Medical errors and improper care of patients are estimated to contribute to as many as 250,000 deaths each year. Critical insight into how, why, and where these incidents occur can be gained from close examination of medical professional liability data. Detailed taxonomy and coding of data can help guide organizational leaders and healthcare providers at all levels to identify key gaps in knowledge, skill, and protocols that may contribute to unfavorable outcomes. In this article, the authors explore how a large database of malpractice cases in the United States is assisting organizations in improving their patient safety programs.
BackgroundPregnancy registries, designed to assess the safety of medications and vaccines for the exposed mother and fetus, have been developed since the 1990s. Malformations present in the exposed liveborn or stillborn infant or fetuses in elective terminations are the outcome of greatest concern. The experiences of the North American AED (antiepileptic drug) Pregnancy Registry (NAAPR) can be used to identify the challenges and limitations of a pregnancy registry in identifying congenital malformations.MethodsThe NAAPR enrolls pregnant women who are taking one or more AEDs for any medical condition, but primarily to prevent seizures, and an unexposed comparison group. Participants are interviewed by clinical research coordinators (CRCs) at enrollment, later in pregnancy and postpartum. Malformations are identified in the mother's reports and her infant's medical records through age 12 weeks. A teratologist, blinded to exposure status, evaluates each potential malformation identified.ResultsAmong 10,982 pregnancies enrolled between 1997 and 2022, 282 malformations were identified in the 9677 AED‐exposed and 15 among the 1305 unexposed infants. Isolated malformations, such as cleft palate, accounted for 84% of the malformations identified. Increased frequencies of oral clefts and myelomeningocele were associated with exposure to several different AEDs. Copies of reports from many diagnostic studies were not obtained and very few pregnancy losses had autopsies.ConclusionsThe evaluation of the AED‐exposed infants in a pregnancy registry is indirect. Improvements rely on the rapport established with the mothers by the CRCs and the mothers’ willingness to assist in obtaining information from her infants’ physicians.
Background:
Clinicians are motivated to provide safe, high-quality care to patients with chronic liver disease. This includes the desire to avoid litigation. Data are limited regarding the actual sources of medicolegal risk in chronic liver disease.
Methods:
We conducted a review of a national liability insurer (Candello) with an additional granular analysis of our institution’s registry of liability claims. We included closed cases involving chronic liver disease-related encounters between 2012 and 2021. We determined rates of legal claims from a denominator of unique patients with cirrhosis or transplant care seen over the study period.
Results:
Local database: We retrieved 39 claims of which 15 involved patients with non-cirrhotic chronic liver disease, 13 involved cirrhosis (0.06% incidence), and 11 involved patients who underwent transplantation (0.6% incidence). Most claims involved periprocedural complications. Others included adverse reactions to prophylactic plasma transfusion, medication-induced HE, and falls/fractures.
National database:
We found 94 claims related to liver disease out of 102,575 (0.09%) total claims. Overall, 56% involved diagnosis-related issues (failure/delay in ordering a diagnostic test, failure to appreciate and reconcile a symptom/sign or result, or the misinterpretation of a diagnostic study). Miscommunication between providers and between providers and patients was implicated in 22% of cases. Patient behavior-related factors (nonadherence with scheduled appointments, treatments, or diagnostic testing) factored in 20% of cases. Selection or the management of therapy played a role in 7% of cases. Very rarely were cases associated with technical skill (4%), house staff supervision (3%), or weekend/holiday care (1%). Fifty-one (55%) claims involved HCC.
Conclusion:
We provide the rates and reasons for medical malpractice claims in hepatology.
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