Provincial lab botches drug test results for over 400 patients
A software coding error led to hundreds of inaccurate drug test reports being sent out by the Roy Romanow Provincial Laboratory, according to its executive director, Patrick O’Byrne.
The lab tests roughly 75,000 samples each year. Each sample is tested for 42 different drugs. The tests give doctors an idea of what drugs a patient is using, which helps them determine proper treatment, according to O’Byrne.
"The error was caught, and we thought it had been corrected." However, beginning Oct. 30, two of the 42 drugs tested for — codeine and diphenhydramine (Benadryl) — stopped appearing on reports. "The reports that we had originally sent out to physicians indicated that the patients did not have these drugs in their system," he said. "But that was wrong."
It wasn’t until Nov. 28 that the coding error, which first occurred on Oct. 25, was actually rectified. By then, 484 inaccurate reports had been generated, pertaining to 458 individuals. In cases where patients had either one or both drugs in their system, the report showed no trace of either.
"We have a process if we find an error," he said, noting that amended reports were sent to doctors on Nov. 30 and Dec. 1. "We also phoned the clinics that most often use this service and alerted them to this."
Personalized medication treatments come to Okanagan
Okanagan residents can now take a genetics test to improve the effectiveness of their medication treatments. "Personalized medicine has now advanced to the stage where one simple test can reveal how your body will uniquely respond to medicines you take, based on genetics," said Kelowna pharmacist Cam Bonnell, with Lakeside Pharmacy. Lakeside is one of 60 pharmacies across B.C. that have begun to administer the test service called myDNA.
It involves having a cheek swab sample taken, which is sent to an accredited lab for DNA sequencing, a process that takes three to four weeks. Clients then meet with their pharmacist to discuss the results and learn how their medication can be tailored to their genetic profile for the maximum results and to minimize negative side-effects. Mark Chambers, a pharmacist with Lakeside Pharmacy in Kelowna, says genetic profiling determines how your body processes certain medications. Some process medications too quickly with reduced benefits, others process too slowly increasing the risk of side-effects.
Drugs currently eligible for pharmacogenomic testing include antidepressant, antipsychotic, blood pressure, heart, blood thinner, reflex and pain medications.
The cost is $149 for a single medication test, and $199 for multiple medications.
Related article: University of Iowa to lead national campaign educating Americans, health care professionals about precision medicine
The importance of external quality assessment in HIV enzyme immunoassay testing
The main use of EQA (External Quality Assessment) is to verify the accuracy of laboratory testing. Accuracy refers to the closeness of the obtained result to the "true" value. As EQA is tested using blind samples, operator bias is eliminated and the test system can be appropriately challenged. EQA can also be used to identify pre-analytical, analytical, and post-analytical errors:
- Pre-analytical involves issues with sample/reagent preparation, handling, etc.
- Analytical can include instrument and calibration issues.
- Post-analytical may involve issues with the interpretation of analytical results and general human error.
The most common method of HIV detection is enzyme immunoassay (EIA) antibody testing. EIA tests are highly sensitive and can be optimized for automation, facilitating high-volume testing. However, with higher volumes of testing comes a higher probability of error. With EIA assays, the most common error encountered is false positive results.
False positive results have a number of implications. Any screen-positive results must be verified using a confirmatory test, usually a Western Blot assay. The Western Blot is much more labor-intensive and expensive than EIA tests, and it is not efficient enough for high-volume testing. Therefore, if a laboratory is producing a higher than average number of false positive results due to poor quality assurance practices, it will ultimately spend significantly more time and money on confirmatory tests.
As HIV is classified as a pandemic and a chronic illness, it is of the utmost importance that testing be accurate and consistent. If errors arise, false positive and false negative results can have serious implications for both the patient and the laboratory itself. If incorrect results are reported, patients could potentially file lawsuits, the lab’s reputation will be tarnished, and regulatory bodies could strip the lab of its accreditation status.
Read the entire article by clicking on the article title
FDA Warns Biotin May Interfere With Lab Tests
The US Food and Drug Administration has issued a warning that ingesting high levels of biotin, also known as vitamin B7, can lead to incorrect lab test results.
The agency said it issued the warning because it is seeing an increase in the number of reported adverse effects related to the vitamin's impact on lab results, including one death of a patient taking high levels of biotin whose troponin tests results were falsely low.
Biotin, a water-soluble vitamin often found in multi-vitamins, prenatal vitamins, and dietary supplements marketed for hair, skin and nail growth, can cause falsely high or falsely low lab test results depending on the indication, according to the FDA. Many of the dietary supplements promoted for hair, skin and nail benefits contain biotin levels up to 650 times the recommended daily intake, according to the FDA. Physicians sometimes also recommend high levels of biotin for certain conditions such as multiple sclerosis.
The agency is advising physicians to be aware that many lab tests, including cardiovascular diagnostic tests and hormone tests, may generate incorrect results if there is biotin in the patient's specimen. Physicians are also advised to tell the labs performing testing if patients are taking biotin.
Irish study contradicts former belief regarding common bleeding condition
Contrary to the former belief that people with the inherited bleeding disorder Low Von Willebrand Factor only posed a mild risk for bleeding, a new Irish clinical study has found that people with the disorder have a marked increased bleeding tendency.
These findings from the LoVIC study, led by the Irish Centre for Vascular Biology at RCSI, may alter doctors’ perception and management of this condition, particularly in relation to surgery or childbirth preparation.
Conducted in the National Coagulation Centre, St. James’ Hospital, the study is the first of its kind to research the causes and management of bleeding experienced by people diagnosed with Low Von Willebrand Factor. Dr Michelle Lavin, Clinical Research Fellow in St. James’s Hospital Dublin and the Irish Centre for Vascular Biology, RCSI commented: "Low Von Willebrand Factor was previously considered to cause only mild or no bleeding symptoms. We have conclusively shown that people with Low Von Willebrand Factor can experience serious bleeding, especially at surgery or childbirth. However, with targeted medications, we can effectively manage patients at these times to minimise bleeding risk".
Donor platelet variation does not affect transfusion outcomes
Variations in donor platelet function did not affect the outcome of prophylactic transfusions among patients with hematologic disorders, according to a semi-randomized, double-blind study published in Blood.
These results support policies of not selecting donors based on platelet function for prophylactic platelet transfusion.
"In the first controlled trial to assess whether differences in the level of platelet responsiveness in the donor population affect clinical outcome, we have shown that the outcome from prophylactic platelet transfusion in hematology patients does not differ whether the donor of the platelets has very low or highly responsive platelets to agonists in vitro," Rebecca A. Cardigan, PhD, FRCPath, head of components development at NHS Blood and Transplant at University of Cambridge in the United Kingdom, and colleagues wrote.
Researchers assessed whether platelets collected from donors with highly responsive platelets to agonists in vitro — assessed by flow cytometry — are cleared more quickly from circulation than those from low-responder donors, resulting in lower platelet count increments following transfusion.
Click on the article title to read the study results
Longer cervical cancer screening intervals may be safe after negative HPV tests
Women with one or more negative cervical co-tests with HPV and cytology screening have a lower risk for cervical cancer; therefore, it may be safe to extend screening intervals to every 5 years or more in these women, according to research published in Annals of Internal Medicine.
"Current U.S. cervical cancer screening and management guidelines do not consider previous screening history, because data on multiple-round HPV and cytology ‘co-testing’ have been unavailable," Philip E. Castle, PhD, MPH, from the Albert Einstein College of Medicine, and colleagues wrote.
Castle and colleagues conducted an observational cohort study to determine the cervical cancer risk in routine practice after a history of negative co-tests, HPV test or cytology results at 3-year intervals.
The researchers analyzed data of 990,013 women who had one or more co-tests between 2003 and 2014 from Kaiser Permanente Northern California’s integrated health care system to measure the 3- and 5-year risk for cervical intraepithelial neoplasia grade 3, adenocarcinoma in situ and cervical cancer. Among the included women, there was a variation in the number of negative co-tests both overall and within subgroups by either previous co-test results or baseline age.
Results showed that after each successive negative co-test screening round, the 5-year risk for cervical cancer diminished (0.098%, 0.052% and 0.035%). Regardless of the cytology result, the 5-year risk for cervical cancer after an HPV-negative co-test was similar to the performance of a negative co-test for each consecutive screening round (0.114%, 0.061% and 0.041%).
The cervical cancer risk for the cytology-negative co-test declined after each round regardless of the HPV result (0.199%, 0.065% and 0.043%). However, after an HPV-negative co-test result, 3- and 5-year risks were similar.
Most people in favour of screening for spinal muscular atrophy
Research from the University of Warwick indicates that most people are in favour of newborn screening for the potentially deadly condition spinal muscular atrophy (SMA). The study Newborn genetic screening for spinal muscular atrophy in the UK: The views of the general population has been published in the journal Molecular Genetics & Genomic Medicine.
SMA is an inherited neuromuscular disorder with a wide spectrum of severities and is a leading genetic cause of infant death worldwide. However, there is no routine screening programme for SMA in the UK. This is in spite of the licensing of a new therapy for SMA in December 2016, Nusinersen which is marketed as Spinraza, which has the potential to reduce the severity of the disease when given early in life, before the onset of SMA symptoms. Up until now, however, lack of treatments and the inability of screening tests to accurately predict disease severity have been among the key reasons that the implementation of a screening programme has faltered in the UK.
The research was led by Dr Felicity Boardman of the University's Warwick Medical School. Dr Boardman said: "With the recent release of the first therapy for SMA, calls are being made internationally for a reconsideration of the current stance on screening; however, very little is known about the views of the general public. We decided to address this gap in evidence by surveying people about their views."
Canadian BRCA Screening Project Aims to Demonstrate Public Health Benefits of Universal Testing Program
A Canadian project trying to expand access to BRCA1 and BRCA2 genetic screening has tested more than 500 people and identified cancer risk mutations in individuals who wouldn't have qualified for such assessments according to existing guidelines.
Hereditary cancer genetics experts Mohammad Akbari and Steven Narod at the Women's College Hospital in Toronto, launched The Screen Project earlier this year in collaboration with Boston-based Veritas Genetics. Those leading the project hope to ultimately demonstrate that a program providing BRCA screening to women starting age 30 can be implemented in a cost-effective manner and benefit public health by preventing cancer.
Since March, 515 individuals have gotten tested, and researchers have reported results to more than 330 participants. Eight patients have mutations in BRCA1/2, conferring significantly heightened risk compared to the general population for breast, ovarian, and prostate cancer.
However, only half of these patients meet testing criteria set forth by the Ontario provincial government dictating who can receive covered testing. The other four "wouldn't have been caught at all," according to existing guidelines, said Veritas Chief Commercial Officer Doug Flood.
Canadian provinces generally pay for BRCA testing when individuals meet strict criteria around their personal and family history of cancer. Studies have now shown that these guidelines are insufficient in that they fail to identify 50 percent of individuals who have deleterious BRCA1/2 genetic mutations but lack family history for cancer.
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