Archives 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?

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. 

When reviewing content from the electronic health record (EHR), there are many elements to assess.  One of the elements is the use of the copy/paste functionality (CPF).  In this blog, I’ll be reviewing the use of CPF within the EHR.  I’ll also will be reviewing The American Health Information Management Association’s (AHIMA) position on the use of CPF, statistics, and risks associated with CPF.  I will conclude with reviewing the role of the medical legal consultant, as well as best practice recommendations to mitigate documentation risk. 

Use of the Copy/Paste Functionality (CPF) in EHR’s: The American Health Information Management Association (AHIMA) maintains the position that “the use of copy/paste functionality in EHRs should be permitted only in the presence of strong technical, and administrative controls, which include organizational policies, and procedures, requirements for participation in user training and education, and ongoing monitoring.  Users of the copy/paste functionality should weigh the efficiency and time savings benefits it provides against the potential for creating inaccurate, fraudulent or unwieldy documentation.”

CPF – A Common Occurrence in the EHR: The use of CPF continues to be a common occurrence which can lead to adverse outcomes. 

The Joint Commission published the results of the Partnership for Health IT Patient Safety work group.  Their literature review identified 51 publications:

• One study of diagnostic errors found that CPF led to 2.6% of errors in which a missed diagnosis required patients to seek additional unplanned care.

• Several case reports identified clinical harm related to CPF, including a patient who died from a heart attack after his primary care physician (PCP) failed to diagnose cardiac disease.

A. Two years prior, the patient was discharged from the ED after a new diagnosis of atrial fibrillation, and potential heart disease; he was instructed to follow up with his PCP for a stress test.

B.  The PCP copied and pasted the assessment and plan (A/P) section of the patient’s record
for 12 office visits during the next two years, updating the A/P or reviewing medical entries
from the ED or other department.

C.  The PCP was found liable in the death.

• A study published in 2017 reviewed inpatient progress notes written in 2016 by direct care hospitals, residents, and medical students totaling 23,630 notes by 460 clinicians.  In a typical note, 18% of the text was manually entered, 46% copied, and 36% imported.

Risks of CPF:

• Inaccurate or outdated information can lead to medical errors.
• Redundant information, which makes it difficult to identify the current information.
• Inability to identify the author or intent of documentation.
• Inability to identify when the documentation was first created.
• Propagation of false information: inflates, duplicates or creates fraudulent healthcare claims.
• Internally inconsistent progress notes.
• Unnecessarily lengthy progress notes.

Role of the Medical Legal Consultant:

Attorney-Client Education

• EHR documentation standards
• Discoverable items not included in the designated record set
• Regulatory requirements: user specific

Development of interrogatories & requests for production

Development of discovery responses

Recommend expert witnesses – specific to the EHR at issue

Witness Preparation

Educate staff/end users of the EHR

• Assess knowledge of the workflow
• Evaluate if end users have observed the native EHR in printed format
  A. Determine if they know how to read the printed version
• Types of assessments
  A. Standardized by EHR platform
  B. Customized by provider
  C. Use of free text

Evaluate the type of, and how much training the end user received prior to
using the EHR.  Evaluate what the training consisted of

Evaluate if the organization has consistency across EHR user roles,
access and permissions

Evaluate the organizations processes specific to record set-up, changes, revisions, additions,
and retirement of modules to the EHR

Ways to Mitigate Risk / Joint Commission Best Practice Recommendations:

• Chart timely: during the same scheduled shift
• Limit use of copy/paste functionality
• Be cognizant of scope of practice
• Disable drafts
• Utilization of the EHR report feature to track, trend, and audit. Ensure that copy/paste practices are regularly monitored, measured, and assessed
• Provide a mechanism to make copy/paste material easily identifiable
• Ensure adequate staff training, and education regarding the appropriate, and safe use of CPF
• Develop policies, and procedures addressing the proper use of the CPF to assure compliance with governmental, regulatory, and industry standards
• Address the use of features such as copy/paste in the organization’s information governance processes
• Monitor compliance, and enforce policies, and procedures regarding use of copy/paste, and institute corrective action as needed.

Resources:

The Joint Commission. Sentinel Event Alert 54. “Safe Use of Health
Information Technology.” March 31, 2015. Retrieved from: https://www.jointcommission.org/resources/patient-safety-topics/sentinel-event/sentinel-event-alert-newsletters/sentinel-event-alert-54-safe-use-of-health-information/#.YpkLlFTMIos

The Joint Commission. “The Joint Commission Standards.” https://www.jointcommission.org/standards

The Joint Commission. Quick Safety 10. “Preventing Copy-and-
Paste Errors in EHRs.” Updated July 2021. Retrieved from: https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety–issue-10-preventing-copy-and-paste-errors-in-ehrs/preventing-copyandpaste-errors-in-ehrs/#.YpkLcFTMIos

P.S. Comment and share – How will this information change your documentation practices, or how you analyze the EHR?

In this post, I’ll be addressing the most current evidence, published standards of care, and guidelines from professional associations, and regulatory agencies specific to fetal heart rate interpretation and management. 

Fetal heart rate pattern interpretation, communication, and documentation continues to be one of the most common areas of perinatal liability claims. It is best practice to utilize current practice guidelines, and standards of care as a guide for the revisions, and development of institutional policies as a means to decrease professional liability exposure, and minimize the risk of perinatal injury.

Common Themes: In review of birth injury cases, I have observed common themes (allegations):

• Failure to interpret a non-reassuring fetal heart rate (FHR) tracing
• Failure to accurately assess maternal-fetal status
• Failure to recognize a deteriorating fetal condition
• Failure to appropriately treat an indeterminate or abnormal FHR in a timely manner (E.g., failure to initiate intrauterine resuscitation based on FHR pattern and/or plan for expeditious birth when clinically indicated)
• Failure to accurately communicate the maternal-fetal status to the physician/certified nurse midwife
• Failure to request bedside evaluation based on concern for fetal status to the physician/certified nurse midwife
• Failure of the physician/certified nurse midwife to respond appropriately when notified of indeterminate or abnormal fetal status
• Failure to initiate the chain of command (communication) when there is a clinical disagreement between the nurse, and responsible physician/certified nurse midwife, regarding fetal status   

Standards of Care:

• Use of EFM definitions and descriptions based on the 2008 National Institute of Child Health and Human Development (NICHD) Working Group findings (ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring, 2017)
• In the presence of an EFM tracing with minimal or absent variability, and without spontaneous accelerations, an effort should be made to elicit accelerations by means of vibroacoustic stimulation, or scalp stimulation.  When there is an acceleration with stimulation, acidemia is unlikely, and labor can continue (ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring, 2017).
• Be aware of the EFM findings consistent with an abnormal acid-base status: absence of accelerations; minimal to no variability (ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring, 2017).
• Be aware of when to implement intrauterine resuscitation based on interpretation of EFM: Category 2, and category 3 FHR tracings, uterine tachysystole (dependent on FHR pattern, and presence or absence of oxytocin (ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring, 2017).
• Implement intrauterine resuscitation based on the presumed etiology of the FHR pattern: maternal repositioning, intravenous fluid bolus, oxygen administration (if oxygen is being administered for intrauterine resuscitation, oxytocin should be discontinued), reduction of uterine activity, correction of maternal hypotension, amnioinfusion, modification of maternal pushing efforts during second stage labor (AWHONN Perinatal Nursing, 2021).
• Be able to recognize uterine tachysystole: 5 contractions in 10 minutes, averaged over 30 minutes. 
• Be aware of the interventions to manage tachysystole in the presence, and absence of oxytocin.  E.g., uterine tachysystole in the presence of oxytocin with a Category 1 tracing requires a reduction in oxytocin.  Uterine tachysystole in the presence of oxytocin with a Category 2 or 3 tracing requires a reduction or discontinuation of oxytocin, and implementation of intrauterine resuscitative measures.  If no resolution, a tocolytic should be considered.
• During induction or augmentation of labor with oxytocin, the FHR should be evaluated and documented before each dose increase, and following each dose increase (AWHONN Position Statement, Fetal Heart Monitoring, 2015)
• If continuous EFM is ordered, monitoring of FHR, and uterine activity should continue until birth (AWHONN Perinatal Nursing, 2021).
• Development of institutional policies, procedures, and protocols that outline responsibility for ongoing FHM documentation (AWHONN Position Statement, Fetal Heart Monitoring, 2015).
• Documentation should include communication with providers (AWHONN Position Statement, Fetal Heart Monitoring, 2015).
• Documentation should include communication within the chain of resolution / chain of command (AWHONN Position Statement, Fetal Heart Monitoring, 2015).
• Ongoing education and competency validation for RN’s, and other healthcare providers responsible for FHM (AWHONN Position Statement, Fetal Heart Monitoring, 2015).
• Use of oxytocin safety checklists are recommended as they provide prerequisites to safely initiate oxytocin, and to help identify situations that require discontinuation (ACOG Optimizing Protocols in Obstetrics, Oxytocin for Induction, 2011).  

References:

ACOG (2011). Optimizing protocols in obstetrics, Oxytocin for induction   

ACOG (2017). Practice Bulletin, Intrapartum fetal heart rate monitoring

AWHONN (2021). Perinatal nursing

JOGNN (2015). AWHONN position statement: fetal heart monitoring

P.S. Comment and share your experience with a birth injury case related to fetal monitoring interpretation, communication and/or documentation.

In this blog, I’ll be reviewing the national, and New York State statistics related to maternal mortality associated with obstetrical hemorrhage.  I’ll also highlight one of the risk factors associated with obstetrical hemorrhage, and discuss the standards of care that should be employed to mitigate the risk of maternal morbidity and mortality. 

Statistics: Obstetrical hemorrhage is a preventable cause of maternal morbidity and mortality and continues to be one of the leading causes of maternal death in the U.S.

How the U.S. compares to 10 other developed countries:

In New York State, postpartum hemorrhage is the 2^nd most frequently reported postpartum complication, and accounted for 29% (18) of maternal deaths between 2012-2013 according to the NYS Maternal Morbidity and Mortality Review Report (2017).

Prolonged oxytocin exposure as a risk factor: In a recent (published May, 2022) retrospective cohort study performed by Boston University School of Medicine, prolonged (greater than or equal to 12 hours) oxytocin exposure for induction of labor increased the risk of obstetrical hemorrhage by 52% compared to those women exposed for less than 12 hours.  Use of obstetrical risk assessment tools alert the perinatal team to the risk of obstetrical hemorrhage and prompts evidence-based interventions.

The importance of standardized safety bundles: The American College of Obstetricians and Gynecologists (ACOG) recommends the use of the Obstetrical Safety Bundle as a means to guide standardized management of obstetrical emergencies associated with maternal morbidity and mortality in accordance to evidence-based practice.  ACOG’s Safe Motherhood Initiative (SMI) focuses on the four leading causes of maternal death: maternal sepsis, obstetric hemorrhage (severe bleeding), venous thromboembolism (blood clots), and severe hypertension in pregnancy (high blood pressure).

The Obstetrical Hemorrhage Safety Bundle includes:

• Risk assessments: prenatal, antepartum, labor & delivery, and postpartum.
• Use of a staged obstetrical hemorrhage checklist to guide interventions in real-time.
• Team debriefing recommendations and a standardized debriefing form.
• Suggested standardized obstetrical hemorrhage tool kit.
• Recommendation to perform quantitative blood loss assessment (QBL) with every delivery.

The Joint Commission Perinatal Safety Standards: Effective January 1, 2021, the Joint Commission implemented new perinatal safety standards required of all Joint Commission accredited hospitals.   One of the new standards aims to improve care for women experiencing maternal hemorrhage.  The Joint Commission requirements focus on evidence-based written procedures, education, training, and drills for staff and providers, education for patients and families, and quality review.  The requirement also focuses on evidence-based risk assessments and hemorrhage supply kits. 

References:

ACOG’s Obstetrical Hemorrhage Safety Bundle. https://www.acog.org/community/districts-and-sections/district-ii/programs-and-resources/safe-motherhood-initiative/obstetric-hemorrhage

MedPage Today. 2022. https://www.medpagetoday.com/meetingcoverage/acog/98676

NYS Department of Health. 2017. NYS Morbidity and Mortality Review Report

OECD Health Data. 2020

P.S. Comment and share your experience with a maternal death case associated with obstetrical hemorrhage. What were the deviations in the standards of care? 

In this blog, I’ll be reviewing the purpose of medical staff hospital credentialing, identifying who is responsible for credentialing, comparing the roles and responsibilities of the medical staff, and the hospital Board, and reviewing criteria-based systems recommended for the credentialing process.  It’s important to have an understanding of the above concepts to ensure that hospital systems have an effective credentialing process that promotes patient safety, sustains a system that mitigates the risk of malpractice litigation, while also mitigating the risk of restraint of trade. 

Credentialing Purpose: The primary purpose of credentialing is to protect patients by ensuring quality patient care.  A credentialing process appropriately overseen by the hospital Board reduces patient exposure to poorly performing providers, ultimately, reducing the risk of preventable patient injury. 

secondary purposes:

• To ensure that only qualified providers are admitted and allowed to remain on medical staff.  Medical staff includes Physicians, Physician Assistants (PA), and Advanced Practice Registered Nurses (APRN): Certified Nurse Midwives (CNM), Nurse Practitioners (NP), and Certified Registered Nurse Anesthetists (CRNA).   
• To ensure that providers are practicing within their scope, consistent with quality standards of the hospital.
• The appointment, re-appointment into medical staff.
• The granting, and renewal of privileges (delineation of privileges) – what a provider is allowed, and not allowed to do, types of patients a provider is able to manage, types of diseases the provider is able to treat, procedures the provider is able to perform, or not perform based on privileging delineations, and clear credentialing criteria.  For example, CNM management of low-risk obstetrical patients; CNM collaborative management with Ob/Gyn for high-risk obstetrical patients.

Who is Responsible for Hospital Credentialing? Medical staff credentialing is the core responsibility of the hospital Board, and serves to be the most important responsibility of the Board secondary to the impact on patient safety, and the role credentialing has within the hospital’s quality improvement and patient safety system. 

The legal structure (as shown below) needs to be understood by the Board, medical staff, and management to ensure clear role delineation, and to ensure an effective credentialing system.

                              

Roles and Responsibilities: It’s important to have a clear understanding of role delineation to ensure that the hospital has an effective credentialing process that promotes safe work environments, while reducing the risk of patient injury. 

Board:

• Reviews recommendations received from the medical executive committee and compares the recommendations against established credentialing criteria
• Makes sure the credentialing criteria is consistently applied to all applicants: efforts need to be made to avoid loose criteria that could result in patient injury and increase the risk of malpractice litigation.  Contrary, efforts need to be made to avoid tight / biased criteria that could result in claims of negligent credentialing, and/or restraint of trade
• Makes sure the medical executive committee has a credentialing procedure in place
• Makes final decisions: grants privileges, grants admission into medical staff 

Medical Staff (Medical Executive Committee):

• Makes recommendations to the Board
• Identifies credentialing criteria for evaluating providers
• Evaluates performance
• Evaluates applicants

Credentialing is proven to be the most difficult governance function to perform effectively for the following reasons:

• Many Boards and medical staff do not accept the Boards role to oversee the medical staff
• Many lay Board members are not comfortable with the responsibility
• Neither the Board, nor the medical staff know how to do credentialing

The hospital Board maintains liability for inappropriate decisions made regarding (re)credentialing and delineation of privileges.  The Board cannot exclusively rely on the recommendations of the medical executive committee as a defense to justify a poor decision.

How To Do Hospital Credentialing – The Use of Criteria Based Systems for (Re)Credentialing and Privilege Delineation: It’s best practice to have a clear decision criterion for credentialing and delineation of privileges that sets the hospitals quality and safety bar high.  The criteria should be based on internal information sources.  Additionally, privilege delineation should be unique and specific to each provider.  The Joint Commission requires provider specific data to be collected continuously and reviewed at the time of re-credentialing.  It’s recommended that this provider specific data is compared to the aggregate data as a means to identify how each individual provider is performing in each performance measure in comparison to his/her provider colleagues.  Typically, the specific credentialing criteria are developed by the clinical department, and submitted to the medical executive committee (MEC) for approval.  MEC then makes the recommendation to the Board who makes the final decision. 

Examples of Criteria Based Credentialing:

               Frequency Criteria: A number of professional organizations suggest frequency criteria for (re)credentialing and privileging.  For example, Surgeon A is required to perform 20 laparoscopic cholecystectomies in a 2-year period (credentialing term per Joint Commission is 2-years).

               Minimum Volume Required Criteria: For example, Surgeon A is required to perform a minimum of 10 laparoscopic cholecystectomies in a 2-year period. 

               Clinical Outcomes: Internal data – individual provider specific data (outcome measures).  For example, Surgeon A’s specific data (outcomes): post-operative complications, morbidity and mortality rates, returns to the OR, wound infections.

               Behavior Criteria: Patient complaints, malpractice claims per individual provider

References:

American Hospital Association Trustee Service. 2017. The Role of the Board in Medical Staff Credentialing:https://trustees.aha.org/quality/the-boards-role-in-medical-staff-credentialing

Credentialing and Privileging – Requirements for Physician Assistants and Advanced Practice Registered Nurses:https://www.jointcommission.org/standards/standard-faqs/hospital-and-hospital-clinics/medical-staff-ms/000002124/

JCAHO’s new credentialing, privileging standards require provider-specific data: https://www.reliasmedia.com/articles/122719-jcaho-s-new-credentialing-privileging-standards-require-provider-specific-data

P.S. Comment and share your experience with hospital credentialing.