DLPSS|HEALTHCARE NEWS|January 30, 2014
Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
January 30, 2014
News Highlights
Don’t Rely on Quick Flu Tests, CDC Tells Doctors
Lab Services Grow Despite Payment Cuts
Waived Testing: The Last Mountain
Pre-analytical Errors: Working With Manufacturers to Help Improve Quality
Why Do We Test for Urea and Electrolytes?
HPV Test Awareness, Knowledge Still Low
Procalcitonin Levels Predict Positive Blood Culture in Sepsis Patients
DNA Test Unravels Titanic Claim
NIH Researchers Infect Live Subjects With Influenza in Study Intended to Improve Vaccine
Good Cholesterol 'can Turn Nasty and Clog Arteries'
Docs in for Stage 2 Rude Awakening
Are Hospital Faucets Putting Patients at Risk?
CARTER CENTER: 148 Cases of Guinea Worm Disease Remain Worldwide
View Previous Issues - Healthcare News Archive
NIH to Researchers: Credibility Counts
The NIH is planning "significant interventions" to ensure that basic biomedical studies stand the test of time, its two top officials say. In the long term, science remains self-correcting, according to NIH Director Francis Collins, MD, PhD, and Principal Deputy Director Lawrence Tabak, DDS, PhD. But in the short term -- and especially in preclinical research using animal models -- "the checks and balances that once ensured scientific fidelity have been hobbled," they argue in a Comment article in Nature. One report has suggested that "as many as two-thirds of studies related to preclinical animal trials were not able to be reproduced," Tabak told MedPage Today.
Source: http://www.medpagetoday.com/
Don’t Rely on Quick Flu Tests, CDC Tells Doctors
Flu is now widespread in 41 U.S. states, and as patients fill clinics and emergency rooms, federal health officials are advising doctors not to rely entirely on quick flu tests. The H1N1 swine flu — which first emerged in 2009, when it caused a pandemic — is causing 99 percent of the cases that are being tested, the Centers for Disease Control and Prevention said in its weekly flu report. It’s not clear why, but the rapid flu tests used in many clinics are getting what are called false negatives — that is, they indicate someone does not have influenza when in fact they do, said Dr. Angela Campbell, a medical officer in CDC’s respiratory diseases branch.
Source: http://www.nbcnews.com/
Top of Page
Lab Services Grow Despite Payment Cuts
The demand for clinical laboratory services is accelerating even in the face of large reimbursement cuts, especially from Medicare, a report from Kalorama Information has found. The world market for clinical lab service grew just 1.2 percent over the past five years to $99.1 billion for 2013 from $92.7 billion in 2008. Of that, the U.S. clinical lab market share increased 1.4 percent to $54.1 billion for 2013 compared to $50.6 billion in 2008. The increasing incidence of chronic diseases, aging populations, emphasis on diagnosis and disease monitoring and more advanced testing technologies and practices are driving increased use of clinical lab services. The use of preventive and risk-factor testing has been especially strong in oncology, endocrinology and gynecology, the report said.
Source: http://www.healthcarefinancenews.com/
Top of Page
Waived Testing: The Last Mountain
Have you noticed how much more attention waived testing is getting these days?
We know that CLIA has defined waived tests as laboratory procedures which employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; and which pose no reasonable risk of harm to the patient if the test is performed incorrectly. Tests cleared for home use by the FDA are also classified as waived; We also know that facilities performing only waived tests have no routine oversight and no personnel requirements and are only required to obtain a Certificate of Waiver (CW), and follow manufacturers' test instructions. The latter account for over 70% of all clinical laboratories in the U.S.
As efforts intensify to reduce medical errors, improve health-care quality, and increase patient safety, there is a renewed focus on how to better monitor waived testing. After all, since 1988, the number of CLIA approved waived tests has increased from 8 to 120. As the number of approved analytes for waived testing has increased, the potential for serious impacts on healthcare has also increased. The concern is usually not about the kits or instruments themselves, but the human factor: is the testing staff adequately trained and competent to perform the testing as required by the manufacturer? Is quality control monitored, and corrective action taken if needed, before patient results are reported? Are reagents and specimens properly stored? Who is supervising the staff?
Source: http://community.advanceweb.com/
Top of Page
Pre-analytical Errors: Working With Manufacturers to Help Improve Quality
Laboratory medicine is integral to clinical decisions, providing healthcare professionals with information for prevention, diagnosis, treatment, and management of patients’ health. Up to 60% to 70% of all medical decisions are based on laboratory testing results. But errors occur in clinical laboratories—often in the pre-analytical phase. Laboratory professionals can reduce the frequency of errors by aggressively investigating their causes. In the pre-analytical phase, as in all phases, working with the applicable product or service manufacturer(s) can be an important part of helping to ensure that the error is not repeated. When an error occurs in the clinical laboratory, a complaint registered with the applicable product or service manufacturer(s) can be an opportunity to gain needed support and information to help resolve the error. This support and information from a manufacturer is a valuable tool for the laboratory in finding the solution to an error that can, in the long run, help contribute to the laboratory’s overall continuous quality improvements.
Source: http://www.mlo-online.com/
Top of Page
Call Genetic Counselors, Maybe?
The steady rise of the numbers of genetic tests being used in clinical care, the ever-expanding number of known functional genetic markers, and the possibility that whole-genome sequencing may be used more widely in treatment, all suggest that there may be a need for more genetic counselors. Telephone consultations could make it easier for patients and consumers to get more information about what tests and results mean, and these tele-sessions are likely just as effective as face-to-face visits, a new study says. It also could save money.
Source: http://www.genomeweb.com/
Less Is More? Multistage CVD Screening Could Eliminate LDL Lab Tests
A screening approach that selectively uses laboratory-based cholesterol testing to assess cardiovascular risk is able to identify patients at risk for cardiovascular disease to a similar extent as a widely used risk model, according to the results of a new study. The multistage primary cardiovascular disease screening approach, in which only patients first identified as at intermediate risk of cardiovascular events are sent to the laboratory to measure cholesterol levels, performed as well as the Framingham Risk Score (FRS), which utilizes laboratory testing in all patients to assess cholesterol levels, in terms of discriminating risk of cardiovascular disease.
Source: http://www.medscape.com/
Why Do We Test for Urea and Electrolytes?
Urea and electrolytes (U&Es) are the most frequently requested biochemistry tests. They provide useful information about several aspects of health, such as the volume of blood and its pH. The most important aspect of U&Es is what they tell us about kidney functioning. The kidneys have the following three main functions:
Homoeostasis: regulating blood volume, and maintaining the acid/base balance (pH) and levels of electrolytes, principally sodium and potassium;
Endocrine activity: regulating blood pressure, supporting red blood cell production and contributing to blood calcium;
Excretion: removing urea and creatinine.
The glomerular filtration rate
Despite the value of the U&Es, the ultimate test of kidney function is the rate at which blood is filtered by passing over the glomerulus to begin urine production, known as the glomerular filtration rate (GFR). It is accepted that the GFR falls slowly with age, and the minimum level for concern is 90ml/minute/1.73m2. GFR was previously assessed by taking a 24-hour urine sample, but is now estimated (eGFR) from one of two equations. The Cockcroft-Gault equation uses serum creatinine, weight, age and sex, while the MDRD formula takes in to account age, sex, creatinine and ethnicity to determine the eGFR. Free online calculators are available for both equations (Box 1), but health professionals must check with their local pathology laboratory to find out which they should use.
Source: http://www.nursingtimes.net/
Top of Page
HPV Test Awareness, Knowledge Still Low
Americans are more aware that there is a test for the human papilloma virus (HPV) than counterparts in the UK and Australia, according to a new study, but few people knew much more than that. "Awareness of HPV has tended to be low but has been rising since the introduction of testing and vaccination," said Jo Waller, the study's senior author. People seem to be more aware of HPV vaccination than testing, however, which is not surprising given the publicity around the vaccine, added Waller, a public health researcher at University College London. The Pap test, used to look for abnormal cell changes in the cervix, is much older and generally familiar to most people, but the newer HPV test looks for the virus that causes those changes, Waller said. The HPV test was only introduced in the 1990s and it's used a little differently in each of the countries that were included in the new study, Waller pointed out.
Source: http://www.reuters.com/
Top of Page
Cytopathology and More: Evidence Emerging for HPV-negative Cervical Cancer
Some studies indicate that nearly all cervical cancers are high-risk human papillomavirus (hrHPV)-related. Recent studies suggested hrHPV testing had a very high sensitivity; therefore, the American Society for Colposcopy and Cervical Pathology recommended Pap cytology and hrHPV co-testing as the preferred screening method in women 30 or older. However, a wide range of negative detection rates of hrHPV have been reported in cervical cancers by different HPV testing methods, including the HC2 test (Qiagen), the most widely used HPV assay in the United States.
Source: http://www.captodayonline.com/
High Risk of Poor Pap Tests for Female-to-male Transgender Patients
Before the introduction of cervical cancer screenings, the disease used to be the leading cause of cancer death for women in the US. Though it is now the 14th cause of death, new research suggests that compared with female patients, female-to-male transgender patients are much more likely to have inadequate cell samples taken during screening. The research team, led by Dr. Jennifer Potter, director of women's health at Fenway Health in Boston, MA, published their findings in the Journal of General Internal Medicine.
Source: http://www.medicalnewstoday.com/
Procalcitonin Levels Predict Positive Blood Culture in Sepsis Patients
Procalcitonin testing can predict whether sepsis patients will have positive blood cultures, a new pilot study shows. Among 40 patients admitted to the hospital with a diagnosis of sepsis, using a cutoff of 1.35 ng/ml identified all 10 who had positive blood cultures, Dr. Walid Saliba of Technion School of Medicine in Haifa, Israel, and colleagues found. They reported their findings January 3 in the American Journal of Emergency Medicine. Although the results need to be replicated, "this approach may be time and resources saving by precluding the need for obtaining blood cultures from almost half of the patients with sepsis while still enabling the detection of all positive blood cultures," Dr. Saliba told Reuters Health.
Source: http://www.medscape.com/
Top of Page
DNA Test Unravels Titanic Claim
A DNA test has solved a long-standing mystery surrounding a possible Titanic survivor, the Telegraph reports. Years after the ocean liner sank in 1912, Helen Kramer came forward to say that she was Loraine Allison, a two-year-old traveling on the ship who was thought to have died when it sank. The results indicated that Kramer was not Loraine Allison. Loraine, then, the Telegraph notes, was the only child in first or second class to die in the sinking of the Titanic.
Source: http://www.genomeweb.com/
Top of Page
NIH Research Network Finds Many Youth Have High Levels of HIV
More than 30 percent of young males who had sex with other males and who were subsequently enrolled in a government treatment and research network were found to have high levels of HIV, reported researchers from the National Institutes of Health and other institutions. The health status of the study participants, who ranged in age from 12 to 24 years, was monitored as part of their participation in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN).
Source: http://www.nih.gov/
Diagnostic Tool and Biomarker Promising in Pancreatic Cancer
Pancreatic cancer continues to have one of the highest mortality rates of any of the major cancers, mostly because of late diagnosis, so there is a great interest in developing improved diagnostic tools and biomarkers. Two new studies are addressing this. In one, researchers found that circulating tumor cells (CTCs) could be used to distinguish between benign and malignant disease and could identify metastasis. In the second, patients with pancreatic cancer who had low serum levels of matrix metalloproteinase (MMP)-7 were most likely to benefit from adjuvant treatment with gemcitabine. Although the data are very early, results from both studies were presented at the 2014 Gastrointestinal Cancers Symposium.
Source: http://www.medscape.com/
New Hope for Lupus Screening and Treatment
Researchers from the University of Alabama at Birmingham (UAB) have discovered a new immune protein influencing autoimmune diseases such as lupus and multiple sclerosis. In autoimmune diseases like lupus, the body's immune system overreacts and attacks healthy tissue, instead of just eliminating germs. Lupus can affect lots of different areas of the body including the joints, skin, kidneys, lungs, heart and the brain. The researchers behind the new study think a new mutation of an immune protein called an "Fc receptor" may help scientists develop more personalized autoimmune disease treatments.
Source: http://www.medicalnewstoday.com/
Danish Duo Introduces Microbe Identification Scheme Based on Random Subset of Raw Sequence Reads
Danish researchers have developed a computational search method for identifying organisms from a small subset of raw reads randomly selected from across a newly sequenced genome — a tool that they hope will be applicable in infection tracking, food safety, and other settings. The approach, known as TAPIR, uses randomized raw reads and a k-mer-based scoring algorithm to identify organisms represented within a large database of genome sequences. It can be used with or without additional software that aligns the newly sequenced reads to the reference genomes of organisms identified during the initial search step for more detailed local analyses.
Source: http://www.genomeweb.com/
NCCC Physicians Use New Gene Sequencing Equipment for Testing Abnormal DNA in Cancerous Tumor Cells
Clinical laboratory experts and physicians at Dartmouth-Hitchcock Norris Cotton Cancer Center (NCCC) achieved 100 percent accuracy in testing for abnormal DNA in cancerous tumor cells with its new gene sequencing equipment and panels. The results, published in the journal Clinical Chemistry and Laboratory Medicine, confirm the precision of the test for routine patient care so physicians can tailor treatment to an individual person's DNA, improving the chances of a successful outcome.
Source: http://www.news-medical.net/
More Consolidation in the Clinical Laboratory Industry, as Quest Diagnostics Agrees to Pay $570 Million to Acquire Solstas Lab Partners
Another big lab domino fell in the continuing consolidation of the clinical laboratory testing industry. This time it was Solstas Lab Partners, which announced that it would be acquired by Quest Diagnostics Incorporated. Quest Diagnostics will pay $570 million to acquire Solstas, which is based in Greensboro, North Carolina. Solstas provides medical laboratory testing services to clients in nine states across the South. Quest Diagnostics says it expects to close the sale by the middle of this year, subject to the usual regulatory reviews of such transactions.
Source: http://www.darkdaily.com/
Sony and M3 Join Forces
Sony and M3 have joined forces, with backing from Illumina, to form a company that will offer genome analysis services in Japan. The endeavor will also aggregate genomic data with medical and other related information. The new company, currently called P5, is to "facilitate genome research that further advances Japanese medical care, and, in the future, establish a new service platform for the medical industry," Tadashi Saito, a corporate executive officer, executive vice president, and officer in charge of Sony's Medical Business, said in a statement.
Source: http://www.genomeweb.com/
<h3 style="background-color: white; font-family: 'Trebuchet MS', Arial, sans-serif; font-size: 1.5