05 Apr

Annual Obstetric Malpractice Review

MalpracticeEvery year, according to a study published by The New England Journal of Medicine in 2011, just over 11% of obstetricians and the hospitals and clinicians serving them, will be faced with malpractice complaints. The average payout will be approximately $360,000 with significant state-by-state variation.¹

PeriGen’s Annual Review of
Labor & Delivery Malpractice Awards

Following is a summary of 2015 perinatal malpractice awards, settlements and complaints:

    • $8.4 Million Awarded for Hypoxic Ischemic Brain Injury:   Mother was admitted to the a Georgia medical center for delivery of a full-term baby. The labor continued throughout the evening.  Baby was delivered around noon the next day. Her admitting physician was not present at the delivery, but delivery was overseen by a CNM. For several hours prior to the delivery, fetal heart rate was noted as decelerating and variable. Infant was born severely depressed, with low APGAR scores and metabolic acidosis. He was not intubated for 8 minutes, and he continued to deteriorate, a full code ensued, and resuscitation occurred. Ultimately, infant was diagnosed with a hypoxic ischemic brain injury and developed cerebral palsy. Click for details
    • A Michigan court granted the right to appeal for a case stemming from a 2008 delivery outcome.  Mother  was admitted to the hospital with ruptured membranes. She had a lengthy labor – 29 hours – augmented by the drug Pitocin.  The baby failed to descend after two hours of pushing. The mother had developed chorioamnionitis (placental infection) and the doctors noticed the presence of meconium. The labor was terminated with a caesarian section. Records revealed “delivery of a healthy baby boy who weighed 9 lbs 13 oz. However, the infant began to show signs of seizing shortly after his birth and a CT scan revealed an acute left middle cerebral artery ischemic stroke, which was “days to hours old.” The complaint alleged that “[t]he baby was at risk for, and did develop, brain injury from traumatic head compression and regional cerebral ischemia caused by failure to descend, macrosomia (large baby), excessive contractions in the presence of failure of descent as augmented with oxytocin, hypoxia-ischmeia (regional cerebral and/or systemic) caused by uteroplacental insufficiency and by cord compression and head compression.” The complaint alleged that defendants were negligent in administering oxytocin, in failing to properly respond to fetal heart rate changes, and in failing to perform a timely c-section. Click for details
    • A couple in Puerto Rico filed a suit for $27 million against two hospitals as a result of respiratory failure, perinatal asphyxia, and clinical sepsis. After experiencing pelvic pressure and secretions the mother was admitted without contractions or amniotic rupture. The mother underwent induced labor. Upon birth, the newborn was found  to be in critical condition. His skin was blue from poor circulation, and he did not respond to any external stimuli.  The boy was rushed to NICU and hooked up to a mechanical ventilator. He was diagnosed with respiratory failure, perinatal asphyxia, and clinical sepsis. After nearly a month of care, the boy was released from treatment. Then in January 2013 doctors diagnosed him with multicystic leukoencephalopathy and microcephaly, from which stemmed a host of motor, mental, and sensory complications, such as seizures and impaired vision and hearing. Click to review case
    • A New Jersey family realized a $700,000 malpractice settlement as a result of a Erbs palsy brachial plexus injury.  The case contends that the attending physician used excessive traction during  delivery, resulting in stretching and tearing of the brachial plexus. See details
    • Another settlement, this one for $562,500 followed a complaint that the obstetrician and nurse, monitoring a patient in labor, failed to recognize that the infant’s heart rate had slowed when the fetal monitor strips was actually demonstrating the mother’s heart rate. The mother’s uterus had abrupted, causing a lack of blood flow and oxygen to the baby. By the time the error was recognized, the infant had died from lack of oxygen.  Details provided here
    • Hypoxic ischemic encephalopathy (HIE) with extensive brain injury is the subject of a recent medical malpractice claim brought against a military hospital in the District of Columbia. The complaint states that after being admitted to the medical center in the early stages of labor, the plaintiff was given oxytocin to help augment contractions. Subsequent fetal heart monitoring suggested an abnormally high rate of contractions, but augmentation was continued. Following this, medical records indicated an increase in the fetal heart baseline along with intermittent late decelerations. Shortly thereafter, the mother developed a fever and was diagnosed with chorioamnionitis (a bacterial infection of the fetal membranes). After several hours of prolonged labor, the plaintiff was delivered, at which point shoulder dystocia was noted.  Allegedly, a first year resident then unsuccessfully attempted to relieve the shoulder dystocia with downward pressure. Next, a third-year resident tried several maneuvers to free the baby’s shoulder, including the McRoberts maneuver, the Rubin maneuver and others. All were ineffective. At this point, contends the complaint, the attending obstetrician arrived and was able to successfully free the shoulder allowing for a vaginal delivery. Upon delivery, the plaintiff’s little girl was was described as having bruising on the face and scalp, a fractured right clavicle and Erb’s palsy. She was also hypotonic and experienced seizures. About five days after her birth an MRI revealed that the child showed hypoxic ischemic encephalopathy with extensive brain trauma. See more
    • Honolulu based hospital faced with $9,000,000 obstetric settlement:  The mother arrived at the hospital at 35 weeks into her pregnancy, she had severe lower abdominal pain. Because of her previous history of miscarriage and the complicated delivery of her first child, the mother had undergone a procedure to keep her uterus closed until delivery and the pregnancy was under close supervision. However, when she arrived at the hospital, the hospital failed to notify and consult her obstetrician. An emergency C-section was performed, but the complaint contends that the procedure was not performed in time to prevent reduced oxygen flow to the fetal brain, causing brain damage. Click for more information
    • A $5 million suite filed against a military hospital in Kentucky also results from HIE. The suit contends that connected to a fetal heart rate monitor, the healthcare workers failed to properly monitor and interpret the tracings. The plaintiff claims that the medical records indicate her daughter was in respiratory failure for a long period of time. In addition, the complaint states that, despite knowing that the labor was not progressing properly, healthcare providers failed to perform a cesarean section. The newborn was diagnosed with intracerebral hemorrhage and interventricular hemorrhage. Click for details

 

¹Anupam B. Jena, M.D., Ph.D., Seth Seabury, Ph.D., Darius Lakdawalla, Ph.D., and Amitabh Chandra, Ph.D. Malpractice Risk According to Physician Specialty N Engl J Med 2011; 365:629-636

23 Mar

HIStalk interviews CEO Matt Sappern

Matthew Sappern is PeriGen's Chief Executive Officer“The Safest Place to
Have a Baby”

PeriGen CEO Matt Sappern shares an anecdote about his time at this year’s HIMMS conference.  Seems that a client CIO made quite an impression on those manning the booth of a major EHR vendor when he proclaimed that PeriGen was helping make his hospital be the safest place to have a baby.

Matt closes the interview with another great story about a cesarean avoided through PeriCALM’s power of delivering the right information in real-time at the bedside

Read the Inteview

15 Mar

Perinatal Webinar Summary for Tomorrow

Better perinatal assessment of fetal heart rate patterns

Here’s a summary of what Emily Hamilton, MDCM will be covering during tomorrow’s free perinatal nursing training webinar designed to help clinicians improve their ability to understand FHR variation and decelerations.

  • What regulates the fetal heart rate
  • Fetal heart rate decelerations
  • Variable decelerations
  • Late decelerations
  • How they affect clinical interpretation of tracings

Perinatal Training Summary:

The clinical goal of electronic fetal monitoring is to identify fetuses with increased risk of hypoxic injury so that intervention can be executed to avoid adverse outcomes without also causing excessive number of interventions.  Understanding the mechanisms of fetal heart rate control is important because it can help us to infer the physiological state of the baby and gauge whether intervention is truly necessary.

Unlike in adult cardiology, where ECG changes are used to diagnose myocardial infarction, labor & delivery clinicians depend upon the heart rate to infer the condition of another organ, namely the fetal brain.  Although the fetal heart rate is related to fetal brain state, is is also affected by a number of other factors.

During tomorrow’s training webinar, Dr. Hamilton will provide an overview of recent perinatal research on these factors.

Registration is still open, but “seats” are filling fast

Register now by completing form below

14 Mar

Discuss EFM data vs clinical information

Are you using just data or rich clinical information to assess labor?

Here’s a definition of data

According to Merriam-Webster’s dictionary, data is the output from a sensing device that includes both useful and relevant or redundant information and must be processed to be meaningful.

Typical perinatal EFM software provides labor data

Here’s a familiar example:
Traditional electronic fetal monitoring systems, developed long before computers made real-time analysis possible in a hospital setting, deliver numeric measurements of fetal heart rate and contractions and presents them in graph form.

Converting this obstetric data to information of actual use is left entirely up to clinicians in their role as human calculators.

Here’s a definition of clinical information

Knowledge obtained from investigation, study, or instruction which justifies change in a plan or theory.

Perinatal Clinical Information fuels better childbirth decision-making

Information-rich decision support tools, illustrated in the PeriCALM® screenshot shown above, convert data into intelligence that make more robust interpretation and decision-making possible.

How many perinatal nurses are limited to just using data to assess labor?

Does your EFM software system deliver data or information?

Which is of more use?  How would having the rich clinical information shown above make a difference with your work?

10 Mar

Free L&D Training Session

Register for WebinarThe following is this week’s excerpt from The Physiology of EFM.  Hear author Emily Hamilton review the entire contents of this white paper during the free online training webinar designed for labor & delivery clinicians on March 16th (Noon – 12:30 PM ET).

Register today for free L&D training session
The Physiology of EFM

Wednesday, March 16th
Noon – 12:30 PM ET

Fetal Heart Rate Variability

Current clinical guidelines that classify tracings rely heavily on reduced baseline heart rate variability as an indicator of significant acidosis and/or need for intervention.6-12 Minimal variability, especially when it persists and is accompanied by decelerations, is associated with marked acidemia, low Apgar scores and hypoxic injury.

Minimal variability, especially when it persists and is accompanied by decelerations, is associated with marked acidemia, low Apgar scores and hypoxic injury.

All of the mechanisms controlling fetal heart rate depicted in Figure 1 influence heart rate variability. Fetal behavioral states, breathing and movements affect heart rate variability acting though the central pathways to the medulla, and then to the heart via the sympathetic and parasympathetic systems. Fetal heart rate variability is suppressed by factors that depress fetal brain function.

Animal experiments have shown that blockage of the parasympathetic system with atropine results in a reduction in short-term variability.13 A reduction in long-term variability occurs after sympathetic blockade.14, 15 Fetal heart rate variability is more than the simple “push-pull” interactions between the inhibitory and acceleratory limbs of the autonomic nervous system. The heart itself contributes to variability. Even with complete double blockade of the sympathetic and parasympathetic systems, around 35-40% of fetal lamb heart rate variability persists.13 A clinical demonstration of the intrinsic rhythmicity of the heart is found in transplantation surgery. An excised heart continues to beat and demonstrate heart rate variability.

Marked variability may be a sign of activation of compensatory pathways.

The association between variability and metabolic acidosis is less clear. This is important because all contemporary EFM classification methods place high reliance upon baseline fetal heart rate variability to exclude the presence of metabolic acidosis.6-12 The 2008 NICHD Update publication in which the Category I, II, III classification method was first described includes a statement that “moderate variability reliably predicts the absence of metabolic acidemia at the time that it is observed.”6 This concept was softened in the 2009 ACOG Practice Bulletin 106 with the statement “The data relating FHR variability to clinical outcomes, however, are sparse.”7 This practice bulletin endorsed the 3-level categorization of tracings where the third level required absent baseline variability.

The 2010 ACOG Practice Bulletin 116 presented a clinical management algorithm with high reliance on moderate variability.8 In this management algorithm, the recommendations for tracings in Category 2 were continued surveillance and intrauterine resuscitation measures, as long as there was moderate variability. Only a failure to respond to intrauterine resuscitative measures in the presence of absent or minimal variability lead to the recommendation of “consideration of delivery” for Category II tracings.

There is a growing body of literature that does not support the statement that moderate variability reliably excludes the presence of metabolic acidemia.

In animal studies, vascular instrumentation allows for blood gas measurement at any specific time to be correlated with the coexisting fetal heart rate features. Martin demonstrated that in sheep the initial fetal heart rate response to sudden hypoxemia was a slowing of the heart rate with increased variability.1 Others observed similar changes in sheep and in monkeys.16-18 Field et al found initial decreases in heart rate variability with iliac occlusion in sheep, but variability returned to normal by 36 minutes despite worsening metabolic acidosis.19 These observations of normal variability in the face of acidemia led researchers to postulate that some aspect of variability control could be different in animals compared to humans.

In the human literature, four recent and independent studies using various definitions of acidosis and examining the last 30-60 minutes of the tracing reported that the percentage of babies with acidosis who had moderate variability ranged from 15% to 91%.20-23 Even with near lethal levels of uterine artery base deficit (>=16 mmol/L), a full 15 to 32% of these babies had moderate baseline variability in the tracing recorded just before birth.20, 21 Another study examined baseline variability in term babies who required supplemental oxygen for more than 6 hours or mechanical ventilation.24 In this study, marked variability in the last 30 minutes was significantly associated with these respiratory morbidities. Minimal variability was not. This finding is in keeping with other direct observations on the correlation between increased heart rate variability and catecholamines concentration on non-acidotic term fetuses.25 It appears that marked variability may be a sign of activation of compensatory pathways.

10 Mar

Best practices for High Reliability

best practices for high reliability in obstetricsUsing their extensive experience in implementing approaches to promote efficiency and high reliability in health care, the team of obstetric leaders who collaborated to author the recently released eBook A Vision of the Future of Obstetrics identified five key clinical best practices.  Here they are in summary:

Best practices for obstetric units

  1. Select a reasonable process
  2. Analyze and modify
  3. Target critical behaviors
  4. Clarify and define
  5. Choose wisely

The free eBook details clinical processes, developed by leading health systems, to execute these broad principles.

What practices is your hospital or health system using to improve efficiency and high reliability in labor & delivery?

Click to continue reading eBook in the Apple Store or as a PDF

03 Mar

A look behind to look ahead

Look into the future of obstetricsA look behind to look ahead for PeriGen

by Matthew Sappern
Chief Executive Officer, PeriGen

I know we are well in to 2016 already, but I want to take a moment to reflect on 2015 and the State of PeriGen.

This past year, PeriGen enjoyed explosive growth. Almost twice as many hospitals went live on PeriGen solutions than in any other year in our history! At the same time, we introduced a remarkable new module called the PeriCALM Checklist which helps makes checklist compliance easier; this tool won the 2015 FIERCE Healthcare Innovation Award.

In 2016, we will introduce a few more tools – tools designed to save nurses time as well as to leverage precious clinical resources across an entire healthcare system – more on these exciting innovations in a few months!

Now, we all know that explosive growth is a double-edged sword. PeriGen cannot allow this growth to come at a cost of service and responsiveness. To that end, we have added some new staff and tools to our implementation and support groups. Inside you will read about new FAQ tools and about Securelink, an application providing our team with secure, remote access – at a hospital’s request – to help troubleshoot issues. We are making support simpler, easier and more efficient. As I made clear to the entire PeriGen team on a recent “all-hands” call, we need to commit to providing an exceptional customer experience in 2016, nothing less.

Finally, as we all settle in to 2016, I invite you to spend some time with PeriGen’s SVP of Clinical Research Dr. Emily Hamilton, who has penned an article with some predictions about continued innovation in healthcare. Emily is one of the most forward-thinking professionals in healthcare today, I am sure you will enjoy her article and you will see PeriGen’s solutions continue to reflect her thinking.

As always, thank you for being a member of the PeriGen family and thank you for taking such great care of all the mothers and babies whose lives you touch.  Have a wonderful 2016!

02 Mar

PeriGen Predictions 2016

Rethinking the Labor CurvePeriGen Predictions 2016

by Emily Hamilton, MDCM
Senior Vice President of Clinical Research

We all enjoy lists of predictions for the coming year; hot stocks picks, fashion styles – what’s cool, what’s not, baby names- what’s in, what’s out and the rising or falling stars of society’s influencers, to name a few.

At PeriGen, our thoughts also turn to the future and we have prepared some projections of our own.   But first, history does inform the future. Upon reflection, the common thread throughout PeriGen’s history has been innovation.   However turning ideas into concrete solutions is much more than having a bright idea.

…turning ideas into concrete solutions that work is much more than having a bright idea.

At the most fundamental level our innovations must solve a real need in a fashion that improves the efficiency of clinicians, in a cost beneficial fashion favorable to both institutions and individuals. Furthermore they must do this in a manner that is better, safer, cheaper, faster, and more expedient and sustainable than the solution currently in place. These criteria make innovation a very tall order. Successful innovation teams focus on the problems they understand deeply, but they – when needed — also recognize and source missing resources of expertise to create novel solutions.   Failure to involve real clinicians, assessing the new prototypes in real world situations, early on when product definition is still malleable, is a pitfall that leads to failure.

With those lessons in mind here is our list for 2016 (and a bit beyond). We invite you to comment on it.

An EHR’s ability to meet the requirements for Meaningful Use, e-prescribing, health information exchanges, interoperability, and ICD-10 coding are all major considerations for health care institutions. We expect to see the trend toward EHR convergence continue.

In reverse order, here are the top 3 trends in 2016 and beyond.

PeriGen’s Projection for
Healthcare Technology Trends

#3  More Personalized and Intelligent Data Analysis

With improved interoperability well underway hospitals are searching for solid evidence of both health and financial benefits. We expect to see HIT applications specifically tailored to address underlying causes of error at the bedside, improve diagnosis and treatment, and help managers track performance in their departments.

There are only so many rules that a human mind can hold and process, especially when considering multiple factors that change over time in busy clinical environments. However, with the computational capacity of everyday computers it is possible to apply a number of well-established statistical techniques to reduce subjective and inconsistent human assessment, to assess personalized likelihood of adverse outcome and warn clinicians in time so they can change management and minimize untoward consequences.

Statistical reports analyzing trends in outcomes and processes help unit directors define, prioritize, and monitor quality-of-care benchmark initiatives. Performance measurements are essential to show where progress has occurred or where it is needed. They also help to motivate clinical teams (and individuals) with evidence of their own success or need for improvement.

We expect to see many more applications layered onto the basic EHR for intelligent analysis and data display, making it easier for clinicians to care for patients and for directors to manage their departments.

#2  Increased Use of Cloud-Based Technologies

Increasing prevalence of wearables and devices using mobile and cloud-based technologies bring individualized data to patients and clinicians wherever they are, whenever they want. Pregnant women in general are well-educated, young, and accustomed to technology. This modern reality gives rise to expectations that health records and even meaningful healthcare itself can be provided this way as well.   Not only will these technologies collect and return personalized analysis, the collective data is a gold mine for medical researchers.

#1  Expansion of Virtual Centers of Expertise

The two trends mentioned above facilitate the creations of virtual centers of expertise. Once a novelty, the virtual center of expertise is becoming common place in business and in healthcare.

Evidence of this includes:

In healthcare, virtual ICUs are increasingly common in the US.   A virtual command center staffed with nurses and doctors using high-resolution video conferencing and transmission of monitoring data can be hundreds of miles away and serve multiple remote sites simultaneously. Not only are such centers showing improvement in outcomes, patients are reporting high levels of satisfaction with much easier access to clinical expertise.

In some places the center acts as a second set of eyes, in others it is a source of consultative expertise.

By 2018, the global market for telemedicine devices and services is projected to grow to US$4.5 billion and the U.S. market is expected to grow to $1.9 billion1.

Virtual centers of expertise are feasible only with reliable infrastructure to support rapid data exchange. If gathering, assimilating and sharing information are the foundations upon which decisions are made at the bedside, in virtual centers their importance is multiplied many-fold. Although standardization may be easier to achieve given the relatively small group of experts who staff such a virtual center, they will face other pressures, such as vigilance fatigue when potentially hundreds of virtual patients are under their care at any one time.

Automated intelligent methods to prioritize the true level of abnormality and direct the expert’s attention to the most urgent issues are imperative in such centers. Good prioritization is particularly important in obstetrical situations where false alarms are common and adverse events are rare but can devolve rapidly with dire consequences.

To quote Geoff Mulgan, CEO, National Endowment for Science Technology and the Arts (NESTA) , London, UK : “As the Internet of Things advances, the very notion of a clear dividing line between reality and virtual reality becomes blurred, sometimes in creative ways.”

We project the healthcare will see an increasing numbers of virtual centers of expertise offering an expanded set of services. Our challenge will be to apply technology wisely, measure its performance, and continue to evolve it guided by the search for what is best for patients, efficient for clinicians, and cost effective for society.

“As the internet of things advances, the very notion of a clear dividing line between reality and virtual reality becomes blurred…”

What do you think?  Will these happen?  What else do you expect to change in our world this year?

 

1 Bruce Japsen, “ObamaCare, Doctor Shortage to Spur $2 Billion Telehealth Market,” Forbes, Dec. 22, 2013; “Global Telehealth Market Set to Expand Tenfold by 2018,” IHS, Jan. 17, 2014.

 

01 Mar

Research on Late FHR Decelerations

The following excerpt is taken from The Physiology of EFM, a PeriGen white paper written by Emily Hamilton, MDCM and Philip Warrick, Ph.D. Its contents are among the topics to be covered at the free March 16th lunchtime labor & delivery training webinar.

Click Here to Register | Space is Filling Fast

Late Fetal Heart Rate (FHR) Decelerations

Two pathways are involved with late fetal heart rate decelerations

Figure 3: Two pathways are involved with late decelerations, adapted from Martin 1979 (1) and Freeman et al. (2)

To simulate decreased uteroplacental oxygen delivery, Martin applied repeated hypogastric artery occlusions in sheep. These occlusions resulted in fetal hypertension which was followed by vagally mediated decelerations. The degree of hypertension and the amount of deceleration were closely related, although some deceleration remained when the transient hypertension was prevented by alpha-adrenergic blockade. The timing of the onset, nadir and end of the deceleration was delayed with respect to the occlusion and mirrored the timeline of the hypertensive response. Vagal blockade eliminated these decelerations in the non-acidemic sheep. Thus, “intermittent placental insufficiency” can cause decelerations and its effects are mediated by the vagus nerve. These “late” decelerations were not associated with fetal acidosis. 1, 3

When the occlusions were extended to produce fetal acidosis, the fetal hypertensive response lost its progressive character, reaching a plateau early after the beginning of the occlusion, while the deceleration continued to fall with its nadir occurring at or after the end of the occlusion. With progressive acidemia the decelerations became deeper and longer. In the presence of very severe acidemia (pH=6.96) they could not be eliminated by vagal blockade. With complete vagal and alpha and beta adrenergic blockade, the decelerations persisted. The fetal heart, devoid of any sympathetic and parasympathetic influences, showed decelerations suggesting that intrinsic myocardial depression was the deceleration mechanism in the presence of severe acidosis and hypoxia.3

Although the individual pathways described above cover the major mechanisms of fetal heart rate decelerations, the actual situation is more complex. Even in the sheep experiments using precisely controlled conditions, consistent fetal heart rate decelerations could not be produced equally in all animals despite 2 hours of repetitive maternal vascular occlusions.3

25 Feb

Share the Vision | Excerpt

Obstetrics challenge - standardization of care

 

Our OB 3.0 team of thought leaders focused on two key challenges for obstetric patient care.  The first, covered in Section I of the new ebook A Vision of the Future of Obstetrics is standardization of health care.  Here’s an excerpt:

Issues preventing

Standardization of Care

The quest for exciting and game changing approaches to solve today’s medical problems is appealing.  However, not only are such miracles seldom found, but experience shows that much improvement can be gained by applying existing best practices uniformly. 7-9   Across all large endeavors, such uniform processes have been shown to improve outcomes.  The lessons learned from recent and dramatic stories of implementation of various aspects of a comprehensive safety program on the obstetrical unit demonstrate that such uniform processes have, like in other complex organizations, led to widespread improvement in such outcomes as lowering cesarean section rates and decreasing malpractice claims and costs.10-15  In health care, standardization generally reduces costs.

When considering impediments, two issues quickly took the lead: Miscommunication and normalization of deviance.

Are miscommunication and normalization of deviance challenges that your labor & delivery unit face?  What has your team done to combat them?

Continue reading via Apple Store download or as a PDF

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