Establishing the shadowline: the border between legally acceptable and unacceptable standards of surgical practice.

INTRODUCTION: Our study investigated how the standard of surgical care is assessed within the English and Welsh litigation process. The 'shadowline' represents the dividing line between acceptable and unacceptable standards of care. Our hypothesis was that different assessors risk adopting materially different interpretations regarding the acceptable standard of care. Any variation in the interpretation of where the shadowline falls will create uncertainty and unfairness to surgeons and patients alike. METHODS: We summarised the legal literature and suggested the factors affecting the assessment of surgical standards. We illustrated our findings on distribution curves. RESULTS: There was a risk that the shape of the curve and the location of the shadowline may vary according to the assessor. Importantly, a gap may have developed between the legal and clinical shadowlines in respect of the consenting process. DISCUSSION AND CONCLUSION: We suggested how a gap between the surgical and legal shadow lines could be narrowed. Clinical governance, balanced literature and realistic expert assessments were all part of the solution.

Intraoperative injuries from abdominopelvic surgery: an analysis of national medicolegal data.

Background: Intraoperative injuries during abdominopelvic surgery can be associated with substantial patient harm. The objective of this study was to describe abdominopelvic intraoperative injuries and their contributing factors among medicolegal cases. Methods: This study was a descriptive analysis of medicolegal matters reported to a national body, with subgroup analyses by type of surgery. We reviewed medicolegal matters involving a population-based sample of physicians who were subject to a civil legal action or complaint to a regulatory authority that was closed between 2013 and 2017 in Canada. Results: Our analysis included 181 civil legal cases and 88 complaints to a regulatory authority. Among legal cases, 155 patients (85.6%) (median age 47 yr) underwent elective procedures. The most common injury site was the bowel (53 cases [29.3%]). Injuries frequently occurred during dissection (79 [43.6%]) and ligation (38 [21.0%]), were identified postoperatively (138 [76.2%]) and necessitated further surgery (139 [76.8%]). Many patients experienced severe harm (55 [30.4%]) or died (25 [13.8%]). Peer experts in nongynecologic cases were more likely than those in gynecologic cases to include criticisms of a provider in a harmful incident (79 [71.2%] v. 30 [42.9%], p < 0.01). Peer expert criticisms often related to clinical evaluation, decision-making and misidentification of anatomy. Criticisms of nontechnical skills identified documentation and communication deficiencies. Conclusion: This study confirms the importance of provider and team training to improve clinical evaluation and decision-making, documentation and communication. Effective protocols may help support clinicians in providing safer surgical care.

Contexte: Les blessures survenant durant une chirurgie abdominopelvienne peuvent être associées à d'importants préjudices chez les patients. La présente étude avait pour but de décrire les blessures peropératoires abdominopelviennes faisant l'objet d'enquêtes médicolégales et à connaître leurs facteurs contributifs. Méthodes: Cette étude comprend une analyse descriptive d'affaires médicolégales signalées à un organisme de réglementation national, ainsi que des analyses par sousgroupes selon le type de chirurgie. Nous avons examiné des cas impliquant un échantillon de médecins canadiens représentatifs de la population qui avaient fait l'objet d'une poursuite au civil ou d'une plainte auprès d'un organisme de réglementation. Toutes les poursuites et plaintes étudiées ont été résolues entre 2013 et 2017. Résultats: Notre analyse comprenait 181 poursuites au civil et 88 plaintes auprès d'un organisme de réglementation. En ce qui concerne les poursuites au civil, 155 patients (85,6 %) (âge médian 47 ans) avaient subi une intervention non urgente. Les blessures déclarées touchaient généralement les intestins (53 cas [29,3 %]). Elles sont fréquemment survenues durant la dissection (79 cas [43,6 %]) et la ligature (38 cas [21,0 %]), ont été repérées en période postopératoire (138 cas [76,2 %]) et ont nécessité une autre chirurgie (139 cas [76,8 %]). De nombreux patients ont subi de graves préjudices (55 cas [30,4 %]) ou sont décédés (25 cas [13,8 %]). Les pairs experts dans un domaine autre que la gynécologie étaient plus susceptibles que ceux experts en gynécologie de critiquer un fournisseur en cas d'incident avec préjudice (79 cas [71,2 %] c. 30 cas [42,9 %]; p < 0,01). Les critiques formulées par les pairs experts portaient souvent sur l'évaluation clinique, la prise de décision et les erreurs d'identification des structures anatomiques. Les critiques visant les habiletés non techniques avaient trait aux lacunes dans la documentation et la communication. Conclusion: Cette étude vient confirmer l'importance que revêt la formation des fournisseurs et de leur équipe dans l'amélioration de la prise de décision, de la documentation et de la communication. Des protocoles efficaces pourraient soutenir l'offre de soins chirurgicaux sûrs par les professionnels de la santé.

Impact of COVID-19 on procedure volume at a tertiary pediatric hospital.

INTRODUCTION: In March 2020, the COVID-19 pandemic threatened to overwhelm entire healthcare systems. Here we characterize changes in surgical volumes at a regional tertiary pediatric hospital during the early phase of the COVID-19 pandemic. METHODS: Data on all procedures performed during the state-wide ban on elective procedures (March 19th, 2020 to May 18th, 2020) that required anesthesia involvement were collected retrospectively and compared to the same time period in 2019. RESULTS: A total of 5785 procedures were performed: 4005 (69%) in 2019, and 1780 (31%) in 2020, representing a 55% decrease in total cases. The percentage decrease was disproportionate across surgical services. Add-on cases increased from 23% to 39%, and outpatient procedures decreased from 60% to 27%. DISCUSSION: The ban on elective procedures during the COVID-19 pandemic resulted in a significant decrease in the volume of procedures performed at a tertiary pediatric hospital that differed among surgical services.

Monitorización neurofisiológica intraoperatoria en cirugía raquimedular. Aspectos clínicos y médico-legales / Neurophysiological monitoring during spine and spinal cord surgery. Clinical and medico-legal issues

El objetivo de la monitorización neurofisiológica intraoperatoria es la detección de daño o alteración funcional en el sistema nervioso lo más precozmente posible, asegurando la funcionalidad medular, evitando las complicaciones neurológicas. Sin embargo, la falta de estandarización en la metodología, junto con cierta inconsistencia en los estudios sobre su utilidad, limita el establecimiento de unas recomendaciones universales para su utilización. El presente trabajo pretende revisar los procedimientos de monitorización neurofisiológica, sus fortalezas y debilidades, así como la conveniencia de su empleo en cirugía espinal. Concluimos que, con carácter general, su falta de uso en dicha cirugía no contraviene la «lex artis», pues no existe evidencia de que pueda ayudar en revertir el daño neurológico. Sin embargo, puede emplearse como elemento de prueba tanto para detectar el momento y el tipo de daño neurológico como para aumentar la defensibilidad. Se requieren protocolos de uso, bien por las sociedades científicas o por los propios centros hospitalarios

The purpose of neurophysiological monitoring during surgery is to identify damage or functional neurological disturbances as soon as possible, ensuring spinal cord functionality and avoiding neurological complications. However, the lack of standardisation of the methodology, together with some inconsistencies in the studies on its usefulness, limit the establishment of universal recommendations for its use. The present paper intends to review neurophysiological monitoring procedures during surgery, including their strength and weaknesses, as well as to assess the convenience of their use during spinal surgery. It is concluded that, in general, the lack of its use in this surgery does not legally contravene the standard of care, as there is no evidence it could result in reverting neurological damage. Nevertheless, it can be used as evidence both in detecting the time and kind of neurological injury, and for increasing the defensibility. Protocols of use, provided either by scientific societies or hospitals themselves, are required

Legal & ethical dilemmas in incidental findings during surgery: Review article.

BACKGROUND: Discovering IF (incidental findings) during surgery results in ethical and legal dilemmas for the surgeon, especially those in training or recently qualified. The situation is further compounded as these can occur in an emergency. The immediacy of making the correct decision can be paramount for both the surgeon and the patient. METHODS: Firstly, this article will review the ethical and legal frameworks of IF during surgery for those unfamiliar on the literature. Secondly, it will evaluate the use of a proposed IF tool to illustrate the decision-making processes in published case reports for those unfamiliar to the process. After the above two have been completed, a decision-making IF guidance tool will be constructed, which could help educate trainee surgeons. RESULTS: The ethical and legal frameworks include the Hippocratic oath, domestic and European legislation, case law, civil and criminal laws. In the evaluated case reports there were IF which were either life-threatening or affecting the immediate life of the patients. 90% of the cases were emergency and 10% were elective operations. Using the proposed IF tool and combining it with peer-reviewed published best practice, 60% of the cases were correct in their intra-operative decision-making. This demonstrates the need of some type of guidance on the subject. As a consequence of these results, the article describes the construction of an IF decision-making guidance tool. The essential components of the guidance tool involve decision-making, the inference from other medical fields, ethical and legal elements, the available experience, skills and specialist knowledge at the time, best clinical practice and post-operative management and counselling. CONCLUSIONS: On finding an IF during surgery, the surgeon must balance the ethical dilemmas of autonomy, beneficence, justice, and non-maleficence for the patient. This is further complicated by applying these principals to current civil and criminal laws. By constructing an IF guidance tool may assist in improving patient safety and help the trainee and newly qualified surgeon and his team to come to the correct decisions in the best interests of the patient.

Litigation involving pediatric surgical conditions.

PURPOSE: Malpractice litigation among pediatric surgeons is a subject of concern and interest, but minimal factual data are known. Our goal was to investigate national litigation trends regarding pediatric surgical conditions. METHODS: We queried WestlawNext database for malpractice cases involving pediatric (age ≤ 18) surgical conditions. Cases were included if they named a care provider or health center. We gathered data on diagnoses, procedures, care providers, allegations, location, and outcomes. RESULTS: Our search revealed 4754 cases, and 170 met inclusion criteria. These ranged from 1965 to 2017 and represented 40 states. 110 cases involved a surgeon (41% pediatric surgeons). Appendicitis was the most common diagnosis identified. Cases frequently involved delayed/missed diagnoses or interventions (45.9%), technical concerns (35.9%), mortalities (26.5%), negligent perioperative care (23.6%), and informed consent concerns (4.7%). Technical complication was the most common allegation against surgeons (49.1%), and nonsurgeon cases typically involved a delayed/missed diagnosis (78.3%). 39% of cases resulted in favor of the defendant, 35% plaintiff, and 14% had a split verdict. CONCLUSION: Litigation involving pediatric surgical conditions is diverse, but appendicitis and circumcision comprise almost a third of cases. A greater understanding of these trends can help steer efforts in quality and safety as well as guide improved communication with families. LEVEL OF EVIDENCE: N/A.

Surgical smoke: articulating the problem.

This six-part series focuses on surgical smoke evacuation legislation and policy. It provides answers to important frequently asked questions (FAQs) about surgical smoke from policymakers and people not working in perioperative services and suggests resources and tools to help you become a strong advocate for surgical smoke evacuation. The FAQs and legislative checklists that will be shared will cover the basics of surgical smoke and its harmful effects, strategies and solutions for eradicating surgical smoke in the OR, the role of regulatory agencies, and how to lay the groundwork for successful state legislation on your own and in tandem with AORN's Government Affairs Department.

An Interdisciplinary Review of Surgical Data Recording Technology Features and Legal Considerations.

Surgical data recording technology has great promise to generate patient safety and quality data that can be utilized to potentially reduce medical errors. Variations of these systems aim to improve surgical technique, develop better training simulation, and promote adverse event investigation similar to the aims of black box technology utilized in other industries. However, many unknowns remain for surgical data recording utilization in operating rooms and clinical settings in the United States. This includes the need to appropriately design systems so they collect meaningful and useful data that can be discussed by surgical team members in an open and safe environment to optimize clinical care processes. In order to better understand the clinical and regulatory environment for surgical data recording systems, we conducted an interdisciplinary review to identify key technology approaches, and assess legal and regulatory implications associated with this potentially disruptive technology. We found technology ranging from audio and visual data, to systems utilizing mobile applications, and kinematic data capture. The data collected present legal questions over ownership of information and privacy, along with regulatory issues at the federal and state levels. The benefits of these data should be balanced with the need to develop appropriate policies and regulations that protect the interests of both clinicians and patients in order to encourage further innovation and better realize the potential of surgical data recording technology to improve clinical decision making and patient safety outcomes.

Nigerian laws on informed consent before a surgical procedure.

Informed consent is a process of communication between a clinician and a patient, which results in the patient's agreement to undergo a medical procedure. Rule 19 Part A: Code of Medical Ethics of Nigeria and Section 23 of the National Health Act 2004 prescribe the process of obtaining consent before a medical intervention. The equitable law of torts and/or criminal liabilities that deal with medical negligence should be invoked more often by patients whose right to informed consent is denied by medical practitioners.

Patients' informed consent to medical services in Georgia.

Informed consent requires that a patient understands the purpose, benefits and potential risks of a medical or surgical intervention and then agrees to it. It is important not only ethically and legally but for the effectiveness of care. Studies show that, in some cases, patients have no real information on the medical service to be provided so their informed consent is just a formality. This study aims to determine problems arising from a patient's informed consent. As part of a cross-sectional study, surgical patients were interviewed using a semi-structured questionnaire. 34% of patients (n = 68) did not know what the surgical intervention was; 57% (n = 114) received sufficient information on their diagnosis and methods of treatment; however, 26% (n = 52) agreed with it only partially; 62% (n = 124) of patients knew they needed surgery; 66% (n = 132) were adequately informed on risks and benefits of alternative ways of treatment; 58% (n = 116) were informed of potential risks during surgery. The study demonstrated patients need to be better informed about different treatment options, consequences of treatment refusal. Doctors have to provide information to patients in a manner understandable to them. Medical personnel need to be educated as to what constitutes informed consent and the importance of adhering to such requirements.

Analysis of malpractice claims: The Franco-Belgian "Cœlio Club" experience.

Malpractice claims are a regularly increasing concern in gastrointestinal surgery. The goal of this study was to compare the current status of claims in two different French-speaking communities by a retrospective descriptive study of surgeons' experiences, from the beginning of their practice up until December 31 2014. Data included the number, the reasons, and the results of medicolegal claims and their jurisdictions. Forty-three surgeons participated in this study. Two hundred medicolegal claims were analyzed. The mean number was 5.8 per surgeon. Bariatric surgery, colorectal surgery and parietal surgery were the most exposed. Forty-six (23%) faults were noted, while no fault was pronounced in 139 (69.5%) cases. The main reasons for lodging complaints were nosocomial infections, anastomotic leaks, poor postoperative care, hollow organ perforation, peripheral neurologic complication, and insufficient preoperative information. Forty-four percent of the complaints were analyzed by the conciliation and compensation commissions and 43.5% by the High Court. In the French-speaking group, there were 13 complaints, two of which gave rise to compensation. French surgeons are highly exposed to complaints: in French law, clumsiness or technical maladdress is considered as a fault. The patient should be informed preoperatively of all possible severe risks of a medical procedure. In Belgium, complications are exceptional and are considered random therapeutic events. Adhering to the recommendations emanating from the French High Authority of Health and Learned Societies as well as accreditation issued by the same High Authority should allow to decrease the number of undesirable events related to care and malpractice.

Regulation of Surgical Procedures and Health Care Facilities Rankings in Nepal.

Globally, millions of surgeries are performed each year to compliment and manage a diverse set of medical conditions. Adverse surgical outcomes constitute a major proportion of avoidable death and disabilities in the hospital, especially in low-income countries like Nepal. A comprehensive study on the standards of surgical procedures and its institutional regulations is missing. We discuss here the importance of surgical regulation based on it's financial as well as healthcare implications in the Nepalese healthcare system. Keywords: health care facilities; safety; surgery; surgical procedures; WHO.

Impact of the Affordable Care Act on trauma and emergency general surgery: An Eastern Association for the Surgery of Trauma systematic review and meta-analysis.

BACKGROUND: Trauma and emergency general surgery (EGS) patients who are uninsured have worse outcomes as compared with insured patients. Partially modeled after the 2006 Massachusetts Healthcare Reform (MHR), the Patient Protection and Affordable Care Act was passed in 2010 with the goal of expanding health insurance coverage, primarily through state-based Medicaid expansion (ME). We evaluated the impact of ME and MHR on outcomes for trauma patients, EGS patients, and trauma systems. METHODS: This study was approved by the Eastern Association for the Surgery of Trauma Guidelines Committee. Using Grading of Recommendations Assessment, Development and Evaluation methodology, we defined three populations of interest (trauma patients, EGS patients, and trauma systems) and identified the critical outcomes (mortality, access to care, change in insurance status, reimbursement, funding). We performed a systematic review of the literature. Random effect meta-analyses and meta-regression analyses were calculated for outcomes with sufficient data. RESULTS: From 4,593 citations, we found 18 studies addressing all seven predefined outcomes of interest for trauma patients, three studies addressing six of seven outcomes for EGS patients, and three studies addressing three of eight outcomes for trauma systems. On meta-analysis, trauma patients were less likely to be uninsured after ME or MHR (odds ratio, 0.49; 95% confidence interval, 0.37-0.66). These coverage expansion policies were not associated with a change in the odds of inpatient mortality for trauma (odds ratio, 0.96; 95% confidence interval, 0.88-1.05). Emergency general surgery patients also experienced a significant insurance coverage gains and no change in inpatient mortality. Insurance expansion was often associated with increased access to postacute care at discharge. The evidence for trauma systems was heterogeneous. CONCLUSION: Given the evidence quality, we conditionally recommend ME/MHR to improve insurance coverage and access to postacute care for trauma and EGS patients. We have no specific recommendation with respect to the impact of ME/MHR on trauma systems. Additional research into these questions is needed. LEVEL OF EVIDENCE: Review, Economic/Decision, level III.

Legal perspectives on black box recording devices in the operating environment.

BACKGROUND: A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review. METHODS: A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre. RESULTS: After removing duplicates, 116 citations were retrieved and abstracts screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record. CONCLUSION: Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.

ANTECEDENTES: Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico. MÉTODOS: Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano. RESULTADOS: Se obtuvieron 116 referencias, de las que una vez eliminadas las duplicadas (n = 5) y revisados los resumenes, 31 artículos cumplían los criterios de eligibilidad. En el estudio final se incluyeron 20 artículos. De acuerdo con la Ley Orgánica de Protección de Datos (General Data Protection Regulation, GDRP) y la Ley de Transferencia y Responsabilidad de Seguro Médico (Health Insurance Portability and Accountability Act, HIPAA), los investigadores deben asegurar que los datos personales recopilados pertenecientes a los pacientes y profesionales de la salud se utilicen de manera justa y legal, con fines definidos y bien establecidos, de manera adecuada y relevante, y mantenidos a resguardo y almacenados no más tiempo del estrictamente necesario. No es necesario que los datos recopilados con el único propósito de mejorar la calidad de la atención médica se agreguen a la historia clínica del paciente. CONCLUSIÓN: Se debe asegurar por parte del personal sanitario como del paciente, la transparencia tanto en la utilización como en el objetivo de los datos almacenados. Los datos registrados en video no es necesario que sean usados como evidencia en procesos judiciales si la historia clínica de los pacientes cumple los estandares establecidos. Se precisa una legislación clara sobre la responsabilidad de los datos para la utilización óptima de los registros médicos en las iniciativas de mejora de la calidad.

Regulation on introducing process of the highly difficult new medical technologies: A survey on the current status of practice guidelines in Japan and overseas.

Since serious problematic cases regarding the technical safety of technically demanding operations were reported in Japan, the Ministry of Health, Labor and Welfare issued new regulations on June 10, 2016 requiring each hospital to check the status of informed consent, skill of surgery team and governance system of the surgical unit, when the highly difficult new medical technologies were introduced to a hospital. In order to firmly establish this new system for highly difficult new medical technologies, it is very important and informative to survey the current situation for guidelines and consensus regarding introduction of medical technology with special skills in Japan and overseas. Based on the survey of questionnaires, document retrieval, and expert interviews, we found that documentation related to the introduction process of highly difficult medical technologies is very rare, and the regulations were mainly issued by academic societies. Moreover, even if such documentation existed, the quality of the regulations is poor and not sufficient enough to perform surgical practice safely. Therefore, for medical practitioners, comprehensive and concrete regulations should be issued by the government or ministry to legally follow in regard to technically demanding operations. A new practice guideline was proposed by our special research group to regulate the introduction process of highly difficult new medical technologies in hospitals in Japan. This guideline, gained understanding from relevant academic societies, provided a comprehensive view on the interpretation of "high difficulty new medical technology" prescribed by the law and show the basic idea at a preliminary examination from the viewpoints of "Surgeon's requirement", "Guidance system", "Medical safety" , and "Informed consent". These efforts will contribute to the improvement of the quality of guidelines regarding "highly difficult new medical technology".

Proceedings From the Society for Advancement of Blood Management Annual Meeting 2017: Management Dilemmas of the Surgical Patient-When Blood Is Not an Option.

Vigilance is essential in the perioperative period. When blood is not an option for the patient, especially in a procedure/surgery that normally holds a risk for blood transfusion, complexity is added to the management. Current technology and knowledge has made avoidance of blood transfusion a realistic option but it does require a concerted patient-centered effort from the perioperative team. In this article, we provide suggestions for a successful, safe, and bloodless journey for patients. The approaches include preoperative optimization as well as intraoperative and postoperative techniques to reduce blood loss, and also introduces current innovative substitutes for transfusions. This article also assists in considering and maneuvering through the legal and ethical systems to respect patients' beliefs and ensuring their safety.

The Price of Medical Tourism: The Legal Implications of Surgery Abroad.

Medical tourism, or traveling abroad to obtain medical services, has evolved into a global health care phenomenon, with over 15 million U.S. patients each year seeking medical care internationally, representing a $50 billion dollar industry in 2017. Speculation and media fascination about the growing industry, diverse destinations, and rationale behind the medical tourists is rampant; however, the legal implications of tourism medicine, particularly when it goes wrong, are often unclear. On the international stage, accreditation agencies are limited in scope and practice, legal jurisdiction is difficult to establish, and the enforcement of rulings is nearly impossible. Patients seeking tourism medicine have little legal recourse and shoulder all the legal burden.