Archives January 2022

In this blog I’ll be reviewing the most common nursing malpractice claims, common causes of nursing litigation, common plaintiff allegations, common defenses for nursing liability claims, and ways to mitigate risk. 

The Role of the Healthcare Consumer: Our society is evolving into savvy healthcare consumers who are increasingly more aware, frequently relying on their electronic devices to capture events, and for some, have adopted the notion that hospitals are “deep pockets” when it comes to litigation. 

Most Common Nursing Malpractice Claims: The Nurses Service Organization (NSO), the largest provider of nurses’ liability insurance in the United States, and CNA, the liability insurance underwriter, published a report of nursing malpractice claims from 2006 to 2010.  While the claim history range is not current, the findings are applicable in regards to what lessons we can learn from the report.  I’ll be comparing some of the findings from the 2011 report to the most current NSO nurses’ claim report. 

The 2011 report reviewed 3,222 closed claims against nurses insured by CNA through NSO. The total payment on behalf of the RNs was approximately $80 million. 

• The average cost of a registered nurses’ malpractice claim (payment per case) was approximately  $170,000.
• Insurers paid approximately $8.6 million in indemnities related to medication administration. 26% of the claims were related to wrong medication dose, 20% to improper technique, 18% to wrong medication, and 13% to failure to properly monitor and maintain the infusion site.

In comparison to the most current nurses’ claim report (5-year study) (NSO, 2021),  

Over $90.3 million was paid for malpractice claims over a 5-year period by CNA. This is 10.3 million dollars more that what was reported in 2011.

• The average cost of a registered nurses’ malpractice claim is $201,916. This is $31,916 more than what was reported in 2011.  
• Death is the most common patient injury that results in a lawsuit.  It accounts for 44.3% of all malpractice claims against nurses.
• Comas resulted in the highest severity among patient injury claims, averaging $620,833.  They were often due to medication errors.  The high cost reflects the need for lifelong medical care. 
• Allegations related to treatment and care continue to represent the highest percentage (45.9%) of all malpractice claims asserted against nurses. 
• Lawsuits against nurses due to medication errors were reduced by nearly half, while the claim cost almost doubled since the last 5-year study. 
• The number of license defense paid claims increased by 15.4% since the last study in 2011.
• Unprofessional conduct resulted in the majority of license complaints (24.2%) made against RNs.  The majority of complaints against LPN/LVNs involved medication errors. 
• Experience as a nurse does not equate to less risk of malpractice claims.  The majority of nurses (85%) who experienced a malpractice claim had been in practice at least 16 years. 

Common Causes of Litigation:

• Professional malpractice
• Unprofessional conduct
• Professional negligence
• Involuntary manslaughter

Common Plaintiff Allegations:

• Failure to assess and monitor the patient
• Failure to administer a medication
• Failure to provide treatment and care
• Failure to maintain patient advocacy
• Failure to respond to a change in condition
• Patient abuse or neglect

Common Defenses for Nursing Liability Cases:

• Physician was informed
• Care was provided consistent with the standards of care
• Care was provided within the scope of nursing practice
• Death was related to the patients pre-existing condition and co-morbidities

Ways to Reduce Nursing Liability Risk:

• Practice within the regulations of your State Nurse Practice Act, remain in compliance with your professional organizations and facilities policies and procedures, practice within national standards of care
• Maintain clinical competencies
• Clarify your direct care assignments and responsibilities
• Document in real time to the best of your ability, objectively, accurately, completely, and legibly.  Document all patient assessments, re-assessments, observations, communications, and actions.  Comply with your employer’s documentation standards.
• Do not alter the medical record for any reason after the fact, unless necessary for patient care.  If you must add to the medical record after the fact, be sure to label the entry as a late entry.
• Maintain signed and dated copies of employer contracts
• Maintain effective communication with your work team
• Utilize the chain of command (communication) when necessary to advocate for interventions with significant change in patient status

Having an awareness of common causes of nursing litigation, as well as plaintiff allegations may help reduce risk.  Being armed with knowledge reduces risk of potential litigation, and improves patient outcomes.

P.S. Comment and share your role in mitigating nursing, or APRN (APP) liability risk

References:

CNA Healthpro and Nurses Service Organization. Understanding Nurse Liability, 2006–2010: A Three-Part Approach. http://www.nso.com/nurseclaimreport2011

Nurses Service Organization. 2021. 10 Surprising Facts from the Nurses Claim Report. https://www.nso.com/Learning/Artifacts/Articles/10-most-surprising-things-from-the-nurse-s-claim-report

All adverse outcomes cannot be prevented; however, defensibility is strengthened when care rendered is consistent with standards of care.

In this blog I’ll provide a brief overview of Hypoxic Ischemic Encephalopathy (HIE) neonatal brain injury.  I will review the definition, the incidence (U.S. and worldwide), associated complications, possible causes, and recommended treatment.  I will also share possible defenses to consider when developing a HIE neonatal brain injury case. 

What Is It? HIE neonatal brain injury is injury to the brain as a result of hypoxia.  Hypoxia is a deficiency of well oxygenated tissue.  This can result from a combination of insufficient blood flow and/or decreased oxygen levels. 

How Common Is HIE? HIE is the leading cause of brain injury in the perinatal period.

• Occurs in 1 to 8 of every 1,000 live births in the United States
• HIE causes 30% of cerebral palsy cases in the United States
• HIE causes 23% of neonatal deaths world-wide. The fifth leading cause of deaths worldwide in children under 5 years of age (World Health Organization, 2020).

Complications of HIE (including, but not limited to…): cerebral palsy, epilepsy, mental retardation, visual impairment, hearing impairment, learning disabilities, cardiac arrest, death.

Causes (including, but not limited to…) of HIE neonatal brain Injury: (literature suggests 70-80% of HIE neonatal brain injury cases are not preventable)

1. Antepartum and Intrapartum Events – placental abruption, umbilical cord prolapse, uterine rupture, acute blood loss (maternal hemorrhage), infection
2. Maternal Underlying Risk Factors – hypotension, hypertension, placental vasculopathies, insulin dependent diabetes
3. Neonatal Risk Factors – congenital heart disease, pulmonary disease, severe apnea, patent ductus arteriosus, hypoglycemia, hyperglycemia, meconium aspiration syndrome, infection

Treatment:  Therapeutic hypothermia, or induced cooling, has been shown to reduce death and disability in many HIE cases.  Reduction in the core body temperature reduces the brain temperature resulting in neuroprotection.  Therapeutic hypothermia is the standard of care for infants who are diagnosed with moderate to severe HIE following birth (no later than 6 hours of life) and who meet specific criteria per standard of care adopted by organizational policy, procedure, and order set. 

*Sarnat Staging System is the standard of care to grade severity of HIE

Cooling can be done on the whole body, or through a cooling cap placed on the head.  The infant may need other medical interventions to support their organs or to treat seizures.

Infants who experience HIE may require early intervention therapy services after discharge.  These include services from a neurodevelopmental pediatrician, physical therapist, occupational therapist, speech therapist, feeding and swallowing therapist, and/or a pediatric neurodevelopmental ophthalmologist.

Possible Plaintiff Allegations for HIE Neonatal Brain Injury:

Failure to transfer mother to tertiary care center (higher level of care)

Failure to or delay in transferring infant to Level III NICU for hypothermia therapy

Failure to attend or delay in arrival of a NICU team to a high-risk delivery

Failure of medical staff to recognize and treat neonatal seizures

Failure of Midwife to have appropriate resuscitative equipment and personnel for home delivery

Failure to follow hypothermia treatment protocol

Possible Defenses for HIE Neonatal Brain Injury:

The infant did not meet criteria for hypothermia protocol

The manifestations of the brain injury were metabolic or genetic in nature and not a result of HIE

The infant was not stable for transport to a higher level of care

The mother was non-compliant with regimen for high-risk pregnancy conditions

The mother had no prenatal care

Synthesis of Data and Case Development:  Knowing which relevant maternal and infant medical records to request and what questions to ask are essential.  Having an awareness of standard physician orders, and standing nursing orders will support the development of a case.  A strong understanding of the electronic medical record and documentation requirements, as well as standard laboratory and diagnostics ordered will support case development. 

Below are some clinical areas of focus for case development:

• pathophysiology of fetal monitoring and fetal strip interpretation: identification of fetal hypoxia
• acid-base balance: identification of fetal and/or neonatal metabolic acidosis
• newborn Apgar scoring: identification of the presence of birth asphyxia
• gestational age assessment: evaluation of the appropriateness of implementing hypothermia treatment
• staging and classification criteria for HIE: identification of the level of neurological compromise, identification of eligibility criteria of newborn for hypothermia treatment
• hypothermia treatment: identification of treatment as the standard of care, criteria for treatment, treatment modalities, procedure, staff competencies and continuing education

Perinatal Safety and Professional Liability: All adverse outcomes cannot be prevented; however, defensibility is strengthened when care is consistent with relevant, current evidence-based practice recommendations and standards of care. 

P.S. Comment and Share: What were your successes and challenges working through a HIE birth injury case?

References:

Douglas-Escobar & Weiss. (2015). Hypoxic-Ischemic Encephalopathy: A review for the clinician. JAMA pediatrics. 169(4):397–403. doi:10.1001/jamapediatrics.2014.3269 

Simpson K.R., & Creehan P.A. (2020). AWHONN’s Perinatal Nursing. 5^th edition. Lippincott Williams & Wilkins

World Health Organization. (2020). Newborns: improving survival and wellbeing. https://www.who.int/news-room/fact-sheets/detail/newborns-reducing-mortality

World Health Organization. (2022). The top 10 causes of death. https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death

(Share the American College of Obstetricians and Gynecologists patient FAQs)

In this blog I’ll be addressing cervical cancer incidence and mortality, risk factors, the role that the Human Papilloma Virus (HPV) plays in the development of cervical cancer, as well as screening recommendations. 

Incidence and Mortality:

It is estimated that in the U.S., in 2021, there were 14,480 new cervical cancer diagnoses, and 4,290 cervical cancer deaths (American Cancer Society, 2021). 

Approximately 1,250,000 women are diagnosed with precancers annually by cytology using the Papanicolaou (Pap) smear. Lesions can regress, persist, or progress to malignancy (American Cancer Society, 2021).  

Who’s At Risk / The Role of HPV:

Carcinogenic types of HPV are the primary agents that cause virtually all cases of cervical cancer (U.S. Department of Health and Human Services).  Once HPV infection occurs, additional risk factors are associated with a higher risk of the development of cervical cancer.  For example: high parity (5 or more pregnancies with gestational ages greater than or equal to 20 weeks), long-term use of oral contraceptives, as well as active and passive cigarette smoking. Diethylstilbestrol (DES) exposure in utero is also associated with an increased risk of developing cervical dysplasia.

HPV vaccination:

• Based on reliable evidence, vaccination against HPV types 16 and 18 is effective in preventing HPV infection in HPV negative individuals and is associated with a reduced incidence of cervical intraepithelial neoplasia 2 and 3. By extrapolation, these vaccines should also be associated with a reduced incidence of cervical cancer.
• Magnitude of Effect: Vaccination against HPV types 16 and 18 reduces incident and persistent infections with efficacy of 91.6% (95% confidence interval [CI], 64.5%–98.0%) and 100% (95% CI, 45%–100%), respectively (U.S. Department of Health and Human Services).
• All forms of the HPV vaccine are currently recommended by the Centers for Disease Control and Prevention (CDC) in the United States as a two-dose schedule at least 6 months apart for adolescents younger than 15 years. The current CDC recommendation for older individuals is to receive the original three-dose series.

Cervical Cancer Screening:

Screening With the Papanicolaou (Pap) Test:

• Based on reliable evidence, regular screening with the Pap test in an appropriate population of women reduces mortality from cervical cancer. The benefits of screening women younger than 21 years are small because of the low prevalence of lesions that will progress to invasive cancer. Screening is not beneficial in women older than 65 years if they have had a recent history of negative test results.
• Magnitude of Effect: Regular Pap screening decreases cervix cancer incidence and mortality by at least 80%.

Screening With the Human Papillomavirus (HPV) DNA Test:

• Based on reliable evidence, screening with an HPV DNA or HPV RNA test detects high-grade cervical dysplasia, a precursor lesion for cervical cancer. Additional studies show that HPV DNA testing is superior to other cervical cancer screening strategies.
• Magnitude of Effect: In one prospective, clustered, randomized trial, HPV DNA testing was superior to other strategies for preventing cervical cancer mortality

Screening With the Pap Test and the HPV DNA Test (Co-testing):

• Based on reliable evidence, screening every 5 years with the Pap test and the HPV DNA test (co-testing) in women aged 30 years and older is more sensitive in detecting cervical abnormalities, compared with the Pap test alone. Screening with the Pap test and HPV DNA test reduces the incidence of cervical cancer.
• Magnitude of Effect: HPV based co-testing provides 60% to 70% greater protection against invasive cervical carcinoma, compared with cytology (pap smear) alone

Screening Women Without a Cervix

• Based on reliable evidence, screening is not helpful in women who do not have a cervix as a result of a hysterectomy for a benign condition.
• Magnitude of Effect: Among women without cervices, fewer than 1 per 1,000 had abnormal Pap test results.

 

U.S. Preventive Services Task Force (USPSTF) cervical cancer screening recommendations adopted by the American College of Obstetricians and Gynecologists (ACOG):

Barriers: In 2020, the American Cancer Society (ACS) updated its cervical cancer screening guidelines to recommend primary hrHPV testing (High Risk HPV DNA testing) as the preferred screening method for average-risk women aged 25–65 years.  Despite the efficacy and efficiency of primary hrHPV testing, adoption of this screening method has been slow secondary to the limited availability of FDA-approved tests and the laboratory infrastructure changes required to switch to this screening platform (The American College of Obstetricians and Gynecologists, 2021).

Future Implications:

• The ACS strongly advocates phasing out cytology-based screening options (pap smears) in the near future
• Although HPV self-sampling has the potential to improve access to cervical cancer screening, and has been identified as effective, it is still investigational in the United States
• The Journal of the American Medical Association (JAMA) published a study demonstrating that self-collected menstrual blood capture and testing for hrHPV is a
  feasible and accurate approach for cervical cancer screening. This study found that this
  method is associated with superior performance in identification of HPV genotypes and true-negative events compared with cervical HPV testing (Zhang, 2021).

Risk Mitigation:

As a means to reduce the risk of delayed or missed cervical cancer diagnosis, and to ensure cervical cancer treatment is rendered in accordance to current standards of care, it is essential to be aware of cervical cancer signs and symptoms, risk factors, screening guidelines, as well as treatment recommendations.

P.S. Comment and share if you have learned of other alternatives to self-collected hrHPV DNA testing options that are currently being studied.

References:

American Cancer Society: Cancer Facts and Figures 2021. American Cancer Society, 2021. Available onlineExit Disclaimer. Last accessed October 8, 2021.

Moyer VA; U.S. Preventive Services Task Force: Screening for cervical cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 156 (12): 880-91, W312, 2012. [PUBMED Abstract]

The American College of Obstetricians and Gynecologists. (2021). Practice advisory, Updated cervical cancer screening guidelines.

U.S. Department of Health and Human Services, National Cancer Institute https://www.cancer.gov/search/results?swKeyword=cervical

Zhang J, Tian X, Chen Y, et al. (2021). Feasibility and accuracy of menstrual blood testing for high-risk human papillomavirus detection with capture sequencing. JAMA. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787432?resultClick=3

 

Facts found within the electronic medical record (EMR) and electronic health record (EHR), or missing from either source, can strengthen or weaken a medicolegal case.  Having an understanding of the EMR and EHR is crucial to the discovery process.   In this blog, I’ll be addressing the differences between the EMR and EHR.  I will also share EMR and EHR elements to consider for discovery. 

Differences Between the EMR and EHR: The EMR is an electronic record of health-related information on an individual that can be gathered, stored, managed, and consulted by authorized clinicians and staff within one healthcare organization.  The EHR is also an electronic record of health-related information on an individual, however, it must conform to nationally recognized interoperability standards.  The EHR can be created, managed, and consulted by authorized clinicians and staff across more than one healthcare organization (McBride et al., 2019).

Discovery: Discovery involves procedures for obtaining information (admissible to trial) from other parties, and witnesses prior to trial. 

Objective: The purpose of discovery is to get the facts, narrow down the issues of the case, identify the strengths and weaknesses of the case, plan a trial strategy, or negotiate a settlement. 

Having someone knowledgeable about the EMR and EHR systems on the legal team proves to be a valuable approach to success.  The reason for this is that there are many elements of the EMR and EHR to consider in the process of discovery. McBride et al., (2019) references that there are unintended consequences of missing the patients story secondary to “data noise.” These unintended consequences include patient morbidity, poor outcomes, and even death.  The problem is that there is so much EMR/EHR data.  Professionals need to know where to find the needed (or missing) information in the EMR and EHR, both within clinical and legal practice.    

Elements of the EMR and EHR to Consider for Discovery (including, but not limited to:)

• Name of EMR/EHR, EMR/EHR version, vendor representative contact, technician support service member contact
• Each component part, section, sub-section of the systems
• When the EMR/EHR system was originally implemented and when any upgrades were installed
• The programs capabilities and limitations, how and where entries are made, who can make entries, how dates and times are entered, who has access to the EMR/EHR
• Does the EMR have pre-set standard responses (E.g., automatic times for medication administration), are templates used for the pre-set standard responses, number of templates created or used to create the EMR
• Are electronic signatures (e-signatures) used,  if so which health care providers (HCPs) are assigned and use e-signatures, do medical and nursing staff share signature blocks, does the facility and/or provider have a policy specific to the use of signature blocks and passwords
• Is there a requirement to verify entries of unlicensed staff, if so, which entries must be verified
• Is there a policy specific to making corrections to the EMR/EHR
• Is the EMR, or section of the EMR printed, is so when (E.g., daily, or at the end of admission)
• How is the EMR/EHR secured, who is responsible for security
• Downtime policies (precautions to secure the EMR/EHR, as well as policies specific to documentation)

P.S. Comment and share how the presence, or absence of specific documentation either bolstered or weakened a recent case.

P.P.S. Comment and share if strong knowledge of the EMR/EHR system was able to better support your case.

Reference:

McBride S., & Tietze M. (2019). Nursing informatics for the advanced practice nurse. Patient safety, quality, outcomes, and interprofessionalism. (2^nd ed.) Springer Publishing Company.