News
Centers for Medicare & Medicaid Services urged to scrap policy letting nurses evaluate lab tests
Hospital lab workers are urging the U.S. Centers for Medicare & Medicaid Services (CMS) to do away with an Obama-era regulation that allowed nurses to analyze clinical lab tests.
The policy in question was issued in 2016 over concerns there was a shortage of testing personnel, especially in rural areas. However, lab personnel say that nurses don't have the training necessary to analyze such tests and are asking the Trump administration to junk the policy.
"Clinical judgment of results cannot be made if the laboratory scientist has no understanding about molecular biology; genetics and polymerase chain reaction testing," Byron Serna, director of laboratory services at Baylor Scott & White Health said in a comment. "There is already enough risk with patient safety within the field of transfusion medicine. Why increase that risk by placing under-educated staff members in that area of the laboratory?"
The remarks are in response to the CMS' request for information on whether regulations governing clinical laboratories need to be updated. Comments were due March 12. Specifically, the CMS is interested in whether personnel requirements, testing standards and industry fee structures need to be updated.
There has been an increased reliance by clinical labs on undertrained staff to perform and analyze increasingly complicated tests.
"I am aware of workforce shortages in the laboratory; these should not be solved by employing individuals from another healthcare discipline that has its own shortage situation," Samuel Ryan Galorport, senior clinical laboratory scientist at Bartlett Regional Hospital in Alaska said in a comment. "Patient safety demands quality laboratory testing performed by qualified individuals."
Major trade groups like the American Society for Clinical Laboratory Science and American Society for Clinical Pathology have also been lobbying the CMS to reverse course, arguing that nurses do not take the same amount of scientific coursework necessary to conduct and analyze complex laboratory tests.
But some nurses and staff disagree with that assertion. Ruth Blackman, a nurse in New York, said in comments that she had extensive biological science education and supported others in her profession being able to read lab tests.
Read the full story by clicking on the article above.
New vaccine targets pneumonia, blood poisoning, meningitis among children in Canada's North
Federal researchers have collaborated to develop a preventative vaccine for a potentially deadly bacteria that causes pneumonia, blood poisoning and meningitis in children and affecting predominantly children in northern and Indigenous communities.
Scientists with the Public Health Agency of Canada first identified Haemophillus influenzae Type A (Hia) infections in the mid-2000s in Winnipeg, Edmonton and Montreal hospitals.
Hia has become more common since then, evolving into an emerging public health concern among children under five and for adults whose immune systems aren't working properly, said Dr. Guillaume Poliquin, the senior medical adviser for the Public Health Agency of Canada at the National Microbiology Laboratory (NML) in Winnipeg.
About 500 people are exposed to Hia every year, and about 10 per cent of those die.
"It can spread anywhere in the body and can cause things from pneumonia to skin, soft tissue and bone infections, but the complication we fear the most is when it gets to the lining of the brain and can cause … meningitis," Poliquin said during a recent tour of the Level 2 lab.
Dr. Raymond Tsang's Winnipeg-based research team identified the Hia Type A bacteria as the one responsible for the cases they were seeing. They isolated the piece of the bacteria most vulnerable to a vaccine and sent that to the National Research Council of Canada (NRC) in Ottawa.
Scientists there developed a vaccine using specialized chemistry and technology. It involves engineering a molecule called a carrier protein that they attached to the bacteria, making it easier for the vaccine to recognize and generates a stronger immune response.
It was found effective in tests on mice and rabbits.
Blame Canada's history for low rates of cancer screening among Indigenous women, doctor says
A B.C. doctor says the colonial history of Canada's health care system is preventing Indigenous women from being screened for cervical cancer and she hopes a solution can be found in a health initiative in East Africa.
Indigenous women in B.C. are 92 per cent more likely to develop cervical cancer than non-Indigenous women, according to a joint study from the B.C. Cancer Agency and First Nations Health Authority. The same study also found lower survival rates for Indigenous people with cancer.
Part of that disparity can be explained by the colonial history of healthcare in Canada said Dr. Sheona Mitchell-Foster, an obstetrician-gynecologist and assistant professor in the University of British Columbia's Northern Medical Program in Prince George. For decades, Indigenous people were treated in segregated, government-run "Indian hospitals" where, according to those who lived through the system, they were subject to abuse and experimentation that included forced sterilization of hundreds of women.
Mitchell-Foster said that history needs to be considered when looking at the modern-day healthcare system. Other factors cited by Mitchell-Foster include the distances Indigenous women in northern B.C. have to travel to be screened and that many doctors who administer pap smears are men. "That's a uniquely invasive exam," she said.
To counter this, Mitchell-Foster is working with Carrier Sekani Family Services and Métis Nation B.C. to give Indigenous women in northern B.C. take-home kits that allow them to self-test for the human papillomavirus or HPV, the virus that causes cervical cancer. The screening model is based on a project the B.C.'s Women's Health Research Institute is running in Uganda.
Should the experiment see increased rates of screening among participants, Mitchell will advocate for it to be adopted in rural B.C.
Transfusion Medicine
Blood stored longer may be less safe for patients with massive blood loss and shock
In a collaborative study using a mouse model, researchers have found mechanistic links between older stored red blood cell transfusions and subsequent bacterial pneumonia. This may reveal new approaches to improve safety of stored red blood cell transfusions.
Human blood from donors can be stored for use up to 42 days, and it is a mainstay therapy in transfusion medicine. However, recent studies looking back at patient records have shown that transfusion with older, stored blood is associated with adverse effects.
For severely injured patients who have massive bleeding and receive many transfusion units, older blood was associated with dysfunction in blood flow, increased injury and inflammation in critical end organs, and lung infection.
In a collaborative study using a mouse model, University of Alabama at Birmingham researchers from the departments of Anesthesiology and Perioperative Medicine, Biostatistics, Emergency Medicine, Pathology, and Surgery have found mechanistic links between older stored red blood cell transfusions and subsequent bacterial pneumonia.
The key player is free heme, a breakdown product from degraded red blood cells. Heme is part of the oxygen-binding hemoglobin pigment that gives blood cells their red color and carries oxygen through the body from the lungs. While in the red blood cell, heme is relatively safe; but once outside the confines of the red cells, free heme is toxic and can cause tissue injury. During storage and upon transfusion, stored red blood cells lyse open, releasing free heme.
An adverse role for heme suggests that finding ways to limit heme exposure or prevent heme toxicity may improve safety of stored red blood cell transfusions, say UAB researchers Rakesh Patel, Ph.D., and Jean-Francois Pittet, M.D.
Microbiology
Potential New Urine Test for TB Could Speed Up Diagnosis and Treatment of Disease
Tuberculosis is a major killer that ranks alongside HIV/AIDS as a leading cause of death worldwide. This deadly disease takes the lives of more than a million people each year. And, unfortunately, traditional medical laboratory testing using X-rays, blood/skin/sputum specimens, or the new molecular diagnostic systems can be time consuming and expensive.
Now, scientists at George Mason University (GMU) in Virginia have developed a urine test for tuberculosis (TB) that could lead to a dip-stick technology that would accurately and rapidly diagnose the deadly lung disease.
Similar to a pregnancy test, if successfully developed for use in clinical settings, the dip-stick could not only enable public health agencies to test for TB more effectively, but also allow primary care physicians and other doctors to easily test their patients for TB at the point of care.
Such a breakthrough would certainly be a boon to public health and global healthcare, especially in resource strapped areas of the world. According to the World Health Organization (WHO), more than 95% of the 1.7 million TB deaths each year occur in low- and middle-income countries. This is one reason why an inexpensive and easy-to-use detection method for diagnosing the lung disease has long been sought. TB is curable, particularly if diagnosed early.
With that goal in mind, an international team led by Alessandra Luchini, PhD, Associate Professor at GMU, and Lance Liotta, PhD, MD, co-director and co-founder of the GMU Center for Applied Proteomics and Molecular Medicine, developed the potentially revolutionary urine test that uses nanotechnology to measure a sugar molecule in urine that identifies TB with a high degree of accuracy. The scientists published their results in Science Translational Magazine.
Molecular Genetics
23and Me can sell genetic tests for cancer risk without a prescription
On March 6, the US Food and Drug Administration approved 23 andMe’s at-home genetic test as a diagnostic tool for increased risk of breast, ovarian, and prostate cancer.
This test analyzes a sample of saliva and screens for three mutations of the BRCA1 and BRCA2 genes. In women, these mutations can raise the likelihood of developing breast cancer from 12% (the average baseline) to 45% to 85%, and of developing ovarian cancer from 1.3% to between 17% and 44%. In men, the mutations also raise the risk of breast cancer, and possibly prostate cancer as well, although the research is less clear for the latter.
23 andMe’s test involves taking a simple saliva swab at home, and sending it to the company’s labs for analysis. It’s the first at-home BRCA1/BRCA2 screening tool to be approved for use in the US, and could significantly raise the number of people aware of having the cancer-related mutations.
Currently, pretty much all BRCA1 and BRCA2 screenings are called for by a doctor, for patients already identified as either having cancer, or as having a high risk of cancer.
Research
Blood test can diagnose early-stage Alzheimer’s disease
A blood test that can diagnose Alzheimer’s disease in its early stages and predict how it will progress has been developed by Irish scientists. It is the first accurate test to diagnose the disease when symptoms are mild.
Researchers at the Royal College of Surgeons in Ireland identified concentration changes in the blood of a small molecule that can diagnose the disease when other symptoms are mild.
The project’s principal investigator, Tobias Engel, a lecturer in physiology at RCSI, said that they found changes in blood levels of a small molecule called microRNA. They were also able to distinguish Alzheimer’s from brain diseases with similar symptoms.
Asked when the Alzheimer’s test is likely to be available, he said: “We are still at the stage of clinical testing. I would predict, if everything goes well, we are talking about five years.”
New diagnostic method makes testing for infections in people and animals quick and easy
Glucometer-inspired technology brings the lab to your home or pasture.
Researchers in the University of Calgary Faculty of Veterinary Medicine (UCVM) have developed a fast, portable and inexpensive way to test humans and animals for different types of chronic and infectious diseases. This new “point of care” method tests for signals of infection, such as specific antibodies, in blood, milk or saliva samples.
“For a long time, there’s been a need in the health-care system for a diagnostic device that’s available to test for anything, anywhere, anytime, to anyone,” says Jeroen De Buck, associate professor, bacteriology, at UCVM.
De Buck and PhD student Marija Drikic built on the concept of a simple glucometer to develop their new biosensor technology. Their invention — the TreAsure Assays Biosensor — uses an engineered enzyme to convert signals of infection into glucose and the resultant glucose can then be measured. It forms the basis of convenient point-of-care tests for animal or human chronic and infectious disease.
“A cow infected with bovine leukemia virus produces antibodies as a response,” De Buck explains. “Our biosensor will detect the antibodies in a pin-prick of blood. The enzyme will make glucose proportionately to the antibodies that can then be instantaneously measured.”
The new portable device doesn’t need complex sample preparation or handling. So, testing a cow in a remote field, for instance, is simple. The technology has many potential applications, from people using it at home to monitor their health to veterinarians checking the progression of a disease in animals.
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