Enjoy an overview on the most recent clinical trials , publications &researches and lab diagnostic business news and events.
Association for Molecular Pathology (AMP)
SOFT
Scientific International Exhibitions Ltd
INFORMA
College Of American Pathologists
The American Association of Blood Banks (AABB)
American Society For Clinical Pathology
International Society for Experimental Hematology (ISEH)
American Association of Clinical Chemistry
International Federation for Clinical Chemistry (IFCC)
The Association of Genetic Technologists (AGT), American Society for Clinical Laboratory Science (ASCLS), and Society of American Federal Medical Laboratory (SAFML)
Bitotechnology Innovation Orgnization (BIO)
American Society For Microbiology
ISBER
The Association for Pathology Informatics (API)
Saudi Society for Clinical Chemistery (SSCC) and Healthcare Interest Group, Saudi Quality Council (HIG-SQC)
About CLSI: The hub for the Global Leader in Setting Clinical Laboratory Standards. The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit organization that develops laboratory standards worldwide. CLSI standards are recognized by laboratories, accreditors, and government agencies as the best way to improve medical laboratory testing. We in Future Lab are proud to adopt CLSI standards in our laboratory’s methodologies. For more information about CLSI, you may refer to www.clsi.org
The American Society for Clinical Pathology celebrates the 100th anniversary. To celebrate this incredible achievement, ASCP is showcasing the history of the Society, highlighting major accomplishments, and more. To celebrate, visit the following video link: https://lp.ascp.org/ascp100anniversary/?_ga=2.160400637.1980950300.1647250189-208910509.1646893329 or visit www.ascp.org/100
On Dec 1, 2021, the American Society for Clinical Pathology (ASCP) and the Clinical Laboratory Management Association (CLMA) announced that CLMA will join the ASCP as a division of ASCP, thus aligning the organizations to Provide Excellence, Education, and Advocacy for Laboratory Professionals. For more information, you visit https://www.ascp.org/content/news-archive/news-detail/2021/12/01/ascp-and-clma-align-to-provide-excellence-education-and-advocacy-for-laboratory-professionals#
Biobanking is a critical facility in many drug discovery, pathology, and personalized medicine organisations. It enables researchers to effectively manage biological sample collections in an easily accessible repository. Unfortunately, while smaller biobanks and biorepositories still need to select tubes from cold racks straight from the freezer, they cannot necessarily afford the significant investment in robotics to fully automate the picking and placing of sample storage tubes from racks. A new paper, courtesy of Ziath, describes an affordable semi-automated solution that provides reliable, high-throughput cherry-picking of frozen or thawed sample tubes from 96-position SLAS format racks with full data reporting. For viewing the full paper, you may refer to: https://www.labbulletin.com/articles/sample-management-without-the-complexity-and-cost-full
Biotechnology Innovation Organization (BIO) launched COVID Vaccine Facts, a new website with scientific and evidence-based information related to the COVID-19 vaccine development process. COVID Vaccine Facts (www.covidvaccinefacts.org) is an educational tool that links health care providers and the public to scientific and evidence-based information related to the vaccine development process.
Natera developed a personalized, tumor-informed approach for molecular residual disease (MRD) detection by using Signatera after surgery to evaluate the need for adjuvant chemotherapy and potentially avoid unnecessary treatment. For more information, you refer to https://natera.showpad.com/share/tjYrvLiWX9XKSTyjfJJL3
“Elevating the clinical laboratory's role in healthcare transformation” The clinical laboratory has an essential role in all aspects of life and the diagnosis process starts early on in medical examination through blood testing or non-invasive testing. It plays an important role in any clinical decision and will have a 30 to 100 per cent impact based on the diagnosis itself and the continuity and outcome of the medical condition according to Dr Ismail A Bakhsh, Consultant Clinical Scientist, Director of Ancillary Services, National Medical Care. For full access to this article: https://insights.omnia-health.com/laboratory/elevating-clinical-laboratorys-role-healthcare-transformation?utm_source=Medlab-Website&utm_medium=Website&utm_campaign=AEL21DML-LE-ATT-MEDLABME2021-NewsArticle-Website-Clinical-Lab-Healthcare-Transformation-ENG-Visprom&utm_term=Lab-elevating-clinical-article
ECCMID
Competency framework to build a strong foundation. The purpose of this article is to introduce the first edition of Laboratory Leadership Competency Framework published by the World Health Organization (WHO) in 2019. This Framework was sought for many years worldwide by laboratories in order to establish a unified “know-how” model, which can be used to build sustainable national health laboratory systems that are a component of overall health systems. The Framework is intended to be used as a tool in mentoring current and emerging laboratory leaders engaged in the process of building, strengthening and sustaining national laboratory systems. It can be used as a roadmap to build an effective and efficient learning and training programme for leadership and used as a benchmark tool to assess competency of not only laboratory leadership but healthcare leaders worldwide. It is the first of its kind that provides a consensus process by six leading organisations as a holistic approach for leadership competency. The Framework consists of nine competencies where each competency is designed in a way that allows complementary learning opportunities for those who need to develop a particular competency. The leadership performance activities are designed in three levels according to proficiency, which are developing, skilled or expert. The framework is a tool for assessment that has been launched and ready for use, however, the Learning Package, with its attendant course materials and guidance, is currently under evelopment. The following sections are captured from the framework to emphasise on its importance of implementation in laboratories in particular and healthcare settings in general.
In one of the sessions at Arab Health, quality expert Dr. Nashat Nafouri, Executive Officer, Saudi Quality Council spoke about how, in an era of digital natives and proactive consumers seeking quality at the right price, it is imperative to future proof the lab. According to Dr. Nafouri, lab directors are excellent at the science but need to step up to assume the leadership skills that will be required to be effective in the future. Dr. Nafouri introduced the concept of triangle success for future laboratories: the 3Cs and I model . The 3Cs are competency, confidence and consistency, while the I refers to the intellectual property built into all lab processes. With standards, laboratories will have consistency. Peer review gives confidence, and building human capital will take care of competency, said Dr. Nafouri. The intellectual aspect can be ensured by using an approach for management with ISO 15189. Dr. Nafouri explained the importance of leadership in the laboratory, in particular how lab managers could benefit from using the Clinical and Laboratory Standard Institute (CLSI) standards to structure the lab quality system and improve processes. Labs should adopt the body of knowledge of the Clinical Laboratory Management Association (CLMA) as it can help shape future lab leaders. There needs to be an emphasis on the value of proficiency testing programme and unified checklists of the College of American Pathology (CAP). In addition, the international standard ISO 18159 is an approved international approach which can be used to advance quality in clinical laboratories.
A dilemma comes to end In the last decade, senior management in healthcare (voluntary or mandatory) implemented quality concepts in their facilities due to many reasons including globalisation, industry competitiveness, customers demand, emergence of social media, resources brain drain, and regulations became more robust, in order to achieve better health care outcomes. On their strategic radar, the use of different accreditation or certification models as an approach to improve healthcare services, operations and outcomes was the catalyst that would solve all problems and gain the blessing of the stockholder. Therefore, one can notice a tenfold increase in the number of healthcare facilities obtaining different types of accreditation and/or certification over the last 15 years such as different ISO certifications, Joint Commission International (JCI) accreditation, Canadian accreditation, Australian accreditation, College of American Pathologist (CAP) accreditation, American Association of Blood Bank accreditation and recently local Central Board for Accrediting Healthcare Institutions (CBAHI) etc. To some extent it became an accreditation marathon where you may find a healthcare facility that has a boutique of different types of accreditations.
The rationale behind the need for organisational excellence in healthcare. Transforming from good to excellent is not easy. If it were easy, every organisation would be great for treating all patients’ population, and as we know, few are. Most healthcare organisations are very good, but very good isn’t good enough. We don’t accept airlines being 99.99 per cent accident free in their landings, and we can’t accept that in healthcare either. The Institute of Medicine’s To Error Is Human report estimated as many as 98,000 people die in U.S. hospitals each year as a result of medical errors. The Centers for Disease Control and Prevention (CDC) has estimated for every person who dies from a hospital error or an infection, five to 10 others suffer a non-fatal infection. The Institute estimated the cost of all these medical errors at over US$20 billion annually. “With approximately 33.3 million hospitalisations in the U.S. each year, that means as many as 88 people out of every 1,000 will suffer injury or illness, and perhaps six of them will die as a result.”
BACKGROUND: Cell-free DNA noninvasive prenatal screening for trisomies 21, 18, and 13 has been rapidly adopted into clinical practice. However, previous studies are limited by a lack of follow-up genetic testing to confirm the outcomes and accurately assess test performance, particularly in women at a low risk for aneuploidy. OBJECTIVE: To measure and compare the performance of cell-free DNA screening for trisomies 21, 18, and 13 between women at a low and high risk for aneuploidy in a large, prospective cohort with genetic confirmation of results STUDY DESIGN: This was a multicenter prospective observational study at 21 centers in 6 countries. Women who had single-nucleotide- polymorphism-based cell-free DNA screening for trisomies 21, 18, and 13 were enrolled. Genetic confirmation was obtained from prenatal or newborn DNA samples. The test performance and test failure (no-call) rates were assessed for the cohort, and women with low and high previous risks for aneuploidy were compared. An updated cell-free DNA algorithm blinded to the pregnancy outcome was also assessed.
In the event of chemical and nuclear explosions, sudden accidents, natural disasters, and ethnic studies, the first priority in the identification process of a person by forensic investigators is determination of an individual's sexual identity (Laverde 2013, Ramakrishnan et al. 2015). Human sex (or gender) determination is important in criminal investigations of missing persons, and in archeology and anthropology for the exploration of gender differences in past populations and for the study of cultures and human activities (Laverde 2013, Faerman et al. 1995, Masuyama et al. 2017). Human sex (or gender) determination is also a part and an essential priority of forensic odontology when it is impossible to traditionnally identify the deceased (Chowdhury et al. 2018). Human sex determination can help when seeking sexual assault evidence as it can serve as confirmation that the "sperm fraction" extracted from swabs and stains do contain male DNA. In this regard, it can also serve as an indicator of the amount of male DNA present in the non-sperm fraction (Reynolds and Varlaro 1996). Ornoy et al. (2019) believe that human gender assessment is crucial when the proper definition of the sex is of diagnostic and/or therapeutic importance such as the cases of ambiguous genitalia and intersex. In criminal investigations, determining sex based on morphology (of the tooth, skull, and other soft tissues in the oral and sub-lumbar region) is very difficult or even impossible in many cases. Sex determination of forensic and archeological samples which lack morphological diagnostic characteristics, such as fragmentary bones and body fluid samples, is also not applicable using morphology (Masuyama et al. 2017).
Pancreatic cancer is often detected late, when curative therapies are no longer possible. Here, we present non-invasive detection of pancreatic ductal adenocarcinoma (PDAC) by 5-hydroxymethylcytosine (5hmC) changes in circulating cell free DNA from a PDAC cohort (n = 64) in comparison with a non-cancer cohort (n = 243). Differential hydroxymethylation is found in thousands of genes, most significantly in genes related to pancreas development or function (GATA4, GATA6, PROX1, ONECUT1, MEIS2), and cancer pathogenesis (YAP1, TEAD1, PROX1, IGF1). cfDNA hydroxymethylome in PDAC cohort is differentially enriched for genes that are commonly de-regulated in PDAC tumors upon activation of KRAS and inac- tivation of TP53. Regularized regression models built using 5hmC densities in genes perform with AUC of 0.92 (discovery dataset, n = 79) and 0.92–0.94 (two independent test sets, n = 228). Furthermore, tissue-derived 5hmC features can be used to classify PDAC cfDNA (AUC = 0.88). These findings suggest that 5hmC changes enable classification of PDAC even during early stage disease.
In September 2008, the National Library of Medicine (NLM) of the National Institutes of Health (NIH) expanded the database at ClinicalTrials.gov to include the results of registered clinical trials in response to the Food and Drug Administration Amendments Act (FDAAA). This database consists of structured tables of summary data regarding the results of trials without discussion or conclusions. The FDAAA, its implementing regulations (42 CFR Part 11),2,3 and several policies require the reporting of results to ClinicalTrials.gov to address issues related to the nonpublication of results of clinical trials and incomplete reporting of outcomes and adverse events. These issues have necessitated process changes for sponsors and investigators in both industry and academic medical centers. We previously estimated that the regulations and the trial-reporting policy of the NIH would affect more than half the registered trials conducted at academic medical centers in the United States. The scope and importance of these requirements demand that we monitor and evaluate the effect of this evolving results-reporting mechanism on the clinical trials enterprise. In 2011, we characterized early experiences with nearly 2200 posted results. A decade after launch, the results database contained more than 36,000 results as of May 2019. In this article, we de- scribe the current requirements, the state of results reporting at ClinicalTrials.gov, and challenges and opportunities for further advancement.
BACKGROUND: Historically, prenatal screening has focused primarily on the detection of fetal aneuploidies. Cell-free DNA now enables noninvasive screening for subchromosomal copy number variants, including 22q11.2 deletion syndrome (or DiGeorge syndrome), which is the most common microdeletion and a leading cause of congenital heart defects and neurodevelopmental delay. Although smaller studies have demonstrated the feasibility of screening for 22q11.2 deletion syndrome, large cohort studies with confirmatory postnatal testing to assess test performance have not been reported. OBJECTIVE: This study aimed to assess the performance of single- nucleotide polymorphismebased, prenatal cell-free DNA screening for detection of 22q11.2 deletion syndrome. STUDY DESIGN: Patients who underwent single-nucleotide polymorphismebased prenatal cell-free DNA screening for 22q11.2 dele- tion syndrome were prospectively enrolled at 21 centers in 6 countries. Prenatal or newborn DNA samples were requested in all cases for genetic confirmation using chromosomal microarrays. The primary outcome was sensitivity, specificity, positive predictive value, and negative predictive value of cell-free DNA screening for the detection of all deletions, including the classical deletion and nested deletions that are 500 kb, in the 22q11.2 low-copy repeat A-D region. Secondary outcomes included the prevalence of 22q11.2 deletion syndrome and performance of an updated cell-free DNA algorithm that was evaluated with blinding to the pregnancy outcome.
While many areas of health care are still struggling with the issue of patient safety, laboratory diagnostics has always been a forerunner in pursuing this issue. Significant progress has been made since the release of “To Err is Human.”1 This article briefly reviews laboratory quality assessment and looks at recent statistics concerning laboratory errors. Keywords: laboratory error, patient safety, medical error. It has been 12 years since the Institute of Medicine (IOM) reported the alarming data on the cause and impact of medical errors in the United States.1 Besides causing serious harm to patients, medical errors translate into huge costs for the national economy. In 1999, Berwick and Leape published that the estimated cost of medical errors in the United States was between $17 billion-$29 billion a year.2 In 2006, Null and colleagues published an article indicating the overall estimated annual economic cost of improper medical intervention was much higher, approaching $282 billion.3 While many areas of health care are still struggling with the issue of patient safety, laboratory diagnostics has always been a forerunner in pursuing this issue. The concepts and practices of quality assessment programs have long been routine in laboratory medicine, and error rates in laboratory activities are far lower than those seen in overall clinical health care.4 This article briefly reviews laboratory quality assessment and looks at recent statistics concerning laboratory errors.
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