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Il Point-Of-Care TEsting: una sfida alla pratica tradizionale del laboratorio clinico

Mario Plebani
Dipartimento Medicina di Laboratorio. Azienda Ospedaliera-Università di Padova e Centro di Ricerca Biomedica c/o Ospedale Civile di
Castelfranco Veneto (TV)

Biochimica Clinica: 2004; 28(5-6): 523-531 [Article in italian]

ABSTRACT. In the last decades, clinical laboratories have experienced a significant increase of workload and productivity, and a simultaneous decrease in overall cost for test. However, the responsiveness, as expressed as the time to return a test result or test turnaround time (TAT) to Emergency Department (ED) has not improved in US hospitals, as well as, possibly, in our Country. In fact, when considering the TAT as order-to-reporting, a growing body of evidence has been accumulated to demonstrate that analytical steps do not represent major critical factors, while pre-analytical (specimen collection and transport), and post-analytical (reporting and clinicians' reaction to results) steps significantly affect the final TAT. In a College of American Pathologists Q-Probe study, it was demonstrated that only 28% of delays in TAT were caused by the analytical phase, most delays being associated with pre-, and post-analytical steps. In the changing scenario of the healthcare system, hospitals are more and more involved in the treatment of acute disease, and clinical laboratories have to increase their efficiency. Therefore, laboratory professionals, who are requested to reduce costs, simplify processes and decrease the staff number, have considered the possibility to consolidate stat testing into routinary work as a result of the improved productivity and flexibility of laboratory automation. In many situation, it is faster to perform both routine and stat testing with the priority of stat testing, thereby simplifying laboratory processes at the same time TAT is improved. However, this TAT does not satisfy ED physicians, who may require to activate Point of Care testing (POCT) to shorten the time between request and results, thus improving clinical decision making and patient management. The creation of large core laboratories as the centrepiece of multitrust pathology consortiums will increase the demand for Point of Care testing unless transport of specimens and information technol-ogy facilities are radically improved. The critical revision of current literature clearly demonstrates that:a) it has not been unequivocally proven that POCT results in a reduced length of say, an increased hospital discharge rate, and reduced morbidity and mortality rates.b) Uncritical and unjustified expansion of POCT provides more data and more costs rather than reliable information and benefit.c) Depending on the local situation, a consensus has to be achieved among clinicians and laboratory professionals both on the real need of POCT, as well as on types of tests and instrumentations.d) POCT should be rigorously restricted to the measurement of vital function with a requirement for an immediate therapeutic response, for example blood glucose and electrolytes (sodium, potassium, ionized calcium) measurement.e) Not always faster is better. A prerequisite for POCT is the assessment and continuous improvement of total quality, including quality of devices, internal and external quality control and training of personnel.It is time to re-evaluate the true clinical needs to better define quality specifications of laboratory tests, includin a turn-around time. POCT cannot be regarded as a surrogate answer or palliative response to the information gaps experienced in the emergency departments. Today, the most common information gap is laboratory information as a result of the evidence that care is fragmented and that different sectors of the healthcare system do not communicate each other. A patient-centred organization is the unique solution for better defining, implementing and monitoring a TAT wich can assure efficiency and effectiveness to the management of patients with life-threatening conditions and for early therapeutic interventions. Also in primary care, the use of POCT should be considered if it really produces benefits to the diagnostic or treatment strategy, and thus overall health outcomes.

Emogasanalisi

Paola Pezzati, Michele Tronchin e Gianni Messeri
Dipartimento Diagnostica di Laboratorio-Azienda Ospedaliera Universitaria Careggi, Firenze

Biochimica Clinica: 2004; 28(5-6): 532-541 [Article in italian]

ABSTRACT. Blood gas analysis is a very important tool in diagnosing and monitoring respiratory parameters. Critical patients, which require rapid therapeutic interventions, are often monitored with these analyzers. As a matter of fact, blood gas analysis is particularly important in two main kind of respiratory pathology (ipoxemia/hypercapnia and acidosis/alkalosis) but present technology widens dramatically the original panel (pH, PaCO2 and PaO2) making blood gas analyzers seem "small laboratories" typical of a POC. In this paper, we will first recall respiratory physiopathology. Clinical indication for blood gas analysis, data usage and interpretation will follow. After treating the technology of this kind of devices critical factors will be exposed and indications for decentralization will be discussed.

Il Point of Care in Coagulazione

Rita Paniccia^1,2, Domenico Prisco^1,2
1Dipartimento di Area Critica Medico-Chirurgica, Sezione e di Clinica Medica Generale e Cliniche Specialistiche, Università degli Studi di Firenze
²Centro Trombosi. Dipartimento del Cuore e dei Vasi, Azienda Ospedaliero-Universitaria Careggi, Firenze

Biochimica Clinica: 2004; 28(5-6): 542-551 [Article in italian]

ABSTRACT. Point-of-care testing in coagulation is spreading out and decentralizing in different clinical settings. The most widespread applications concern: 1) the monitoring of anticoagulation by high-level heparin during cardiopulmonary bypass and catheterization procedures, 2) the guidance of transfusion therapy, 3) the monitoring of low-level heparin treatment and 4) the monitoring of oral anticoagulation therapy. To introduce the point-of-care testing in coagulation in these clinical settings, an aimed approach based on the use of data from clinical outcome studies and on the organization of non-specialized staff training-courses in the different wards and of the quality control of tests and devices are necessary.

Ruolo del point of care nella gestione del diabete mellito

Stefano Rapi e Alessandra Fanelli
Laboratorio Generale Azienda Ospedaliero-Universitaria Careggi, Firenze

Biochimica Clinica: 2004; 28(5-6): 552-556 [Article in italian]

ABSTRACT. Portable meters are not recommended in the diagnostic phase but they are very important in achieving and maintaining glycemic control in diabetic patients. Use of glucometer devices are unquestionable in self monitoring and patient's bedside in hospitals and clinics. Performance of modern device are consistent with technical and analytical requirements but operator's adequate education is mandatory in order to obtain clinicallly significant results. New technologies, non invasive and minimally invasive, studied for glucose testing may produce interesting improvements. More questioned is the utility of portable devices for microalbuminuria and glycated haemoglobin determination.

Point of Care per le emergenze su un territorio insulare: l'esperienza dell'Ospedale di Venezia

Gabriella Azzarini*, Giovanni Cocco*, Daniela Contri*, Daniela Durante°, Maria Rotolo*, Ferdinando Tonin°, Fabrizio Uliana°, Giorgio Vallotto*, Massimo Gion*
*U.O. Laboratorio Analisi Cliniche e Microbiologiche Azienda ULSS 12 Veneziana-Sede Ospedale Civile Venezia
° U.O. Punto di Primo Intervento-Sede Ospedale al Mare del Lido di Venezia

Biochimica Clinica: 2004; 28(5-6): 557-562 [Article in italian]

ABSTRACT. The need to carry out diagnostic tests for emergency situations, in hard to reach areas without healthcare units, determined the Point Of Care Testing (POCT) deployment within "Ospedale al Mare" at Lido, Venice. In this site, the most common tests for emergencies are carried out by nurses in the First Aid Point (FAP) under the supervision of Laboratory-core personnel, who, in order to do this, makes use of a dedicated management software. The positive outcome has subsequently led to the POCT deployment in other Operative Units in the same Healthcare Unit in Venice.

Le Analisi Decentrate presso l'ospedale di Trecenta. Tecnologie, addestramento, qualità e connettività consentono una chiara definizione delle responsabilità ed una organizzazione centrata sul paziente

Francesco Carmignoto, Alessandro Camerotto
Dipartimento di Patologia Clinica, ULSS n. 18, Rovigo
Servizio di Medicina di Laboratorio, Ospedale S. Luca di Trecenta

Biochimica Clinica: 2004; 28(5-6): 563-568 [Article in italian]

ABSTRACT. The managing of laboratory assays in decentralized POCT structures is a relevant topic in the discussion about outlook and development of Laboratory Medicine. The organization implemented at the Hospital of Trecenta ( ULSS n. 18, Rovigo), in order to carry out urgent tests in POCT, gives us the opportunity to address the problems related in particular to the assumption of the liability of the results. The two Laboratory structures located by the hospital wards (Emergency Department and Division of Geriatric Medicine) are managed according to procedures of the Laboratory Quality Assurance System, certified as ISO 9001:2000. We obtained the full sharing of the managing rules with the clinicians and the General Management. After the selection of tests to be carried out and a appropriate ECM training of the nursery employees, the managing system, the quality controls and all managing procedures have been approved as a direct responsibility of the Laboratory Medicine Department. The two POCT structures are available during the night service from march 2003. All the procedures are activated in total connectivity, in particular the managing of technologies and of quality control, the error checking and the training of operators, the perfect traceability of samples and results, the correct preservation of materials, the managing of archives in the laboratory informatics' system. Together with the sharing of the adopted rules by the General Management and the clinicians, the hight level of connectivity allows a correct assumption of liability. The authors are convinced that all the above might be a crucial point to clearly define, once and for all, that the professional ownership of the laboratory tests, wherever they are taken, belongs to the Laboratory Medicine.

Gestione degli esami di emergenza in Point of Care: l’esperienza di tre ospedali con il servizio di laboratorio totalmente esternalizzato

Alberto Dolci, Emanuela Ferrari, Massimo Barberis
Dipartimento di Patologia MultiLab, Gruppo MultiMedica, Milano

Biochimica Clinica: 2004; 28(5-6): 569-578 [Article in italian]

ABSTRACT. Point-of-care testing technologies (POCT) are a well established choice for emergency blood testing at the site of patient care delivery. We describe the realization, analitycal validation and 14 months results of 8 sites POCT network at MultiMedica, a private healthcare group consisting of 3 hospitals and a central outsourced laboratory. On 37 POCT systems, all provided by Roche Diagnostics (6 blood gas analyzers, 14 coagulometers, 3 blood cell counters, 11 cardiac markers systems and 3 reflectometers) we checked validity by comparing their results to those obtained on laboratory analyzers with acceptable correlations for all analytes. During 14 months of activity we performed 76225 tests and 22319 IQC assays, finding some analitycal problems only on bilirun assay. POCT are validated, rapid and reliable assays to manage emergency tests in hospitals after laboratory outsourcing.

POCT sull’isola di Procida: l’attività diagnostica d’emergenza garantita 24 ore

Reginaldo Iovine
Dipartimento di Patologia Clinica, Azienda Sanitaria Locale "Napoli 2

Biochimica Clinica: 2004; 28(5-6): 579-582 [Article in italian]

ABSTRACT. This work describes the path followed by the Azienda Sanitaria Locale (local health agency) “Napoli 2” to meet the needs for emergency laboratory services, originating on the island of Procida. The solution has been found in an organization model based on the adoption of extremely easy to use equipment. This can also be operated by non-specialized laboratory personnel and is connected with the Clinic Pathology Laboratory in Pozzuoli’s Hospital via ISDN. The specific operation procedures both for the POCT workers and for the Laboratory personnel in charge of the periodical support activity are reported.

Sistema di analisi decentrate (POCT). Motivazioni della scelta e prime valutazioni

Gabriella Maritano, Giovanni Orso Giacone, Angela Andriotta
Dipartimento Servizi Diagnostici ASL 5 del Piemonte, Laboratorio Analisi di Avigliana

Biochimica Clinica: 2004; 28(5-6): 583-585 [Article in italian]

ABSTRACT. Here are described the reasons that hare led to the choice of a POCT in the emergency facility of the Hospital of Avigliana (Turin), the management formalities of the same exam, the experience of the first working operating year and the relative statistics.

L'esperienza di Careggi: il controllo centralizzato degli emogasanalizzatori

Michele Tronchin, Silvia Artioli, Stefano Salti, Giacomo Targioni
Laboratorio Generale Dipartimento Diagnostica di Laboratorio -Azienda Ospedaliero-Universitaria Careggi-Firenze

Biochimica Clinica: 2004; 28(5-6): 586-593 [Article in italian]

ABSTRACT. The experience at the hospital of Firenze. Centralized control of blood gas analyzers.
The Azienda Ospedaliero-Universitaria Careggi, is equipped with 28 blood gas analyzers (ABL, Radiometer, Copenaghen) widespread over a 1.5 squared kilometers. The instruments were connected to a workstation installed in the Central Laboratory and monitored by dedicated software. This paper reports the experience of a centralized managing of the instrumentation and most of all the evaluation of their stability with respect to the nature of the ward and to the intervention of the central laboratory staff. An active monitoring process, a continuous educational program and few direct actions greatly improved the performances of the instruments, regardless the nature of the ward.

Il governo clinico del Point of Care Testing: un documento aperto alla discussione

Mario Plebani¹, Paolo Carraro¹, Anna Cremaschi², Silvia Mengozzi³, Gianni Messeri⁴, Massimo Tocchini⁵, Tommaso Trenti^6
1Dipartimento Medicina di Laboratorio, Azienda Ospedaliera-Università di Padova
²Ufficio Qualità, Azienda Ospedaliera di Treviglio (BG)
³Laboratorio Analisi Chimico-Cliniche e Microbiologia, AUSL Cesena,
⁴Dipartimento Diagnostica di laboratorio, Azienda Ospedaliera Universitaria Careggi, Firenze
⁵Laboratorio Analisi Chimico-Cliniche, Azienda Ospedaliera Universitaria, Ancona
⁶Dipartimento Patologia Clinica, AUSL Modena
Biochimica Clinica: 2004; 28(5-6): 594-597 [Article in italian]

ABSTRACT. Point of care testing (POCT) encompasses a range of testing of many analytes across laboratory medicine. POCT is capable of delivering results in a timely manner that allow clinical decisions to occur quickly, potentially allowing better clinical and economical outcomes. However, its widespread use must be considered carefully to ensure that it is used safely, effectively and economically. In particular, some guidelines have to be implemented to assure an appropriate training of the personnel, the implementation and dissemination of standard operating procedures and an effective quality control of the results. The role of laboratory scientists in assuring an effective management of all these points is mandatory.

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