Evidence-based Quality Control

This article will discuss a new approach for automated hematology analyzers’ daily control limits. The discussion will cover some common issues around control of analyzers, suggest a new evidence-based approach to daily control limits, and conclude with a discussion of the benefits of this approach in the laboratory.

Some QC contexts

Too many false control rejections are the laboratory equivalent of crying wolf. Accustomed to false control rejections and not believing the problem is the analyzer, laboratorians often presume that the problem is the control and just repeat the control again. This practice often leads to multiple repetitions. It is frustrating, and difficult for operators to know when there actually is an analyzer issue.

The 1994 CAP Q-Probe study,1 completed to assess QC (Quality Control) practices and their impact on hospital laboratories, showed that 95 percent of labs repeated the same vial of control when a control run failed. In the overwhelming majority of cases, this was due to the belief that random error had occurred. (In control rules, the 13SD [Standard Deviation] means one control failure if one parameter falls outside of +/-3SD limits.) The study also found there was no benefit in using complex multi-rules or control processes for modern automated analyzers, due to the difficulty in understanding and following these complex processes. The recommendation from the study was to simplify control processes. Twenty-three years later, we have the same control issues.

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Source: MedicalLaboratoryObserver

Validation of Hematology Analyzers

Perhaps the most common laboratory procedure performed for hospital patients and outpatients is complete blood count (CBC) or CBC with differential. CBC serves as a screening and diagnostic test for a wide range of conditions and diseases as well as a monitoring tool for treatment and disease status. Given its foundational nature and despite its relative simplicity, the veracity of this basic blood testing is essential. Therefore, thorough validation testing on all new hematology analyzers must be performed to ensure patient safety.

It is reasonable to assume that a newly acquired piece of diagnostic equipment would run as intended, as manufacturers perform their own validation testing to prove intended use and to fulfill regulatory requirements prior to launching a product in the market. However, the ultimate responsibility of verifying instrument performance specifications and characteristics prior to the patient testing falls to the end-user laboratory.

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Source: MedLabMag

Sepsis And The Hematology Laboratory

An affordable, widely available test can impact today`s biggest healthcare challenge.

Sepsis, the inflammatory response to infection, is quickly becoming one of the biggest healthcare problems worldwide. No matter the perspective one takes, the numbers are staggering. Currently the number of diagnosed cases per year in the United States is at least 750,000; some estimates surpass one million. Worldwide mortality estimates are as high as 20 percent, and thus we are dealing with one of the biggest drivers of mortality in modern medicine. Sepsis kills nearly as many people as heart attack, HIV, and breast cancer combined.

Viewed from the perspective of health economics, the average in-hospital cost per case is approximately $20,000 dollars, and yearly estimates of sepsis-related expenses in the U.S. alone exceed $20 billion.

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Source: MedicalLaboratoryObserver

Study Finds Potential New Biomarker For Cancer Patient Prognosis

To treat or not to treat? That is the question researchers at the Department of Energy's Lawrence Berkeley National Laboratory (Berkeley Lab) hope to answer with a new advance that could help doctors and their cancer patients decide if a particular therapy would be worth pursuing.

Berkeley Lab researchers identified 14 genes regulating genome integrity that were consistently overexpressed in a wide variety of cancers. They then created a scoring system based upon the degree of gene overexpression. For several major types of cancer, including breast and lung cancers, the higher the score, the worse the prognosis. Perhaps more importantly, scores could accurately predict patient response to specific cancer treatments.

The researchers said the findings, to be published Wednesday, Aug. 31, in the journal Nature Communications, could lead to a new biomarker for the early stages of tumor development. The information obtained could help reduce the use of cancer treatments that have a low probability of helping.

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The centromeres and kinetochores of a chromosome play critical roles during cell division. In mitosis,
microtubule spindle fibers attach to the kinetochores, pulling the chromatids apart. A breakdown in this
process causes chromosome …more

Source: medicalxpress

Biomedical Laboratory Automation

Improve safety and efficiency in various types of clinical laboratories with Thermo Scientific™ TCAutomation™ Laboratory Automation Solutions. This expandable and scalable, fully-featured laboratory automation solution allows labor-intensive tasks in pre- and post-analytical phases of sample management to be automated in different combinations. Depending on the floor plan and efiiciency requirements, the TCAutomation™ systems can be expanded step-by-step.

TCAutomation™ systems throughput can range from 250 up to 1000 tubes per hour. Because solutions are modular, they are easy to expand. Automating can be started from a certain function and built up towards total laboratory automation. Samples are transported in the system within dual-lane conveyors in a multitube carrier which accommodates several tube sizes. The carrier includes an embedded microchip, based on RFID technology, making sample identification fast and reliable, and enabling excellent real-time sample tracking possibilities.

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Download: Thermo Scientific TCAutomation Laboratory Automation Solution

Source: ThermoFisherScientific

Lab-grown sperm makes healthy offspring

Sperm have been made in the laboratory and used to father healthy baby mice in a pioneering move that could lead to infertility treatments.

The Chinese research took a stem cell, converted it into primitive sperm and fertilised an egg to produce healthy pups.

The study, in the Journal Cell Stem Cell, showed they were all healthy and grew up to have offspring of their own.

Experts said it was a step towards human therapies.

It could ultimately help boys whose fertility is damaged by cancer treatment, infections such as mumps or those with defects that leave them unable to produce sperm.

Sperm factory

Making sperm in the testes is one of the longest and most complicated processes in the body - taking more than a month from start to finish in most mammals.

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Source: bbc

Scientists are growing billions of blood cells in the lab

From helping humans live longer and hacking our performance, to repairing the body and understanding the brain, WIRED Health will hear from the innovators transforming this critical sector. Read all of our WIRED Health coverage here.

Jo Mountford is making billions of red blood cells in a laboratory in Glasgow. And now she wants to scale-up production. Big time.

Mountford, from the Institute of Cardiovascular and Medical Sciences at the University of Glasgow, started trying to create blood in the lab in 2007 and is now able to create it on demand.

In 2008, her team produced 100,000 red blood cells; by 2014 output had reached ten billion cells for the year. The ten billion cells were stored in 88 flasks and made up 8.8 litres of blood.

The team – funded by the Wellcome Trust and incorporating universities and organisations from around the UK – is now able to produce the cells in 30-31 days. "We can choose what blood group we make," Mountford told the audience at WIRED Health.

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The NHS Blood and Transplant facility in Bristol, where donated blood is screened. A British team
called Novosang wants to render this process obsolete

Source: Greg White

Visualizing looks of the future lab

Driven forward by improving technologies and increasing demands, the lab of the future could be markedly different in appearance from the laboratories we work in today. From incorporating 3D printing technology to changing the way that lab data is recorded, we take a closer look at how the next generation of laboratories might evolve. 

The paperless lab concept is not a particularly new one, and many laboratories currently operate without physically recording research and development. Tablet devices allow laboratory teams to record their findings electronically, reducing physical waste and optimising storage organisation.

However, Cloud storage tools have made it simpler for laboratory workers to save their findings in a safe and accessible location. This allows laboratories around the world to help and assist each other in real time. The commercial science lab of the future could incorporate Cloud-connected devices to alert the team of relevant updates and developments. Increased connectivity could help ensure less of the budget and less time is wasted, and more is invested in genuine progress. This momentum towards a paperless research laboratory will require labs to obtain access to trusted servers, data centres and secure network connectivity.

The increasing power and availability of 3D printers have made it possible (not to mention affordable) to create pieces of hardware in the laboratory. Specially designed nails, screws and other important components can be created to fit specific requirements. A number of design companies offer open-source hardware printing services, which enable labs with access to 3D printers to immediately develop their own hardware essentials.

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Source: shutterstock

Automatiion in the clinical microbiology laboratory

In spite of some exceptions, the clinical microbiology lab has been a late starter as far as automation is concerned. It has also traditionally been viewed as ‘low tech’, especially when compared to its cousins in clinical chemistry or pathology. A variety of factors, however, have been converging to reverse such a situation.

Automation hampered by process complexity

One of the most important barriers to the automation of a clinical microbiology lab is process complexity. Unlike hematology or chemistry labs, which have little diversity in specimens and generally use standard collection tubes, microbiology laboratories need to work with a vast range of specimen types in a multitude of transport containers. The complex nature of specimen processing and culturing and the ensuing lack of standardization have been major deterrents to automation.

Nevertheless, growth in the presence of automated technologies in clinical microbiology labs is now expected to accelerate as a result of several factors, above all rising demand. This requires agility and high responsiveness, making automation indispensable.

Aging populations drive demand

Aging populations with more-complex diseases and conditions require a growing number of tests - for example, to monitor implants and prosthetic devices for infections. The elderly also need greater care in medicating, since they are more prone to adverse drug events.

In the year 2000, an article by Dr. Thomas T. Yoshikawa of the King-Drew Medical Center in Los Angeles noted that though “the major focus in infectious diseases for the past decade has been on young adults”, in the future “the vast majority of serious infectious diseases will be seen in the elderly population.”

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Source: captodayonline