Tag #riskmanagement

It’s estimated that approximately half of all paid obstetrical litigation claims involve allegations of Pitocin misuse.  Recognizing that Pitocin is a high alert medication warranting safe initiation, and management consistent with standardized evidence-based practices reduces patient harm, while reducing litigation risk for perinatal team members, and hospital systems. 

In this blog, I’ll identify what Pitocin is, and what it’s used for.  I’ll also address why Pitocin is considered a high alert medication.  Additionally,  I’ll highlight common allegations related to Pitocin management identified in past obstetrical related law suits.  I’ll close by offering some risk management approaches that can be integrated into practice.  

What is Pitocin? Pitocin is the synthetic (made by chemical synthesis) form of oxytocin, and serves as the most common labor induction agent.  Pitocin is chemically, and physiologically identical to endogenous oxytocin that is made, and circulated by the body.  Endogenous oxytocin  is synthesized by the hypothalamus in the brain, then is transported to the posterior lobe of the pituitary gland where it is then released into maternal circulation. Oxytocin is typically released in response to breast stimulation, sensory stimulation of the lower genital tract, and cervical stretching which results in uterine contractions.  The half-life of Pitocin is between 10-12 minutes with uterine response typically occurring within 3-5 minutes of intravenous (IV) administration.

What are high alert medications? High alert medications are defined as those bearing a heightened risk of harm when they are used in error, and that may require special safeguards to reduce the risk of error.

In 2007, Pitocin was added to the Institute for Safe Medication Practices (ISMP) list of high-alert medications due to the potential negative maternal, and fetal effects (patient harm) that can occur when used in error, such as inappropriate timing of administration, and/or excessive dosing. 

It’s important to note that Pitocin administration using pharmacological principles can be therapeutic during labor.  Pitocin is not a high-risk or dangerous drug, but rather a high-alert medication warranting safe initiation, and management.  If managed properly, Pitocin has no inherent risks. 

Examples of other high alert medications utilized in labor and delivery settings, include:

• Promethazine intravenously: an antihistamine, sedative, antiemetic commonly used to treat nausea, and vomiting
• Methotrexate: an immune-system suppressant used to treat ectopic ‘tubal’ pregnancies
• Magnesium Sulfate intravenously: used for the prevention of eclamptic seizures in pregnant women diagnosed with severe preeclampsia
• Insulin: used to treat diabetes in pregnancy, and during the course of labor
• Epinephrine (adrenaline): used for resuscitative efforts

General Incidence of Adverse Drug Events (ADEs): It has been reported that 400,000 Americans die annually as a result of medication errors.  In 2016, the CDC identified unintentional death, including medical mistakes, as the third leading cause of death in the U.S. The CDC’s Healthy People 2030 indicated that annual adverse drug events (ADEs) or harm resulting from medication errors, have led to 1.3 million emergency department encounters, 350,000 hospitalizations, and over $3.5 billion in excess medical costs.  ADEs remain a significant public health issue, with most instances being preventable. 

How do ADEs relate to the use of Pitocin? Pitocin is the most frequently used medication for labor induction, and augmentation.  Additionally, Pitocin is the medication most commonly associated with preventable adverse events during childbirth.  The risks of Pitocin are generally dose related, and include uterine tachysystole, excessive uterine activity, fetal compromise, neonatal acidemia, placental abruption, and uterine rupture.

Other types of Pitocin errors, and ALERTS include:

• Mistaken intravenous (IV) fluids with oxytocin in the management of IV fluid resuscitation during indeterminate or abnormal fetal heart rate (FHR) patterns and/or maternal hypotension
• Inappropriate elective (in the absence of a medical indication) administration to women < 39 completed weeks of gestation
• Failure to respond to high/low alerts:
  • The Joint Commission issued a sentinel event alert concerning medical devise alarm safety as alarm related events have been associated with permanent loss of function or death.  Among the most common contributing factors were improper alarm settings, alarm settings turned off inappropriately, alarm signals not audible to staff.
  • Risk Management Approach: Ensure FHR, and maternal vital signs alarm limits are set appropriately, and that alarms of turned on, functioning properly, and audible to staff. Follow hospital guidelines regarding prevention of alarm fatigue.
• Failure to reconnect the postpartum oxytocin infusion at the time of patient transfer, transition of care:
  • The Joint Commission issued a sentinel event alert related to managing the risk during transition.  Tubing connector standards are designed to prevent dangerous tubing  misconnections, which can lead to serious patient injury, and death.
  • Risk Management Approach: During the transition of care, be sure to trace the tubing, and catheter from the patient to the point of origin before connecting or reconnecting any device or infusion, at any care transition (such as a new floor, unit, hospital, or service), and as part of the hand-off process; route tubes, and catheters with different purposes in different standardized directions; when there are different access sites, or several bags are hanging, label the tubing at the distal and proximal ends; use tubing, and equipment only as intended; and store medications for different delivery routes in separate locations.
• Failure to adhere to sterile technique at the time of initiating IV access:
  • The Centers for Medicare and Medicaid Services considers vascular catheter-associated infection to be a hospital acquired condition because it can be reasonably prevented using a variety of best practices.
  • Risk Management Approach: Follow evidence-based infection prevention practices, such as performing hand hygiene, maintaining sterile no-touch technique when preparing, and administering infusions, and performing a vigorous mechanical scrub of needless connectors to reduce the risk of vascular catheter-associated infections.

Risk Management Perspectives: It’s estimated that approximately half of all paid obstetrical litigation claims involve allegations of Pitocin misuse.

• Common Allegations:
  • initiation of Pitocin in the absence of evidence of fetal well-being.  Failure to complete a non-stress test prior to initiation of Pitocin.
  • failure to accurately assess maternal-fetal status during labor induction.  Continuous fetal monitoring not performed; failure to assess, and document fetal heart rate, and uterine activity per organizational policy, and standard of care.
  • excessive doses of Pitocin resulting in uterine tachysystole, with or without an indeterminate or abnormal FHR pattern.
  • failure to discontinue or decrease Pitocin in the presence of a Category II and/or Category III FHR tracing unresolved with intrauterine resuscitation.

 Pitocin management also serves as a source of clinical conflict between nurses, midwives, and physicians during labor. Such clinical conflict increases the risk of patient harm, and litigation. By developing a shared mental model across specialties, and incorporating agreed upon standardized policies, clinical conflict, and inter-observer variability is reduced leading to positive birth outcomes, as well as less liability risk for the perinatal teams, and hospital systems.

Additional Risk Management Strategies:

• Prior to the administration of Pitocin, have another nurse perform a double check (2^nd RN verification) to verify patient identity, and to make sure you have the correct medication in the prescribed concentration, the medication indication corresponds with the patient diagnosis, the dosage calculations are correct, and the dosing formula used to derive the final dose is correct, the prescribed route of administration is safe, and proper for the patient, the pump settings are correct, and the infusion line is attached to the correct port.
• Utilize pre-oxytocin, and in-use oxytocin safety checklists.
• Have standardized policies for oxytocin dosing, definitions, and interventions for indeterminate, and abnormal FHR patterns, as well as excessive uterine activity that are agreed upon by all members of the perinatal team, used to guide management, and consistent with the standards of care.
• Ensure completion of a full assessment of uterine activity in labor including contraction frequency, duration, intensity or strength, resting tone, and relaxation time.
  • 2008 NICHD workshop report: “uterine contractions are quantified as the number of contractions present in a 10-minute window, averaged over 30 minutes.  Contraction frequency alone is a partial assessment of uterine activity.  Other factors such as duration, intensity, and relaxation time between contractions are equally important in clinical practice to safe guard fetal, and uterine acid-base status”.
  • Ensure hospital systems are not guided by limiting tachysystole protocols exclusively, but rather on excessive uterine activity protocols.
    • consider the clinical context (stage/phase of labor, maternal, and fetal risk factors, labor progress)
• Ensure that nurses and Ob providers are properly trained.  Implement multidisciplinary education related to electronic fetal monitoring, assessment of uterine activity, and Pitocin management.
• Maintain a 1:1 nurse-patient ratio while managing Pitocin.
• Real-time, and complete documentation including a full evaluation of uterine contractions, and a complete assessment of the fetal status, using a flowsheet or progress note.
• Be knowledgeable about fetal heart rate, and uterine activity physiology, including the significance of adequate relaxation time between contractions.
• Remain current with your professional organization, and remain current with organizational literature.

The purpose of this blog is to educate, and inform in an effort to promote patient, and perinatal team safety, promote positive birth outcomes while reducing the incidence of obstetrical related medical malpractice lawsuits by lowering the recurrence risk of errors.

References

American College of Obstetricians and Gynecologists, 2020. ACOG Practice Bulletin No. 107: Induction of labor.

Centers for Medicare and Medicaid Services, 2020. Condition of participation: 42 C.F.R.

Centers for Disease Control and Prevention, 2024. Leading causes of death.

Institute for Safe Medication Practices, 2024

Makary, 2016. Medical error – The third leading cause of the death in the U.S.

Simpson, et al., 2021. AWHONN Perinatal nursing, 5^th ed.

The Joint Commission, 2021. Standards NPSG. Comprehensive accreditation manual for hospitals.

U.S. Department of Health and Human Services. Healthy People 2030.

COMMENT AND SHARE: Do you have experience with an adverse drug event related to Pitocin? What was the outcome? Were organizational, or system changes made to minimize the risk of recurrence?

You can learn so much from the metadata in the electronic health record (EHR).  Metadata is data, about data.

Example: data entered, patterns of missing data, when data was entered, who entered it, who viewed it, how long it was viewed for, and whether it was modified.

Metadata can identify incidences of errors, as well as patterns of patient care delivery (i.e., recurrent late entries)

Metadata is discoverable per the Federal Rules of Civil Procedures. This means that attorneys can acquire access to EHR information, including the metadata, through the discovery process. Metadata is typically  obtained by a computer-generated record of audit trails showing user access and actions.  

Providers Can Minimize Risk by Effectively Documenting: During the litigation process, metadata can play an integral role in determining the credibility of evidence, including healthcare provider’s testimony, and documentation.

• Avoid documentation gaps
• Don’t copy and paste text from one patient’s EHR to another
• Use templates and checklists cautiously
• Do not share your password
• Make any changes to the record as soon as possible, per organizational policy
• Know that what you view is recorded
• Document referrals and notifications of other nurses about changes in a patient’s condition

Metadata analysis can support — or not support — a lawsuit. Frequent errors, and errors of omission can negatively impact a healthcare providers credibility in court.  Contrary, metadata that demonstrates  complete, and accurate documentation can help exonerate healthcare providers by bolstering their credibility, and providing evidence that adherence to organizational policies, and procedures, as well as  standards of practice were followed.

RESOURCES

• AHIMA. E-discover litigation and regulatory investigation response planning: Crucial components of your organization’s information and data governance processes. n.d. https://bok.ahima.org/doc?oid=107115#.ZByfmBXMJhE
• Barrett M, DeAngelo TR, DeAngelo JG. E-discovery: Metadata analysis in medical malpractice litigation. The Legal Intelligencer. 2020. Commentary. https://www.law.com/thelegalintelligencer/2020/04/09/e-discovery-metadata-analysis-in-medical-malpractice-litigation/?slreturn=20230223103325
• Conn J. Making IT legal-size; As electronic health-record systems become more complex, so do the issues involving the legal status of those records. Modern Healthcare. 2008;38(20),
• Gardner E. The weight of the I.T. evidence; why EHRs won’t reduce your malpractice premiums. Health Data Management. 2013;21(10).
• Hansen MD, Pratt TJ. Follow the audit trial: The impact of metadata in litigation. Defense Counsel J. 2017;84(3).
• NSO, 2024. What nurses need to know about metadata, documentation, and legal liability. https://www.nso.com
• Shwayder JM. Electronic records and metadata: Old and new liability risks: Metadata from an EHR form an audit trail of activity, which can make or break a malpractice case. Cont OB/GYN. 2018;63(9).

P.S. COMMENT & SHARE: What has been your experience utilizing metadata to support your medical legal cases?

In this blog, I’ll be reviewing the incidence of cardiovascular disease (CVD) in pregnancy, and postpartum.  Additionally, I’ll present a case presentation in an effort for the reader to reflect on the learned knowledge from the blog post in the context of the presented case. I’ll also address the challenges associated with diagnosing CVD in pregnancy, and postpartum, while highlighting the signs, and symptoms as well as risk factors for CVD. In closing, I’ll conclude with key takeaways.

Incidence: Cardiovascular disease (CVD) is one of the leading causes of maternal mortality in the United States accounting for >33% of all pregnancy-related deaths in the U.S.  One of every three intensive care admissions in pregnancy, and the postpartum period are related to CVD. CVD is under-recognized in pregnant, and postpartum women with rates higher among African-American women.

It’s estimated that 25% of deaths caused by cardiovascular disease in pregnancy or during the postpartum period may have been prevented if CVD had been diagnosed earlier.  Only a small fraction of women who die from CVD have a known diagnosis of CVD prior to death.  The majority of women who die from CVD present with symptoms either during pregnancy or after childbirth

CMQCC, 2017. CARDIOVASCULAR DISEASE IN PREGNANCY AND POSTPARTUM TOOLKIT

Diagnostic Challenges and Signs/Symptoms: Signs, and symptoms of normal pregnancy, and postpartum mirror CVD making it difficult to diagnose.  This is due to the normal physiological changes that occur in pregnancy, and the postpartum period.  However, a diagnosis of CVD should be suspected when symptoms are severe (see red flags below) with vital sign abnormalities, and underlying risk factors.  Having an increased awareness of the prevalence of CVD, and a high index of suspicion, along with preconception counseling, and referral to a higher level of care can prevent adverse maternal outcomes. 

CMQCC, 2017. CARDIOVASCULAR DISEASE IN PREGNANCY AND POSTPARTUM TOOLKIT

Risk Factors: Risk factors for the development of CVD in pregnancy, and postpartum include polycystic ovary syndrome, infertility, adverse pregnancy outcomes such as hypertensive disorders of pregnancy, gestational diabetes, preterm delivery, and intrauterine growth restriction. 

Key Takeaways:

• Symptoms related to the normal physiological changes of pregnancy should improve in the postpartum period.
• The highest risk period for CVD worsening is between 24-28 weeks of pregnancy or postpartum.
• Emergency Room visits for dyspnea (shortness of breath) should heighten suspicion level for CVD.
• Postpartum dyspnea or a new onset cough should heighten suspicion for CVD.
• New onset asthma is rare in adults.
• Bilateral crackles are likely related to congestive heart failure (CHF).
• Bilateral infiltrates on chest x-ray may be due to heart failure rather than pneumonia.
• Hypertension and diabetes in pregnancy increases the risk of CVD.
• Healthy lifestyle changes can reduce future CVD risk by 4-13%.

References:

ACOG, 2019. Pregnancy and heart disease.

AHA, 2020. Cardiac arrest in pregnancy in-hospital ACLS algorithm.

AWHONN, 2023. Obstetric patient safety ob emergencies workshop, 3^rd ed.

CMQCC, 2017. Cardiovascular disease in pregnancy and postpartum toolkit.

P.S. COMMENT AND SHARE: What is your experience with cardiovascular disease in pregnancy or in the postpartum period?  Have you been involved in an adverse outcome as a result of a CVD diagnosis, or failed diagnosis?

Learning From Lawsuits: Verdict Review – Wrongful Maternal Death Case Involving Preeclampsia,

In an effort to help improve maternal health outcomes, we need to be open minded to learning from lawsuits, and implementing necessary change in an effort to prevent recurrence.

In this blog, I’ll be discussing preeclampsia.  I’ll review symptoms of preeclampsia, as well as the incidence, and I’ll introduce a lawsuit involving a maternal death as a result of severe preeclampsia.  In closing, I’ll identify key clinical takeaways regarding the standard of care specific to timely diagnosis, treatment, and follow up when caring for women with a diagnosis of preeclampsia.

Preeclampsia Definition: Preeclampsia is a disorder of pregnancy associated with a new onset of hypertension, which can affect every body organ.  The onset occurs after 20 weeks of pregnancy;  It can also develop in the weeks after childbirth.  Symptoms can include:

• swelling of the face or hands
• headache that will not go away with rest, hydration, Tylenol
• seeing spots or changes in eyesight
• pain in the upper abdomen or shoulder
• nausea and vomiting (in the second half of pregnancy)
• sudden weight gain
• difficulty breathing

A woman with preeclampsia whose condition is worsening can develop “severe features”. Severe features include:

• low number of platelets in the blood
• abnormal kidney or liver function
• pain in the upper abdomen
• changes in vision
• fluid in the lungs
• severe headache
• systolic pressure of 160 mm Hg or higher or diastolic pressure of 110 mm Hg or higher

Incidence: preeclampsia complicates up to 8% of pregnancies globally.

• Annually, 16% of global pregnancy related deaths can be attributed to hypertensive disorders.
• In the U.S., between 2017-2019, hypertensive disorders caused 6.3% of pregnancy related deaths. 

Case Facts: The plaintiff’s decedent was a 34-year-old who was hospitalized at Samaritan North Hospital due to preeclampsia at 36 weeks gestation.  The patient was under the care of a board-certified family physician who had minor privileges to deliver uncomplicated pregnancies.  The family physician saw the patient in her office for a routine prenatal visit.  At that time, the patient reported a headache and cough.  The patient’s blood pressure was increased from her baseline to 130/90, and she had a 6.8-pound weight gain since her last visit.  The patient was advised to return to the office in two weeks.  Two days later, the patient contacted her family physician, and reported vaginal bleeding and a headache.  The family physician instructed the patient to go to the emergency room.  The patient was subsequently admitted with a diagnosis of a potential placental abruption.  An ultrasound revealed oligohydramnios (decreased amniotic fluid for gestational age), intrauterine growth restriction, and a Grade II placenta (some placental calcification/hyperechoic areas).  During the patients admission she experienced repeated high blood pressures, headaches, variable, and late decelerations, an abnormal D-Dimer reading, and a drop in her platelet count.  Five days later, the patient was discharged from the hospital and advised to go to M. Valley Hospital to obtain an ultrasound.  That same evening, the patient called the family physician, and reported vomiting, abdominal pain, and headaches.  The family physician reportedly instructed the patient to call her back in one hour which she did, and was told to go to the hospital.  Upon arrival to the hospital the patients’ blood pressure was 128/103, and 155/100.  The patient was allegedly grimacing, complaining of a headache, was vomiting and had facial edema.  The family physician ordered the patient to be admitted for observation. Approximately six hours following the patients arrival to the hospital, she was found with her head hanging over the bed, having vomited, and in an obtunded state.  The emergency response team was called, and an obstetrician who was physically on the unit was called to evaluate the patient.  The obstetrician ordered magnesium sulfate, and hydralazine.  The obstetrician diagnosed the patient with eclampsia, and immediately transported her to the operating room for delivery of her baby boy by cesarean section.  The patient remained unresponsive.  A CT scan confirmed a massive intracranial hemorrhage.  A brain scan was subsequently performed which showed lack of brain flow, and the patient was pronounced dead. 

Plaintiff’s Allegations: The plaintiffs’ counsel contended that the family physician egregiously deviated from the accepted standards of medical care.  The lawsuit further claimed that the family physician materially misrepresented to the patient that she was experienced and trained in the treatment of all her obstetrical conditions, and fraudulently concealed from her that her ability to practice obstetrics was restricted to minor obstetrics in accordance with the Samaritan North Hospital policy.  The lawsuit also claimed that the family physician was guilty of constructive fraud, was inadequately trained and inexperienced to treat the patient, and abandoned her patient by failing to adequately diagnose, and treat her condition or refer her to an obstetrician who could provide treatment to her. 

Defendant’s Allegations: The defense argued that the family physician met the standard of care applicable in this case.  The defense pointed to the fact that the family physician was credentialed to practice obstetrics at Samaritan Hospital.  Also, the defense contended that the patient’s blood pressures were never sustained, and never reached a level that would require a consult with an obstetrician before the event occurred.  The defense maintained that the family physician did consult with a board-certified obstetrician, and maternal fetal medicine specialist who ordered continuous antepartum testing, and induction at 39 weeks, and that the family physician appropriately instructed the patient to return to the hospital for monitoring.  The defense argued that the patients complications, and death were unforeseeable.  The defense argued that the patient never had an eclamptic seizure, and that she never met criteria for preeclampsia.  Additionally, the defense argued that the evidence demonstrated that, more likely than not, this was a ruptured aneurysm in a patient with a family history of stroke.    

Physical Injuries Claimed by Plaintiff: The patient allegedly died from complications of preeclampsia that caused a major intracranial hemorrhage. 

Gross Verdict (Award): The jury found that the negligence of the family physician, and the private practice was a direct, and proximate cause of the patients death.  The jury awarded compensatory damages of $6,067,830.10, which included loss of support from earning capacity of the patient; loss of services; loss of society including companionship, consortium, care, assistance, attention, protection, advise, guidance, counsel, instruction, training, and education suffered by the surviving spouse, children, parents, and next of kin; mental anguish; and reasonable funeral and burial expenses.  The award was reduced to $900,000 pursuant to a high/low agreement. 

Standard of Care Takeaways:

• Early Recognition and Management: Health care systems responsible for rendering care to pregnant and postpartum persons should develop procedures for (re)measuring blood pressure, and integrate standardized criteria for the diagnosis, and management of preeclampsia, and severe hypertension.
• Education: Role specific multidisciplinary education, simulation training, and team de-briefing should be required for all members responsible for caring for obstetrical, and postpartum patients.  Care areas should include labor and delivery, anesthesia, emergency department, and intensive care unit. 
• Quality Improvement: Organizational review of severe hypertension/preeclampsia cases should occur as part of a quality improvement process.  Additionally, printed patient and family education should be disseminated focusing on risk factors for severe hypertension/preeclampsia, as well as signs and symptoms to report.
• Maternal Safety Bundles: Multiple organizations (i.e., ACOG, AWHONN, CDC, CMQCC, NIH) have maternal safety bundles that focus on prevention, early identification, and early treatment of preeclampsia in an effort to reduce maternal mortality. Organizations are encouraged to integrate such safety bundles into their policies and procedures.

Resources:

American College of Obstetricians and Gynecologists, (2020). Gestational hypertension & preeclampsia. Practice Bulletin #222.

American College of Obstetricians and Gynecologists. (n.d.). Safe motherhood initiative. Retrieved March 8, 2023, from https://www.acog.org/community/districts-and-sections/district-ii/programs-and-resources/safe-motherhood-initiative

California Maternal Quality Care Collaborative. Retrieved December 17, 2023, from https://www.cmqcc.org/

Centers for Disease Control and Prevention. Pregnancy Mortality Surveillance System. Retrieved December 27, 2023, from  https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm

Collier A.Y., Molina R.L. (2019).  Maternal Mortality in the United States: Updates on Trends, Causes, and Solutions

P.S. COMMENT AND SHARE:  Have you had a case theme centered around diagnosis, and/or management of preeclampsia?   What were some of the case facts?  How did the case facts impact the case outcome?

In this blog I’ll review the objective of the Emergency Medical Treatment and Active Labor Act (EMTALA), obstetrical standards of care, consequences of EMTALA violations, common obstetrical allegations and offer a case scenario for reflection. 

Emergency Medical Treatment and Active Labor Act (EMTALA):  The Federal EMTALA Act was created as anti-discriminatory legislation to protect people who could not afford emergency care services.  The over-arching purpose of EMTALA is to ensure access to health care. 

Obstetrical Standards, Guidelines and Recommendations: EMTALA requires participating hospitals (hospitals participating in the Medicare program) to have policies and procedures that ensure that:

• Healthcare providers offering obstetrical triage:
  • Perform a medical screening examination (MSE) to determine whether an emergency medical condition exists (including a maternal and fetal evaluation)
  • Provide necessary stabilization treatment when an emergency medical condition exists
  • Stabilize the pregnant patient, or if the healthcare provider certifies that the benefits of transfer outweigh the risks, arrange for proper transfer to another hospital.
• Pregnant women may come to the hospital’s labor and delivery unit not only for obstetrical care but also for evaluation and treatment of non-obstetrical illness.  A pregnant woman who presents for care should be evaluated in a timely fashion.  Minimally, evaluation by an obstetrical nurse should include assessment of maternal vital signs, fetal heart rate, and uterine contractions.  Further evaluation includes assessment for vaginal bleeding, acute abdominal pain, temperature of 100.4 degrees Fahrenheit or higher, preterm labor, preterm premature rupture of membranes, hypertension and indeterminate or abnormal fetal heart rate patterns.  If these findings are present or suspected, the responsible obstetrical care provider should be promptly informed.
• The initial triage process requires one nurse to one woman presenting for care.  This ratio may change to one nurse to two, or three women as maternal fetal status is determined to be stable, until patient disposition.
• Any patient who is suspected to be in labor or who has ruptured membranes, or vaginal bleeding should be evaluated promptly.  Minimally, the following should be assessed: maternal vital signs, frequency and duration of contractions, documentation of fetal well-being, urinary protein concentration, cervical dilation and effacement (unless contraindicated such as with placenta previa or preterm premature rupture of membranes), cervical length, fetal presentation and station of presenting part, status of membranes, estimated fetal weight, and assessment of maternal pelvis.  In addition to these assessments, date and time of the patient’s arrival and notification of the obstetrical provider should be included in the medical record.
• If the woman has received prenatal care and a recent examination has confirmed the normal progress of pregnancy, triage evaluation may be limited to an interval history and physical examination directed at the presenting condition. 

Consequences of EMTALA Violations:

• Hospital fines up to $250,000 per violation
• Physician fines up to $50,000 per violation
• Hospital termination from its Medicare provider agreement
• Physician exclusion from Medicare and Medicaid programs
• A patient who suffers personal injury from a violation may sue the hospital for damages in civil court
• A receiving facility, having suffered financial loss as a result of another hospital’s violation of EMTALA, can bring suit to recover damages

Common Obstetrical Triage Allegations:

• Failure to perform a medical screening examination
• Failure to include a timely assessment of fetal status as part of the maternal medical screening examination
• Delay in performing a medical screening examination (E.g., having a pregnant woman wait in the waiting room prior to maternal-fetal status being evaluated)
• Failure to have a policy in place delineating conditions that require bedside evaluations by a physician or midwife prior to discharge after MSE by labor and delivery RN
• Failure of provider to complete bedside evaluation for pregnant woman who presents with high-risk medical or obstetrical condition
• Discharge of a pregnant woman who is unstable for discharge (E.g., pregnant woman with elevated blood pressures and complaints of unresolved headache.)
• Discharge of a pregnant woman without establishing fetal well-being (E.g., completion of a non-stress test at or greater than 28weeks gestation)
• Failure to meet all aspects of the EMTALA regulations in assessing, treating, and discharging a pregnant woman who presents for care

Case Scenario:

The patient is a 33-week pregnant woman, presented to Hospital “A” complaining of leaking fluids, pelvic pain and vomiting. An ED nurse told the patient that the hospital did not have an obstetrician on site and that the patient could either start treatment at Hospital “A” and be transferred later, or that her support person could drive her immediately to Hospital “B” where her obstetrician practiced.

After being told this, the patient left Hospital “A” by private vehicle to Hospital “B,” a thirty-minute drive. Hospital “A” never provided the patient or her unborn child a MSE and failed to transfer this patient who had an emergency medical condition. At Hospital “B,” the patient underwent an emergency cesarean delivery and delivered a male infant without a heartbeat. The receiving hospital’s efforts to revive the infant were unsuccessful.

The hospital entered into a $50,000 settlement agreement with the Office of Inspector General regarding allegations that it failed to provide an adequate MSE and transfer for a patient.

References

Moffat J.C. (2021), The EMTALA Answer Book, 1^st edition.

Simpson K.R., Creehan P.A., (2008). Perinatal Nursing, 4^th edition.

Simpson K.R. et al.,  (2021). Perinatal Nursing, 5^th edition.

P.S. Comment and Share: What is your experience with developing EMTALA policies, or auditing compliance?  Do you have an EMTALA violation case to share?

In this blog, I’ll review the findings from the most recent Nurse Professional Liability Exposure Claim Report, as well as findings from the Joint Commission, specific to communication
as a root cause factor that contributes to adverse patient events.  I’ll highlight barriers to effective communication, as well as risk mitigation strategies. 

Communication Barriers: According to the Nurse Professional Liability Exposure Claim Report (2023), communication barriers can prevent or delay nurses from reporting changes in the patient’s condition, invoking the chain of command, clarifying orders, or raising
concerns about systems and processes.

Total Incurred: It has been reported that allegations specific to communication had an average total incurred of $324,260, which is more than one and a half times greater than the overall average total incurred for all nursing professional liability claims of $210,513 (Nurse Professional Liability Exposure Claim Report, 2023).

Risk Mitigation Strategies

Communication Techniques: The Institute for Healthcare Improvement (IHI) and the Agency for Healthcare Research and Quality (AHRQ) provides supportive education and training specific to effective communication.  Specific techniques that promote effective communication across the multidisciplinary team includes, but is not limited to, the following:

TeamSTEPPS® program: Teaches healthcare teams effective strategies to improve communication across all specialties and promotes situational awareness. One of the several verbal strategies that are recommended includes:

1. TeamSTEPPS® program: Teaches healthcare teams effective strategies to improve communication across all specialties and promotes situational awareness. One of the several verbal strategies that are recommended includes:
   • SBAR: This acronym stands for Situation, Background, Assessment, and Recommendation/Request. SBAR is a communication technique intended to relay significant information regarding a patient’s condition or may be used during hand off report (AHRQ, 2013).   
2. Check-back: Involves closed-loop communication to ensure that
   information communicated by the sender is understood by the
   receiver as intended by repeating back information.
3. Hand-offs: Require timely, complete and accurate transfer of information from one
   caregiver to another (Joint Commission, 2018).

Nurses as Patient Advocates: Nurses have a duty and obligation to serve as patient advocates.  This duty ensures that their patients receive safe and appropriate care.  Nurses must be comfortable implementing the chain of command whenever they believe a practitioner is not responsive to calls for assistance, fails to appreciate the seriousness of a situation or neglects to initiate an appropriate intervention (Nurse Professional Liability Exposure Claim Report, 2023).

Enhancing knowledge of the root cause of adverse events, influences the power to reduce the risk of recurrence.  Identifying the barriers to effective communication and mindfully applying communication techniques reduces adverse patient outcomes.  Supporting a culture of safety within healthcare organizations supports open communication, promotes patient advocacy, shared accountability, and most importantly, patient safety.     

References

Agency for Healthcare Research and Quality. TeamSTEPPS®, (2013). Retrieved from https://www.ahrq.gov/teamstepps/instructor/fundamentals/index.html

Institute for Healthcare Improvement. SBAR Tool: Situation-Background-Assessment-Recommendation, (2017). Retrieved from https://www.ihi.org/resources/Pages/Tools/SBARToolkit.aspx

Nurse Professional Liabiilty Exposure Claim Report, (2023). 4th Edition. Retrieved from www.nso.com/nurseclaimreport

The Joint Commission. 8 tips for high-quality hand-offs, (2018). Retrieved from

https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/sentinel-event/sea_8_steps_hand_off_infographic_2018pdf.pdf

 P.S. Comment and share: How did communication barriers impact a past, or current case? How were patient outcomes influenced?