Operational considerations and challenges of biochemistry laboratories during the COVID-19 outbreak: an IFCC global survey.

Objectives: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 conducted a global survey to understand how biochemistry laboratories manage the operational challenges during the coronavirus disease 2019 (COVID-19) pandemic. Materials and methods: An electronic survey was distributed globally to record the operational considerations to mitigate biosafety risks in the laboratory. Additionally, the laboratories were asked to indicate the operational challenges they faced. Results: A total of 1210 valid submissions were included in this analysis. Most of the survey participants worked in hospital laboratories. Around 15% of laboratories restricted certain tests on patients with clinically suspected or confirmed COVID-19 over biosafety concerns. Just over 10% of the laboratories had to restrict their test menu or services due to resource constraints. Approximately a third of laboratories performed temperature monitoring, while two thirds of laboratories increased the frequency of disinfection. Just less than 50% of the laboratories split their teams. The greatest reported challenge faced by laboratories during the COVID-19 pandemic is securing sufficient supplies of personal protective equipment (PPE), analytical equipment, including those used at the point of care, as well as reagents, consumables and other laboratory materials. This was followed by having inadequate staff, managing their morale, anxiety and deployment. Conclusions: The restriction of tests and services may have undesirable clinical consequences as clinicians are deprived of important information to deliver appropriate care to their patients. Staff rostering and biosafety concerns require longer-term solutions as they are crucial for the continued operation of the laboratory during what may well be a prolonged pandemic.

Laboratory practices to mitigate biohazard risks during the COVID-19 outbreak: an IFCC global survey.

Objectives: A global survey was conducted by the IFCC Task Force on COVID-19 to better understand how general biochemistry laboratories manage the pre-analytical, analytical and post-analytical processes to mitigate biohazard risks during the coronavirus disease 2019 (COVID-19) pandemic. Methods: An electronic survey was developed to record the general characteristics of the laboratory, as well as the pre-analytical, analytical, post-analytical and operational practices of biochemistry laboratories that are managing clinical samples of patients with COVID-19. Results: A total of 1210 submissions were included in the analysis. The majority of responses came from hospital central/core laboratories that serve hospital patient groups and handle moderate daily sample volumes. There has been a decrease in the use of pneumatic tube transport, increase in hand delivery and increase in number of layers of plastic bags for samples of patients with clinically suspected or confirmed COVID-19. Surgical face masks and gloves are the most commonly used personal protective equipment (PPE). Just >50% of the laboratories did not perform an additional decontamination step on the instrument after analysis of samples from patients with clinically suspected or confirmed COVID-19. A fifth of laboratories disallowed add-on testing on these samples. Less than a quarter of laboratories autoclaved their samples prior to disposal. Conclusions: The survey responses showed wide variation in pre-analytical, analytical and post-analytical practices in terms of PPE adoption and biosafety processes. It is likely that many of the suboptimal biosafety practices are related to practical local factors, such as limited PPE availability and lack of automated instrumentation.

[Controversial issues in colorectal screening in Hungary: conflict of clinical and public health viewpoints]. / A vastag- és végbéldaganatok szurésének vitatott kérdései: klinikai és népegészségügyi nézopontok ütközése.

In Hungary, mortality rates from colorectal cancer are dramatically high, therefore the reduction by population screening as a public health measure is considered as one of the priorities of National Public Health Program. In the beginning, a human-specific immunological test was applied in the "model programs", as a screening tool, to detect the occult blood in the stool; compliance was 32% in average. However, the objectives of the model programs have not been achieved, because, among other reasons, a debate on the method of choice and the strategy to follow have divided the professional public opinion. In this study the debated issues are critically discussed, being convinced that, at present, population screening seems to be the most promising way to alleviate the burden of colorectal cancer.

Systematic reviews in laboratory medicine: principles, processes and practical considerations.

BACKGROUND: Systematic reviews and meta-analyses are generally accepted to represent the highest level of evidence, and are a cornerstone in practising evidence-based medicine. So far, these efforts have been largely confined to the evaluation of the efficacy and effectiveness of therapeutic and preventive interventions. Systematic reviews in laboratory medicine are scarce and many of them do not meet essential quality criteria [Clin. Chem. Lab. Med. 38 (2000) 577]. Most of these problems are related to the poor design and heterogeneity of primary research, and that there are no agreed methods or quality standards for making systematic reviews in laboratory medicine. AIMS AND OBJECTIVES: For better evidence in laboratory medicine, not only higher quality primary studies but also standardized methodologies for designing, conducting and reporting systematic reviews in diagnostics are needed. The aim of this review is to present the general principles and provide a step-by-step process of systematic reviewing in laboratory medicine. METHODS: This narrative review is based on the overview of the medical literature on the methodology of systematic reviewing and that of the "state of the art" of evidence-based diagnosis. RESULTS: Systematic reviews of diagnostic interventions differ from that of therapeutic interventions in the methods of question formulation, the choice of study design, the assessment of study quality and the statistical methods used to combine results. Therefore, the general principles of systematic reviewing are adapted to the specialist field of laboratory medicine. The process of systematic reviewing consists of six key steps: (1) preparation for the review, (2) systematic search of the primary literature, (3) selection of papers for review, (4) critical appraisal of the selected literature, (5) analysis and synthesis of data, and (6) interpretation of data. The most important technical and methodological aspects of each step and the essential elements of a good systematic review in laboratory medicine are presented. CONCLUSIONS: Systematic reviews of diagnostic interventions support clinical and policy decisions, the development of practice guidelines, clinical audit, technology assessment, economic evaluations, education and training, and identify gaps in our knowledge for future research. Systematic reviewing of laboratory data is expected to result in better, bigger and more reliable primary studies, which hopefully will support the diffusion of new diagnostic technologies with scientifically proven efficacy and effectiveness in the future.

[Quality improvement of medical diagnostic laboratories]. / Orvosi diagnosztikai laboratóriumok minóségfejlesztése.

Service quality in medical laboratories is influenced by a number of variables. Medical laboratories have long recognized the need for total quality management that incorporates the continuous improvement of all stages, such as the pre-analytical, analytical and post-analytical phases, of the diagnostic process, in addition to the traditional internal and external quality control of analytical procedures. Based on national and international experience, continuous improvement of quality and its external assessment are of high priority in order to guarantee a reliable, effective and cost-effective diagnostic service. Certification of health care services, according to ISO 9001 standards in Hungarian hospitals, is not sufficient to prove professional competence of medical laboratories, which called for a system of laboratory accreditation. Accreditation is an external professional audit by which an independent accreditation body gives formal recognition that the medical laboratory is competent to provide high quality services that are compliant with rigorous professional standards of best practice. The primary aim of accreditation is the improvement of the quality of diagnostic services by voluntary participation, professional peer review, continuous training and education and compliance with professional standards. In vitro medical laboratories have pioneered quality control and quality assurance in health care. Based on these strengths and traditions, the introduction of the accreditation program of medical laboratories in Hungary is one of the key professional and ethical responsibilities of diagnostic professions, in order to improve the quality, efficiency and effectiveness of laboratory services during the course of Hungary's accession to the European Union.