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Biomedical subjects

J F Quaranta

Publications and source records attributed to J F Quaranta.

At least 19 recordsLinked to original sources
PubMed2004

[The responsibility of the physician prescriber of blood products].

Blood transfusion presents mainly virological, bacteriological, immunohaematological and volemic risks; with the latter two particularly concerning health establishment employees. This article tackles the physician's responsibility in blood transfusion. Taking into account the regulations that surround the activity, prescribing physicians must know and put into action the relative requirements in their practises in order to avoid taking on its responsibility, or that of the health establishment in which they work, as any lack of respect for the rules and regulations could result in being held liable for any side affects suffered by the patient. The article has the objective of identifying the main regulation requirements in order to control them despite a difficult environment, from the point of view of patients' rights regarding the benefits and the consequences of transfusion. These requirements focus mainly on information and patient consent, the prescription of blood products as well post transfusion information and the follow-up care. Proof of respect for these rule requirements must be available for each of these aspects.

Blood Component Transfusion↗
PubMed2003

[How the information system can contribute to the implementation of a risk management program in a hospital?].

Nowadays, information system is recognised as one of the key points of the management strategy. An information system is regarded conceptualised as a mean to link 3 aspects of a firm (structure, organisation rules and staff). Its design and implementation have to meet the objectives of medical and economical evaluation, especially risk management objectives. In order to identify, analyse, reduce and prevent the occurrence of adverse events, and also to measure the efficacy and efficiency of the production of care services, the design of information systems should be based on a process analysis in order to describe and classify all the working practices within the hospital. According to various methodologies (usually top-down analysis), each process can be divided into activities. Each activity (especially each care activity) can be described according to its potential risks and expected results. For care professionals performing a task, the access to official or internal guidelines and the adverse events reporting forms has also to be defined. Putting together all the elements of such a process analysis will contribute to integrate, into daily practice, the management of risks, supported by the information system.

Delivery of Health Care↗
PubMed2002

[Biovigilance, a vigilance exercised on the utilization of products obtained from the human body].

Organ transplantations and tissue/cells grafts are efficacious in many diseases. Nevertheless, beside the risk due to the technology which permits to carry out transplantations and grafts (surgery, tissue and cells collection, preservation, storage, cell expansion technics, immunosuppressive regimen,...), the microbiology risk must be controlled throughout the process leading to the transplantation or the graft. The structures, the organizations, the procedures, the information network and the controls assure the control of the risk. It is the main objective of human product vigilance. Future regulations will define the objectives of this sanitary vigilance more precisely.

Algorithms↗
PubMed2001

Modelling health care processes for eliciting user requirements: a way to link a quality paradigm and clinical information system design.

Healthcare institutions are looking at ways to increase their efficiency by reducing costs while providing care services with a high level of safety. Thus, hospital information systems have to support quality improvement objectives. The elicitation of the requirements has to meet users' needs in relation to both the quality (efficacy, safety) and the monitoring of all health care activities (traceability). Information analysts need methods to conceptualise clinical information systems that provide actors with individual benefits and guide behavioural changes. A methodology is proposed to elicit and structure users' requirements using a process-oriented analysis, and it is applied to the blood transfusion process. An object-oriented data model of a process has been defined in order to organise the data dictionary. Although some aspects of activity, such as 'where', 'what else', and 'why' are poorly represented by the data model alone, this method of requirement elicitation fits the dynamic of data input for the process to be traced. A hierarchical representation of hospital activities has to be found for the processes to be interrelated, and for their characteristics to be shared, in order to avoid data redundancy and to fit the gathering of data with the provision of care.

Cost Control↗
PubMed2001

Towards health care process description framework: an XML DTD design.

The development of health care and hospital information systems has to meet users needs as well as requirements such as the tracking of all care activities and the support of quality improvement. The use of process-oriented analysis is of-value to provide analysts with: (i) a systematic description of activities; (ii) the elicitation of the useful data to perform and record care tasks; (iii) the selection of relevant decision-making support. But paper-based tools are not a very suitable way to manage and share the documentation produced during this step. The purpose of this work is to propose a method to implement the results of process analysis according to XML techniques (eXtensible Markup Language). It is based on the IDEF0 activity modeling language (Integration DEfinition for Function modeling). A hierarchical description of a process and its components has been defined through a flat XML file with a grammar of proper metadata tags. Perspectives of this method are discussed.

Blood Transfusion↗
PubMed2000

[Materials surveillance, a surveillance performed on the use of medical devices].

One of the missions of the Agence Française due Sang was to set up a haemovigilance system based on a national network of surveillance and alert, for the whole blood chain from blood collection to receivers' follow-up. This system is now operational and contributes with efficacy to the safety of blood transfusions (see: A quoi sert l'hémovigilance? Transfus Clin Biol 1998; 5: 415-21.). The French law No. 98-535 dated July 1st 1998, whose enforcement orders were published in March 1999, is the legal foundation of the system. In this article the national and regional structures of the national system of sanitary safety are described, and the main guidelines of material vigilance, the last element of this system, is presented.

Blood Preservation↗
PubMed2000

[Computer-based hospital transfusion process: why and how does one establish a link between continuous quality improvement and clinical information system?].

Within a hospital, the need for a computer-based transfusion system has became mandatory. It facilitates the tracing of healthcare activities, which is the basis of the security of the care and a functional element of continuous quality improvement procedures. In order to implement this traceability, reactive and real-time information systems are needed close to healthcare participants, which is not the case of current information systems which rely on a recorded collection of data, far from the needs of the caregiver, and mainly answering to an objective evaluation of results. In the context of continuous quality improvement programmes started in our hospital, hemovigilance was the first to use a process analysis approach, from the prescription of blood units to their administration and follow-up. Several questions arise from this: 1) how to use the process analysis work to specify the users' needs of a generalized and real-time transfusion information system? 2) how to spread this model to other healthcare activities? 3) how to integrate or interface the whole of these quality programmes with a clinical information system? A user-centered methodology was used, based on 'usage cases'. For each step of the transfusion process, this method allowed us to specify participants, data necessary for an activity (observed, deduced or decision-support data), data issuing from the activity, roles (the interaction between user and activity) and functions (the result of the interaction between user and activity).

Blood Transfusion↗
PubMed2000

Integration of health care process analysis in the design of a clinical information system: applying to the blood transfusion process.

Hospital information systems have to support quality improvement objectives. The requirements of the system have to meet users' needs in relation to both the quality (efficacy, conformity, safety) and the monitoring of all health care activities (traceability). Information analysts need complementary methods to conceptualize clinical information systems that provide actors with immediate individual benefits and guide collective behavioral changes. A methodology is proposed to elicit users' needs using a process-oriented analysis, and it is applied to the field of blood transfusion. We defined a process data model, the main components of which are: activities, resources, constrains, guidelines and indicators. Although some aspects of activity, such as "where", "what else", and "why" are poorly represented by the data model alone, this method of requirement elicitation fits the dynamic of data input for the process to be traced. A hierarchical representation of hospital activities has to be found for this approach to be generalised within the organisation, for the processes to be interrelated, and for their characteristics to be assessed.

Blood Transfusion↗
PubMed2000

Modelling health care processes for eliciting user requirements: a way to link a quality paradigm and clinical information system design.

Hospital information systems have to support quality improvement objectives. The design issues of health care information system can be classified into three categories: 1) time-oriented and event-labelled storage of patient data; 2) contextual support of decision-making; 3) capabilities for modular upgrading. The elicitation of the requirements has to meet users' needs in relation to both the quality (efficacy, safety) and the monitoring of all health care activities (traceability). Information analysts need methods to conceptualize clinical information systems that provide actors with individual benefits and guide behavioural changes. A methodology is proposed to elicit and structure users' requirements using a process-oriented analysis, and it is applied to the field of blood transfusion. An object-oriented data model of a process has been defined in order to identify its main components: activity, sub-process, resources, constrains, guidelines, parameters and indicators. Although some aspects of activity, such as "where", "what else", and "why" are poorly represented by the data model alone, this method of requirement elicitation fits the dynamic of data input for the process to be traced. A hierarchical representation of hospital activities has to be found for this approach to be generalised within the organisation, for the processes to be interrelated, and for their characteristics to be shared.

Blood Transfusion↗
PubMed1999

[Risk management program in a health facility using a project approach: transfusion risk management].

Risk management in the hospital, which is one of the referentiels of the ANAES accreditation manual, may be considered on two levels. Firstly, risk management may be approached globally, in the same way as it is tackled in the accreditation process. Secondly, risk management may be more definite. A specific risk chosen in accordance with the priorities of a particular plan may be dealt with individually. In this respect, the tranfusion process allows the risk management method to be tested and developed. f1

Blood Banks↗
PubMed1999

Occurrence of Leishmania infantum parasitemia in asymptomatic blood donors living in an area of endemicity in southern France.

Visceral leishmaniosis (VL) due to Leishmania infantum (L. chagasi) is a lethal disease if untreated, but asymptomatic L. infantum infections have been reported previously. A better understanding of parasite transmission, dissemination, and survival in the human host is needed. The purpose of this study was to assess whether L. infantum circulated in peripheral blood of subjects with no history of VL. Sera from 565 blood donors were screened by Western blotting to detect Leishmania-specific antibodies and identify individuals with probable past exposure to Leishmania. Seropositivity was found in 76 donors whose buffy coats were examined by PCR and direct culture. The parasite minicircle kinetoplast DNA was amplified from blood samples of nine donors. Promastigotes were detected by culture in blood samples from nine donors. Only two donors were PCR and culture positive. These results indicate that L. infantum circulates intermittently and at low density in the blood of healthy seropositive individuals, who thus appear to be asymptomatic carriers. Implications for the safety of blood transfusion are discussed.

Animals↗
PubMed1998

Visceral leishmaniosis in HIV-positive patients: primary infection, reactivation and latent infection. Impact of the CD4+ T-lymphocyte counts.

OBJECTIVE: To discriminate cases of visceral leishmaniosis (VL) following a primary infection from cases originating in a reactivation of a latent Leishmania infection and to assess the impact of CD4+ T-cell counts on the occurrence of VL in patients with HIV disease. METHODS: We searched by Western blotting for the presence of Leishmania infantum-specific antibodies in the sera of 236 HIV-positive patients. We performed a follow-up of antileishmanial serology and analysed the evolution of the CD4+ T-cell counts for 14 HIV-positive VL patients and for 18 HIV-positive Leishmania-seropositive patients without VL. RESULTS: This study (1) showed that the VL disease/Leishmania infection ratio in HIV-positive individuals is high (1 : 10); (2) discriminated between a primary Leishmania infection (five patients who converted from Leishmania-seronegative to Leishmania-seropositive) and a reactivation of a latent infection (seven patients); (3) showed that HIV-positive individuals with dramatically low CD4+ T-cell counts maintained or generated a specific antileishmanial antibody production; (4) demonstrated that the primary-VL appeared at significantly higher (P = 0.028) CD4+ T-cell levels than the reactivation-VL; (5) documented the existence of HIV-positive Leishmania-seropositive individuals who despite a severe and prolonged immunosuppression did not develop VL (eight of 18). CONCLUSION: Our data stress the utility of the follow-up by Western blotting for an early diagnosis of VL, and therefore an early treatment, for HIV-positive patients living in endemic areas. They suggest that in a latent Leishmania infection supplementary control mechanism(s) might operate in addition to the T-cell-mediated response, and provide a further example of non-appearance of an opportunistic infection despite a severe reduction in CD4+ T cells.

AIDS-Related Opportunistic Infections↗
PubMed1998

[Data interchange in blood transfusion: the impact of a new standard on the evolution of health electronic data exchange in France].

The sanitary and social data interchange within care establishments or networks is today the subject of many national or international considerations. Electronic data interchange in the health field has characteristics linked to ethical and deontological principles of care staff. Used daily, this tool contributes to the quality of care, to the optimization of patient treatment and to the organization of the system care. In the transfusion field, the standardization of messages related to the traceability of blood products in now required by the No. 2 instruction of French Blood Agency, which rules the using of national norms elaborated by the French Agency of Normalization. If the technicality is the greater part of these regulated and formalized messages, this standardization systematizes and justifies the nominative and ciphered data interchange in an open environment, opening a new dimension in the interoperability of data system between care establishments. This article analyzes the characteristics and the potential impact of this normalization on the evolution of the electronic data interchange in the health field.

Blood Transfusion↗
PubMed1998

[What is the use of hemovigilance?].

The French Blood Agency has developed a national system of surveillance and alert, from blood collection to the follow-up of the recipients, called haemovigilance. The French haemovigilance network is now operational, and aims at detecting, gathering and analysing unexpected or undesirable effects associated with transfusion in order to remedy their causes and prevent their recurrence. Thanks to 1) traceability of blood products from donors to recipients, 2) spontaneous reports of transfusion adverse events, and 3) rigorous management of information related to the transfusion process, haemovigilance effectively contributes to blood transfusion safety.

Blood Banks↗
PubMed1997

[Implementation of a continuous quality improvement program in transfusion medicine].

The transfusion safety is one of the themes of National Quality Assurance Programme 1995/1996 (National Agency for the Promotion of Medical Evaluation-ANDEM/Direction des Hôpitaux (National Hospital Authority)). The Quality Assurance Programme (QAP) in transfusion medicine of our University Hospital has been selected. The QAP is a prospective and normative programme, in which all the actors of the transfusion process are involved. The goals are: i) to assure the quality and the safety of the blood products delivered all along the chain leading to blood or blood components transfusion; ii) the guarantee of the exhaustiveness and the quality of information about the transfusion process that are used to mark out blood products; iii) the standardization of the different steps and the creation of "tools" in order to control the application of written procedures.

Blood Transfusion↗
PubMed1996

[Immediate and late complications of human albumin use].

Human albumin, considered as the most physiological solution for volume loading, devoid of viral risk due to the procedure of preparation, presents an excellent innocuousness. Some anaphylactoid reactions, ranging from erythema to cardiac arrest, have been reported. However, these are less frequent now, with the current techniques of purification. Renal, cardiac and respiratory complications may occur more frequently in patients presenting with severe injuries. The contamination of albumin by metals, especially by aluminium, is well documented. It requires appropriate procedures of manufacturing, and the information of the users about the residual concentration of aluminium. Albumin is a replacement solution which is safe with regard to the infectious risk, insofar as the production process is well controlled. However, human albumin should not escape the vigilance rules which guarantee, in the long term, an optimal safety.

Albumins↗