In this blog, I’ll be reviewing maternal sepsis. I’ll be defining what maternal sepsis is, national statistics, the causes of maternal sepsis, the recommended screening and diagnostic criteria, assessment and monitoring recommendations, management recommendations, and the role of the Safe Motherhood Initiative Sepsis Bundle.
What is Maternal Sepsis:
Maternal sepsis is a life-threatening condition defined as organ dysfunction resulting from infection during pregnancy, childbirth, post-abortion, or postpartum period.
Presentation: pregnant patients appear clinically well prior to rapid deteriorationwith the development of septic shock, multiple organ dysfunction syndrome, or death. This is due to pregnancy-specific physiologic, mechanical, and immunological adaptations (JAMA, 2021).
National Statistics:
Maternal sepsis is the second leading cause of maternal mortality in the United States. Among all maternal deaths in the U.S., 13% are attributed to infection or sepsis, with case fatality rates as high as 10% to 30% in the obstetric population (JAMA, 2021). It is estimated that 4 to 10 per 10,000 live births are complicated by maternal sepsis (ACNM, 2018).
Causes of Maternal Sepsis:
Screening & Diagnostic Criteria:
The use of a maternal early warning system (MEWS) is recommended. This is a set of specific vital sign and physical exam findings that prompt a bedside evaluation and/or work-up (see ACOG’s MEWS example below)
Management Recommendations:
Survivability requires early detection, prompt recognition of the source of infection, and targeted therapy
How the ACOG Safe Motherhood Initiative (SMI) Sepsis Bundle Reduces Maternal Morbidity:
The SMI is a collaborative initiative between ACOG and the New York State Department of Health (NYSDOH) to improve patient safety and raise awareness about risk factors that contribute towards maternal morbidity & mortality. The SMI supports provider readiness and recognition through the availability of education, standardized sepsis work-up criteria and diagnostic tools. The SMI supports timely provider response and reporting by the availability of a standardized sepsis management algorithm, recommended criteria for consultation and transfer to a higher level of care, and case debriefing tools.
If you are in need of a medical legal expert specific to a maternal sepsis case, contact Barber Medical Legal Nurse Consulting, LLC
Resources:
ACNM, 2018. Recognition and Treatment of Sepsis in Pregnancy
ACOG, 2020. Maternal Safety Bundle for Sepsis in Pregnancy
JAMA Network Open. 2021;4(9): Perinatal Outcomes Among Patients with Sepsis During Pregnancy
P.S. Comment and Share your experience with a maternal sepsis case. Was the case a wrongful death case or missed diagnosis, other?
In this blog, I’ll be reviewing the trends in hypertensive disorders of pregnancy in the U.S., associated complications, common allegations and defenses specific to hypertensive disorders of pregnancy and recommendations to mitigate risk.
What are Hypertensive Disorders of Pregnancy?
This umbrella term encompasses gestational hypertension, preeclampsia, preeclampsia with severe features, eclampsia, hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome, chronic hypertension and superimposed preeclampsia. All of these conditions involve blood pressure elevations during pregnancy, and after pregnancy (postpartum).
Trends in the U.S.:
The American College of Obstetricians and Gynecologists (2022) published a research letter informing readers that hypertensive disorders of pregnancy now affect 8% of pregnancies. Hypertensive disorders of pregnancy increased from 2.79% in 1989 to 8.22% in 2020 (ACOG, 2022). This is an average annual percentage change of 3.6%. Since 2010, U.S. rates of hypertensive disorders of pregnancy and chronic hypertension have been increasing (ACOG, 2022). This is a significant finding as hypertensive disorders of pregnancy are associated with significant morbidity and mortality. Hypertensive disorders of pregnancy account for 7.4% of pregnancy-related deaths with as many as 60% of maternal deaths from preeclampsia identified as preventable (AWHONN, 2021).
Everyone caring for women during pregnancy must be aware of the significance of the disease process, current diagnostic criteria, and management recommendations. Prompt recognition of the disease, monitoring for complications and timely treatment of hypertension reduces the risk of significant maternal, fetal, and neonatal morbidity.
Complications from Hypertension in Pregnancy:
Complications include, but are not limited to, placental abruption, disseminated intravascular coagulation (DIC), cerebral hemorrhage, cerebral vascular accident (stroke), hepatic failure and acute renal failure. Additionally, there is an increased risk of fetal and neonatal death. Neonatal morbidities include low Apgar scores, seizures, and neonatal encephalopathy (AWHONN, 2021).
Common Areas of Liability / Common Allegations:
Failure to accurately diagnose preeclampsia
Failure to timely treat hypertension / Failure to treat acute severe hypertensive crisis
Failure to treat preeclampsia
Failure to advise the patient to seek outpatient or inpatient evaluation and treatment during telephone triage
Failure of the provider to perform bedside evaluation
Failure to have a policy in place specific to diagnosis and treatment of hypertensive disorders of pregnancy
Discharge of the unstable patient
Common Defenses:
The standard of care was adhered to by the perinatal team
The mother was non-compliant with the recommended plan of care
The mother maintained an unhealthy lifestyle before and during pregnancy (patient was overweight pre-pregnancy, patient was a smoker)
The mother had pre-existing risk factors
Documentation reflected timely and appropriate communication between the perinatal team members
Recommendations:
Implement evidence based national standards and guidelines as they serve as the hallmark of safe, high-quality perinatal care. Establish a process whereby provider and nursing leadership complete a monthly review of new standards and guidelines published by professional organizations and timely adopt the standards in hospital (inpatient and outpatient) policies.
Have policies, procedures, protocols, and algorithms based on national standards and guidelines available to the perinatal service team (accessible in multiple formats – laminated algorithms in care areas, links available on electronic devises, necessary membership to support access).
Ensure all clinicians and staff are competent in knowledge and skills for the responsibilities they are assigned. Have a standardized new hire perinatal orientation, and on-going training/simulation specific to diagnosis and management of acute severe hypertensive crisis.
Keep up with evidence, standards, and guidelines through membership in professional organizations (recommended organizations – AWHONN, ACNM, AAP, ACOG, ASA, SMFM)
References:
ACOG (2022). Trend in hypertensive disorders of pregnancy in the U.S. from 1989 to 2020. 140(1)
P.S. Comment and share your experience with a case involving maternal, fetal or neonatal complications associated with a hypertensive disorder of pregnancy.
When reviewing content from the electronic health record (EHR), there are many elements to assess. One of the elements is the use of the copy/paste functionality (CPF). In this blog, I’ll be reviewing the use of CPF within the EHR. I’ll also will be reviewing The American Health Information Management Association’s (AHIMA) position on the use of CPF, statistics, and risks associated with CPF. I will conclude with reviewing the role of the medical legal consultant, as well as best practice recommendations to mitigate documentation risk.
Use of the Copy/Paste Functionality (CPF) in EHR’s: The American Health Information Management Association (AHIMA) maintains the position that “the use of copy/paste functionality in EHRs should be permitted only in the presence of strong technical, and administrative controls, which include organizational policies, and procedures, requirements for participation in user training and education, and ongoing monitoring. Users of the copy/paste functionality should weigh the efficiency and time savings benefits it provides against the potential for creating inaccurate, fraudulent or unwieldy documentation.”
CPF – A Common Occurrence in the EHR: The use of CPF continues to be a common occurrence which can lead to adverse outcomes.
The Joint Commission published the results of the Partnership for Health IT Patient Safety work group. Their literature review identified 51 publications:
One study of diagnostic errors found that CPF led to 2.6% of errors in which a missed diagnosis required patients to seek additional unplanned care.
Several case reports identified clinical harm related to CPF, including a patient who died from a heart attack after his primary care physician (PCP) failed to diagnose cardiac disease.
A. Two years prior, the patient was discharged from the ED after a new diagnosis of atrial fibrillation, and potential heart disease; he was instructed to follow up with his PCP for a stress test.
B. The PCP copied and pasted the assessment and plan (A/P) section of the patient’s record for 12 office visits during the next two years, updating the A/P or reviewing medical entries from the ED or other department.
C. The PCP was found liable in the death.
A study published in 2017 reviewed inpatient progress notes written in 2016 by direct care hospitals, residents, and medical students totaling 23,630 notes by 460 clinicians. In a typical note, 18% of the text was manually entered, 46% copied, and 36% imported.
Risks of CPF:
Inaccurate or outdated information can lead to medical errors.
Redundant information, which makes it difficult to identify the current information.
Inability to identify the author or intent of documentation.
Inability to identify when the documentation was first created.
Propagation of false information: inflates, duplicates or creates fraudulent healthcare claims.
Internally inconsistent progress notes.
Unnecessarily lengthy progress notes.
Role of the Medical Legal Consultant:
Attorney-Client Education
EHR documentation standards
Discoverable items not included in the designated record set
Regulatory requirements: user specific
Development of interrogatories & requests for production
Development of discovery responses
Recommend expert witnesses – specific to the EHR at issue
Witness Preparation
Educate staff/end users of the EHR
Assess knowledge of the workflow
Evaluate if end users have observed the native EHR in printed format A. Determine if they know how to read the printed version
Types of assessments A. Standardized by EHR platform B. Customized by provider C. Use of free text
Evaluate the type of, and how much training the end user received prior to using the EHR. Evaluate what the training consisted of
Evaluate if the organization has consistency across EHR user roles, access and permissions
Evaluate the organizations processes specific to record set-up, changes, revisions, additions, and retirement of modules to the EHR
Ways to Mitigate Risk / Joint Commission Best Practice Recommendations:
Chart timely: during the same scheduled shift
Limit use of copy/paste functionality
Be cognizant of scope of practice
Disable drafts
Utilization of the EHR report feature to track, trend, and audit. Ensure that copy/paste practices are regularly monitored, measured, and assessed
Provide a mechanism to make copy/paste material easily identifiable
Ensure adequate staff training, and education regarding the appropriate, and safe use of CPF
Develop policies, and procedures addressing the proper use of the CPF to assure compliance with governmental, regulatory, and industry standards
Address the use of features such as copy/paste in the organization’s information governance processes
Monitor compliance, and enforce policies, and procedures regarding use of copy/paste, and institute corrective action as needed.
In this post, I’ll be addressing the most current evidence, published standards of care, and guidelines from professional associations, and regulatory agencies specific to fetal heart rate interpretation and management.
Fetal heart rate pattern interpretation, communication, and documentation continues to be one of the most common areas of perinatal liability claims. It is best practice to utilize current practice guidelines, and standards of care as a guide for the revisions, and development of institutional policies as a means to decrease professional liability exposure, and minimize the risk of perinatal injury.
Common Themes: In review of birth injury cases, I have observed common themes (allegations):
Failure to interpret a non-reassuring fetal heart rate (FHR) tracing
Failure to accurately assess maternal-fetal status
Failure to recognize a deteriorating fetal condition
Failure to appropriately treat an indeterminate or abnormal FHR in a timely manner (E.g., failure to initiate intrauterine resuscitation based on FHR pattern and/or plan for expeditious birth when clinically indicated)
Failure to accurately communicate the maternal-fetal status to the physician/certified nurse midwife
Failure to request bedside evaluation based on concern for fetal status to the physician/certified nurse midwife
Failure of the physician/certified nurse midwife to respond appropriately when notified of indeterminate or abnormal fetal status
Failure to initiate the chain of command (communication) when there is a clinical disagreement between the nurse, and responsible physician/certified nurse midwife, regarding fetal status
Standards of Care:
Use of EFM definitions and descriptions based on the 2008 National Institute of Child Health and Human Development (NICHD) Working Group findings (ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring, 2017)
In the presence of an EFM tracing with minimal or absent variability, and without spontaneous accelerations, an effort should be made to elicit accelerations by means of vibroacoustic stimulation, or scalp stimulation. When there is an acceleration with stimulation, acidemia is unlikely, and labor can continue (ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring, 2017).
Be aware of the EFM findings consistent with an abnormal acid-base status: absence of accelerations; minimal to no variability (ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring, 2017).
Be aware of when to implement intrauterine resuscitation based on interpretation of EFM: Category 2, and category 3 FHR tracings, uterine tachysystole (dependent on FHR pattern, and presence or absence of oxytocin (ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring, 2017).
Implement intrauterine resuscitation based on the presumed etiology of the FHR pattern: maternal repositioning, intravenous fluid bolus, oxygen administration (if oxygen is being administered for intrauterine resuscitation, oxytocin should be discontinued), reduction of uterine activity, correction of maternal hypotension, amnioinfusion, modification of maternal pushing efforts during second stage labor (AWHONN Perinatal Nursing, 2021).
Be able to recognize uterine tachysystole: 5 contractions in 10 minutes, averaged over 30 minutes.
Be aware of the interventions to manage tachysystole in the presence, and absence of oxytocin. E.g., uterine tachysystole in the presence of oxytocin with a Category 1 tracing requires a reduction in oxytocin. Uterine tachysystole in the presence of oxytocin with a Category 2 or 3 tracing requires a reduction or discontinuation of oxytocin, and implementation of intrauterine resuscitative measures. If no resolution, a tocolytic should be considered.
During induction or augmentation of labor with oxytocin, the FHR should be evaluated and documented before each dose increase, and following each dose increase (AWHONN Position Statement, Fetal Heart Monitoring, 2015)
If continuous EFM is ordered, monitoring of FHR, and uterine activity should continue until birth (AWHONN Perinatal Nursing, 2021).
Development of institutional policies, procedures, and protocols that outline responsibility for ongoing FHM documentation (AWHONN Position Statement, Fetal Heart Monitoring, 2015).
Documentation should include communication with providers (AWHONN Position Statement, Fetal Heart Monitoring, 2015).
Documentation should include communication within the chain of resolution / chain of command (AWHONN Position Statement, Fetal Heart Monitoring, 2015).
Ongoing education and competency validation for RN’s, and other healthcare providers responsible for FHM (AWHONN Position Statement, Fetal Heart Monitoring, 2015).
Use of oxytocin safety checklists are recommended as they provide prerequisites to safely initiate oxytocin, and to help identify situations that require discontinuation (ACOG Optimizing Protocols in Obstetrics, Oxytocin for Induction, 2011).
References:
ACOG (2011). Optimizing protocols in obstetrics, Oxytocin for induction
ACOG (2017). Practice Bulletin, Intrapartum fetal heart rate monitoring
AWHONN (2021). Perinatal nursing
JOGNN (2015). AWHONN position statement: fetal heart monitoring
P.S. Comment and share your experience with a birth injury case related to fetal monitoring interpretation, communication and/or documentation.
In this blog, I’ll be reviewing the national, and New York State statistics related to maternal mortality associated with obstetrical hemorrhage. I’ll also highlight one of the risk factors associated with obstetrical hemorrhage, and discuss the standards of care that should be employed to mitigate the risk of maternal morbidity and mortality.
Statistics: Obstetrical hemorrhage is a preventable cause of maternal morbidity and mortality and continues to be one of the leading causes of maternal death in the U.S.
How the U.S. compares to 10 other developed countries:
In New York State, postpartum hemorrhage is the 2nd most frequently reported postpartum complication, and accounted for 29% (18) of maternal deaths between 2012-2013 according to the NYS Maternal Morbidity and Mortality Review Report (2017).
Prolonged oxytocin exposure as a risk factor: In a recent (published May, 2022) retrospective cohort study performed by Boston University School of Medicine, prolonged (greater than or equal to 12 hours) oxytocin exposure for induction of labor increased the risk of obstetrical hemorrhage by 52% compared to those women exposed for less than 12 hours. Use of obstetrical risk assessment tools alert the perinatal team to the risk of obstetrical hemorrhage and prompts evidence-based interventions.
The importance of standardized safety bundles: The American College of Obstetricians and Gynecologists (ACOG) recommends the use of the Obstetrical Safety Bundle as a means to guide standardized management of obstetrical emergencies associated with maternal morbidity and mortality in accordance to evidence-based practice. ACOG’s Safe Motherhood Initiative (SMI) focuses on the four leading causes of maternal death: maternal sepsis, obstetric hemorrhage (severe bleeding), venous thromboembolism (blood clots), and severe hypertension in pregnancy (high blood pressure).
The Obstetrical Hemorrhage Safety Bundle includes:
Risk assessments: prenatal, antepartum, labor & delivery, and postpartum.
Use of a staged obstetrical hemorrhage checklist to guide interventions in real-time.
Team debriefing recommendations and a standardized debriefing form.
Recommendation to perform quantitative blood loss assessment (QBL) with every delivery.
The Joint Commission Perinatal Safety Standards: Effective January 1, 2021, the Joint Commission implemented new perinatal safety standards required of all Joint Commission accredited hospitals. One of the new standards aims to improve care for women experiencing maternal hemorrhage. The Joint Commission requirements focus on evidence-based written procedures, education, training, and drills for staff and providers, education for patients and families, and quality review. The requirement also focuses on evidence-based risk assessments and hemorrhage supply kits.
NYS Department of Health. 2017. NYS Morbidity and Mortality Review Report
OECD Health Data. 2020
P.S. Comment and share your experience with a maternal death case associated with obstetrical hemorrhage. What were the deviations in the standards of care?
In this blog, I’ll be reviewing the purpose of medical staff hospital credentialing, identifying who is responsible for credentialing, comparing the roles and responsibilities of the medical staff, and the hospital Board, and reviewing criteria-based systems recommended for the credentialing process. It’s important to have an understanding of the above concepts to ensure that hospital systems have an effective credentialing process that promotes patient safety, sustains a system that mitigates the risk of malpractice litigation, while also mitigating the risk of restraint of trade.
Credentialing Purpose: The primary purpose of credentialing is to protect patients by ensuring quality patient care. A credentialing process appropriately overseen by the hospital Board reduces patient exposure to poorly performing providers, ultimately, reducing the risk of preventable patient injury.
secondary purposes:
To ensure that only qualified providers are admitted and allowed to remain on medical staff. Medical staff includes Physicians, Physician Assistants (PA), and Advanced Practice Registered Nurses (APRN): Certified Nurse Midwives (CNM), Nurse Practitioners (NP), and Certified Registered Nurse Anesthetists (CRNA).
To ensure that providers are practicing within their scope, consistent with quality standards of the hospital.
The appointment, re-appointment into medical staff.
The granting, and renewal of privileges (delineation of privileges) – what a provider is allowed, and not allowed to do, types of patients a provider is able to manage, types of diseases the provider is able to treat, procedures the provider is able to perform, or not perform based on privileging delineations, and clear credentialing criteria. For example, CNM management of low-risk obstetrical patients; CNM collaborative management with Ob/Gyn for high-risk obstetrical patients.
Who is Responsible for Hospital Credentialing? Medical staff credentialing is the core responsibility of the hospital Board, and serves to be the most important responsibility of the Board secondary to the impact on patient safety, and the role credentialing has within the hospital’s quality improvement and patient safety system.
The legal structure (as shown below) needs to be understood by the Board, medical staff, and management to ensure clear role delineation, and to ensure an effective credentialing system.
Roles and Responsibilities: It’s important to have a clear understanding of role delineation to ensure that the hospital has an effective credentialing process that promotes safe work environments, while reducing the risk of patient injury.
Board:
Reviews recommendations received from the medical executive committee and compares the recommendations against established credentialing criteria
Makes sure the credentialing criteria is consistently applied to all applicants: efforts need to be made to avoid loose criteria that could result in patient injury and increase the risk of malpractice litigation. Contrary, efforts need to be made to avoid tight / biased criteria that could result in claims of negligent credentialing, and/or restraint of trade
Makes sure the medical executive committee has a credentialing procedure in place
Makes final decisions: grants privileges, grants admission into medical staff
Medical Staff (Medical Executive Committee):
Makes recommendations to the Board
Identifies credentialing criteria for evaluating providers
Evaluates performance
Evaluates applicants
Credentialing is proven to be the most difficult governance function to perform effectively for the following reasons:
Many Boards and medical staff do not accept the Boards role to oversee the medical staff
Many lay Board members are not comfortable with the responsibility
Neither the Board, nor the medical staff know how to do credentialing
The hospital Board maintains liability for inappropriate decisions made regarding (re)credentialing and delineation of privileges. The Board cannot exclusively rely on the recommendations of the medical executive committee as a defense to justify a poor decision.
How To Do Hospital Credentialing – The Use of Criteria Based Systems for (Re)Credentialing and Privilege Delineation: It’s best practice to have a clear decision criterion for credentialing and delineation of privileges that sets the hospitals quality and safety bar high. The criteria should be based on internal information sources. Additionally, privilege delineation should be unique and specific to each provider. The Joint Commission requires provider specific data to be collected continuously and reviewed at the time of re-credentialing. It’s recommended that this provider specific data is compared to the aggregate data as a means to identify how each individual provider is performing in each performance measure in comparison to his/her provider colleagues. Typically, the specific credentialing criteria are developed by the clinical department, and submitted to the medical executive committee (MEC) for approval. MEC then makes the recommendation to the Board who makes the final decision.
Examples of Criteria Based Credentialing:
Frequency Criteria: A number of professional organizations suggest frequency criteria for (re)credentialing and privileging. For example, Surgeon A is required to perform 20 laparoscopic cholecystectomies in a 2-year period (credentialing term per Joint Commission is 2-years).
Minimum Volume Required Criteria: For example, Surgeon A is required to perform a minimum of 10 laparoscopic cholecystectomies in a 2-year period.
Clinical Outcomes: Internal data – individual provider specific data (outcome measures). For example, Surgeon A’s specific data (outcomes): post-operative complications, morbidity and mortality rates, returns to the OR, wound infections.
Behavior Criteria: Patient complaints, malpractice claims per individual provider
In this blog I’ll be reviewing the difference between rotational and non-rotational maneuvers in the management of a shoulder dystocia. I’ll also discuss the efficacy in relieving the shoulder dystocia, and the risk of brachial plexus injury, comparing both types of maneuvers.
Non-rotational maneuvers: pose the least risk on the degree of stretch on the brachial plexus nerve. Examples include: McRoberts maneuver, suprapubic pressure, and delivery of the poster arm.
According to ACOG, in cases where the McRoberts maneuver and suprapubic pressure are unsuccessful, delivery of the posterior arm can be considered as the next maneuver to manage shoulder dystocia. Recent evidence has shown that delivery of the posterior arm has a high degree of success in accomplishing delivery. In a computer-generated model, delivery of the posterior arm required the least amount of force to effect delivery and resulted in the lowest amount of brachial plexus stretch. The use of the above maneuvers will relieve 95% of cases of shoulder dystocia within 4 minutes.
Below Image (delivery of the posterior arm) requires the delivering provider to insert a hand into the vagina and deliver the posterior arm by sweeping it across the fetal chest
Non-Rotational Maneuver
Rotational maneuvers: Examples include: The Rubin maneuver, the Woods Screw maneuver
The Rubin maneuver requires the delivering provider to insert a hand into the vagina and on the back surface of the posterior fetal shoulder. The provider then rotates the fetal shoulder anteriorly towards the fetal face with his/her hand.
The Woods Screw maneuver requires the delivering provider to rotate the fetus by exerting pressure on the anterior, collar bone region of the posterior shoulder to turn the fetus until the anterior shoulder emerges from behind the maternal symphysis (pubic bone).
Below Image (Rubin Maneuver)
Rotational Maneuver
References:
The American College of Obstetricians and Gynecologists. (2014). Neonatal brachial plexus palsy. ACOG Task Force on Brachial Plexus Palsy
The American College of Obstetricians and Gynecologists. (2017). Shoulder dystocia [Clinical Practice Bulletin #178]
P.S. Comment and Share: What has been your experience in a brachial plexus case involving a shoulder dystocia? How did the standards of care, specific to type of maneuvers, and type of traction employed, impact the outcome of the case?
In this blog, I’ll be reviewing the U.S. maternal morbidity statistics associated with hypertensive disorders of pregnancy. Additionally, I’ll be highlighting the elements of performance, specific to severe hypertension and preeclampsia, Joint Commission accredited hospitals are required to be in compliance with. Lastly, I will offer risk mitigation strategies specific to care delivery, risk assessment, prevention, documentation, consultation, and referral.
Statistics: Hypertensive disorders of pregnancy (chronic hypertension, gestational hypertension, severe hypertensive crisis, preeclampsia, eclampsia, HELLP Syndrome) continue to be the leading cause of maternal and infant death. Preeclampsia specifically, complicates 8% of pregnancies globally. It is estimated that 60% of maternal deaths from preeclampsia may be preventable. In the U.S., hypertensive disorders of pregnancy account for 6.8% of pregnancy related deaths. For women who had a hypertensive disorder of pregnancy cause of death, 12.2% had a stillbirth (fetal demise). Almost all (96.8%) pregnancy related deaths occurred by 42 days postpartum (CDC, 2018).
The Joint Commissions Perinatal Safety Standards: In response to the worsening maternal morbidity and mortality in the U.S. associated with severe hypertension and preeclampsia, The Joint Commission has identified clinical areas of greatest potential impact based on review of maternal mortality reports, and evidence-based practice recommendations.
The literature review performed revealed that prevention, early recognition of signs and symptoms, and timely treatment for severe hypertension, and preeclampsia had the highest impact on maternal, fetal, and neonatal outcomes.
Joint Commission accredited hospitals are now required to conform to the six new elements of performance (EPs) as identified below:
GOAL: PC.06.03.01 – Reduce the likelihood of harm related to maternal severe hypertension/preeclampsia
Requirement EP 1: Develop written evidence-based procedures for measuring and remeasuring blood pressure. These procedures include criteria that identify patients with severely elevated blood pressure.
Rationale: Procedures should address appropriate blood pressure measurement, including cuff size, proper patient positioning, and frequency of measurement. Inaccurate measurement can lead to a mother not receiving proper treatment and being discharged with elevated blood pressure. Untreated hypertension can lead to morbidities or even death. Criteria for what constitutes a severely elevated blood pressure should be established by the organization utilizing current recommendations from national organizations.
Requirement EP 2: Develop written evidence-based procedures for managing pregnant and postpartum patients with severe hypertension/preeclampsia that includes the following:
• The use of an evidence-based set of emergency response medications that are stocked and immediately available on the obstetric unit
• The use of seizure prophylaxis
• Guidance on when to consult additional experts and consider transfer to a higher level of care • Guidance on when to use continuous fetal monitoring
• Guidance on when to consider emergent delivery
• Criteria for when a team debrief is required
Note: The written procedures should be developed by a multidisciplinary team that includes representation from obstetrics, emergency department, anesthesiology, nursing, laboratory, and pharmacy.
Rationale: Studies have shown that delays in the diagnosis and treatment of severe hypertension/preeclampsia and receipt of suboptimal treatment of severe hypertension/preeclampsia are linked with adverse maternal outcomes. Having clear procedures in place and educating staff around these procedures should decrease failures to recognize and treat severe hypertension/preeclampsia
Requirement EP 3: Provide role-specific education to all staff and providers who treat pregnant/ postpartum patients about the hospital’s evidence-based severe hypertension/preeclampsia procedure. At a minimum, education occurs at orientation, whenever changes to the procedure occur, or every two years.
Note: The emergency department is often where patients with symptoms or signs of severe hypertension present for care after delivery. For this reason, education should be provided to staff and providers in emergency departments regardless of the hospital’s ability to provide labor and delivery services.
Rationale: Decreasing the blood pressure through rapid recognition and treatment has been shown to decrease maternal morbidity and mortality. It is imperative to provide education for staff and providers on how to measure accurate blood pressures, recognize severe hypertension/ preeclampsia, and provide evidence-based treatments to lower blood pressure in a safe and timely manner. Although not required, in situ simulations that allow staff to practice organizational procedures in actual clinical settings are encouraged.
Requirement EP 4: Conduct drills at least annually to determine system issues as part of ongoing quality improvement efforts. Severe hypertension/preeclampsia drills include a team debrief.
Rationale: Multidisciplinary drills give an organization the opportunity to practice skills and identify system issues in a controlled environment. It is crucial to have members from as many disciplines as possible available during drills to truly be able to test each level of the emergency and identify areas of improvement. Organizations should assess their level of proficiency to determine the frequency drills should be performed; organizations that have reached a high level of mastery may need less frequent drills.
Requirement EP 5: Review severe hypertension/preeclampsia cases that meet criteria established by the hospital to evaluate the effectiveness of the care, treatment, and services provided to the patient during the event.
Rationale: Continuous feedback loops are imperative for organizations to find errors and improve skills to ensure that patients are receiving the highest level of care. Root cause analysis, apparent-cause analysis, or similar tools to review the care in a rigorous, psychologically safe environment is critical to identify successes and opportunities for improvement in a way that creates a culture of safety and empowers staff to design safe and effective procedures and processes.
Requirement EP 6: Provide printed education to patients (and their families including the designated support person whenever possible). At a minimum, education includes:
• Signs and symptoms of severe hypertension/preeclampsia during hospitalization that alert the patient to seek immediate care
• Signs and symptoms of severe hypertension/preeclampsia after discharge that alert the patient to seek immediate care
• When to schedule a post-discharge follow-up appointment
Rationale: Maternal mortality reviews have shown that some patients with severe hypertension/ preeclampsia due after discharge because they were unaware of which symptoms to watch for and when to seek care urgently. Women should understand their severe hypertension/ preeclampsia diagnosis and inform healthcare providers of their pregnancy history when the seek care after discharge to ensure correct diagnosis and treatment.
How to Mitigate Medicolegal Risk & Increase Defensibility:
Confirm that your organization is conforming to the six elements of performance (EPs) that is now required for Joint Commission accredited hospitals. Become an active provider leader in implementing and educating staff/providers on the above (EPs). Render care according to the above (EPs). Consider implementing re-credentialing requirements to support required simulation drills and debriefings.
Identify women at risk: first pregnancy, new genetic makeup, pregnancy of artificial reproductive technology, multiple pregnancy, gestational diabetes, preexisting medical history: diabetes, chronic hypertension, renal disease, lupus, older maternal age, African American race, obesity, personal or family history of preeclampsia (list is not inclusive)
Document risks, and plan of care for surveillance and prevention strategies in pregnancy within the medical record.
Implement prevention strategies in plan of care, and document in medical record: exercise, low dose aspirin therapy, dietary supplementation
Diagnose and initiate timely management according to evidence-based practice criteria, and organizational policy: document diagnosis and management plan in the medical record.
Consider referral to Maternal Fetal Medicine, or higher level of care delivery based on organizational level of care, and maternal consultation and transfer agreement with Regional Perinatal Center.
Consultation/collaboration: ensure patient assessment is complete within the time frame designated within organizational by-laws, rules and regulations. Ensure timely entry of consultation / progress note as the consulting, or collaborating provider.
References:
Association of Women’s Health, Obstetric, and Neonatal Nurses. 2021.
CDC. 2018. Pregnancy mortality surveillance system
The Joint Commission. 2019. Provision of care, treatment, and services standards for maternal safety. Issue 24
P.S. Comment and Share: Do you have experience with a maternal hypertensive case that resulted in a maternal death. Did this case impact policy, procedure, process, or system changes as a result?
In this blog, I’ll be reviewing Independent Medical Examinations (IME’s): What they are, the role of the IME examiner, and IME nurse observer.
What is an IME: Independent Medical Examinations (IME’s) are medical examinations performed by a qualified physician or other examiner who has not previously treated the injured client. The IME examiner’s goal is to evaluate the injured client’s prior treatment, and the current condition of the injuries reported by the plaintiff. The IME serves as ammunition, a means to challenge claims, lawsuits, and evaluations of injured workers’ treating physicians. IMEs are also referred to as Defense Medical Examinations (DME’s) as the provider examining the client was hired by the defendant’s attorney, or insurance company to defend their side of the case.
IME Examiner: The role of the IME examiner is restricted to examining only what pertains to the event in question, questioning about the nature of the accident, or how the injury occurred. The IME examiner is not permitted to ask questions that would raise liability issues/concerns. E.g., inquiring about cell phone use while driving.
IME Nurse Observer: Legal Nurse Consultants are well qualified to serve as IME observers. LNC’s have the dual nursing, and legal nurse consulting educational background (LNC educational background should be verified by the hiring attorney client), hands-on clinical experiences to support application of knowledge, and skill sets, strong leadership acumen, and effective communication skills. These qualities leverage IME nurse observers favorably to professionally, and diplomatically hold the IME examiner accountable.
Roles of the IME nurse observer:
Educate the client on the IME process, procedures, limitations per the state’s regulations, and case specific court paperwork, as well as office procedures (E.g., evolving Covid-19 safety protocols)
Observe the examination, and take detailed notes during the examination specific to tests performed, client’s response to tests, type of focused assessment performed, completion of comprehensive head to toe assessment, omissions in examination, or tests.
Compile time stamped authoritative reports of all that was said and done during the examination to be compared with the IME examiner’s reports
Be aware of what screening and diagnostic tests are permitted within the IME examiner’s scope of practice, and based on the alleged injury
Object to inappropriate history taking, screening processes, and tests not relevant to the alleged injury
Serve as a client advocate
Testify regarding the examination (E.g., in the event the IME examiner’s report differs from the IME nurse observers report)
Paralegals are at time sent to attend IMEs to act as legal representatives as they are knowledgeable about what is and is not permitted during an IME. However, paralegals cannot testify in the event a discrepancy is identified.
Paralegals do not have the medical training to support a critical IME observation.
The profession of nursing is viewed as the most honest and ethical profession. When nurses serve as testifying experts, they are often viewed honorably by jury members.
Know Your State Codes and Regulations: Review your states Code of Civil Procedure, and regulations. In New York State, for example, the plaintiff is “entitled to be examined in the presence of his or her attorney or other legal, or non-legal representative, as well as interpreter.” Additionally, in NYS, women have the right to have a female IME examiner, or a woman of their choosing present when the IME is performed by a male IME examiner. This section of the NYS Labor Law (Section 206A) is often violated.
Importance of Knowing Basic IME Rules: Failure to comply with the rules and regulations of IMEs can influence the outcome for the client, and the lawsuit.
Know your state’s Code of Civil Procedure as each state has different regulations.
Identify yourself upon entry into the examination room
Observe examination without interference
Refrain from bringing surveillance materials (applicable to NYS) (Know your state’s Code of Civil Procedure as each state has different regulations)
If the IME examiner refuses to allow the IME nurse observer into the examination room, encourage the client to leave the examination location. The IME nurse observer should then follow up with the client’s attorney
Prevent the client from completing unnecessary intake forms that could be misinterpreted. Support the opportunity for relevant intake questions to be asked in the presence of the IME nurse observer to allow for recording
Ensure that the client does not sign documents unless the legal team permits
No member from the defense team should be permitted to attend the IME examination
P.S. Comment and Share: What has been your experience with IMEs? Historically, who have you retained as IME observers? What worked well? What didn’t work well?
When is missed or delayed colorectal cancer (CRC) considered negligence?
In this blog, I’ll be reviewing the elements that are reviewed to identify if a missed, or delayed CRC diagnosis constitutes negligence. I will also provide some examples of breaches in the standards of care specific to missed CRC cases. As a means to promote greater awareness of colorectal health, and CRC awareness, I will also share current statistics, screening recommendations from authoritative sources, risk factors for CRC, and CRC symptoms.
Evaluating your CRC Case for Negligence / Mitigating Risk for Medical Negligence:
Having an awareness of the current standards of care, and rendering care in accordance to current standards of care specific to risk-based screening, and treatment reduces the risk of medical negligence. A missed or delayed diagnosis of CRC is associated with greater morbidity and mortality. Literature suggestions that delays in diagnosis are related to avoidable factors, such as improving the quality of bowel preparation, ensuring further investigations in patients with incomplete endoscopies, and colonoscopies, having endoscopies performed in accredited endoscopy centers, and timely follow up when non-cancer pathology is identified.
Secondary to the fact that 2%-6% of CRC cases are missed following colonoscopy, most professional societies recommend counseling patients about this “miss rate.”
When evaluating a missed CRC diagnosis case for negligence, the four legal elements of negligence must be proven:
Duty: Did the defendant have a duty to the plaintiff?
Breach of Duty: Did the defendant fail to deliver care that an ordinarily careful, reasonable, and prudent person would do under the same or similar circumstance? Were there acts of omission related to the standards of care being met?
A. Failure to identify that the patient was at high risk for CRC.
B. Failure to recognize the patient’s symptoms as a risk factor for CRC.
C. Failure to order CRC screening.
D. Failure to include CRC in the differential diagnoses.
E. Failure to order appropriate tests, and/or referrals following a diagnosis of CRC
3. Damages & Injuries: Were there damages or injuries, such as economic and non-economic damages, that the plaintiff is alleging?
4. Causation: Did the acts of the defendant cause the damages, or injuries that the plaintiff is claiming?
Statistics:
CRC is the third most commonly diagnosed cancer in men and women combined in the U.S.
CRC is the second leading cause of cancer death in men and women combined in the U.S.
Estimates for 2022:
151,030 people will be diagnosed with CRC in the U.S.
52,580 people will die from CRC in the U.S.
Young-onset CRC is on the rise
Rates for people under 50 increased 2.2% each year
Median Age of Diagnosis: Age 66 (both men and women)
Screening:
All men and women without a family history, or risk factors for colorectal cancer (CRC) should begin CRC screenings at age 45, according to the American Cancer Society.
With screening, CRC is one of the most preventable cancers, and highly treatable if caught early.
If you have certain risk factors, you may need to be screened earlier than 45.
Risk Factors:
Family history of CRC or polyps
African American
Have a genetic link to CRC such as Lynch Syndrome
Have a personal history of cancer
Have ulcerative colitis, inflammatory bowel disease, or Crohn’s disease
Types of screening chart
Symptoms: CRC often does not cause symptoms early on. When symptoms do occur, they may include:
Change in bowel habits such as diarrhea and/or constipation, a change in the consistency of your stool, or stools that are more narrow than usual.
Persistent abdominal discomfort such as cramps, gas, or pain. Feeling full, bloated, with or without nausea & vomiting.
Rectal bleeding. You may notice blood in or on your stool that is bright red, or the stool may be black, tarry, or brick red.
Weakness and/or fatigue associated with anemia (a low red blood cell count).
Hayes B., et al. (2019). Why are we missing colorectal cancer? A study investigating the cause of delays in diagnosis. BMJ Journal. 68:A190
P.S. Comment and share your experience with reviewing the standards of care to develop your delayed or missed CRC diagnosis case, while considering the “miss rate.”
