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This is the final edition of LabBuzz for 2016. We’ll be back in your inbox on Friday, January 6th, 2017.
Province proposes new college of diagnostic and therapeutic health professions
British Columbia is proposing to establish a new college of diagnostic and therapeutic health professions to enhance patient safety and quality of care. The new college would initially oversee four types of health care professionals: respiratory therapists, radiation therapists, clinical perfusionists and medical laboratory technologists. “Diagnostic and therapeutic health professionals are a key part of our health system,” Health Minister Terry Lake said.
The ministry has proposed the new college following extensive consultation with stakeholders. Eleven different diagnostic and therapeutic health professions were examined, and self-regulation under the Health Professions Act has been recommended as a priority for respiratory therapists, radiation therapists, clinical perfusionists and medical laboratory technologists because they perform invasive procedures and/or provide care that poses a higher degree of potential risk to patients. Following this consultation, the new college is anticipated to be established in about 18-24 months. Thereafter, the ministry will continue its work on regulatory options for a number of other diagnostic and therapeutic health care occupations, including medical laboratory assistants.
The proposed regulation is posted for feedback and can be accessed here.
Quest Diagnostics breach exposes health data of 34,000 customers
Quest Diagnostics, a New Jersey-based medical laboratory company, disclosed a data breach affecting about 34,000 people on Monday. Digital intruders stole personal and medical information of customers, including names, dates of birth, lab results, and, in some cases, telephone numbers. The thieves did not steal financial information such as Social Security or payment card numbers. Attackers gained access to the data on November 26 through an improperly secured mobile app, called MyQuest by Care360, that lets patients share and store electronic health records. "When Quest Diagnostics discovered the intrusion, it immediately addressed the vulnerability," Quest said in a statement. The company said it is now reviewing and bolstering its security posture with help from an unnamed cybersecurity firm.
The breach is the latest in a string of high-profile cyberattacks in the health care sector. Last year, for example, health insurance giant Anthem announced a massive breach that compromised the data of 78.8 million people.
Clinical Chemistry
Recent advances in the clinical application of mass spectrometry
Since the latter half of the 20th century, mass spectrometry (MS) applications, associated with gas chromatography (GC) separation, have been the "gold standard" in specialised clinical laboratories for the quantitation of drugs, organic acids and steroids. This status quo remained unchallenged until just over a decade ago when liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) and inductively coupled plasma mass spectrometry (ICP-MS) were introduced into routine clinical chemistry testing. There has since been a rapid succession of methods in the peer reviewed literature which attest to their accuracy and precision. Whilst this technology clearly offers a number of significant advantages, including improvements in specificity and sensitivity, there is a dichotomous divide between advocates and detractors of MS based applications.
As we embrace MS, the author argues that our current and future scientists ideally should have the combined skills to 1) validate and run the current and new clinical MS applications, 2) work within a quality framework and 3) apply appropriate statistical analysis for the interpretation of the data. Developing scientists with these combined skills will support the robustness of methods, goals of harmonisation and eventual standardisation with traceability of MS methods. In their conclusion, it is determined that MS is now firmly established in the clinical space and the range of applications will continue to expand. Although MS is not yet applicable for all regions, in the future just like the manual immunoassays of old, MS throughput and user friendliness will improve.
Hematology
Therapeutic vaccine shows 'game-changing' promise against a leukemia
Patients with acute myeloid leukemia, one of the most aggressive blood cancers, must undergo intense chemotherapy knowing a high likelihood of remission once treatment is stopped. Now, an anti-cancer vaccine made from a leukemia patient's own cells can dramatically increase the chance of long-term survival against the deadly disease.
Published in Science Translational Medicine, a new study has demonstrated remission for nearly five years of patients with acute myeloid leukemia. The research team then injected patients with the vaccine after they entered remission through chemotherapy. The vaccine has produced long-term remission for 70% of a small group of 17 vaccinated patients with an average age of 63, the researchers reported. Also, as the vaccine relies on the patient's own immune cells, rather than donated cells, it avoids the toxic side effects associated with bone marrow transplants. Chemotherapy can never kill off all a person's leukemia cells, so this sort of immunotherapy is important to teach the immune system to find and attack those remaining blood cancer cells. Susanna Greer, director of clinical research and immunology for the American Cancer Society, called the new vaccine "a really tremendous discovery" that "changes the ball game for acute myeloid leukemia."
Transfusion Medicine
Researchers seek clearer guidelines for red blood cell transfusions
Nearly half of red blood cell (RBC) transfusions are not given based on suggested guidelines, according to results of a cross-sectional survey conducted at three Jerusalem hospitals and presented at the ASH Annual Meeting and Exposition. The findings highlight the need for clearer guidelines and better understanding of clinical decision-making, researchers wrote.
Revel-Vilk and colleagues evaluated data from 584 RBC transfusions given to 302 patients. The mean number of transfusions per patient was 1.9 (± 1.3); 52.6% of patients received one transfusion. Two patients received eight transfusions. Nearly all patients (n = 291) had at least one underlying medical condition and nearly half (n = 142) of patients took antithrombotic therapy. The prevalence of off-protocol RBC transfusion was 48.1%, occurred more in surgical departments than nonsurgical departments, and was performed on patients with a higher mean age than on-protocol patients. Off-protocol RBC transfusion was not related to presence of underlying malignancy, heart disease, nephrology conditions or pulmonary disease. However, it was more common among patients who took antithrombotic therapy. Pretransfusion recording of patients’ blood pressure, pulse rate and saturation were not associated with off-protocol RBC transfusion. “Although clinical considerations, such as underlying disease or patients’ pretransfusion signs, may explain nonadherence to guidelines, no clear pattern was observed in the current study to support this explanation,” Revel-Vilk and colleagues wrote.
How chilling! Amsterdam is using its underground water supply to cool its blood bank
A blood bank in Amsterdam is using public drinking water to flash-cool its drug production line - reducing the city's water-heating needs in the process. Working with Dutch water company Waternet, Sanquin Blood Supply Foundation has found a way to draw water from Amsterdam's two main public drinking-water lines, both of which pass near its campus on the west side of the city. Then, using a heat exchanger, Sanquin extracts the cold from the water, leaving the rest of Amsterdam's drinking water 0.5°C warmer in the winter months. A portion of this harvest cools the air in Sanquin's facilities, and the rest is stored underground.
"Sustainability is important, but we also need to efficiently meet our cooling needs," says Jordy Pedd, facilities project manager at Sanquin. "This turned out to be our best option." Sanquin says it could save about 1,900 tonnes of carbon dioxide a year, which, according to the city of Amsterdam, is the annual energy usage for up to 1,800 households.
Like many other blood banks, Sanquin recruits volunteer blood donors, collects blood and isolates the samples' red blood cells and platelets to send back to hospitals for clinical treatments. But Sanquin goes one step further: it keeps the blood's leftover plasma in order to manufacture plasma-based therapies on-site. This production process requires a year-round stream of sterile water to sanitize its lab tools. Sanquin heats the process water up to 80°C before using a quick burst of energy to cool it down rapidly to 20°C before use.
Microbiology
New generation of tuberculosis diagnostic tests recommended in updated IDSA guidelines
As more antibiotic-resistant forms of the Mycobacterium tuberculosis bacterium (Mtb) are evolving, so too, should new ways to diagnose and treat tuberculosis (TB). Now, new guidelines from an international panel of doctors recommend that people who are at risk for TB undergo infection screening with a new generation of diagnostic tests. A recent report found that nearly one in four of the world’s human population have latent TB. An estimated 5-10% of latent TB will go on to develop TB disease, unless the individual receives proper treatment.
With the advent of better diagnostic tools, the Diseases Society of America recently released a new set of guidelines on the best test for diagnosing latent TB infections, along with a set of recommendations for patients showing signs of active TB. Their report appears in the journal Clinical Infectious Diseases.
In the new guidelines, there is support for replacing traditional tuberculin skin tests (TST) with newer tests called interferon-gamma release assays (IGRAs), blood tests used to diagnose infection with TB that measures interferon gamma (IFN-γ) released by sensitized T-cells in response to highly-specific Mtb antigens. The tests can be given in a single visit with results available within 24 hours, though results cannot differentiate between latent TB and TB disease. The new recommendations call for the use of IGRA tests in those aged five and older and for individuals likely to be infected with Mtb with a low or intermediate risk of disease progression. The TST remains an acceptable alternative when an IGRA is either unavailable or too costly.
Molecular Genetics
AMP issues new joint guidelines to standardize interpretation and reporting of sequence variants in cancer
The Association for Molecular Pathology (AMP) recently published guideline recommendations for both clinical laboratory professionals and oncologists that assess the status of next-generation sequencing (NGS)-based cancer tests and establish standardized classification, annotation, interpretation, and reporting conventions for somatic sequence variants.
The increasing use of NGS technologies has raised new challenges, especially regarding how cancer-associated sequence variants are interpreted and how molecular results are reported by different clinical laboratories. To help standardize this process, AMP convened a panel of experts to develop a new set of guidelines based on evidence from a comprehensive review of published literature, empirical data, current laboratory practice surveys, feedback from multiple public meetings, and their own professional experiences. The report proposed a four-tiered system to categorize somatic sequence variations based on their clinical significance in cancer diagnosis, prognosis, and/or therapeutics:
- Tier 1: Variants with strong clinical significance
- Tier 2: Variants with potential clinical significance
- Tier 3: Variants of unknown clinical significance
- Tier 4: Variants deemed benign or likely benign
"This joint consensus recommendation represents a significant step forward in this era of precision medicine and our fight against cancer," said Marilyn M. Li, MD, Vice Chief of the Division of Genomic Diagnostics and Director of Cancer Genomic Diagnostics at Children's Hospital of Philadelphia.
Cytogenetics
Unique FISH lab: Crossing disciplines, creating opportunity
Diagnostic Services Manitoba’s (DSM) new FISH (fluorescent in situ hybridization) lab is a first for DSM in that it has brought three disciplines together to create a multidisciplinary service that will improve testing capabilities and access for all three disciplines. "The creation of this lab presented a unique first opportunity to change the way we look at things," said Lisa Manning, Pathology Technical Director. "We are gaining time," said Dr. Angie Dawson, Molecular Cytogeneticist and Director of DSM’s Cytogenetics Laboratory, referring to what she regards as the biggest improvement that FISH will bring. "We are learning not only new technical and interpretive skills, but also the terminology and frames of reference of other disciplines. This will be evidenced by a reduction in send-outs, which will allow for earlier diagnosis and initiation of appropriate therapy and, hopefully, an improvement in outcomes."
The DSM multidisciplinary FISH lab was able to acquire two new and sophisticated technologies that would not have been possible as individual discipline labs: a high capacity loader, which speeds up the analytical process by automatically scanning slides with the appropriate FISH probes; and a SKY (spectral karyotyping) interferometer, which uses spectral karyotyping to solve complex chromosomal rearrangements for both constitutional and oncology samples, not identifiable by standard cytogenetic techniques. "This is only the beginning for the FISH Lab and for multidisciplinary partnerships," emphasized Lisa. "As we explore ways to innovate our services more and more shared opportunities will present themselves."
Research
Communicating laboratory test results for rheumatoid factor: what do patients and physicians want?
There is inconsistency in how laboratory test results are communicated. To explore ways in which laboratory test results can be communicated in a patient-friendly manner, two independent surveys were conducted to explore physician and patient perspectives regarding: 1) the current content of RF blood test reports; 2) the adequacy of physician–patient communication about laboratory reports in general; 3) the adequacy of physician–patient communication about RF laboratory reports; and 4) potential areas for improvement in the presentation of laboratory test results to patients. Perspectives from the United States and physicians in three European countries (the United Kingdom, Germany, and Switzerland) were included.
Both physicians and patients expressed a desire for patient-friendly information on laboratory reports. Most (76%) of 210 patients have reported that doctors always or most of the time tell them the reasons why the tests are being done. Physicians expressed a need for education for patients around false-positive and false-negative results within laboratory reports, while patients sought context around the meaning of results, relevance to other tests, and follow-up steps. Almost half of 211 patients (47%) usually do not look for more information when they receive their laboratory results. Among those who do look for more information, most prefer to go to the Internet (78%), while a sizable minority talk to their physician (36%) or to other patients (25%).
The study suggests that patients and physicians have unique perspectives on laboratory reporting. Including both patients and physicians when designing laboratory test reports may lead to better patient engagement, doctor–patient communication, and potentially improved outcomes.
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