Estrategias para la reconversión del ejercicio profesional: Proyecto Bioquímico Nexo / Strategies for the reconversion of professional practice: Biochemical Nexus Project

El avance de la ciencia y la tecnología en el área de la bioquímica clínica ha ocasionado la necesidad de reflexionar acerca de una reingeniería de la práctica profesional. El proceso diagnóstico es complejo y dinámico, requiere del trabajo interdisciplinario y de la comunicación efectiva, además de un cambio en el accionar profesional, con el eje centrado en el paciente y en un laboratorio "a puertas abiertas". En este marco se planteó el Proyecto Bioquímico Nexo (BN) con el propósito de lograr las competencias y habilidades necesarias para formar profesionales bioquímicos clínicos integrales que puedan cumplir con este nuevo rol sobre la base de una construcción colectiva de los saberes (AU)

Advances in science and technology in the area of clinical biochemistry have prompted the need to reflect on the reengineering of professional practice. The diagnostic process is complex and dynamic, requiring interdisciplinary work and effective communication, as well as a change in professional action, with the focus on the patient and an "open-door" laboratory. Within this framework, the Biochemical Nexus Project (BN) was proposed with the purpose of achieving the competencies and skills necessary to comprehensively train clinical biochemists who can fulfill this new role based on a collective construction of knowledge (AU)

Audit of laboratory sensitivity of human papillomavirus and cytology testing in a cervical screening program.

The globally recommended public health policy for cervical screening is primary human papillomavirus (HPV) screening with cytology triaging of positives. To ensure optimal quality of laboratory services we have conducted regular audits of cervical smears taken before cervical cancer or cancer in situ (CIN3+) within an HPV-based screening program. The central cervical screening laboratory of Stockholm, Sweden, identified cases of CIN3+ who had had a previous cervical screening test up to 3 years before and randomly selected 300 cervical liquid-based cytology (LBC) samples for auditing. HPV testing with Roche Cobas was performed either at screening or with biobanked samples. HPV negative samples and subsequent biopsies were retrieved and tested with modified general primer HPV PCR and, if still HPV-negative, the LBCs and biopsies were whole genome sequenced. The Cobas 4800 detected HPV in 1020/1052 (97.0%) LBC samples taken before CIN3+. Further analyses found HPV in 28 samples, with nine of those containing HPV types not targeted by the Cobas 4800 test. There were 4 specimens (4/1052, 0.4%) where no HPV was detected. By comparison, the proportion of CIN3+ cases that were positive in a previous cytology were 91.6%. We find that the routine HPV screening test had a sensitivity in the real-life screening program of 97.0%. Regular laboratory audits of cervical samples taken before CIN3+ can be readily performed within a real-life screening program and provide assurance that the laboratory of the real-life program has the expected performance.

Strategies to ensure efficient laboratory functioning while navigating through the COVID-19 crisis in developing countries: An early experience from a tertiary care centre in India.

BACKGROUND: The coronavirus disease 2019 (COVID 19) is a zoonotic viral infection that originated in Wuhan, China, in December 2019. It was declared a pandemic by the World Health Organization shortly thereafter. This pandemic is going to have a lasting impact on the functioning of pathology laboratories due to the frequent handling of potentially infectious samples by the laboratory personnel. To deal with this unprecedented situation, various national and international guidelines have been put forward outlining the precautions to be taken during sample processing from a potentially infectious patient. PURPOSE: Most of these guidelines are centered around laboratories that are a part of designated COVID 19 hospitals. However, proper protocols need to be in place in all laboratories, irrespective of whether they are a part of COVID 19 hospital or not as this would greatly reduce the risk of exposure of laboratory/hospital personnel. As part of a laboratory associated with a rural cancer hospital which is not a dedicated COVID 19 hospital, we aim to present our institute's experience in handling pathology specimens during the COVID 19 era. CONCLUSION: We hope this will address the concerns of small to medium sized laboratories and help them build an effective strategy required for protecting the laboratory personnel from risk of exposure and also ensure smooth and optimum functioning of the laboratory services.

COVID-19-another influential event impacts on laboratory medicine management.

BACKGROUND: Before public health emergencies became a major challenge worldwide, the scope of laboratory management was only related to developing, maintaining, improving, and sustaining the quality of accurate laboratory results for improved clinical outcomes. Indeed, quality management is an especially important aspect and has achieved great milestones during the development of clinical laboratories. CURRENT STATUS: However, since the coronavirus disease 2019 (COVID-19) pandemic continues to be a threat worldwide, previous management mode inside the separate laboratory could not cater to the demand of the COVID-19 public health emergency. Among emerging new issues, the prominent challenges during the period of COVID-19 pandemic are rapid-launched laboratory-developed tests (LDTs) for urgent clinical application, rapid expansion of testing capabilities, laboratory medicine resources, and personnel shortages. These related issues are now impacting on clinical laboratory and need to be effectively addressed. CONCLUSION: Different from traditional views of laboratory medicine management that focus on separate laboratories, present clinical laboratory management must be multidimensional mode which should consider consolidation of the efficient network of regional clinical laboratories and reasonable planning of laboratories resources from the view of overall strategy. Based on relevant research and our experience, in this review, we retrospect the history trajectory of laboratory medicine management, and also, we provide existing and other feasible recommended management strategies for laboratory medicine in future.

The Impact of COVID-19 Containment Actions on Extra-Analytical Phases of the Clinical Laboratory: A Case Report.

Laboratory information systems need to adapt to new demands created by the COVID-19 pandemic, which has set up new normals like containment measures and social distancing. Some of these have negatively impacted the pre- and postanalytical phases of laboratory testing. Here, we present an intriguing finding related to the generation of the accession number/specimen number on the investigation module of a hospital management information system and its impact on the dissemination of reports resulting in the wrong release of reports on a female patient amidst the background of COVID-19 containment measures. We analyze the situation that led to this false reporting and the importance of the proper customization of information software in laboratories along with a robust postanalytical framework of laboratory work culture to avert such untoward incidents. This introspection has made us realize that COVID-19 has been a scientific, medical, and social challenge. We need to redefine our priorities in the days to come because SARS-CoV-2 is here to stay.

A Snapshot of Lipid-Reporting Practices in Canadian Clinical Laboratories: An Urgent Need for Harmonisation.

To effectively implement the Canadian Cardiovascular Society (CCS) guidelines for dyslipidemia management into clinical laboratories, clear recommendations for lipid reporting are essential. In this study, the Canadian Society of Clinical Chemists Working Group on Reference Interval Harmonisation surveyed Canadian laboratories on adult lipid reporting practices to set a foundation for the development and implementation of harmonised lipid reporting across Canada. Key aspects of the survey asked laboratories: what reporting parameters were in place to assess lipid results; what interpretative comments were provided; whether nonfasting lipids were permitted and, if so, what strategy was used to document fasting status; and whether there was interest in implementing a harmonised lipid report. A total of 101 laboratories were represented by 24 respondents, as many responses were submitted by laboratory networks that included more than 1 laboratory. There was at least 1 response from 9 Canadian provinces and representation across 5 testing platforms. Upper and lower limits for lipid parameters and referenced source of limits varied substantially across laboratories, with only 56% of laboratories (9 respondents) referencing the 2016 CCS guidelines. Eighty-six percent of laboratories (19 respondents) report nonfasting lipids, although the method of documenting nonfasting status varied. Overall, 36% of laboratories (8 respondents) reported interest in implementing a harmonised lipid report. Assessment of current lipid-reporting practices supports the need for harmonised lipid reporting across Canada. Development of a harmonised lipid report for the adult population, consistent with up-to-date Canadian guidelines, will improve continuity of lipid test interpretation across Canada and improve clinical decision making.

Changes in Test Volumes During Coronavirus Disease 2019 (COVID-19): A Laboratory Stewardship Opportunity.

CONTEXT.­: Coronavirus disease 2019 (COVID-19) changed the dynamics of health care delivery, shifting patient priorities and deferring care perceived as less urgent. Delayed or eliminated care may place patients at risk for adverse outcomes. OBJECTIVE.­: To identify opportunities for laboratory test stewardship to close potential gaps in care created by the COVID-19 pandemic. DESIGN.­: The study was a retrospective time series design examining laboratory services received before and during the COVID-19 pandemic at a large metropolitan health system serving women and children. RESULTS.­: Laboratory test volumes displayed 3 distinct patterns: (1) a decrease during state lockdown, followed by near-complete or complete recovery; (2) no change; and (3) a persistent decrease. Tests that diagnose or monitor chronic illness recovered only partially. For example, hemoglobin A1c initially declined 80% (from 2232 for April 2019 to 452 for April 2020), and there was a sustained 16% drop (28-day daily average 117 at August 30, 2019, to 98 at August 30, 2020) 4 months later. Blood lead dropped 39% (from 2158 for April 2019 to 1314 for April 2020) and remained 23% lower after 4 months. CONCLUSIONS.­: The pandemic has taken a toll on patients, practitioners, and health systems. Laboratory professionals have access to data that can provide insight into clinical practice and identify pandemic-related gaps in care. During the pandemic, the biggest patient threat is underuse, particularly among tests to manage chronic diseases and for traditionally underserved communities and people of color. A laboratory stewardship program, focused on peri-pandemic care, positions pathologists and other laboratory professionals as health care leaders with a commitment to appropriate, equitable, and efficient care.

An Australian diagnostic microbiology surge response to the COVID-19 pandemic.

Diagnostic microbiology services form a critical component of the response to infectious disease outbreaks. Like previous respiratory virus pandemics, the COVID-19 pandemic has placed significant strains on the standing capacity of laboratories around the world. In this case study, we describe the surge response required by our laboratory to meet the fluctuating demand for SARS-CoV-2 in our regional pathology service in Western Sydney, Australia between March and May 2020. While the overall number of SARS-CoV-2 PCR positive cases was relatively low compared to other Australian local health districts, testing numbers were highly unpredictable and changed on a weekly basis as local outbreaks were detected. As with other laboratories, numerous other challenges were also faced during this period, including the requirement to introduce a new and unaccredited diagnostic PCR assay for SARS-CoV-2, local and global shortages of reagents for sampling and sample processing, and a significant institutional SARS-CoV-2 outbreak in our laboratory catchment area. A successful service delivery during this period could only be maintained by a dynamic whole-of-laboratory and organizational response including (1) operational changes to the hours of service and the expansion of diagnostic testing at our laboratory site and other sites within our organization (2) careful management of specialist staff and re-training and recruitment of additional staff (3) changes to laboratory workflows to improve SARS-CoV-2 PCR test turnaround time and to accommodate limits to precious laboratory reagents; (4) clear communication within our laboratory and the NSW Health Pathology organization; and (5) collaborative co-ordination and support by NSW Health Pathology.

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.

Building a network of TP53 and IGHV testing reference centers across Spain: the Red53 initiative.

Among the different biomarkers predicting response in chronic lymphocytic leukemia (CLL), the most influential parameters are the mutational status of the IGHV genes and the presence of TP53 gene disruptions. Nevertheless, these important assessments are not readily available in most centers dealing with CLL patients. To provide this molecular testing across the country, the Spanish Cooperative Group on CLL (GELLC) established a network of four analytical reference centers. A total of 2153 samples from 256 centers were analyzed over a period of 30 months. In 9% of the patients, we found pathological mutations in the TP53 gene, whereas 48.96% were classified as IGHV unmutated. Results of the satisfaction survey of the program showed a Net Promoter Score of 85.15. Building a national network for molecular testing in CLL allowed the CLL population a broad access to complex biomarkers analysis that should translate into a more accurate and informed therapeutic decision-making.

The Lab Must Go On.

OBJECTIVES: The clinical laboratory community has faced unprecedented challenges in responding to the coronavirus disease 2019 (COVID-19) pandemic. Long-held assumptions about laboratory management have been reconsidered in light of these new circumstances. METHODS: Experience during the first 6 months of the COVID-19 pandemic at a clinical reference laboratory was reviewed in the context of several commonly held management principles to assess their relevance to clinical laboratory operations during a crisis. RESULTS: Management and operational ideas regarding different modes of communication, physical proximity and interaction, operating under a fixed budget, and maintaining a breadth of laboratory service offerings have been challenged during the COVID-19 pandemic. The importance of putting people first, maintaining collaboration, and providing effective leadership and communication throughout an organization have been highlighted. CONCLUSIONS: The collaborative activities of highly interdependent teams and individuals have helped the clinical laboratory community respond to society's needs in the COVID-19 crisis. Not all laboratory management principles apply equally well in the course of an international respiratory pandemic. When navigating crises, leaders need to distinguish situational management principles from those that are universal.

[How did the private labs fit onto COVID-19 crisis?] / Comment les laboratoires de biologie médicale privés français se sont adaptés à la crise de la COVID-19 ?

Confronted with the COVID-19 crisis, healthcare professionals have had to tackle an epidemic crisis of a huge magnitude for which they were not prepared. Medical laboratories have been on the front line, from collecting samples to performing the analysis required to diagnose this new pathology. Responding to the needs and to the urgency of the situation, the authorities relied on the network of private laboratories. In France, private laboratory medicine represents 70% of overall activity, and with a network of more than 4,000 local laboratories, private laboratory medicine has been the cornerstone of the « screen-trace-isolate ¼ strategy. This article gives feedback from private laboratory medicine professionals, directly involved in the reorganization carried out at the pre-analytical, analytical and post-analytical stages, during the crisis from March to October 2020.

Pregunte al experto COVID-19: ¿Cómo funcionan las nuevas pruebas rápidas de antígenos?

[Management of a global health crisis: first COVID-19 disease feedback from Overseas and French-speaking countries medical biologists]. / Gestion d'une crise sanitaire mondiale : premiers retours d'expérience de biologistes médicaux d'Outre-mer et de francophonie face au COVID-19.

The French society of clinical biology "Biochemical markers of COVID-19" has set up a working group with the primary aim of reviewing, analyzing and monitoring the evolution of biological prescriptions according to the patient's care path and to look for markers of progression and severity of the disease. This study covers all public and private sectors of medical biology located in metropolitan and overseas France and also extends to the French-speaking world. This article presents the testimonies and data obtained for the "Overseas and French-speaking countries" sub-working group made up of 45 volunteer correspondents, located in 20 regions of the world. In view of the delayed spread of the SARS-CoV-2 virus, the overseas regions and the French-speaking regions have benefited from feedback from the first territories confronted with COVID-19. Thus, the entry of the virus or its spread in epidemic form could be avoided, thanks to the rapid closure of borders. The overseas territories depend very strongly on air and/or sea links with the metropolis or with the neighboring continent. The isolation of these countries is responsible for reagent supply difficulties and has necessitated emergency orders and the establishment of stocks lasting several months, in order to avoid shortages and maintain adequate patient care. In addition, in countries located in tropical or intertropical zones, the diagnosis of COVID-19 is complicated by the presence of various zoonoses (dengue, Zika, malaria, leptospirosis, etc.).

Assessing the COVID-19 diagnostic laboratory capacity in Indonesia in the early phase of the pandemic.

The coronavirus disease 2019 (COVID-19) pandemic has put a great burden on countries as a result of the demand for laboratory diagnostic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This paper reports our experiences in rapidly assessing Indonesia's COVID-19 laboratory testing capacity in the early phase of the pandemic response. Through a questionnaire-based survey carried out between 23 March and 2 April, we estimated the daily tests that could be done by the 44 facilities, excluding the national referral laboratory, first assigned to be COVID-19 diagnostic laboratories. The capacity constraints were lack of reagents and equipment, and limited human resources; because of these constraints, most of the laboratories were not yet operational. A major hindrance was reliance on imported supplies and the associated procurement time. Expanding real-time polymerase chain reaction testing capacity, through increased numbers of laboratories and optimization of existing facilities, was clearly the main priority. We also assessed the potential yield from using rapid molecular testing machines in the country's referral hospitals. Even assuming this potential could be tapped, several provinces would still be poorly served by diagnostic services in the event of a surge in cases. Since this rapid assessment, the number of designated COVID-19 laboratories has increased and, by 1 July 2020, was 163. On 29 July 2020, for the first time, the number of specimens examined in a day reached more than 30 000, achieving the WHO testing capacity target of 1 in 1000 inhabitants per week.

Monitoring COVID-19 where capacity for testing is limited: use of a three-step analysis based on test positivity ratio.

In an effort to monitor coronavirus disease 2019 (COVID-19), many countries have been calculating the ratio of cases confirmed to tests performed (test positivity ratio - TPR). While inferior to sentinel surveillance, TPR has the benefit of being easily calculated using readily available data; however, interpreting TPR and its trends can be complex because both the numerator and the denominator are constantly changing. We describe a three-step process where the ratio of relative increase in cases to relative increase in tests is accounted for in an adjusted TPR. This adjusted value more appropriately reflects the case number and factors out the effect of changes in the number of tests done. Unadjusted and adjusted TPRs are then assessed step-wise with reference to the epidemic curve and the cumulative numbers of cases and tests. Use of this three-step analysis and its potential use in guiding public health interventions are demonstrated for selected countries and subnational areas of the World Health Organization South-East Asia Region, together with the Republic of Korea as a reference. To date, application of the three-step analysis to data from countries of the region has signalled potential inadequacies of testing strategies. Further work is needed on approaches to support countries where testing capacity is likely to remain constrained. One example would be enumeration of the average number of tests needed to detect one COVID-19 case, which could be stratified by factors such as location and population. Such data would allow evidence-informed strategies that best balance the highest detection rate with the prevailing testing capacity.

How many are we missing with ID NOW COVID-19 assay using direct nasopharyngeal swabs? Findings from a mid-sized academic hospital clinical microbiology laboratory.

Here, we retrospectively analyzed the comparative results of 182 paired dry nasopharyngeal swabs tested by Abbott ID NOW and nasopharyngeal swabs in viral transport medium by real-time RT-PCR methods. While the overall agreement was 96.2%, we found that of 15 samples that were tested positive with RT-PCR methods, 7 were missed by ID NOW, resulting in a false-negative rate of 47%.