CME Information

Sponsored by:
NORCAL Mutual Insurance Company, a member of the NORCAL Group. The NORCAL Group of companies includes NORCAL Mutual Insurance Company, Medicus Insurance Company, NORCAL Specialty Insurance Company and FD Insurance Company.

NORCAL Mutual Insurance Company is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

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Method and Medium

To obtain CME credit, read the article then take the quiz and fill out the evaluation form. You can print or email your CME certificate from this application.

Please complete and submit the online quiz by the expiration date indicated below:

Original Release Date: July 15, 2017

Expiration Date: August 1, 2019

Learning Objectives

By reviewing medical professional liability claims and/or emerging topics in healthcare risk management, this enduring material series will support your ability to:

• Assess your practice for risk exposures.
• Apply risk management best practices that increase patient safety and reduce medical professional liability claims.

Target Audience

All clinicians, healthcare staff and administrators who serve pregnant patients or who are involved in perinatal care.

Credit Designation Statement

NORCAL Mutual Insurance Company designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure Policy

As an ACCME accredited provider, NORCAL Mutual Insurance Company requires planners, reviewers or authors who influence or control the content of a CME activity to disclose financial relationships (of any amount) they have had with commercial interests associated with this CME activity during the year preceding publication of the content.

Any identified conflicts of interest are resolved prior to the commencement of the activity.

Disclosures

Individuals involved in the planning, reviewing or execution of this activity have indicated they have no relevant financial relationships to disclose.

Why the maternal mortality rate in the United States continues to rise is not entirely clear, but appears to be multifactorial. Commentators suggest that the increase is partially associated with the increasing number of pregnant women in the United States who have chronic conditions such as high blood pressure, diabetes, obesity or heart disease.² A review of NORCAL Group closed claims revealed that mothers who died in the immediate postpartum period usually

had one or more of these conditions, and that their healthcare experiences involved various communication breakdowns and teamwork failures. Research indicates that consistently applied communication and teamwork strategies increase maternal safety,³ which in turn decreases liability risk. Therefore, this article focuses on identifying high-risk conditions and improving communication and teamwork strategies during antepartum, peripartum and postpartum healthcare.

Case One

Allegation:

The patient’s death from hemorrhage was preventable.

A morbidly obese, 45-year-old female patient with chronic hypertension and diabetes presented to an obstetrician (OB) for prenatal care. She had undergone two previous uneventful Caesarean section (C-section) deliveries. Ultrasounds revealed that the placenta was anterior and low lying. In her 39th week of pregnancy, the OB admitted the patient to the hospital for a planned C-section. Her blood pressure at admission was 150/69.

The OB delivered a healthy baby without complication. During the C-section, the patient’s placenta was mostly delivered without incident, but the OB had to place his hand between the placenta and uterine wall to detach it. There was no evidence of retained placenta; however, the wall of the uterus was briskly bleeding in various spots. Over the next hour, the OB worked on suturing the uterus to control the bleeding.

Meanwhile, the patient was losing blood. The anesthesiologist estimated blood loss at 2,500 ml, and she was having trouble maintaining the patient’s blood pressure. The anesthesiologist infused 3,500 ml of crystolloid and transfused four units of packed red blood cells following the delivery of the placenta. The anesthesiologist administered two different medications indicated for the treatment of postpartum hemorrhage and vasopressors to increase blood pressure. Although the anesthesiologist had indicated to the nurses that she had trouble maintaining the patient’s blood pressure and that the patient’s condition was tenuous, she did not communicate this to the OB.

The OB believed he had stopped the bleeding. He and the assistant surgeon confirmed hemostasis by observation and by flushing the abdomen with saline. They closed the surgical site. At this point, the patient’s blood pressure had risen from a low of 70/40 to 97/34. Following surgery, the patient was lucid, communicating and seemed to be appropriately responding to the transfusions. Unaware of the anesthesiologist’s trouble maintaining the patient’s blood pressure, the OB and assistant surgeon left the surgical suite. The OB went to talk to the patient’s husband.

Forty minutes after the surgery was completed, the patient lost consciousness. A code blue was called, but she could not be resuscitated. Placenta accreta was diagnosed microscopically, which the pathologist concluded was the source of the hemorrhaging.

The patient’s husband and children filed a wrongful death claim against the anesthesiologist, OB, assistant surgeon, nurses and hospital. The plaintiff’s allegations included:

• The anesthesiologist should have informed the OB that she was having trouble maintaining blood pressure.
• The OB failed to vigilantly monitor the patient’s status following the C-section, and should have been more thorough in communicating with the anesthesiologist regarding the patient’s status before he left the operating room.
• The obstetrician failed to recognize the patient needed alternative aggressive measures, possibly including a hysterectomy to control the hemorrhaging. He needed to have a higher index of suspicion.
• The anesthesiologist failed to adequately communicate the hemodynamic signs of hemorrhage to the obstetrician and failed to call for assistance.
• The anesthesiologist failed to transfuse enough blood.
• The anesthesiologist failed to call the obstetrician back to the operating room when she continued to have trouble maintaining the patient’s blood pressure.

Maternal Obesity
Increasing maternal obesity is one of the reasons cited for the rise in the maternal mortality rate in the U.S. (Almost half of the women who become pregnant are overweight or obese, according to CDC studies.⁵) Obesity-related maternal risks include:^6,7

• Gestational diabetes
• Preeclampsia
• Failed trial of labor and C-section
• Anesthesia complications
• Blood loss greater than 1,000 ml
• Venous thromboembolism and pulmonary embolism
• Wound breakdowns and infection
• Difficult epidural placement and intubation

Advanced Maternal Age
The risk of dying from pregnancy complications is more than twice as likely for women over 40 as it is for women aged 20 to 24.⁵

Heart Conditions
Heart conditions contribute to 25% of pregnancy-related deaths.⁵ Changes in the circulatory system during delivery and the immediate postpartum period can place overwhelming strain on an abnormal heart.⁸ Because heart conditions were never discussed with the patient, it is unlikely she would have recognized the symptoms, which can be confused with benign pregnancy-related conditions (e.g., dyspnea on exertion, orthopnea, ankle edema and palpitations).⁸ Once the patient in this case arrested, experts surmised she had very little reserve, which probably contributed to her inability to survive a cardiac arrest.

Hemorrhage

Communication failures and lack of effective teamwork among the members of a healthcare team are well-recognized barriers to patient safety.9 The foregoing case shows how lack of communication can lead to false assumptions that can undermine patient safety. Effective policies and protocols are a major aspect of ensuring adequate communication and teamwork. However, the best protocol may be useless if it has never been practiced. According to the American Congress of Obstetricians and Gynecologists (ACOG), failing to drill on protocols “is similar to a football team that studies its plays but never works through the timing on the practice field.”¹⁰ Consider the following recommendations:^11,12

Administrators

• Develop and utilize policies and protocols to identify women at increased risk for maternal hemorrhage.
  • Develop policies and protocols for advising members of the healthcare team about a patient’s elevated risk of hemorrhage.
• Create a protocol for identifying a hemorrhagic emergency and taking action to control it.
• Ensure all members of the labor, delivery and recovery teams are trained in accurately assessing and consistently communicating the amount of blood loss.
• Develop policies and protocols for responding to hemorrhage.
  • Engage frontline staff in the design and approval of hemorrhage policies and procedures.
  • Devote an adequate amount of time for clinicians and staff to learn new protocols.
  • Ensure compliance with policies and protocols.
  • Provide education on the protocols annually and ensure new staff members are appropriately trained.
  • Test the effectiveness and efficiency of protocols and make necessary changes.
  • Include the recovery and early postpartum period in hemorrhage monitoring policies and protocols.
• Ensure all members of the labor, delivery and recovery team, including nurses, physicians and ancillary staff, participate in drills and simulations, including training as a team, as appropriate.
  • Assess teamwork and communication during simulations and drills.
    • TeamSTEPPS is an evidence-based teamwork system designed to improve communication and teamwork skills among healthcare professionals. Materials are available at: www.ahrq.gov/... (accessed 5/24/2017).
  • Conduct simulations and drills at different times of the day to ensure that appropriate team members and resources are available.
• Ensure rapid access to equipment/blood and clotting factors.
• Update protocols in response to findings from obstetrical quality improvement initiatives and updates to clinical guidelines. See, for example, the California Maternal Quality Care Collaborative (CMQCC) Improving Health Care Response to Obstetric Hemorrhage Toolkit, available at: www.cmqcc.org/... (accessed 5/25/2017).

• Post protocols for hemorrhage management in delivery rooms or operating suites. The CMQCC Obstetric Hemorrhage Emergency Management Plan Chart is reproduced at the end of this article and is also available online at: www.cmqcc.org/... (accessed 5/25/2017)).
• Provide checklists, for example, the ACOG Obstetric Hemorrhage Checklist, available at www.acog.org/... (accessed 5/25/2017).

Clinicians and Staff

• Adopt a team mentality during delivery, such that the entire team becomes responsible for assessing the mother’s status and any member speaks up if he or she becomes concerned in any way about a deviation from the normal course of events (i.e., high blood loss).
• Use protocols and checklists to identify women at increased risk for maternal hemorrhage.
• Develop a childbirth and postpartum plan specific to the patient’s increased risk of hemorrhage, including:
  • Obtaining a preoperative anesthesia assessment.
  • Scheduling at-risk patient C-sections at times when access to adequate surgical personnel and resources is guaranteed, which might mean scheduling the patient for delivery at a different hospital than originally planned. The surgical team should include:
    • A surgeon with experience and expertise in controlling massive hemorrhage
    • A critical care physician or anesthesiologist experienced with massive hemorrhage to assess organ perfusion and cardiovascular function
    • An onsite hematologist or clinical pathologist to provide blood product advice and coordination of product availability
  • Scheduling the patient for delivery at a hospital that can handle high-risk deliveries.
  • Vigilantly monitoring blood loss during labor and delivery and in the early postpartum period.
• Ensure all members of the delivery team are aware of a patient’s elevated risk of hemorrhage.
  • Conduct a “team meeting” prior to labor and delivery.
• If placenta previa or placenta accreta is diagnosed or strongly suspected, counsel the patient about the possibility of hysterectomy and blood transfusion.
• Use accurate methods for estimating blood loss (e.g., weighing blood on pads/chux) and use accurate suction devices during surgery.
• Use flow charts, checklists and other documentary materials to prepare for and manage a hemorrhagic emergency. See, for example, the ACOG Guidance Document on Morbidly Adherent Placenta, available at: www.acog.org/... (accessed 5/25/2017).
• Know where hemorrhagic emergency equipment is and how to use it.
• Debrief with the entire delivery team after every drill and after every hemorrhagic emergency.

Obstetric Hemorrhage Resources

Resources and guidelines are provided below, and in later pages of this article; however, it is important to remember that emerging scientific and clinical advances result in frequent updates.

• CMQCC. Improving Health Care Response to Obstetric Hemorrhage, Version 2.0: A California Toolkit to Transform Maternity Care, available at: www.cmqcc.org/... (accessed 5/25/2017).
• ACOG. Obstetric Hemorrhage Bundle, available at: www.acog.org/... (accessed 5/25/2017).
• Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN). Postpartum Hemorrhage Project, available at: www.awhonn.org/... (accessed 5/25/2017).
• Council on Patient Safety in Women’s Healthcare. Obstetric Hemorrhage (+AIM). Available at: safehealthcareforeverywoman.org/...(accessed 5/25/2017).

Maternal Obesity

Research seems to indicate that obese pregnant women are at increased morbidity and mortality risk. Their antenatal, intrapartum and postpartum care pathways should take this increased risk into account.¹³ Consider the following recommendations:^14,15,16

• At the initial prenatal visit and periodically throughout the pregnancy, review appropriate weight gain.
• Counsel obese patients about how obesity can complicate pregnancy, labor, delivery and postpartum recovery.
  • American College of Obstetricians and Gynecologists provides patient-oriented obesity educational resources for patients at: www.acog.org/... (accessed 5/25/2017).
• Offer obese pregnant patients nutrition counseling and urge exercise.
• Test for diabetes in the first trimester, then repeat testing later in the pregnancy if the results are negative.

• Create a multidisciplinary team (primary care, OB/GYN, anesthesia, nursing, wound care, dieticians, physical therapy, etc.) to increase patient compliance and safety.
• Have resources available for obesity-related complications during delivery (e.g., additional blood products, a large operating table and extra personnel in the delivery room).
• Because of an increased risk of emergent C-section and anesthetic complications among obese patients, consult with anesthesiology early in the labor.
• Because of an increased risk of thromboembolism in patients undergoing C-section, ensure appropriate thromboprophylaxis.
• Because of an increased risk of infection, ensure appropriate preoperative antibiotic dosages prior to C-section.
• Because of an increased risk of wound disruption, ensure appropriate closure of the subcutaneous layer during C-section.

Cardiovascular Disease

Profound changes in maternal circulation during pregnancy can increase morbidity and mortality risk, particularly for women with pre-existing heart conditions.12 Consider the following recommendations:^12,17

• Develop and utilize policies, protocols, checklists and other resources to identify women with or at risk of developing cardiovascular disease symptoms.
• Know how to distinguish heart conditions from benign pregnancy-related conditions.

• Teach patients how to recognize the symptoms of cardiac conditions during pregnancy.
  • Counsel patients to report these symptoms to you.
• When a pregnant patient reports a constellation of symptoms that may signal heart disease, take the necessary measures to rule it out or refer the patient to a specialist.

Maternal Cardiovascular Disease Resources

• CMQCC. Signs & Symptoms of Heart Disease during Pregnancy and Postpartum. Available at: www.cmqcc.org/... (accessed 5/25/2017).
• European Society of Cardiology (ESC). Regitz-Zagrosek V. et al. Guidelines on the management of cardiovascular diseases during pregnancy. European Heart Journal (2011) 32, 3147–3197. Available at: www.escardio.org/... (accessed 5/25/2017).

Case Two

Allegation:

Delayed diagnosis of HELLP syndrome resulted in maternal death.

A 37-year-old nulliparous woman presented to a community clinic after a positive home pregnancy test. Other than developing gestational diabetes, which was mostly controlled with medication, her pregnancy progressed normally. At her 37-week appointment, the patient was unable to provide a urine sample prior to being examined by the OB. The medical assistant (MA) told her she could provide her sample after the exam. The MA did not enter the blood pressure reading of 161/87 in the patient's chart immediately, because she was waiting until she had the urinalysis results and wanted to do all of the charting at the same time.

The patient reported no complaints to the OB, who did not notice the absence of urine dipstick results or the blood pressure reading. The OB told the patient to return the following week for a routine examination. Following the examination, the patient provided a urine sample and was told she could leave. The MA noted the presence of 4+ protein in the urine sample. Per clinic policy, the MA had a clinician sign off on the test result. The clinician she chose for this task was a physician’s assistant (PA) who had never examined or treated the patient. The PA did not bring the abnormal result to the attention of the patient's OB.

During the week following the appointment, the patient felt as if she had the flu. She called the OB and described feeling unusually fatigued and nauseous, with a constant dull headache and abdominal pain. The OB agreed with her self-diagnosis of flu. He told her to go to the Emergency Department (ED) if it got worse. As the week wore on, she started to vomit and developed heartburn. Her husband, who also thought she had the flu, became alarmed when her face and extremities became very swollen, and she had trouble taking full breaths. This prompted him to take his wife to the ED. She was diagnosed with HELLP syndrome and scheduled for an immediate C-section. A healthy infant was delivered without complication. Despite heroic efforts on the part of the healthcare team, however, the patient’s condition continued to decline, and she died the next day.

The patient's husband sued the OB, PA and clinic, alleging the OB negligently failed to order follow-up tests after the abnormal lab results were obtained during the week-37 examination, which he claimed would have resulted in a timely diagnosis of HELLP syndrome and the patient's survival.

Test Result Communication and Follow-Up

Abnormal test result communication is a well-recognized patient safety issue. Joint Commission patient safety goal NPSG.02.03.01 — “Report critical results of tests and diagnostic procedures on a timely basis”²² — reinforces the importance of this issue, even in settings that do not seek Joint Commission accreditation. In this case, confusing and inconsistent communication policies and clinical practices contributed to the tragic outcome. Consider the following recommendations:

Clinicians and Staff

• Ensure patients understand what tests were ordered, why the tests were ordered, when results should be expected and what to do in the event of an abnormal result.
• Communicate test results to the patient, even if they are normal.
• Bring any deviation from normal to the attention of the clinician in charge. Do not assume that someone else will communicate a critical result to a person who can take action on it.
• Err on the side of redundancy and follow up on tests you have ordered.
• Avoid criticizing colleagues or staff for redundant critical results reporting practices.
• Educate patients about symptoms necessitating immediate follow-up with a clinician.

Administrators

• Establish clear policies and protocols to ensure abnormal results are appropriately communicated to someone who can take action.
  • Define critical test results
  • Define which results require communication to the ordering physician and the timeframe for doing so.
  • Create a process for communicating critical test results when the ordering physician is not available in the timeframe indicated.
  • Establish clear expectations of responsibility for the communication of test results.
  • Ensure appropriate protocols exist for mid-level practitioners.
• Build redundancy and back-up systems into test result communication.
• Fully utilize tools in the electronic health record (EHR) system to ensure timely communication of results.
• Reduce the number of hand-offs between test ordering and results communication.
• Establish methods to confirm the effectiveness and implementation of communication policies and procedures.

Test Result Follow Up Resource

NORCAL Risk Management Resource Follow Up Bundle

The different stages of pregnancy provide multiple opportunities for healthcare clinicians and staff to lessen morbidity and mortality risks for patients who present with or develop the conditions that can result in maternal mortality. During labor and delivery, robust communication and teamwork policies and protocols are critical. Any deviation from normal should prompt notification of the clinician in charge, and contemporaneous communication is encouraged. Reversing the upward trend of maternal mortality in the U.S. is a job that clinicians can address one pregnancy at a time. Communication and teamwork policies and procedures can increase patient safety if they are appropriately developed and implemented. A vital aspect of any protocol implementation is practicing it and fine tuning it to best achieve optimal results. Clinicians, staff and administrators are encouraged to consider and, where appropriate, implement the risk management and patient safety strategies introduced in this month’s publication.

| Special thanks to Kurt Wharton, MD, for reviewing this article.