Guiding Principles for Surgical Pathways: A Tool for Improving Outcomes and Patient Safety.

Surgical activity is an important aspect for the management of health and safety processes and from an organizational perspective is one of the most complex activities performed in hospitals. It is often a defining and high value feature for any healthcare facility while being one of the most high-risk procedures for patients with the highest number of avoidable adverse events. To ensure effective management of surgical pathways, they need to be considered from the perspective of clinical governance which takes a global approach to planning and management with the goal of improving safety and quality for patients. This paper contains the main features of this objective outlined within the document issued subsequent to the State-Regional Italian Government conference. This regulatory effort includes effective recommendations to make surgical pathways safer and more efficient with particular reference to lean management, patient blood management and patient safety.

Pharmacological Abortion in a Pandemic: An Italian Medico-Legal Perspective.

The limitations caused by the spread of the SARS-CoV2 virus have had repercussions on the voluntary termination of pregnancy. During the pandemic, Italy issued updated guidelines regarding voluntary termination of pregnancy by means of mifepristone and prostaglandin. This included news concerning the time limit and location in which this procedure could be accessed: updates partially recognize women's needs, and they are into line with the European parliament's recent exhortations. However, these updates do not change the previously provided responsibilities that lie with doctors. This article aimed to compare regulations concerning medical abortion in Italy and other countries, with a focus on recent Italian updates in the context of pandemic.

Organizational Strategies for the Management of Intravenous Iron Therapy in Non-Hospitalized Settings: A Safe Opportunity to Implement Patient Blood Management in Italy.

This article analyzes the recommendations issued by the Emilia Romagna region in July 2020 on "Organizational strategies for the safe management of intravenous iron therapy in patients in non-hospitalized settings". The objective of these recommendations is to set up safe intravenous iron administration sites outside the hospital environment across the national territory. The document facilitates the organization of methods for intravenous iron infusion that are safe for the patient and correct from a medico-legal perspective. In addition, it opens the way for the widespread use of iron infusion in the field, providing benefits to patient quality of life. This program prevents unnecessary transfusions, reduces costs, prevents overcrowding in hospitals in the event of a pandemic, and enables patient treatment in the field, thus, saving on the use of personnel.

COVID-19 Pandemic and Equal Access to Vaccines.

The COVID-19 pandemic has evidenced the chronic inequality that exists between populations and communities as regards global healthcare. Vaccination, an appropriate tool for the prevention of infection, should be guaranteed by means of proportionate interventions to defeat such inequality in populations and communities affected by a higher risk of infection. Equitable criteria of justice should be identified and applied with respect to access to vaccination and to the order in which it should be administered. This article analyzes, as regards the worldwide distribution of anti-COVID-19 vaccines, the various ways the principle of equity has been construed and applied or even overlooked. The main obstacle to equal access to vaccines is vaccine nationalism. The perception of equity varies with the differing reference values adopted. Adequate response to needs appears to be the principal rule for achieving the criterion of equity in line with distributive justice. Priorities must be set equitably based on rational parameters in accordance with current needs. The entire process must be governed by transparency, from parameter identification to implementation. The issue of equal access to vaccination affects the entire world population, necessitating specific protective interventions. In light of this, the World Health Organization (WHO) has devised the COVAX plan to ensure that even the poorest nations of the world receive the vaccine; certain initiatives are also supported by the European Union (EU). This pandemic has brought to the fore the need to build a culture of equitable relationships both in each country's own domain and with the rest of the world.

The Difficult Balance between Ensuring the Right of Nursing Home Residents to Communication and Their Safety.

The COVID-19 epidemic has had a profound impact on healthcare systems worldwide. The number of infections in nursing homes for the elderly particularly is significantly high, with a high mortality rate as a result. In order to contain infection risks for both residents and employees of such facilities, the Italian government passed emergency legislation during the initial stages of the pandemic to restrict outside visitor access. On 30 November 2020, the Italian President of the Council of Ministers issued a new decree recognizing the social and emotional value of visits to patients from family and friends. In addition, it indicated prevention measures for the purposes of containing the infection risk within nursing homes for the elderly. This article comments on these new legislative provisions from the medicolegal perspective, providing indications that can be used in clinical practice.

Physician autonomy and patient rights: lessons from an enforced blood transfusion and the role of patient blood management.

This article provides an ethical and medico-legal analysis of ruling no. 465 of 30 May 2018 issued by the Court of Termini Imerese (Palermo) and confirmed on appeal on 11 November 2020, which, in the absence of similar historical precedents in Europe, convicted a medical doctor of a crime of violent assault for having ordered the administration of a blood transfusion to a patient specifically declining blood transfusion on religious grounds. We analyse the Court's decision regarding the identification of assault in performing the blood transfusion and its decision not to accept exculpatory urgent 'necessity' as a defence. In addition, we present an updated revision of the current standard of care in transfusion medicine as well as the ethical principles governing the patient's declining of transfusion. In doing so, we highlight that respect for the patient's self-determination in declining transfusions and respect for the professional autonomy of the doctor protecting the safety and life of the patient could be equally satisfied by applying the current peer-reviewed evidence.

Proposal for the Application of a Quality Indicator to Medico-legal Consultations in the Field of Medical Liability.

INTRODUCTION: In recent decades, the number of professional liability disputes has increased, especially in the civil sector. In these liability assessments, medico-legal experts have become the linchpin. Law No. 24/2017, concerning professional liability in Italy, requires that guidelines and best practices be established to identify the necessary elements for writing expert reports in the legal sector. MATERIALS AND METHODS: The authors have created a numerical indicator to be applied to 150 legal expert reports on professional liability, enabling them to evaluate the methodological quality of those reports. The results are then compared with the outcome of the legal proceedings in order to establish the suitability of this quality index for evaluating the work of medico-legal experts. RESULTS: Of the 150 reports considered, 14 were scored inadequate, 75 adequate and 31 good. These inadequate (according to the indicator) reports presented a higher probability of being scored inadequate in court proceedings, compared to the risk of inadequacy of all the reports; OR 4.6 (95% CI 1.25-16.90). This probability significantly increased on comparing the inadequate reports with the adequate; OR 5.6 (95% CI 1.28-24.41), and the inadequate with the good; OR 7.73 (95% CI 1.50- 39.87). DISCUSSION: Application of the proposed indicator is simple and produces a high-quality result, thus ensuring an accurate and tenable appraisal of methodological quality. CONCLUSION: The indicator proposed serves as a useful starting point for creating the necessary methodological standards for medico-legal experts in the field of professional liability as recommended by Law No. 24/2017.

The Motion of the Italian National Bioethics Committee on Aggressive Treatment towards Children with Limited Life Expectancy.

The motion of the Italian National Bioethics Committee entitled "Aggressive treatment or therapeutic obstinacy on young children with limited life expectancy" comprises a premise that rejects therapeutic obstinacy and makes 12 recommendations. Recommendation no. 1 states the general rules: it ascribes a cardinal role to a shared care plan, it supports pain management therapy and pain relief, it opposes ineffective and disproportionate clinical treatment and defensive medicine. The other recommendations are correlated to the enacting of a national law establishing clinical ethics committees in paediatric hospitals; participation of parents and their fiduciaries in the decision-making processes; recourse to courts only as extrema ratio in the event of irremediable disagreement between the medical team and the family members; accompaniment at the end of life also through continuous deep sedation combined with pain therapy; access to palliative care; the need to reinforce research on pain and suffering in children; clinical trials and research studies conducted in children; the training of doctors, healthcare personnel and psychologists, to support parents in emotional and practical terms; the facilitation of the closeness of parents to children in extremely precarious clinical conditions; the relevant role of the associations of parents of sick children. Comments are made, in particular, about the innovative recommendations respectively relating to the adoption of care planning, the establishment, by law, of clinical ethics committees in paediatric hospitals and the limitation of recourse to courts-only as extrema ratio-in the event of irremediable disagreement between the medical team and the family members.

Risk Management in the New Frontier of Professional Liability for Nosocomial Infection: Review of the Literature on Mycobacterium Chimaera.

Background: Mycobacterium chimaera (MC) is of recent origin and belongs to the large family of non-tuberculous mycobacteria. In recent years, it has shown a high infectious capacity via the aerosol produced by operating room equipment, such as heater-cooler units (HCU). The infection has a long latent period and high mortality rate. Genetic and epidemiological studies have shown that there is a clear link between the infection and a specific HCU model manufactured by LivaNova/Sorin. There is, therefore, a strong possibility that contamination occurs during device construction. The objective of this article is to describe the characteristics of this particular infection in view of the medico-legal implications on professional liability, specifically focusing on current evidence regarding contamination prevention. Methods: we have analyzed the clinical characteristics and data from the autopsic investigations performed on a patient who died as a result of MC infection, in addition to analyzing all pertinent recommendation documents available internationally. We searched for all articles in the literature available on MEDLINE between 1995 and 30 July 2020, using the search words "Mycobacterium chimaera". We then analyzed those articles and reported only those that provide useful information regarding prevention techniques for containing dissemination and contamination. Results: the literature review produced 169 results that highlight the need to develop systems to mitigate and eliminate the risk of MC infection in operating rooms such as physical containment measures, e.g. device replacement, use of safe water, providing patients with information, and training healthcare professionals. Conclusions: from a medico-legal viewpoint, this particular situation represents a new frontier of professional liability, which includes manufacturers of electromedical equipment. In order to comprehend the true extent of this silent global epidemic, the development of an organic, preventative monitoring system is essential.

Is the Italian consent to transfusion really informed? A medico-legal analysis between old ghosts and new evidence.

In healthcare systems of developed countries, obtaining informed consent is a necessary and fundamental requirement for the administration of any medical treatment. In Italy, for the administration of the recipient's informed consent for a blood transfusion, a pre-printed form is used in line with the Decree of the Ministry of Health dated 2 November 2015. This paper aims to analyse this form in light of the European legal provisions and following the enactment of Italian Law No. 219 of 2017 on informed consent and advance treatment directives. Our review shows that the structure of the form can be improved in light of the new direction provided by Italian law, the scientific advancement on transfusion risks, and the potential to reduce the use of blood components. Revising this form could be the opportune time to include written information on Patient Blood Management strategies. Though not exhaustive, this proposal may stimulate debate on the point and produce further contributions.

Patient blood management: The best approach to transfusion medicine risk management.

In advanced health systems it is increasingly important to offer effective medical services that have high quality and safety standards. We present an overview of the direct hazards and the indirect hazards associated with blood transfusions. Our aim is to focus on the potential medico-legal impacts of these hazards in the context of clinical risk management, incorporating the accumulating evidence from Patient Blood Management programs. The direct or deterministic hazards of transfusion refer to scenarios where the mechanisms for post transfusion damage are clearly traceable to the blood transfused in a 1:1 cause and effect manner. The indirect hazards can be defined as probabilistic and are associated with transfusion through epidemiological studies. The implementation of Patient Blood Management programs demonstrates that the use of a blood transfusion is not always necessary or unavoidable but can be considered modifiable. Review of the literature confirms that transfusion should not be the default option to manage anemia or blood loss. Instead, accumulating evidence demonstrates that a patient-centred, proactive approach to managing a patient's own blood is the new standard of care. It thus follows, an adverse transfusion event, where the transfusion was avoidable through the application of patient blood management, may constitute a profile for medical professional medical negligence. In an effort to maximise patient safety, transfusion medicine practice culture needs to shift towards a patient blood management approach, with hospitals implementing it as an important tool to minimize the risks of allogeneic blood transfusion.

Patient blood management implementation in light of new Italian laws on patient's safety.

The present work aims to analyze the impact - from legal and medical perspective - of the recent Italian legislative provisions on the subject of healthcare safety, and how these affect current transfusion practices, also in light of the accumulation of evidence deriving from the implementation of the Patient Blood Management (PBM) program. The scientific evidence shows that PBM is a bundle of care that improves patient outcomes including mortality and morbidity, improves the quality of life of patients and the population, reduces healthcare costs and decreases consumption of blood components. These aspects should be largely sufficient to carry out an urgent implementation of PBM in Italian hospitals. However, it is now also possible to indicate a further incentive for implementation which is made up of medico-legal aspects and is characterized by the need to decrease the intrinsic risks of the use of blood products so as to protect doctors and hospitals from possible future medico-legal disputes regarding adverse transfusion events that could be effectively avoided.

[Ethical, deontologic and legal considerations about SIAARTI Document "Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances".] / Considerazioni etiche, deontologiche e giuridiche sul Documento SIAARTI "Raccomandazioni di etica clinica per l'ammissione a trattamenti intensivi e per la loro sospensione, in condizioni eccezionali di squilibrio tra necessità e risorse disponibili".

On 6 March 2020, the Italian Society of Anaesthesia Analgesia Resuscitation and Intensive care (SIAARTI) published the document "Clinical Ethics Recommendations for Admission to and Suspension of Intensive Care in Exceptional Conditions of Imbalance between Needs and Available Resources". The document, which aims to propose treatment decision-making criteria in the face of exceptional imbalances between health needs and available resources, has produced strong reactions, within the medical-scientific community, in the academic world, and in the media. In the current context of international public health emergency caused by the CoViD-19 epidemic, this work aims to explain the ethical, deontological and legal bases of the SIAARTI Document and to propose methodologic and argumentative integrations that are useful for understanding and placing in context the decision-making criteria proposed. The working group that contributed to the drafting of this paper agrees that it is appropriate that healthcare personnel, who is particularly committed to taking care of those who are currently in need of intensive or sub-intensive care, should benefit from clear operational indications that are useful to orient care and, at the same time, that the population should know in advance which criteria will guide the tragic choices that may fall on each one of us. This contribution therefore firstly reflects on the appropriateness of the SIAARTI standpoint and the objectives of the SIAARTI Document. It then turns to demonstrate how the recommendations it proposes can be framed within a shared interdisciplinary, ethical, deontological and legal perspective.

The clinical legal medicine: a need for quality of care and patient's safety. A single center five-year experience.

INTRODUCTION: Clinical legal medicine is a branch of legal medicine that takes place in a clinical setting approaching the patient's bedside and using a particular attention not only for conceptual or normative references but also for every possible medical and social aspect. MATERIAL AND METHODS: The requests of medico-legal opinions received by the Department of Legal Medicine of a large university hospital were retrospectively collected over a 5-years period. The analysis focused on the recurrence rate of the requests and the most common medico-legal issues to be solved in a clinical context, differentiating between adult and minor patients. RESULTS: The collected medico-legal advices amounted to 448. The most clearly involved clinical area was Medicine (54%) followed by Gynecology and Obstetrics (15.6%), Pediatrics and Surgery (10.7%). The requests concerning patient's self-determination in therapeutics choices, including refusal of proposed treatments, covered almost one-half of total casuistry. The designation of support administrator represented also a relevant issue (20.5%). In case of minors, the queries related to reporting crimes were three times higher than in adults, while the appointment of a support administrator was never requested. CONCLUSION: Clinical legal medicine, through medico-legal advices, plays a primary role in contributing to the safeguarding of health and to the decision-making process of clinicians.

Shared care plan: an extraordinary tool for the personalization of medicine and respect for self-determination.

BACKGROUND: On 22 December 2017, Law No. 219 was approved in Italy. This law provides citizens with effective tools with which to express healthcare decisions: namely, advance treatment directives (ATD) and shared care plans (SCP). METHODS: This article presents an analysis of 70 SCP cases carried out in a tertiary hospital in Italy during the period between 01.02.2018 and 29.02.2020 inclusive. RESULTS: In 90% of cases, the objective of the plan pertained to situations regarding patients' refusal of transfusions of blood components, the majority (97%) due to their belonging to the religious movement of Jehovah's Witnesses. 46% of the sample had drafted ATDs. The course of treatment recommended by the attending physicians was confirmed in 93% of the SCP cases. Trustees were appointed in 96% of cases. In 55% of cases, patients assigned trustees with attestative functions and the remaining 45% with creative functions. The results demonstrate that each patient personally dictates his or her wishes and the role assigned to the trustee. SCP meetings serve as a useful tool for providing the patient and his or her relatives with information, and for appointing a trustee. However, it has never been necessary to solicit the intervention of the trustee following a surgical operation. CONCLUSIONS: The SCP has proven to be an essential tool in achieving the objective of personalised medicine. However, there is still notable passivity in its application. Further effort is required in order for it to become a common asset in clinical practice.

The contribution of legal medicine in clinical risk management.

BACKGROUND: In advanced health services, a main objective is to promote the culture of safety and clinical risk management. In this regard, the reporting of sentinel events fits within a perspective of error analysis, attempting to propose solutions aimed at preventing a new occurrence of the harmful event. The purpose of this study is to analyze the contribution of medico-legal litigation in the management of clinical risk and to propose an organizational model so as to coordinate the intervention of clinical risk management and medico-legal services. METHODS: Retrospective review of 206 cases of medico-legal litigation, settled against a Hospital of a North-eastern city in Italy from January 1, 2014 and December 31, 2015. RESULTS: Approximately 20% of cases, that are classifiable as "sentinel events", were not reported due to various factors. The reason that these events are under-reported is mainly due to the latency between the event itself and its manifestation as a serious damage to health as well as the discomfort in reporting the events of this kind, which is still widespread among healthcare workers. The systematic research of the available documentation for medico-legal purposes permits the acquisition of more information concerning the clinical event, thereby increasing the number and accuracy of the reports to the clinical risk unit. CONCLUSION: The analysis of medico-legal litigation is a valid tool to enhance the reporting of "sentinel events". One possible proposal is the implementation of an organizational model to establish a rapid procedure for the reporting of sentinel events during the evaluation of medico-legal litigations.

Certification ISO 9001 in clinical ethics consultation for improving quality and safety in healthcare.

This paper refers to the quality management process of the Laboratory of Clinical Bioethics (LCB) of the University of Padua (Italy), which has obtained the quality certification to ISO 9001:2008, as a Clinical Ethics Support Service. Its activities consist mainly in clinical ethics consultations and training services, addressed to those who are called to decisions with ethical implications in the clinical setting, proposing a structured approach to identify and analyze the ethical issues that may loom in the relationships between health professionals and patients, and participating in their solution. The expected benefits of the application of ISO 9001 were mainly the following: to formalize the procedure adopted for clinical ethics consultation and training, to obtain a controlled management of documents, information and data, to ensure and demonstrate the quality of the provided activities and to make methods and organization publicly available. The main results which have been achieved with the 'quality management project' are summarized as follows: the enunciation of LCB Mission and Quality Policy; the drafting of the procedure by which clinical ethics consultation is provided; the formalization of members' skills and the adoption of relevant process and outcome indicators. Our experience may be useful in promoting accountability for the quality of ethics consultation services. We consider the certification process as a tool for transparent and reliable management of one of the most critical tasks in the current context of healthcare, motivating similar facilities to undertake similar pathways, with the aim to provide quality control on their activities.

Disabling Outcomes After Peripheral Vascular Catheter Insertion in a Newborn Patient: A Case of Medical Liability?

BACKGROUND The positioning of peripheral venous catheters (PVC) is an invasive procedure commonly performed in pediatrics hospital wards to obtain vascular access for the administration of fluids, medications and other intravenous (IV) therapies. Many studies exist about management of peripheral venous access in adults. On the contrary, scientific evidence on the management of this procedure in children and newborns, especially regarding the optimal duration of infusion and the possible related side effects, is still poor. To minimize the risk of phlebitis, the guidelines of the US Centers for Disease Control and Prevention suggest the replacement of the catheter every 72-96 hours in adult patients, while in pediatric patients the catheter can remain in place for the entire duration of the IV therapy, unless complications arise. CASE REPORT In the presented case, after the positioning of a PVC in a newborn, no clear signs/symptoms of phlebitis were registered before the sixth day and, despite the immediate removal of the catheter, the thrombotic process, secondary to phlebitis, was already occurring, causing serious and permanent disabling outcomes, susceptible to legal medical evaluation and financial compensation. CONCLUSIONS The knowledge of this case is particularly interesting to clinicians working in the field of neonatal care and to clinical risk management services inside hospital structures, since similar cases may be the source of requests for extremely high financial compensations due to medical liability.

Delayed diagnosis of Wernicke encephalopathy with irreversible neural damage after subtotal gastrectomy for gastric cancer: A case of medical liability?

INTRODUCTION: Wernicke's encephalopathy (WE) is a neurological syndrome caused by thiamine deficiency, and clinically characterized by ophthalmoplegia, ataxia and acute confusion. In developed countries, most cases of WE have been seen in alcohol misusers. Other reported causes are gastrointestinal tract surgery, hyperemesis gravidarum, chronic malnutrition, prolonged total parenteral nutrition without thiamine supplementation, and increased nutrient requirements as in trauma or septic shock. WE is a well-known postoperative complication of gastric restrictive surgery for morbid obesity, after which patients often experience protracted nausea and vomiting, leading to malnutrition and massive weight loss. PRESENTATION OF CASE: This case report concerns WE occurring in a patient who underwent Roux-en-Y subtotal gastrectomy for gastric cancer, and subsequently experienced neurological symptoms that proved irreversible probably due to the lengthy time elapsing between their clinical presentation and the diagnosis of WE. DISCUSSION: There have been some reports of WE occurring after total or subtotal gastrectomy for gastric cancer in non-obese patients with no history of alcoholism, but monitoring for WE has yet to be recommended in the clinical guidelines in this setting (as it has for bariatric surgery). Because of its rarity and variable clinical presentation, WE is often under-diagnosed and under-treated, and confused with other neurological problems. CONCLUSION: There is an urgent need for the specific guidelines to take into account not only the neoplastic follow-up of such patients, but also the possible side effects of necessary surgery, since this could help to ensure the timely diagnosis and management of WE in this setting, and to avoid, when possible, claims for medical malpractice that may cause enormous costs both in economical and professional terms.

An unusual case of chronic cough: Professional liability in dentistry?

Foreign body aspiration (FBA) is a serious medical problem, also in dental practice. The case report describes the case of a patient who for 12 years has suffered from chronic cough as a result of the aspiration of a polymeric silicone resin fragment during a dental procedure. In November 2002, the patient was underwent dental care, and she points out that, when performing dental imprint, she had sensed that something "went down in the throat" but she was immediately reassured by the dentist. After lung CT was performed, the foreign body was identified and removed with benefit to the patient. The knowledge of this case report could be useful for dentists who perform dental impressions, to be aware of the fact that the material used is radiolucent e.g. cannot be seen on plan radiographs and it can be accidentally inhaled by the patient. The knowledge of the case is also important for doctors who come in contact with patients who previously underwent dental treatment, suffering from persistent cough, in the absence of positive radiological signs.