The Centers for Medicare and Medicaid Services (CMS) Response
In December 2021, a Maternity Care Action Plan was introduced by CMS to improve maternal health.The focus of this action plan is on improving access to and quality of care during pregnancy, childbirth, and the postpartum period. Proposals and steps in progress include, but are not limited to, implementing quality measurements. For example, hospitals are required to report to CMS if they have participated in a maternity care quality collaborative, and if so, whether they have implemented best practices to improve maternity care quality, such as initiatives to reduce maternal hemorrhage. CMS’ Hospital Inpatient Quality Reporting Program reduces payment to hospitals that fail to meet program requirements, including the submission of quality data.
The Centers for Disease Control and Prevention Response
In response to the rise in maternal mortality, the CDC has a number of initiatives focused on two of the top causes: obstetrical hemorrhage and hypertension.
Perinatal Quality Collaboratives (PQCs)
The CDC has formed multi-state networks of teams called Perinatal Quality Collaboratives (PQCs). These PQCs work to improve the quality of care for mothers. PQC members identify healthcare processes that need to be improved and use the best available methods to make changes in collaboration with participating hospitals.
Examples of PQC initiatives include the following, designated to reduce severe pregnancy complications associated with hypertension and hemorrhage:
- Hypertension: Within participating hospitals, a protocol for event-specific debriefings for every severe pregnancy hypertensive event should be implemented. This quality improvement initiative is associated with an increase in the number of perinatal care teams administering antihypertensive medications within the recommended 60 minutes from the time of diagnosis.
- Hemorrhage: Within participating hospitals, The California Maternal Quality Care Collaborative’s Improving Health Care Response to Obstetric Hemorrhage toolkitshould be implemented. This tool kit, like many others from national organizations, is based on the National Partnership for Maternal Safety Consensus Bundle on Obstetric Hemorrhage;hospitals that are not currently participating in a PQC should review the bundles available and select the one that works best for their organization.
The CDC Levels of Care Assessment Tool (CDC LOCATe)
This is a web-based tool to help states create standardized assessments specific to levels of maternal and neonatal care based on the most recent guidelines and policy statements issued by the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine.
The determination of the appropriate level of care (level I–IV) to be provided by a given facility can be guided by CDC LOCATe. Hospitals should have policies that promote and support a regionalized system of perinatal care.
The American College of Obstetricians and Gynecologists Response
The American College of Obstetricians and Gynecologists (ACOG) has a long-standing history of being committed to addressing the rise in maternal morbidity. In 2001, the Safe Motherhood Initiative (SMI) was established through collaborative efforts between ACOG and the New York State Department of Health (NYSDOH). The SMI reviewed cases of reported hospital-based maternal deaths, which led to protocol changes and efforts to increase the awareness of risk factors contributing to maternal morbidity.
In 2013, the SMI broadened their scope and began working with obstetric hospitals in various states to develop and implement standard approaches for handling obstetric emergencies associated with maternal mortality. SMI maternal safety bundles, such as the obstetrical hemorrhage and the severe hypertension in pregnancy bundles, were introduced in 2020. These maternal safety bundles focus on prevention, early identification, and early treatment in an effort to reduce maternal mortality.
Analyzing Maternal Wrongful Death Cases
Every hospital organization should have a quality and risk management department involved in root cause analysis for every maternal death case. Maternal deaths are reportable to the state department of health and should be filed within an adverse event reporting system. There is an existing problem with underreporting and misclassification of maternal deaths.It is crucial that specific information is recorded and reported. For example, it’s important to establish pregnancy status, as well as timing and cause of death, in an effort to identify maternal death. There is significant variation in identifying symptoms, signs, diseases, and methods of deciphering, and reporting cause of death. This negatively affects global coding of maternal deaths.
Review of a number of state maternal morbidity and mortality review reports found that preventable pregnancy-related deaths involved care that was not in accordance with national professionally recognized standards.There were deficiencies in care among physicians, midwives, nurses, residents, and the systems, as well as hospital, and support services.
In the realm of personal injury law, medical malpractice cases that result in the death of a patient are governed by both medical malpractice and wrongful death laws. In the event of an alleged wrongful death due to medical malpractice, the decedent’s family members may be entitled to pursue claims for monetary damages for past medical expenses, funeral expenses, loss of monetary support, loss of household services, as well as money for mental pain and suffering related to the loss of their loved one. Such cases can cost hundreds of thousands of dollars in attorney fees and costs, and feature years of complex litigation. In the event of a settlement or verdict, some states require reporting of any settlement or verdict for potential disciplinary action through the Board of Medicine or Board of Nursing, and sometimes for reporting on publicly searchable online practitioner profiles. As a starting point, the retained lawyers will hire medical and nursing experts to perform a root-cause analysis of the maternal death to determine if it was the result of deviations from the standard of care.
Causation
When reviewing a maternal wrongful death case, counsel should determine if there were contributory risk factors. Review of the following records will assist with analysis: past medical history (primary care and specialty care records), obstetrical history (prenatal records), labor, delivery, and postpartum course (labor and delivery records). Legal causation often hinges on whether or not the conduct in question caused or substantially contributed to the death. Most jurisdictions have jury instructions that make clear that negligence need only be “a cause” of death, and not “the sole cause” of death.
There are several potential pitfalls for negligence with regards to assessment, evaluation, detection, diagnosis and/or treatment of conditions that put mothers at risk for maternal death. These include failing to take a detailed and accurate history, one which asks detailed questions which could reveal that the patient is at increased risk of maternal complications, and failing to recognize presenting signs and symptoms that indicate that something may be going wrong with the pregnancy. While a mother may start the pregnancy in excellent health and without problems, issues impacting the pregnancy may begin to manifest during prenatal care, and they can be subtle. With the rise of these issues comes the need for decision making with regards to ordering diagnostic testing and/or referral to a maternal fetal medicine specialist. Finally, there may be a need to make adjustments to the treatment plan and to inform the patient of their increased risks. At each juncture, there is the capability for conduct to be within or below the standard of care, which is why each and every chokepoint must be recognized and approached with required caution.
Requests for Production
Medical records are a necessary component of any medical malpractice/wrongful death case as they represent the contemporaneous account of what occurred between the healthcare providers and patients. When recordkeeping is inaccurate, incomplete, or simply underwhelming, it could require medical and nursing experts to make assumptions about what actually transpired. Underwhelming chart entries are those which fail to paint a comprehensive clinical picture, often by omitting key details of the encounter including medical/nursing decision making. Consider a chart entry wherein a nurse is following protocol by cutting infusion of Pitocin in half in order to address contractions occurring too close together. A chart entry of “Pit down to 10” tells us clearly what the nurse did but fails to mention that it is being done in response to an abnormal finding, fails to mention that it was reported to the attending physician, and fails to reference any discussion informing the patient.
With regards to assessment and evaluation of conditions that could potentially result in maternal death, it is imperative that healthcare providers clearly document their understanding of the patient’s risks, which should include a medical history, subjective complaints, objective complaints, and any diagnostics or labs that were reviewed and considered.
Documentation counsel should request include:
- Complete legal labor and delivery record, including all outpatient and inpatient fetal surveillance (biophysical profiles, non-stress tests, ultrasounds [written reports, tracings, and images])
- Missing records, e.g., nursing flowsheet, health and physical (H&P), obstetrical ultrasound images, and reports
- Delivery summary
- Postpartum records
- Standard unit protocols and standing orders
- Subsequent treating records
- Audit trails
- Unit policy table of contents for inpatient labor and delivery, and outpatient OB/GYN offices; relevant policies and procedures counsel should request, specific to this article, includes hypertensive disorders of pregnancy, and obstetrical hemorrhage
Common Plaintiff Allegations
Plaintiffs’ attorneys have evolved over the years as many have taken advantage of online resources to educate themselves on the medicine. Regardless of their acquired knowledge, most jurisdictions require the input of medical and nursing experts so as to corroborate suspicions of medical and/or nursing negligence. In the event of a wrongful death, experts will be asked to review if the standard of care was met or not, and if not, if those deviations from the standard of care caused or substantially contributed to the maternal death.
Following are common allegations in maternal wrongful death cases:
Failure to assess antepartum, intrapartum, postpartum risk for hemorrhage
Within the prenatal record, as well as labor and delivery record, a hemorrhage risk (re)assessment should be documented. Additionally, interventions employed based on risk status should be documented on the risk assessment tool and/or within a progress note. A significant pitfall is the failure to consider historical factors or acute factors that increase the risk of hemorrhage. Very often a patient starts out low risk, but develops an increased risk throughout pregnancy and labor.
Failure to order appropriate labs
At the time an obstetrical hemorrhage is identified, STAT (not routine) labs should be ordered, including a complete blood count (CBC) and a coagulation panel. These lab studies evaluate clotting factors, platelet functions, and the ability for an individual to clot/control bleeding. Within the medical record, lab orders should be located in order history or on an order requisition form. Lab results should be located in lab reports. Critical lab values are printed on a communication and follow-up form, and a call is made from the lab to the care unit to inform of the critical lab value. The plan of care in response to abnormal lab findings should be documented in the provider and nursing progress notes.
Failure to diagnose / delayed diagnosis / failure to quantify blood loss
This occurs when estimated blood loss (EBL) is performed rather than the standard quantitative blood loss (QBL) measurement. EBL can result in underestimation of blood loss and result in failure to diagnose or a delay in diagnosis. QBL should be documented on every labor and delivery summary. Additionally, the QBL should be documented in the intake and output (I&O) record.
Failure to order appropriate medications / blood products
At the time an obstetrical hemorrhage is diagnosed, the following first-line uterotonics (medications that induce uterine contractions) should be considered: oxytocin, methergine (should be avoided in patients with hypertension), hemabate (should be avoided in patients with asthma), and/or cytotec. A second-line agent, tranexamic acid (TXA), should be considered if bleeding is not controlled with the above first-line agents. At the time a stage 2 hemorrhage is identified, two units of packed red blood cells (PRBCs) should be obtained for transfusion. The transfusion should not be delayed while waiting for the lab results, but rather, initiated based on clinical signs and symptoms. Additionally, fresh frozen plasma (FFP) should be ordered. The medications administered should be documented on the medication administration record (MAR), located in the order history, and may be documented on an obstetrical emergency event flowsheet.
Failure to establish IV access
Obstetrical care units have policies specific to labor admission, regardless of hemorrhage risk assessment. One of the procedures is placement of a large bore (16–18 gauge) IV access. At the time a stage 2 hemorrhage is diagnosed, the standard is placement of a second IV access. The two large bore IVs allow for rapid fluid and blood replacement, which are crucial to effective management of obstetrical hemorrhages. IV placement should be documented in the medical record under procedures / tasks and should link to the I&O. Variation exists specific to documentation locations dependent on the type of electronic medical record used.
Failure to plan for severe hypertension/preeclampsia based on risk factors / failure to identify high-risk pregnancy
Risk factors and the affiliated plan of care should be documented in the prenatal record. The following are risk factors for preeclampsia and should prompt early diagnostic testing and baseline assessments, such as a 24-hour urine for protein and a complete metabolic panel (CMP): history of preeclampsia in previous pregnancy, multiple gestation (being pregnant with more than one baby), chronic hypertension, pre-pregnancy diabetes, kidney disease, and in vitro fertilization.
Failure to recognize severe range blood pressures
An SBP ≥ 160 or DBP ≥ 110 is a severe range blood pressure requiring continued surveillance. The BP should be reassessed every five minutes for 60 minutes. The attending provider should be notified after one severe range BP. Blood pressure assessments should be documented within the vital signs flowsheet. The recognition of a severe BP, the communication with the provider, and follow-up plan of care should be documented in a progress note.
Failure to medically treat severe range blood pressures
If severe BP elevations persist for 15 minutes or more, treatment with first-line antihypertensive medications should be initiated within 60 minutes of the second elevated value. If two severe BPs are obtained within 15 minutes, treatment should be initiated. In addition to first-line antihypertensive medications, seizure prophylaxis with magnesium sulfate IV should be initiated. Contraindications to the use of magnesium sulfate include pulmonary edema, renal failure, and myasthenia gravis. Medication administration should be documented in the MAR, and observed in provider orders.
Failure to follow the chain of command (chain of resolution) policy
Hospital organizations and individual units have chain of command (chain of resolution) policies. These policies describe who employees should report to in the event of unresolved clinical management conflicts. For example, the nurse identifies that the attending OB/GYN physician should be involved in the care of a high-risk preeclampsia patient being managed by the midwife. The nurse has communicated the recommendation for OB/GYN physician consultation to the midwife, but the midwife refuses to communicate with the attending OB/GYN physician. If the nurse does not communicate the conflict to the charge nurse, house supervisor, or attending OB/GYN physician, the nurse has failed to follow the chain of command. Documentation of resolution conflict efforts should be documented in the progress note.
Common Defenses
Following are common defenses in maternal wrongful death cases. The most common defense seen is one which argues that the condition resulting in death could not have been predicted or prevented. While it is always superior to be able to argue that the standard of care was always met, even in instances where it was not, a defense commonly presented is that the deviations did not cause or substantially contribute to the death.
Patient was not compliant with recommended treatment or management
Common defenses presented involve negligence on the part of the patient, including failing to provide an accurate history, failing to follow instructions or recommendations regarding follow-up, failing to take medication as prescribed, or failure to report to an emergency room.
Patient’s delay in seeking care contributed to injuries/damages
A patient’s delay in initiating prenatal care, failure to initiate prenatal care, inconsistent prenatal care visits (scanty prenatal care), delay in postpartum follow-up, failure to follow up postpartum, or failure to keep scheduled appointments can result in an inability to timely diagnose a high-risk obstetrical or postpartum condition such as severe hypertension, chronic hypertension, preeclampsia, risk factors for obstetrical hemorrhage, and postpartum hemorrhage.
Patient’s pre-existing conditions contributed to injuries/damages
Specific to obstetrical hemorrhage, the following are risk factors (not inclusive): suspected placenta previa, accreta, increta, percreta (abnormal placental implantation), pre-pregnancy body mass index (BMI) >50, bleeding disorders, prior classic (vertical) uterine incision, prior uterine surgery, multiple gestation, more than four prior births, and prior postpartum hemorrhage. Risk factors increase the risk of recurrence and associated morbidity and mortality.
Obstetrical staff used appropriate judgement in decision making and treatment based on the patient’s signs and symptoms
The initial review for merit assesses compliance with nursing, medical, and hospital standards of care. Documentation reviewed within the medical records validates if care was consistent with that of a reasonable and prudent practitioner with the same level of education and training, in the same clinical circumstance.
Conclusion
Developing an awareness of national and state responses to the current maternal mortality crisis and enhancing knowledge specific to obstetrical and postpartum standards of care will prepare an organization to defend its next maternal wrongful death case. Multidisciplinary efforts should be focused not only on evaluating medical negligence and seeking justice, but also on educating others in an effort to mitigate the risk of recurrence. In response to the 50% of pregnancy-related deaths that are preventable, regardless of one’s role in medical legal cases, a unified approach to influencing policy and reform in the area of maternal morbidity is essential.