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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?

In this blog, I’ll be reviewing the purpose of a literature search and the importance of employing a systematic approach.  I’ll highlight search strategies and offer some search tips.  I’ll also identify some common databases used in the field of healthcare law, review different types of publications, as well as ways to access authoritative literature.  Lastly, I’ll highlight the various levels of evidence and how synthesis of your search findings can be applied to work products.

Evidence and standards of care:  Both are evolving faster than ever before and staying current is essential to ensure the best patient care that results in safe outcomes.   The volume and complexity of medical literature is growing rapidly.  Employing a systematic literature search strategy ensures an efficient and comprehensive approach to acquiring the information that you or your client requires.

What’s the Purpose of a Literature Search: The primary purpose is to obtain factual and current information that supports the standards of care.  The acquired knowledge from a literature search can be used to educate yourself, your clients, expert witnesses (can result in impeachment of the expert witness) and the jury.  Additionally, a number of medical consultants utilize literature searches to identify possible expert witnesses. 

Barriers to Systematic Literature Searches: These range from lack of time, lack of knowledge/lack of searching skills, lack of motivation and information overload.  

What’s a Search Strategy? This is a plan that helps locate the information being searched for.

A literature search strategy is an intellectual and practice focused endeavor.  The process should start with a clinical question, followed by a formal written search strategy.

The Clinical Question: Use key words from a clinical question to guide the literature search.  Use of the PICOT format guides search success.  This is a process in which clinical questions are phrased in a manner that yields the most relevant information from a search.  P = patient population, I = intervention or issue of interest, C = Comparison intervention or status, O = outcome, T = timeframe for (I) to achieve (O). 

• Example Clinical (PICOT) Question: In newborns who meet inclusion criteria for therapeutic hypothermia (P), does passive cooling, (I) compared to not being passively cooled, (C) result in a lower incidence of neonatal encephalopathy O) if implemented within the first 6 hours of life (T)? 

• Note: Keywords to be used in the literature search are highlighted.

Written Search Strategy: Use of a literature search tool will help you track your original search, and refined searches.  This method allows you to track your keywords, synonymous words, Boolean phrases used (will be discussed below), the search engine(s) used, and the number of sources your search yielded

• (See Literature Search Tool attached)

Know What Type of Service or Resource is Needed Before you Begin your Search:  The type of service or resource is going to guide the source you retrieve information from. 

• Textbooks: A good resource forfactual information.  Textbooks contain summaries of known established facts from previously published literature as well as new material from the author.
  • Learn about the resources your local medical library offers.  Many medical textbooks can be found within a medical library. 
  • Inquire about the availability of an interlibrary loan service if the library doesn’t own a specific textbook (or journal) you’re looking for.  The library can get the textbook from another library.
  • “Doody’s Core Titles” is a listing of authoritative textbooks. 

• Databases:  To locate new or changing information use databases to search for medical or journal articles.  
• Know the Databases: Each database covers its own range of journals and each has its own search protocol.
• Multiple relevant databases should be searched systematically
• Commonly Used Online Databases (not an inclusive list):
• 1. MEDLINE/PubMed: http://www.ncbi.nlm.nih.gov/pubmed

This database is free, however, can be over-whelming as it has over 35 million references.   The database provides full text articles in over 5,500 journals.  This database serves as a flagship database for journal articles in health sciences.

2. Cumulative Index to Nursing and Allied Health Literature (CINAHL Plus): http://www.ebsco.com/products/research-databases/cinahl-plus

This is a comprehensive database specific to nursing and allied health research offering more than 770 journals and full text articles.

How Do You Gain Access to Databases?: Through the use of the internet, subscription through work or home, medical library, private or public library, freelance librarian or a database vendor (E.g., Ovid technologies, HealthSource, ProQuest, SNT). 

How Can Membership in Professional Organizations Assist with Literature Searches?  Through active membership, you have access to published journals, practice bulletins and committee opinions.  Additionally, with active membership, you’re better positioned to remain current with the evolving evidence and standards of care.  Examples of professional organizations: American Medical Association (AMA), American Nurses Association (ANA), American Association of Nurse Practitioners (AANP), American College of Obstetricians and Gynecologists (ACOG), Association of Operating Room Nurses (AORN), etc.

Value in Building your Personal Reference Library:  Through membership in professional organizations, you can quickly begin to build your own reference library.  Many organizations circulate their published journals  on a monthly or quarterly basis.  These can be maintained for future reference in a hard or electronic copy.  Over time, purchase authoritative textbooks that pertain to your specialty.  If you’re uncertain which textbook to purchase, inquire with a consultant in the field, a clinician or educator.    

When Synthesizing Information from your Search, Know the Levels of Evidence:  Level of evidence refers to the degree that information can be trusted, based on study design.  Many of you are familiar with the levels of evidence being represented as a pyramid with systematic reviews on top, followed by randomized controlled trials, then observational studies such as cohort studies or case controlled studies, with case studies and expert opinion at the bottom.

 It’s important to correlate this pyramid to the notion that all evidence (information) is not created equal.  When evaluating sources of evidence to use, you want to focus on high level (level 1-2) evidence.  These high level sources of evidence help clinicians to translate research into practice, and inform clinician and patient decision making.  

Importance in Knowing the Types of Publications:

• Peer reviewed publications are generally authoritative.  Commonly used peer-reviewed journals (not an inclusive list):
  • Annals of Internal Medicine:  https://www.acpjournals.org/journal/aim
  • The Journal of the American Medical Association (JAMA): https://jamanetwork.com/
  • The Lancet: https://www.thelancet.com/
  • The New England Journal of Medicine: https://www.nejm.org/

• Industry, published by or about a particular industry is not consistently authoritative. 

• Newsletters have general health information, but are not considered authoritative. 

What is an Authoritative Source of Literature? Work known to be reliable because its authority or authenticity is widely recognized by experts in the field.  These sources are generally accepted as controlling in the subject area.

How to locate authoritative textbook sources:

• Refer to “Doody’s Core Title’s”
• Look for textbooks placed in the library’s core, reference, or reserve collections
• Refer to publications used in medical and/or nursing schools, or teaching aids in hospitals
• Begin growing your personal reference library

How to locate authoritative journal articles:

• Review relevant content in the Cochrane Reviews. Cochrane Reviews is a collection of databases of systematic reviews and meta-analyses which summarize and interpret the results of medical research, technology assessments, and clinical trials for the purposes of making informed clinical decisions.  http://www.cochrane.org/
• Check textbooks for relevant references to journal articles you may be able to use.  Search for journal articles written by the authors of relevant textbooks.
• Consult with experts, specialists, authorities for names of authoritative publications or authors.

Other Search Tips:

• Determine how far back you want to go with your literature search. 
  • For standard of care issues, search the year the incident occurred. 
  • For causation issues, search the most current information. 
• Validate information by cross-referencing with other sources.
• Use a filtered search strategy to narrow your search to peer reviewed sources.
• Consider synonymous terms to use in subsequent searches to yield a more robust, or more manageable search.
• Consider alternative relevant databases if your search, and refined searches, don’t yield results.
• The chosen database may require or allow for Boolean search operators. 
  • Use of the word “and” or a “+” sign between two or more words will narrow your search. 
  • Use of the word “or” or a “/” will broaden your search.
  • Use of the word “not” or “-“ will indicate that the word shouldn’t appear in your search
  • Use of the word “near” will indicate words that should be found close to each other in your search.
• Consider pleural and alternative spellings.  E.g., splint, splints, labor, labour.
• Some databases allow you to search by author.  This will help narrow your search.

 A systematic literature search is an intellectual and practice focused endeavor that can be mastered over time. 

If you have a medical related case that could be strengthened by a systematic literature search, but don’t know where to begin, contact Barber Medical Legal Nurse Consulting, LLC. 

Resources:

Evidence Based Practice in Nursing and Healthcare, 4^th ed. 2019. A Guide to Best practice.

How to Read a Paper, 6^th ed. 2019. The Basics of Evidence-Based Medicine and Healthcare.

P.S. Comment and Share:  How do you plan to integrate this information into practice?

In this blog, I’ll be reviewing the importance of considering genetic and metabolic disorders when evaluating neonatal encephalopathy or cerebral palsy cases.  I’ll review the features of genetic disorders that mimic encephalopathy, as well as offer recommendations specific to elements of the medical record to review when reviewing a case for merit.  Lastly, I’ll review findings in the newborn assessment that prompts suspicion for genetic causation.

Genetic conditions and metabolic disorders can mimic the signs and symptoms of neonatal encephalopathy.  In a genetically susceptible fetus (a fetus already affected by a genetic disorder), maternal infection (E.g., chorioamnionitis: an acute inflammation of the membranes and chorion of the placenta, typically due to a bacterial infection in the setting of ruptured membranes) and fetal hypoxia (inadequate oxygen supply) can compound the adverse outcomes for these newborns. 

Neonatal Encephalopathy and Hypoxic Ischemic Encephalopathy (HIE):  The recommendation is that these two terms not be used interchangeably as not all cases of neonatal encephalopathy are caused by hypoxia and ischemia (decreased blood flow).  Very few cases of cerebral palsy are due to severe hypoxia or ischemia at birth (CDC; MacLennan et al., 2015).   

• Neonatal encephalopathy is defined as a syndrome of disturbed neurological function in the earliest days of life in the infant born at or after 35 weeks of gestation manifested by subnormal level of consciousness or seizures, often accompanied by difficulty initiating and maintaining respiration and depression of tone and reflexes (AAP, ACOG, 2019).
• Neonatal encephalopathy is often mis-labeled as hypoxic ischemic encephalopathy (HIE) based on historical assumptions that all cases of neonatal encephalopathy are caused by HIE, therefore, termed HIE. This has resulted in the terms being used interchangeably (AAP, ACOG, 2019).

The Role of Genetics: Genetic susceptibility, along with the number, duration, severity and timing of insult (if applicable); gestational age; presence of fetal growth restriction; and placental function all affect cellular health and neonatal long-term outcome (AAP, ACOG, 2019).  There are multifactorial causes of neonatal encephalopathy.  Genetic causes of encephalopathy and cerebral palsy need to be considered when establishing causation.  Genetic variations are risk factors for cerebral palsy.  Examples include, but are not limited to, single nucleotide polymorphisms in genes involved in inflammation and coagulation.  Another example includes the allele of the apolipoprotein E gene associated with ischemic stroke (AAP, ACOG, 2019). The presence of variants of uncertain significance (VUS) in gene testing requires further evaluation which may include tracing the variant in other family members who have or do not have the same health condition. Variants can be either pathologic, benign, or unknown. These unknown variants involve variations in a genetic sequencing for which the association with disease risk is unclear. Therefore, the disease cannot be ruled out (NIH, 2023).

Distinguishing Neonatal Encephalopathy from Features of Genetic Disorders Mimicking Encephalopathy: Clear documentation of appropriate care and evaluation should support evidence-based conclusions. 

• Review the parents past medical history, as well as history since the birth of the affected child.
• Review the prenatal record including all fetal surveillance (non-stress tests ‘NST’s’ and biophysical profile’s ‘BPP’s’) and all ultrasounds (imaging and reports).
• Review the labor and delivery record, including the placenta pathology report and consider consultation with a placental pathologist.  Be aware of the findings associated with an increased risk of encephalopathy (E.g., funisitis ‘inflammation of the umbilical cord’ combined with a diagnostic finding of chorioamnionitis; vasculopathy ‘lesions on the placenta which can be on the fetal or maternal side causing impaired blood flow’ (AAP, ACOG, 2019).
• Review the physical examination findings of the newborn (review the newborn admission record and subsequent treating records if transfer to a higher level of care occurred).
• Review the child’s medical history for physical changes observed over time (review the following records:  pediatric, behavioral pediatric, neurology, neuropsychology, and all brain imaging performed ‘imaging and reports’).

Consider Further Evaluation: When obvious congenital defects are present at the time of birth, this should prompt further evaluation and consideration that a genetic cause may exist.  Additional diagnoses should be considered in the neonate presenting initially with encephalopathy (AAP, ACOG, 2019).

Phenotype: AAP, ACOG (2019) identifies phenotype as the observable characteristics in an individual resulting from their genes; the clinical presentation of an individual with a particular genetic constitution.

Clues in the Newborn Assessment that May Point to a Genetic Cause:

• Findings that are significant that should increase the level of suspicion that a genetic disorder may be the cause, in the presence of hypotonia, impaired level of consciousness, seizures, or periods of apnea occurring without explanation:  
  •  Disproportionate fetal growth: A small or large head circumference compared to the length of the body may point to a genetic neurological disorder. 
  • The absence of an intrapartum event (examples include, but are not limited to, a non-reassuring fetal heart rate, prolonged second stage labor, Apgar score of less than 5 at 5 minutes, placenta abruption) (AAP, ACOG, 2019)

Metabolic Disorders and Encephalopathy: Metabolic disorders (inborn errors of metabolism) may manifest in the first few days to weeks of life with features that mimic neonatal encephalopathy.  Metabolic disorders may cause or contribute to some cases of neonatal encephalopathy.  There are well over 48 known metabolic disorders that can cause neonatal encephalopathy.  Prompt identification of newborns with a metabolic disorder is essential to initiate prompt dietary changes and treatment in an effort to prevent neonatal morbidity and mortality (AAP, ACOG, 2019).

• Newborn screening is a public health service done in each U.S. state.
• Each state’s public health department decides both the number and types of conditions on its testing panel.
• Most states allow parents to opt out for religious or other reasons.
• Be aware of your state’s newborn screening program requirements.
• Every newborn should have a newborn metabolic screening performed between 24-36 hours of life.
• According to the most current CDC data available, approximately 12,500 newborns annually are diagnosed with one of the conditions detected through newborn screening. This means that almost 1 out of every 300 newborns screened is diagnosed with a metabolic disorder (NICHD).

Conclusion: When evaluating a neonatal encephalopathy and/or cerebral palsy case for causation (either medically or legally), consider the contribution of genetic and metabolic disorders.  Be aware that hypoxic ischemic encephalopathy (HIE) may mimic encephalopathy and other features associated with a genetic disorder.

Accurate diagnosis is essential, not only to establish causation, but to support the family with a plan of care with the inclusion of genetic counseling if applicable.  Accurate diagnosis is also crucial for the understanding of future risk of recurrence.

References:

American Academy of Pediatrics, American College of Obstetricians and Gynecologists, (2019). Neonatal encephalopathy and neurologic outcomes, 2^nd Ed.

Centers for Disease Control and Prevention. Retrieved on 1/26/23 from,  https://www.cdc.gov/ncbddd/cp/causes.html

MacLennan et al., 2015. American Journal of Obstetrics and Gynecology. Cerebral palsy: causes, pathways, and the role of genetic variants.

National Institute of Child Health and Human Development. Retrieved on 1/26/23 from, https://www.nichd.nih.gov/health/topics/newborn/conditioninfo/infants-screened#

National Institute of Health (2023). National Human Genome Research Institute. Variant of uncertain significance (VUS). Retrieved on 1/26/23 from, https://www.genome.gov/genetics-glossary/Variant-of-Uncertain-Significance-VUS

P.S. COMMENT AND SHARE – Do you have a complex neonatal encephalopathy or cerebral palsy case that involved multiple factors, including genetics, that influenced causation?

Barber Medical Legal Nurse Consulting, LLC is available to review complex neonatal encephalopathy and cerebral palsy cases. Email their medical legal consulting team today at: Contact@Barbermedicallegalnurse.com

In this blog, I’ll be providing information on what informed consent is, the fundamentals of the informed consent process, data about consent related injuries and deaths, the legal and ethical obligation of providers, and risk mitigation strategies.

What is Informed Consent? The Joint Commission defines informed consent as agreement or permission accompanied by full notice about the care, treatment, or service that is the subject of the consent. A patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course. After receiving this information, the patient then either consents to or refuses such a procedure or treatment (The Joint Commission, 2016).

Data About Consent Related Sentinel Events: A sentinel event is a patient safety event that results in death, permanent harm, or severe temporary harm.  The Joint Commission’s Sentinel Event database includes 44 reports since 2010 of informed consent related sentinel events. 

Informed consent is one of the top 10 most common reasons for medical malpractice lawsuits.

Legal and Ethical Obligation of Providers: Healthcare providers who treat a patient without documented informed consent may be subject to litigation for battery, defined as unauthorized touching and intentional contact with another person’s body, as well as exposure to medical malpractice claims alleging lack of informed consent, depending on the jurisdiction (CNA).

Informed consent statutes vary between states.  For example, some states require evidence of the informed consent process occurring by means of a written signed informed consent form.  There are states that do not require a written signed informed consent.  Another example of variation: during litigation, some states focus on what a typical provider would say to a patient receiving a similar treatment or procedure.  Other states focus on the perspective of a reasonable patient; what a patient would need to know to make an informed decision.   

State legislation establishes the framework to guide consent discussions between patients and their physicians or other healthcare providers. Despite laws and regulations varying, most states require that patients be given sufficient information on three major subjects:

1. Foreseeable risks: potential complications of the proposed treatment and probable consequences of refusing it.
2. Nature of the proposed care: the procedure and anticipated benefits
3. Alternatives to the proposed treatment:  risks and benefits associated with the
   alternatives

What are the Fundamentals of Informed Consent?

• Informed consent involves two-way education and communication intended to prevent patients from being treated without their understanding and permission (CNA).
• The process of informed consent occurs when communication between a patient and provider results in the patient’s authorization or agreement to undergo a specific medical intervention (AMA).
• Patients should be encouraged to ask questions and obtain information about proposed treatments or interventions as they become more aware of potential benefits, risks and alternatives prior to authorizing care (AMA).
• All providers to be involved in the proposed surgery/procedure, as well as their roles, should be disclosed to the patient and documented in the medical record.  
• The informed consent process must be documented. Many organizations require
  utilization of a standardized consent form, signed and dated by the patient, to memorialize the consent discussion. Some states accept written
• While a signed informed consent form provides legal defensibility in the event of a claim, the consent process also may be conducted in spoken form. It is appropriate
  practice for the provider to write a progress note about major steps in the consent process (CNA).

Can a Provider Delegate Obtaining Informed Consent to a Registered Nurse? NO – The informed consent process is a non-delegable duty owed to the patient by
the healthcare provider who will perform the proposed treatment/procedure. Nurses can witness the consent process; however, they are not permitted to conduct the consent discussion.

Strategies to Mitigate Liability Risk:

• Use a standardized consent form
• Have translated consent forms for commonly spoke foreign languages
• Individualize consent discussions and forms based on literacy level. 
• Have a staff member present during the discussion who can serve as a witness
• Utilize brochures, visual aids, online resources and other
  educational tools to enhance understanding of concepts and document use of these materials in a progress note
• Use a qualified language interpreter as needed
• Confirm the patients understanding by having them communicate the proposed plan in their own words.  Courts have held that providing information when a patient does not understand does not constitute informed consent (AHRQ).

P.S. Comment and share: What is your experience specific to lack of informed consent in a medical malpractice case?

References:

CNA (2021). A Risk Management Update, Issue 3

Informed Consent, from the American Medical Association: https://code-medical-ethics.ama-assn.org/ethics-opinions/informed-consent

Informed Consent, from the National Telehealth Policy Resource Center: https://www.cchpca.org/policy-101/?category=informed-consent

“Informed Consent: More Than Getting a Signature.”
Quick Safety, February 2016, Issue 21. Published by the

Joint Commission: https://www.jointcommission.org/-/media/tjc/documents/newsletters/quick_safety_issue_twenty-one_february_2016pdf.pdf

“Making Informed Consent an Informed Choice: Training for
Health Care Professionals,” from the Agency for Healthcare
Research and Quality: https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/systems/hospital/training-for-healthcare-professionals.pdf

In this blog, I’ll be communicating key findings specific to the 2022 Nurse Practitioner Professional Liability Exposure Claim Report.  Key findings that will be highlighted will be specific to the specialty that has the highest total incurred (funds that have been paid out) of closed claims, distribution of the top closed claims by allegation, top license defense (protection) closed matters and risk management recommendations. 

KEY FINDING: Highest Total Incurred By Specialty –

The neonatal specialty represents the highest average total incurred in the 2022 and 2017 datasets. 

Many of the neonatal and pediatric claims have indemnity (compensation for damages or loss)
payments in the mid-to-high six-figure range. These payments were due primarily to the cost of lifelong, one-on-one nursing care required by the injured party.

Example of allegations against Nurse Practitioners that resulted in patients requiring lifelong, one-on-one nursing care includes:

• Failure to diagnose pertussis

• Failure to recognize contraindication and/or known adverse
interaction between/among ordered medications

Examples of a neonatal claims involving the cost of lifelong and
one-on-one nursing care for the patient includes:

1. A Neonatal Nurse Practitioner (NNP) was providing care to an infant immediately following premature birth at 32 weeks.  At the time of birth, the infant was in respiratory distress and needed
resuscitation measures. The NNP successfully resuscitated the infant and contacted the perinatologist due to the infant’s metabolic status. Twenty minutes after the birth, the perinatologist arrived to assume the care of the infant. The perinatologist and NNP were preparing the infant for transfer to a higher acuity
facility while she continued to experience difficulty breathing, as well as severe hypotension and hypovolemia. In the rush to transfer the infant, the NNP failed to timely initiate normal saline
boluses and inotropes (medications that tell your heart muscles to contract with more power increasing the amount of blood your heart can pump; increases cardiac output) to address her severe hypotension and hypovolemia, which led to brain injury. The parents alleged that this delay in treatment caused permanent neurological issues in the infant. The claim resolved with a total incurred of greater
than $240,000

2. A Women’s Health Nurse Practitioner (WHNP) provided prenatal care to a 35-37 week gestational age patient. Prior to 35 weeks, the patient had an uneventful pregnancy with normal weight gain, blood pressure readings and fetal growth. At 35 weeks, the WHNP documented a three pound weight gain from the previous week, blood pressure of 122/85 and a uterus measuring 35 cm. At 36 weeks, the WHNP documented another three pound weight gain, blood pressure of 129/89 and uterus measuring 36 cm.
At the 37 week appointment, the patient’s blood pressure was 132/92, with a fundal height of 35 cm and 1+ protein in her urine. The WHNP documented that there was positive fetal movement and fetal heart rate. At 38 weeks, the patient was seen by the co-defendant OB/GYN. The OB/GYN documented an
additional three pound weight gain, a blood pressure of 130/93 and a fundal height of 36 cm The OB/GYN ordered a contraction stress test (CST) and biophysical profile (BPP). The BPP was 0/10,
leading to an emergent caesarean section being performed with delivery of a neurologically compromised infant. The WHNP was added as a co-defendant to the lawsuit following the OB/
GYN’s deposition which stated that the insured WHNP should have notified him of the patient’s intrauterine growth restriction at her 37 week office visit Despite supportive testimony on behalf of the WHNP, the claim was resolved with a total incurred of greater than $975,000

KEY FINDING: Top Closed Claims By Allegation – Inaccurate or missed patient diagnosis accounted for the greatest number of closed claims (37.1).  The allegation resulting in the highest total incurred was patient assessment ($484,680.00).

KEY FINDING: Top License Defense (Protection) Closed Matters – Professional conduct, medication prescribing and scope of practice complaints account for more than half of all license protection closed matters at 58.4%

Risk Management Recommendations: Implementation of the below recommendations specific to every day practice, the diagnostic process, and documentation will reduce the risk of liability.    

Reference: ANA, CNA. (2022). Nurse Practitioner Professional Liability Exposure Claim Report. 5th Ed. Minimizing Risk, Achieving Excellence

P.S. Comment and Share: How do you plan to integrate this information into medical, nursing and/or legal practice?

In this blog, I’ll be reviewing the common allegations specific to obstetrical triage.  I’ll also review the incidence of obstetrical triage, the sources of recommendation specific to the use of standardized obstetrical triage acuity tools, and offer an introduction to the Maternal Fetal Triage Index (MFTI):

Common Allegations Specific to Obstetrical Triage:

• Failure to perform a medical screening exam
• Failure to perform a timely assessment of the fetus
• Delay in completing a medical screening exam
• Failure to have a policy delineating conditions that require a bedside evaluation by an obstetrical care provider prior to discharge following a medical screening exam by an obstetrical nurse
• Failure of the provider to perform a bedside evaluation for an obstetrical patient with a high risk medical or obstetrical condition
• Discharge of a patient without confirming fetal well-being
• Discharge of a pregnant woman who is unstable for discharge
• Failure to meet all aspects of the Emergency Medical Treatment and Labor Act (EMTALA) regulations in assessing, treating, and discharging a pregnant woman who presents for care

Incidence of Obstetrical Triage:

According to the American College of Obstetricians and Gynecologists, ACOG (2020), obstetrical triage exceeds the overall number of hospital births by 20–50%.  Up to one third of evaluated obstetrical patients will not deliver. These obstetrical patients will be discharged home, or transferred to another unit following initial obstetrical evaluation.   In addition to labor evaluations, obstetrical patients commonly present for (but not limited to) evaluation of preterm labor, preeclampsia, decreased fetal movement, preterm premature rupture of membranes, vaginal bleeding, and acute abdominal pain.  Critical conditions such as motor vehicle collision injury, large placental abruption, or seizure, are less common, but require immediate triage, assessment, and management (ACOG, 2020).

Recommendations for Standardized Obstetrical Triage Acuity Tools:

ACOG recommends that women should be cared for according to triage acuity rather than by time of arrival.  Historically, women have been evaluated on a first come, first serve basis when presenting to the labor and delivery unit (or, obstetrical triage unit).  This method didn’t support timely identification of urgent or emergent obstetrical events (AWHONN).

Several obstetrical triage acuity tools have been developed to classify patients based on the urgency of the patient’s condition, often using a five-level system. These tools have increased the proportion of high-acuity patients being seen urgently.  Several of these tools have been tested for content validity and interrater reliability and may be used to improve quality and efficiency of care and guide allocation of resources (JOGNN, 2015).

Many professional organizations recommend that hospital obstetrical units develop triage protocols based on local conditions, resources, but also informed by evidence-based decision making. ACOG recommends the validated algorithm, the Association of Women’s Health, Obstetric and Neonatal Nurses’ Maternal–Fetal Triage Index (MFTI).

The Maternal Fetal Triage Index (MFTI):    

The Association of Women’s Health, Obstetric and Neonatal Nurses’ (AWHONN) implemented a Maternal Fetal Triage Index (MFTI) which serves as the first obstetrical acuity tool developed by a professional society for use across the United States.

The MFTI serves as an acuity tool (scale) that standardizes obstetrical triage and assists providers and nursing staff to prioritize urgency for provider evaluation and promotes effective multidisciplinary communication. 

The MFTI evaluates maternal vital signs, fetal heart rate, presenting condition, status of labor, fetal movement, current obstetrical, medical and surgical history. 

The ultimate goal of utilizing this tool is to improve patient safety and care.  These improvements will assist in mitigating the common allegations associated with obstetrical triage medical malpractice cases.  The elements of the MFTI prompts timely medical screening exams, with the inclusion of fetal assessment and evaluation of current history that supports risk stratification of the patient and fetus.  Based on the risk assessment, the tool offers clinical guidance specific to follow up care.     

Resources:

American College of Obstetricians and Gynecologists (ACOG) 2020. Hospital Based Triage of Obstetrical Patients, Committee Opinion, #667.

Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN)

Ruhl C, Scheich B, Onokpise B, & Bingham D. 2015. Content Validity Testing of the Maternal Fetal Triage Index. J Obstet Gynecol Neonatal Nurs. 44(6):701-9. doi: 10.1111/1552-6909.12763.

P.S. Comment and Share:  What is your experience in representing an obstetrical triage case?  During case development, did you identify the use of an obstetrical triage acuity tool?

In this blog, I’ll be reviewing common allegations specific to the use of oxytocin for labor management, as well as current standards of care.  I’ll also identify some risk reduction strategies. 

Oxytocin management is a common area of professional perinatal liability claims.  Knowledge of this, and being armed with current evidence and standards of care from professional organizations can reduce a clinician’s liability risk.  

Common Allegations:

• Initiation of oxytocin in the absence of evidence of fetal well-being.  Failure to complete a non-stress test prior to initiation of oxytocin
• 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 oxytocin resulting in uterine tachysystole, with or without an indeterminate or abnormal fetal heart rate (FHR) pattern.
• Failure to discontinue or decrease oxytocin in the presence of a Category II and/or Category III fetal heart rate (FHR) tracing unresolved with intrauterine resuscitation

Standards of Care:

• Assess and document fetal well-being prior to the initiation of oxytocin
• Administer the lowest dose to achieve cervical change and labor progress (ACOG, 2017)
• Initiate oxytocin at 1-2mU/min and increase by 1-2mU/min no more frequently than every 30-40 minutes.  Approximately 90% of women at term will have labor successfully induced with 6mU/min or less (AWHONN, 2014).
• Titrate the dose of oxytocin to fetal response and uterine activity / labor progress (ACOG, 2017)
• Avoid uterine tachysystole (more than 5 contractions in 10 minutes averaged over 30 minutes) and treat (decrease or discontinue) in a timely manner if it occurs (ACOG, 2017; JOGNN, 2020)
• Avoid prolonged uterine contractions lasting greater than 2 minutes, avoid inadequate uterine resting tone (contractions occurring less than 1 minute of each other) (ACOG, 2017)
• If labor is progressing, there is no need to increase the dosage rate
• If utilizing a labor management and/or oxytocin policy, follow all policy elements
• Ensure adequate personnel are available to monitor maternal-fetal status (ACOG, 2017).  E.g. one nurse to one woman receiving oxytocin for labor induction or augmentation (AWHONN, 2014)

Risk Reduction Strategies:

• Ongoing education and periodic competence validation for health care professionals who engage in fetal heart monitoring (FHM) (JOGNN, 2015)
• Consider the requirement for electronic fetal monitoring (EFM) education for obstetrical provider re-credentialing   
• Implementation of a pre-oxytocin and in-use oxytocin checklist.  Such checklists offer a guideline for care and reinforces to the providers that if the checklists cannot be completed, Oxytocin should not be initiated and/or continued (HCA, 2009) 
• Utilize the organizational chain of command and conflict resolution policy in the event of disagreement in fetal monitor strip interpretation.  Document employment of the chain of command.
• Per JOGNN, 2020: Organizational implementation of a quality improvement initiative – Identify quality measures related to induction of labor and augmentation of labor that emphasizes
  • perinatal structure measures:
    • completed 39 weeks gestation prior to elective induction
    • criteria for prioritizing inductions based on medical necessity
    • standard policy for oxytocin administration
    • standard order set for oxytocin
    • agreed upon definitions of tachysystole base on NICHD/ACOG/AWHONN terminology
    • agreed upon and standardized treatment for tachysystole
  • perinatal process measures:
    • greater than or equal to 39 weeks gestation if elective induction
    • if <39 weeks, indication is consistent with ACOG and The Joint Commission (TJC) clinical indications
    • cervical readiness or ripening before induction
    • oxytocin protocol starting at 1-2mU/min; increase by 1-2mU/min; at least 30min. between oxytocin dosage increase
    • fetal status is normal
    • appropriate and timely interventions for tachysystole if it occurs (use of a tachysystole audit tool)
    • compliance with all aspects of care (clearly identified aspect of care)

References:

ACOG. (2017). Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and General Management Principles

AWHONN. (2014). Perinatal Nursing 4^th ed.

HCA. (2009). Perinatal Safety Initiative Recommended Pre-Oxytocin Checklist For Women with Term-Singleton Babies

JOGNN. (2015). Fetal Heart Monitoring

JOGNN. (2020). AWHONN Practice Monograph

P.S. Comment and Share: What has been your experience with a case involving oxytocin for labor induction or augmentation?

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 deterioration  with 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

Delayed antibiotics > 1 hour = increased mortality

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)

AWHONN (2021). Perinatal Nursing, 5^th ed. Wolters Kluwer

P.S. Comment and share your experience with a case involving maternal, fetal or neonatal complications associated with a hypertensive disorder of pregnancy.