A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
May 07, 2015
- More than 85 Percent of Surgeons Disregard USPSTF Breast Screening Recommendation
- Americas Region Becomes World’s First to Eliminate Rubella
- US 'Will Not Fund Research for Modifying Embryo DNA'
- How to Handle a PT Challenge Miss
- Ensuring Quality in the Laboratory: Tips and Training from the CDC
- Promise of Liquid Biopsy as Clinical Tool Continues to Grow among Cancer Researchers
- Breakthrough Test Could Predict Cancer Many Years before You Actually Develop the Disease
- Researchers Closer to Being Able to Change Blood Types
- Gene Editing Drives Development of Cancer T-Cell Therapies
- U.S. CDC Cautions against Unprotected sex with Ebola Survivors
- Colorado Dog Key to U.S. Plague Outbreak, Study Confirms
- Leapfrog Updates Hospital Safety Grades
- Adopting Electronic Laboratory Reports
- ONC: Health IT Adoption, Use Has Improved Patient Safety
- Poor Data Security Hinders Healthcare Progress, Innovation
View Previous Issues - Healthcare News Archive
More than 85 Percent of Surgeons Disregard USPSTF Breast Screening Recommendation
The vast majority of surgeons continue to recommend that women 40 years old or older with an average risk for breast cancer be screened annually for the disease, despite a 2009 U.S. Preventive Services Task Force (USPSTF) recommendation that such women be screened biennially beginning at 50 years old and continuing through age 74. A team of researchers studying the efficacy of policy recommendations on practicing surgeons found that 88% of breast surgeons and 82% of general surgeons continue to recommend annual mammography for women with an average risk of developing breast cancer. An even greater percentage - 93% - reported that they began or would begin annual screenings for themselves at age 40. "We found that the majority of surveyed breast surgeons advocate and personally follow the screening mammography recommendations of the American Cancer Society, the American College of Radiology, and the Society of Breast Imaging, instead of those of the USPSTF," said coauthor Vilert Loving, director of breast imaging at the Banner MD Anderson Cancer Center. Coauthors Jiyon Lee (NYU Cancer Institute) and Elaine Tanaka (VA San Diego Healthcare System and UC San Diego School of Medicine) added, "As we anticipate the USPSTF's impending guidelines this year, the public should know that the physicians who diagnose and treat women with breast cancer still believe in annual mammography starting at age 40 for average-risk women." The study was presented at the ARRS 2015 Annual Meeting in Toronto.
Americas Region Becomes World’s First to Eliminate Rubella
The Americas region has become the first to successfully eliminate rubella, a contagious viral infection with similar symptoms to measles, health officials announced. Medical experts are calling the milestone against the endemic transmission of the infection a “historic achievement.” Rubella and congenital rubella syndrome (CRS) are now the third and fourth vaccine-preventable diseases to be eliminated in the Americas, following small pox in 1971 and polio in 1994, and experts say it also speaks to the success of a 15-year initiative to provide widespread vaccination against mumps and rubella (MMR) in the area. Though rubella has been eliminated in the Americas, it’s still prevalent in other regions in the world. Dr. Susan E. Reef, the team leader for rubella in the Global Immunization Division at the U.S. Centers for Disease Control and Prevention (CDC), told reporters that the Americas region and the European region are the only two regions that have an official elimination goal for the disease. “Now that we have achieved this goal,” Reef said, “the next step is to continue to maintain it.”
US 'Will Not Fund Research for Modifying Embryo DNA'
Modifying the DNA of embryos is a "line that should not be crossed", a leading figure in US research says. Dr Francis Collins, National Institutes of Health director, was responding to reports that the first embryos had been modified in China. He argued there were "serious and unquantifiable safety issues", big ethical questions and no compelling medical reason to do it. He said the NIH would not fund such research in the US. The advent of "CRISPR technology" - which is a more precise way of editing DNA than anything that has come before - has spurred huge progress in genetics. But there had been growing concern these tremendous advances were making the modification of human embryos more likely. Dr Tony Perry, a pioneer in cloning, told the BBC News website in January that designer babies were no longer "HG Wells" territory. Concerns were also raised in the journal Nature as rumours circulated that it had already taken place.
USPSTF Weighs In on Diabetes Screening
About 21 million people in the U.S. were diagnosed with diabetes in 2010, and an estimated 8 million people went undiagnosed. A new U.S. Preventive Services Task Force (USPSTF) review of existing literature assessed the benefits and harms of screening people who do not have symptoms of type 2 diabetes, impaired fasting glucose (IFG), or impaired glucose tolerance (IGT). Published in the Annals of Internal Medicine, it found that screening for type 2 diabetes did not affect mortality but that treatment of IFG and IGT delayed progression to diabetes. The panel looked at studies published from 2007 to October 2014. They found that screening helped delay the onset of type 2 diabetes because it identified those who could benefit from treatment of IGT or IFG; however, they did not find improved mortality rates in this group at the 10-year mark of follow-up.
Glucose Meters in Critically Ill Patients What New Guidance Means for Labs
What is all the buzz about use of glucose meters in critically ill patients? Glucose meters have been used for more than 30 years to provide rapid measurement of glucose on whole blood fingersticks from patients with diabetes. So, why is there now a concern over the use of glucose meters? Problems with glucose meters have been known from the start. Glucose meters designed for patient self-monitoring are validated primarily on ambulant, well patients who happen to have diabetes. These meters are calibrated for normal hematocrits and physiology. Study data from patient self-management is how many of the current meters gained market approval through the Food and Drug Administration (FDA). Unfortunately, when the same meters and test strip methodologies are applied to sick inpatients, comparable performance to outpatient use is not always achieved. Hospitalized patients present with extremes of hematocrit, pH, and perfusion that challenge glucose meter performance. They also often are on intravenous drug and oxygen therapies that pose potential for interferences not found in patient self-management. Recent incidents with maltose interference and a specific glucose meter methodology led to death in several hospitalized patients.
These concerns caused FDA to respond in two ways: 1) to add a sentence to the limitations section of all glucose meter package inserts that meters have not been evaluated in critically ill patients; and 2) to release, in January 2014, draft guidance on Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. The latter describes the studies that FDA recommends for manufacturers who intend to submit premarket notifications (510k) for blood glucose meters.
How to Handle a PT Challenge Miss
In CLN’s April Ask the Expert column, Dr. Rex Astles offers advice on proficiency testing (PT), starting with a response to this question: I missed a PT challenge. What now?
Astles, a health scientist in the Centers for Disease Control and Prevention’s (CDC) Division of Laboratory Systems (DLS), described the steps forward as follows. “If the challenge involves one of the approximately 100 analytes explicitly required by CLIA regulations, then a miss causing an unsatisfactory PT event (<80% correct) is likely to have regulatory implications. CLIA requires that the root causes for any PT miss be investigated and fixed, and the outcomes documented.” The consequences of a PT miss depend upon how many challenges were missed and the frequency of errors, explained Astles. PT events usually occur three times per year and most events involve five challenges. For most required analytes, missing only one of five challenges (80% score) is passing and the event is “satisfactory.” An “unsatisfactory” score will involve scrutiny by CLIA surveyors or accreditation organizations. Fortunately, there is something laboratorians can do in this situation. By carefully reviewing PT results from every event, a laboratory can frequently detect and deal with analytical problems before they result in inaccurate patient testing.
Ensuring Quality in the Laboratory: Tips and Training from the CDC
Given the importance of laboratory test results, the Centers for Disease Control and Prevention (CDC) includes many divisions related to laboratory services, and guidelines for achieving quality are offered online. The CDC’s Division of Laboratory Systems (DLS) established the Clinical Laboratory Integration into Healthcare Collaborative (CLIHC™) to develop solutions to optimize the effective use of laboratory services for better patient care. Toward that end, the group has been exploring the “challenges” clinicians face in relation to appropriate laboratory test selection and result interpretation. Providing solutions to these “will improve utilization of laboratory services and reduce diagnostic and treatment errors and delays.”
Here’s a partial list of the challenges that the CLIHC found in a national survey conducted in 2012 of 1,700 internal and family medicine physicians:
- Multiple or confusing test names for the same test
- Diverse testing panels with the same name
- Differing practice guidelines
- Communicating with laboratory professionals
- Result interpretation, including:
- Variation in laboratory normal values and reporting format,
- Previous results not readily available,
- Lack of timely reporting, and
- Results inconsistent with patient’s symptoms.
- Computerized physician order entry (CPOE) with electronic suggestions for appropriate test-ordering,
- Clinical algorithms/pathways to guide test selection,
- Interpretive comments, and
- Reflex testing.
Information Source: An overview of topics relating to clinical labs can be found at the website of the CDC Division of Laboratory Systems (DLS) athttp://www.cdc.gov/ophss/csels/dlpss/index.html.
Promise of Liquid Biopsy as Clinical Tool Continues to Grow among Cancer Researchers
Enthusiasm for liquid biopsy tools and techniques is booming, as early adopters amass ever more promising validity and utility data, while new players enter the market hoping to advance novel methods for increasingly sensitive detection of cancer markers in blood and other body fluids. This much was clear at the annual meeting of the American Association for Cancer Research in Philadelphia, which featured numerous symposia and presentations on the anticipated clinical potential of liquid biopsy across multiple technologies and disease areas, alongside heaps of new research presented in posters by both old and new faces in the field. Initially a small pond, the liquid biopsy space is rapidly catching up to the overall cancer genomics field in its diversity. During the meeting, presenters highlighted a wide variety of techniques for analyzing both circulating tumor cells and circulating cell-free tumor DNA (ctDNA), and methods ranging from broad sequencing to more tightly targeted molecular assays with potential utility as companion diagnostics, in disease monitoring, or even for early cancer detection. Many at the meeting expressed a sense that the analytical and even clinical validity of blood-based cancer testing has been, or is close to being proven, and the next steps for the field will be decidedly clinical in nature. "There is enough evidence to say at this point … from concordance studies with tissue and plasma that there is no question that you can use blood to [analyze the genomics of a cancer]," Alberto Bardelli of the University of Turin said during a presentation at the conference.
ACP Prefers Cervical Cytology over DNA Screens for Young Women
The American College of Physicians (ACP) said Pap smears should be the mainstay of cervical cancer screening in normal-risk women younger than 30, with molecular testing for human papilloma virus (HPV) reserved for older patients only. The recommendation was part of a new clinical practice guideline for cervical cancer screening in asymptomatic, average-risk women aged 21 years or older. The guidelines aim to reduce the overuse of screening in women who do not have an increased risk of cervical cancer, wrote George Sawaya, MD, an obstetrician-gynecologist at the University of California San Francisco and director of San Francisco General Hospitals' Colposcopy and Cervical Dysplasia Clinic, and colleagues.
Blood Test 'Boost' in Ovarian Cancer Fight
Regular blood tests can detect 86% of ovarian cancers before the point at which women normally would be diagnosed, according to a trial that could lead to national screening. The first results of the 14-year trial of more than 46,000 women suggest tumours can be detected early. However, the University College London team caution that it is still unknown whether more lives were saved. Around 7,100 women are diagnosed with ovarian cancer and 4,200 die of the disease each year in the UK. The UK Collaborative Trial of Ovarian Cancer Screening performed annual blood tests on post-menopausal women across 13 NHS Trusts. They tracked changes in the levels of CA125 over time and if levels became elevated then the women were sent for further tests including an ultrasound scan. The trial results, published in the Journal of Clinical Oncology, showed 86% of cancers were picked up.
Abbott's Pregnancy Blood Test Gets FDA Nod
Abbott’s i-Stat Total β-hCG pregnancy blood test has won FDA regulatory approval, the Abbott Park, Ill., devicemaker announced. The first-of-its-kind blood test rapidly and accurately detects the human chorionic gonadotropin hormone commonly associated with pregnancy, the company says. By measuring very low levels of hCG in the blood stream using two to three droplets, the test can determine if a woman is in the early stages of pregnancy within 10 minutes.
Breakthrough Test Could Predict Cancer Many Years before You Actually Develop the Disease
Scientists have developed a way to accurately predict whether you will develop cancer years in the future. A team from Harvard and Northwestern universities has discovered that minuscule changes in the "protective end caps on our DNA strands" provide a definitive tip-off of cancer long before the disease actually develops, Northwestern University reports. Researchers hope this breakthrough in understanding the end caps, or telomeres, could lead to a simple blood test warning patients of the future development of cancer. Patients would then be able to take action -- from lifestyle changes to medical intervention -- to either avoid the impending cancer or kill it in its earliest stages. In the Harvard-Northwestern study, scientists measured telomeres in nearly 800 people over 13 years. 135 of the study participants were diagnosed with some form of cancer during or after the study. The researchers found that the telomeres in those who eventually developed cancer looked up to 15 years "chronologically older" than those who did not develop cancer. A key finding, however, was that the advanced aging of the DNA end caps suddenly stopped a few years before cancer was diagnosed in participants. The reason: the cancer had "hijacked the telomere shortening in order to flourish in the body," says Dr. Lifang Hou, the lead study author and a professor at Northwestern University's Feinberg School of Medicine. The study was published April 30 in the medical journal EBioMedicine.
Researchers Closer to Being Able to Change Blood Types
What do you do when a patient needs a blood transfusion but you don’t have their blood type in the blood bank? It’s a problem that scientists have been trying to solve for years but haven’t been able to find an economic solution – until now. University of British Columbia chemists and scientists in the Centre for Blood Research have created an enzyme that could potentially solve this problem. The enzyme works by snipping off the sugars, also known as antigens, found in Type A and Type B blood, making it more like Type O. Type O blood is known as the universal donor and can be given to patients of all blood types. “We produced a mutant enzyme that is very efficient at cutting off the sugars in A and B blood, and is much more proficient at removing the subtypes of the A-antigen that the parent enzyme struggles with,” said David Kwan, the lead author of the study and a postdoctoral fellow in the Department of Chemistry.
Gene Editing Drives Development of Cancer T-Cell Therapies
As genome-editing technologies continue to rapidly develop and spread throughout academic labs, they're beginning to make a serious impact in the realm of therapeutics. Though direct clinical applications appear to still be anything but close, gene editing is proving essential to developing one of the most promising areas of cancer treatment, T-cell therapy. In the last year, major players in the pharmaceutical industry have formed alliances to access gene-editing experts to help them develop chimerical antigen receptor (CAR) T cells. These immune system-derived killers are cells that have been genetically reengineered to express receptors that allow them to recognize and eliminate cancerous cells. "There have been some profound clinical responses over the last few years with CAR T cells, success where all the other drug classes didn't succeed" in treating hematological cancers, Robert Friesen, head of biologics research at Janssen, told GenomeWeb. "This has turned out to be a very effective way to deal with a lot of cancers."
Scientists Discover an Important New Driver of Aging
Scientists reported that they had identified an important new potential driver of aging, a finding that could have vast implications for human longevity and the treatment of diseases such as cancer, diabetes and Alzheimer's. In studying the genetic mutations underlying Werner syndrome, an extremely rare genetic disorder that causes rapid aging, researchers discovered that the condition appears to lead to a disorganization in tightly packed bundles of DNA found in a cell’s nucleus known as heterochromatin. This bundling acts as a switchboard for the gene's activity. When it is disrupted, it affects critical processes, resulting in a kind of cellular mayhem.
Colored Pencils Developed for Easy Chemical-Based Diagnostic Testing
Thanks to a team of researchers from California Polytechnic State University, chemicals formed into pencils can be used to react with each other by simply drawing with them on a piece of paper. The work, published recently in the journal Lab on a Chip, is based on a well-known technique called paper-based microfluidics, which uses the capillary effect of paper to mix chemicals, indicating the presence or absence of a substance. Additionally, the reagents used for the test are stable for two months in the pencil form, whereas as liquids they degrade within a few days, making transport and storage easier and less expensive
Rapid Tests for Fungal Infections
Of the 1.5 million different species of fungi around us, a mere 300 or so are known to make people sick, according to the Centers for Disease Control (CDC). Often caused by fungi that are common in the environment, fungal diseases range from Athlete's foot to fungal meningitis and bloodstream infections. The demand for fast, easy-to-use and sensitive diagnostic tests for fungal infections is on the rise. Labs desperately need accelerated detection solutions to isolate and identify fungi quickly. NanoLogix has developed three types of technology that can detect fungal infections: BioNanoPore sandwiched-membrane petri-based detection technology, BioNanoFilter Ab/Ag tests, and N-Assay multiwell microplate assay.
U.S. CDC Cautions against Unprotected Sex with Ebola Survivors
U.S. health officials are now recommending people avoid contact with the semen of Ebola survivors after a woman in Liberia contracted Ebola through sexual intercourse with a survivor of the disease. In a report issued on Friday, the U.S. Centers for Disease Control and Prevention said a review of the 44-year-old woman's case now suggests that the Ebola virus persists longer in semen that previously thought.
Colorado Dog Key to U.S. Plague Outbreak, Study Confirms
A Colorado dog last year caused the largest outbreak of pneumonic plague – also called the Black Death – in the United States since 1924, scientists reported. Four people, including the dog's owner, ended up contracting the rare and potentially deadly infection, Colorado public health officials reported. Their findings were published in the May 1 issue of the U.S. Centers for Disease Control and Prevention's journal, Morbidity and Mortality Weekly Report. The dog had to be put to sleep in June 2014 after developing a mysterious illness that caused bloody mucous. The pit bull's owner, a friend of the owner, and two veterinary clinic workers developed similar symptoms in the days that followed. All wound up testing positive for Yersinia pestis, the bacterium that causes plague.
Leapfrog Updates Hospital Safety Grades
The Leapfrog Group published new results for its Hospital Safety Score, which grades more than 2,500 U.S. hospitals on quality and safety metrics such as error prevention and infection rates. "Patient safety requires constant vigilance," said Leapfrog President and CEO Leah Binder in a statement announcing the Spring 2015 results. That's why these latest scores, for the first time, are displayed alongside a hospital's previous letter grades for the past three years, offering patients an easy way to tell whether hospitals have shown consistent performance or continuous improvement.
Most People Eager to Know the Secrets of Their Genetics
A survey of nearly 7000 people has revealed that 98 per cent want to be informed if researchers using their genetic data stumble upon indicators of a serious preventable or treatable disease. The study, which comes after the Government's announcement that Genomics England will sequence 100,000 genomes by 2017, begins an important and on-going conversation about how our genomic data is used. The results show that genomic data has a perceived value to participants even if it is not currently clear what the information means for health outcomes. However, in general, the majority of people were interested in clinically actionable data and genetic professionals surveyed were concerned about returning data that cannot yet be interpreted accurately. The survey was conducted as part of the Deciphering Developmental Disorders (DDD) project, which seeks to find genetic diagnoses for rare developmental disorders using patients' sequence data.
Two Minutes of Walking Lengthens Life
Want to live longer? Get up from that desk, at least once an hour. Walking two minutes every hour means a longer life, according to a new study by a University of Utah team in the Clinical Journal of the American Society of Nephrology. A 33 percent lower risk of dying was discovered for those that got up every hour to walk around, the school said. Among the patients with chronic kidney disease in the study group, the risk of death was lower by 41 percent among those who walked for two minutes each hour. Exercise might not even counteract the bad effects of sitting too long. A study published by the Annals of Internal Medicine in January found that sitting cause more disease, from cancer to cardiovascular disease, regardless of time spent exercising.
Adopting Electronic Laboratory Reports
The Centers for Disease Control and Prevention (CDC) has been providing resources from the Prevention and Public Health Fund of the Affordable Care Act to 57 state, local, and territorial health departments since 2010, in an effort to assist with putting electronic laboratory reporting (ELR) systems into place. As of July 2014, 67% of about 20 million laboratory reports received annually for notifiable conditions were received electronically, compared with 62% in July 2013. The electronic reports came from 3,269 of 10,600 laboratories and were received by 55 of 57 health departments. That’s up from 2,900 laboratories that sent electronic reports in July 2013. “National implementation of ELR continues to progress steadily, as evidenced by increases in both the number of laboratories using ELR and the proportion of reports being sent via ELR,” according to the CDC’s “Update on Progress in Electronic Reporting of Laboratory Results to Public Health Agencies—United States, 2014,” which was published in Morbidity and Mortality Weekly Report(MMWR).
ONC: Health IT Adoption, Use Has Improved Patient Safety
The increased adoption of electronic health records and other health IT has improved patient safety, according to an issue brief by the Office of the National Coordinator for Health IT. In a blog post about the issue brief, ONC Chief Medical Information Officer and Office of Clinical Quality and Safety acting Director Andrew Gettinger and Senior Policy Analyst Kathy Kenyon wrote that the Institute of Medicine's "To Err is Human" patient safety report recommended "health IT as part of 'redesigned systems of care.'" They noted that in the years following the report, studies have shown that health IT has resulted in more benefits than harm. For example, the brief cited a series of four systematic reviews conducted between 2006 and 2014, one of which found that data-driven technologies -- such as clinical decision support, computerized provider order entry and EHRs -- were associated with:
- Better adherence to evidence-based protocols;
- Improved capability to monitor conditions and make better-educated decisions about care utilization; and
- Lower rates of medication errors.
Poor Data Security Hinders Healthcare Progress, Innovation
Progress in the healthcare industry depends on the free flow of information--but with that comes the need to ensure that data is secure, Harry Greenspun, M.D., director of the Deloitte Center for Health Solutions, writes at the Wall Street Journal. "From lapses in protocols to sophisticated cyberattacks, the public is confronted with exposure on a massive scale," he writes. As healthcare begins to embrace big data, Greenspun says there are some things to consider:
- Healthcare information is in a category all its own compared to other data. A person's personal health data is some of the most sensitive data there is, he writes; compromising that information has far-reaching consequences that can impact patient safety.
- Privacy is an individual thing. Some patients may be willing to share data for research or on social media and websites, but they also "fiercely protect other personal health data," Greenspun says. That will cause tensions between patient privacy and data use for the greater good.
- Communication is lacking in the industry. "While we have invested heavily in [electronic health records] and health information exchange, we have done little to educate the public whose data may be at risk," he writes.
David Blumenthal: Healthcare's Future Depends on Security, Interoperability
New health information technologies could revolutionize the quality and convenience of future healthcare services, but privacy and security issues, as well as the looming problem of interoperability, must be dealt with first, according to David Blumenthal, president of the Commonwealth Fund. Blumenthal, who also served as National Coordinator for Health IT from 2009 to 2011, outlined several forward-looking scenarios an article in The Wall Street Journal. Without assurances of privacy and security, Blumenthal said, people won't use such tools even if they are available.
Big Data's Biggest Healthcare Challenge: Making Sense of It All
Collecting healthcare data on patients and populations will soon be easier than ever for the industry, it's making sense of all the information that will be the biggest challenge, Drew Harris, M.D., director of health policy at Thomas Jefferson University's School of Population Health in Philadelphia, writes at the Wall Street Journal. The most significant change will come when data systems are merged; when electronic health records can link people who live, work and commute together, according to Harris. For population health management to be successful, there needs to be a blend of predictive analytics, chronic care management, a timely feedback mechanism and measurable outcomes, according to Kori Krueger, M.D., medical director for the Institute for Quality, Innovation and Patient Safety at the Marshfield Clinic.
Medical Providers Should Make Health Data Free to Patients
Technology makes patient access to medical records easier than ever, but the cost of such data prevents many from doing so, according to Niam Yaraghi and Joshua Bleiberg, fellows at the Brookings Institution. Access to health information is beneficial for patients, allowing them to take a bigger role in their care and enabling them to share the information with other providers, Yaraghi and Bleiberg write at Brookings' TechTank. The latter is especially important because of the lack of interoperability of electronic medical records, they add. But while there are virtually no costs of reproducing digital records, "many states still use the same regulatory model--which is based on the number of copied pages--for paper and digital records," they write.
Innovation Pulse: Portals Are Key to Population Health Success
When Mayo Clinic CEO John Noseworthy challenged his staff to broaden its reach, he went big, really big. To make that happen, Mayo is building its portal as “a new front door” into the care delivery system via which visitors can access multitudinous levels of care, according to Mark Parkulo, MD, vice chair of Mayo’s meaningful use coordinating group. “We’re talking about how to deliver information to patients, other providers, being able to enhance the patient-doctor relationship with tools,” Parkulo says. “If you’re only thinking about meaningful use – and I say that as someone who does MU for a living – you’re thinking way too small.”
State Health Department Celebrates Opening of New Public Health Laboratory
The Louisiana Department of Health and Hospitals (DHH) hosted a ceremony marking a new public health laboratory in Baton Rouge this morning. The public health laboratory serves as the primary daily testing center for many purposes from ensuring safe drinking water for our residents to screening for genetic and metabolic disorders in newborns. It also is a central part of Louisiana's response during public health events, including food borne illness, Ebola and radiation events, to name a few. "Our ability to respond to public health threats is directly affected by the ability of our staff to test samples quickly and efficiently," said DHH Secretary Kathy H. Kliebert. "The new public health lab site allows us to better identify food outbreaks, test infectious disease samples and any number of other public health concerns.
FDA Releases Final Guidance on Reprocessing of Reusable Medical Devices
The U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection. Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. While the majority of reusable devices are successfully reprocessed in health care settings, the complex design of some devices makes it harder to remove contaminants. FDA’s guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.
UnitedHealthcare Pilot to Curb Lab Costs Draws Protest
A UnitedHealthcare pilot to control rising clinical laboratory costs in Florida has sparked an uprising among physicians and lab companies who say the program is burdensome and unfairly limits competition. After a delay caused by physician complaints, in mid-April UnitedHealthcare started requiring doctors in its Florida provider network to give prior notice when ordering one of 79 lab tests, and to use a limited group of pre-approved labs for those tests. The new lab benefit-management program is run by Beacon Laboratory Benefit Solutions, a subsidiary of Laboratory Corporation of America. The program is being closely watched by other insurers, who say lab costs are rising because of over-ordering by physicians. UnitedHealthcare says overutilization may be the result of increased demand from patients influenced by reports or marketing campaigns touting the benefits of genetic and other types of tests to avoid diseases.
HIV Home Test Kit Goes On Sale in UK
The first legally approved HIV self-test kit that allows people to get a result in 15 minutes at home has gone on sale in England, Scotland and Wales. Unlike other kits, these tests do not need to be sent off to a lab to get the results. It works by detecting antibodies on a small drop of blood, which are often only detectable three months after the infection is caught. Experts warn that any positive tests must be reconfirmed at clinics. Charities hope it will reduce some of the 26,000 people estimated to have undiagnosed HIV in the UK.
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