org
Dedicated gynecology
attending on call (2004)
A gynecology attending on call schedule
was established separately from the ob-
stetric coverage. Before this change, the
labor and delivery attending covered
both the obstetric and gynecology ser-
vices and there had been occasions when
there were concurrent emergency gyne-
cologic and obstetric cases. This situa-
tion prevented the attending from suffi-
ciently covering both services. The added
Grunebaum. Obstetric patient safety measures and compensation payments. Am J Obstet Gynecol 2011. gynecology coverage allowed the labor
and delivery attending to cover the labor
floor exclusively.
granted or renewed if CRM is not com- record charting with Eclipsys XA (Eclip-
pleted and nursing staff and residents sys Corporation, Boca Raton, FL) for all Limitation of misoprostol to induction
are informed that they must take the patients on labor and delivery. OB of labor or cervical ripening
CRM program within a year after em- Tracevue (Phillips, Andover, MA) is for a nonviable fetus (2004)
ployment begins. used for electronic fetal monitoring Misoprostol is not US Federal Drug Ad-
(EFM). All documentation occurs in ministration (FDA) approved for use
Electronic medical record these electronic formats. Paper docu- during labor. There is evidence that
charting (2003) mentation is not allowed, except when misoprostol is not effective,14 and its
Good medical record charting can help the electronic format is temporarily use is associated with an increase in
defend professional liability cases and incapacitated. hyperstimulation/tachysystole.15
may persuade potential plaintiffs to Misoprostol has never been used at the
forego filing a suit11 and electronic Chain of communication for medical center for a live fetus. After the
health records on labor and delivery are labor and delivery (2003) warning from the Searle company dis-
less likely to miss key clinical informa- Communication on labor and delivery is couraging its use in the year 2000, there
tion.12 To facilitate communication and crucial to ensure patient safety and to was no incentive to begin using this med-
to improve patient safety, we were provide the best care for patients and ication at our institution, and our con-
among the first departments in our insti- prevent errors,13 but there are times cern about potential adverse outcomes
tution to require electronic medical when physician’s orders and actions led us to conclude that misoprostol use
TABLE 1
Standardized protocol for induction or augmentation with oxytocin
Item Protocol
a. Only a premixed oxytocin solution is used
................................................................................................................................................................................................................................................................................................................................................................................
b. The oxytocin infusion is limited to intravenous route via an infusion pump
................................................................................................................................................................................................................................................................................................................................................................................
c. A buretrol infusion is used with a “smart pump” (a pump that comes with error reduction system and drug library capabilities)
................................................................................................................................................................................................................................................................................................................................................................................
d. The infusion is piggybacked into the port most proximal to patient
................................................................................................................................................................................................................................................................................................................................................................................
e. A written attending order (electronic template) is required before the start of oxytocin
................................................................................................................................................................................................................................................................................................................................................................................
f. Before the start of oxytocin an attending must document the plan of care including indication, fetal presentation and station,
cervical status, estimated fetal weight, pelvic adequacy, and fetal heart rate assessment.
................................................................................................................................................................................................................................................................................................................................................................................
g. An attending must be available on the same floor as labor and delivery floor at all times while the patient is on oxytocin
................................................................................................................................................................................................................................................................................................................................................................................
h. Before initiation of oxytocin a reassuring fetal heart rate must be present for a minimum of 20 minutes
................................................................................................................................................................................................................................................................................................................................................................................
i. The oxytocin concentration is a premixed solution of 30 U per 500 mL. No individual mixing of solutions is permitted onsite.
................................................................................................................................................................................................................................................................................................................................................................................
j. The oxytocin infusion begins at 1 mU per minute.
................................................................................................................................................................................................................................................................................................................................................................................
k. The infusion is increased by 1 mU per minute no more frequently than every 15 minutes
................................................................................................................................................................................................................................................................................................................................................................................
l. An attending must evaluate, document, and determine the plan of care if the oxytocin dosage reaches 20 mU per minute
................................................................................................................................................................................................................................................................................................................................................................................
m. The maximum oxytocin dosage cannot exceed 40 mU per minute
................................................................................................................................................................................................................................................................................................................................................................................
n. If the oxytocin infusion was discontinued for 20 minutes or less, it may be restarted at a lower rate than before discontinuation. If
it was stopped for greater than 20 minutes then it should be restarted at 1 mU per minute
................................................................................................................................................................................................................................................................................................................................................................................
o. Only a nurse can titrate oxytocin. The nurse can stop or titrate the oxytocin infusion if indicated. The doctor must be notified of
this.
................................................................................................................................................................................................................................................................................................................................................................................
p. The oxytocin infusion must be stopped or titrated for any of the following: uterine hyperstimulation/tachysystole (contractions less
than 2 minutes in frequency and/or lasting longer than 90 seconds and/or more than 5 contractions in any 10 minute period);
elevated uterine resting tone; nonreassuring fetal heart rate tracing; presumed uterine rupture; water intoxication
................................................................................................................................................................................................................................................................................................................................................................................
q. The attending physician must be notified of any hyperstimulation/tachystole, abnormal fetal heart rate changes and/or stoppage
or down titration of oxytocin.
................................................................................................................................................................................................................................................................................................................................................................................
r. Terbutaline may be given if stopping oxytocin does not lead to a normalization of fetal heart rate changes in the presence of
hyperstimulation
................................................................................................................................................................................................................................................................................................................................................................................
s. Oxytocin should be discontinued as soon as a cesarean delivery is planned
................................................................................................................................................................................................................................................................................................................................................................................
Grunebaum. Obstetric patient safety measures and compensation payments. Am J Obstet Gynecol 2011.
should be limited to induction of labor a premixed oxytocin solution, a required delivery.17 More recently, in addition to
and cervical ripening only in the nonvi- written attending order and note before seizure prophylaxis and tocolysis, pre-
able fetus. starting the oxytocin infusion, a stan- vention of cerebral palsy was added as a
dardized starting dosage and increases, potential indication for giving magne-
and a “smart pump” (a pump that comes sium sulfate on labor and delivery.18,19
Standardized oxytocin labor induction
with an error reduction system and drug To improve the safe use of magnesium
and stimulation protocol (2005)
library capabilities). The protocol paid sulfate, we implemented several changes,
A standardized protocol enables the staff
special attention to tachysystole and fetal including the use of premixed magne-
to become facile in handling the myriad
heart rate concerns. If there was tachysy- sium sulfate and oxytocin solutions,
of problems that occur on any busy unit,
tole, or there were concerns about the color coded magnesium sulfate and oxyto-
quickly and efficiently.16 In 2005, we im-
fetal heart rate, the oxytocin infusion had cin containers and intravenous lines, as
plemented a standardized low-dose oxy-
to be decreased or stopped. well as using both with “smart pumps.”
tocin labor induction and stimulation
policy (Table 1) and a standardized or-
der template was designed in the hospi- Premixed and safety color-coded Electronic medical record templates
tal’s electronic ordering system (Eclip- labeled magnesium sulfate and for shoulder dystocia and operative
sys, Atlanta, GA). No other method of oxytocin solutions (2005) deliveries (2005)
using intrapartum oxytocin was permit- Magnesium sulfate is among the most Both shoulder dystocia and operative de-
ted. Highlights of this protocol included dangerous solutions used on labor and liveries are associated with an increase in
neonatal and maternal injury and conse- ity cases and expedited reviews would be Electronic fetal monitor interpretation
quently litigation.20 Making the correct implemented. If a clear medical error certification (2006)
diagnosis, performing the correct ma- was identified, we planned to approach Effective communication is essential
neuvers, time management, prevention the patient with the goal of an early set- when discussing and interpreting fetal
of traction, and documenting manage- tlement. Since the implementation of heart rate and uterine activity and it re-
ment and maneuvers are therefore es- this program, 1 adverse outcome (an quires a mutual understanding of termi-
sential.21 We designed and implemented early neonatal death) was identified and nology. We required that all staff in-
required templates and electronic medi- quickly settled. volved in interpreting electronic fetal
cal charting tools for several clinical sit- monitoring, including attendings, resi-
uations, including shoulder dystocia and Obstetric patient safety nurse (2005) dents, physician assistants, and nurses,
operative delivery (Table 2). As part of our patient safety efforts, our become certified in electronic fetal
insurance carrier (MCIC Vermont, Inc) monitoring by National Certification
Early identification of potential funded an obstetric patient safety nurse. Corporation (NCC), a not-for-profit or-
obstetric professional liability The patient safety nurse is employed full- ganization that provides a national cre-
cases (2005) time by the hospital and is involved in dentialing program for nurses, physi-
Our medicolegal department met with staff education, team training, imple- cians, and other licensed health care
our department and decided that early mentation of protocol changes on labor professionals. In addition, all staff are
identification of adverse obstetric out- and delivery, obstetric emergency drills, required to use the National Institute
comes and potential professional liabil- and collection of data. of Child and Human Development
(NICHD) standardized language for fe- rhage. Obstetricians, anesthesiologists, program (http://www.InPrep.com) for
tal heart rate interpretation23 and tem- neonatologists, nurses, residents, fellows, protocols and other publications related
plates for documenting fetal heart rates and physician assistants participate in to labor and delivery safety. All attend-
based on the NICHD language were these drills. The shoulder dystocia and ma- ings and residents have been required to
added in the electronic charting tools. ternal hemorrhage drills are performed regularly read assigned literature and
with a maternal and fetal manikin and in pass a multiple choice test related to the
Electronic antepartum small groups of 6-8 individuals so each can reading material.
medical records (2006) obtain practice in performing the neces-
We implemented uniform antepartum sary fetal manipulations. Compensation payments
medical record charting (Epic Systems The main objectives of the shoulder and sentinel events
Corporation) for all full-time faculty and dystocia drill are to diagnose shoulder We performed a retrospective review of
staff patients (about 75% of all deliver- dystocia, prevent injury by performing obstetric compensation payments from
ies). The availability of electronic ante- the correct maneuvers, time manage- 2003 to 2009 collected by the MCIC. Ob-
partum charts on a 24-hour/7 day a week ment, prevention of traction, and teach stetric compensation payments were de-
basis improves availability of data, such proper documentation. fined as all actual payments made as a
as laboratory results and helps in im- Recruitment of a laborist (2007) sum of indemnity paid plus medicolegal
proving communication among the expenses paid for by the hospital for de-
Inhouse oncall attending coverage is
staff. fending the case. In New York City, most
provided on a 24-hour basis by one of
professional liability suits are initiated
the full-time faculty attendings that have
Routine thromboembolism within 2-3 years after delivery, and they
obstetric privileges. To address lifestyle
prophylaxis for all cesarean are often not settled until many years
and patient safety concerns, Weinstein
deliveries (2006) later. Therefore, in addition to actual
recommended a practice of having hos-
compensation payments, we also as-
Pulmonary thromboembolism is among pitalists and laborists,28 Clark recom-
the leading causes of maternal deaths in sessed new and ongoing significant pro-
mended a reassessment of group obstet-
fessional liability suits (expected at
the United States, and most events of ve- ric practice to improve patient safety,29
nous thromboembolism can be reduced and a survey showed that laborists can $1,000,000 and above) and potential fu-
with either medical or mechanical throm- have a high career satisfaction.30 In 2006, ture professional liability suits. Data on
boprophylaxis,24,25 and it has been sug- sentinel events at our institution were
we hired a laborist to provide inhouse
gested that a systematic reduction in ma- evaluated from 2000 to 2009 by analyz-
coverage for the labor and delivery floor
ternal death rate in the United States can ing data obtained from a sentinel event
for nights and weekends and therefore
be expected if all women undergoing ce- adverse outcome database that is pro-
reduce inhouse oncall responsibilities of
sarean delivery receive thromboembo- spectively recorded by the hospital’s
other physicians.
lism prophylaxis.5 Therefore, in addition quality assurance committee. Sentinel
to using pharmacologic anticoagulation Oxytocin initiation checklist (2009) events are determined by the Medical
prophylaxis for high-risk patients, we We implemented a checklist with the Center according to Joint Commission
also implemented the routine use of in- most important elements of the stan- standards. The Joint Commission de-
termittent lower extremity pneumatic dardized oxytocin policy. Completion of fines a sentinel event as “. . . an unex-
compression devices for all cesarean the checklist is required by nurses before pected occurrence involving death or se-
deliveries. initiation of oxytocin for induction or rious physical or psychological injury,
stimulation of labor. or the risk thereof . . .” (http://www.
jointcommission.org/SentinelEvents/).
Obstetric emergency drills (2006) Postpartum hemorrhage kit (2009) At our institution, sentinel events included
The Joint Commission recommends We made available a single hemorrhage kit maternal deaths, and serious newborn in-
that obstetric departments consider pe- that includes the 4 most important drugs juries, including birth asphyxia and hy-
riodically conducting clinical drills to used for postpartum hemorrhage (oxyto- poxic ischemic encephalopathy.
help staff prepare for shoulder dystocia, cin [Pitocin; King Pharmaceuticals, Bris-
conduct debriefings to evaluate team tol, TN], misoprostol [Methergine; No- Results
performance, and identify areas for im- vartis Pharmaceuticals, Basel, Switzerland, Compensation payments
provement.13 Such drills appear to im- Cytotec; Bristol-Myers Squibb, Skillman, Figure 2 shows the yearly obstetric com-
prove recognition and management of NJ], carboprost [Hemabate; Pfizer, New pensation payment totals paid out from
shoulder dystocia and can improve phy- York, NY]). 2003 to 2009. The 2009 compensation
sician’s communication skills as well as payment total constituted a 99.1% drop
reduce traction forces.26,27 Drills were Internet based required reading from the average 2003-2006 payments
instituted over time for maternal cardiac assignments and testing (2009) (from $27,591,610 to $ 250,000). The av-
arrest, shoulder dystocia, emergency ce- We created an inhouse internet-based erage yearly compensation payment in
sarean section, and maternal hemor- password protected reading and testing the 3 years from 2007 to 2009 was
tween staff. The main goal of these 2003-2009 $117,991,848 6.9 (0.6–17.1)
..............................................................................................................................................................................................................................................
changes was to improve patient safety Grunebaum. Obstetric patient safety measures and compensation payments. Am J Obstet Gynecol 2011.
and decrease adverse outcomes. We did
not expect a rapid and significant effect
on compensation payments. below the reported 25 of 10,000 deliver- sistent variations even within the same
Our results show that implementing a ies.34 On follow-up, this infant had no institution.42 Clark et al41 concluded that
comprehensive obstetric patient safety moderate or severe neurodevelopment a physiologically sound and evidence-
program not only decreases severe ad- impairments and hence for the last 3 based approach to oxytocin use is possi-
verse outcomes but can also have an im- years there are presently no known HIE ble and explained that it may be difficult
mediate impact on compensation pay- brain damaged infants “in the pipeline.” to effect change in practice when physi-
ments. Beginning with the fourth year of As the amount of compensation pay- cians so often see no untoward effects of
the program, compensation payments ments for an infant with neurodevelop- excessive uterine activity.
began to drop significantly. Yearly pay- ment impairments can be well in excess It has been suggested that implement-
ments for the most recent 3 years (2007- of $10 million in New York City, the pre- ing a uniform oxytocin policy and using
2009) averaged $2,550,136 as compared vention of each and every 1 of these cases an oxytocin checklist may improve peri-
with average yearly payments of is crucial to minimize such payments. natal outcomes.43-45 We also found that
$27,591,610 for the preceding 4 years The Institute for Safe Medication implementing a uniform oxytocin pro-
(2003-2006). The $25,041,475 yearly Practices (ISMP) has added oxytocin to tocol and checklist helped our staff make
savings in compensation payments for its list of high alert medications.35 The better use of oxytocin and allowed nurses
the last 3 years alone dwarf the incre- use of oxytocin during labor has been to focus on better patient care instead of
mental cost of the patient safety program found to be associated with malpractice following protocols that varied from
and are well above those reported by claims.36 Using oxytocin during labor physician to physician. Implementing a
Simpson et al.32 In our opinion the doc- may have a negative impact on the prob- uniform oxytocin protocol likely con-
umented success of our patient safety ability of successfully defending a pro- tributed to our improved patient safety
improvement program in decreasing fessional liability case, and its misuse, and prevention of adverse outcomes.
compensation payments for the past especially its association with hyper- Our experience supports the recommen-
years understates the true long-term im- stimulation, has been alleged to be re- dation that: “. . . Malpractice loss is best
pact of the program on patient safety, as sponsible for many if not most of the ad- avoided by reduction in adverse out-
we expect significant savings to continue verse outcomes and professional liability comes and the development of unam-
into the future. litigation involving abnormal labor.37-40 biguous practice guidelines.”5
Our neonatal intensive care unit is a The best defense against legal chal- Many pregnant women are given mi-
center for “cool cap” treatments (treat- lenges involving the misuse of oxytocin soprostol “off-label” for cervical ripen-
ment of infants with neonatal encepha- is to use the drug judiciously and in ac- ing and labor induction even though this
lopathy with hypothermia helmets), and cord with institutional policies.41 How- medication is not approved for use in la-
it regularly treats infants with HIE.33 Of ever, despite reports that standardized bor and is associated with an increase in
the more than 50 infants with HIE who and uniform practice patterns are uterine hyperstimulation and resultant
were treated in this program over the last known to have better outcomes than fetal asphyxia and uterine rupture, am-
3 years, only 1 among our own 15,932 greater practice variations, medical prac- niotic fluid embolism, perinatal mortal-
deliveries came from our institution (the tice continues to be characterized by ity, and HIE in surviving infants.46 Be-
only 2007 sentinel event). Our observed wide variations that have little basis in cause of these concerns, we decided to
departmental incidence of 0.6 HIE of clinical science.16 This is especially true limit the use of misoprostol in labor to
10,000 deliveries in the last 3 years is well for oxytocin usage, which has many per- inductions in a nonviable fetus.
Good teamwork promotes profes- To paraphrase Ralph Waldo Emerson 9. Mann S, Pratt SD. Team approach to care in
sional integrity and is essential in deliv- (1803-1882) who said “Life is a journey labor and delivery. Clin Obstet Gynecol 2008;
51:666-79.
ering optimal patient care,47 and failure not a destination,” we believe that 10. Nielsen PE, Goldman MB, Mann S, et al.
in communication and teamwork is of- achieving patient safety on labor and de- Effects of teamwork training on adverse out-
ten cited as a common cause of adverse livery is a journey, not a destination. comes and process of care in labor and deliv-
events.6,48,49,50 We found that teamwork Improving patient safety requires ex- ery: a randomized controlled trial. Obstet Gy-
can be further improved in labor and de- necol 2007;109:48-55.
tensive and considerate changes, physi- 11. Williams DG. Practice patterns to decrease
livery by maintaining an electronic com- cian and staff cooperation, constant vig- the risk of a malpractice suit. Obstet Gynecol
prehensive communication board as the ilance, flexibility, and rapid adaption 2008;51:680-7.
essential hub for communications among based on new experiences and it may 12. Eden KB, Messina R, Li H, Osterweil P,
staff. take considerable time to reap financial
Henderson CR, Guise JM. Examining the value
Sleep deprivation can impair safety, of electronic health records on labor and deliv-
benefits in the future. ery. Am J Obstet Gynecol 2008;199:
and establishing a laborist program has Making significant changes on a labor 307.e1-9.
been recommended to improve safety.28 13. Joint Commission on Accreditation of
and delivery unit including such features
The hiring of a laborist allowed our ob- Healthcare Organizations: Sentinel event alert.
as the implementation of a standardized
stetricians to work reduced inhospital Issue 30, July 21, 2004. Available at: www.
oxytocin protocol, electronic charting, jointcommission.org/SentinelEvents/Sentinel
hours and likely contributed to the im-
team training, and improving situational EventAlert/sea_30.html. Accessed July 1,
proved safety climate and improved out-
awareness through a central communi- 2010.
comes at our institution. 14. Fonseca L, Wood HC, Lucas MJ, et al. Ran-
The traditional erasable labor and de- cation system, should be considered
domized trial of preinduction cervical ripening:
livery white board usually reflects situa- by all obstetric services. As we have misoprostol vs oxytocin. Am J Obstet Gynecol
tional awareness, the state of knowing shown, these changes can increase pa- 2008;199:305.e1-5.
what is going on with patients and in the tient safety, decrease sentinel events, 15. Hofmeyr GJ, Gülmezoglu AM Vaginal miso-
and, as a consequence, reduce compen- prostol for cervical ripening and induction of la-
unit. Unfortunately, most obstetric units bour. Cochrane Database Syst Rev 2003;
still use a dry erasable white board that sation payments. f CD000494.
has severe limitations, including accessi- 16. Wennberg JE. Unwarranted variations in
bility and space limitations. We believe healthcare delivery: implications for academic
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