Solid Organ Transplant Litigation at One of Europe's Largest University Hospitals.

Due to its intrinsic complexity and the principle of collective solidarity that governs it, solid organ transplantation (SOT) seems to have been spared from the increase in litigation related to medical activity. Litigation relating to solid organ transplantation that took place in the 29 units of the Assistance Publique-Hôpitaux de Paris and was the subject of a judicial decision between 2015 and 2022 was studied. A total of 52 cases of SOT were recorded, all in adults, representing 1.1% of all cases and increasing from 0.71% to 1.5% over 7 years. The organs transplanted were 25 kidneys (48%), 19 livers (37%), 5 hearts (9%) and 3 lungs (6%). For kidney transplants, 11 complaints (44%) were related to living donor procedures and 6 to donors. The main causes of complaints were early post-operative complications in 31 cases (60%) and late complications in 13 cases (25%). The verdicts were in favour of the institution in 41 cases (79%). Solid organ transplants are increasingly the subject of litigation. Although the medical institution was not held liable in almost 80% of cases, this study makes a strong case for patients, living donors and their relatives to be better informed about SOT.

Sharing ICU Patient Data Responsibly Under the Society of Critical Care Medicine/European Society of Intensive Care Medicine Joint Data Science Collaboration: The Amsterdam University Medical Centers Database (AmsterdamUMCdb) Example.

OBJECTIVES: Critical care medicine is a natural environment for machine learning approaches to improve outcomes for critically ill patients as admissions to ICUs generate vast amounts of data. However, technical, legal, ethical, and privacy concerns have so far limited the critical care medicine community from making these data readily available. The Society of Critical Care Medicine and the European Society of Intensive Care Medicine have identified ICU patient data sharing as one of the priorities under their Joint Data Science Collaboration. To encourage ICUs worldwide to share their patient data responsibly, we now describe the development and release of Amsterdam University Medical Centers Database (AmsterdamUMCdb), the first freely available critical care database in full compliance with privacy laws from both the United States and Europe, as an example of the feasibility of sharing complex critical care data. SETTING: University hospital ICU. SUBJECTS: Data from ICU patients admitted between 2003 and 2016. INTERVENTIONS: We used a risk-based deidentification strategy to maintain data utility while preserving privacy. In addition, we implemented contractual and governance processes, and a communication strategy. Patient organizations, supporting hospitals, and experts on ethics and privacy audited these processes and the database. MEASUREMENTS AND MAIN RESULTS: AmsterdamUMCdb contains approximately 1 billion clinical data points from 23,106 admissions of 20,109 patients. The privacy audit concluded that reidentification is not reasonably likely, and AmsterdamUMCdb can therefore be considered as anonymous information, both in the context of the U.S. Health Insurance Portability and Accountability Act and the European General Data Protection Regulation. The ethics audit concluded that responsible data sharing imposes minimal burden, whereas the potential benefit is tremendous. CONCLUSIONS: Technical, legal, ethical, and privacy challenges related to responsible data sharing can be addressed using a multidisciplinary approach. A risk-based deidentification strategy, that complies with both U.S. and European privacy regulations, should be the preferred approach to releasing ICU patient data. This supports the shared Society of Critical Care Medicine and European Society of Intensive Care Medicine vision to improve critical care outcomes through scientific inquiry of vast and combined ICU datasets.

The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care.

Objectives: The new European In Vitro Diagnostic (IVD) Regulation 2017/746 (IVDR) restricts the use of lab-developed tests (LDT) after 26th May 2022. There are no data on the impact of the IVDR on laboratories in the European Union. Methods: Laboratory tests performed in UZ Leuven were divided in four groups: core laboratory, immunology, special chemistry, and molecular microbiology testing. Each test was classified as Conformité Européenne (CE)-IVD, modified/off-label CE-IVD, commercial Research Use Only (RUO) or LDT. Each matrix was considered a separate test. Results: We found that 97.6% of the more than 11.5 million results/year were generated with a CE-IVD method. Of the 922 different laboratory tests, however, only 41.8% were CE-IVD, 10.8% modified/off-label CE-IVD, 0.3% RUO, and 47.1% LDT. Off-label CE-IVD was mainly used to test alternative matrices not covered by the claim of the manufacturer (e.g., pleural or peritoneal fluid). LDTs were mainly used for special chemistry, flow cytometry, and molecular testing. Excluding flow cytometry, the main reasons for the use of 377 LDTs were lack of a CE-IVD method (71.9%), analytical requirements (14.3%), and the fact the LDT was in use before CE-IVD available (11.9%). Conclusions: While the large majority of results (97.6%) were generated with a CE-IVD method, only 41.8% of laboratory tests were CE-IVD. There is currently no alternative on the market for 71.5% of the 537 LDTs performed in our laboratory which do not fall within the scope of the current IVD directive (IVDD). Compliance with the IVDR will require a major investment of time and effort.

[Successful completion of an ISO 9001 v 2015 certification process in clinical investigation research]. / Réussir une démarche de certification ISO 9001 v 2015 en investigation clinique.

Clinical investigation at the University Hospital of Nantes is carried out within the investigation department, which consists of coordination and 24 clinical research teams gathered at four different hospital sites. The Clinical Investigation Units are all equipped with a Quality Management System. This has been in place for more than 12 years and was initially created for the Clinical Investigation Units of the Clinical Investigation Centre (CIC 1413) in Nantes and then transposed in 2013, to the emerging Clinical Investigation Units. OBJECTIVE: In order to evaluate the performance of this quality approach applied to all UHC investigations, the Investigation Department is committed to obtaining an ISO 9001:2015 certification. METHODS: The quality division of the investigation department conducted the project according to a methodology, based on internal and external evaluations to determine an inventory and the retro-planning of the certification approach. RESULTS: The scope of the certification involved the investigation department of the University Hospital: 24 clinical investigation units, over 500 medical staff, 150 non-medical staff. In our certification approach, the client was the promoter of the clinical study. The process lasted 18 months and included phases of training and awareness-raising for all the staff involved. The quality management system of the investigation department has been revised and improved in accordance with current regulations. The Investigation Department obtained the ISO 9001:2015 certification for all clinical investigations at the Nantes University Hospital in June 2017 without any non-compliance. CONCLUSION: Our work shows that the investigation department has successfully adapted the ISO 9001:2015 standard to institutional clinical research. The certification for specific activities in clinical investigation is the guarantee of an optimized and relevant organization for the safety of volunteers, participating in clinical research as well as the scientific quality of the research and contributes to the satisfaction of sponsors.

[Six years of open-door policy at the University Psychiatric Hospital Basel]. / Sechs Jahre "offene Türen" an den Universitären Psychiatrischen Kliniken Basel.

BACKGROUND: Coercive measures in psychiatry have well-known negative consequences for the patients and their treatment. They are considered ethically problematic and must only be used as a last resort. Locked wards may promote a threatening atmosphere leading to more aggression and a subsequent higher use of coercive measures. The aim of this was to investigate the frequency of seclusion and forced medication during clinic-wide implementation of an open-door policy. MATERIAL AND METHODS: In this 6­year longitudinal observational study (2010-2015) the frequencies of seclusion and forced medication were investigated on the basis of 17,359 cases treated in the University Psychiatric Hospital Basel. During the observational period, six formerly permanently locked wards were opened. RESULTS: The examined data showed a clinically relevant decrease in the frequency of seclusion (from 8.2% to 3.5%) and forced medication (from 2.4% to 1.2%) during the observational period. CONCLUSION: These results underline the potential of a less restrictive policy in psychiatry to reduce the frequency of coercive measures.

Assessing of policies and practices for occupational exposure to blood-borne viral infections in Tanta University Hospitals, Egypt.

One of the best ways to investigate and improve the effectiveness of polices for prevention and control of infections is through systematic and rigorous evaluation of the structural, functional, and practical elements of these polices. To assess the policies for managing occupational exposure to blood-borne viral infections in Tanta University Hospitals. A cross-sectional survey was carried out. A checklist was used to collect data related to the hospital policy regarding occupational exposure to blood-borne viral infections which was filled by direct personal interviews with the members of infection control (IC) committee of Tanta University Hospitals where the percentage of those in compliance with specific occupational management policies were reported. All studied participants reported lack of access to written infection control manual and only 14.3 % reported that infection control policies and procedures are updated yearly. Only 32.5 % of studied healthcare workers (HCWs) were not aware by the availability of a needle injury clinic. Only 28.6 % of the members of IC committee reported that pre-placement screening of HCWs for baseline blood tests for HBV, HCV, or HIV was conducted; however, periodic screening for these infections was not conducted as reported by all of the members. Among the members of IC committee, 57.1 % recorded availability of post-exposure evaluation. Only 42.8 % of the members of IC committee reported ensuring HCWs' confidentiality when reporting their exposure incidents. Both exposure management policies and practices were not aligning with the national guidelines.

[Required Framework for the Collection of Real-life Data: An Example from University Eye Hospital Munich]. / Rahmenbedingungen zur Sammlung von "Real-Life"-Daten am Beispiel der Augenklinik der Universität München.

Background The importance of evaluating real-life data is constantly increasing. Currently available computer systems better allow for analyses of data, as more and more data is available in a digital form. Before a project for real-life data analyses is started, technical considerations and staff, legal, and data protection procedures need to be addressed. In this manuscript, experiences made at the University Eye Hospital in Munich will be shared. Materials and Methods Legal requirements, as found in laws and guidelines governing documentation and data privacy, are highlighted. Technical requirements for information technology infrastructure and software are defined. A survey conducted by the German Ophthalmological Society, among German eye hospitals investigating the current state of digitalization, was conducted. Also, staff requirements are outlined. Results A database comprising results of 330,801 patients was set up. It includes all diagnoses, procedures, clinical findings and results from diagnostic devices. This database was approved by the local data protection officer. In less than half of German eye hospitals (n = 21) that participated in the survey (n = 54), a complete electronic documentation is done. Fourteen institutions are completely paper-based, and the remainder of the hospitals used a mixed system. Conclusion In this work, we examined the framework that is required to develop a comprehensive database containing real-life data from clinics. In future, these databases will become increasingly important as more and more innovation are made in decision support systems. The base for this is comprehensive and well-curated databases.

[ISO 9001:2015 Certification in Quality Management]. / Zertifizierung des Qualitätsmanagements nach DIN EN ISO 9001:2015.

Quality management improves the structures, processes and results of organizations of all kinds. Many practices and clinics have their existing quality management system certified according to ISO 9001, (e.g., to check their own quality management system or to obtain a testimonial against third parties). The latest version ISO 9001:2015 contains some changes, both structurally and in terms of content. These changes can be met with reasonable efforts. An ISO 9001:2015 certification represents a value for your organization, but these advantages are often not directly measurable.

[Litigation in gynecological surgery: A retrospective study in the French university hospital of Lille between 1997 and 2015]. / Sinistralité en chirurgie gynécologique : expérience de 1997 à 2015, au sein du CHRU de Lille.

OBJECTIVE: Analysis of litigation in gynecological surgery in the French university hospital of Lille. METHODS: It is a longitudinal and retrospective study. We collected all cases of complaints between November 1997 and August 2015 concerning the department of gynecological surgery, university hospital of Lille. Medical data were obtained using electronic medical record and hospital's legal unit gave data about the complaints. RESULTS: Forty cases were identified during the reporting period. Thirty-three records concerned medical injuries and seven cases failing to provide information or lack of communication. Eleven complaints were reviewed by the French "commission de conciliation et d'indemnisation". Five cases were brought to administrative court. Finally, Lille high court examined two records. Most of complaints concerned perforation during endoscopic procedures, nosocomial infections and forgotten foreign bodies. It was not observed any increasing number of complaints during the whole period. It was noticed a decreasing number of legal action in favor of "commission de conciliation et d'indemnisation". CONCLUSION: This study evaluated specifically litigation in gynecological surgery. It is necessary to conduct this type of study so as to improve medical care and to provide information for practitioner about consequences of their exercise.

[Nonnative guidelines for allocating human resources in child and adolescent psychiatry using average values under convergence conditions instead of price determination - analysis of the data of university hospitals in Germany concerning the costs of calculating day and minute values according to Psych-PV and PEPP-System]. / Normative Vorgaben zum Personaleinsatz in der Kinder- und Jugendpsychiatrie statt Preisfindung anhand von Mittelwerten unter Konvergenzbedingungen.

OBJECTIVE: Despite substantial opposition in the practical field, based on an amendment to the Hospital Financing Act (KHG). the so-called PEPP-System was introduced in child and adolescent psychiatry as a new calculation model. The 2-year moratorium, combined with the rescheduling of the repeal of the psychiatry personnel regulation (Psych-PV) and a convergence phase, provided the German Federal Ministry of Health with additional time to enter a structured dialogue with professional associations. Especially the perspective concerning the regulatory framework is presently unclear. METHOD: In light of this debate, this article provides calculations to illustrate the transformation of the previous personnel regulation into the PEPP-System by means of the data of §21 KHEntgG stemming from the 22 university hospitals of child and adolescent psychiatry and psychotherapy in Germany. In 2013 there was a total of 7,712 cases and 263,694 calculation days. In order to identify a necessary basic reimbursement value th1\t would guarantee a constant quality of patient care, the authors utilize outcomes, cost structures, calculation days, and minute values for individual professional groups according to both systems (Psych-PV and PEPP) based on data from 2013 and the InEK' s analysis of the calculation datasets. CONCLUSIONS: The authors propose a normative agreement on the basic reimbursement value between 270 and 285 EUR. This takes into account the concentration phenomenon and the expansion of services that has occurred since the introduction of the Psych-PV system. Such a normative agreement on structural quality could provide a verifiable framework for the allocation of human resources corresponding to the previous regulations of Psych-PV.

[Prevention of accidental needle sticks before the Directive 2010/32/EU in a sample of Italian hospitals]. / Prevenzione delle puncture accidentali prima della Direttiva 2010/32/UE in un campione de ospedali Italiani.

INTRODUCTION: Needlesticks and cuts are the most common occupational injuries in healthcare workers (HCWs). Directive 2010/32/EU defines principles and preventive interventions. OBJECTIVES: To assess, in hospitals participating in the Italian Study on Occupational Risk of HIV (SIROH) project, which are very active in prevention, the degree of application of the measures provided for by the Directive, prior to its incorporation into Italian law. METHODS: An open questionnaire covering the 9 focal points of the Directive, as a guide for a presentation at the SIROH meeting in 2013. RESULTS: Of 100 SIROH hospitals, 97% and 96% respectively provide specific information and education initiatives (54% and 73% of which expressly for new employees). All centres reinforce the ban on recapping, and 30 monitor its application by inspecting sharps containers; all hospitals place containers on mobile trolleys and 78 provide operating procedures for their replacement; all introduced at least one needlestick-prevention device (NPD; 4 on average, range 1-11), most frequently intravenous catheters (91%) and winged needles (87%), but 39% only in selected units; 14 centres implemented initiatives to eliminate unnecessary needles. Regarding hepatitis B, all centres screen and vaccinate HCWs but only 78% monitor their response: 89% of HCWs were immunized. Post-exposure management protocols, although based on the same rationale, differ significantly causing considerable differences in  costs. CONCLUSIONS: Most of the preventive interventions covered by the Directive were implemented in SIROH hospitals. It is necessary to invest in NPD availability and dissemination, elimination of unnecessary needles, and streamline post-exposure protocols. The situation in the remaining Italian facilities should be investigated.

[Health care power of attorney project at the University Hospital Frankfurt]. / Patientenautomonie und Aufklärung - Implementierung einer "Gesundheitsvollmacht" am Universitätsklinikum Frankfurt.

Under German law it is the patient alone who has the right to decide whether or not to undergo a particular medical procedure. Treating a patient without his or her consent always constitutes a serious infringement of the patient's constitutional right of self-determination as well as the right to physical integrity. By issuing a power of attorney in health care matters to a person he or she trusts, a patient can safeguard his or her rights in the event of incapacitation. At the University Hospital Frankfurt patients who are scheduled for major elective surgery are informed about the advantages of a health care power of attorney during premedication. The University Hospital has developed its own health care power of attorney form for patient use. In addition, patients have the option of receiving additional information about other types of health care advance directives, such as a living will.