines. Obstet Gynecol 2008;112:661-6. 24. Duhl AJ, Paidas MJ, Ural SH, et al. Anti- thrombotic therapy and pregnancy: consensus report and recommendations for prevention http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_30.html http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_30.html http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_30.html www.AJOG.org Patient Safety Series Reviews and treatment of venous thromboembolism and adverse pregnancy outcomes. Am J Obstet Gynecol 2007:197:457.e1-21. 25. Quiñones J, James D, Cleary K, Stamilio D, Macones G. Thromboprophylaxis after cesar- ean section: a decision analysis. Am J Obstet Gynecol 2004;191:S93. 26. Goffman D, Heo H, Pardanani P, Merkatz IR, Bernstein PS. Improving shoulder dystocia management among resident and attending physicians using simulations. Am J Obstet Gy- necol 2008;199:294.e1-5. 27. Gurewitsch E, Cha S, Johnson T, et al. Traction training for routine and shoulder dys- tocia deliveries: an experimental study. Am J Obstet Gynecol 2005;193:S41. 28. Weinstein L, Garite TJ. On call for obstetrics—time for a change. Am J Obstet Gy- necol 2007;196:3. 29. Clark SL. Sleep deprivation: implications for obstetric practice in the United States. Am J Obstet Gynecol 2009;201:136.e1-4. 30. Funk C, Anderson BL, Schulkin J, Wein- stein L. Survey of obstetric and gynecologic hospitalists and laborists. Am J Obstet Gynecol 2010;203:177.e1-4. 31. Laros RK, Presidential address: medical-le- gal issues in obstetrics and gynecology Am J Obstet Gynecol 2005;192:1883. 32. Simpson KR, Kortz CC, Knox E. A compre- hensive perinatal patient safety program to re- duce preventable adverse outcomes and costs of liability claims. Jt Comm J Qual Patient Saf 2009;35:565-74. 33. Perlman J. Induced hypothermia: a novel neuroprotective treatment of neonatal enceph- alopathy after intrapartum hypoxia-ischemia. Curr Treat Options Neurol 2005;7:451-8. 34. Graham EM, Ruis KA, Hartman AL, North- ington FJ, Fox HE. A systematic review of the role of intrapartum hypoxia-ischemia in the cau- sation of neonatal encephalopathy. Am J Ob- stet Gynecol 2008;199:587-95. 35. Institute for Safe Medical practices. ISMP’s List of High-Alert Medications. Available at: http://www.ismp.org/Tools/highalertmedications. pdf. Accessed Jan. 24, 2010. 36. Jonsson M, Nordén SL, Hanson U. Analysis of malpractice claims with a focus on oxytocin use in labour. Acta Obstet Gynecol Scand 2007;86:315-9. 37. Simpson KR, James DC. Effects of oxyto- cin-induced uterine hyperstimulation during la- bor on fetal oxygen status and fetal heart rate patterns. Am J Obstet Gynecol 2008;199: 34.e1-5. 38. Milsom I, Ladfors L, Thiringer K, Niklasson A, Odeback A, Thornberg E. Influence of mater- nal, obstetric and fetal risk factors on the prev- alence of birth asphyxia at term in a Swedish urban population. Acta Obstet Gynecol Scand 2002;81:909-17. 39. Berglund S, Grunewald C, Pettersson H, Cnattingius S. Severe asphyxia due to delivery- related malpractice in Sweden 1990-2005. BJOG 2008;115:316-23. 40. Cohen WR, Schifrin BS. Medical negligence lawsuits relating to labor and delivery. Clin Peri- natol 2007;34:345-60, vii-viii. 41. Clark SL, Simpson KR, Knox GE, Garite TJ. Oxytocin: new perspectives on an old drug. Am J Obstet Gynecol 2009;200:35.e1-6. 42. American College of Obstetrics and Gyne- cology Committee on Practice Bulletins-Ob- stetrics. ACOG practice bulletin no. 49, Decem- ber 2003: dystocia and augmentation of labor. Obstet Gynecol 2003;102:1445-54. FEBRUARY 2011 Am 43. Clark S, Belfort M, Saade G, et al. Imple- mentation of a conservative checklist-based protocol for oxytocin administration: maternal and newborn outcomes. Am J Obstet Gynecol 2007;197:480.e1-5. 44. Freeman RK, Nageotte M. A protocol for use of oxytocin. Am J Obstet Gynecol 2007; 197:445-6. 45. Hayes EJ, Weinstein L. Improving patient safety and uniformity of care by a standardized regimen for the use of oxytocin. Am J Obstet Gynecol 2008;198:622.e1-7 46. Wagner M. Off-label use of misoprostol in obstetrics: a cautionary tale. BJOG 2005;112: 266-8. 47. Chervenak FA, McCullough LB. Neglected ethical dimensions of the professional liability crisis. Am J Obstet Gynecol 2004;190: 1198-200. 48. Arora V, Johnson J, Lovinger D, Humphrey HJ, Meltzer DO. Communication failures in pa- tient sign-out and suggestions for improve- ment: a critical incident analysis. Qual Saf Health Care 2005;14:401-7. 49. Gawande AA, Zinner MJ, Studdert DM, Brennan TA. Analysis of errors reported by sur- geons at three teaching hospitals. Surgery 2003;133:614-21. 50. Clark SL, Belfort MA, Byrum SL, Meyers JA, Perlin JB. Improved outcomes, fewer cesarean deliveries, and reduced litigation: results of a new paradigm in patient safety. Am J Obstet Gynecol 2008;199:105.e1-7. 51. MacEachin SR, Lopez CM, Powell KJ, Cor- bett NL. The fetal heart rate collaborative prac- tice project: situational awareness in electronic fetal monitoring-a Kaiser Permanente Perinatal Patient Safety Program Initiative. J Perinat Neo- natal Nurs 2009;23:314-23; quiz 324-5. erican Journal of Obstetrics & Gynecology 105 http://www.ismp.org/Tools/highalertmedications.pdf http://www.ismp.org/Tools/highalertmedications.pdf Effect of a comprehensive obstetric patient safety program on compensation payments and sentinel events Materials and Methods Patient safety program Consultant Review (2002) Labor and delivery team training (2003) Electronic medical record charting (2003) Chain of communication for labor and delivery (2003) Dedicated gynecology attending on call (2004) Limitation of misoprostol to induction of labor or cervical ripening for a nonviable fetus (2004) Standardized oxytocin labor induction and stimulation protocol (2005) Premixed and safety color-coded labeled magnesium sulfate and oxytocin solutions (2005) Electronic medical record templates for shoulder dystocia and operative deliveries (2005) Early identification of potential obstetric professional liability cases (2005) Obstetric patient safety nurse (2005) Electronic online communication whiteboard (2006) Recruitment of physician's assistants for labor and delivery (2006) Electronic fetal monitor interpretation certification (2006) Electronic antepartum medical records (2006) Routine thromboembolism prophylaxis for all cesarean deliveries (2006) Obstetric emergency drills (2006) Recruitment of a laborist (2007) Oxytocin initiation checklist (2009) Postpartum hemorrhage kit (2009) Internet based required reading assignments and testing (2009) Compensation payments and sentinel events Results Compensation payments Sentinel events and adverse outcomes Comment References