viernes, 15 de mayo de 2015



A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems

May 14, 2015

News Highlights

  • Many People Are Not Getting the Recommended Cancer Screening Tests
  • FDA Publishes Draft of Rules Allowing Gay Men to Give Blood
  • FDA Withdraws Older Guidance Documents
  • New Blood Tests, Liquid Biopsies, May Transform Cancer Care
  • Screening Test Developed for Pregnancy Complications
  • Pediatric Estimation of Glomerular Filtration Rate
  • New Biomarkers May Shorten Year-Long Diagnosis to Days
  • Microbiomes Raise Privacy Concerns
  • Scientists Find New Link between Diabetes and Alzheimer’s
  • CDC Releases 1st Natl Study on Latino Health Risks, Causes of Death
  • After Nearly Claiming His Life, Ebola Lurked in a Doctor’s Eye
  • Ebola Virus Lives on Hospital Surfaces for Days
  • CDC: Electronic Quality Data a Boon to Public Health Reporting
  • The Patient Portal and Abnormal Test Results: An Exploratory Study of Patient Experiences

View Previous Issues - Healthcare News Archive

Leading News

Many People Are Not Getting the Recommended Cancer Screening Tests
Many adults in the U.S. are not getting the recommended screening tests for colorectal, breast and cervical cancers, according to data published in the Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report. For 2013, screening for these types of cancers either fell behind previous rates or showed no improvement. Among adults in the age groups recommended for screening, about 1 in 5 women reported not being up-to-date with cervical cancer screening, about 1 in 4 women reported not being up-to-date with breast cancer screening, and about 2 in 5 adults reported not being up-to-date with colorectal cancer screening. The report found that colorectal cancer testing was essentially unchanged in 2013 compared with 2010. Pap test use in women age 21-65 years was lower than 2000, and the number of mammography screenings was stagnant, showing very little change from previous years. “It is concerning to see a stall in colorectal cancer screening rates,” said Lisa C. Richardson, M.D., M.P.H., director of CDC’s Division of Cancer Prevention and Control. “We must find new ways to make people and providers aware that getting tested for colorectal cancer could prevent cancer and save their lives.”
FDA Publishes Draft of Rules Allowing Gay Men to Give Blood
The Food and Drug Administration published proposed guidelines Tuesday that would allow gay men to donate blood for the first time in 30 years, a move that follows a recommendation from an agency advisory committee late last year. The draft of the guidelines states that a man should be barred from giving blood only for one year after he has had sex with another man. The FDA has banned blood donations from any man who has had sex with another man at any time since 1977. An agency task force writes in the proposed guidelines that allowing gay men to donate after a one-year deferral would not diminish the safety of the blood supply and might significantly increase the pool of donors.
FDA Withdraws Older Guidance Documents
The FDA pulls 47 draft guidance documents it never made official, covering medical devices, diagnostics, pharmaceuticals and more. Agency officials posted the announcement in the Federal Register, explaining that the move is designed to boost efficiency and transparency regarding its development of guidance documents The soon-to-be-banished draft guidances cover areas including face masks for CPR, PMA applications for a testicular prosthesis, medical device interactions with MRI machines, portable blood glucose monitoring in vitro diagnostic devices, electrical nerve stimulators for pain relief, a recommended warning for surgeon and patient examination gloves and more.
Big Increase in Hepatitis C Accompanies Epidemic of Injection Drug Use
There's been a big increase in hepatitis C across central Appalachia, especially rural parts of the region, the Centers for Disease Control and Prevention reported. That only stands to reason, because young people in that part of the country are injecting heroin and other opioids at epidemic rates. Hepatitis C infection is serious, often chronic and sometimes fatal. It leads to cirrhosis of the liver and liver cancer, and by far the most common way of acquiring it is by sharing a drug needle, which exposes users to the virus in someone else's blood. The CDC looked at drug use rates and hepatitis C infection reports in Kentucky, West Virginia, Virginia and Tennessee. The results were pretty disturbing, if not surprising. From 2006 to 2012, the region saw a 364 percent increase in reports of acute hepatitis C infection among people age 12 to 29, with the rural rate more than twice the urban rate. (Rural, or "non-urban" in CDC parlance, was defined as a town of less than 50,000).
AACC Urges CMS to Delay Enforcing Regulations that Could Limit Diabetes Patients’ Access to Testing
The American Association for Clinical Chemistry (AACC) has sent formal comments to the Centers for Medicare and Medicaid Services (CMS) addressing CMS’ proposal to enforce more stringent regulatory requirements for testing with blood glucose monitors. AACC endorses CMS’ effort to improve patient care by ensuring these devices are used appropriately, but recommends creating a transition period that would give hospitals sufficient time to adjust to the new requirements and prevent the disruption of rapid, point-of-care blood glucose results for patients.


Laboratory Testing / Diagnostics

New Blood Tests, Liquid Biopsies, May Transform Cancer Care
The tests, called liquid biopsies, capture cancer cells or DNA that tumors shed into the blood, instead of taking tissue from the tumor itself. A lot is still unknown about the value of these tests, but many doctors think they are a big advance that could make personalized medicine possible for far more people. They give the first noninvasive way to repeatedly sample a cancer so doctors can profile its genes, target drugs to mutations, tell quickly whether treatment is working, and adjust it as the cancer evolves. Two years ago, these tests were rarely used except in research. Now, several are sold, more than a dozen are in development, and some doctors are using them in routine care.
Screening Test Developed for Pregnancy Complications
The world's first screening test which can predict a woman's risk of developing one or more of the four common pregnancy complications has been developed in South Australia. Researchers at the University of Adelaide's Robinson Research Institute have developed algorithms (or calculations) that combine subtle variations in DNA sequences in genes involved in placental development with clinical, socioeconomic, lifestyle and family history data that can predict a woman's risk of having a pregnancy complication. Professor Claire Roberts says this new screening test can be used in early pregnancy and will allow clinicians to initiate treatments for women at risk earlier, helping to reduce the severity of, or prevent, the complications. "On average, 25% of first pregnancies in Australia are affected by one of the four major complications: preeclampsia, preterm birth, intrauterine growth restriction and gestational diabetes," Professor Roberts says.
Pediatric Estimation of Glomerular Filtration Rate
As in adults, measured glomerular filtration rate (mGFR) is considered the best overall index of kidney function in pediatric health and disease. GFR is measured by determining the clearance of an ideal filtration marker (e.g., inulin, iohexol, and iothalamate). These procedures may be complex and time consuming, which limits their availability and use in routine clinical practice. As a result, estimated GFR (eGFR) is commonly used. Importantly, equations used to estimate GFR differ between adults and children. More than 10 equations currently exist for determining pediatric eGFR. Some are based on serum creatinine or cystatin C individually, and others include a combination of biomarkers. Pediatric eGFR equations commonly account for other variables, such as age, sex, and height or weight. Estimating equations that include a combination of biomarkers correlate better with mGFR, when compared to eGFR equations that employ only creatinine or cystatin C.  Currently, the best equations for estimating GFR in children are those developed and validated within the CKiD (Chronic Kidney Disease in Children) study cohorts, published in 2009 and 2012. Commonly referred to as the CKiD Schwartz equations, these incorporate serum creatinine (Scr), cystatin C (Scys) and blood urea nitrogen (BUN) with variables for height and sex. When using eGFR equations, it is imperative to remember that an equation performs best when applied to a similar patient population and using measurement methods that are equivalent to those used in the equation’s development.
Foundation Medicine CSO Calls for Caution on Clinical Use of ctDNA Assays, CTC Test Development
As a number of companies forge ahead with blood-based cell-free tumor DNA [ctDNA] or circulating tumor cell "liquid biopsy" tests for cancer diagnostics, Foundation Medicine is taking a more cautious approach. "We fundamentally believe that cell-free DNA tests, in the vast majority of clinical settings, should only be used when it's absolutely impossible to get hold of an FFPE [Formalin-Fixed, Paraffin-Embedded] biopsy, or that biopsy has been exhausted with the pathology work-up," Foundation Medicine CSO Phil Stephens told GenomeWeb recently. "The biopsy has been the gold standard for diagnosis for decades," he said, and most clinical trials of targeted therapies for FDA approval have involved biopsies. "Until one does a systematic correlation between what's going on in the cell-free DNA and what's going on in the biopsy, we don't believe it's appropriate to make informed treatment decisions" based on cell-free DNA tests, Stephens added.
New Point of Care Test for Anemia that Patients Can Administer Themselves Has Potential to Impact Pathology Groups and Clinical Laboratories
Developed by researchers at Emory University, Children’s Healthcare of Atlanta, and the Georgia Institute of Technology, the anemia test device is awaiting clearance by the FDA.  New diagnostic technology may shift some hemoglobin testing for anemia out of clinical laboratories and into near-patient settings. It may also be possible to use this new diagnostic device for patient self-testing. The developers describe this as a new, easy, inexpensive point-of-care test (POCT) that detects anemia. The device may be available as early as 2016. It is possible for the test to be used in situations where resources are low and illiteracy is high. The new medical laboratory test is called AnemoCheck and was developed by scientists and students at Emory University, Children’s Healthcare of Atlanta and the Georgia Institute of Technology in Atlanta.
Smartphone Microscope Scans Blood for Parasitic Worms in Minutes
For years, a team of researchers at the University of California Berkeley has been refining the CellScope, a mobile phone attachment that repurposes the device as a clinical-grade microscope. The group's latest offering is dubbed CellScope Loa. It comprises a 3D-printed plastic base fitted out with LED lights, microcontrollers, gears and a USB port. Sliding a smartphone into the base and loading it with a single drop of blood, users can conduct an analysis of the sample in around two minutes. Over Bluetooth, the purpose-built app communicates with the base, running the sample in front of the phone's camera and creating a video. An algorithm then processes the footage, searching for the wriggling worms in action and displaying the total count on screen. "We previously showed that mobile phones can be used for microscopy, but this is the first device that combines the imaging technology with hardware and software automation to create a complete diagnostic solution," says Daniel Fletcher, professor of bioengineering at UC Berkeley who pioneered the CellScope. "The video CellScope provides accurate, fast results that enable health workers to make potentially life-saving treatment decisions in the field." The team has carried out a pilot study with CellScope Loa in Cameroon, where workers are trying to tackle river blindness and lymphatic filariasis. It was found that it was able to detect the parasitic worms with accuracy equal to conventional methods. These findings are reported in the journal Science Translational Medicine.
Adaptive Biotechnologies, MD Anderson Create Assay to Detect Hodgkin’s Disease
Adaptive Biotechnologies has said it has developed an assay to help detect Hodgkin’s disease through a blood draw. The Seattle-based Adaptive worked with the University of Texas MD Anderson Cancer Center in Houston to develop the test, which focuses on identifying populations of B cells that can detect tumor-specific DNA sequences. Hodgkin’s disease is characterized by the presence of malignant Hodgkin Reed-Sternberg cells, which are derived from B cells. However, they had usually been in quantities too low to detect in non-molecular blood tests. The findings were recently published in theBritish Journal of Haematology.
Quest Diagnostics Launches LeukoVantage, a Genomic Test Service for Hematologic Malignancies
Quest Diagnostics has announced the launch of LeukoVantage, an evidence-based genomic test service that aids in the diagnosis, prognosis, monitoring, and selection of treatment for myeloid neoplasms, a group of hematologic malignancies that includes acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPNs). A wide range of gene mutations are associated with myeloid neoplasms. Next-generation sequencing (NGS) technologies can simultaneously test for mutations in multiple genes associated with myeloid neoplasms to diagnose, subclassify, monitor, and predict the course of disease. LeukoVantage is a lab-developed test that uses NGS, polymerase chain reaction (PCR), and other techniques to interrogate DNA from leukocytes in blood or bone marrow specimens for the presence of mutations in 30 genes most frequently associated with myeloid neoplasms.
With BRCA Share, Quest Hopes to Provide Field with Variant Database to Support Clinical Decisions
Recently launched BRCA Share is jointly led by Quest, and Inserm, France's national institute of health and medical research. In launching BRCA Share, Quest doesn't want to discourage labs and healthcare providers from submitting data to other public variant databases under development, such as the NIH's ClinGen effort. At the same time, Quest's Charles Strom is quick to point out that most currently available public resources aren't robust enough for labs to use when figuring out whether to report to a patient that a detected variant is benign, deleterious, or of uncertain significance. Quest is hoping BRCA Share will come to fill this need. To participate in BRCA Share, labs must agree to submit all past, present, and future deidentified BRCA test results into Inserm's Universal Mutation Database (UMD), which has been collecting variant data for more than a decade from 16 French academic labs comprising the Unicancer Genetic Group. UMD will experience a deluge of data submissions, forecasted Strom, senior medical director of genetics at Quest Diagnostics Nichols Institute. Inserm currently has three dozen people working on curation and annotation, but Strom expects the institute will have to hire more experts.


Research and Development

New Biomarkers May Shorten Year-Long Diagnosis to Days
Scientists have identified new biomarkers that could distinguish Sjögren’s Syndrome (SS) from other autoimmune diseases in days or weeks, improving on a current time to diagnosis of four-plus years. The research is being presented at the 2015 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) this week in Denver, Colo.  Looking at the tears of patients with SS and other autoimmune diseases, researchers identified four proteins that are found at significantly different levels in SS patients.
Microbiomes Raise Privacy Concerns
DNA from microbes living on the human body can be used to identify individuals.
Call it a ‘gut print’. The collective DNA of the microbes that colonize a human body can uniquely identify someone, researchers have found, raising privacy issues. The finding, published in Proceedings of the National Academy of Sciences on 11 May, suggests that it might be possible to identify a participant in an anonymous study of the body’s microbial denizens — its microbiome — and to reveal details about that person’s health, diet or ethnicity. A publicly available trove of microbiome DNA maintained by the US National Institutes of Health (NIH), meanwhile, already contains potentially identifiable human DNA, according to a study published in Genome Research on 29 April.
Scientists Find New Link between Diabetes and Alzheimer’s
Researchers have uncovered a unique connection between diabetes and Alzheimer’s disease, providing further evidence that a disease that robs people of their memories may be affected by elevated blood sugar, according to scientists at Washington University School of Medicine in St. Louis. While many earlier studies have pointed to diabetes as a possible contributor to Alzheimer’s, the new study – in mice – shows that elevated glucose in the blood can rapidly increase levels of amyloid beta, a key component of brain plaques in Alzheimer’s patients. The buildup of plaques is thought to be an early driver of the complex set of changes that Alzheimer’s causes in the brain. The research is published May 4 in The Journal of Clinical Investigation.
NIH Study Solves Ovarian Cell Mystery, Shedding New Light on Reproductive Disorders
Scientists at the National Institutes of Health have solved a long-standing mystery about the origin of one of the cell types that make up the ovary. The team also discovered how ovarian cells share information during development of an ovarian follicle, which holds the maturing egg. Researchers believe this new information on basic ovarian biology will help them better understand the cause of ovarian disorders, such as premature ovarian failure and polycystic ovarian syndrome, conditions that both result in hormone imbalances and infertility in women. Researchers at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, published the findings online April 28 in the journal Nature Communications. According to NIEHS researcher and corresponding author Humphrey Yao, Ph.D., the ovarian follicle is the basic functional unit of the ovary, which contains the egg surrounded by two distinct cell types, known as granulosa cells and theca cells. Yao said scientists had known the cellular origins of the egg and granulosa cells, but did not know where theca cells came from or what directed their development.
Antibiotic Resistance: 'A Natural Feature of Most Bacteria'
While the proliferation of antibiotic resistance and "superbug" bacteria is credited to the clinical overuse of antibiotics, new research suggests the root of resistance may be of an older and more organic nature than commonly believed. By looking at the microbiomes — the trillions of bacteria that call the human body home — of an isolated tribe of Yanomami Amerindians, a team of scientists have discovered something that could impact how health professionals view the nature of antibiotic resistance. The tribe, who had been living in the mountains of southern Venezuela for over 10,000 years, was only discovered by westerners in 2009. And yet, bacterial specimens taken from their skin, mouth, and intestines, revealed antibiotic resistance genes.
GTEx Findings Reveal New Insights into How DNA Differences Influence Gene Activity, Disease Susceptibility
Researchers funded by the National Institutes of Health Genotype-Tissue Expression (GTEx) project have created a new and much-anticipated data resource to help establish how differences in an individual’s genomic make-up can affect gene activity and contribute to disease. The new resource will enable scientists to examine the underlying genomics of many different human tissues and cells at the same time, and promises to open new avenues to the study and understanding of human biology.
Whole-Genome Data from Multiple Populations Helps Researchers Home in on Causal Variants
Combining whole-genome data from multiple populations can help resolve causal variants from within expression quantitative loci (eQTL), Stanford University's Marianne DeGorter said during a presentation at the Biology of Genomes meeting. "It is difficult to distinguish causal variants from multiple tightly linked variants," she noted. These days, DeGorter added, the wider availability of whole-genome sequences from multiple populations makes it possible to tease out causal variants based on differing linkage disequilibrium patterns among various populations. Further, many of the variants she and her colleagues found often overlapped with transcription factor binding sites. To break down these ties between variants and narrow in on the single best causal variant, DeGorter and her colleagues turned to sequence data from six human populations: Utah residents with European ancestry, Han Chinese, Gujarati Indians in Texas, Japanese, Luhya in Kenya, and Yoruban.
Near-Atomic Resolution of Protein Structure by Electron Microscopy Holds Promise for Drug Discovery
A new study shows that it is possible to use an imaging technique called cryo-electron microscopy (cryo-EM) to view, in near-atomic detail, the architecture of a metabolic enzyme bound to a drug that blocks its activity. This advance provides a new path for solving molecular structures that may revolutionize drug development, noted the researchers. The protein imaged in this study was a small bacterial enzyme called beta-galactosidase; the drug to which it was bound is an inhibitor called phenylethyl-beta-D-thiogalactopyranoside (PETG), which fits into a pocket in the enzyme.


Public Health and Patient Safety

CDC Releases 1st Natl Study on Latino Health Risks, Causes of Death
The Centers for Disease Control and Prevention (CDC) released its first-ever national study of the leading causes of death as well as risk factors, disease prevalence and access to health services among U.S. Hispanics. It found that while the death rate among the nation's fastest-growing ethnic group is 24 percent lower than non-Hispanic whites, the Latino community is hit hard by certain diseases and conditions. "This report is good news and bad news," said CDC Director Dr. Tom Frieden in a conference call with reporters around the release of the "Vital Signs" report, "A La Buena Salud - To Good Health!"  "There are some areas of health that are worse, some that are better, but they can be improved." Frieden said, adding that improvements can be as simple as a brisk, 30-minute walk three times a week, along with changes to diet to improve cardio health and reduce obesity. For Hispanics the top five are cancer, heart disease, unintentional injuries, stroke and diabetes. For non-Latino whites its heart disease, cancer, chronic lower respiratory disease, unintentional injuries and stroke.
After Nearly Claiming His Life, Ebola Lurked in a Doctor’s Eye
When Dr. Ian Crozier was released from Emory University Hospital in October after a long, brutal fight with Ebola that nearly ended his life, his medical team thought he was cured. But less than two months later, he was back at the hospital with fading sight, intense pain and soaring pressure in his left eye. Test results were chilling: The inside of Dr. Crozier’s eye was teeming with Ebola. His doctors were amazed. They had considered the possibility that the virus had invaded his eye, but they had not really expected to find it. Months had passed since Dr. Crozier became ill while working in an Ebola treatment ward in Sierra Leone as a volunteer for the World Health Organization. By the time he left Emory, his blood was Ebola-free. Although the virus may persist in semen for months, other body fluids were thought to be clear of it once a patient recovered. Almost nothing was known about the ability of Ebola to lurk inside the eye. Despite the infection within his eye, Dr. Crozier’s tears and the surface of his eye were virus-free, so he posed no risk to anyone who had casual contact with him. Besides eye trouble, he has had debilitating joint and muscle pain, deep fatigue and hearing loss. Similar problems are being reported in West Africa, but it is not clear how common, severe or persistent they are. There have even been reports of survivors left completely blind or deaf, but these accounts are anecdotal and unconfirmed.
Ebola Virus Lives on Hospital Surfaces for Days
The Ebola virus can live on surfaces in hospitals for nearly two weeks, a new study suggests. Researchers tested how long the Ebola virus could survive on plastic, stainless steel and Tyvek, a material used in Ebola suits. The researchers also simulated different environmental conditions, including a climate-controlled hospital at 70 degrees Fahrenheit (21 degrees Celsius) and 40 percent humidity, and the typical environment of West Africa, at 80 F (27 C) and 80 percent humidity. In general, the virus survived on surfaces for a longer time when in the climate-controlled conditions than in the West African environment, the study found. Under hospital-like conditions, the virus lived for 11 days on Tyvek, eight days on plastic and four days on stainless steel. The longest the virus was able to survive in the tropical conditions of the West African environment was three days, on Tyvek.
Whooping Cough Epidemic Hit Vaccinated Kids Hard
The 2012 pertussis epidemic in Washington State affected a surprising number of adolescents who were vaccinated on schedule, researchers reported. Compared with over 1,200 controls, 450 adolescent cases of pertussis showed similar rates of having received five rounds of their vaccinations on the recommended schedule, but the vaccine's effectiveness rate dropped dramatically over time from 73% within 1 year to as low as 34% after 2 to 4 years from the last dose, Anna M. Acosta, MD, of the CDC, and colleagues, reported in Pediatrics. In 2012, Washington state experienced a pertussis epidemic with 2,520 cases reported by June of that year, a 1,300% increase over the previous year.
Gates Foundation Plans Teams to Determine Causes of Child Mortality
The Bill & Melinda Gates Foundation plans to create a network of disease-surveillance teams in poor countries to do “minimal autopsies” on children to plumb causes of child mortality and also possibly spot emerging epidemics, the foundation announced. Although the effort will be modest at first — a $75 million donation to start small teams in six countries — the foundation hopes to expand to as many as 25 Asian and African countries, with dozens of members on each team. The network will include the United States Centers for Disease Control and Prevention and Emory University’s Global Health Institute.


Health IT

CDC: Electronic Quality Data a Boon to Public Health Reporting
The use of electronic clinical quality measures (eCQM) for reporting data will be “invaluable” for monitoring numerous clinical conditions, according to research published in the Center for Disease Control and Prevention’s Morbidly and Mortality Weekly Report. The report used eCQM data that was submitted by 63,000 health care providers to the Medicare Electronic Health Records (EHR) Incentive Program to be analyzed to assess progress in achieving blood pressure control among their patients with hypertension. It found that 62 percent of patients with hypertension achieved controlled blood pressure throughout three reporting years of 2011-2013. In addition, the use of eCQMs were integrated with clinical performance goals of Million Hearts, a U.S. Department of Health and Human Services initiative that was launched in 2012 to prevent 1 million heart attacks and strokes by 2017. The report found that 36 percent of reporting providers met the Million Hearts’ clinical target of 70 percent or more of their patients with hypertension under control. This is first example of eCQM data being used to evaluate nationwide progress toward a public health improvement goal, the report said.
The Patient Portal and Abnormal Test Results: An Exploratory Study of Patient Experiences
Many health care institutions are implementing patient portals that allow patients to track and maintain their personal health information, mostly in response to the Health Information Technology for Economic and Clinical Health Act requirements. Test results review is an area of high interest to patients and provides an opportunity to foster their involvement in preventing abnormal test results from being overlooked, a common patient safety concern. However, little is known about how patients engage with portals to review abnormal results and which strategies could facilitate that interaction in order to ensure safe follow-up on abnormalities. The objective of this qualitative study was to explore patients’ experiences related to abnormal test result notifications through patient portals. Respondents strongly favored access to all types of abnormal test results, but they raised several concerns including need for more timely notification and not being able to interpret the exact relevance of the result. Respondents’ personal experiences with physicians, test result notification, and the portal heavily influenced respondents’ notification preferences. Patient experiences with portals could be improved by development of strategies to help patients understand and manage the information received. These findings suggest important considerations for health professionals and institutions aiming to better engage patients in follow-up of their test results.
FDA Releases Final, Slimmed-Down GUDID Guidance, Leaving Many Details for Later
The US Food and Drug Administration (FDA) has finalized a guidance document intended to outline the appropriate use of its Global Unique Device Identification Database (GUDID), an integral part of its attempt to overhaul how medical devices are kept track of in the US. But not included in the final guidance is more than half of what the agency originally set out to define. The system has a number of advantages for regulators. "The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA wrote in 2012.
CMS Makes Annual Update to 2016 eCQMs
If you were just getting used to CMS' electronic clinical quality measures, get ready for its annual update after the federal government recently announced measure changes for the 2016 reporting period. Providers will use these revised CQMs to electronically report 2016 quality data for the Physician Quality Reporting System, Inpatient Quality Reporting Program, along with the EHR Incentive Programs. According to an update from the Office of the National Coordinator for Health IT, 29 measures have been updated for eligible hospitals, and 64 measures have been updated for providers.
Epic, IBM Watson, Mayo Clinic to Embed Cognitive Computing in EHRs
A new collaboration between three of healthcare's biggest players seeks to use cognitive computing and EHR data to personalize healthcare and enhance care delivery. Epic plans to embed Waton's cognitive computing capabilities into its EHR using open standards, which will then allow patient data to be pulled from health records and delivered to Watson. The supercomputer will then analyze that data in comparison to its massive volumes of stored clinical data and produce medical literature and case studies most relevant to that patient's care to help inform clinical decisions in real time.
More Security Vulnerabilities Cited Within HHS
Many of the same problems found in a recent audit of the Health Resources and Services Administration (HRSA) also exist at the Information Technology Infrastructure and Operations (ITIO) office, according to a report published by the Office of Inspector General for the Health and Human Services Department. OIG staff interviewed ITIO's security and IT staff, reviewed policies and procedures and tested controls in place at ITIO and selected operating divisions.
It found six categories of vulnerabilities:
  • Ineffectively tracking and managing IT inventory
  • Inadequate patch management that could allow hackers into critical data
  • Ineffective antivirus monitoring
  • Lack of policies and procedures to manage USB port control access
  • Lack of a standard configuration management program that ensures that all the devices it manages are configured properly
  • Insufficient reviews of its logical access control process


Other News

Speakers from UCLA, Alverno Clinical Laboratories, and TriCore Reference Labs Discuss the Creation of Value-Added Lab Services at 20th Annual Executive War College
Two clear themes for clinical labs and pathology groups emerged from opening presentations at the 20th annual gathering of the Executive War College on Laboratory and Pathology Management in New Orleans.
Transitioning from Fee-For-Service to Value-based Reimbursement Programs
Theme one is that the pace of transformation within the U.S. healthcare system is accelerating. In his opening remarks, Executive War College Founder Robert L. Michel warned medical laboratory professionals that they must not allow their lab organizations to be unprepared or unresponsive to the changes now unfolding across the nation’s healthcare system.
Delivering Clinical Intelligence to Physicians
Theme two is that the clinical lab industry’s first-mover and early-adopter labs are devoting substantial resources to developing information technology that gives them the capability to combine lab test data with other types of healthcare “big data.” The goal of these innovative labs is to become consultants with physicians, with payers, and with their parent hospitals and health systems.


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