Archives November 2022

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?