A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
April 23, 2015
- WHO Issues First Hepatitis B Guidelines
- FDA and CMS Form Task Force on LDT Quality Requirements
- The Doctor Is Out: LabCorp to Let Consumers Order Own Tests
- Study Backs Co-Testing for Cervical Cancer
- New Blood Test Shows Promise in Cancer Fight
- New Guidance on High Sensitivity Cardiac Troponin Testing
- Dementia 'Halted in Mice Brains'
- Study Shows Blood Cells Need Nitric Oxide to Deliver Oxygen
- Father's Sperm May Hold Clues to Autism Risk
- Ebola Survivors 'Safe Sex Warning' Issued by WHO
- E-cigarette Use Triples among Middle and High School Students in Just One Year
- Global Pandemic of Fake Medicines Poses Urgent risk, Scientists Say
- IBM Creates Watson Health to Analyze Medical Data
- AMA Outlines Plan to Engage Physicians in Health Innovation
- ONC Releases Updated Health IT Privacy and Security Guide
View Previous Issues - Healthcare News Archive
WHO Issues First Hepatitis B Guidelines
The World Health Organization (WHO) recently released its first-ever guidelines for treatment of hepatitis B virus (HBV), which affects 240 million people worldwide and results in approximately 650,000 deaths per year, predominantly in low- and middle-income countries. The document, "WHO guidelines for the prevention, care and treatment of persons living with chronic hepatitis B infection," was published in March. Of note to laboratorians, for people who have cirrhosis at baseline, the guidelines recommend the use of simple, non-invasive tests to determine the stage of liver disease in order to decide who needs treatment, as well as routine monitoring that can provide early detection of liver cancer and determine whether treatment is working or if patients can stop treatment. The aspartate aminotransferase (AST)-to-platelet ratio index (APRI) should be used to look for cirrhosis (which has an APRI score >2 in adults) in countries with limited resources. Also, transient elastography, also known as FibroScan, is another non-invasive test that can be used to detect cirrhosis in locations where the test is available and in which cost does not bar it as an option. Also, the following tests should be used to monitor people with HBV at least annually, according to WHO: alanine aminotransferase (ALT) level, AST (for APRI), hepatitis B surface antigen (HBsAg), Hepatitis B e antigen (HBeAg), and HBV DNA levels, where HBV DNA testing is available.
FDA and CMS Form Task Force on LDT Quality Requirements
Under FDA’s proposed framework for the oversight of laboratory developed tests (LDTs), outlined in draft guidance documents issued in October 2014, FDA would oversee the quality of these laboratory tests, alongside the Centers for Medicare and Medicaid Services (CMS), which regulate the laboratories themselves through the Clinical Laboratory Improvement Amendments (CLIA). We have heard stakeholder confusion about the roles of the two agencies in ensuring quality and concerns about potentially duplicative efforts. To coordinate efforts across the Department, FDA and CMS are establishing an interagency task force that will continue and expand on our collaboration related to the oversight of LDTs, which are tests intended for clinical use and designed, manufactured, and used within a single lab.
Although the roles of the agencies are different, FDA and CMS share an interest in ensuring effective and efficient oversight of LDTs so laboratories can offer tests to the American public with confidence that they are accurate and provide clinically meaningful information without unnecessary or duplicative agency oversight.
The goals of the FDA/CMS Task Force on LDT Quality Requirements include:
- identifying areas of similarity between the FDA quality system regulation and requirements under CLIA;
- working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and
- leveraging joint resources to avoid duplication and maximize efficiency.
We welcome any feedback and encourage you to contact us at LDTFramework@fda.hhs.gov.
The Doctor Is Out: LabCorp to Let Consumers Order Own Tests
Consumers will soon be able to bypass their doctors by going online to order cholesterol readings, thyroid tests and other bloodwork from the biggest diagnostics company in the U.S. Laboratory Corp. of America Holdings will let customers go online to pay for tests, visit a service center to get blood drawn, then view the results on the Web. The company has already been doing back-office lab work for a number of Internet firms that let people order up tests without a doctor. Rapid and at-home diagnostics are a growing corner of the health-care market, with businesses like WellnessFX Inc. and Direct Laboratory Services LLC tapping into demand from patients who want to get sensitive results in private or seek to monitor their health outside of the traditional doctor’s office.
New Genetic Tests for Breast Cancer Hold Promise
A Silicon Valley start-up with some big-name backers is threatening to upend genetic screening for breast and ovarian cancer by offering a test on a sample of saliva that is so inexpensive that most women could get it. At the same time, the nation’s two largest clinical laboratories, Quest Diagnostics and LabCorp, are joining with French researchers to pool their data to better interpret mutations in the two main breast cancer risk genes, known as BRCA1 and BRCA2. Other companies and laboratories are being invited to join the effort, called BRCA Share.
Are CLIA Inspections of Clinical Pathology Laboratories Getting Tougher? Why It Pays to Achieve “Inspection Readiness”
Recent reports indicate that regulatory inspections of clinical laboratories are getting tougher. Some pathologists and medical lab managers acknowledge that they’ve had to scramble in response to the unexpected deficiencies identified by Clinical Laboratory Improvement Amendments (CLIA) inspectors following inspections of their labs. These developments make it more important than ever that clinical laboratories work to become “inspection ready.” At the same time, it is essential that every laboratory compliance officer stay up to date with changes in how CLIA and other regulatory inspections are conducted.
Study Backs Co-Testing for Cervical Cancer
Cervical cancer screening with a test for human papillomavirus (HPV) resulted in a 50% higher rate of false-negative results versus Pap testing and three times greater versus co-testing, a large retrospective study showed. Data encompassing more than 250,000 women showed a false-negative rate of 18.6% compared with 12.2% for Pap testing. With a false-negative rate of 5.5%, screening women with the HPV test and Pap test missed the fewest cancers. The results support clinical guidelines that recommend co-testing, according to authors of a report in Cancer Cytopathology. The results differ dramatically, however, from those of previous studies that have consistently shown greater diagnostic accuracy for the HPV test compared with the Pap test.
CMS Proposes Coverage for Joint Pap Smear and HPV Screenings
Under a proposed national coverage decision, Medicare would pay for women to get a joint Pap smear and human papillomavirus test every five years in an effort to screen for cervical cancer. “Based on a systematic review of the evidence, we propose that HPV and Pap smear co-testing in Medicare beneficiaries using an FDA approved test is reasonable and necessary for the prevention or early detection of illness or disability and appropriate for Medicare beneficiaries,” the agency says in its proposed coverage notice. Medicare now covers a screening pelvic examination and Pap test for all female beneficiaries at 12 or 24 month intervals but does not cover HPV testing. The scope of the current review is limited to screening for cervical cancer along with HPV testing. The CMS is taking comments on its proposed decision through May 16, and then plans to issue a proposed decision by August 2015.
Personalizing Cancer Treatment with Genetic Tests Can Be Tricky
It's becoming routine for cancer doctors to order a detailed genetic test of a patient's tumor to help guide treatment, but often those results are ambiguous. Researchers writing in Science Translational Medicine say there's a way to make these expensive tests more useful. Here's the issue: These genomic tests scan hundreds or even thousands of genes looking for mutations that cause or promote cancer growth. In the process, they uncover many mutations that scientists simply don't know how to interpret — some may be harmless. "What we found is, you essentially get a lot of inaccurate information," says Dr. Victor Velculescu, a professor of oncology and pathology and co-director of cancer biology at the Johns Hopkins Kimmel Cancer Center. The consequences of misinterpreting these results could be significant.
New Blood Test Shows Promise in Cancer Fight
In the usual cancer biopsy, a surgeon cuts out a piece of the patient’s tumor, but researchers in labs across the country are now testing a potentially transformative innovation. They call it the liquid biopsy, and it is a blood test that has only recently become feasible with the latest exquisitely sensitive techniques. It is showing promise in finding tiny snippets of cancer DNA in a patient’s blood. The hope is that a simple blood draw — far less onerous for patients than a traditional biopsy or a CT scan — will enable oncologists to quickly figure out whether a treatment is working and, if it is, to continue monitoring the treatment in case the cancer develops resistance. Failing treatments could be abandoned quickly, sparing patients grueling side effects and allowing doctors to try alternatives. “This could change forever the way we follow up not only response to treatments but also the emergence of resistance, and down the line could even be used for really early diagnosis,” said Dr. José Baselga, physician in chief and chief medical officer at Memorial Sloan Kettering Cancer Center.
New Guidance on High Sensitivity Cardiac Troponin Testing
The International Federation of Clinical Chemistry (IFCC) Task Force on Clinical Applications of Cardiac Bio-Markers (TF-CB) recently issued a position statement, “IFCC educational materials on selected analytical and clinical applications of high sensitivity cardiac troponin assays.” The task force was formed in 2011, charged with providing evidence-based educational materials to assist users of biomarkers, including laboratorians, clinicians, researchers, and those working in in-vitro diagnostics and regulatory agencies. The goal was to help these professionals understand key analytical and clinical aspects of established and novel cardiac biomarkers for use in research and clinical practice. In addition to the position statement, IFCC preparedtwo reference guides in extended and pocket form to assist laboratories in implementing high-sensitivity cardiac troponin (hs-cTn) assays in clinical practice. The task force is composed of laboratory medicine scientists, emergency medicine physicians and cardiologists, and its goal was to address two key issues related to implementing hs-cTn assays in clinical practice: the 99th percentile upper reference limit (URL) and calculating serial change values in accordance with the universal definition of acute myocardial infarction (AMI), according to the position statement.
High-Sensitivity Cardiac Troponin T Effectively Rules Out, Rules In MI in 1 Hour, in Study
A novel algorithm that includes measuring high-sensitivity cardiac troponin T (hs-cTnT) levels can safely and effectively rule out acute MI within 1 hour in patients presenting to the emergency department with chest pain, according to a new study. In 1320 patients, a baseline assessment of hs-cTnT coupled with changes in these levels within 60 minutes ruled out acute MI in 59.5% of patients and had a negative predictive value of 99.9%. The use of hs-cTnT "ruled in" an acute MI in 16.4% of the patients with chest pain and had a positive predictive value of 78.2%. "Taken together, the algorithm allowed for a definite diagnosis after 1 hour in 75.9% of patients (either rule-in or rule-out)," report Dr Tobias Reichlin (Cardiovascular Research Institute, Basel) and colleagues April 13, 2015 in CMAJ. In addition, the 1-hour algorithm had higher negative and positive predictive values than the standard interpretation of hs-cTnT using a single value, say researchers.
Prostate Cancer Blood Test May Avert Biopsies
The Prostate Health Index (phi), a blood test that combines 3 PSA measurements into a single score, improves detection of clinically significant prostate cancer (PCa) and could help decrease the number of unnecessary prostate biopsies, researchers reported. In a study of 658 men aged 50 years and older with PSA levels of 4–10 ng/mL, Stacy Loeb, MD, of New York University, and colleagues investigated whether phi can improve specificity for detecting clinical significant PCa and reduce PCa over diagnosis. The researchers used the Epstein definition of clinically significant PCa (Gleason score 7 or higher, 3 or more positive cores, and more than 50% involvement of any core). The test measures total, free, and [-2]proPSA (p2PSA), the latter being an isoform of free PSA identified as the most PCa-specific form found in tumor extracts. Phi outperformed its individual components in detecting clinically significant PCa, the researchers reported in The Journal of Urology (2015;193:1163-1169). Using a 90% sensitivity cutoff for significant versus insignificant PCa (a phi threshold of 28.6) could potentially avoid 30% of biopsies with indolent or no PCa compared with 21.7% using free PSA alone, the investigators reported.
Breath Test Might Spot Stomach Cancer Risk
A new breath test may one day help spot the earliest signs of stomach cancer, a small trial from Israel suggests. This novel technology senses small changes in the levels of particular compounds in exhaled breath, and accurately identifies changes that signal the development of disease, the researchers said. If the findings are confirmed in larger trials, the test might be a noninvasive way to screen those who are at high risk for stomach cancer, they added. "Our study is based on the hypothesis that detection of precancerous lesions may provide a tool to decrease either cancer deaths or incidence [of stomach cancer]," said lead researcher Hossam Haick, head of the laboratory for nanomaterial-based devices and volatile biomarkers at the Technion -- Israel Institute of Technology in Haifa. The new test uses nanotechnology that analyzes a set of atoms called nanoarrays. In this case, the array includes atoms from breath samples and the computer looks for the amount of specific compounds that are linked to stomach cancer. Nanoarray analysis is accurate, simple and inexpensive, the researchers said.
Get Tested Campaign Encourages Biomarker Testing in Metastatic Colorectal Cancer
A new campaign aims to bring awareness to the importance of biomarker testing in people newly diagnosed with metastatic colorectal cancer (mCRC). Called “Get Tested: Unlock your treatment options,” the campaign was launched in March by the International Colorectal Cancer Association (ICCA). The campaign’s primary goal is to “improve outcomes for mCRC patients through the use of biomarker testing as part of a personalised cancer care plan,” according to the Get Tested website. Organizers hope to raise awareness and understanding of the importance of biomarker testing among people newly diagnosed with mCRC, as well as their families. They also plan to establish a call to action that encourages newly diagnosed patients to discuss biomarker testing with their healthcare providers prior to selecting a first-line treatment for their cancer.
Cepheid Gets CE Mark for Hepatitis C Viral Load Test
Cepheid said that it has received a CE IVD mark for Xpert HCV Viral Load, a test that provides quantitative, on-demand confirmation of infection and monitoring of hepatitis C virus. The test is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. It can be used to measure HCV RNA levels at baseline and during treatment, and to help predict sustained and nonsustained virological responses to HCV therapy. In addition, it can be used to confirm HCV serologic test results.
Genetic Testing's Beginnings
Tay-Sachs disease jump-started the genetic disease testing field, but testing for that disease brought up fewer ethical questions than newer tests now are, writes Alexandra Ossola at Nautilus. Tay-Sachs is a rare, recessive disease that's more common among people of Ashkenazi Jewish descent. It, Ossola writes, leads to seizures, developmental delay, weakened muscles, and early death, and there is no cure. "Because Tay-Sachs was more frequent in a specific population and was so objectively severe, it was a good first candidate to be addressed through widespread genetic testing," she says.
2015 Lab of the Year: Children's Hospital of Wisconsin
Milwaukee also has something else going for it: the Children’s Hospital of Wisconsin (CHW). The editors of Medical Laboratory Observer have chosen the CHW Laboratory as the 2015 Lab of the Year. We salute the CHW Lab and the two runners-up, University Medical Center of Southern Nevada Department of Laboratory Services in Las Vegas, Nevada; and The Permanente Medical Group (TMPG) Regional Reference Laboratory in Berkeley, California. The choice was not an easy one. Many excellent labs submitted nomination forms, and all are to be congratulated on their commitment to laboratory medicine and to the patients they serve.
All labs should give themselves a pat on the back, this month, as we celebrate Medical Laboratory Professionals Week, April 19-April 25, 2015.
Dementia 'Halted in Mice Brains'
Tweaking the brain's immune system with a drug has prevented mice developing dementia, a study shows. The team at Duke University, in the US, showed immune cells which start attacking nutrients in the brain may be a trigger for the disease. They say their findings could open up new avenues of research for a field that has not developed a single drug to slow the progression of the disease. Experts said the findings offered new hope of a treatment. The researchers indentified microglia - normally the first line of defence against infection in the brain - as major players in the development of dementia. They found some microglia changed to become exceptionally adept at breaking down a component of protein, an amino acid called arginine, in the early stages of the disease. As arginine levels plummeted, the immune cells appeared to dampened the immune system in the brain. In mouse experiments, a chemical was used to block the enzymes that break down arginine.
Study Shows Blood Cells Need Nitric Oxide to Deliver Oxygen
In the Proceedings of the National Academy of Sciences, cardiologist Jonathan Stamler, a professor of medicine at Case Western Reserve University School of Medicine in Cleveland, OH, and colleagues describe how they conducted a study that shows the respiratory cycle involves three gases and not just two. The current convention describes the respiratory cycle as using blood to transport two gases - oxygen and carbon dioxide. Red blood cells pick up freshly inhaled oxygen from the lungs and carry it to cells in the tissues of the body, and bring back carbon dioxide - a waste product of metabolism - to be exhaled from the lungs. But because of what they have found, Prof. Stamler and colleagues argue that the respiratory cycle also involves a third gas - nitric oxide - that controls the release of oxygen from red blood cells into the tissues that need it. In their study they show that hemoglobin - the protein in red blood cells that picks up oxygen from the lungs - also needs to carry nitric oxide to enable blood vessels to open and supply the oxygen to tissues.
Father's Sperm May Hold Clues to Autism Risk
Sperm may hold clues about whether a man's children will be at increased risk for autism, a small study suggests. The CDC estimates that one in 68 U.S. children has an autism spectrum disorder. Many experts believe that autism is usually inherited, but there is no genetic test to assess autism risk, the Johns Hopkins University researchers said in a Hopkins news release. The researchers analyzed DNA in the sperm of 44 fathers of children with early signs of an autism spectrum disorder. The focus was not on genes themselves, but on "epigenetic tags" that help regulate genes' activity. The team identified 193 sites where the presence or absence of an epigenetic tag was related to autism. Many of the genes near these sites were involved in brain development. Four of the 10 sites most strongly linked to autism were located near genes associated with Prader-Willi syndrome, a genetic disorder that causes some of the same behavioral symptoms as autism, the study authors said.
Polygene Test Can Predict Risk for Breast Cancer
A new polygenic risk score (PRS) can be used to predict a woman's risk of developing breast cancer, especially when it is used in conjunction with information about breast tissue density and family history. The PRS is described in the May issue of the Journal of the National Cancer Institute. "This genetic risk factor adds valuable information to what we already know can affect a woman's chances of developing breast cancer," said study coauthor Celine Vachon, PhD, an epidemiologist at Mayo Clinic in Rochester, Minnesota. "We are currently developing a test based on these results, and although it isn't ready for clinical use yet, I think that within the next few years we will be using this approach for better personalized screening and prevention strategies for our patients," she said in a statement. The PRS, developed by Dr Vachon and an international team of researchers, is based on 76 single-nucleotide polymorphisms (SNPs). Individual SNPs confer small but not necessarily equal components of overall risk for a condition or trait. The SNPs used in the PRS were identified in studies for a variety of cancers and other disease phenotypes, and because they are associated with breast cancer, were made available on a customized microarray device.
Ebola Survivors 'Safe Sex Warning' Issued by WHO
The WHO has urged Ebola survivors to be even more cautious during sexual contact to ensure the virus is not passed on to their partners. The warning comes after a survivor was found to have traces of Ebola in his semen almost six months after recovery. This is some 90 days later than previously documented. It is unclear whether Ebola can still be spread at this point. But officials have launched further investigations to evaluate the risks. Dr Broutet told the BBC: "The patient is the first we have seen where there is a trace of virus present in semen beyond three months. "This made us change our recommendations to go beyond three months." The new advice says: "For greater security and prevention of other sexually transmitted infections, Ebola survivors should consider correct and consistent use of condoms for all sexual acts beyond three months until more information is available." "Even though the sample was positive for fragments of the virus this does not prove it was passed on sexually. "We need to be very careful and need more clarity about this," she said. Scientists are planning to send the sample to the Centres for Disease Control in the United States to see if the traces of Ebola they found are active and capable of being spread. And Dr Broutet is helping to set up studies in Sierra Leone and Guinea to offer male survivors further checks.
Ebola Lying in Wait
A growing body of scientific clues — some ambiguous, others substantive — suggests that the Ebola virus may have lurked in the West African rain forest for years, perhaps decades, before igniting the deadly epidemic that swept the region in the past year, taking more than 10,000 lives. Until recently, Ebola had been considered a threat mostly to Central African nations. Yet studies tell of possible Ebola antibodies in human blood samples drawn in West Africa long before the current outbreak. And genetic analysis suggests the West African virus broke off from a parent strain in Central Africa at least 10 years ago, possibly as long as 150 years ago. “My gut feeling,” said Dr. Peter Piot, the director of the London School of Hygiene and Tropical Medicine, who helped discover the Ebola virus in 1976, is that the evidence points to “infection before the current epidemic.”
E-cigarette Use Triples among Middle and High School Students in Just One Year
Current e-cigarette use among middle and high school students tripled from 2013 to 2014, according to data published by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) in the Morbidity and Mortality Weekly Report (MMWR). Findings from the 2014 National Youth Tobacco Survey show that current e-cigarette use (use on at least 1 day in the past 30 days) among high school students increased from 4.5 percent in 2013 to 13.4 percent in 2014, rising from approximately 660,000 to 2 million students. Among middle school students, current e-cigarette use more than tripled from 1.1 percent in 2013 to 3.9 percent in 2014—an increase from approximately 120,000 to 450,000 students.
Global Pandemic of Fake Medicines Poses Urgent risk, Scientists Say
Poor quality medicines are a real and urgent threat that could undermine decades of successful efforts to combat HIV/AIDS, malaria and tuberculosis, according to the editors of a collection of journal articles. Scientists report up to 41 percent of specimens failed to meet quality standards in global studies of about 17,000 drug samples. Among the collection is an article describing the discovery of falsified and substandard malaria drugs that caused an estimated 122,350 deaths in African children in 2013. Other studies identified poor quality antibiotics, which may harm health and increase antimicrobial resistance. However, new methodologies are being developed to detect problem drugs at the point of purchase and show some promise, scientists say.
Fasting at Night Lowers Risk of Breast Cancer and Diabetes
A night time snack might seem like a harmless treat, but a new study suggests it could raise the risk of breast cancer and diabetes. Researchers have discovered that fasting at night is crucial for good health and people who snack in the early hours are putting themselves at risk of disease. It is the first study to show that nocturnal eating should be avoided to allow the body’s metabolism to work in alignment with natural sleep-wake cycles. Eating regular meals at set times and then waiting longer between dinner and breakfast appears to regulate blood sugar and lower risk of illness. For every three hours of extra fasting at night women were 20 per cent less likely to have hyperglycemia - or high blood sugar - a known risk factor for breast cancer and diabetes. "Increasing the duration of overnight fasting could be a novel strategy to reduce the risk of developing breast cancer,” said lead author Catherine Marinac, a doctoral student at University of California, San Diego School of Medicine.
Breast Cancer May Increase 50% by 2030
By 2030, the number of breast cancer cases in the United States will grow by 50% compared their 2011 rates, according to new research from the National Cancer Institute. In the new study, presented at the American Association for Cancer Research’s annual meeting, researchers used cancer surveillance data, census data and mathematical models to arrive at projections. Part of the reason the numbers are so high, they note, is because women are living longer. Another factor is the increase in screening that enables doctors to spot and diagnose more cases of in-situ tumors—very early stage growths that may not require treatment—as well as more invasive tumors.
IBM Creates Watson Health to Analyze Medical Data
IBM is taking its Watson artificial-intelligence technology into health care in a big way with industry partners, a pair of acquisitions and an ambitious agenda. The initial three industry partners are Apple, Johnson & Johnson and Medtronic. IBM also announced it would buy two start-ups: Explorys, a spin-off from the Cleveland Clinic whose data on 50 million patients is used to spot patterns in diseases, treatments and outcomes; and Phytel, a Dallas maker of software to manage patient care and reduce readmission rates to hospitals. The IBM plan, put simply, is that its Watson technology will be a cloud-based service that taps vast stores of health data and delivers tailored insights to hospitals, physicians, insurers, researchers and potentially even individual patients. “We’re going to enable personalized health care on a huge scale,” said John E. Kelly, a senior vice president who oversees IBM’s research labs and new initiatives.
AMA Outlines Plan to Engage Physicians in Health Innovation
Physician engagement is one key to make new healthcare innovations prosper, and the American Medical Association is aiming to take a greater role in that area, according to AMA President Robert M. Wah, M.D. He outlined reforms he says the AMA will promote to help engage physicians in innovation. These include:
- Use lessons gleaned from current regulations to allow of adoption of new tech.
- Make electronic health records patient-focused tools.
- Increase use and reach of telemedicine and remote monitoring.
ONC Releases Updated Health IT Privacy and Security Guide
The Office of the National Coordinator for Health IT issued a new version of its privacy and security guide to help healthcare providers better understand how to integrate the requirements into their practices. The Guide to Privacy and Security of Electronic Health Information has new information on Medicare and Medicaid electronic health record incentive programs and on HIPAA Privacy, Security and Breach Notification Rules. The guide is the first step toward fulfilling the commitment made by the ONC in its Interoperability Roadmap to foster better understanding in the industry of how security regulations in place help support interoperability,
ONC’s Lucia Savage Dissects Health IT Privacy, Security Guide
The Office of the National Coordinator (ONC) released the updated version of its health IT privacy and security guide, as a way to highlight “practical information that accurately reflects the guidance that is in the current regulations,” according to ONC Chief Privacy Officer Lucia Savage. In an interview with HealthITSecurity.com at HIMSS, Savage explained that the immediate feedback has already been very positive on the 60-page health IT privacy and security document. “We’ve shown it to some physicians and they’re like ‘I get this. I get what you’re trying to say, this is helpful information. Can you give me guidance on this too?’ We’re already working on what can go into the next version.” In the future, the ONC will probably work on implementing more information about best practices on cybersecurity in healthcare, Savage said. That is an issue that is definitely on the forefront of people’s minds in the industry, and it’s something that small to medium-sized practices might not have access to the same resources as larger firms.
MU Proposed Rule Provides 'Relief,' but Raises New Concerns, Questions
The Centers for Medicare & Medicaid Services has finally issued its promised reprieve of some of the harsher provisions of the Meaningful Use program, releasing its proposed rule that shortens the attestation period in 2015 from 365 to 90 days and reduces reporting and other burdens. The rule, revealed April 10 and slated to be published in the Federal Register, changes Stages 1 and 2 of the Meaningful Use program for 2015 through 2017 so that they align with CMS' proposed vision of Stage 3 beginning in 2017. It softens some of the measures and objectives currently required, such as reducing the patient access obligation from 5 percent to one patient, and reduces reporting requirements to ease provider burdens, support interoperability and improve outcomes, according to CMS.
Precision Medicine Must Pair Real-time, Searchable Databases with Genomics
Precision medicine will require robust clinical databases of patient medical histories that physicians can use together with genomic data to tailor individual treatments, according to a commentary published in the journal Nature. For President Barack Obama's Precision Medicine Initiative to be successful, genomic data needs to be linked, in real time, to the patient sitting in front of his or her doctor, writes Mark A. Rubin, M.D., director of the Institute for Precision Medicine at Weill Cornell Medical College. Integrated genomic and clinical data will also need to be available in a searchable way to a broad community of practitioners and researchers. Though there are promising prototypes of the necessary centralized data banks, he says, they will have to be scaled up.
Kaiser Permanente to Grow IT Workforce in Georgia by 900
Kaiser Permanente is setting its sights on Georgia for health IT, announcing it will create about 900 tech jobs in Atlanta over the next four years. The addition of those jobs will bring Kaiser's presence in the Peach State to more than 4,000 employees and physicians, the announcement says. There also will be a new Kaiser IT campus in the city, which will span 157,000 square feet. "Our IT organization drives the technology that enables Kaiser Permanente to coordinate patient care and improve health outcomes," Kaiser Permanente Chief Information Officer Dick Daniels says in the announcement.
Telemedicine a High 2015 Priority for Healthcare Execs
Telemedicine is maturing from a specialty service into a mainstream form of healthcare, according to REACH Health's first annual telemedicine survey. Key findings, according to an executive summary, include:
- About 60 percent of respondents listed telemedicine as a high priority in 2015
- Telemedicine programs in "lower acuity settings" are sparse, but there is planning and preparation in place to add the service
- The biggest obstacle to using the tool is reimbursement
- Improved care is the primary reason for using telemedicine, not to save costs
Americans Get Too Many Tests before Cataract Surgery, Study Finds
Older Americans get a lot of unnecessary tests before they undergo cataract surgery, a new study suggests. Experts said the findings highlight an area of wasteful health care spending. Plus, they said, there is a risk for harm if the tests pick up a mild abnormality that prompts further tests, then turns out to be nothing. Because of that simplicity, guidelines from the American Academy of Ophthalmology and other groups say there is no need to routinely do tests ahead of cataract surgery. Yet, Chen's study – reported April 16 in the New England Journal of Medicine – found that more than half of Medicare patients who had cataract surgery in 2011 underwent at least one test beforehand. That included blood work, urine tests to measure kidney function, and tests of heart and lung function – such as exercise stress tests and electrocardiograms.
Reports to Feds on Deadly Bacteria Outbreaks Arrived Late
Reports alerting federal officials that contaminated medical scopes appeared to be spreading deadly superbugs among hospital patients sometimes arrived months late – or not at all, according to federal records and interviews. Medical device makers are required to file reports to the Food and Drug Administration within 30 days of learning that a product may pose safety risks. But as duodenoscopes were tied to the transmission of drug-resistant bacteria among patients in at least eight U.S. hospitals from 2012-2014, the agency wasn't notified of some outbreaks until long after they occurred, an ongoing USA TODAY investigation finds. And in some cases, the disclosures never were filed.
Isolated Hunter-Gatherers Have Most Diverse Microbiome
Investigators report on the first characterization of the microbiome and resistome of uncontacted Amerindians in an article published online April 17 in Science Advances. The data show the population has the highest level of bacterial diversity yet found in a human population and suggest that potentially beneficial microbes may be harbored in the bodies of such populations. In their analysis, Jose C. Clemente, PhD, from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues characterized an isolated group of Yanomami hunter-gatherers that has been minimally exposed to modern practices. The Yanomami have remained relatively isolated in the 11,000 years since their ancestors arrived in the Americas.
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