Webinar – Safeguarding the Future – Reducing Obstetric Liability Risk

Webinar – Safeguarding the Future – Reducing Obstetric Liability Risk

[Operator] At this time all participants are in a listen only mode. During the question and answer session please
press *1 on your touch-tone phone. Today’s conference is being recorded if you
have any objections you may disconnect at this time. And now I would like to turn the meeting over
to Barbara Easterling. You may begin. [Barbara] Thank you. Good afternoon, I am Barbara Easterling from HRSA’a
Office of Quality and Data within the of Bureau Primary Health Care. Thank you for joining us for this audio conference
entitled “Safeguarding the Future: Reducing Obstetric Liability Risk”. Here at HRSA we continue to listen to
your feedback and suggestions on risk management quality and accreditation needs.

Today with us we have our partners, Keystone Peer Review also known as KePRO, and the ECRI Institute. Who look forward to meeting your risk management
needs by providing topics that will enable you to enhance your provision of services.
I will now turn the presentation over to Amy
Goldberg-Alberts, Program Director for the ECRI Institute who will lead us through the broadcast. At the end of the broadcast we will be able to answer your questions about this topic. Thank you again for joining us. [Amy] Thank you Barbara and thank you everyone for attending. I am Amy Goldberg-Alberts, Director of the Program of Clinical Risk Management Resources provided on behalf of HRSA here at ECRI Institute. I’ll begin with a couple of words about KePRO, a quality improvement and care management organization founded in 1985 and headquartered in Harrisburg, Pennsylvania. KePRO selected ECRI Institute to provide you free, clinical risk management resources. KePRO works with HRSA on Medical Malpractice Claims Reviews and Risk Management Services under a contract initiated in 2004. and provides risk management and patient safety technical assistance to Section 330 FTCA deemed Health Centers and Free Clinics. ECRI Institute, an independent non-profit applied research institute, over the past four decades, has helped thousands of healthcare organizations
across the nation develop patient safety, health care quality and risk management programs to improve patient
care. Over half of all the HRSA grantee organizations
throughout the country have now activated their userid’s and have set up passwords so that they can access the full
suite of clinical risk management resources being made available by ECRI Institute to you
free, on behalf of HRSA. This website contains risk management guidance
articles, sample policies and procedures, risk assessment tools, educational courses with TME credit, and other resources to make your jobs easier. So that you can learn from others, so that you can
customize material to your own organizations needs and not have to reinvent the wheel you can read about all of the resources offered
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and you can login from
http://www.ecri.org/Clinical_RM_Program With your audio conference registration confirmation
you received an email link to the slide handout we hope that you’ve had the opportunity to
print or download the handout. If for any reason you do not have it in front
of you it’s also available now
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by going to
http://www.ecri.org/Clinical_RM_Program You do not need a password in order to download
the handout.
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once more that address is
http://www.ecri.org/Clinical_RM_Program Throughout this audio conference we will refer to
slide numbers in the handout so that you can follow along. This is our sixth in a series of brown bag audio conferences all of which are archived on the website if
you Ms. them live. I am pleased now to introduce our speakers
for today’s program. Madelyn Quattrone and Kathy Shostek,
will be our speakers. Before joining ECRI Institute in 1999, as a Serior Risk Management Analyst, Madelyn was a board certified civil trial
attorney. She has nearly twenty years experience defending physicians, nurses, hospitals, and other health care providers. Her extensive trial experience includes the Defense of
Obstetricians, certified nurse midwives, obstetrics nurses,
and hospitals in cases involving brain-damaged infants. At ECRI Institute Madalyn is a Senior Risk Management Analyst and she serves as legal editor of risk management
publications. For those of you on our previous audio conferences,
you already are familiar with Kathy’s experience in ambulatory care risk management. Kathy is a nurse with twenty years experience in health care risk
management, the most recent of which have been focused on patient safety and medical
error prevention. She has risk management consultative experience within
the medical malpractice insurance industry, and management experience at the corporate risk management level of a large multi-specialty physician group. Ms. Shostek serves as ECRI Institute’s chief risk management and patient safety liaison to the HRSA funded health centers and free clinics. With that I will first hand the program over
to Madelyn. [Madelyn] Thank you Amy and welcome everyone. Slide 4 contains the objectives for today’s audio conference. In order to lay the foundation for today’s program we’ll first provide some background information on the magnitude of the risks involved in obstetrical practice by reviewing malpractice claims frequency and severity. Then we’ll look at common high risk areas in obstetrical practice and review ways to reduce risks drawing from successful perinatal safety initiatives
and addressing important informed consent issues. Throughout this program we will refer to resources available at the clinical risk management website that are available to help you address the risks in your obstetrical practice. On slide 5 we see that 91% of obstetricians
have been sued for professional negligence, according to the results of 2009
ACOG survey on professional liability. Claims experience also begins early
in obstetricians careers. 43% of respondents to this survey
reported at least one claim arising from their residency experience. A report just released from the American Medical Association’s
2007/2008 physician practiced information survey of 5,825 positions, across 42 specialties, revealed that the number of claims per 100 physicians was more than five times greater for general surgeons and obstetrician gynecologists then it was for other specialists such as
pediatricians and psychiatrists. Obstetric cases are also among the highest in damage awards of all specialties. Among examples are a $100 million
damage award in year 2000 by a Philadelphia Pennsylvania jury, a $60.5 million Florida verdict in 2008 and $38.5 million verdict in 2009
in Connecticut. These astronomical verdicts were awarded in obstetrical
cases involving severely impaired infants. On slide 6, we see a summary of a claims study by the Physician Insurers Association of America or PIAA. This report from PIAA data sharing project noted more than 5,400 cesarean section closed claims between the years 1985 and 2009. Among these claims 38% were paid with an average indemnity of $541,883, that’s 2009 dollars. PIAA reviewed claims in 12 year increments
and found a 21% decline in the number or frequency of claims but over that same period the average
indemnity payment, that is monies paid to claimants increased
by 29%, so although the number of claims dropped the claims severity increase. Moving to slide 7, nearly half of the claims for brain-damaged
infants resulted in payments. Compensation for a brain-damaged infant may include an award for pain and suffering, past, president, and future medical expenses for life-long care, loss of potential income, and hedonic damages. That is the loss of enjoyment of life, in jurisdictions where this legal cause
of action is recognized. Parents may recover damages for their emotional
distress where the facts and circumstances warrant so under applicable state law. Plaintiffs typically present evidence to support
their damage claims with testimony and evidence provided by forensic economic expert witnesses and
or nursing and rehabilitation professionals. Typically a trial will involve some display or brief
presentation of the injured child, during the trial, for example a brain injured child, for example
maybe 4 years old, may be brought into a courtroom in a wheelchair to allow the judge or jury
to see the child. In addition plaintiffs’ attorneys typically present
as evidence of damages a carefully edited day in the life video that illustrates the child’s
daily struggles and challenges as well as the parents’ efforts to care for the
disabled child around the clock. KePRO’s medical review and risk analysis summary for HRSA fiscal year 2009 lists obstetrics related incidents on
slide 8 as the most costly category resulting in malpractice claims. Costs are represented by the line graph and
noted as the highest point on the line, so although diagnosis related incidents are more
frequent as noted by the bar graph obstetrics presents the highest risk in
terms of cost or severity and when we are concentrating on risk reduction severity should always be the primary focus. On slide 9, is an example of a high severity case involving
allegations of negligence during childbirth that reportedly resulted in the infant experiencing
quadriplegia. In their law suit brought under the Federal Tort
Claims Act, the plaintiffs alleged negligence against the
involved obstetricians, pediatricians, obstetrical and pediatric nurses, and the hospital. They alleged that the defendants failed to properly
assess and treat the mother who was admitted with unknown group B strep status. They also alleged that the defendants failed to
follow up and convey information to other members of the health care team about the need to follow up on testing for group B strep during the anti natal period, and failed to order antibiotics when the pregnant patient presented
with unknown GBS status and further failed to recognize and respond
to the mother’s risk of infection as a result of suspected prolonged rupture
of the membranes and that the nurses failed to advocate on behalf of the mother. The plaintiffs further alleged that the defendants failed to follow the chain of command when a physician did not timely respond to the nurses
request to come to the hospital. There were additional allegations of negligence against the pediatrician and nurses that related to delay in diagnosis and treatment. After a week-long trial before a federal judge, sitting without a jury, judgment was entered for $22.6 million to be
paid by the federal government on behalf of the physicians involved. That damage award within addition to a previous $6.5 million out of court
settlement that was reached with the hospital before trial. On slide 10, are the three highest risk areas reported by PIAA for claims related
to common obstetrics practices. Cumulative data from PIAA close claims from
1985 through 2007, shows that the claims associated with cesarean section delivery were the most prevalent and resulted in the highest average and highest total
indemnity payments. While these statistics generally refer to delays
in responding to fetal distress and or delays in performing cesarean sections
resulting in infant brain-damage it should be noted that the current rate of cesarean
deliveries at over 30% in the United States is also cause for concern. We will address this further a little later in
the program Forceps deliveries were associated with significantly
fewer claims but more more than half the forceps delivery claims in law
suites resulted in indemnity payment. Nearly half of all claims involving a brain-damaged
infant closed with an indemnity payment. And for claims closed in 2007, the claims that involved brain-damaged infants
had the highest average indemnity payment totaling more than $688,000. Shoulder dystocia was the third most frequent patient condition associated with claims closed by PIAA in 2007. 45% of these claims resulted
in an indemnity payment averaging nearly $453,000. In PIAA’s cumulative analysis of claims involving
obstetric and gynecological surgery the associated issues listed on slide 11 rose to the top in terms of frequency. In just a few minutes I will discuss
informed consent and review the latest recommendations by the
American Congress of Obstetricians and Gynecologists Committee on ethics, statement on informed consent released in 2009. The legal concept of vicarious liability when it applies, assigns legal responsibility
for the wrongdoing of one individual to another individual, depending on the facts, circumstances and state law. For example, a physician who directs a nurse to
act in a manner that violates facility policy might be held vicariously liable if the nurse’s
action is found to have been negligent. And so obstetrical providers need to be concerned
about the following issues; supervision, chain of command, and communication among the obstetrical team and clearly defining the roles and responsibilities
of ancillary care providers Fetal demise and other adverse outcomes
have been associated with failure to obtain and remain aware of a patient’s full medical and obstetrics history
and or failure to conduct a careful evaluation of the patient’s medical and
non-medical risk factors for adverse outcome. Communication failures among providers and
inadequate documentation also amplify the risk to the patient. During a difficult labor members of the obstetrics team should resolve any differences of opinion among themselves about the patient’s
proposed plan of care and resolve team differences regarding their
opinions out of the hearing range of the patient or family members. It cannot be over emphasized that communication
failures may directly result in patient injury and
poor communication between provider and patient, resulting in patient dissatisfaction and motivates
litigation. For example recent studies show that physicians
often don’t realize if they are not on the same page as the patient. A simple way to find out is to ask the patient to
repeat to you in her own words what she has been told. Slide 12, reviews informed consent issues
and obstetrics GYN claims. But so many informed consent claims result in a
verdict or other payment demonstrates that these claims are not frivolous. ACOG for example, in its recent statement, states that informed
consent is an ethics issue. It expresses respect for the patient’s right to make medical decisions and a caring relationship
with health care providers. Informed consent enables patients to become
actively involved in their care and ACOG emphasizes that communication is the bedrock
of informed consent. And that it requires an environment that fosters and facilitates communication. ACOG also emphasizes that informed consent is an
information sharing process that occurs over time. It is not just obtaining a signature on a
form. Informed consent involves respect for the
whole patient and takes into account circumstances in which
surrogate informed consent may be required or emergencies when consent cannot be obtained. And finally ACOG emphasizes that informed consent incorporates
ethics principles As well as state and federal legal requirements and institutional policy. Moving to slide 13, we see a list of the top five obstetrics related incidents for health centers and clinics by cause of occurrence. They include improper management, improper performance of vaginal delivery, improper
choice of delivery, delay in performance, and failure to identify fetal distress. But it should be noted that a category of other
actually ranked fourth in cause of occurrence. On slide 14, we note that training and lack of
supervision are secondary factors in Federal Tort Claims Act covered incidents
reviewed by KeyPRO and they assumed dominance during the fiscal
year 2009. Training needs repeatedly identified included
many related to obstetrics such as electronic fetal monitoring, shoulder dystocia, and preeclampsia. Communication issues were also among the top
secondary factors identified by KeyPRO in medical malpractice incidence claims for year 2009 and 2010 involving HRSA Federal Tort Claims Act health centers and
free clinics. Over the next several slides we’ll review a report of a
malpractice case involving a delay in responding to fetal distress. As we go through the reported facts as they
occurred please try to spot the patient safety and risk
issues. The patient was an obese woman para 4, pregnancy induced hypertension
controlled with atenolol and gestational diabetes. She was admitted at three centimeters, 50% effaced, -4 station. The fetus was transverse lie, the fetal heart rate ranged between
130 and 140, an epidural was administered, the fetus was in vertex position, and after the amniotic fluid was ruptured,t was clear, a scalp electrode was placed.
At 12:30 pm the fetal heart rate was 70, a scalp pH was ordered, the attending obstetrician decided on a cesarean
section. At 12:40 pm the fetal heart rate
ranged between 110 and 120 with scalp stimulation it ranged between 130 and 140 and so the obstetrician cancelled the cesarean section. At the same time the mother was 6-7 centimeters, 75% effaced and the fetus was -3 station. Moving to slide 16, at 1:00 pm the fetal heart rate
dropped, a cesarean section was reordered, the fetal heart rate recovered and the cesarean section
was cancelled. In between 1:00 and 3:00 pm the fetal heart rate was shown to have increased but there were variable decelerations, the patient
was repositioned, the obstetritian was notified. The nurse was worried, informed the head nurse who
conferred with the attending. At 4:00 pm the fetal baseline was 180. At 4:20 pm the fetal heart rate dropped to
the 90s. There were variable decelerations, the attending tried to get a scalp pH while the fetal
heart rate was dropping with recurring deep decelerations. The attending was unsuccessful, the RN paged another
obstetrician but he or she was unavailable. And on slide 17, at 4:45 pm the mother was fully dialated, the scalp pH showed severe acidosis,
the patient was taken immediately to the OR for vaginal
delivery. The attending believed that vaginal delivery
would be faster than a cesarean section but declined vacuum assist. Vaginal delivery occurred, there was a tight double nuchal cord. Apgars were 1, 3, and 5. The pediatric resident transferred the infant to
the ICU. The blood cord pH was 6.86, Metabolic acidosis, hypoxemia and DIC was diagnosed, and on the 5th day the infant’s life support was removed. On review the case was found to have met ACOG’s criteria for
acute intrapartum hypoxic event and an autopsy was normal in the sense that there were no genetic abnormalities. The conclusions reached from the claimant’s analysis, was that the attending obstetrician demonstrated
inexperience and indecision. That he lacked confidence in his knowledge of a
concerning fetal heart pattern, and backed off a plan for cesarean section. The obstetrician failed to consult a more
experienced obstetrician in the face of his own uncertainty. The attending obstetrician did not appreciate
the patient’s medical history, which may have been a contributing factor to the adverse outcome. The attending also met the patient for the first
time on the day of labor and delivery. Communication among the obstetrical team broke
down and may have resulted in delayed response to fetal distress because of inability to resolve the differences
and failure to seek a consultation. Although the obstetrics nurse did speak with
her supervisor about her concerns, the nurse’s discomfort was not resolved because her
supervisor did not continue the chain of command until the concerning issues were appropriately resolved. The end result, was the birth of an infant whose adverse outcome
met ACOG criteria
for acute intrapartum hypoxic event. We now have reviewed the highest risk areas for obstetrical practice, and identify contributing factors through
malpractice claims reviews. In the next part of this program Kathy will
discuss strategies for reducing these risks and improving patient safety. But before I hand over the program to Kathy Kathy will conduct her first poling question
to gauge what levels of obstetrical care participants in today’s program are providing. [Kathy] Thank you Madelyn. Please listen to the following instructions in regards to our
polling question. If your health center directly provides pre- and or post natal care Please press *1. So, if your health center provides prenatal
care and postnatal care or either prenatal care or postnatal care only
please press *1. If your health center directly provides complete
obstetrical care through labor and delivery Please press *2. And if your health center does not provide direct pre-natal care or post-natal care or does not provide either Please press *3
Thank you for taking the time for our poll. We are now on slide 19, which summarizes the
five key principals forming the foundation of the redesigned patient
safety process implemented over the past decade by the Nashville
Tennessee based Hospital Corporation of America. These strategies include standardizing processes and procedures. For example using perinatal care bundles for oxytocin induction and augmentation of labor. Creating a culture of safety. hTis includes improving communication and teamwork
and empowering team members to intervene anytime patient safety is jeopardized. This topic is covered in detail in the clinical
risks management basics audio conference, which is archived on the website. Viewing cesarean delivery as a process alternative
and not an outcome or a quality endpoint. Despite evidence that a cesarean section rate
of 5-10% would be optimal in reducing the risks inherent with more
invasive surgical deliveries and that rates approaching 15%
may have aggregate harm to a population, the current national cesarean section rate in the United States is
over 30%. Reasons given for this steady and alarming increase
over the past decade are numerous, but they include, side effects from common labor intervention
such as elective induction for nulliparous woman with an unfavorable cervix. Providers or facilities unwilling or unable
to offer a vaginal birth after a cesarean, due to liability concerns or obstetrical coverage shortfalls and a limited awareness in general that harms
are more likely with cesarean section. Well time does not allow a discussion of vaginal
birth after cesarean per se, I would mention that ACOG in consideration of the 2010 National Institute of Health Report on vaginal birth after cesarean and a review of the scientific evidence, has just released an updated practice bulletin
on the topic, published in the august 2010
issue of Obstetrics and Gynecology. The next strategy is, using unambiguous practice guidelines. For example, having 24 hour hospital
obstetric coverage and physician availability at the bedside within 5 minutes during vaginal birth after cesarean section. And the last strategy but certainly not the least is conducting effective peer review based on
perinatal quality and risk indicators. Use of these redesigned patient safety processes for obstetrical care by HCA, has been associated with improved perinatal outcome , a reduced primary cesarean delivery rate, and lower maternal and fetal injury, with reduced litigation as evidenced by a
reduction in the number of claims by one half. And a nearly five fold reduction in the cost of claims. HCA is not alone in its success. A number of other organizations and cooperative initiatives to improve perinatal safety and reduced liability risk have also seen positive accomplishments. Over the next several slides we will review some of these specific strategies. Slide 20 contains examples of successful uniform processes for obstetrical care. In the practice of obstetrics, process standardization
helps to ensure that all caregivers on the team know what the attending provider is expecting
and what the other team members rolls are. Perinatal care bundles are defined as a group
of evidence-based interventions, that when executed together result in better outcomes than when implemented
individually. The all or none feature is the source of the
bundled power. On slide 21 are two care bundles that
were implemented as part of an innovative perinatal improvement project by Premier, Ascension Health, and the Institute for Health
Care Improvement. The group first reported on their project in a
white paper called the Idealized Design of Perinatal Care. Among the key components of this project are reliable processes to evaluate and manage labor and delivery using these perinatal bundles. The bundles summarized here are aimed at improving the use of oxytocin, a commonly used high risk drug. Many malpractice cases against obstetricians allege misuse or overuse of oxytocin. Oxytocin was a number one drug among the top
10 medications involved in wrong dose and overdose errors in the labor and delivery unit reported
by the Pennsylvania Patient Safety Authority in its advisory on medication errors and
labor and delivery. A guidance article based on this advisory is available at the clinical risk management website. The American Congress of Obstetricians and Gynecologists
and the Association of Women’s Health, Obstetric, and Neonatal Nurses, or AWHONN accept the definition of fetal monitoring,
by the National Institute for Child Health and Human Development, or I’ll call NICHHD, use of these definitions provides a standard
terminology to describe fetal heart rate monitoring as well as a plan of action to ensure compliance
with elements of these perinatal bundles. Documented pelvic examination to determine
fetal presentation is part of both bundles, as is acceptance of the NICHHD definition the nomenclature
for uterine activity. Important to the success of this perinatal improvement project, is the use of the same validation tool for
interpretation of the fetal heart rate among obstetric providers and nurses. When all members of the labor and delivery management
team understand each other and can communicate effectively, patient safety is enhanced and risk of communication failure is
reduced. Slide 22 lists references with sample protocols and check
lists and documentation forms, to guarantee that all elements of the bundles are dependably addressed and ensure the safest use of oxytocin and other drugs, the use of standardized order tab orders that and documentation forms with checkboxes and
fill-in blanks are advocated. These checklists and forms are meant to serve as
forcing functions aimed at making it easy to do the right thing. On slide 23, we see the components of another successful patient safety strategy focused on obstetrical care. This multi-faceted approach, was used to improve
safety and reduce the rate of adverse outcomes in obstetrics By the Yale New Haven Hospital in partnership
with its medical malpractice carrier. Goals were to decrease injury as well as liability loses by creating a culture of safety and initiating specific risk reduction practices. Listed here on the slide are the elements of the program. Yale began with a review of their obstetrical services by outside expert consultants. These yielded recommendations for improvement. They developed a series of protocols and guidelines,
delineating practice standards. A patient safety nurse position was
created to evaluate clinical care and outcomes, activate an anonymous event reporting system and database, initiate team training and electronic fetal monitoring
certification. An obstetrical patient safety committee was formed to define and track adverse events and address the needs of protocols. An assessment of the safety culture was undertaken followed by teamwork training as a condition for employment
or clinical privileges. Electronic fetal monitoring certification
that incorporated the NICHHD guidelines and culminating in an examination was implemented and all providers and staff responsible for
fetal monitoring were obliged to take the exam. Effectiveness of these initiatives was gauged
in part by the use of a quarterly composite adverse event rate, expressed as the number of deliveries or mothers, with associated adverse events for total
deliveries for each three month period. On slide 24 is a line chart approximating Yale’s three-year trend in the adverse
outcome index. Defined as the number of deliveries with one or more identified adverse events as a proportion of total deliveries. The types of adverse events included in the analysis, are listed in the left hand corner of the slide. The downward slope of the line is indicative
of the progressive effectiveness of the obstetric patient safety strategies in reducing the adverse outcome index. Other aspects of care were also monitored and these included the cesarean
delivery and episiotomy rates, occurrences of shoulder dystocia, and changes in the safety culture and electronic
fetal monitoring training results. During the course of the project, perceptions among nurses and physicians of a good team work climate improved from 16% to 89% and from 40% to 72% respectively. We now turn our attention to operative vaginal deliveries
and slide 25 lists the Institute for Health Care Improvement
vacuum delivery bundle. It begins with requiring that consideration be given
to other delivery alternatives. Serious complication of vacuum deliveries occur
in approximately 5% of

vacuum attempts. Patients need to be aware of these risks and
therefore informed consent should be obtained and documented. Because trauma associated with operative vaginal
deliveries are varied, it must be insured that forceps and vacuum
extractors are used according to ACOG guidelines. Operative vaginal delivery becomes a high risk procedure when there is a low chance of success, when the provider uses a trial of operative vacuum delivery, uses a combination procedure with forceps, and when
the gestational age is less than thirty-four weeks. According to experts writing in the literature for a safe vacuum assisted vaginal delivery, the most
important thing is to obtain a proper application. Estimated fetal weight is critical to the procedural risk and station and position of the fetus must be known. Because cephalhematoma is directly correlated with
application time and multiple pop-offs are associated with cephalopelvic disproportion, fetal injury and failed procedure, application time and maximum number of pop-offs should be predetermined by protocols. And in the case of failure alternative delivery
options such as cesarean section should be readily available. Slide 26, lists a protocol for instrumented deliveries. Another term for operative vaginal deliveries. As part of Ascension Health National Perinatal
Safety Program the Seton Family of hospitals implemented transformational practices in labor
and delivery, aimed at reducing the rate of birth trauma in their facilities. Participating facilities created systems to
ensure that evidence-based practices were reliably followed for high-risk conditions associated for perinatal harm, that robust strategies for communication were
adopted, and that collaborative practices promoted among
caregivers. At the end of a 3 year period all facilities achieved birth trauma rates that were at or near zero with the implementation of these practices. Using the instrumented delivery protocol in
conjunction with other perinatal safety initiatives hte Seton Hospital first reported in 2007 a reduction in the use of vacuum and forceps from a frequency of 7.4% to 4.7% and subsequently reported that the use
continued to decline to a rate of 4.1%. The incidence of birth trauma associated with the use of these devices also decreased. Most significantly Seton reported that there were no occurrences of birth trauma associated with instrumented deliveries for fifteen consecutive months. Slide 27, lists risks reduction strategies, specifically for vacuum assisted delivery, and they indicate that residency training
should be supplemented with formal mentoring programs, and proper credentialing of providers is a must. Policy should be established that specify parameters such as indications and contraindications for vacuum assisted delivery, total time of procedure, maximum time and pressure of vacuum use, and maximum number of pop-ups. It is important to practice teamwork drills to refine effective
communication of the parameters. Standardized documentation of vacuum assisted vaginal deliveries is recommended. An audit should be implemented, to audit the care unit as well as individual obstetrical providers. Slide 28, addresses documentation. It is important to document the indication
for instrumented delivery, position and station of the fetal head and
how it was assessed, vaginally or abdominally. Assessment of maternal pelvis, ease in application of vacuum and placement position, duration of traction and force used, and description of any maternal or neonatal injuries; and of course the informed consent process. For more information on this, log on to the clinical risk management website and access the guidance article called “Preventing Maternal and Neonatal Harm During Vacuum Assisted Vaginal Deliveries”. Slide 29, begins our review of shoulder dystocia. Shoulder dystocia is the 4th most common cause of medical litigation involving delivering providers and accounts for 11% of all obstetrics related law suits. The causes are mechanical and associated with impaction of the anterior fetal shoulder behind the maternal pubic synthesis or impaction of the posterior fetal shoulder on the sacral promontory, or impaction of both, which results in the fetal head being delivered while the shoulders are impacted. Shoulder dystocia may result from the failure to
deliver the fetal shoulder without using external or internal maneuvers. There is a subjective component of this
diagnosis that requires internal and/or external maneuver determination by the delivery
provider. Moving to slide 30, we see that for a 4 year period, the Pennsylvania Patient Safety Authority
received 316 reports involving shoulder dystocia. In a 124 or 39% of them neonatal injuries including fractures and
brachial plexus injuries were identified as well as fetal deaths. Several of the facilities reported that shoulder dystocia events through the system identified contributing
risk factors that led to the injuries sustained during antipartum care, interpartum care, and at delivery. Risk factors for shoulder dystocia are noted on slide 32. Excuse me 31. Maternal risk factors for shoulder dystocia include
gestational diabetes, obesity and post term pregnancy. Inter-partum risk factors, for shoulder dystocia include instrumented, assisted vaginal delivery, using forceps or a vacuum, precipitous or protracted second stage labor, and delayed head-to-body delivery time. Specific fetal factors for increased risk of shoulder dystocia include macrosomia, large chest, or biparietal diameter.

and the fetal shoulders remaining in the anterior, posterior plane. Fetal manipulation can be reasonably used during shoulder dystocia deliveries, but it is important for birthing providers to be aware of the natural tendencies of applied traction when faced with a difficult delivery. Increasing clinically applied traction to the head during the birth process may produce stretch injuries of the fetal’s brachial plexus. The extent of nerve injury depends on the magnitude and direction of the delivery force as well as the rate at which it is applied. Prolonged labor and the use of forceps or vacuum extraction are associated with an increased risk, or shoulder dystocia, although the risk is significantly greater with vacuum
extraction. There are no evidence based guidelines for
the prediction, prevention, or management of shoulder dystocia. The current practice guidelines are based on limited
scientific evidence and the consensus opinions of experts. ACOG developed guidelines to aide obstetric practitioners in making decisions about appropriate care. Most cases of shoulder dystocia can now be predicted or prevented because there is no accurate method to identify
fetuses that will develop the complication. That being said and as indicated on slide 32, shoulder dystocia risk management involves identification and communication of patients at risk, before delivery, management of shoulder dystocia before it occurs to minimize potential injury to the fetus and the mother. Thorough documentation and treatment upon discovery of the problem and ongoing interdisciplinary simulation drills for all obstetric staff that include the
application of external and or internal maneuvers. On slide 33, we see that clinical risk management of shoulder dystocia begins with the recognition of risk factors. A thorough patient history should be obtained during a part of antenatal care. Noting that birth weight of the mothers, other
infants in the case of multiparity is important because subsequent births can result in shoulder dystocia. Prenatal laboratories and diagnostic studies include glucose screening. Any history of maternal diabetes may also
indicate propensity. Documentation of estimated fetal weight is very
important despite the controversy and margin of error. Because a failure to assess and document fetal weight during pregnancy or labor may constitute a deviation from the standards of communicating any suspicion of fetal macrosomia will help the delivery team to collaborate and plan for the management of such an emergency. A number of maneuvers are available for the
relief of shoulder dystocia and the order of them is not as important as their effective and appropriate use. Descriptions of the maneuvers are included
in the guidance article ”Neonatal Complications, Recognition and Prompt Treatment of Shoulder Dystocia,” along with documentation, suggestions for the
resolution. This is available at the clinical risk management
website. It is important to provide factual information and consistently
document any episode of shoulder dystocia. The information on slide 34 is useful to document
when encountering a delivery complicated by shoulder dystocia for retrospective review. This list is included in the guidance article previously mentioned. Slide 35, summarizes communication and
information flow, the effectiveness of which is to improve obstetrical safety and reduce the risk of liability. Inadequate communication among providers regarding the plan of care for a patient is a common path for substandard care. In the office setting, protocols should be in place so that there is consistent delivery of care across all providers and all types of clinical problems. It is also important to communicate clearly that all administrative delays, such as lack of availability of a timely diagnostic test, faulty equipment, or insurance delays for preauthorization, are brought to the attention of the practice manager to avoid unnecessary delays in patient treatment. Covering providers need some process to gain
an understanding of the patient’s history, status, and any aspects that may place the patient at increased risk. Whenever possible, insure that patients rotate
through your help center and see all providers that could be involved in their delivery. Seeing the attending obstetrical provider
who meets a patient with a complicated obstetrical history and numerous health issues on the day she is admitted to labor and delivery is very risky. When a different team of providers will be delivering the patient, clinical risk management demands a failsafe means of communicating patient information among prenatal, labor and delivery, and postnatal providers. It’s also important to develop a mechanism to insure that obstetrical records are transported to the hospital or birth center by the 36th week of gestation. Prenatal care can lead to care by many providers at several locations such as offices or clinics, hospitals, emergency rooms. It is important to ensure that there is a way to
address updated information and transfer that information to the record. There are a number of resources available at the clinical risk management
website. Slide 36 includes additional resources
available at the website. Before I hand the program back to Amy, we’ll conduct a second polling question just
to gauge the number of participants at each registered site. Operator? [Operator] Thank you. We will now begin the second polling question. After each question is asked please respond by pressing * followed by the appropriate digit on your phone. You will hear a tone upon making your selection. How many people are in the room? Please press *1, for one person * two, for two people * three, for three people * four, for four people * five, for five people * six, for six people * seven, for seven people * eight, for eight people. and * nine for nine or more. [Amy] Okay, thank you very much. At this point we are going to open up the phone lines for questions. And thank you very much for joining us. [Operator] Thank you, we will now begin the question and answer session. If you would like to ask a question please
press *1. Please un-mute your phone and record your name clearly when prompted. To withdraw your request press * two. One moment please for the first question. [long audio silence]
We have no questions at this time. [Amy] Okay, if we have no questions, then we will conclude.

Barbara, do you have any closing comments? Or should we conclude? [Barbara] Yes, I just want to say on behalf of HRSA, I want to thank our partners, KeyPRO, ECRI Institute speakers for the information they have provided on this timely topic and I’d like to thank all of
the participants on the line today and our operator. [Amy] Thank you very much everyone.
[Operator] Thank you for joining today’s conference,
you can disconnect at this time.

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