[Critical results reporting: the importance of local partnership agreements]. / Overdracht van sterk afwijkende laboratoriumuitslagen.

Critical results should be reported to the physician as soon as possible so that the physician can take the necessary follow-up actions. Failure or non-timely reporting of such results may lead to serious health damage or death to the patient. This article focusses on the reporting of results from the laboratory to the physician and discusses the bottlenecks and the separate (legal) responsibilities of the physician and the laboratory. Improving the process of the reporting and follow-up of critical results is a joint responsibility of the laboratory and the physician requesting the laboratory tests. This could be achieved by local partnership agreements.

Encuesta de recursos diagnósticos de las ITS en España / Survey of diagnostic resources for STI in Spain

Introducción: Hay escasa información sobre los recursos disponibles tanto en las consultas como en el laboratorio para hacer frente a las infecciones de transmisión sexual (ITS). El objetivo es describir y conocer la realidad de las consultas y laboratorios que atienden las ITS en España. Métodos: Estudio observacional transversal con obtención de datos mediante una encuesta dirigida a los miembros del Grupo de ITS de la SEIMC (GEITS). Resultados: Se obtuvieron respuestas de 24 centros (tasa de respuesta, 38,1%) pertenecientes a 10comunidades autónomas. Respecto a las consultas de ITS, el 38% precisan que el paciente presente tarjeta sanitaria para proporcionar asistencia, y un 31,8% solo la prestan mediante derivación de otro médico. El 52,4% realizan métodos diagnósticos en la propia consulta. El 18,2% de los laboratorios no ofrecen pruebas diagnósticas de respuesta inmediata, aunque el 100% disponen de PCR frente a Neisseria gonorrhoeae y Chlamydia trachomatis, el 47,8% frente a Mycoplasma genitalium y el 65% detectan genotipos del linfogranuloma venéreo. El 20% realizan técnicas de detección molecular de resistencias antimicrobianas. Todos los laboratorios realizan cultivo y técnicas de sensibilidad a gonococo. Conclusiones: Existe una gran variabilidad en las dotaciones de medios humanos y materiales en las consultas y en los laboratorios que atienden ITS. En un número importante de centros existen limitaciones para el acceso de los pacientes. Todos los laboratorios disponen de técnicas de biología molecular y detectan la infección de N.gonorrhoeae mediante PCR y cultivo, lo que permite la realización de pruebas de sensibilidad en todos los centros.(AU)

Background: Scarce information is available on the resources to deal with the Sexually Transmitted Infections (STIs), both in the clinic and in the laboratory. The objective is to describe and know the reality of the clinics and laboratories that treat these infections in Spain. Methods: Cross-sectional observational study with data collection through a survey aimed at the members of the GEITS Group. Results: Responses were obtained from 24 centers (response rate 38.1%) belonging to 10Autonomous Communities. Regarding STI consultations, 38% require that the patient present a health card to provide assistance, and 31.8% only provide it by referral from another doctor. The 52.4% perform diagnostic methods in the care center. Regarding laboratories, 18.2% do not offer immediate response diagnostic tests, although 100% have PCR against Neisseria gonorrhoeae and Chlamydia trachomatis, 47.8% against Mycoplasma genitalium and 65% detect lymphogranuloma venereum genotypes. All laboratories continue to perform culture and gonococcal sensitivity techniques, and 20% perform molecular methods for detection of MG antimicrobial resistance. Conclusion: There is great variability in the provision of human and material resources both in the clinics and in the laboratories that attend STIs. In a significant number of centers there are limitations for patient access. Although laboratories have molecular biology technologies, not all of them offer immediate response tests. All laboratories detect N.gonorrhoeae infection by PCR and also by culture, which allows sensitivity testing in all centers.(AU)

A SHORT HISTORY OF OCCUPATIONAL DISEASE: 1. LABORATORY-ACQUIRED INFECTIONS.

Laboratory-acquired infections are as old as laboratories themselves. As soon as the culture of microorganisms was introduced, so too was their transfer to laboratory workers. It is only in relatively recent history that such infections have been fully understood, and methods of spread and their prevention or avoidance developed. This paper endeavours to provide an overview of the history of laboratory-acquired infection and the steps taken, particularly in the UK, for its prevention.

COVID-19: A review and considerations for the resumption of activities in an IVF laboratory and clinic in Brazil.

COVID-19 has caused radical effects on the daily lives of millions of people. The causal agent of the current pandemic is SARS-CoV-2, a virus that causes symptoms related to the respiratory system, leading to severe complications. In the in vitro fertilization (IVF) universe, there are several protocols for infection control and laboratory safety. Some professional associations have issued guidelines recommending measures involving patient flow and IVF practices. This study presents a review and considerations for the resumption of activities in IVF laboratories and clinics in Brazil during the COVID-19 pandemic, according to the guidelines and statements from professional organizations and societies in reproductive medicine.

Pathology Laboratory Policies and Procedures for Releasing Diagnostic Tissue for Cancer Research.

CONTEXT.­: The Surveillance, Epidemiology, and End Results (SEER) cancer registry program is currently evaluating the use of archival, diagnostic, formalin-fixed, paraffin-embedded (FFPE) tissue obtained through SEER cancer registries, functioning as honest brokers for deidentified tissue and associated data. To determine the feasibility of this potential program, laboratory policies for sharing tissue for research needed to be assessed. OBJECTIVE.­: To understand the willingness of pathology laboratories to share archival diagnostic tissue for cancer research and related policies. DESIGN.­: Seven SEER registries administered a 27-item questionnaire to pathology laboratories within their respective registry catchment areas. Only laboratories that processed diagnostic FFPE specimens and completed the questionnaire were included in the analysis. RESULTS.­: Of the 153 responding laboratories, 127 (83%) responded that they process FFPE specimens. Most (n = 88; 69%) were willing to share tissue specimens for research, which was not associated with the number of blocks processed per year by the laboratories. Most laboratories retained the specimens for at least 10 years. Institutional regulatory policies on sharing deidentified tissue varied considerably, ranging from requiring a full Institutional Review Board review to considering such use exempt from Institutional Review Board review, and 43% (55 of 127) of the laboratories did not know their terms for sharing tissue for research. CONCLUSIONS.­: This project indicated a general willingness of pathology laboratories to participate in research by sharing FFPE tissue. Given the variability of research policies across laboratories, it is critical for each SEER registry to work with laboratories in their catchment area to understand such policies and state legislation regulating tissue retention and guardianship.

Implementation of an Emergency Use Authorization Test During an Impending National Crisis.

The laboratory response to the current severe acute respiratory syndrome coronavirus 2 pandemic may be termed heroic. From the identification of the novel coronavirus to implementation of routine laboratory testing around the world to the development of potential vaccines, laboratories have played a critical role in the efforts to curtail this pandemic. In this brief report, we review our own effort at a midsized, rural, academic medical center to implement a molecular test for the virus; and we share insights and lessons learned from that process, which might be helpful in similar situations in the future.

How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles - the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA - effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

Investigating the New Zealand policy response to methamphetamine-contaminated houses.

The contamination of houses from clandestine methamphetamine manufacture emerged as an issue in New Zealand in the early 2000s. This perspective reviews and discusses the series of policies developed to address methamphetamine contamination in New Zealand houses over a 15-year period, ending with the reversal of the established policy approach in 2018. The policies addressing methamphetamine contamination of New Zealand properties were influenced by a range of sources including overseas scientific guidelines, local scientific reviews, public housing agency policies, and the local methamphetamine testing industry. A post-remediation methamphetamine level of 0.5 µg/100 cm2 was initially implemented in 2010, leading to the termination of public housing tenancies, suspensions from the public housing list, and financial charges for decontamination on public housing tenants. Subsequent reviews of the policy led to some increase in the thresholds (up to 1.5-3.8 µg/100 cm2 ) and the adoption of less punitive sanction processes. A scientific review in 2018 recommended a substantial threshold increase to 15 µg/100 cm2 (a 30-fold increase on the 2010 standard), resulting in HNZ initiating a plan to compensate previously sanctioned tenants. Overreliance on the "precautionary principle"; strict interpretation of scientific guidelines; and the public housing agency's "zero tolerance approach" to drug use, contributed to an overly punitive policy approach to methamphetamine contamination in New Zealand that negatively impacted vulnerable public housing tenants, landlords, and property owners. Investigation into the extent that all possible influences had on the development of the policies, as well as the consequences of their implementation, should be undertaken.

Laboratorio de diagnóstico clínico y/o de vigilancia epidemiológica: norma técnica No. 22-2019-DRACES / Laboratory for clinical diagnosis and / or epidemiological surveillance: technical standard No. 22-2019-DRACES

La tinta del documento está bastante opaca. DRACES [Departamento de Regulación, Acreditación y Control de Establecimientos de Salud] Este documento tiene como objeto: "la regulación, autorización y control de los laboratorios de diagnóstico clínico y/o de vigilancia epidemiológica, en concordancia con el Reglamento para la Regulación, Autorización, Acreditación y Control de Establecimientos de Atención para la Salud, Acuerdo Gubernativo 376-2007." Es de carácter obligatorio, por lo que se aplica tanto al sector público, privado, social o subsector de la seguridad social, en todo el territorio nacional. Contiene además, las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada clínica, incluidos el equipo y recurso humano y técnico. En el capítulo II, incluye una clasificación del nivel de laboratorios, describiendo sus características, servicios, horarios, materiales técnicos y equipos.

Establishment of a National Inventory of Dangerous Pathogens in the Republic of Uganda.

One of the challenges of global biosecurity is to protect and control dangerous pathogens from unauthorized access and intentional release. A practical and feasible option to protect life science institutes against theft and sabotage, and secure their biological materials against misuse, is to establish a national electronic database with a comprehensive overview of the locations of all controlled dangerous pathogens in a country. This national database could be used as an instrument to secure and account for dangerous pathogens in a country, but it could also assist in establishing a biosecurity assessing and monitoring system for laboratories that work with these controlled biological agents. The Republic of Uganda is one of the first countries, prompted by the World Health Organization's (WHO's) Joint External Evaluation (JEE), to implement a national electronic database that assembles information collected from relevant Ugandan laboratories. This Ugandan Inventory of Dangerous Pathogens is different from an institute-specific pathogen inventory system, as it is intended to store the information collected from laboratories in the country working with dangerous pathogens in 1 centralized secure location. The Uganda National Council for Science and Technology (UNCST) has coordinated the implementation of the Ugandan national inventory. The inventory was recognized by the WHO JEE as contributing to Uganda's developed capacities regarding biosafety and biosecurity. This article describes the steps in implementing Uganda's National Inventory of Dangerous Pathogens. In addition, it presents a straightforward approach that can be adapted by other countries that aim to enhance their biosecurity capacities.

[Medical biology in the face of the evolution of health care needs]. / Rapport des Académies nationales de médecine et de pharmacie sur la biologie médicale La biologie médicale face aux défis de l'évolution des besoins de santé.

Since the publication of the ordinance of January 13th 2010, ratified by the law of May 30th 2013, medical biology in France has undergone a massive restructuration with the emergence of groups of several hundred laboratories. This evolution, which leads to a considerable reduction in the number of structures, causes numerous problems related to increased industrialization and financialization, difficulties of accreditation and disappearance of the proximity link between the biologist and the prescriber or the patient. It also leads to a clear disaffection of students, especially medical students, for this specialty whose medical character has been clearly affirmed by the law. This report takes stock of the current situation of medical biology and makes recommendations to strengthen the role of the medical biologist in the health system and patients' care.

Developing an evidence-based approach for antimicrobial resistance reporting for British Columbia diagnostic animal health laboratory data.

Antimicrobial resistance (AMR) data generated by diagnostic animal health laboratories are underutilized for AMR reporting in Canada. Data assessment, review of practices in other jurisdictions, and expert interviews were used to develop an evidence-guided plan to generate AMR reports from British Columbia Animal Health Centre (AHC) data that would provide transparent, timely, and useful information to public health practitioners, the food animal sector, and the general public. Using the Canadian Animal Health Surveillance Network (CAHSN) platform was the most efficient method of data retrieval. Project outputs included 2 publicly available reports. The public health report included AMR information for methicillin-resistant Staphylococcus aureus, Escherichia coli, and Salmonella. The animal health report included AMR information for Aeromonas salmonicida and Yersinia ruckeri from Atlantic salmon, bacteria from bovine milk samples, and staphylococci from broiler chickens. A preliminary comparison was conducted between selected AHC data and publicly available Canadian Integrated Program for Antimicrobial Resistance Surveillance (CIPARS) reports.

Développement d'une approche factuelle pour la déclaration de la résistance aux antimicrobiens pour les données des laboratoires diagnostiques de santé animale en Colombie-Britannique. Les données sur la résistance aux antimicrobiens produites par les laboratoires diagnostiques de santé animale sont sous-utilisées pour la déclaration de la résistance aux antimicrobiens au Canada. L'évaluation des données, l'examen des pratiques dans les autres territoires et des entrevues avec des experts ont été utilisés afin de développer un plan fondé sur des données probantes pour produire des rapports sur la résistance aux antimicrobiens à partir des données du British Columbia Animal Health Centre (AHC) qui fourniraient des renseignements transparents, opportuns et utiles aux praticiens de la santé publique, au secteur des animaux destinés à l'alimentation et au grand public. L'utilisation de la plate-forme du Système canadien de surveillance de la santé animale (SCSSA) était la méthode d'extraction des données la plus efficace. Les résultats du projet incluaient deux rapports rendus publics. Le rapport sur la santé publique incluait les renseignements sur la résistance aux antimicrobiens pour Staphylococcus aureus résistant à la méthicilline, Escherichia coli et Salmonella. Le rapport sur la santé animale comprenait des renseignements sur la résistance aux antimicrobiens pour Aeromonas salmonicida et Yersinia ruckeri du saumon atlantique, les bactéries provenant d'échantillons de lait bovin et les staphylocoques des poulets à griller. Une comparaison préliminaire a été réalisée entre les données de l'AHC et les rapports publics du Programme intégré canadien de surveillance de la résistance aux antimicrobiens (PICRA).(Traduit par Isabelle Vallières).

European guidelines for workplace drug testing in oral fluid.

These guidelines for Legally Defensible Workplace Drug Testing have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing should use these guidelines as a template for accreditation. These guidelines are relevant to laboratory-based testing only. These guidelines follow current best practices and are constantly under review.