A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
January 10, 2013
View Previous Issues - Healthcare News Archive
Cancer Screening Rates Have Fallen in US
Despite evidence that earlier diagnosis and improved treatment increases survival, rates of people seeking preventive cancer screening have fallen in the US in the last ten years. Failure of leading bodies to agree screening guidelines, plus reductions in workers with insurance cover could be among reasons for the decline, suggest researchers from the University of Miami Miller School of Medicine.
They write about their NIH-funded study in a paper published 27 December in the online open-access journal Frontiers in Cancer Epidemiology. Their analysis reveals that although cancer survivors tend to show much higher rates of screening adherence, their numbers too have started falling off in the last three years. When they analyzed the data researchers found the general population did not meet the government's "Healthy People" screening goals for any type of cancer, apart from colorectal cancer.
Cervical Cancer Screening Among Women Aged 18–30 Years —United States, 2000–2010
To assess trends in Pap testing before the new guidelines were introduced, CDC analyzed 2000–2010 data from the Behavioral Risk Factor Surveillance System (BRFSS) for women aged 18–30 years. CDC found that, among women aged 18–21 years, the percentage reporting never having been screened increased from 26.3% in 2000 to 47.5% in 2010, and the proportion reporting having had a Pap test in the past 12 months decreased from 65.0% to 41.5%. Among those aged 22–30 years, the proportion reporting having had a Pap test within the preceding 12 months decreased from 78.1% to 67.0%. These findings showed that Pap testing practices for young women have been moving toward the latest guidelines. However, the data also showed a concerning trend: among women aged 22–30 years..., the proportion who reported never having had a Pap test increased from 6.6% to 9.0%.
Breast Cancer Diagnosis Could Benefit Greatly From Spectroscopy
The analysis of small deposits of calcium in breast tissue can help differentiate cancerous and benign tumors, but it is sometimes not easy to make such a diagnosis. A team from Massachusetts Institute of Technology and Case Western Reserve University writes about the work that led them to this conclusion in a paper published online in Proceedings of the National Academy of Sciences on 24 December. In this latest study, the researchers describe how they turned to another method, called "diffuse reflectance spectroscopy", and found it gave results just as accurately as Raman spectroscopy, but much faster and at less cost.
V-Chip Brings Dozens of Tests to the Point of Care
A new device about the size of a business card could allow healthcare providers to test for insulin and other blood proteins, cholesterol, and even signs of viral or bacterial infection all at the same time—with one drop of blood. Preliminary tests of the V-chip, created by scientists at The Methodist Hospital Research Institute and MD Anderson Cancer Center, were recently published in Nature Communications - article. "The V-chip could make it possible to bring tests to the bedside, remote areas, and other types of point-of-care needs," says principal investigator Lidong Qin, PhD.
USDA Explores Using Novel Genetic Labs for Faster Detection of E. coli
An article published in Frontiers in Microbiology on the 20th of December, explores using a next-generation real-time polymerase chain reaction (PCR) system to discover specific gene targets that indicate the presence of dangerous foodborne pathogens. The results show that assays performed using this PCR system are rapid, sensitive, and reliable.
Shiga toxin-producing E. coli also known as STEC can be found in raw meat and cause serious food poisoning in humans. The PCR protocol has already been used for some time in the meat industry. The genetic test detects the presence of specific gene targets that indicate the existence of STEC in meat.
MicroRNAs Present Exciting Opportunities for Cancer Therapy and Diagnosis
As many as 50 percent of all human protein-coding genes are regulated by microRNA (miRNA) molecules. While some miRNAs impact onset and progression of cancer, others can actually suppress the development of malignant tumors and are useful in cancer therapy. They can also serve as potential biomarkers for early cancer detection. In a new issue of Cancer Biomarkers, investigators report on non-coding miRNAs as appealing biomarkers for malignancy.
Six articles follow the editorial of Pier Jr Morin, PhD, MBA, Assistant Professor of Biochemistry, Department of Chemistry and Biochemistry, Université de Moncton, New Brunswick, Canada., each discussing the diagnostic and therapeutic potential of miRNAs across a variety of cancer malignancies.
Quest Diagnostics Divests OralDNA Labs
Quest Diagnostics today said that it has sold substantially all of the assets of its OralDNA Labs business to Access Genetics for an undisclosed sum. The business, which currently provides saliva-based testing from a facility in Tennessee and will be consolidated with Access Genetics' CLIA- and CAP-certified lab in Eden Prairie, Minn. The divestiture is part of Quest's ongoing efforts to refocus on its core diagnostic information services business for physicians and hospitals.
Quest Diagnostics Clinical Trials’ Biorepository Accredited by the CAP
Quest Diagnostics has announced that the specimen biorepository of its Quest Diagnostics Clinical Trials business has been accredited by the College of American Pathologists (CAP), the international laboratory accrediting organization. Based at the Quest Diagnostics clinical laboratory in California, the biorepository maintains de-identified tissue, blood, and urine specimens, including molecular and genetic material, collected from the United States and internationally for use primarily by pharmaceutical and biotechnology companies in clinical trials to research and develop new drug treatments.
Abbott Splits Company With AbbVie Spinout
Abbott said today that it has completed the separation of its research-based pharmaceutical business, which has been spun out into a publicly traded entity called AbbVie.
Abbott said that it is now composed of four businesses — diagnostics, medical devices, nutritionals, and branded generic pharmaceuticals — all of roughly equal size.
Meridian Bioscience Successfully Completes Beta Trials for Two New Illumigene Tests
Meridian Bioscience, Inc., has successfully completed beta trials for two new illumigene molecular amplification tests. These assays are designed to specifically detect the DNA of Chlamydia trachomatis and Neisseria gonorrhoeae, respectively, from both swab and urine samples. These two new assays will also incorporate Meridian Bioscience’s new nucleic acid preparation device, which further simplifies the illumigene test procedure. This novel sample preparation device does not require excessive sample manipulation steps, such as centrifugations or washing, and takes five minutes to process a clinical specimen.
EHRs May Turn Small Errors Into Big Ones
As electronic health record systems become more interconnected, errors may propagate much farther than under old paper-based systems, a recent study suggested. According to a review by the Pennsylvania Patient Safety Authority [PDF 330KB], mistakes and near misses involving electronic health records were analogous to those made with paper-based records with one caveat: those made with EHRs tend to be amplified and can affect a larger group of people. The study highlighted the need for tracking the number of near misses and mistakes caused by electronic health records. It pointed out that an Institute of Medicine report called attention to the lack of hazard and risk reporting data on health information technology as a hindering factor in building safer systems.
Health IT Standards: Looking Forward to Another Successful Year
Health IT.Gov /Buzz-Blog: One of my resolutions is a renewed commitment to a broader conversation about all things standards, technology, research and innovation. My goal is to increase the communication (and conversations) that we can have with the larger health IT community. The community of providers, vendors, standards geeks (of which I am one), and innovators has accomplished a lot this past year in terms of health IT standards, and should be proud. There are more accomplishments than I can list here, but here’s a sample:
- Standardizing Meaning - We established four primary vocabulary standards for medications (RxNorm), problem lists (SNOMED), administrative transactions (ICD-10), and laboratory test results (LOINC).
- Standardizing Structure - We have, for the first time, agreed upon a national standard to support transitions of care and patient care summaries (C-CDA).
- Standardizing Reporting - We have a consistent national standard for public health reporting of laboratory tests, based on HL7 2.5.1 standards.
- Standardizing Transport - We have a universal way to consistently and securely send information from one EHR system to another using the DIRECT protocol.
- Standardizing Access - The Blue Button activities have made it possible for millions of veterans and people with Medicare to gain access to their health information.
HHS Stops Short of Calling for Safety Regulation of Digital Records
The Obama administration Friday urged cooperation between software companies and caregivers to prevent patient harm caused by faulty electronic records. But it stopped short of calling for regulation or a federal requirement to report computer mistakes that pose a risk to patients. “We are saying to the vendors: Step up and prove your ability to create a code of conduct that would be enforceable, that would bind you voluntarily to reporting safety events,” Dr. Farzad Mostashari, the administration’s coordinator for health information technology, said about the report. “And what we’re saying is: If you don’t step up, we can always look at more classic regulatory approaches.”
That doesn’t go far enough, said Arthur Levin, director of the Center for Medical Consumers, which promotes safety and effectiveness in health care. “These are very baby steps,” he said.
Health care providers have voluntarily reported adverse health events to the Food and Drug administration that researchers say were linked to dozens of patient injuries and several deaths. Problems included small fonts causing caregivers to click on the wrong medication and lost or misdated test results that caused unnecessary surgery or delayed treatment.
NIH Plans to Relocate Its Chimpanzees From New Iberia to the Federal Sanctuary System
The National Institutes of Health, after extensive collaboration with the Chimp Haven federal sanctuary, New Iberia Research Center (NIRC), and other organizations, has developed a plan to formally retire directly to the Federal Sanctuary System all of its chimpanzees at New Iberia that were recently designated as permanently ineligible for biomedical research.
Chimp Haven is home to 106 federally owned chimpanzees that have been retired from medical research. The Federal Sanctuary System was established in 2002 by the Chimpanzee Health Improvement, Maintenance and Protection (CHIMP) Act and Chimp Haven operates the Federal Sanctuary System, which is overseen by NIH.
"This is a ray of light for captive chimpanzees," said Wayne Pacelle, president and CEO of HSUS. "NIH has worked diligently to see that the federally owned chimps at New Iberia Research Center will be sent to a world-class sanctuary, and The Humane Society of the United States is pleased to fund a portion of the construction costs at this facility."
Public Good Genomics
Genomics is moving beyond single-gene disorders into the realm of infectious and non-infectious diseases to improve public health, writes Jane Parry at The Guardian Professional. "Genomics is absolutely changing the way we deal with public health issues and as the technology involves gets a lot cheaper, there will be a massive shift in diagnostics towards molecular technology," Hilary Burton, the director of PHG Foundation, tells Parry. Parry notes that public health genomic efforts also raise ethical questions, such as what to do with incidental findings and confidentiality concerns as well as how to implement it in low-income countries.
Tumor Boards Linked to Little Association With Effects on Cancer Care
There is little association of multidisciplinary tumor boards with measures of use, quality, or survival, and measuring only the presence of tumor boards may not be adequate in determining their effects on cancer care, according to a study published December 28 in the Journal of the National Cancer Institute. Tumor board reviews offer a multidisciplinary approach to treatment planning, which encompasses doctors from many specialties reviewing and discussing the medical condition and the treatment of patients. Even though the use of tumor boards is widespread, there is little data on how it affects cancer care.
In an accompanying editorial, Douglas W. Blayney, M.D., Stanford Cancer Institute, Stanford School of Medicine, notes that tumor boards may not influence quality in a large, integrated health system such as the VA as much as they might in smaller centers.
J&J Sirturo Wins FDA Approval to Treat Drug-Resistant TB
Johnson & Johnson (JNJ) won accelerated U.S. Food and Drug Administration approval for its tuberculosis tablet Sirturo, the first medicine in 40 years that provides a new way to treat the contagious lung infection. FDA Commissioner Margaret Hamburg said the drug adds a new weapon “to the arsenal for fighting this deadly, contagious disease.”
“The fact that the drug is active against drug-resistant forms of the disease makes it a potential game changer,” Dr. Manica Balasegaram, executive director of the Doctors Without Borders Access Campaign, said in an e-mailed statement.
Hydrogen Peroxide Vapor Enhances Hospital Disinfection of Superbugs
Infection control experts at The Johns Hopkins Hospital have found that a combination of robot-like devices that disperse a bleaching agent into the air and then detoxify the disinfecting chemical are highly effective at killing and preventing the spread of multiple drug-resistant bacteria, or so-called hospital superbugs. A study report on the use of hydrogen peroxide vaporizers was recently published in the journal Clinical Infectious Diseases. Read the study abstract.
In what is believed to be the first head-to-head comparison between traditional hand cleaning and mopping with bleaching agents and robotic vaporizers, researchers routinely tested patients and their surroundings not only for VRE but also for the more common methicillin-resistant Staphylococcus aureus, or MRSA, as well as Clostridium difficile and Acinetobacter baumannii.
Johns Hopkins Malpractice Study: Surgical 'Never Events' Occur At Least 4,000 Times Per Year
After a cautious and rigorous analysis of national malpractice claims, Johns Hopkins patient safety researchers estimate that a surgeon in the United States leaves a foreign object such as a sponge or a towel inside a patient's body after an operation 39 times a week, performs the wrong procedure on a patient 20 times a week and operates on the wrong body site 20 times a week. The researchers, reporting online in the journal Surgery, say they estimate that 80,000 of these so-called "never events" occurred in American hospitals between 1990 and 2010 - and believe their estimates are likely on the low side.
"There are mistakes in health care that are not preventable. Infection rates will likely never get down to zero even if everyone does everything right, for example," says study leader Marty Makary, M.D., M.P.H., an associate professor of surgery at the Johns Hopkins University School of Medicine. "But the events we've estimated are totally preventable. This study highlights that we are nowhere near where we should be and there's a lot of work to be done."
Dust-Plumes Power Intercontinental Microbial Migrations
Along with pollutants from Asia, transpacific dust plumes deliver vast quantities of microbes to North America, according to a manuscript published online ahead of print in the journal Applied and Environmental Microbiology. "We detected thousands of unique microbial species, many of which seem particularly well-suited for atmospheric transport," says first author David J. Smith, a graduate student at the University of Washington, Seattle. "We also detected archaea, a domain of life that has never before been sampled at high altitude. We are just starting to understand the consequences of long-range microbial transport."
"Over 70 million tons of Asian aerosols - mostly dust - reach our continent every year," says Smith. "There could be thousands of microbes per gram of dust. Do the math. The number is staggering. Distant continents are essentially sneezing on each other."
NEJM Begins Series of Review Articles on Global Health
The January 3 issue of the New England Journal of Medicine "includes the first article in a series of review articles on global health," Harvey Fineberg of the Institute of Medicine and David Hunter of the Harvard School of Public Health write in an NEJM editorial. "The series is built around articles that explain the need for global health, the challenges to achieving it, and the solutions to problems related to it," they add. They discuss how "the meaning of the term global health has evolved over time," and say, "In developing this series, we adopted the concept of global health as 'public health for the world,'" which "condenses the definition offered by the Institute of Medicine's Expert Committee on the U.S. Commitment to Global Health in 2008."
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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