Tag #medicalmalpractice

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

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

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

CMQCC, 2017. CARDIOVASCULAR DISEASE IN PREGNANCY AND POSTPARTUM TOOLKIT

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

CMQCC, 2017. CARDIOVASCULAR DISEASE IN PREGNANCY AND POSTPARTUM TOOLKIT

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

Key Takeaways:

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

References:

ACOG, 2019. Pregnancy and heart disease.

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

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

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

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

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