News
Government predicts legal pot will lead to influx of lab tests
Are forensic laboratories across Canada about to be overwhelmed by samples of blood, urine, saliva and hair when recreational marijuana becomes legal? Prime Minister Justin Trudeau has promised legislation will be tabled by the spring, and a distribution system could be in place by early 2018.
In published documents, Public Safety Canada notes that as usage increases, police may soon be doing a lot more testing for the presence of marijuana in a person’s system. In anticipation of that influx, the government is looking to hire an outside contractor to determine if 80 labs across the country will be able to handle the increase in testing. “The fact that American labs are being included in the study suggests Canada might look south of the border to help keep up with the increased workload, said Christine Nielsen, CEO of the Canadian Society for Medical Laboratory Science. “This could be a burden to the system, without a doubt,” Nielsen said. “I think it’s really positive that the government is trying to assess capacity before they implement the actual policy.”
If it turns out Canada’s labs can’t handle a looming increase, officials might need to look at alternate forms of testing that could detect the amount of THC in someone’s system on the spot; something akin to a glucose meter. The problem is that the law doesn’t yet have limits to determine when someone is impaired by drugs while driving.
Quality
New recommendations seek to improve the quality of pathology practice
The Canadian Partnership Against Cancer is releasing a first of its kind set of recommendations to improve the quality of interpretive pathology practice in Canada. The Pan-Canadian Quality Assurance Recommendations aim to enhance patient safety by promoting better and more consistent pathology quality assurance processes across the country. “Pathology leaders across the country recognized that there were gaps in quality assurance activities as it relates to the practice of pathology,” said Dr. John Srigley, Expert Lead in Pathology at the Partnership.
While the technical and administrative processes performed by laboratory staff are well regulated and accredited, quality systems governing the medical practice of pathology are less well developed and not standardized across the country. Currently, only a few provinces such as Alberta, Ontario and Prince Edward Island have coordinated provincial-level quality assurance programs that relate to interpretive aspects of pathology. For these reasons, there was a growing interest at the provincial, national and international levels, in developing a more standardized approach to quality assurance in interpretive pathology.
The threat is real
If you work in a clinical laboratory, you are a guardian of valuable data. Even if the data you deal with on a day-to-day basis feels routine, the threat of hackers breaching laboratory information systems is a real and a growing one, according to experts. Labs often have their own record systems, devices, and IT support that operate independently from the broader hospital or healthcare system. In IT, these silos pose particular risks. For example, when information passes between silos, it often presents a weak spot for hackers to access. Moreover, devices run within silos might not receive enough attention from IT professionals compared to the main systems.
“If you connect to the internet, you’re not safe,” said David Finn, the healthcare IT officer of Symantec, a large enterprise cybersecurity company. In 2015, more than 113 million health records were compromised, according to the Department of Health and Human Services Office of Civil Rights. Increasingly, hackers penetrate hospital networks by infecting medical devices with their malware and ransomware, using out-of-date instruments as holes in the system. “Healthcare hasn’t been as robust in its security as other industries,” said Marti Arvin, the vice president of audit strategy at CynergisTek, a healthcare security consulting firm. “As a result, we’re now seeing hacks and threats aimed at healthcare that you might not see in the financial sector or credit card industry.”
Check out the 5 Expert Tips to protect your lab against cyber threats
Pre-Analytical
Center for Phlebotomy Education's tip of the month
You like to be ready when the next patient comes in. Your tubes are all lined up in the rack, neatly sorted by size and stopper color so you can pick them out quickly once you see the next patient’s order. The tourniquet is nicely draped over the arm of the drawing chair, and the bandage is unwrapped and ready to go. Your gauze pad is sitting out on top of the alcohol prep like they can’t wait, either. You even have the needle assembled to the tube holder so you can get right to it. If this describes you, you’ve just gone too far. You’re too organized. There’s nothing wrong with being ready, but by preassembling the needle with the tube holder or syringe, you’ve just eliminated a crucial element to every patient’s phlebotomy experience: confidence that the needle you’re about to use isn’t left over from the last patient.
A new needle looks exactly like a used needle with the sheath put back on. Exactly.
Assembling your devices in advance saves you about 3 seconds, but costs you the patient’s confidence. If those three seconds matter that much, you should be trading on the floor of the New York Stock Exchange or saddled to the back of a race horse. But you’re not. You’re a phlebotomist. You’re not timing a trade or racing your horse; you’re drawing a blood sample from a patient who has three seconds to spare. Those three seconds aren’t yours anyway; they’re his, reserved for him to see you take the separate components of the blood collection device out of their packages and put them together.
Hematology
Testosterone therapy may be linked to serious blood clots
Testosterone treatment can increase a man's risk of potentially fatal blood clots, a new study suggests. These clots can cause a heart attack, stroke, organ damage or even death, according to the American Heart Association. Published in the British Medical Journal, researchers found that men taking the male hormone seem to have a 63 percent increased risk of venous thromboembolism (VTE).
Data from about 19,000 male British patients with confirmed VTE was reviewed and compared with 909,000+ age-matched patients in a control group. The overall risk increase translates to about one additional case of blood clots for every 1,000 men a year. "Risk peaks rapidly in the first six months of treatment and lasts for about nine months, and fades gradually thereafter," said Dr. Carlos Martinez, a consultant for the Institute for Epidemiology, Statistics and Informatics in Frankfurt, Germany.
The study didn't establish a direct cause-and-effect relationship, however. No one is sure why testosterone might help cause blood clots according to experts. One theory holds that testosterone in some way interferes with the enzymes that break up blood clots, particularly in people already inclined toward VTE, Martinez said.
Transfusion Medicine
Another step closer to artificial blood
Researchers have created an artificial red blood cell that effectively picks up oxygen in the lungs and delivers it to tissues throughout the body. This artificial blood can be freeze-dried, making it easier for combat medics and paramedics to keep on hand for emergencies, said senior researcher Dr. Allan Doctor, critical care specialist at Washington University School of Medicine.
"It's a dried powder that looks like paprika, basically," Dr. Doctor said. "It can be stored in an IV plastic bag that a medic would carry, either in their ambulance or in a backpack, for a year or more. When they need to use it, they spike the bag with sterile water, mix it, and it's ready to inject right then and there." The artificial blood cell, which is about one-fiftieth the size of a normal red blood cell, is made from purified human hemoglobin proteins that have been coated with a synthetic polymer.
The hunt for an artificial blood substitute has been underway for more than 80 years, but the closest prior attempts have failed in two major ways. Earlier versions could capture oxygen in the lungs, but then would not effectively release the oxygen after traveling out to tissues and organs. There also was an unintended reaction between "naked" hemoglobin and nitric oxide, a substance released by the lining of blood vessels that allows the vessels to relax and open up, Dr. Doctor noted. The synthetic polymer coating of the latest artificial blood cell appears to solve both these problems.
Microbiology
MALDI-ToF is poised to speed diagnosis for bacterial and fungal infections
There is a growing recognition within the lab industry that MALDI-ToF may be a transformative technology. However, some commercial laboratories have not adopted it yet as an exclusive or primary means for identification of bacteria, yeast, and mycobacteria. Many industry leaders believe this is a missed opportunity.
Benefits: Identification with MALDI-ToF is a relatively simple process. Once a slide has been prepared, it is introduced into a high-vacuum environment, where the sample is ionized with a laser burst that releases proteins. These proteins are then accelerated using an electric charge, and the time of flight is recorded. At the end of travel, the proteins are detected with a sensor. The sensor then creates a spectrum representing the protein makeup for each sample. Identification is made when the spectrum from a sample is compared against a large database of spectra of characterized bacteria, yeast, and mycobacteria. The process can reduce the time needed for identification and diagnosis from days to hours. The easiest way to see the value of MALDI-ToF for patient care is to think of it in terms of specific life-threatening infections where the time from initial infection, to diagnosis, to treatment is highly correlated to patient morbidity.
Limitations: Some organisms may require repeat analysis and additional processing, and some closely related organisms are not differentiated and may cause challenges with identification. The technique also is generally not useful for direct testing of clinical specimens. Finally, the initial purchase price of the equipment is high, which may limit the types of labs that can adopt it.
Conclusion: After weighing the benefits and limitations of MALFI-ToF, an increasing number of commercial laboratories will likely be making efforts to incorporate it as their primary means for identification of bacteria, yeast, and mycobacteria. When it happens, they will be designing a new workflow to optimize the technology and ensure that results get from the lab to clinicians and patients quickly.
Anatomic Pathology
A rare transition of non-hodgkin lymphoma into classical hodgkin disease reported in PiscoMed's Journal AMOR
“Through a series of biopsies, we report a unique case of diffuse large B-cell lymphoma (DLBCL) with stepwise development of classical Hodgkin lymphoma (cHL),” said pathologists Dr. Haipeng Shao and Pardis Vafaii from the Department of Hematopathology and Laboratory Medicine a Moffitt Cancer Center and Research Institute. “To the best of our knowledge, this is the first report of an intermediate stage of transformation from DLBCL into cHL,” they added.
The patient was an elderly male with a history of stage IV DLBCL. Biopsies taken from the patient’s left arm and upper back revealed results consistent with DLBCL of the non-germinal center subtype. The patient then underwent chemotherapy, salvage therapy and an autologous bone marrow transplant. Following the transplant, the patient’s biopsies started manifesting features of cHL, indicating a hybrid intermediate stage, according to the authors. "In the second biopsy…scattered Reed-Sternberg/Hodgkin-like cells were admixed with the DLBCL cells," Shao and Vafaii wrote of the large atypical lymphoid cells which resemble Reed-Sternberg in cHL but do not develop into cHL. Three months later, however, an excisional biopsy performed on the patient’s lymph node no longer showed evidence of DLBCL but instead exhibited "many scattered clusters of Reed-Sternberg/Hodgkin cells with prominent cherry-red nucleoli in a background of small mature lymphocytes and granulocytes," which are findings consistent with a cHL of the nodular sclerosis subtype, the authors reported.
Molecular Genetics
Gene editing tool CRISPR used to correct blood clotting, treat hemophilia in mice
A dual gene therapy approach was employed for the first time in delivering key components of a CRISPR/Cas-9 mediated gene targeting system that would help treat hemophilia B. The research was conducted on mice, and it addressed the disease that is also called factor IX deficiency.
The study, conducted by scientists at the Perelman School of Medicine at the University of Pennsylvania, tried to treat the illness triggered by a missing or defective clotting protein. The researchers experimented on a mouse model where the clotting factor IX was knocked out in order to cure hemophilia. The team employed a two-vector method. Vector 1 expressed the SaCas9 gene for the gene-editing system to home to the liver, thus producing the clotting factor IX. Vector 2 is where this study is different from previous ones conducted as part of the same program; it contains an RNA sequence which targets a specific region, making the approach more accurate in curing hemophilia.
The researchers injected the two vectors with progressively increasing doses in newborn and adult knockout mice. The results were a stable factor IX activity. Eight weeks after administrating the treatment, the researchers created a subgroup of the mice category, who were also administered a partial liver removal. All the mice survived the medical procedure, and no complications followed this medical approach. "Basically, we cured the mice," noted Lili Wang PhD, research associate professor in the Penn Gene Therapy Program.
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