A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
December 10, 2015
- U.S. Still in Danger of Losing War on AIDS, “CDC” Director Says
- Half of Those Who Need Them Not Taking Cholesterol-Lowering Medications
- Scientists Seek Moratorium on Edits to Human Genome That Could Be Inherited
- Collaborating Across Disciplines
- Scrutinizing PSA Assay Methods
- Implementing High Sensitivity Cardiac Troponin Assays
- Study Uncovers Potential Urine Marker for Chronic Kidney Disease Progression
- Researchers Have Discovered BRCA1 Link to Alzheimer’s
- New Discovery: This Is Why We Do Not Constantly Get Ill despite Viruses and Bacteria
- New Diabetes Cases, at Long Last, Begin to Fall in the United States
- Increased Cancer Risk Seen after False-Positive Mammograms
- WHO Issues Recommendations on Linkage to Care, Retention, to Help Bring HIV Treatment to All
- Privacy Risks in Genome Sharing Network
- Hospital IT Outsourcing on the Rise
- Healthcare Pros Enthusiastic about IBM Watson, Despite Hurdles
View Previous Issues - Healthcare News Archive
U.S. Still in Danger of Losing War on AIDS, “CDC” Director Says
Despite major medical advances and more than 30 years of effort, the United States is still in danger of losing the war on AIDS, according to the country’s top disease-control official. In an essay in The New England Journal of Medicine published World AIDS Day, Dr. Thomas R. Frieden, the director of the Centers for Disease Control and Prevention, and Dr. Jonathan Mermin, the agency’s chief of AIDS prevention, paint a bleak picture of the fight. “Hundreds of thousands of people with diagnosed H.I.V. infection are not receiving care or antiretroviral treatment,” they wrote. “These people account for most new H.I.V. transmission.” There are 45,000 new H.I.V. infections each year, the article noted. In an interview, Dr. Frieden said he “still views the glass as half full.” While medicines are improving, legal barriers have been lifted and Americans are getting tested, more people with H.I.V. need to be put on treatment and kept on it.
Half of Those Who Need Them Not Taking Cholesterol-Lowering Medications
More than a third of American adults are eligible to take cholesterol-lowering medications under the current guidelines or were already taking them – but nearly half of them are not, according to a report by Centers for Disease Control and Prevention researchers published in the current issue of Morbidity and Mortality Weekly Report (MMWR). Blacks and Mexican Americans are less likely than whites to be taking cholesterol-lowering medications. Data from 2007 through 2014 show a decline in the number of Americans with high blood levels of cholesterol. There also has been a recent increase in the use of cholesterol-lowering medications. But a high blood level of LDL cholesterol – also known as “bad” cholesterol - remains a major risk factor for heart disease and stroke in the United States. Some people with high LDL cholesterol and who have or are at risk of heart disease are eligible for cholesterol-lowering medications. They should also make lifestyle changes such as getting regular exercise, eating a heart-healthy diet, and losing weight. Yet fewer than half of people eligible for or who were taking cholesterol-lowering medication make these changes, the study found.
Scientists Seek Moratorium on Edits to Human Genome That Could Be Inherited
An international group of scientists meeting in Washington called on what would, in effect, be a moratorium on making inheritable changes to the human genome. The group said it would be “irresponsible to proceed” until the risks could be better assessed and until there was “broad societal consensus about the appropriateness” of any proposed change. The group also held open the possibility for such work to proceed in the future by saying that as knowledge advances, the issue of making permanent changes to the human genome “should be revisited on a regular basis.” The meeting was convened by the National Academy of Sciences of the United States, the Institute of Medicine, the Chinese Academy of Sciences and the Royal Society of London. The academies have no regulatory power, but their moral authority on this issue seems very likely to be accepted by scientists in most or all countries.
Infections, Other Health Issues Caused by Hospitals Are Down, Feds Say
Infections and other health problems caused by hospitals dropped 17% from 2010 to 2014, which prevented 87,000 deaths and saved $20 billion in health care costs, federal health officials said. The new report from the Centers for Medicare and Medicaid Services follows a report last December that showed 50,000 fewer patients died in hospitals and $12 billion was saved from 2010 through 2012. Still, the rate these conditions in 2013 and 2014 remained the same and nearly 10% of hospital patients get at least one of them. "That rate is still too high," the report says. The "hospital-acquired conditions" in the report include adverse drug events, catheter-associated urinary tract infections, central line-associated bloodstream infections, pressure ulcers, and surgical site infections, but those are far from all or the most serious possible.
Laboratory Testing / Diagnostics
Collaborating Across Disciplines
Recognizing the importance of educating its members about Choosing Wisely® recommendations from other societies, the American Society of Hematology (ASH), at its annual meeting this month, announced a Choosing Wisely list that incorporates recommendations from the American College of Radiology, American Society for Reproductive Medicine, Society for Hospital Medicine, American Association of Blood Banks and American Society of Clinical Oncology that are highly relevant and important to the practice of hematology.
ASH has been a partner in Choosing Wisely since December 2013 when they released their first list of five tests and procedureshematologists and patients should question. ASH added five more items to its list in December 2014. In early 2015, the ASH Choosing Wisely Task Force launched a review using a validated reliability tool (MORETM scale), which is similar to those used to review medical literature, in order to assess the hematologic relevance of all existing Choosing Wisely recommendations. By prioritizing recommendations that would avoid patient harm, the task force reached consensus on 10 that were most important to hematologists and their patients and presented the top five highest ranked items at their annual meeting this December.
Scrutinizing PSA Assay Methods
Inter-assay Variability Could Lead to 50% Under- or Over-diagnosis of Disease.
Variability among prostate specific antigen (PSA) assays may increase the risk of misdiagnosing biochemical failure in prostate cancer patients, Indian researchers concluded in a study published in Clinical Biochemistry. “Although PSA is an integral part of prostate cancer management, PSA measurement is subject to variability owing to the presence of several types of PSA assays in different formats,” the article stated. There are chemiluminescence-based systems, which are used for automated assays (a-PSA), and ELISA-based systems or manual measurement assays (m-PSA). A-PSA systems are commonly used by the best-equipped centers, yet the ELISA assay is still popular among many labs and hospitals. Developing countries in particular tend to favor the latter for economic reasons. Inter-assay variability issues remain, however, despite efforts to improve characterization of antibodies, and the World Health Organization’s attempt to standardize PSA methods. “With variability in assay formats, analytical sensitivity, capture-detection antibodies and calibrator preparations the results reported by clinical laboratories are variables causing discordance in PSA concentration measurements for clinical purpose,” the authors noted.
Implementing High Sensitivity Cardiac Troponin Assays
High-sensitivity cardiac troponin (hs-cTn) assays promise better diagnostic accuracy for acute myocardial infarction (AMI), allowing earlier and more effective treatment for patients. This is why it is essential that laboratory medicine professionals and clinicians understand the performance of these tests and how to use them. With this challenge in mind, an expert group of laboratorians, emergency medicine clinicians, and cardiologists worked for more than 2 years on hs-cTn education materials, following-up on a mini-review that tackled the question, how does an assay become designated high-sensitivity? This group, all members of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Clinical Applications of Cardiac Bio-Markers, also collaborated with representatives from in vitro diagnostics companies who have expertise in hs-cTn troponin immunoassays.
Effectiveness of Acetic Acid Wash Protocol on Bloody Cervical ThinPrep® Specimens
ThinPrep®; (TP) cervical cytology, as a liquid-based method, has many benefits but also a relatively high unsatisfactory rate due to debris/lubricant contamination and the presence of blood. These contaminants clog the TP filter and prevent the deposition of adequate diagnostic cells on the slide. An acetic acid wash (AAW) protocol is often used to lyse red blood cells, before preparing the TP slides. While AAW had a significantly higher percent of UNS [unsatisfactory smear] interpretations, the protocol was effective in rescuing 94.2% of specimens which otherwise may have been reported unsatisfactory. This improved patient care by avoiding a repeat test. The prevalence of ASCUS and HSIL interpretations between AAW and non-AAW groups were comparable. Though not statistically significant, HSIL interpretations were relatively higher in the AAW group. LSIL interpretations showed lower prevalence in AAW group.
Ariosa Reaffirms NIPT Performed by Microarray as Good as NGS
In switching from a noninvasive prenatal test that ran on next-generation sequencing technology to one that runs on a microarray, Roche's Ariosa Diagnostics aims to speed up its turnaround time and lower its costs, while maintaining accuracy, according to the company. The firm recently evaluated the clinical performance of its microarray-based Harmony test, which analyzes aneuploidies in chromosomes 21, 18, and 13, in 799 pregnant women, in a study published in Prenatal Diagnosis.
Scientists Design a New Method for Screening Cancer Cells
Scientists have previously established that many types of cancer cells are squishier and more pliable than normal, healthy cells. Now, researchers led by UCLA’s Amy Rowat have developed a screening method that utilizes this information to classify many more different types of cancer cells and that could ultimately lead to better treatments for cancer, diabetes, malaria and other diseases. Cancer cells are generally two to five times squishier than normal cells, with a pliability similar to that of a wobbly Jell-O, said Rowat, senior author of the research and an assistant professor of integrative biology and physiology. “We want to screen cells based on their squishiness or stiffness,” said Rowat, who is also a member of UCLA’s Jonsson Comprehensive Cancer Center. “We created a technology to probe the deformability of hundreds of cell samples at the same time, so we can identify compounds that make the cells stiffer. Our hope is that we can identify new compounds that can help to prevent the spread of cancer.” Rowat calls the approach the parallel microfiltration method, or PMF. A study detailing the method is published in the journal Scientific Reports.
Smaller, Faster Flow Cytometer Could Be Used by Clinical Laboratories in Community Hospitals to Support Personalized Medical Diagnostics
Flow cytometers, essential to the diagnosis of blood cancers, are in for a major makeover, if researchers at a technology institute in Germany are successful at engineering a smaller, cheaper, and more automated version of today’s large and expensive flow cytometer systems. If this happens, it would make it possible for clinical laboratories in many community hospitals to use these more compact flow cytometers in support of patient care. Flow cytometers have been around for about 40 years; however, the equipment is expensive, large, and the process so lengthy and complex that only specially-trained scientists can operate it. Those factors make it difficult for patients and clinicians to reap the full benefit of the information that flow cytometry can yield. That may be changing thanks to the development of a much smaller, more automated flow cytometer. The PoCyton is a product being developed by the Fraunhofer Institute for Chemical Technology (ICT-IMM) in Pfinztal, Germany.
Research and Development
Study Uncovers Potential Urine Marker for Chronic Kidney Disease Progression
A University of Michigan-led team has tracked down a urine biomarker that appears to coincide with progression to serious, end-stage disease in those with chronic kidney disease. Starting with kidney biopsy samples from more than 150 individuals, the researchers used array-based expression profiling to narrow in on transcripts whose expression coincided with kidney function, as measured by each individual's baseline estimated glomerular filtration rate (eGFR), validating three of these markers through targeted testing in two groups of patients with chronic kidney disease. From there, the team looked at whether protein products of these transcripts in the urine also coincided with kidney injury or baseline eGFR. Indeed, it found a set of urine markers — most notably epidermal growth factor protein — successfully predicted end-stage kidney disease and/or a significant decline in baseline eGFR levels in three different groups of patients with chronic kidney disease. Results of the study appeared online in Science Translational Medicine.
Researchers Have Discovered BRCA1 Link to Alzheimer’s
In a study published in the journal Nature Communications, scientists experimentally reduced BRCA1 levels in the neurons (cells that transmit nerve impulses) of mice. They discovered that the mice had learning and memory issues as a result. Researchers then studied BRCA1 levels in post-mortem brains of human Alzheimer’s patients and found that the levels were reduced by 65 to 75 percent, as compared with patients that didn’t have dementia. To figure out why this depletion happens, researchers then grew neurons in a lab and treated them with amyloid-beta proteins, which accumulate in the brains of people with Alzheimer’s. The proteins depleted BRCA1 levels. What does this mean, exactly? BRCA1 is important for our brains to function properly, and Alzheimer’s disease depletes the levels of the protein in our brains, making it difficult for them to work the way that they should. The work is the latest to emphasize the importance of functional BRCA1 for our overall health.
New Discovery: This Is Why We Do Not Constantly Get Ill despite Viruses and Bacteria
Fever, sore muscles and other influenza-like symptoms are typical signs that your immune system is fighting against viruses and bacteria. The unpleasant condition is, among other things, due to the body forming a substance called interferon, which must defeat the virus. For many years researchers and doctors have assumed that this was the body's earliest response when attacked by various infections. But new research shows that the body's very first defense mechanism is not interferon, but rather a hitherto unknown mechanism, which begins working even earlier. The newly discovered immune reaction is activated when the body’s mucous membranes are disrupted, as they are when viruses and bacteria attempt to establish an infection. The immune system recognizes the virus and produces a substance that neutralizes the uninvited guest. The process goes on continuously without us being aware of it. If this first immune reaction is not sufficient to suppress the virus, the infection establishes itself in the body. This in turn triggers the next reaction involving interferon, which not only helps to fight the virus, but also means we become ill. The discovery has just been published in the scientific journal Nature Immunology.
Safer Way to Do Gene Editing
Scientists say they have fine-tuned a gene editing method to make it safer and more accurate - vital if it is to be used in humans to cure inherited diseases or inborn errors. The advance, outlined in Science Magazine, comes as world leaders in the field gather to debate the ethics of altering human DNA using the method, known as Crispr-Cas9. Gene editing holds medical promise. But changing a person's DNA also has potential risks and ethical quandaries. Researchers at the Broad Institute of MIT and Harvard believe they have solved this problem by changing the molecular structure of the Cas9 enzyme. Their modified version should now only snip out the DNA it is designed to, leaving the rest of the precious genetic code intact, the US team say.
Genes May Help Shield Seniors from Mental Decline: Study
Humans have evolved to have gene variants that protect older adults from mental decline, new research suggests. "We unexpectedly discovered that humans have evolved gene variants that can help protect the elderly from dementia," study co-leader Dr. Ajit Varki, a professor of medicine and cellular and molecular medicine at the University of California, San Diego School of Medicine, said in a university news release. Varki and colleagues found that levels of a CD33 gene variant that protects against Alzheimer's are four times higher in humans than in chimpanzees. They also found that the APOE2 and APOE3 gene variants appear to have evolved to protect against dementia. The study was published Nov. 30 in the Proceedings of the National Academy of Sciences.
New MRSA Antibiotic May in Future Replace Obsolete Drugs
Maynooth University researchers are developing a promising new kind of antibiotic that readily kills off the main hospital superbug, MRSA. It may provide the basis for an entirely new class of antibiotic that could substitute for others that are no longer effective. MRSA and E coli are the key organisms involved, accounting for 64 per cent of cases. The discovery is the result of three years of work. “We took a Lego-type strategy, looking at building blocks that might improve the medicinal chemistry,” said Dr John Stephens, a principal investigator at Maynooth’s Department of Chemistry. He led the research with Maynooth’s Dr Kevin Kavanagh at the Department of Biology, and Niamh Dolan, lead author of a research paper published online in the journal Bioorganic and Medicinal Chemistry Letters. The team used quinoline thiourea as the starting point of their research. The molecule was known but was not used in medical chemistry, Dr Stephens said.
Type 2 Diabetes Reversed by Losing Fat from Pancreas
A team from Newcastle University, UK, has shown that Type 2 diabetes is caused by fat accumulating in the pancreas -- and that losing less than one gram of that fat through weight loss reverses the diabetes. The research led by Professor Roy Taylor is being published online inDiabetes Care and simultaneously he is presenting the findings at the World Diabetes Conference in Vancouver. Previous work by Professor Taylor and his team highlighted the importance of weight loss through diet in reversing Type 2 diabetes.
Coffee Compounds That Could Help Prevent Type 2 Diabetes Identified
Much to coffee lovers' delight, drinking three to four cups of coffee per day has been shown to decrease the risk of developing type 2 diabetes. Now, scientists report in ACS' Journal of Natural Products that they have identified two compounds that contribute to this health benefit. Researchers say that this knowledge could someday help them develop new medications to better prevent and treat the disease. The researchers investigated different coffee compounds' effects on cells in the lab. Cafestol and caffeic acid both increased insulin secretion when glucose was added. The team also found that cafestol increased glucose uptake in muscle cells, matching the levels of a currently prescribed antidiabetic drug. They say cafestol's dual benefits make it a good candidate for the prevention and treatment of type 2 diabetes. However, because coffee filters eliminate much of the cafestol in drip coffee, it is likely that other compounds also contribute to these health benefits.
Chikungunya Virus Triggers Brain Infections in Adults and Children
An outbreak of the mosquito-borne Chikungunya virus on La Réunion Island in the Indian Ocean that occurred between September, 2005 and June, 2006 resulted in 57 cases of associated central nervous system disease initiated by encephalitis. This was a highly significant outbreak of a modified strain with more serious outcomes than previous outbreaks of the virus, according to a study published in Neurology. Of the 57 patients studied who had Chikungunya virus (CHIKV) associated central nervous system (CNS) disease, 24 had altered mental status that corresponded to encephalitis according to International Encephalitis Consortium (IEC) criteria, for a regional incidence of 8.6 per 100,000. The burden of the La Réunion outbreak therefore, was greater than that reported from 1999 to 2007 with the West Nile virus in the U.S. or the worldwide spread of Japanese encephalitis.
Public Health and Patient Safety
New Diabetes Cases, at Long Last, Begin to Fall in the United States
After decades of relentless rise, the number of new cases of diabetes in the United States has finally started to decline. The rate of new cases fell by about a fifth from 2008 to 2014, according to researchers at the Centers for Disease Control and Prevention, the first sustained decline since the disease started to explode in this country about 25 years ago. The drop has been gradual and for a number of years was not big enough to be statistically meaningful. But new data for 2014 released serves as a robust confirmation that the decline is real, officials said. There were 1.4 million new cases of diabetes in 2014, down from 1.7 million in 2008. “It seems pretty clear that incidence rates have now actually started to drop,” said Edward Gregg, one of the C.D.C.’s top diabetes researchers. “Initially it was a little surprising because I had become so used to seeing increases everywhere we looked.”
Increased Cancer Risk Seen after False-Positive Mammograms
Are 'false-positive' scans still picking up something important?
Women with positive mammography screens ultimately judged to be false were still at significantly increased likelihood for developing invasive breast cancer within the next 10 years, a study involving 1.3 million women showed. The 10-year breast cancer risk was higher by 39% in women who had false-positive mammograms and additional breast imaging as compared with women who had true-negative mammograms, Louise M. Henderson, PhD, of the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, and co-authors reported in the December issue of Cancer Epidemiology, Biomarkers & Prevention. Moreover, the risk increase reached 76% in the subgroup of women who had breast biopsies after false-positive mammograms, and was independent of breast density, a known risk for breast cancer. The reasons for the association remain unclear, but the results suggest that a history of false-positive screening mammography should be incorporated into breast cancer risk-prediction models, the researchers said. "Now that we have this information, our hope is that we can add it into existing risk-prediction models to improve their ability to discriminate between women who will go on to develop breast cancer and those who won't," Henderson told MedPage Today.
WHO Issues Recommendations on Linkage to Care, Retention, to Help Bring HIV Treatment to All
The World Health Organization (WHO) has issued new recommendations on how to organise services in order to promote linkage to care and retention in care as part of its new guidelines recommending antiretroviral treatment for all adults and adolescents. The recommendations on antiretroviral treatment and for pre-exposure prophylaxis for people at substantial risk of HIV infectionwere announced in September 2015. This week the World Health Organization makes a series of new recommendations on service delivery. These are designed to maximise linkage to care and retention in care as part of efforts to expand access to antiretroviral treatment to ensure that 90% of people diagnosed with HIV infection are on treatment by 2020. HIV programmes should provide people-centred services that are organised around the health needs and preferences of people living with HIV, WHO says. In practice this means following the evidence regarding how to optimise linkage and retention in care, through decentralisation of care, reduction in clinic visits and clinic waiting times, and “upholding individual dignity and respect, especially for vulnerable populations.”
Superbug Known as ‘Phantom Menace’ on the Rise in U.S.
A particularly dangerous superbug, dubbed the "phantom menace" by scientists, is on the rise in the United States, according to a report by the Centers for Disease Control and Prevention. This superbug's strains belong to the family of bacteria known as [Carbapenem-Resistant Enterobacteriaceae] CRE which are difficult to treat because they are often resistant to most antibiotics. They are often deadly, too, in some instances killing up to 50 percent of patients who become infected, according to the CDC. Health officials have called CRE among the country's most urgent public health threats. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6447a3.htm?s_cid=mm6447a3_e
Annual HIV Diagnoses Down 19 Percent over the Past Decade
The number of annual HIV diagnoses declined by 19 percent between 2005 and 2014, the Centers for Disease Control and Prevention reported, but diagnoses jumped 6 percent among men who have sex with other men. Though they represent only about 2 percent of the population, men who have sex with other men accounted for nearly 67 percent of all HIV diagnoses in 2014 -- 26,612 cases, according to the CDC report. The rise was driven by sizable increases among African Americans (from 8,235 diagnoses in 2005 to 10,080 last year) and Latinos (from 5,492 to 6,829). Among whites, the number fell considerably (from 9,966 to 8,207). Still, the report showed that the rate of increase among black gay and bisexual men has slowed in recent years. The data were released as a CDC-sponsored conference focused on preventing HIV infections began in Atlanta.
Farmers Urged to Cut Antibiotic Use
Farmers need to dramatically cut the amount of antibiotics used in agriculture, because of the threat to human health, a report says. Some infections are becoming almost impossible to treat, because of the excessive use of antibiotics. And more than half of those used around the world are used in animals, often to make them grow more quickly. The Review on Antimicrobial Resistance called for new targets on the amount of antibiotics used. The great threat of excessive antibiotics use in agriculture was highlighted in China last month. Scientists warned the world was on the cusp of the "post-antibiotic era" after discovering bacteria resistant to the antibiotic colistin - the medication used when all others have failed. It appeared to develop in farm animals before also being detected in hospital patients.
Privacy Risks in Genome Sharing Network
Stanford University researchers describe how a global genomic database could get hacked—and how to prevent such occurrences.
If there’s a will, there’s a way to hack global genomic databases. Researchers in The American Journal of Human Genetics describe how this could happen, and what steps could help prevent such privacy breaches. The Global Alliance for Genomics and Health (GA4GH) has created a network of “beacons,” or web servers that facilitate data sharing of genomic information by answering allele-presence questions on specific genomes. As an example, someone could ask the web server about a genome that has a specific nucleotide, and the beacon would respond “yes” or “no.” Although they’re set up to share data and protect patient privacy simultaneously, there are instances in which beacons could potentially leak phenotype and membership information.The Genetic Information Nondiscrimination Act (GINA) offers some genetic privacy protection, yet not all insurance situations are covered under GINA, including long-term, life, and disability.
Hospital IT Outsourcing on the Rise
More healthcare organizations are starting to look outside their walls for app development, infrastructure services and more. In fact, about 73 percent of organizations with more than 300 beds responding to a Black Book survey said they are outsourcing IT solutions. For health systems under 300 beds, 81 percent said they will make IT outsourcing a priority next year, according to an announcement. "Most hospital leaders see no choice but to evaluate and leverage next generation information and financial systems as an outsourced service in order to keep their organizations solvent and advancing technologically," Doug Brown, Managing Partner of Black Book Market Research, said in the announcement.
Healthcare Pros Enthusiastic about IBM Watson, Despite Hurdles
Hospitals and health systems across the country are using IBM's Watson--and so far healthcare leaders are enthusiastic about the system, according to a report in the Wall Street Journal. Thomas H. Davenport, a professor at Babson College in Massachusetts and research fellow at the MIT Center for Digital Business, spoke with people who have worked with the cognitive computing system, including leaders at Memorial Sloan Kettering Cancer Center, the University of Texas MD Anderson Cancer Center, Mayo Clinic and more.
Some highlights from his report include:
- Industry experts see Watson as the future of healthcare. Mark Kris, M.D., an oncologist at Memorial Sloan Kettering, said it's "the way medicine is going to be practiced."
- It's a work in progress, and can be both difficult and time-draining. Sloane Kettering started its Watson oncology project in 2012--and it's still not finished.
- The system requires many organizational changes, including network infrastructure, security controls, data sharing and reimbursement, Lynda Chin, M.D., of MD Anderson Cancer Center, told Davenport.
- The amount of "cognitive application program interfaces" is growing, as is interest in those programs by users, including ones that help with image analysis and an English language dialog application.
"This is real and it's going to revolutionize cancer and other types of medical care. … It's clearly going to take some time to work out," Kris said.
Healthcare API Task Force Gets to Work
An 11-member task force convened by the Office of the National Coordinator for Health IT to address the use of application programming interfaces, or APIs, to better share health information met for the first time last week. APIs are a major component of health IT work underway at the Health and Human Services Department. ONC is pushing forward a capability called "view, download, transmit," which will allow patients to send data from any healthcare portal to the API of a selected third party. ONC has a certification criteria for an API that supports patient access to health data, said Josh Mandel, co-chair of the new committee and a member of the research faculty at Harvard Medical School. The 2015 EHR Certification rule requires electronic health record vendors to house APIs that allow patients to view and download records, but according Mandel, there were some concerns about security and privacy implications.
HIMSS Launches Value Score for Quality/Value Measurement of Health IT
HIMSS announced the launch of the HIMSS Value Score, healthcare’s first international quality measurement for the value of health IT. Developed with the assistance of McKinsey & Company, the Value Score builds off of HIMSS’ Value Suite and HIMSS Analytics’ Electronic Medical Record Adoption Model (EMRAM). The new standards will help healthcare providers optimize and use IT to improve clinical and financial outcomes, and drive efficiencies in care. The Value Score is the next generation of several HIMSS-developed standards and resources that have served as the leading health IT adoption models for providers over the last decade.
Why Electronic Health Records Aren't More Usable
Physicians often have difficulty entering structured data in EHRs, especially during patient encounters. The records are hard to read because they're full of irrelevant boilerplates generated by the software and lack individualized information about the patient. The American Medical Association in 2014 issued an eight-point framework for improving EHR usability. According to this framework, EHRs should:
- enhance physicians' ability to provide high-quality patient care
- support team-based care
- promote care coordination
- offer product modularity and configurability
- reduce cognitive workload
- promote data liquidity
- facilitate digital and mobile patient engagement
- expedite user input into product design and post-implementation feedback
Nevertheless, it does not appear that EHR vendors are placing more emphasis on UCD. The Office of the National Coordinator for Health IT requires developers to perform usability tests as part of a certification process that makes their EHRs eligible for the government's EHR incentive program.
HHS’ Top Ten Management Problems Include Labs
The OIG’s FY 2015 Top Management and Performance Challenges target clinical laboratories among other providers as a necessary focus of efforts to fight fraud, abuse and waste in Medicare. Specifically, the report notes that while “[f]raud schemes shift over time, … certain Medicare services have been consistent targets”—namely, clinical laboratories. The OIG report notes “CMS is not realizing the full potential of contractors to proactively identify fraud and address other program integrity concerns.” The OIG does commend the Health Care Fraud and Abuse Control Program for its ability to return $7.70 for every $1 invested in fighting fraud and abuse,
VA Loosens Rules for Referrals to Private Doctors in Effort to Expand Access to Care
The Department of Veterans Affairs, under pressure to expand veterans’ access to private doctors outside its understaffed medical system, announced new rules to expand the number of patients who are eligible under the Veterans Choice Program. The agency said its staff has now been given broader flexibility to determine if a veteran can be referred to a private clinic or doctor’s office. For example, if a patient faces an “undue burden” getting to treatment at a VA medical center, he or she can be referred outside the system. These burdens include geographic barriers, environmental factors, severe medical conditions or a need for frequent care, such as chemotherapy or tests that can be done quickly closer to home, officials said. The changes, which are effective immediately, also include a tweak to the requirement that a veteran must live more than 40 miles from a VA medical center to be eligible for private care.
E-mails Reveal Concerns about Theranos’s FDA Compliance Date Back Years
Years before Theranos, the Silicon Valley upstart that promised to revolutionize blood testing, came under harsh public scrutiny in October, a military official raised concerns that the secretive company was violating federal law. E-mail correspondence obtained by the Post reveals that an official evaluating Theranos’s signature blood-testing technology for the Department of Defense sounded the alarm in 2012 and launched a formal inquiry with the Food and Drug Administration about the company’s intent to distribute its tests without FDA clearance – a problem that has resurfaced this year, leading Theranos to temporarily stop offering almost all of its tests.
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