viernes, 13 de noviembre de 2015

DLS|HEALTHCARE NEWS|November 12, 2015: Centers for Disease Control and Prevention (CDC) Healthcare News Update

DLS|HEALTHCARE NEWS|November 12, 2015

CDC. Centers for Disease Control and Prevention. CDC 24/7: Saving Lives. Protecting People.

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


November 12, 2015


News Highlights

  • Unsettling Finding from CDC Investigation: Tapeworms Can Transmit Cancer Cells to Humans
  • Advanced Notification: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services
  • National Patient Safety Goals Effective January 1, 2016, Laboratory Accreditation Program—The Joint Commission
  • The Laboratory Workforce Shortage Demands New Solutions
  • Rapid Diagnostic Testing for Influenza: Information for Health Care Professionals
  • New Guidelines Aim to Enhance Accuracy of Medical Tests
  • Swedish Diagnostic Method for Alzheimer’s Becomes International Standard
  • New Way to Measure if People are Pre-diabetic Discovered
  • Disparities in Breast Cancer Survival Rates Can Be Explained by Differences in Vitamin D Status
  • CDC Director: Healthcare Must Focus on 'Pyramid' of Population Health
  • Researchers Say Their Path to Better Health Starts with Patients’ Input
  • Gonorrhea Becoming More Resistant to One Antibiotic: CDC
  • 20 Schools Join AMA Effort to Bring Medical Education into the Future
  • AARC Launches Data-Sharing Project for Cancer Genomic Research
  • How to Maintain Privacy during Genomic Data-Sharing
  

View Previous Issues - Healthcare News Archive


Leading News

Unsettling Finding from CDC Investigation: Tapeworms Can Transmit Cancer Cells to Humans
Scientists from the Centers for Disease Control and Prevention have identified a puzzling and unsettling new cancer-like condition in a 41-year-old man, who is believed to have become ill through a common stomach bug.  The case — the first known transmission of cancer cells from a parasite to a human — involves an HIV patient from Colombia who developed multiple, large tumors in various parts of his body. Local doctors biopsied those tumors and found that the cells acted like cancer cells in their destructiveness but were strange in other respects. For one, they were about 10 times smaller than normal human cancer cells. The doctors contacted the CDC for help. Atis Muehlenbachs, an agency pathologist in the special unit that investigates unexplained mystery illnesses and deaths, wasn't sure what to make of the cell samples when he and his team received them in 2013. The cells' growth pattern was cancer-like, they noticed, with overcrowding and a high rate of multiplication. But the cells also fused together, which is rare for human cells. One early theory, Muehlenbachs said in an interview, was that they could be a new type of infectious organism. But after performing dozens of tests, the team discovered the cells contained DNA snippets of a dwarf tapeworm, Hymenolepis nana. That analysis was verified by a researcher and tapeworm expert at the Natural History Museum in London. The CDC researchers, who published their findings in the New England Journal of Medicine, now think the Colombian man may have ingested some microscopic tapeworm eggs, most likely in food contaminated by mouse droppings, insects or human feces.

Advanced Notification: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services
The Clinical Laboratory Improvement Amendments (CLIA) Individualized Quality Control Plan (IQCP) procedure in the revised SOM will supersede the IQCP procedure in S&C 13-54.
  • Revisions to Appendix C of the SOM: Revisions include the removal of Equivalent Quality Control (EQC) in the Interpretive Guidelines for §493.1256(d) and the insertion of IQCP in the Interpretive Guidelines for §493.1256(d)
  • Education & Transition Period: The IQCP Education and Transition Period will conclude on 12/31/2015.
  • Implementation of IQCP: The IQCP effective date will be 01/01/2016.
  • Guidance for surveyors after full implementation of IQCP: Surveyors will continue to follow established survey policies and protocols using the Outcome Oriented Survey Process.
  • Educational resources: Resources available on the CLIA Webpage at http://www.cms.gov/CLIA/
IQCP is voluntary. The laboratory director retains overall responsibility for ensuring that QC programs are established and maintained to assure the quality of laboratory services provided, and to identify failures in quality as they occur.
Beginning 01/01/2016, there will be two acceptable options:
  1. Follow the CLIA regulatory requirements as written for control procedures located in Subpart K.
  2. Implement IQCP as described in the SOM, Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services.

National Patient Safety Goals Effective January 1, 2016, Laboratory Accreditation Program—The Joint Commission
Improve the accuracy of patient identification.
Use at least two patient identifiers when providing laboratory services. Wrong-patient errors occur in virtually all stages of diagnosis and treatment. The intent for this goal is two-fold: first, to reliably identify the individual as the person for whom the service or treatment is intended; second, to match the service or treatment to that individual.
Improve the effectiveness of communication among caregivers.
Critical results of tests and diagnostic procedures fall significantly outside the normal range and may indicate a life- threatening situation. The objective is to provide the responsible licensed caregiver these results within an established time frame so that the patient can be promptly treated.
Reduce the risk of health care–associated infections.
Comply with either the current Centers for Disease Control and Prevention (CDC) hand hygiene guidelines or the current World Health Organization (WHO) hand hygiene guidelines.

Big and Deadly: Major Foodborne Outbreaks Spike Sharply
Major foodborne outbreaks in the United States have more than tripled in the last 20 years, and the germs most frequently implicated are familiar to most Americans: Salmonella, E. coli, and Listeria. A new report by the Centers for Disease Control and Prevention makes clear the danger these pathogens pose. In analyzing the illnesses, hospitalizations and deaths from foodborne outbreaks that took place in two or more states between 2010 and 2014, it found 120 multistate outbreaks. Although just a fraction of the more than 4,000 incidents reported during that period, the outbreaks accounted for 34 percent of hospitalizations and 56 percent of deaths. CDC Director Thomas Frieden said the latest multistate outbreaks are more dangerous because they involve deadlier germs. "On average, there are about two per month, and they can be big and they can be lethal," he said during the briefing. Salmonella accounted for most of the illnesses and hospitalizations. Listeria killed the most people; it was responsible for 57 of the 66 deaths during the five-year period. A single outbreak of contaminated cantaloupe in 2011 killed 33 people.

 

Laboratory Testing / Diagnostics

The Laboratory Workforce Shortage Demands New Solutions
The shortage of qualified laboratory professionals is not a new story; it is also one that won’t go away. As the aging population and expanded health insurance coverage increase the demand for healthcare services, the need for qualified laboratory professionals is expected to grow. But whether the nation’s clinical laboratory educational programs can meet the anticipated need is far from certain. In fact, an improving economy—even at its current sluggish pace—is making the shortage more acute, as the unemployment rate falls and older workers feel confident enough to retire. Data released in October show higher vacancy rates as well as higher anticipated retirement rates compared to just 2 years ago (Am J Clin Pathol 2015;144:432–43). By department, chemistry had the highest percentage of employees anticipated to retire in the next 5 years, 23.6%, followed by hematology at 19.51%, microbiology at 19.48%, and blood banks at 19.19%. While it is clear that the demand for medical laboratory professionals is growing, the number of new students graduating from clinical laboratory programs is still declining, partly as the result of program closures. The nation’s labs need to fill more than 7,000 jobs annually, but U.S. clinical laboratory education programs are producing only about 6,000 qualified laboratory professionals each year, according to the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS).

Rapid Diagnostic Testing for Influenza: Information for Health Care Professionals
Rapid diagnostic tests for influenza can help in the diagnosis and management of patients who present with signs and symptoms compatible with influenza. They also are useful for helping to determine whether outbreaks of respiratory disease, such as in nursing homes and other settings, might be due to influenza. 
Reliability and Interpretation of Rapid Test Results
Proper interpretation of test results is very important for accurate clinical management of patients with suspected influenza. The reliability of rapid diagnostic tests depends largely on the conditions under which they are used. Understanding some basic considerations can minimize being misled by false-positive or false-negative results.
  • Sensitivities of rapid influenza diagnostic tests are approximately 50-70%, and specificities of rapid diagnostic tests for influenza are approximately 90-95%, when compared with viral culture or reverse transcription polymerase chain reaction (RT-PCR)
  • False-positive (and true-negative) results are more likely to occur when disease prevalence in the community is low, which is generally at the beginning and end of the influenza season.
  • False-negative (and true-positive) results are more likely to occur when disease prevalence is high in the community, which is typically at the height of the influenza season.
Minimize False Results
  • Use rapid diagnostic tests with high sensitivity and specificity.
  • Collect respiratory tract specimens as early in the illness as possible, (within 3-4 days of illness onset).
  • Follow manufacturer’s instructions, including handling of respiratory specimens, as described in the device package insert.
  • Consider sending respiratory specimens for RT-PCR to confirm results of rapid tests especially when community influenza activity is low and the rapid diagnostic test result is positive and when the rapid diagnostic test result is negative but influenza activity is high. (Contact your local or state health department for information about influenza activity).

New Guidelines Aim to Enhance Accuracy of Medical Tests
Seeking to improve the reliability of medical testing, an international team of top experts is releasing new guidelines for doctors and scientists on how to best report their assessments of new and existing diagnostic tests. "This is really the question of how do you know the test to diagnose disease really does diagnose disease?" said David E. Bruns, MD, of the University of Virginia School of Medicine's Department of Pathology. "It sounds like such a simple question to ask, but like most simple questions, it turns out it's not so easy."
The new guidelines list 30 items that should be included in every report of an accuracy study of a diagnostic test. The guidelines update and streamline the STARD (STAndards for the Reporting of Diagnostic accuracy) guidelines first issued in 2003. "After about 10 years of experience with this, it's been used thousands of times in the literature - we felt it was time to bring it up to date," said Bruns, founding architect of STARD.
STARD 2015 calls on researchers to provide clear details on important study aspects such as the:
specifics of the study hypothesis;
limitations of the study;
sample size assessed by the study; and
intended use and clinical role of the test.

Case for Testing Cancer in Blood Builds, One Study at a Time
Two new studies published of patients with breast and prostate cancers add to growing evidence that detecting bits of cancer DNA circulating in the blood can guide patient treatment. Enthusiasm is building for "liquid biopsies," which offer a non-invasive alternative to standard tissue biopsies and are expected to be a multibillion-dollar market. But a key question remains: Do they really work? The stakes are high. At least 38 companies are working on liquid biopsies for cancer, according to analysts at investment bank PiperJaffray, who think the U.S. market alone could eventually reach $29 billion a year. "If it works, it is fantastic," said Severin Schwan, chief executive of Roche Holding AG. "The question is, does it really work and does it work for all cancers?" "It's like everybody has accepted this as a fait accompli. Like it's real and it means something. But it hasn't been proven."

Cadaver Biopsy Piques Student Interest in Pathology
Undergraduate medical students who perform cadaver biopsies develop a better understanding of pathology and might be enticed to join the field, according to an analysis of a pathology-based grand rounds program. The program covers the entire pathology process, from "picking out a specimen, deciding to biopsy it, getting the cut, making a slide, and then analyzing it," said Jonathan Lavezo, MD, a first-year pathology resident at Stanford University in California. It teaches you what to do with your pathology report when you get it back for a tumor resection, or something else," he toldMedscape Medical News. The study was presented at the American Society for Clinical Pathology 2015 Annual Meeting in Long Beach, California.

Medivo Forms Agreement with Quest Diagnostics to Analyze Laboratory Data to Help Pharmaceutical Companies Match Caregivers with Therapies
Under the agreement, Quest Diagnostics will provide clinical and bioinformatics expertise as well as analysis of its de-identified laboratory data to Medivo, in order to identify patterns in test ordering and result values in specific clinical disease categories. Medivo uses these results, in conjunction with other datasets, to identify physicians whose patients may benefit from FDA approved drugs. One example is the new class of cholesterol lowering drugs, PCSK9 inhibitors, which may be effective in patients in whom traditional statins are ineffective.

ASI Partners with ScreenCell to Develop a Novel, Non-Invasive Prenatal Diagnosis Based on Circulating Fetal Cells
Applied Spectral Imaging and ScreenCell announced that they have entered into a global partnership to develop a procedure enabling genetic analysis of trophoblastic fetal cells for prenatal diagnoses of genetic diseases. In recent years, non-invasive prenatal testing (NIPT) on circulating cell free fetal DNA (cffDNA) in the maternal blood has been introduced, a method that combines advantages of both lower risk and cell-based specificity, but also has serious limitations. ASI and ScreenCell are partnering to develop a new and highly reliable procedure for NIPT which would resolve these limitations. This will be achieved by successfully isolating and analyzing circulating fetal cells to enable accurate diagnosis for a much wider range of genetic abnormalities than currently available methods allow.

Pediatric Syringes Reduce Blood Loss in the ICU
For patients in critical care units, blood can be drawn with a pediatric syringe instead of a standard 3 mL syringe, new research shows. "When overdone, phlebotomy can lead to transfusion and anemia, and transfusions have a lot of complications associated with them," said Phill Jensen, laboratory manager at University of Utah Health Sciences in Salt Lake City.
"We changed from using a 3cc syringe to a 1cc syringe, and in the last year, we saved patients in our cardiovascular intensive care unit alone about 25,000 mL of blood — which is a lot of blood," he told Medscape Medical News. The study results were presented at the American Society for Clinical Pathology 2015 Annual Meeting in Long Beach, California.

How Labs Are Driving Personalized Medicine
Experts in laboratory testing and diagnostics at an AACC-sponsored congressional briefing on Oct. 14 in Washington discussed the important role of labs in the fine-tuning of individual therapies. These speakers also highlighted what AACC has recommended to help streamline care in wake of the growing trend toward personalized medicine. Treating patients under traditional health care protocols can involve a lot of guesswork, observed the briefing’s moderator, James Nichols , PhD, DABCC, FACB, medical director of clinical chemistry at Vanderbilt University School of Medicine in Nashville, Tennessee. Nichols also chairs AACC’s Government Relations Committee.

CMS Releases PAMA Proposed Rule; AACC Urges Members to Comment
On October 1, 2015, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule in the Federal Register (pages 59385 -59422), which implements the clinical laboratory provisions of the Protecting Access to Medicare Act (PAMA).  These provisions include rebasing payments for laboratory tests to reflect private sector rates, creating a new payment category for innovative tests and establishing an advisory committee to assist CMS in making payment decisions. These changes are the most significant to the clinical laboratory fee schedule (CLFS) since its inception in 1984.  CMS will accept comments on the proposed rule through November 24, 2015.

Molecular Test of Thyroid Nodules with Gene-Expression Classifier Shows Mixed Results
New reports detailing results of "real-world" use of the Afirma gene-expression classifier (GEC; Veracyte) molecular test — which is designed to help better classify indeterminate thyroid nodules and therefore reduce thyroid surgeries — show a mixed bag of results. These include some in conflict with published reports of the test's strong negative predictive value, and one suggesting that the GEC test may in fact be having an opposite effect of increasing surgeries. The Afirma GEC molecular test is one of a number of such products available in the United States. "The presence of molecular testing itself may not substantially reduce the number of unnecessary thyroidectomies but rather escalate the usage and cost," senior author of one paper, Allen Ho, MD, of Cedars-Sinai Medical Center, in Los Angeles, California, told Medscape Medical News following presentation of his results at the recent 2015 International Thyroid Congress and Annual Meeting of the American Thyroid Association (ITC/ATA).

 

Research and Development

Swedish Diagnostic Method for Alzheimer’s Becomes International Standard
Researchers at Gothenburg University have developed a reference method for standardized measurements that diagnose Alzheimer’s disease decades before symptoms appear. The method has now formally been classified as the international reference method, which means that it will be used as the standard in Alzheimer’s diagnostics worldwide. After decades of research, Henrik Zetterberg and Kaj Blennow at Sahlgrenska Academy, Gothenburg University, were able to develop a method that measures the exact amount of beta amyloid in spinal fluid and diagnose Alzheimer’s ten to thirty years before the disease becomes symptomatic. “If the concentration of beta amyloid in the spinal fluid is abnormally low, it indicates that the protein is sticking in the brain, which is the earliest sign of Alzheimer’s disease,” says Henrik Zetterberg.

New Way to Measure if People are Pre-diabetic Discovered
A panel of markers have been discovered that helps identify if people are pre-diabetic by measuring the fatty acids in their blood. This discovery by University of Hawaii Cancer Center researchers may allow physicians to warn patient’s years before the onset of diabetes, therefore allowing them to change their lifestyle patterns and potentially avoiding the diagnosis of a chronic disease. “Currently there are no clinical tests that predict the likelihood of developing diabetes, only exams that can tell, for example, if someone that is pre-diabetic has relatively high blood sugar or insulin levels,” said Wei Jia, the director of the UH Cancer Center’s metabolomics shared resources program. “To know if you are likely to get diabetes in a few years is an important discovery. People can hopefully get tested for the disease during physical exams in the future.” The unsaturated fatty acid markers recently identified in a study published online in the journal EBioMedicine can mark if someone is pre-diabetic long before conventional ways of measuring the disease. The levels of these fatty acids can change up to 10 years before the individuals are diagnosed with diabetes.

Disparities in Breast Cancer Survival Rates Can Be Explained by Differences in Vitamin D Status
The American Cancer Society just published a paper reporting that while breast cancer incidence rates for 2008-2012 were similar for black and white women, death rates were 42% higher for black women [DeSantis, 2015]. The factors suggested to explain the disparity in mortality rates included difference in stage at diagnosis, obesity, comorbidities, tumor characteristics, as well as access, adherence, and response to treatments. A review of differences in cancer survival rates found that after consideration of stage at diagnosis, socioeconomic status, and treatment, black Americans had about 25% increased mortality rates for most types of cancer [Grant, 2012]. The difference was consistent with the fact that black Americans have 25-hydroxyvitamin D concentrations about 40% lower than white Americans since their dark skin reduces the production rate of vitamin D in the sun. Further evidence that vitamin D concentration affects cancer survival rates comes from a nine-year study in Norway. The hazard ratio for the nine-year all-cause survival after diagnosis of breast cancer was much lower (63% lower) for women with higher 25-hydroxyvitamin D concentrations [Tretli, 2012]. Based on results in the peer-reviewed scientific literature [Baggerly, 2015], cancer incidence and mortality rates could be greatly reduced if everyone had 25-hydroxyvitamin D concentrations above 40 ng/mL.

Smell Test Offers Hope of Early Parkinson's Diagnosis
A test based on the smell of someone's skin may allow the early diagnosis of Parkinson's disease, say United Kingdom (UK) researchers who have launched a study to investigate chemicals secreted by patients with the disease. The study was inspired by a "super smeller" who detected a distinct odor on the skin of her husband, who had Parkinson's disease that was strongest both before he was diagnosed and toward the end of his life. The smell was subsequently detected in a small pilot study, and now it is hoped that, if this is replicated in a 200-strong controlled study, it could lead to a test that could offer early diagnosis of Parkinson's disease and monitoring of disease progression.The research is led by Perdita Barran, PhD, professor of mass spectrometry and director of the Michael Barber Centre for Collaborative Mass Spectrometry, University of Manchester, UK, and is funded by the charity Parkinson's UK. The as-yet unpublished findings were released by the university.

Study: Blood Vessels Store, Secrete Key Blood-Clotting Protein
Rice University scientists have solved a long-standing mystery about where the body stores and deploys blood-clotting factor VIII, a protein that about 80 percent of hemophiliacs cannot produce due to genetic defects. For years, conventional medical doctrine was that factor VIII was made in the liver, but studies over the past 10 years showed it was made in endothelial cells — the cells that line the walls of blood vessels — in the liver, heart, intestines and other organs. The new study, which is available online in the journal PLOS ONE, offers the first clear images of where factor VIII is stored within those cells. Researchers found the protein is both stored and secreted from a specialized organelle inside the cells that is also known to store and deploy another important blood-clotting protein called “von Willebrand factor” or VWF.

Bi-monthly Injection Blocks HIV in Study from J&J and GSK
A long-acting two-drug injection given once every eight weeks worked as well as three daily pills in suppressing HIV, the virus that causes AIDS, according to a clinical trial backed by Johnson & Johnson and GlaxoSmithKline. Paul Stoffels, J&J’s head of pharmaceuticals, said the finding offered a potentially "transformational" way to fight HIV, if the result is confirmed in larger final-stage trials. He believes the combination could be on the market by 2020. The mix of J&J's rilpivirine and cabotegravir, from GSK's HIV unit ViiV Healthcare, proved just as good as taking three daily pills at maintaining minimal viral levels in HIV-infected patients when given either monthly or every two months.

UF Health Researchers: Novel Compounds Kill Biofilms, May Eliminate Persistent Bacterial Infections
Researchers at the University of Florida have developed potent new compounds with aquatic origins that may offer relief for the 17 million Americans affected by biofilm-associated bacterial infections annually. The series of compounds known as the halogenated phenazines, or HPs, can kill dangerous bacterial biofilms present in recurring and chronic bacterial infections such as methicillin-resistant Staphylococcus aureus, or MRSA. The discovery may one day offer a cure for persistent bacterial infections that are largely resistant to conventional antibiotic treatments. Source: https://ufhealth.org/

New Anemia Treatments Expected from Major Red Blood Cell Discovery
An unexpected result in a lab experiment could be a big step forward in the battle against anemia. The serendipitous discovery of a new way to trigger red blood cell production also reveals a surprising role for dendritic cells, a type of immune cell that was not thought to be involved in red blood cell production. The team that did the work, led by Thomas J. Braciale, a professor of pathology and microbiology at the University of Virginia School of Medicine in Charlottesville, describes the discovery in The Journal of Clinical Investigation.

 

Public Health and Patient Safety

CDC Director: Healthcare Must Focus on 'Pyramid' of Population Health
Healthcare providers must address several levels within a "pyramid" model to maximize public health, the director of the Centers for Disease Control and Prevention (CDC) writes in a column for the New England Journal of Medicine. Truly effective public health addresses five tiers, according to CDC Director Tom Frieden, M.D.:
  • The base, which consists of socioeconomic determinants, including income, employment status, race and education.
  • Public healthcare interventions such as expanded health coverage or contraception access are the next level.
  • Long-term preventive interventions, such as immunizations, are the middle level.
  • Clinical interventions such as blood pressure management, are next.
  • Education and outreach efforts, such as teaching people the value of healthy eating, are at the top level.

Researchers Say Their Path to Better Health Starts with Patients’ Input
The Patient-Centered Outcomes Research Institute (PCORI) already has funded 468 studies, and last month opened the second phase of a program to create research networks covering specific diseases and involving millions of patients across the country. The institute’s work, known as “comparative effectiveness research,” poses deceptively simple questions to find out vital information about which therapy or medication works best in the real world. Institute research goes beyond clinical trials and so-called “best practices” and extracts evidence from the individual experiences of massive numbers of patients. “We like studies embedded in real world settings, with big samples,” said Joe Selby, the institute’s executive director who is also a family practitioner, “in part because you want to be sure of the answer.”

Gonorrhea Becoming More Resistant to One Antibiotic: CDC
One of several antibiotic treatment options for the sexually transmitted disease gonorrhea seems to be losing its effectiveness, U.S. health officials warn in a new report. The U.S. Centers for Disease Control and Prevention's latest tracking suggests that although resistance to the antibiotic treatment cefixime went down between 2011 and 2013, it started to creep back up in 2014. The good news is that cefixime isn't usually the first drug of choice for treating gonorrhea infections. The CDC's most recent guidelines for gonorrhea treatment (issued in 2012) recommend only using cefixime when the preferred option -- ceftriaxone-based combination therapy -- isn't available.

Vaccine for Deadly Respiratory Virus Shows Promise in Early Trial
Another research team is reporting progress toward developing a vaccine to prevent respiratory syncytial virus (RSV), a common lung infection that can cause deadly complications in infants and the elderly. Scientists think a proven vaccine could still be years away. But the new findings add to a growing list of recent advances toward routine immunizations against the disease. "It's impressive," said vaccine researcher Mark Peeples, a professor of pediatrics at Ohio State University College of Medicine, who was not involved in the study. "I'm not sure it's going to be the best possible vaccine, but it shows a good response."

Regular Exercise May Aid Flu Vaccine in Older Men
Regular exercise over a long term may increase the effectiveness of annual flu vaccinations in older men, suggests a study in the journal Age. Men who were consistently active for up to two decades or longer had significantly greater seroprotection, or antibody levels capable of fighting an influenza infection, to three common influenza strains compared with inactive men. The benefits of activity were similar for moderately active men or more intense exercisers, the study found. Studies have suggested physical activity can enhance the body’s immune response to influenza vaccine, but the exercises varied from aerobic to tai chi, making it difficult to establish their relative advantages, the researchers said. Poor response to vaccines, called immunosenescence, is a common cause of illness and death in older people, they said.

Universal Flu Vaccine Could End Need for Annual Injections
A universal flu vaccine which could end the need for annual injections could be available within three years. Scientists from London-based biotech firm Seek have developed a vaccine known as FLU-v which works by protecting against non-mutating proteins which are common to all types of flu. The current system involves people being vaccinated, either by injection or nasal spray, with three or four deactivated strains of flu virus identified each year as posing the highest risk by the World Health Organisation (WHO). But it is often not possible to predict which strains will become dominant and in September the Department of Health was forced to admit that last year’s vaccine was effective for just one in three adults because of a mismatch in the formulation. However FLU-v works by boosting the creation of a certain type of immune cell (T-cells) which kills the part of the virus which does not change. The National Institute of Allergy and Infectious Diseases in Washington (NIAID) has pledged £1 million to launch larger scale trials of the vaccine.

Study: H1N1 Vaccine Only Effective for 2 Years
According to a recent study, those who are administered the H1N1 flu vaccine lose their immunity to the virus within 2 years, not 10 years, as previous research suggested. Using data from 138 countries compiled in FluNet, a database created by the World Health Organization, researchers mapped the spread of various flu strains between 2006 and 2015. They found that H1N1 spread throughout Europe and Eastern Asia in a “skip and resurgence,” meaning that the virus, although expected to reappear in 2011-2012, never materialized. While researchers noticed the “skip and resurgence pattern” throughout Europe and Eastern Asia, North America did not have a skip year.


Health IT

20 Schools Join AMA Effort to Bring Medical Education into the Future
Harvard Medical School, Emory University School of Medicine and Rutgers Robert Wood Johnson Medical School are among 20 new institutionsjoining the American Medical Association's effort to create innovative ways to improve medical education. The initiative originally included 11 medical schools charged with the task of evolving curriculum to better prepare physicians for changes in the healthcare landscape. Projects that came out of those first 11 schools included one at Indiana University School of Medicine, which created a teaching electronic health record using de-identified data, AMA CEO James Madara, M.D., said on the call. The new schools will build up the programs created by the initial 11, as well as working on their own project ideas, which include developing advanced simulation and telemedicine technologies and addressing unique healthcare needs of underserved and diverse communities, Skochelak said. One of the consortium's founding members, New York University School of Medicine, is helping its students gain a better understanding of the use and interpretation of large data sets in healthcare.

AARC Launches Data-Sharing Project for Cancer Genomic Research
The American Association for Cancer Research (AACR) has launched an international genomic and clinical data-sharing project called GENIE (Genomics, Evidence, Neoplasia, Information, Exchange). It will be multiphase, multiyear project that will provide the "critical mass" of genomic and clinical data required to improve clinical decision-making and spur new research, according to an infographic. AARC's U.S. partners include cancer centers at Johns Hopkins and Vanderbilt universities, as well as the Dana-Farber Cancer Institute in Boston and Memorial Sloan Kettering Cancer Center in New York.

How to Maintain Privacy during Genomic Data-Sharing
Two Stanford University researchers have demonstrated a technique to better maintain privacy during genomic research data-sharing. The work, published in The American Journal of Human Genetics, seeks to balance the quest to make genomic data-sharing easier for researchers, but harder for patient data to be re-identified. The research focuses on a network of genomic data sets on servers, or beacons, organized by the Global Alliance for Genomics and Health that allows researchers looking for a particular genetic variant in a multitude of genomic databases to determine whether there's relevant data in a particular database there before applying for access. It also allows researchers investigating the same topic to find each other and collaborate, according to an announcement.

Lessons Learned From a Cyber Attack
It's every security officer's worst nightmare: a cyber attack. IT departments spend years of planning to guard against an attack. But what is the reality? Hackers don't follow a rule book. Daniel Nigrin, MD, chief information officer at Boston Children's Hospital, learned about cyber attacks firsthand. The response needed to operate on multiple levels. A crisis team was formed to monitor developments and make critical decisions, some of which involved the need to turn off non-essential services. With the attack safely behind Boston Children's, Nigrin has been generous in sharing his experience so that other healthcare providers can become better prepared. He has distilled his advice into a presentation, "Lessons Learned from Boston Children's: When Hacktivists Attack Your Hospital," which he shared with the audience at the Healthcare IT News Privacy & Security Forum this past March.

AHA: 2016 Interoperability Standards Advisory Needs More Detail
The 2016 draft Interoperability Standards Advisory, which identifies and assesses the best standards and implementation specifications for supporting interoperability, doesn't provide sufficient information and needs to be fleshed out more, according to the American Hospital Association (AHA). In a comment letter Nov. 6, to National Coordinator for Health IT Karen DeSalvo, AHA Vice President and Acting Senior Executive of Policy Ashley Thompson, asks the agency to provide greater detail about the characteristics and metrics used to assess the standards identified as the "best available."
The 2016 draft Advisory lists six characteristics to determine whether a standard is "best available:"
  • Standards process maturity
  • Implementation maturity
  • Adoption level
  • Regulated
  • Cost
  • Test tool availability

HHS' OIG Steps Up Scrutiny of Health IT in Latest Work Plan
HHS' Office of Inspector General has added two electronic health record-related items to its new 2016 work plan, FierceHealthIT reports. The new plan, indicates that OIG for the first time plans to examine whether FDA's oversight of hospitals' networked medical devices adequately protects electronic protected health information and ensures patient safety. The work plan states, "Computerized medical devices, such as dialysis machines, radiology systems and medication dispensing systems that are integrated with electronic [health] records and the larger health network, pose a growing threat to the security and privacy of personal health information." OIG in its work plan also notes its intent to look at the adequacy of the Office for Civil Rights' oversight of the security of electronic protected health information.

 
Other News
A Cell Therapy Untested in Humans Saves a Baby with Cancer
A baby girl who was close to dying from cancer has been rescued by a cell therapy envisioned as a “one size fits all” treatment that had never been tested in people, doctors reported. The development is significant because it indicates that cell therapies, which represent an exciting new front in the battle against cancer, might not have to be customized for each patient, saving time and money. It also represents one of the first times that a novel “genome editing” technique has been used to treat someone. The therapy was developed by Cellectis, a French biotechnology company.

CMS Finalizes Significant Stark Law Rulemaking
In July of this year, the US Department of Health & Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) proposed significant changes to the regulations implementing the federal physician self-referral law (Stark Law).  On October 30, 2015, CMS issued a final rule adopting the vast majority of these proposed changes. The most prominent of these new rules are summarized below. This Final Rule with comment period is expected to be published in the Federal Register on November 16, 2015. Stakeholders have until December 29, 2015 to submit comments.


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