Evaluation of the risk of occupational exposure to antineoplastic drugs in healthcare sector: part II - the application of the FMECA method to compare manual vs automated preparation.

Healthcare workers handling antineoplastic drugs (ADs) in preparation units run the risk of occupational exposure to contaminated surfaces and associated mutagenic, teratogenic, and oncogenic effects of those drugs. To minimise this risk, automated compounding systems, mainly robots, have been replacing manual preparation of intravenous drugs for the last 20 years now, and their number is on the rise. To evaluate contamination risk and the quality of the working environment for healthcare workers preparing ADs, we applied the Failure Mode Effects and Criticality Analysis (FMECA) method to compare the acceptable risk level (ARL), based on the risk priority number (RPN) calculated from five identified failure modes, with the measured risk level (MRL). The model has shown higher risk of exposure with powdered ADs and containers not protected by external plastic shrink film, but we found no clear difference in contamination risk between manual and automated preparation. This approach could be useful to assess and prevent the risk of occupational exposure for healthcare workers coming from residual cytotoxic contamination both for current handling procedures and the newly designed ones. At the same time, contamination monitoring data can be used to keep track of the quality of working conditions by comparing the observed risk profiles with the proposed ARL. Our study has shown that automated preparation may have an upper hand in terms of safety but still leaves room for improvement, at least in our four hospitals.

[Lean, work and psychological well-being.] / Lean, benessere lavorativo e psicologico.

SUMMARY: Many studies have confirmed the existence of a close relationship between job satisfaction and health. The Siena University Hospital introduced the Lean approach to support personnel development/empowerment and promote a constant improvement in work organization, with the aim of creating value for patients, professionals and the whole organization. The purpose of this study was to examine whether the introduction and the development of this improvement approach in healthcare could contribute to the enhancement of psychological wellbeing and employee satisfaction, with a positive value in preventing related stress work. The Lyne and Barrett Employee Wellbeing Questionnaire (EWQ) was administered to employees involved in selected Lean projects carried out at the Siena University Hospital. The EWQ is composed of 59 items and it is structured in three areas: organizational wellbeing, working satisfaction and workload. The analysis of the results showed significant evidence of the impact of improvement activities on the working satisfaction and the workload.

Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery.

OBJECTIVES: The following study proposes and tests an integrated methodology involving Health Technology Assessment (HTA) and Failure Modes, Effects and Criticality Analysis (FMECA) for the assessment of specific aspects related to robotic surgery involving safety, process and technology. METHODS: The integrated methodology consists of the application of specific techniques coming from the HTA joined to the aid of the most typical models from reliability engineering such as FMEA/FMECA. The study has also included in-site data collection and interviews to medical personnel. RESULTS: The total number of robotic procedures included in the analysis was 44: 28 for urology and 16 for general surgery. The main outcomes refer to the comparative evaluation between robotic, laparoscopic and open surgery. Risk analysis and mitigation interventions come from FMECA application. CONCLUSIONS: The small sample size available for the study represents an important bias, especially for the clinical outcomes reliability. Despite this, the study seems to confirm the better trend for robotics' surgical times with comparison to the open technique as well as confirming the robotics' clinical benefits in urology. More complex situation is observed for general surgery, where robotics' clinical benefits directly measured are the lowest blood transfusion rate.

Development of a web based monitoring system for safety and activity analysis in operating theatres.

BACKGROUND: The management and the monitoring of the operating rooms on the part of the general management have the objective of optimizing their use and maximizing the internal safety. The expenses owed to their safe use represent, besides reimbursements coming from the surgical activity, important factors for the analysis of the medical facility. OBJECTIVE: Given that it is not possible to reduce the safety, it is necessary to develop supporting systems with the aim to enhance and optimize the use of the rooms. METHODS: The developed analysis model of the operating rooms in this study is based on the specific performance indicators and allows the effective monitoring of both the parameters that influence the safety (environmental, microbiological parameters) and those that influence the efficiency of the usage (employment rate, delays, necessary formalities, etc.). This allows you to have a systematic dashboard on hand for all of the OTs and, thus, organize the intervention schedules and more appropriate improvements. RESULTS: A monitoring dashboard has been achieved, accessible from any platform and any device, capable of aggregating hospital information. The undertaken organizational modifications, through the use of the dashboard, have allowed for an average annual savings of 29.52 minutes per intervention and increase the use of the ORs of 5%. The increment of the employment rate and the optimization of the operating room have allowed for savings of around $299,88 for every intervention carried out in 2013, corresponding to an annual savings of $343,362,60. CONCLUSIONS: Integration dashboards, as the one proposed in this study as a prototype, represent a governance model of economically sustainable healthcare systems capable of guiding the hospital management in the choices and in the implementation of the most efficient organizational modifications.

Development of sustainable models for technology evaluation in hospital.

BACKGROUND: This paper reports the development of standard techniques for technology evaluation in hospital carried out at the Florence Teaching Hospital Careggi (AOUC), where, as a complex system, the technological evaluation is a strategic and essential element for the maintenance of high-quality clinical activity and maximization of available resources. OBJECTIVE: The aim of this paper has been the development of a system of economically sustainable models for the implementation of HTA and HS analyses in the hospital environment as well as presenting, in addition to a valid scientific resilience, the methodological and temporary flexibility to satisfy needs of hospital decision-makers. METHODS: The evaluation models call for 3 main phases: an initial analysis of the in-hospital request, a collection of data, and finally a draft of a specific, easily usable set of reports. RESULTS: Three standardized and tested models of evaluation were developed, which, in relation to the objective of the request and schedule of the assignment, provide for the production of a speedy report (1-week), an intermediate report (1-month), or a extensive report typical of classical studies of hospital based HTA (1-year). It is then related to the evaluation model of the IORT (Intra-Operative Radiation Therapy) technology. DISCUSSIONS AND CONCLUSION: The developed models have permitted the construction, using personnel and laboratories within the hospital, of an evaluation system reliable and responsive to the HOSPITAL's temporary needs based on the HS and HTA analyses in the hospital environment. Regarding the applicable case of IORT, this has shown how in-hospital requests have been satisfied in the preset time: although it establishes expected improvements on the social effect and weight of the illness and reveals a high territorial strategic relevance, the introduction of IORT in the hospital presents some criticalities on the impact on the healthcare organization and the necessity of specific training of medical technologist personnel.

Hospital-based health technology assessment on the use of mitral clips in the treatment of mitral regurgitation.

BACKGROUND: This study, carried out at the Florence Teaching Hospital Careggi (AOUC), reports the technological evaluation, through the use of Health Technology Assessment (HTA), on the application of mitral clips in the treatment of mitral insufficiency. OBJECTIVE: The assessment, carried out by analyzing the clinical, technological, social, procedural, safety and economic elements, sought to answer the following research questions: Evaluation of the general technological status of the mitral clips in the treatment process of mitral regurgitation, with particular reference to traditional methods; and contextualisation of the analyses within the hospital structure, by identifying criticality issues and improvements. METHODS: The methodology was based on the following steps: technological description; areas of evaluation and the selection of Key Performance Indicators; research of scientific facts and the collection of expert opinions; evaluation and reporting of findings. RESULTS: The results are based on an analysis which included a total of 50 indicators, effectively evaluating 86.5% of them, from the least from the clinical sector (80%) to the most in the areas of procedure, safety and social (100%). Traditional surgery (repair or valve replacement) still represents the gold standard for the treatment of mitral regurgitation due to its maturity both on a technological and clinical level. The minimally invasive procedures which use the mitral clips present interesting opportunities both on a social level (minimum stay in hospital and no post-operative rehabilitation) and clinical level, especially as an alternative to medication, even if they are still at an emergent level (the long-term results are unknown) and complex to use. From the clinical point of view they show some interesting findings related to immediate and post-operative mortality (none during the operation and a minor and equal amount 30 days and 12 months later in comparison to traditional methods) whilst economically, despite the fact that the cost of the device is greater than those used in traditional interventions, the cost-refund relationship does not show significant differences compared to the traditional types of treatment. CONCLUSION: The HTA evaluation of minimally invasive technologies that use clips for the treatment of mitral regurgitation shows, in the hospital setting, very interesting results, particularly for inoperable patients, where the clinical and social improvements are significant compared to pharmacological treatments, whilst for 'operable' patients, the traditional techniques are still the most appropriate.

HTA decision support system for sustainable business continuity management in hospitals. The case of surgical activity at the University Hospital in Florence.

BACKGROUND: A fundamental element of the social and safety function of a health structure is the need to guarantee continuity of clinical activity through the continuity of technology. OBJECTIVE: This paper aims to design a Decision Support System (DSS) for medical technology evaluations based on the use of Key Performance Indicators (KPI) in order to provide a multi-disciplinary valuation of a technology in a health structure. METHODS: The methodology used in planning the DSS followed the following key steps: the definition of relevant KPIs, the development of a database to calculate the KPIs, the calculation of the defined KPIs and the resulting study report. Finally, the clinical and economic validation of the system was conducted though a case study of Business Continuity applied in the operating department of the Florence University Hospital AOU Careggi in Italy. RESULTS: A web-based support system was designed for HTA in health structures. The case study enabled Business Continuity Management (BCM) to be implemented in a hospital department in relation to aspects of a single technology and the specific clinical process. Finally, an economic analysis of the procedure was carried out. CONCLUSIONS: The system is useful for decision makers in that it precisely defines which equipment to include in the BCM procedure, using a scale analysis of the specific clinical process in which the equipment is used. In addition, the economic analysis shows how the cost of the procedure is completely covered by the indirect costs which would result from the expenses incurred from a broken device, hence showing the complete auto-sustainability of the methodology.

Design of a decision support system for preventive maintenance planning in health structures.

The appropriate maintenance of medical devices, including performance inspections and preventive maintenance, is fundamental in mitigating clinical risk caused by adverse events in health care. Although several models for managing and planning preventive maintenance have been developed, the problem is lacking in standard methodology and still presents an open challenge for today's health experts. This paper aims to provide and develop methodology together with support systems able to assist decision makers in constructing preventive maintenance and performance inspection plans, taking into account both the technical and economic needs of hospital clinical engineering departments. Interventions by decision makers are of crucial importance within complex situations where large numbers, types of devices and different contractual situations are involved. SISMA system has achieved optimal results with minimum expense and maximum security for patients and technicians at the University Hospital of Florence where it has been applied in actual case studies.

Health technology management: a database analysis as support of technology managers in hospitals.

Technology management in healthcare must continually respond and adapt itself to new improvements in medical equipment. Multidisciplinary approaches which consider the interaction of different technologies, their use and user skills, are necessary in order to improve safety and quality. An easy and sustainable methodology is vital to Clinical Engineering (CE) services in healthcare organizations in order to define criteria regarding technology acquisition and replacement. This article underlines the critical aspects of technology management in hospitals by providing appropriate indicators for benchmarking CE services exclusively referring to the maintenance database from the CE department at the Careggi Hospital in Florence, Italy.

Longitudinal expandable shelter for medical response during disasters.

INTRODUCTION: During medical emergencies, hospitals represent the final point of the whole rescue process. Therefore, effective health mobile structures have to be inserted between hospitals and the place of the event with the aim of giving the best of cures (using appropriate and easy to use equipment) for a safer and faster evacuation to hospitals. METHODS: Literature review and national and international disaster medicine standards were the basis for this study to provide clinical, hygienical, and organizational needs to satisfy for the medical structure design. Project requirements have been obtained by analyzing structural, organizational, and clinical process necessities. Structural requirements respond to the possibility of installation on every ground type, resistance to every weather condition, and necessity of easy and fast transportation. Technological equipment is obtained from clinical evaluation for patient stabilization. RESULTS: The designed structure results to be a longitudinal expandable shelter (LES) for medical emergencies response organized in three internal functional areas. Possibility of automatic expandability allows rapid transportation and easy deployment. The functional internal organization provides three areas: "Diagnostic," "Therapeutic," and "Pre-evacuation monitoring." Further, longitudinal expandability supports the basic hygienical rules in healthcare processes allowing the unidirectional flow of casualties from dirtier to cleaner areas of the structure. CONCLUSIONS: LES represents the answer to expressed requisites by disaster medicine standards and guidelines. It aims to provide an efficient and effective support for sanitary aid in response to disasters or emergencies, by improving aspects related to effectiveness, hygiene, and quality of clinical performances especially for highest critical cases.

Custom active RFId solution for children tracking and identifying in a resuscitation ward.

In this work is discussed an active RFId system to track and identify patients in a children's critical care ward. The technical solutions may be very different according to the patients type, age and cognitive conditions and according to the hospital shapes. The proposed system to track and identify patients has been developed taking into account all the constraints induced by the particular environment. The system is composed of five different hardware devices and a tracking software, purposely designed and realized.

Patients tracking and identifying inside hospital: a multilayer method to plan an RFId solution.

This paper shows a method to get a patient tracking RFId solution, basing on a multilayer planning architecture. This approach is thought to guarantee that the found technical solution is as much as possible coherent to the very initial idea. Project aims, functional requirements and technical constraints are defined in order to arrive to an active RFId solution to track and identify patients inside a hospital. The article also deals with economical issues and physical design aspects. In this work it's also defined a three phases process for patient tracking, that could serve as a guideline for different technical solutions to the same problem.

DSS for field hospitals planning. Technological and functional aspects.

During the last 50 years natural and social disasters have increased 250%, affecting at least 800 million people. The causes of these disasters are various and most of them are not predictable. A successful strategy is a well planned medical response. The use of Field Hospitals 'FH' specialized for the disasters and planned to guarantee high technical and medical standards is a fundamental component in reducing mortality. The DSS, 'Decision Support Model', has allowed the planning of Field Hospitals according to the disaster typology and to the disaster area taking into account the number of people involved and the local health system capacity. The DSS specifies also Field Hospital technical requirements and technological support.