Gestión de calidad en equipos de gases en sangre POCT. Expandiendo las fronteras del laboratorio / Quality management in POCT blood gas equipment. Expanding the frontiers of the laboratory

La realización de pruebas de laboratorio en el lugar de atención del paciente (POCT) de equipos de gases en sangre representa un desafío continuo tanto para los usuarios como para el laboratorio. La vulnerabilidad al error y la amenaza del riesgo que rodea esta forma de trabajo obliga a establecer un sistema de trabajo robusto para la obtención de un "resultado confiable" cerca del paciente crítico. La formación de un grupo interdisciplinario, la capacitación de usuarios externos al laboratorio, el aseguramiento de la calidad analítica y la conectividad, son los cuatro pilares sobre los cuales se sostiene el éxito de esta nueva era de laboratorio clínico. Además es necesaria la reinvención de la imagen bioquímica, asumiendo un rol de líder, comunicador, asesor e integrado al sistema de salud (AU)

Point of care laboratory testing (POCT) with blood gas equipment is an ongoing challenge for both the users and the laboratory. The vulnerability to error and the threat of risk that surrounds this way of working necessitates the establishment of a robust working system to obtain "reliable results" for the critically ill patient. The creation of an interdisciplinary group, the training of external users, analytical quality assurance, and connectivity are the four pillars on which the success of this new era of clinical laboratories is based. It is also necessary to reinvent the biochemical image, assuming the role of leader, communicator, and advisor integrated into the health system (AU)

Adaptarnos para sobrevivir. Requerimientos de un nuevo paradigma / Adapting to survive. Requirements for a new paradigm

A lo largo de la historia, el rol del bioquímico en el laboratorio clínico ha ido mutando, adaptándose a nuevos paradigmas, consecuencia del avance de la tecnología1 y la informática, de la presión externa ejercida por las empresas proveedoras de reactivos que reducen el tiempo útil de los equipos, aumentando su tasa de recambio, de una medicina más compleja que impone nuevos desafíos diagnósticos y de los cambios sociales que se ven reflejados en una alteración en el orden de los valores adoptado por las nuevas generaciones de profesionales que conviven con otras, provocando "turbulencia generacional" en los lugares de trabajo. Los laboratorios necesitan hoy someterse a una reingeniería de sus procesos, descartar aquellos que no agreguen valor, que causan fugas innecesarias de insumos, personas y tiempo e intervenir la cultura organizacional de manera integral, para adaptarse a las exigencias que la actualidad requiere, donde la calidad, la seguridad y la sostenibilidad son los principales protagonistas )AU)

Over time, the role of the biochemist in the clinical laboratory has been changing, adapting to new paradigms, as a consequence of the advance of technology and informatics, of the external pressure exerted by the companies supplying reagents that reduce the useful time of the equipment, increasing its replacement rate, of a more complex medicine that imposes new diagnostic challenges, and of social changes that are reflected in an alteration in the values adopted by the new generations of professionals who coexist with others, causing "generational turbulence" in the workplace. Laboratories today need to reengineer their processes, eliminate those that do not add value, that cause unnecessary waste of supplies, people and time, and intervene in the organizational culture in a comprehensive manner, in order to adapt to the demands of today's world, where quality, safety, and sustainability are the main drivers (AU)

Una experiencia de siete años en el laboratorio de Micología del Hospital de Pediatría Juan P. Garrahan / A seven-year experience in the Mycology Laboratory of Hospital de Pediatría Juan P. Garrahan

En noviembre del año 2015 nos incorporamos al Laboratorio de Micología del Servicio de Microbiología del Hospital Garrahan. En este breve resumen queremos compartir los avances logrados a través de nuestra experiencia durante siete años de trabajo profesional. Debido a los diagnósticos realizados y su complejidad, consideramos que el Hospital Garrahan, sus pacientes y la comunidad toda necesitan contar con un laboratorio de Micología que responda a sus necesidades. Creemos haber iniciado un camino que esperamos continúe y culmine con la creación de la Unidad de Micología (AU)

In November 2015 we joined the Mycology Laboratory of the Microbiology Service of the Hospital Garrahan. In this brief summary we want to share the advances achieved through our experience during seven years of professional work. Due to the diagnosis made and their complexity, we believe that the Hospital Garrahan, its patients and the entire community, need to have a Mycology laboratory that responds to their requirements. We believe we have started a path that we hope will continue and culminate with the creation of the Mycology Unit (AU)

COVID-19 Pandemic Planning: Simulation Models to Predict Biochemistry Test Capacity for Patient Surges.

BACKGROUND: Patient surges beyond hospital capacity during the initial phase of the COVID-19 pandemic emphasized a need for clinical laboratories to prepare test processes to support future patient care. The objective of this study was to determine if current instrumentation in local hospital laboratories can accommodate the anticipated workload from COVID-19 infected patients in hospitals and a proposed field hospital in addition to testing for non-infected patients. METHODS: Simulation models predicted instrument throughput and turn-around-time for chemistry, ion-selective-electrode, and immunoassay tests using vendor-developed software with different workload scenarios. The expanded workload included tests from anticipated COVID patients in 2 local hospitals and a proposed field hospital with a COVID-specific test menu in addition to the pre-pandemic workload. RESULTS: Instrumentation throughput and turn-around time at each site was predicted. With additional COVID-patient beds in each hospital, the maximum throughput was approached with no impact on turnaround time. Addition of the field hospital workload led to significantly increased test turnaround times at each site. CONCLUSIONS: Simulation models depicted the analytic capacity and turn-around times for laboratory tests at each site and identified the laboratory best suited for field hospital laboratory support during the pandemic.

Global impact of the COVID-19 pandemic on cytopathology practice: Results from an international survey of laboratories in 23 countries.

BACKGROUND: To the authors' knowledge, the impact of the coronavirus disease 2019 (COVID-19) pandemic on cytopathology practices worldwide has not been investigated formally. In the current study, data from 41 respondents from 23 countries were reported. METHODS: Data regarding the activity of each cytopathology laboratory during 4 weeks of COVID-19 lockdown were collected and compared with those obtained during the corresponding period in 2019. The overall number and percentage of exfoliative and fine-needle aspiration cytology samples from each anatomic site were recorded. Differences in the malignancy and suspicious rates between the 2 periods were analyzed using a meta-analytical approach. RESULTS: Overall, the sample volume was lower compared with 2019 (104,319 samples vs 190,225 samples), with an average volume reduction of 45.3% (range, 0.1%-98.0%). The percentage of samples from the cervicovaginal tract, thyroid, and anorectal region was significantly reduced (P < .05). Conversely, the percentage of samples from the urinary tract, serous cavities, breast, lymph nodes, respiratory tract, salivary glands, central nervous system, gastrointestinal tract, pancreas, liver, and biliary tract increased (P < .05). An overall increase of 5.56% (95% CI, 3.77%-7.35%) in the malignancy rate in nongynecological samples during the COVID-19 pandemic was observed. When the suspicious category was included, the overall increase was 6.95% (95% CI, 4.63%-9.27%). CONCLUSIONS: The COVID-19 pandemic resulted in a drastic reduction in the total number of cytology specimens regardless of anatomic site or specimen type. The rate of malignancy increased, reflecting the prioritization of patients with cancer who were considered to be at high risk. Prospective monitoring of the effect of delays in access to health services during the lockdown period is warranted.

Description of a new biosafe procedure for cytological specimens from patients with COVID-19 processed by liquid-based preparations.

BACKGROUND: Coronavirus disease 2019 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and represents the causative agent of a potentially fatal disease. The spread of the infection and the severe clinical disease have led to the widespread adoption of social distancing measures. Special attention and efforts to protect or reduce transmission have been applied at all social levels, including health care operators. Hence, this reports focuses on the description of a new protocol for the safe management of cytological samples processed by liquid-based cytology (LBC) with an evaluation of the changes in terms of morphology and immunoreactivity. METHODS: From March 11 to April 25, 2020, 414 cytological cases suspicious for SARS-CoV-2 were processed with a new virus-inactivating method suggested by Hologic, Inc, for all LBC specimens. RESULTS: The samples showed an increased amount of fibrin in the background. A slight decrease in cellular size was also observed in comparison with the standard method of preparation. Nonetheless, the nuclear details of the neoplastic cells were well identified, and the immunoreactivity of the majority of those cells was maintained. The cell blocks did not show significant differences in morphology, immunoreactivity, or nucleic acid stability. CONCLUSIONS: Despite some minor changes in the morphology of the cells, the results of this study highlight that the adoption of the new protocol for the biosafety of LBC-processed samples in pathology laboratories is important for minimizing the risk for personnel, trainees, and cytopathologists without impairing the diagnostic efficacy of the technique.

[The future of automation in bacteriology]. / Automatisation en bactériologie : quel avenir ? Un exemple concret dans le cadre d'une consolidation de laboratoires universitaires.

Bacteriology remained essentially manual for many years. After a partial automation for blood cultures, identifications and sensitivity testing, new technological developments including robotisation and digital pictures made it possible to open new ways. In the context of economic pression and need to increase the quality, automation offers multiple advantages concerning increase of productivity, standardization, traceability and decreasing of the delay to obtain the results. Moreover the use of digitalized pictures opens the way to tele-bacteriology, particularly useful when considering the merging of hospital laboratories because it makes it possible to geographically dissociate strict manipulation from the validation of the results and from the consultant activity of the microbiologist. The choice criteria of the equipment are detailed as well as the experience of the LHUB-ULB bacteriological laboratory which was automated at the time of merging of the Brussels public hospital laboratories and developed a conclusive experience of tele-bacteriology for the peripheral lab.

Laboratory investigations in uveitis: current practice and future directions.

Diagnosis and management of uveitis always remains a challenge to the treating ophthalmologists. Rapid diagnosis and timely initiation of appropriate, effective treatment in uveitis are the critical determinants that lead to good visual outcome and reduce the risk of ocular morbidity. In the last decade, significant progress has been made in molecular diagnostic modalities and in development of newer diagnostic tools, which included serological tests and imaging techniques. However, a tailored approach to laboratory investigations based on meticulous history and comprehensive ocular evaluation has been propounded as the gold standard for successful management of an uveitic entity. In this article, we review the laboratory diagnostic tests in uveitis as well as recent technological advances in laboratory science, which may be the future direction for diagnosis of uveitis.

Total laboratory automation: Do stat tests still matter?

During the past decades the healthcare systems have rapidly changed and today hospital care is primarily advocated for critical patients and acute treatments, for which laboratory test results are crucial and need to be always reported in predictably short turnaround time (TAT). Laboratories in the hospital setting can face this challenge by changing their organization from a compartmentalized laboratory department toward a decision making-based laboratory department. This requires the implementation of a core laboratory, that exploits total laboratory automation (TLA) using technological innovation in analytical platforms, track systems and information technology, including middleware, and a number of satellite specialized laboratory sections cooperating with care teams for specific medical conditions. In this laboratory department model, the short TAT for all first-line tests performed by TLA in the core laboratory represents the key paradigm, where no more stat testing is required because all samples are handled in real-time and (auto)validated results dispatched in a time that fulfills clinical needs. To optimally reach this goal, laboratories should be actively involved in managing all the steps covering the total examination process, speeding up also extra-laboratory phases, such sample delivery. Furthermore, to warrant effectiveness and not only efficiency, all the processes, e.g. specimen integrity check, should be managed by middleware through a predefined set of rules defined in light of the clinical governance.

The Politics Underlying the Provision of and Changes in Pathology and Laboratory Services in the United States During the Roaring Twenties.

CONTEXT: -Prior to 1900, laboratory tests were simple enough to be performed by clinicians on the wards and most pathologists were academicians with little involvement in patient care issues. In the next 2 decades, laboratory test menus expanded rapidly and the increasing complexity of the tests created a potential niche for clinical pathologists (ie, pathologists providing patient-oriented anatomic and clinical pathology services). In the late 1910s and early 1920s, most of these services were provided by mail-order commercial laboratories or state public health laboratories rather than by hospital-based pathologists. OBJECTIVE: -To describe the political events in the 1920s that would drastically alter the practice of pathology and laboratory medicine and that would have been important to the discipline at the time the Archives of Pathology and Laboratory Medicine was being conceived and first published. DESIGN: -Available primary and secondary historical sources were reviewed. RESULTS: -In the 1920s, clinical pathologists organized, forming the American Society of Clinical Pathologists, and took on the powerful American Medical Association for permitting advertisements by private laboratories in the pages of the Journal of the American Medical Association that listed test prices as if these were commodities. They found a strong partner in the American College of Surgeons, which was attempting to elevate surgical practice by creating minimum standards for hospitals. Through this symbiotic relationship, hospital-based practice was firmly established and the commercial laboratory model faltered. CONCLUSIONS: -The Roaring Twenties was the time when the practice of pathology and laboratory medicine evolved into what we recognize today.

Trends of Mycobacterium bovis Isolation and First-Line Anti-tuberculosis Drug Susceptibility Profile: A Fifteen-Year Laboratory-Based Surveillance.

BACKGROUND: Mycobacterium tuberculosis causes the majority of tuberculosis (TB) cases in humans; however, in developing countries, human TB caused by M. bovis may be frequent but undetected. Human TB caused by M. bovis is considered a zoonosis; transmission is mainly through consumption of unpasteurized dairy products, and it is less frequently attributed to animal-to-human or human-to-human contact. We describe the trends of M. bovis isolation from human samples and first-line drug susceptibility during a 15-year period in a referral laboratory located in a tertiary care hospital in Mexico City. METHODOLOGY/PRINCIPAL FINDINGS: Data on mycobacterial isolates from human clinical samples were retrieved from the laboratory's database for the 2000-2014 period. Susceptibility to first-line drugs: rifampin, isoniazid, streptomycin (STR) and ethambutol was determined. We identified 1,165 isolates, 73.7% were M. tuberculosis and 26.2%, M. bovis. Among pulmonary samples, 16.6% were M. bovis. The proportion of M. bovis isolates significantly increased from 7.8% in 2000 to 28.4% in 2014 (X(2)trend, p<0.001). Primary STR resistance was higher among M. bovis compared with M. tuberculosis isolates (10.9% vs.3.4%, p<0.001). Secondary multidrug resistance (MDR) rates were 38.5% and 34.4% for M. bovis and M. tuberculosis, respectively (p = 0.637). A rising trend of primary STR monoresistance was observed for both species (3.4% in 2000-2004 vs. 7.6% in 2010-2014; p = 0.02). CONCLUSIONS/SIGNIFICANCE: There is a high prevalence and a rising trend of M. bovis isolates in our region. The proportion of pulmonary M. bovis isolates is higher than in previous reports. Additionally, we report high rates of primary anti-tuberculosis resistance and secondary MDR in both M. tuberculosis and M. bovis. This is one of the largest reports on drug susceptibility of M. bovis from human samples and shows a significant proportion of first-line anti-tuberculosis drug resistance.

The practice of clinical pathology: a quantitative description of laboratory director activities at a large academic medical center.

OBJECTIVES: The scope of activities performed by clinical laboratory directors is sometimes unfamiliar to other physicians or hospital administrators. Consequently, hospital leadership may undervalue the role and assume that many director level activities could be delegated to a professional manager. In this study, we sought to define the activities of academic laboratory directors, and to determine which activities require doctorate level medical or scientific expertise. METHODS: We performed an audit of laboratory director activities at a large academic medical center by reviewing electronic calendars and other available records from the preceding 12 consecutive months. For episodic activities, the directors estimated the average number of hours devoted over the 1-year period. RESULTS: On average, directors worked 54.9 hours per week and performed at least some service work 47.7 weeks per year. Administrative duties accounted for the greatest proportion of effort (47.1%), followed by clinical activities (33.1%) and academic activities (19.8%). Among administrative duties, those that required doctorate level medical or scientific expertise comprised 60.3% of the total administrative effort, whereas the remaining 39.7% (18.7% of total activity) could be performed by a professional manager.. CONCLUSIONS: Although the activities of clinical laboratory directors have been described elsewhere, this is the first study detailing the effort allocated to these various activities in quantitative terms. The study demonstrated that less than 20% of an academic laboratory director's effort involves administrative activities that could potentially be performed by a professional manager lacking doctorate level medical or scientific expertise.

Customising turnaround time indicators to requesting clinician: a 10-year study through balanced scorecard indicators.

AIM: The purpose of this study is, first to present a 10-year monitoring of postanalytical turnaround time (TAT) adapted to different clinicians and patient situations, second to evaluate and analyse the indicators results during that period of time, and finally to show a synthetic appropriate indicator to be included in the balanced scorecard management system. METHODS: TAT indicator for routine samples was devised as the percentage of certain key tests that were verified before a specific time on the phlebotomy day. A weighted mean synthetic indicator was also designed. They were calculated for inpatients at 15:00 and 12:00 and for primary care patients only at 15:00. The troponin TAT of emergency department patients, calculated as the difference between the troponin verification and registration time, was selected as the stat laboratory TAT indicator. RESULTS: The routine and stat TAT improved along the 10-year study period. The synthetic indicator showed the same trend. CONCLUSIONS: The implementation of systematic and continuous monitoring over years, promoted a continuous improvement in TAT which will probably benefit patient outcome and safety.

[Genomic medicine: the new way of thinking medicine present and future--Part two]. / La médecine génomique, une réalité en pleine évolution Deuxième partie.

New sequencing techniques are revolutionizing medical practice as its applications are numerous and considerable. We are living a technological turning point in molecular medicine. Indeed, thanks to these new machines, this technological leap allowed us to analyse the human genome with an elarged or even a total view. Genome analysis has applications in all medical fields from now on. Gene analysis in parallel with personalized therapy help in prolonged survival or even cures in some cancers or other diseases. Genetics is progressively arriving in every field of clinical practice. A new way of thinking clinics is born. This publication describes in its main lines these new applications, their problems and their challenges for geneticists as much as for other practitioners in the medical fields.

[Future roles of clinical laboratories and clinical laboratory technologists in university hospitals].

Clinical laboratories in university hospitals should be operated with a good balance of medical practice, education, research, and management. The role of a clinical laboratory is to promptly provide highly reliable laboratory data to satisfy the needs of clinicians involved in medical practice and health maintenance of patients. Improvement and maintenance of the quality of the laboratory staff and environment are essential to achieve this goal. In order to implement these requirements efficiently, an appropriate quality management system should be introduced and established, and evaluated objectively by a third party (e.g. by obtaining ISO 15189 certification). ISO 15189 is an international standard regarding the quality and competence of clinical laboratories, and specifies a review of the efficient operational system and technical requirements such as competence in implementing practical tests and calibration. This means the results of laboratory tests reported by accredited laboratories withstand any international evaluation, which is very important to assure the future importance of the existence and management of clinical laboratories as well as internationalization of medical practice. "Education" and "research" have important implications in addition to "medical practice" and "management", as the roles that clinical laboratories should play in university hospitals. University hospital laboratories should be operated by keeping these four factors in good balance. Why are "education" and "research" required in addition to "medical practice" services? If individual clinical laboratory technologists can provide an appropriate response to this question, the importance of the existence of clinical laboratories would be reinforced, without being compromised.