Key Performance Indicators in Claims Management: Definition of a Set of Indicators for the Evaluation of the Medico-Legal Activity.

BACKGROUND: In recent decades, in the field of healthcare, awareness of the problems inherent to the quality has steadily increased. Currently, the evaluation of healthcare activities is one of the ways in which health systems regulate internal relationships and define strategic decisions. OBJECTIVE: The study aims to describe in detail the entire process of developing a group of Key Performance Indicators for monitoring and implementing the management of litigation due to medical liability. Particularly, the objective is to centralize and standardize the indicators to provide scientifically reliable data on claims management to hospital professionals responsible for strategic choices. METHODS: The study was conducted to analyze data relating to the claims management at Umberto I General Hospital in Rome from 2012 to 2018. All claims reported were classified according to a selection of the categories coded in the International Classification for Patient Safety system, the economic features, and the chronological references of the main management extrajudicial and judicial phases. The Process Analysis Method was followed to develop significant indicators for measuring the performance and the quality of claims management. RESULTS AND CONCLUSION: The results obtained demonstrate how the assessment of performance in claims management can potentially lead to greater risk control with significant repercussions in terms of reduction of disputes, speed in settling claims, reduction of management times, planning of loss prevention measures, and implementation of quality of care.

Bioethical issues and legal frameworks of surrogacy: A global perspective about the right to health and dignity.

Modern advances in assisted reproduction technology (ART) have disrupted the traditional concept of parenthood. Every year, thousands of people travel abroad from their home countries in order to circumvent restrictive legislation or to benefit from lower fees. In a similar context, surrogacy raises many bioethical and legal issues. The present paper will address the main questions arising from the debate prompted by surrogacy, focusing on international legislation, and looking critically at the different legislative models. As a result of worldwide heterogeneity in policies, legal approaches, and access to ART throughout the world, a growing number of would-be parents are seeking treatment abroad. The lack of regulation on cross-border surrogacy in low income countries can undermine the dignity and rights of women as even modest economic compensation determines a significant purchasing power. The international effort should be aimed at creating an international regulatory framework from which guidelines useful to national governments derive. An international agreement would provide a solid legal basis for the protection of surrogate women. In order to limit the economic interests linked to procreative tourism, so as to truly protect global health and women's rights, legislative uniformity is therefore necessary between the various states.

Post-mortem computed tomography (PMCT) radiological findings and assessment in advanced decomposed bodies.

PURPOSE: The aim of the study is to report radiological findings and features in advanced decomposed bodies obtained by post-mortem computed tomography (PMCT) with autopsy correlation. MATERIALS AND METHODS: This retrospective descriptive multicentric study included 41 forensic cases examined between May 2013 and November 2016. All the bodies were PMCT-scanned prior to autopsy, and internal putrefactive state was determined using the radiological alteration index (RAI) by a radiologist with expertise in forensic radiology and a forensic pathologist trained in forensic imaging. After PMCT scans, grade of external putrefaction (GEP) was assigned during the external examination and the complete autopsy was performed by forensic pathologists. RESULTS: The PMCT images evaluation revealed that the RAI index was > 61 in all bodies, corresponding to a moderate-massive presence of putrefactive gas. The gas grade was > II in correspondence of the major vessels, heart cavities, liver parenchyma, vertebra L3 and subcutaneous pectoral tissues, and varied from I to III in correspondence of the kidney. Cadaveric external examination revealed the presence of advanced transformative phenomena, with a GEP3 and GEP4 in most of the cases, with body swelling, eyes and tongue protrusion, body fluids expulsion and fat liquefaction. CONCLUSION: Radiological imaging by PMCT as an adjunct to autopsy in advanced decomposed bodies represents a useful tool in detecting post-mortem gas, even in very small amounts. A correct interpretation process of the PMCT data is essential to avoid images pitfalls, due to natural decomposition that can be mistaken for pathologic processes.

Advanced Loss Eventuality Assessment and Technical Estimates: An Integrated Approach for Management of Healthcare-Associated Infections.

BACKGROUND: Healthcare Associated Infections (HAIs) represent a crucial issue in health and patient safety management due to the persistent nature, economic impact and possible preventability of the phenomenon. Compensation claims for damages resulting from HAI could provide insights that can improve the understanding of suboptimal steps in the therapeutic process, enable an estimate of costs related to infectious complications, and guide the development of planning tools for implementation of the quality of care. OBJECTIVE: This paper analyzes all the HAI claims received at the Umberto I General Hospital of Rome across a five-year period with the aim of outlining a methodological approach to the litigation management and of characterizing the economic impact of infections on health facilities resources. METHODS: All claims received during the study period have been classified according to the International Classification for Patient Safety (ICPS) system. Subsequently, claims related to Healthcare Associated Infections were evaluated through an innovative tool for determination of the risk of loss, the Advanced Loss Eventuality Assessment (ALEA) score. RESULTS: The results obtained demonstrate the relevance of a correct management of HAI claims in the administration of a health care system. Specifically, the cases examined during the study highlighted the significant impact of infectious diseases of a nosocomial nature in terms of frequency and economic exposure. CONCLUSION: The proposed methodological approach allows a productive analysis of the internal processes, providing fundamental data for the refinement of the preventive strategies and for the rationalization of the resources through the expenditure forecasts. Article Highlights Box: Healthcare-Associated Infections represent an essential element to consider in the management of health facilities. • Many studies highlight the economic burden of Healthcare-Associated Infections in health policies. • Litigation management represents a useful resource in the prevention of Healthcare Associated Infections. • Appropriate clinical risk management policies in the field of Healthcare-Associated Infections allow the implementation of preventive measures, the reduction of the incidence of the phenomenon and the quality of care. • The costs of Healthcare-Associated Infections can be limited through a systematic methodological approach based on Advanced Loss Eventuality Assessment and technical estimate of the value of each case. • The application of a standardized system would be desirable in any health facility despite the potential methodological, technical, behavioral and financial issues.

Healthcare-Associated Infections Due to Multidrug-Resistant Organisms: a Surveillance Study on Extra Hospital Stay and Direct Costs.

BACKGROUND: The increasing antimicrobial resistance poses a challenge to surveillance systems and raises concerns about the impact of multidrug-resistant organisms on patient safety. OBJECTIVE: The study aimed to estimate extra hospital stay and economic burden of infections due to alert organisms - mostly multidrug-resistant - in a teaching hospital. METHODS: The present retrospective matched cohort study was conducted based on the analysis of hospital admissions at Sant'Andrea Teaching Hospital in Rome from April to December 2015. Extra hospital stay was the difference in the length of stay between each case and control. All the patients developing an infection due to an alert organism were considered cases, all others were eligible as controls. The costs of LOS were evaluated by multiplying the extra stay with the hospital daily cost. RESULTS: Overall, 122 patients developed an infection due to alert organisms and were all matched with controls. The attributable extra stay was of 2,291 days (mean 18.8; median 19.0) with a significantly increased hospitalization in intensive care units (21.2 days), bloodstream infections (52.5 days), and infections due to Gram-negative bacteria (mean 29.2 days; median 32.6 days). Applying the single day hospital cost, the overall additional expenditure was 11,549 euro per patient. The average additional cost of antibiotic drugs for the treatment of infections was about 1,200 euro per patient. CONCLUSION: The present study presents an accurate mapping of the clinical and economic impact of infections attributable to alert organisms demonstrating that infections due to multidrug-resistant organisms are associated with higher mortality, longer hospital stays, and increased costs. Article Highlights Box: The increasing antimicrobial resistance poses a challenge for surveillance systems and raises concerns about the impact of multidrug-resistant organisms on patient safety. • Healthcare-associated infections (HAIs) have historically been recognized as a significant public health problem requiring close surveillance. • Despite several and reliable findings have been achieved on clinical issues, our knowledge on the economic impact of healthcare-associated infections due to multidrug-resistant organisms needs to be widened. • Estimating the cost of infections due to multidrug-resistant organisms in terms of extra hospital stay and economic burden is complex, and the financial impact varies across different health systems. • Evaluations of social and economic implications of hospital infections play an increasingly important role in the implementation of surveillance systems. • The costs of infection prevention and control programs and dedicated personnel are relatively low and self-sustainable when efficient.

Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care.

The latest research achievements in the field of stem cells led in 2016 to the publication of "Guidelines for Stem Cell Research and Clinical Translation" by the International Society for Stem Cell Research (ISSCR). Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient's welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.

Personalised Healthcare: The DiMA Clinical Model.

Large-scale application of Personalized Medicine requires a multi-disciplinal environment allowing synergic cooperation among different competences. Strict collaboration between medical and medical sciences, as informatics, ethics, politics, are needed to face the challenges of one-sized healthcare. In spite of the increasing interest, how this system can be globally realized remains tentative. Yet, a relatively small, Personalised Healthcare Service is providing a proof-of principle organizational model to guide implementation into clinical practice.

Assessment of the stability of mephedrone in ante-mortem and post-mortem blood specimens.

AIMS: The aim of this work is to test the stability of mephedrone added to whole blood collected from alive and dead mephedrone free-users and stored at three different temperatures (-20, +4 and +20°C) with and without preservatives up to 6 months, trying to establish the best storage condition in order to reduce possible analyte loss/degradation during the storage period. MATERIALS AND METHODS: Different sources of blood were obtained as follow: 10 samples of blood came from 10 alive mephedrone free-users (mean age 34±15.8 years old) (Group 1), whereas 10 post mortem blood samples were obtained from 10 cadavers, in which the post mortem interval was between 24 and 36h (Group 2). The cause of death in post mortem cases (mean age 45±14.2 years old) was not drug related. Pools of blood were spiked with mephedrone at the concentration of 1mg/L and 1mL aliquots were transferred in 2mL Eppendorf capped tubes with and without preservatives as follow: with ethylenediaminetetraacetic acid (EDTA) 3%; with sodium fluoride/potassium oxalate (NaF/KOx) 1.67%/0.2%, respectively; without preservatives. All samples were stored at three different temperatures: -20°C, 4°C and 20°C and extracted and analyzed in duplicate by GC-MS according to a previously published method by Dickson et al., every other day during the first month and then weekly up to 6 months. RESULTS AND CONCLUSIONS: our study allow us to affirm that -20°C is the best storage temperature for mephedrone stability in ante-mortem and post-mortem blood samples in comparison to the other two tested temperatures (+4 and +20°C), showing higher values in both groups in samples stored with and without preservatives (p<0.0001). The comparison of Group 1 (samples coming from alive subjects) and Group 2 (post-mortem samples) highlights a better stability of mephedrone in Group 1 (p<0.001) at all tested storage conditions. Finally, the analysis of blood specimens stored with and without preservatives in both groups suggests that specimens stored with NaF/KOx maintain mephedrone stability better than those stored with EDTA (p<0.001) and those stored without preservatives (p<0.0001), therefore, we strongly recommend in order to maintain the highest mephedrone stability in blood, to store specimens at -20°C adding NaF/KOx as preservative.