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.
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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.
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.