DATA ABOUT DATA: What You Should Know

You can learn so much from the metadata in the electronic health record (EHR).  Metadata is data, about data.

Example: data entered, patterns of missing data, when data was entered, who entered it, who viewed it, how long it was viewed for, and whether it was modified.

Metadata can identify incidences of errors, as well as patterns of patient care delivery (i.e., recurrent late entries)

Metadata is discoverable per the Federal Rules of Civil Procedures. This means that attorneys can acquire access to EHR information, including the metadata, through the discovery process. Metadata is typically  obtained by a computer-generated record of audit trails showing user access and actions.  

Providers Can Minimize Risk by Effectively Documenting: During the litigation process, metadata can play an integral role in determining the credibility of evidence, including healthcare provider’s testimony, and documentation.

  • Avoid documentation gaps
  • Don’t copy and paste text from one patient’s EHR to another
  • Use templates and checklists cautiously
  • Do not share your password
  • Make any changes to the record as soon as possible, per organizational policy
  • Know that what you view is recorded
  • Document referrals and notifications of other nurses about changes in a patient’s condition

Metadata analysis can support — or not support — a lawsuit. Frequent errors, and errors of omission can negatively impact a healthcare providers credibility in court.  Contrary, metadata that demonstrates  complete, and accurate documentation can help exonerate healthcare providers by bolstering their credibility, and providing evidence that adherence to organizational policies, and procedures, as well as  standards of practice were followed.

RESOURCES

  • AHIMA. E-discover litigation and regulatory investigation response planning: Crucial components of your organization’s information and data governance processes. n.d. https://bok.ahima.org/doc?oid=107115#.ZByfmBXMJhE
  • Barrett M, DeAngelo TR, DeAngelo JG. E-discovery: Metadata analysis in medical malpractice litigation. The Legal Intelligencer. 2020. Commentary. https://www.law.com/thelegalintelligencer/2020/04/09/e-discovery-metadata-analysis-in-medical-malpractice-litigation/?slreturn=20230223103325
  • Conn J. Making IT legal-size; As electronic health-record systems become more complex, so do the issues involving the legal status of those records. Modern Healthcare. 2008;38(20),
  • Gardner E. The weight of the I.T. evidence; why EHRs won’t reduce your malpractice premiums. Health Data Management. 2013;21(10).
  • Hansen MD, Pratt TJ. Follow the audit trial: The impact of metadata in litigation. Defense Counsel J. 2017;84(3).
  • NSO, 2024. What nurses need to know about metadata, documentation, and legal liability. https://www.nso.com
  • Shwayder JM. Electronic records and metadata: Old and new liability risks: Metadata from an EHR form an audit trail of activity, which can make or break a malpractice case. Cont OB/GYN. 2018;63(9).

P.S. COMMENT & SHARE: What has been your experience utilizing metadata to support your medical legal cases?

MATERNAL SEPSIS: CASE STUDY AND REVIEW

In this blog, I’ll be introducing a maternal sepsis case study, followed by supportive content to enhance the readers understanding of the incidence of maternal sepsis in the U.S., causes, risk factors, and complications that can occur as a result of maternal sepsis. I’ll provide information on the recommended screening, diagnostic criteria, as well as assessment, and treatment  recommendations. 

Case Study: A 38-year-old woman, gravida 6 para 5, with an unremarkable past medical history presented to labor and delivery in active labor at 39 weeks of gestation and delivered vaginally shortly thereafter. Delivery was uneventful, without regional anesthesia and without perineal tears nor other complications. Twenty-four hours after delivery, the patient developed isolated left lower quadrant pain. Physical examination, abdominal ultrasound, and laboratory tests including complete blood count and basic metabolic panel were unremarkable, and the pain subsided after a bowel movement. On the following day, abdominal pain worsened, while the patient remained afebrile and was hemodynamically stable. Clinical assessment and physical examination of the pelvis and abdomen by the gynecological and surgical teams were unremarkable and revealed no acute distress; the abdomen was soft and non-tender on palpation, and bowel sounds were normal in all four quadrants. Notably, there was a significant discrepancy between the symptoms (referred abdominal pain) and the objective clinical findings. An abdominal and pelvic CT scan demonstrated normal post-partum uterus, endometrium and pelvic organs without signs of acute pathology. A large fecal burden throughout the colon was seen, suggesting possible constipation. Subsequently, 60 h after birth, her clinical condition deteriorated as the patient developed tachycardia with 130 beats per minute, tachypnea with 20 breaths per minute, and blood pressure of 103/65 mmHg. Laboratory values included a white blood cell count of 1.5 × 109/L and C-Reactive Protein (CRP) of 27.1 mg/dl and Lactic acid of 4.05 mmol/L. Creatinine, liver-function tests, and electrolytes were within the normal range. Due to a high clinical suspicion of puerperal sepsis at this point, a wide-spectrum antibiotic regime of ampicillin, clindamycin and gentamicin was initiated, and the patient was transferred to the intensive care unit (ICU). Shortly afterward, the patient became hemodynamically and respiratorily unstable and required sedation, mechanical ventilation, and the use of inotropes to maintain adequate blood pressure. Laboratory results revealed worsening leukopenia, thrombocytopenia, and lactic acidosis. A post-contrast computed tomography scan showed an enlarged uterus with abundant periovarian and peritoneal fluid. Since the presence of pus in the abdomen was suspected and due to the severe clinical deterioration, an emergency exploratory laparotomy was executed, during which 600 ml of thick yellowish-white abdominal fluid was aspirated. The uterus and both ovaries were swollen, necrotic, and covered with fibrin, therefore a total abdominal hysterectomy and bilateral salpingo-oophorectomy were performed. Ovarian preservation was not possible because of severe necrosis. Gross findings of the post-operative pathological specimen showed an ischemic and partially necrotic uterus, while microscopic examination of the uterus revealed a severe acute inflammatory process with necrotic myometrium and bacterial colonies, confirmed later to be Streptococcus pyogenes on blood-agar medium culture. Post-operatively, the patient underwent a prolonged recovery period and was discharged without any further obstetrical or gynecological complications (Kabiri D, et al., 2022. Case report: An unusual presentation of puerperal sepsis. Front Med).

 

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.

The most common pathogens that cause maternal sepsis include Streptococcus pyogenes, Escherichia coli, Staphylococcus aureus, Group B Streptococcus, Streptococcus pneumoniae, Methicillin-resistant Staphylococcus aureus (MRSA), Clostridium septicum, and Morganella morganii.

Clinical Presentation: The normal changes of pregnancy complicate identification, and treatment of maternal sepsis. 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 pregnancy-related death in the United States.  Among all pregnancy-related deaths in the U.S., 12.5% are attributed to sepsis (JAMA, 2021). It is estimated that 4 to 10 per 10,000 live births are complicated by maternal sepsis (ACNM, 2018). Rates of pregnancy-associated sepsis are increasing in the U.S., as are rates of sepsis-related maternal deaths.

*Approximately 40% of maternal sepsis cases are preventable with early recognition, early escalation of care, and appropriate antibiotic treatment (Kabiri D. et al. 2022).  

Risk Factors: Risk factors for maternal sepsis include advanced maternal age, preterm premature rupture of the membranes (PPROM) and preterm delivery, multiple gestation pregnancies, cesarean delivery, retained products of conception, post-partum hemorrhage, and maternal comorbidities.  It’s important to note that maternal sepsis occurs in patients without risk factors.

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)

Complications of Maternal Sepsis: Complications include, but are not limited to, maternal death, fetal death (pregnancy loss),  preterm premature rupture of membranes, preterm labor and birth, preterm delivery complications of the newborn, lower newborn weight, cerebral white matter damage, cerebral palsy, and neurodevelopmental delay.

Management Recommendations: Survivability requires early detection, prompt recognition of the source of infection, and targeted therapy.

*Delayed antibiotics > 1 hour = increased mortality

How The American College of Obstetricians and Gynecologists’ (ACOG) Safe Motherhood Initiative (SMI) Sepsis Bundle Reduces Maternal Morbidity: The SMI is a collaborative initiative between ACOG and 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.

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

Kabiri D, Prus D, Alter R, Gordon G, Porat S, Ezra Y. 2022. Case report: An unusual presentation of puerperal sepsis. Front Med 15:9.

P.S. Comment and Share: What is your experience with maternal sepsis?

If you are in need of a medical legal expert specific to a maternal sepsis case, contact Barber Medical Legal Nurse Consulting, LLC. Email: Contact@barbermedicallegalnurse.com

PERINATAL SAFETY: ROLE OF THE JOINT COMMISSION SAFETY STANDARDS

In this blog, I’ll be reviewing the data trends and leading causes of obstetrical (Ob) related malpractice claims.  Additionally, I’ll review identified barriers to adopting evidence-based standards of care while contrasting effective implementation strategies.  I’ll conclude with a summary of the 2020 Joint Commission Perinatal Safety Standards and highlight how the required standards align with the Ob related malpractice trends.   

Trends / Statistics: The average Ob malpractice payment is $947,000 which is more than twice that of other clinical areas (Crico, 2010).  The dollar amount reserved for current and future payment is usually 25% – 35% of the total financial liability cost to the hospital and healthcare system. 

Between 2007-2016, Specific to Ob/Gyns (whose rate is historically higher than the average for all MDs), the risk of having a malpractice case filed against them dropped by 44% (Crico, 2018).

It’s suggested that the drop in claims is a result of quality improvement (QI) initiatives such as training to improve team communication during labor and delivery, and multidisciplinary education on fetal heart rate tracings.

Between 2007-2016, defendant rates declined most steeply in Ob/Gyn.  It’s suggested that the declines correlate with long-term safety interventions (Crico, 2018).

There is a risk of permanent and catastrophic damages that can occur as a result of Ob/Gyn medical errors.  The Ob/Gyn specialty incurs significantly disproportionate financial losses when compared to the total number of medical malpractices cases. 

Most Common Ob Malpractice Claims and Contributing Factors:  The majority of Ob related malpractice cases involve birth asphyxia, shoulder dystocia, intrauterine fetal demise and maternal hemorrhage (AWHONN, 2014).

Contributing Factors:

  • Clinical judgement: inadequate patient assessment, inappropriate management of pregnancy, failure to timely diagnose and treat a non-reassuring fetal heart rate tracing, inappropriate management of the 2nd stage of labor via operative vaginal birth
  • Technical skills: inexperience with procedures
  • Communication: provider-provider communication breakdowns, inadequate consent, hierarchical issues

According to FOJP (Hospital Insurance Company), a growing concern has emerged specific to permanent injuries related to shoulder dystocia cases.  FOJP found that while clinical judgment factors were trending downward in labor & delivery cases, technical issues were trending upward.  The proposed action plan provided was specific to teamwork and simulation training.

It is common knowledge that defensibility is enhanced when care is consistent with current evidence-based standards of care.  Despite this knowledge, many organizations continue to struggle with implementing policies, QI and process improvement (PI) initiatives that are consistent with current standards.

Common Barriers to Adopting Evidence-Based Standards of Care:

Leadership Barriers

  • Lack of knowledge specific to QI/PI and QI/PI data analysis
  • Leadership attitudes
  • Leadership practices: not consistently applying new operations, lack of sustainability efforts, lack of time and resources

Clinician Barriers

  • Lack of clinician knowledge specific to their own practices, lack of audit & feedback processes, novice status, lack of knowledge about QI/PI projects
  • Clinician attitudes: not motivated to change, desires autonomy
  • Clinician practices: forgot about QI/PI project, changes add more work or slow down work flow

Characteristics of the QI, or PI Project

  • Positive or negative effect on clinician income or time
  • Complexity of the QI/PI project

Implementation Climate

  • Type of hospital
  • Amount of resources
  • Type of patients

Strategies for Successful Implementation and Sustainability of Evidence-Based Standards of Care:

Educational strategy: grand rounds, conferences, simulation training, competency tests and demonstrations, on-line learning

Data strategy: audit and feedback methodology to support individual and group data sharing of performance against benchmarks, public release of data focused on outcomes reported openly to the community

Discourse strategy: meetings, review of academic research, reminders via checklists, order sets, newsletters, bulletin boards, emails, rewards for reaching a goal, disciplinary discussions providing feedback specific to performance not aligning with required expectations

How the 2020 Joint Commission Perinatal Safety Standards Align with the Ob Related Malpractice Trends: All hospitals accredited by the Joint Commission are required to comply with the 2020 Joint Commission Perinatal Safety Standards.  The safety standards were developed in response to the leading causes of perinatal morbidity and mortality: maternal hemorrhage and severe hypertension/preeclampsia.

A number of the required elements of performance center around:

  • The development of written evidence-based procedures for managing Ob emergency events (educational and discourse strategy).
  • Providing role-specific education to all staff and providers who treat pregnant and postpartum patients about the organization’s procedures at a minimum every two years (educational strategy).
  • Supporting annual multidisciplinary simulation drills to determine system issues as a part of on-going QI efforts (educational strategy).
  • Completing regular reviews of severe maternal morbidity and mortality cases to evaluate effectiveness of the care, treatment, and services provided by the response team during the event (data strategy).  

Knowledge is power, power is change.  We, as a multidisciplinary group of clinicians, and legal representatives, need to be the change we wish to see by propelling healthcare policies that are consistent with current evidence-based standards. 

References

AWHONN, 2014. Perinatal Nursing 4th ed.

AWHONN, 2021. Perinatal Nursing 5th ed.

Crico, 2010. CBS Benchmarking Report – Medical Malpractice in America

Crico, 2018. CBS Benchmarking Report – Medical Malpractice in America

The Joint Commission, 2019. Provision of Care, Treatment, and Services standards for maternal safety

P.S. Comment and Share: Have you been involved in developing and/or implementing a new perinatal policy, QI, or PI initiative in response to the 2020 Joint Commission Perinatal Safety Standards?  If so, what was the policy/QI/PI initiative and how has it improved outcomes?