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 expert model for health technology procurement planning in hospitals.

Although in the last years technology innovation in healthcare brought big improvements in care level and patient quality of life, hospital complexity and management cost became higher. For this reason, necessity of planning for medical equipment procurement within hospitals is getting more and more important in order to sustainable provide appropriate technology for both routine activity and innovative procedures. In order to support hospital decision makers for technology procurement planning, an expert model was designed as reported in the following paper. It combines the most widely used approaches for technology evaluation by taking into consideration Health Technology Assessment (HTA) and Medical Equipment Replacement Model (MERM). The designing phases include a first definition of prioritization algorithms, then the weighting process through experts' interviews and a final step for the model validation that included both statistical testing and comparison with real decisions. In conclusion, the designed model was able to provide a semi-automated tool that through the use of multidisciplinary information is able to prioritize different requests of technology acquisition in hospitals. Validation outcomes improved the model accuracy and created different "user profiles" according to the specific needs of decision makers.

A queueing theory based model for business continuity in hospitals.

Clinical activities can be seen as results of precise and defined events' succession where every single phase is characterized by a waiting time which includes working duration and possible delay. Technology makes part of this process. For a proper business continuity management, planning the minimum number of devices according to the working load only is not enough. A risk analysis on the whole process should be carried out in order to define which interventions and extra purchase have to be made. Markov models and reliability engineering approaches can be used for evaluating the possible interventions and to protect the whole system from technology failures. The following paper reports a case study on the application of the proposed integrated model, including risk analysis approach and queuing theory model, for defining the proper number of device which are essential to guarantee medical activity and comply the business continuity management requirements in hospitals.

Telematics integrated system to perform drugs prescription and administration reducing adverse drug events.

In this paper we present PHARMA 2.0 a telematics integrated system aimed at reducing Adverse Drug Events (ADEs) in the phases of drug prescription, transcription, distribution and administration. The proposed system is grounded on three sub-systems: a CPOE (Computerized Prescription Order Entry), an RFID-based drug container and dispenser and a middleware system. The visualization and management of prescription and administration data are handled through a web application designed to comply with international usability regulation.

External quality assessment for the detection of HCV RNA, HIV RNA and HBV DNA in plasma by nucleic acid amplification technology: a novel approach.

BACKGROUND AND OBJECTIVES: In this EQA study a novel approach was used to assess the performance of blood centres and blood product manufacturers in detecting the possible contamination of plasma with HCV, HIV and HBV by NAT. MATERIALS AND METHODS: A panel of 12 samples, three negative and three positive for each virus, was distributed to the EQA participants. The positive samples were prepared, using the respective WHO standards, in order to obtain a viral concentration of about three times the 95% DL of the methods most commonly used by laboratories involved in blood screening by NAT. Participants were requested to test each sample of the panel on different days, possibly by different operators using their routine NAT assay. RESULTS: Overall, the participants' performance was satisfactory. In particular, 49 of the 59 participants (83%) were able to correctly identify all samples. Regarding the remaining 10 laboratories, in three cases a deviation from the laboratory's procedure that could be attributed to an operator's mistake was observed, in two cases a possible cross-contamination occurred while in the remaining five cases the failure to detect the positive samples couldn't be ascribed to any relevant deviation in the laboratory's procedure. CONCLUSIONS: The novel design of this EQA study allowed participants to verify their day by day activity as the study was carried out in the context of their routine testing. Under these conditions, it was demonstrated that, despite the high level of automation reached by NAT assays, human errors can still occur.

World Health Organization collaborative study to establish a replacement WHO international standard for hepatitis C virus RNA nucleic acid amplification technology assays.

BACKGROUND AND OBJECTIVES: A collaborative study was undertaken to establish a replacement for the current (1st) World Health Organization (WHO) hepatitis C virus (HCV) International Standard, 96/790. MATERIALS AND METHODS: Both the 1(st) International Standard and the replacement standard were prepared from the same starting material by diluting a high titre genotype 1a HCV isolate in pooled, human plasma. The only difference was that each standard was lyophilized in two, separate lyophilisation runs but under the same conditions. RESULTS: In the study to establish the 1st International Standard, no significant difference in potency was found between the material eventually designated as the 1st International Standard and that now selected as the 2nd International Standard. The present study also showed no significant differences between the materials stored at -20 degrees C and no evidence of degradation over 5 years. CONCLUSIONS: Material 96/798 was established as the 2nd HCV International Standard and assigned the same unitage as the 1st International Standard, i.e. 10(5) IU/ml (50,000 IU/vial).

External quality assessment for the detection of blood-borne viruses in plasma by nucleic acid amplification technology: the first human immunodeficiency virus and hepatitis B virus studies (HIV EQA/1 and HBV EQA/1) and the fifth hepatitis C virus study (HCV EQA/5).

BACKGROUND AND OBJECTIVES: This External Quality Assessment (EQA) study was aimed at assessing the proficiency of blood centres and blood product manufacturers in detecting, by nucleic acid amplification technology (NAT), the possible contamination of plasma with hepatitis C virus (HCV), human immunodeficiency virus (HIV) and hepatitis B virus (HBV). MATERIALS AND METHODS: Three independent panels, one for each virus, were prepared at the Istituto Superiore di Sanità (ISS) by diluting the respective reference preparations. NAT methods used by the EQA participants included polymerase chain reaction (PCR) assays by Roche, transcription-mediated amplification (TMA) assays by Chiron and in-house PCR assays. RESULTS: Forty-three of the 45 participants (95.6%) in the HCV EQA/5 who used a validated method were consistently able to detect a nominal concentration of 100 IU/ml for all six major genotypes. In the case of the HIV EQA/1, all 35 participants detected the samples containing 1000 IU/ml HIV, while five (14.3%) did not identify the samples containing 100 IU/ml HIV. With respect to the HBV EQA/1, all 16 participants correctly identified the positive samples containing either 1000 IU/ml or 100 IU/ml HBV. No false-positive results were observed with any of the three panels. CONCLUSIONS: The HCV EQA/5 showed an improved proficiency of laboratories as compared with the HCV EQA/4. In fact, HCV genotypes 1, 2, 3 and 5 were correctly identified in 100% of the assays and genotypes 4 and 6 in 97.8% of the assays. While most of the participants in the HIV EQA/1 showed a good level of proficiency, an excellent performance was shown by all participants in the HBV EQA/1.

High proficiency in detecting the six major hepatitis C virus genotypes of laboratories involved in testing plasma by nucleic acid amplification technology.

Since the introduction of mandatory HCV RNA testing of plasma pools for fractionation by nucleic acid amplification technology, we have organised External Quality Assessment studies (EQAs) addressed to blood products manufacturers and blood centres. Here we report the results of a new EQA, the first one to include all six major HCV genotypes. The results, reported by laboratories worldwide, showed that genotypes 1, 2 and 3 were correctly identified in 100% of the tests, genotype 4 in 96.7% and genotypes 5 and 6 in 98.3% of the assays. As detection of all HCV genotypes is critical for laboratories involved in testing plasma for HCV, all six genotypes should continue to be included in the next EQA studies.