L’Unità Operativa Complessa Tecnologie Sanitarie (The Complex Operational Health Technologies Unit) was established in 2018 following a profound company reorganization and acts as the governing body of technological allocation for the Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The operational unit works directly with the Medical Government Management.
Through the implementation of methods, tools and scientifically strong and clear procedures, the UOC promotes the redesigning of the Fondazione’s health development paradigms, supporting change of the organizational structure necessary to simultaneously guarantee quality, fair accessibility and effective services for citizens and economic sustainability to the hospital.The Health Technology UOC’s work includes both Consulting and Decision making activities.
In accordance with its role within a university IRCCS, it institutionally contributes by publishing its research, when appropriate, and by training staff in the field of health technology assessment.
The Operational unit’s functions can be divided in three distinct macrosectors:
- Hospital Based – HTA
- Health technology management
- Health technology assessment
Giovanni Arcuri – Head
Plinio Cianfanelli – Medical Engineer Manager
Lorenzo Leogrande – Health technology Assessment Unit Manager
Fiammetta Ambrosio – Administration Office
Rossella Di Bidino – Innovative Medicine Sector Advisor
Carmen Furno – High tech / high cost Medical Device (MD) Advisor
Marco Oradei – In Service Technology and Surgical Instruments Sector Advisor
The UOC is administered by a managing director and by two UO managers: Medical engineering and Health technology assessment unit.
Administration Office (F.Ambrosio)
The UOC has an administration office that carries out supporting administrative functions for all the UOC structures. It organizes administrative operational activities and manages work relations at every level, both internally and externally (in Italy as well as abroad). It takes care of the document and filing system (archiflow) management, agenda management for service activities and mail, both printed and electronic, management. It provides operational support for document editing and for organizing meetings and events.
Area hospital based HTA (Ing. G. Arcuri)
The Health Technology Assessment (HTA) is the systematic evaluation of the properties, the effects and/or the impact of technologies and health care services. It refers to the direct and intentional consequences as well as to the indirect and unintentional consequences of technology and health care services.
The HTA’s approach is used to provide information about the health system policies and decisional procedure, particularly regarding the best allocation of limited funds toward services and technologies. The assessment is carried out by multidisciplinary groups that use explicit analytical frameworks that abstract medical, epidemiological, economic and additional types of information.
Within each single hospital facility it is necessary to transform the method used from a “system” policy context into a “managerial” context in which the assessments must become practical decisions and management activities, taking into consideration that these hospitals must function within comprehensive set budgets and, consequently, make choices and assign priorities. In order to help the hospital decision makers the UOC has developed some distinct products:
Data Analytics & Business Intelligence
The use of methods and tools typical of this regulatory field, as well as the creation of business intelligence instruments, are considered strategic during the processes of technological assessment, follow-up and company procedures analysis. The main objective is the development of tools useful for decision making procedures, through data consolidation and validation plans and the development of indicators appropriate for the comprehension and assessment of procedures.
Decisions regarding the introduction or the regular use of a certain technology are based on reports that include reliable estimates concerning the technological effectiveness and costs and the awareness of any legal or ethical matters that could be of significance for its purchase.
Feasible business plan
The development of feasibility plans for projects commissioned by the Administration establishing the objective and the data disclosure grid (spatial, time, human and technological resources), the management of internal and external contacts and plan drafting.
High tech/high cost Medical Device (MD) field (C. Furno)
The Health Technology UOC, with respect to its transversal role compared to the Fondazione’s other Units, is actively involved in the Medical Devices (MD) governing activities. The implementation of the HTA’s own ideas to the Fondazione’s context, through the use of tools such as systematic revisions in publications, meta-analysis, budget impact assessment (BIA), supports the introduction and disinvestment decisions regarding Medical Devices. The Unit’s contribution to the sector is explained in the following functions:
- Needs-based analysis (detection of shortcomings, areas of improvement, development opportunities),
- HT Assessments oriented toward the implementation of new MD in its repertoire;
- Monitoring results, needs and usage of MD in place;
- Editing the technical purchase Documents and technical assessment reports.
Innovative Medicine Sector (R. Di Bidino)
Similarly, in the medication field the UOC is responsible for monitoring technological needs with particular reference to the following functions:
- Internal needs analysis in a horizon scanning scenario through the selection of innovative medicine;
- HT assessments oriented to inserting new Medication in the Hospital Treatment Handbook (HTH);
- Periodic revision of the HTH in collaboration with the Hospital Pharmacy;
- Economic/organizational assessments tied to the introduction/substitution of medication;
- Monitoring results and the consumption of introduced medication.
UOS Medical Engineering (P. Cianfanelli)
The operative unit’s main responsibility is to manage the policies tied to the maintenance, routine and exceptional as well as preventive and corrective, of the medical equipment, to work continuity and to safety and risk management, with the intention of streamlining costs and guaranteeing quality and security.
From this perspective, through a process of various phases, the main objectives are:
- The enhancement of first response activities regarding technology, aimed at guaranteeing a timely analysis and supervision of maintenance activities in quality and economic terms, as well as those tied to the management of in-service devices that currently represent a significant section of company equipment;
- Productivity increase of internal technical resources regarding maintenance activities intended to guarantee a limitation of management costs;
- The reinforcement of predictive maintenance in some critical areas (Rounds);
- Improvement of the management and base analysis of data regarding technical asset information.
This unit is part of the investment plan creation, indicating the technology to be replaced periodically in order to guarantee productive continuity and management cost-effectiveness.
The UO guarantees constant support regarding the various institutional certification (ISO,JCI, etc.) and accreditation activities.
UOS Halt Technologies Assessment Unit (L. Leogrande)
The operational unit’s main responsibility is to create the annual investment plan by preparing the necessary documents and carrying out the assessment activities.
It guarantees the proper technological supply through the following activities:
- Defining the necessary technical specifications regarding the correct acquisition procedures;
- Procedures regarding solution-making and the most appropriate forms of acquisition;
- Validating orders;
The UO is in charge of the development of complex technological projects, Project Management activities and HB-HTA assessments regarding biomedical technology.
In-Service Technology and Surgical Instruments Field (M. Oradei)
As the managing body of the in-service technology and surgical instruments the following are necessary: the assessment of actual needs and the analysis of economic implications of the technology under consideration, not only in terms of budget availability, but also regarding an overall view of sustainability and investment cost-effectiveness.
- In the multi-purpose surgical instruments sector, supply is guaranteed by the surgical instruments Entity that is appropriate in amount and quality compared to the needs, through both purchase as well as other forms of acquisition (service…).
- The In-Service technology sector includes the management of service contracts for the supply of mainly technology (for example, the supply of infusion pumps) and, more in general, all the technology that is purchased on a rental basis regarding the current expenditure.
All the UOC Health Technologies activities are regulated by processes formalized in company procedures available on intranet and divided into sections:
- Hospital based HTA (COFT-DM, MD introduction for each patient, custom-made)
- Medical engineering (viewing on a trial basis, testing, inventory)
- Technologies Assessment
Likewise, the management tools and the KPI developed by the UOC in the business intelligence activities scenario, continuously or upon request by an administrative or health management authority for specific needs, are available on intranet
Documents and reports are sent to the administrative institutions and are made public to the applicants clearly indicating the information and the reasons on which the recommendations are based. If it is in line with the IRCCS research strategies, the UOC proposes the publication of its research on peer-reviewed magazines.
On an international level, the Health Technology UOC is a member of INAHTA (International Network of Agencies for Health Technology Assessment).
On an institutional level, it relies on a structured collaboration with Altems, (Alta Scuola di Economia e Management dei Sistemi Sanitari – Advanced School of Health-care Systems Economics and Management ) headed by Prof. Americo Cicchetti, for activities such as the involvement at EUnetHTA (European NETwork for Health Technology Assessment), the combined study development of HTA ad mini HTA, the combined study development of RWE (Real World Evidence), combined planning and development and/or participation in training activities.