A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
March 28, 2013
View Previous Issues - Healthcare News Archive
MedPAC Proposes Cut in Lab Payments
The Medicare Payment Advisory Commission (MedPAC), an independent advisory panel to Congress, makes bi-annual reports to Congress recommending ways to improve the Medicare program. In its March report, MedPAC suggests two approaches to reforming the seniors' insurance program:
- "First, payment reforms, such as penalties for excessive readmission rates and linking some percentage of payment to quality outcomes, need to be implemented more broadly.
- Second, delivery system reforms that encourage high quality, better care transitions, and more efficient provision of care, such as medical homes, bundling, and accountable care organizations (ACOs), need to be monitored and successful models adopted on a broad scale."
Also included among the options to reduce Medicare spending is a proposal to cut the clinical laboratory fee schedule by ten percent to pay for a permanent fix of the ongoing problem with the physician sustainable rate growth. MedPAC estimates that the adoption of this recommendation would generate $4 billion in savings over five years and $10 billion over ten years.
FDA to Issue Mobile App Guidance Before Oct. 1, Official Says
The Food and Drug Administration plans to issue final guidance about how it will regulate medical mobile applications before Oct. 1, an agency official told a House Energy and Commerce subcommittee. Christy Foreman, director of the office of device evaluation in the FDA's Center for Devices and Radiological Health, said the FDA is finalizing the guidance and expects to release it before the end of the government's fiscal year. Some medical mobile apps have received FDA clearance in recent years, although the vast majority of the estimated 40,000 health and wellness apps on the market do not require federal oversight.
FDA: No ‘iPhone tax’ From Health Law
The Food and Drug Administration said it has no plans to subject smartphones and tablets to a controversial tax in President Obama’s healthcare law. Republican members of House Energy and Commerce Investigations subcommittee seized on reports that the agency could extend the healthcare law's tax on medical devices to iPhones, BlackBerrys and Android devices. But an agency official assured lawmakers that smartphones will be exempt from the tax.
No Stage 3 EHR Regulations in 2013, CMS Says
When organized medicine raises its voice, it often gets the government to bend its way. Case in point is when Marilyn Tavenner, administrator of the Centers for Medicare & Medicaid Services (CMS), announced earlier this month that her agency would not propose stage 3 criteria this year that physicians must meet to earn a bonus for meaningful use of electronic health record (EHR) systems. The agency's decision to postpone development of stage 3 regulations pleased Jeffrey Cain, MD, president of the American Academy of Family Physicians. "Physician practices are struggling with stage 2 implementation," Dr. Cain told Medscape Medical News. "Slowing down is something we want."
New HIPAA Rules Go Into Effect March 26
A 563-page “omnibus” privacy and security rule was released by HHS on Jan. 17, with an effective date of March 26. For most aspects of the rule, however, the compliance deadline is not until Sept. 23, or 180 days after its effective date, said Angela Dinh Rose, director of health information management practice excellence with the Chicago-based American Health Information Management Association.
Senate Passes Budget Amendment to Repeal Device Tax
The Senate votes overwhelmingly in favor of a non-binding amendment that would repeal the medical device tax and establish a reserve fund to help pay for it. The U.S. Senate voted 79-20 in favor of a bipartisan amendment that would repeal the medical device tax. The measure, proposed by Senators Amy Klobuchar (D-Minn.) and Orrin Hatch (R-Utah), is a non-binding amendment contained in a the Senate's continuing budget resolution, but the win may be an important step forward for opponents of the device tax.
Senate Committee Passes Bill to End Ban on HIV-Positive Organ Donation
A Senate committee cleared a piece of legislation that could lead to the end of a ban on HIV-positive to HIV-positive organ donation. The Senate Health, Education, Labor and Pensions (HELP) Committee passed its version of the HIV Organ Policy Equity (HOPE) Act on March 20. One of the bill's cosponsors, Senator Tammy Baldwin (D-Wisc.), applauded the committee's bipartisan cooperation “I am proud to have worked across party lines on this important issue. The HOPE Act is a bipartisan, commonsense bill that reflects the progress we are making in medicine, as well as in breaking down the stigma associated with HIV/AIDS,” Baldwin said in a statement. “By allowing us to move forward with this critical research, the HOPE Act will help decrease the organ wait-time, save countless lives and reduce health care costs in the long-run.”
Vial of Deadly Virus Missing at Texas Bioterror Lab
Officials at a maximum-security research lab in Texas report that a vial of a potential bioterror agent is missing, but they say it's likely that the virus has been destroyed and poses no danger. Scott Weaver, the Galveston lab's scientific director, said that a routine check led to the discovery that one of five small plastic vials of an obscure virus called Guanarito was missing from a locked freezer. Checks of the lab's security systems show no malfunctions and no unusual entries to the lab or the freezer since a previous inventory recorded the vial in November. Weaver said the incident, as required by law, was immediately reported to the Centers for Disease Control and Prevention. He said CDC officials agreed with the lab that it is "extremely unlikely" the virus was stolen. Weaver said the most likely explanation for the missing vial is that it became stuck to a researcher's glove and dropped unnoticed to the lab's floor and rolled under equipment, where it was later swept up and incinerated with other lab waste.
FBI Gets Case of Missing Virus at Texas Biolab
The Centers for Disease Control and Prevention has referred to the FBI the case of the laboratory where one of five vials of a deadly Venezuelan virus went missing, an official from the CDC told ABCNews.com. "CDC reported the incident to the FBI and we understand that the FBI will initiate an investigation concerning the reported incident," Dr. Rob Weyant, director of the CDC's Division of Select Agents and Toxins, told ABCNews.com in an email. "Since the investigation is just underway, the agency will not comment further regarding details of this incident."
Flu Kills 105 Children; Most Not Vaccinated, CDC Says
Influenza has killed 105 children this year, federal officials reported, and almost none of them had been vaccinated against the virus. That’s triple the number who died during last year’s flu season. But flu deaths fluctuate a lot and it’s not anywhere near the worst season for child deaths, the Centers for Disease Control and Prevention says in its weekly report on influenza. “We are getting close to the end of the flu season now but it’s not over,” says CDC flu expert Dr. Michael Jhung. Deaths from flu and pneumonia are “barely” above the annual level designated as “epidemic”, he said. “We get an epidemic of flu every year,” Jhung added in a telephone interview. “It’s just the flu season. We assign the name epidemic to it.”
Colorado Student Receives $100,000 Intel First Prize
A high school senior who cultivated populations of algae under her loft bed won first place and $100,000 in the Intel Science Talent Search. The contestant, Sara Volz, 17, of Colorado Springs, Colo., researched ways to create populations of algae cells with high oil content; this algae oil can be converted into an economically feasible biofuel. “It’s something she’s worked on for years, and that shows a certain passion and drive that you don’t always see in heavily mentored projects,” said David Marker, a mathematics professor at the University of Illinois at Chicago and the chairman of the judging panel.
Second prize in the contest, $75,000, was awarded to Jonah Kallenbach, 17, of Ambler, Pa., for his project, “Characterizing and Identifying Interactions of Intrinsically Disordered Proteins.” Mr. Kallenbach’s research, in the burgeoning field of bioinformatics and genomics, focused on “disordered” regions in protein chains — areas with abnormal molecular structures. These areas eventually may serve as targets for newly developed drugs to treat diseases like breast cancer, ovarian cancer and tuberculosis.
Adam Bowman, 17, of Brentwood, Tenn., won third prize and $50,000 for research into less expensive ways to create ionized gases called plasmas, which have applications ranging from semiconductor manufacturing to nuclear physics.
An Updated Critical Analysis of the Evidence for Patient Safety Practices
Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices (AHRQ Evidence Report No. 211) updates the 2001 report, Making Health Care Safer: A Critical Analysis of Patient Safety Practices (AHRQ Evidence Report No. 43). The 2001 report analyzed the strength of evidence for patient safety practices in use at that time. The 2013 report analyzed a growing body of patient safety research to determine the level of evidence regarding the outcomes, as well as implementation, adoption, and the context in which safety strategies have been used.
What is Competency and CLIA Competency Assessment?
Competency is the ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. Competency assessment is used to ensure that the laboratory personnel are fulfilling their duties as required by federal regulation.
The following six (6) procedures are the minimal regulatory requirements for assessment of competency for all personnel performing laboratory testing:
- Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
- Monitoring the recording and reporting of test results;
- Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
- Direct observations of performance of instrument maintenance and function checks;
- Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
- Assessment of problem solving skills.
Competency assessment, which includes the six procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform.
Cervical Screening Guidelines Updated
New cervical screening guidelines posted online March 21 by the American Society for Colposcopy and Cervical Pathology (ASCCP) now address management of discordant co-tests, in which results of either Papanicolaou (Pap) smear or human papillomavirus (HPV) testing are positive, but not both.
Algorithms in the updated guidelines include the following:
- Management of discordant co-tests, in which results of either Pap smear or HPV testing are positive, but not both, with integration of co-testing into follow-up. Colposcopy and/or HPV DNA typing may be indicated.
- Return to "routine" screening in women treated for cervical cancer.
- Extension of management guidelines for adolescents under 21 years of age to women under 25 years of age. Workup varies according to findings of atypical squamous cells of undetermined significance, or low-grade or high-grade squamous intraepithelial lesion, and may include colposcopy.
- Consideration of whether cervical intraepithelial neoplasia grade 1 (CIN1) on endocervical canal curettage (ECC) should be treated as positive ECC or CIN1.
- Management of women with unsatisfactory cytologic findings and specimens that are missing endocervical or transformation zone components. Colposcopy may be required for women with positive HPV results or with repeated unsatisfactory cytologic findings.
Rare Blood Mystery Solved: Why Vel-Negative Type Rejects Transfusions
Since the 1950's, scientists have been baffled by the elusive blood type. Vel-negative blood contains an antibody that makes blood transfusions dangerous, but the blood type is difficult to identify and supply. The antibody can cause violent rejection of transfused blood, and successive blood transfusions can lead to kidney failure or death for Vel-negative patients. Doctors have unsuccessfully hunted for the cause of this blood type for decades, but a new study may have finally solved the mystery of how to detect it. Researchers led by Bryan Ballif of the University of Vermont (UVM) and the Lionel Arnaud of the French National Institute of Blood Transfusion have discovered a small protein molecule called SMIM1 that is responsible for the debilitating effects of the Vel-negative blood type, and identified two rapid DNA tests for identifying Vel-negative blood in patients.
Rethinking the Use of PSA Tests
Five years ago, the U.S. Preventive Services Task Force recommended against the use of the prostate-specific antigen (PSA) test in men 75 or older. The advisory group looking at these screenings for prostate cancer concluded that their potential for harm to older men outweighed the benefits. Many doctors and patients took heed. A recent study by Emory University and CDC researchers found that the task force recommendation led to a 7.9 percent decline in annual PSA testing rates.
New Prostate Cancer Tests Could Reduce False Alarms
Sophisticated new prostate cancer tests are coming to market that might supplement the unreliable P.S.A. test, potentially saving tens of thousands of men each year from unnecessary biopsies, operations and radiation treatments. Some of the tests are aimed at reducing the false alarms, and accompanying anxiety, caused by elevated P.S.A. readings. Others, intended for use after a definitive diagnosis, examine the genetic workings of the cancer to distinguish dangerous tumors that need treatment from slow-growing ones that might be left alone. The tests could provide a way out of the bitter debate over whether healthy men should be screened for prostate cancer.
Breakthrough Prostate Cancer Test Closer to Clinical Trial
The University of Surrey has signed a world-wide non-exclusive agreement with international diagnostic specialist Zeus Scientific to develop and market its breakthrough urine biomarker, EN2. This signals a significant step forward in the battle against prostate cancer which kills nearly 11,000 men in the UK every year. Colin Stokes, Chairman and co-founder of the Prostate Project, said: "This is a very significant moment for all men. It represents the real possibility of this simple, inexpensive and accurate urine test being in clinical use worldwide within 2 years.
TB or not TB? Newer Assays Settle In
While many areas in TB diagnosis and management remain unchanged, a major advance has taken place in testing for latent TB infection. Several years ago, in vitro blood tests were approved that recognize the presence of TB infection by release of interferon-gamma (interferon-gamma-release assays, IGRAs). Data have accumulated on the performance of these assays in relation to the historical standard, tuberculin skin testing (TST), so that the place of IGRAs in diagnosing TB in various populations is now becoming clear. The CDC published updated guidelines in 2010 on the use of IGRAs; those guidelines are still the governing document (MMWR. 2010; 59[No. RR-5]:1–25). Says Dr. Mase, “For diagnosis of latent TB infection, interferon-gamma-release assays are recommended for all situations in which we have used tuberculin skin testing.”
Simple Breath Test Might Diagnose Heart Failure
Noninvasive method found accurate in small, early study
An experimental breath test, designed to quickly identify patients suffering from heart failure simply by analyzing the contents of a single exhaled breath, has demonstrated promise in early trials, a team of researchers says. The investigators stressed that their evaluation is based on a small group of participating patients, and that more extensive research will have to be done to confirm their initial success. But by subjecting a patient's breath to a rigorous but fast analysis of the hundreds of so-called volatile organic compounds contained therein, the study team said it has so far been able to correctly diagnose heart failure among newly hospitalized patients with 100 percent accuracy.
Device May Lead to Quicker, More Efficient Diagnostics
A twist on thin-film technology may provide a way to optically detect and analyze multiple substances simultaneously, leading to quicker diagnostics in such industries as health care and homeland security, according to Penn State researchers. One current optical-sensing technology can launch and guide a single light wave, called a surface-plasmon-polariton wave -- SPP wave -- that travels along the flat interface of the sample to be analyzed and a metal film. The SPP wave is launched by sending a light beam through a prism to the other face of the metal film. A photon detector eventually collects the beam that was reflected back into the prism. Any change in the optical properties of the sample critically alters the reflected beam.
Sequencing-based Tracking Finds Animal-to-Human MRSA Transmission on Danish Farm
A research team using whole-genome sequencing to track a form of methicillin-resistant Staphylococcus aureus found in livestock and humans has uncovered genetic evidence confirming animal-to-human transmission of the bug during at least one farm outbreak in Denmark. "Our findings demonstrate that the MRSA strains we studied are capable of transmission between animals and humans," first author Ewan Harrison, a veterinary medicine researcher at the University of Cambridge, said in a statement, "which highlights the role of livestock as a potential reservoir of antibiotic-resistant bacteria."
At ACMG, Presenters Discuss False-Positive, False-Negative NIPT Results
While non-invasive prenatal tests [NIPTs] allow patients and their healthcare providers to assess the risk of fetal aneuploidy in a pregnancy, presenters at the American College of Medical Genetics and Genomics annual meeting cautioned that sometimes the screens return false-positive or false-negative results.
Currently, four US companies —Ariosa Diagnostics, Natera, Sequenom, and Verinata Health, which is now owned by Illumina — offer such non-invasive prenatal screening. The tests typically screen fetal DNA circulating in maternal blood for aneuploidies, namely of chromosomes 13, 18, and 21, and are beginning to screen for sex chromosome aneuploidies. The tests are usually offered to pregnant women with an increased risk of aneuploidy due to advanced maternal age, family history, or abnormal ultrasound results.
"[It's] not just a simple blood test," Holli Drendel, a cytogenetics fellow at Indiana University School of Medicine, said during her presentation. She emphasized that NIPT is a screening tool, not a diagnostic one.
Driven by Potential Cost Savings, Convenience, Proteomics Explores Dried Blood Spot Analysis
Used for decades as a sample collection method for newborn screening, dried blood spots have in recent years drawn interest as a potential approach for drug development and clinical work, where the format could offer improved convenience and cost savings compared to conventional blood samples. Much of this recent interest has focused on analysis of small molecules for purposes like pharmacokinetic assays. However, proteomics researchers have begun looking into dried blood spots, as well, with some suggesting that they could prove a key technology for establishing widespread, regular proteomic testing.
AGA [American Genetics Association] Creates Center for Gut Microbiome Research and Education
Recognizing the major influence the gut microbiome is likely to have on the future of digestive disease research and patient care. In a healthy adult, microbial cells are estimated to outnumber human cells 10 to one. Many microbes maintain our health, while others cause illness. Recent investigations of the human gut microbiome have discovered important ways in which gut microbes may influence a number of important disease states including obesity, inflammatory bowel disease, functional gastrointestinal disorders, cancers and liver disease. The AGA Governing Board is pleased to announce the creation of the AGA Center for Gut Microbiome Research and Education.
Novel Method Accurately Predicts Disease Outbreaks
A team of scientists from the Johns Hopkins University Applied Physics Laboratory (APL) has developed a novel method to accurately predict dengue fever outbreaks several weeks before they occur. The new method, known as PRedicting Infectious Disease Scalable Model (PRISM), extracts relationships between clinical, meteorological, climatic and socio-political data in Peru and in the Philippines. It can be used in any geographical region and extended to other environmentally influenced infections affecting public health and military forces worldwide.
This Protein Could Change Biotech Forever
A tiny molecular machine used by bacteria to kill attacking viruses could change the way that scientists edit the DNA of plants, animals and fungi, revolutionizing genetic engineering. The protein, called Cas9, is quite simply a way to more accurately cut a piece of DNA. “This could significantly accelerate the rate of discovery in all areas of biology, including gene therapy in medicine, the generation of improved agricultural goods, and the engineering of energy-producing microbes,” says Luciano Marraffini of Rockefeller University.
QUEST Quality Initiative Sees Big Reductions in Infections, Costs, Premier Says
A quality improvement and cost-cutting initiative that has grown to include more than 333 hospitals has saved more than $9 billion and has reduced rates of central line-associated bloodstream infections, pressure ulcers and other types of patient harm. That's according to newly released data from the QUEST collaborative, a project of the Charlotte, N.C.-based Premier healthcare alliance
A Step Closer to Explaining How Long-Term Infections Occur: Immune Finding Aids Quest for Vaccines to Beat Tropical Infections
Scientists are a step closer to developing vaccines for a range of diseases that affect 200 million people, mainly in tropical south-east Asia, Africa and Central America. Researchers studying infections caused by parasitic worms - which can lead to diseases such as elephantiasis and river blindness - have shown how these can shut down a part of the immune system that might otherwise fight sickness. Preventing this immune reaction enables the infection to persist, causing chronic illness. Scientists have also shown how this immune response can be re-activated to fight invading parasites, and enable the immune system to develop natural resistance to infection.
Disease-Fighters Disrupt Mosquito's Genes With Molecular Scissors
Scientists at Virginia Tech have disrupted the genes that control eye color in mosquitoes, using a genetic-engineering technique that could also disrupt the transmission of diseases such as dengue fever. The technique relies on two specially designed proteins that belong to a class known as transcription activator-like effector nucleases, or TALENs. The technique can target DNA at a specific site in an organism's genetic code, so precisely and efficiently that the journal Science has called the molecules "genomic cruise missiles."
Cold Sore Virus May Raise Risk of Cognitive Problems, Study Suggests
Some potentially bad news for people who get cold sores -- the virus that causes those pesky, itchy sores might also be linked with thinking problems. A new study in the journal Neurology shows an association between having higher infection levels in the blood and risk of cognitive problems. "While this association needs to be further studied, the results could lead to ways to identify people at risk of cognitive impairment and eventually lower that risk," study researcher Dr. Mira Katan, M.D., of the Northern Manhattan Study at Columbia University Medical Center, said in a statement. "For example, exercise and childhood vaccinations against viruses could decrease the risk for memory problems later in life."
Baldness Linked to Prostate Ca Risk in Blacks
Early-onset baldness seemed to significantly increase the odds of prostate cancer in African-American men, including diagnosis of more advanced and aggressive disease, as well as diagnosis at a younger age, results of a case-control study showed. Overall, baldness increased the odds of prostate cancer by 69% as compared with nonbalding African-American men, reported Charnita Zeigler-Johnson, PhD, of the University of Pennsylvania in Philadelphia, and colleagues. In addition, frontal baldness more than doubled the likelihood of high-stage and high-grade cancer, and frontal baldness was more than six times as common in men with prostate cancer diagnoses before age 60, they wrote online in Cancer Epidemiology, Biomarkers & Prevention.
Obesity Tied to DNA Regulation
Body mass index (BMI) and other environmental factors likely have an impact on the way genes are expressed, researchers reported. In a genome-wide study, about 20 regions across 11 autosomes had at least one significant association between BMI and DNA methylation, Ellen Demerath, PhD, of the University of Minnesota in Minneapolis, reported at the American Heart Association's Epidemiology and Prevention/Nutrition, Physical Activity, and Metabolism meeting in New Orleans.
Most Americans With Prediabetes Unaware of Condition
One-in-three Americans has prediabetes, according to the CDC, but most are unaware of their condition, study results suggest. Only about 11% of the estimated 79 million Americans who had prediabetes in 2009-2010 identified themselves as such, YanFeng Li, MD, of the CDC in Atlanta, and colleagues reported in Morbidity & Mortality Weekly Report. Furthermore, from 2005 to 2010, less than 14% of the U.S. population were aware of the condition.
Vitamin D Pregnancy Advice ‘Overstated’
UK researchers have raised questions about recommendations for vitamin D supplementation after finding that maternal vitamin D levels during pregnancy are not linked to the child's future bone health. The study of 3960 mothers, of whom 34% had insufficient or deficient 25-hydroxyvitamin D (25(OH)D) concentrations (<50 nmol/L), failed to find an association between median maternal 25(OH)D concentrations in any trimester and the child's bone mineral content (BMC) at a mean age of 9.9 years. And, the mean offspring BMC in those born to 25(OH)D-insufficient and -deficient mothers was similar to that in those born to mothers with sufficient levels.
Hypercleanliness May Be Making Us Sick
A growing body of evidence suggests that all the antibacterial-wiping, germ-killing cleanliness of the developed world may actually be making us more prone to getting sick — and that a little more dirt might help us stay healthier in the long run. The idea, known as the hygiene hypothesis, was first proposed in 1989 by epidemiologist David P. Strachen, who analyzed data from 17,414 British children and found that those who had grown up with more siblings (and presumably more germs) were less likely to have allergies and eczema. Since then, the theory has been cited as a possible explanation for everything from multiple sclerosis to hay fever and autism. But its particulars aren’t so clean and clear.
Cure in Sight for Kissing Bug’s Bite
Chagas disease, a deadly tropical infection caused by the protozoan parasite Trypanosoma cruzi and transmitted by biting insects called “kissing bugs,” has begun to spread around the world, including the U.S. Yet current treatment is toxic and limited to the acute stage. In The Journal of Infectious Diseases (JID), Galina Lepesheva, Ph.D., and her colleagues at Vanderbilt University and Meharry Medical College report curing both the acute and chronic forms of the infection in mice with a small molecule, VNI. The discovery “represents a possible new way to combat a serious worldwide threat, for which there are currently few good therapeutic options,” said Richard Okita, Ph.D., of the National Institute of General Medical Sciences, part of the National Institutes of Health (NIH), which helped support the research.
U.S. to Revise Cigarette Warning Labels
The U.S. government is abandoning a legal battle to require that cigarette packs carry a set of large and often macabre warning labels depicting the dangers of smoking and encouraging smokers to quit. Instead, the Food and Drug Administration will go back to the drawing board and create labels to replace those that included images of diseased lungs and the sewn-up corpse of a smoker, according to a letter from Attorney General Eric Holder obtained by The Associated Press.
Three Years After Passage of the Affordable Care Act and Months Before its Major Provisions Take Effect, Two-Thirds of the Uninsured (And A Majority of Americans Overall) Say They Have Too Little Information to Know How the Law Will Affect Them
Poll Finds Public Paying Little Attention to Medicaid Expansion, Exchange Decisions in States
As the Affordable Care Act (ACA) turns three this month, the law remains more of a political symbol than a reality for most Americans, including those the ACA is designed to benefit the most, the latest Kaiser Health Tracking Poll shows. Less than a year before the law takes full effect, 57 percent of Americans say they still do not have enough information to understand how it will affect them. The share rises to two-thirds among some of the key groups the law was designed to help: the uninsured (67%) and those with incomes below $40,000 (68%). The poll also finds that Americans’ awareness of key elements of the law has declined somewhat since passage when media attention was at its height.
New Analysis by West Health Institute Finds Medical Device Interoperability Could Save More Than $30 Billion a Year
A new analysis released by the West Health Institute (WHI) at a hearing before the House Energy and Commerce Subcommittee on Health estimates that medical device interoperability – the ability of medical devices and health care systems to seamlessly communicate and exchange information – could be a source of more than $30 billion a year in savings and improve patient care and safety. “Medical devices need to share data, based on standards, so that they can better inform clinicians and help patients,” said Dr. Peter Pronovost, medical director for the Center for Innovation in Quality Patient Care at John Hopkins University. “By doing so, we can both improve quality and reduce costs.”
The Face of Future Health Care
When people talk about the future of health care, Kaiser Permanente is often the model they have in mind. The organization, which combines a nonprofit insurance plan with its own hospitals and clinics, is the kind of holistic health system that President Obama’s health care law encourages. Kaiser has sophisticated electronic records and computer systems that — after 10 years and $30 billion in technology spending — have led to better-coordinated patient care, another goal of the president.
Report Ranks the Health of Georgia Counties
A new report released by the Robert Wood Johnson Foundation and the University of Wisconsin ranks Forsyth County as the healthiest in Georgia. The report ranks the county first out of 159 counties for health outcomes in the state. In general, counties in the metro area fared better than many rural counties in the state. But out of 10 metro Atlanta counties, Clayton County scored the worst for health outcomes. The report ranked the county 42. Clay County in Southwest Georgia was ranked the least healthy county in the state in terms of health outcomes.
Georgia Compounding Pharmacy Widens Recall
A Georgia compounding pharmacy recalled all lots of its sterile products distributed since Oct. 19 based on concerns federal regulators raised about the company's practices. The Food and Drug Administration is alerting healthcare providers and patients of the voluntary recall by Clinical Specialties Compounding Pharmacy. At least five people have acquired serious eye infections associated with the use of the cancer drug Avastin repackaged in syringes, according to reports to the Centers for Disease Control and Prevention.
Diabetes Patients Get Better Care When Seen by Their Usual Provider
Group practice patients with diabetes were more likely to get appropriate care when they saw their usual clinician rather than another provider. People who saw their primary care provider (PCP) for a new health problem were more likely to receive lifestyle counseling and medication changes for poorly managed diabetes. In contrast, patients who saw clinicians that were filling in for their primary care provider were less likely to receive additional treatments for their diabetes. This research was performed using natural language processing technology that examined hundreds of thousands of providers’ notes in just a matter of hours. Natural language processing technology is increasingly considered to be a cost- and time-efficient approach to analysis of clinical encounters, offering the advantages of large sample sizes at a much lower cost than traditional paper-based methods.
“Performance of Primary Care Physicians and Other Providers on Key Process Measures in the Treatment of Diabetes” appeared in the January issue of Diabetes Care. http://www.ahrq.gov/clinic/prevenix.htm
- Results that are truncated
- Comments that do not display
- Results that are not accepted because the patient identifiers do not match
- Results being mapped to incorrect tests in the display
- Errors that aren’t detected because interface error logs are not monitored
Regardless of the particular mechanism chosen to achieve connectivity, a number of common issues arise in the course of establishing these interfaces. They can be grouped into four broad categories:
- Data harmonization and standardization
Mistake #1: Not having standardized test definitions
Mistake #2: Having unsynchronized test catalogs
Mistake #3: Not uniquely identifying test names using LOINC
Mistake #4: Assuming that it will be easy to establish a secure electronic connection
- Validation processes
Mistake #5: Not having a thorough testing plan
Mistake #6: Failing to recognize that validation of the EHR result display is an important responsibility
Mistake #7: Not recognizing challenges and pitfalls associated with patient identifiers
- Report delivery and display
Mistake #8: Not considering all results delivery situations
Mistake #9: Not anticipating that results may be passed through multiple EHRs
Mistake #10: Assuming that EHRs can properly display complex reports
Enhanced Electronic Medical Record Aging Brain Care Software Unveiled
Innovative medical records software developed by geriatricians and informaticians from the Regenstrief Institute and the Indiana University Center for Aging Research will provide more personalized health care for older adult patients, a population at significant risk for mental health decline and disorders. A new study published in eGEMs, a peer-reviewed online publication recently launched by the Electronic Data Methods Forum, unveils the enhanced Electronic Medical Record Aging Brain Care Software, an automated decision-support system that enables care coordinators to track the health of the aging brain and help meet the complex biopsychosocial needs of patients and their informal caregivers.
As health apps flourish, hospitals are beginning to sanction some for patients
Some hospitals are beginning to develop formulary-like lists of smartphone and tablet applications acceptable for use in clinical settings as more patients and physicians incorporate medical apps into their care regimens.
“We can provide some system-level evaluation and structure to help both providers and patients make sense of the complex world of mobile health,” said Dr. Gregory Weidner, medical director of primary-care innovation and proactive health for Charlotte, N.C.-based Carolinas HealthCare System. An estimated 40,000 health and wellness mobile apps are now on the market, a number that is growing at a rapid clip. Yet only about 25 have received clearance from the Food and Drug Administration. The vast majority are unregulated. The FDA has promised to release the guidance by Oct. 1. An FDA official told lawmakers that the agency plans to focus on “higher-risk products” rather than low-risk technologies, such as apps that monitor the number of steps a patient takes each day or remind a patient to refill a prescription.
The Lancet to Launch Open Access Global Health Journal
Articles in the new journal will cover common conditions and wider health policy issues affecting low and middle income countries. A special emphasis will be given to local, context-specific research with regional or global implications, and the intention is for The Lancet Global Health to provide a voice for country based researchers to influence global debates.The Lancet Global Health will launch in June to coincide with the Global Health Metrics & Evaluation (GHME) conference in Seattle, Washington, USA. Papers can be submitted now via The Lancet’s online editorial system (http://ees.elsevier.com/langlh/).
Changes to Medical Device Registration in Egypt Announced
Egypt's Central Administration for Pharmaceutical Affairs (CAPA), the country's medical device market regulator, has published a series of updates and amendments to its registration requirements on its website.
United Kingdom Eyes VA’s Electronic Health Record
The Veterans Affairs Department and the United Kingdom’s National Health Service have teamed up to share ideas, strategies and leadership for development of health information technology, opening the possibility that the NHS could use VA’s electronic health record system. Peter Levin, the former VA Chief Technology Officer who retired this month, told Nextgov the Pentagon also should adopt VA electronic health record.
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.
This symbol means you are leaving the CDC.gov Web site. For more information, please see CDC's Exit Notification and Disclaimer policy.