Laboratory Science, Policy and Practice Program Office
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
June 6, 2013
- FDA Commissioner Hints at New Diagnostic Test Regulations
- Competency Assessment
- The Fourth Annual Laboratory Safety Survey
- New Compounds Found to Curb Staph Infection
- Simple Strategy Works Best to Reduce Infections, Study Finds
- Feds Move Nearer to Patient-Safety Framework for Health IT
- Most Doctors Don’t Meet U.S. Push for Electronic Records
- Public Gains Access to Medicare Physician Data
- For New Doctors, 8 Minutes Per Patient
- Veggies Are Key to Long Life
View Previous Issues - Healthcare News Archive
FDA Commissioner Hints at New Diagnostic Test Regulations
The Food and Drug Administration will take new steps to enforce regulations against certain kinds of diagnostic tests, including some used for personalized medicine, to which it previously took a laissez-faire attitude. The announcement was made in a speech by Margaret Hamburg, the FDA Commissioner, at the annual meeting of the American Society of Clinical Oncology (ASCO). “There is a category of diagnostics called laboratory-developed tests which are produced in and offered by laboratories for use in their own facilities. LDTs are currently marketed without FDA premarket review to determine whether they are safe and effective – whether they are accurate and clinically valid. And that can be a problem.” She gives the example of OvaSure, a test for ovarian cancer that was marketed as an LDT in 2008 but was withdrawn from the market. Hamburg said that the FDA “is working to make sure that the accuracy and clinical validity of high-risks tests are established before they come to market.”
Does the New CLIA Guidance Mean Big Changes?
Under CLIA regulations, all phases of testing should be reflected in a lab’s competency assessment program. A new CMS guidance defines competency as the ability of personnel to apply their skill, knowledge, and experience to perform their duties correctly. Laboratory directors, consultants, supervisors, and managers must be assessed on their administrative duties in addition to performing testing. However, the experience of CMS and accrediting organizations points to the basics of competency assessment as the area where most labs run into trouble. CLIA regulations break down competency assessment for performing testing into six areas, each of which must be completed for each person, each test, each year.
- Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing.
- Monitoring the recording and reporting of test results.
- Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
- Direct observations of performance of instrument maintenance and function checks.
- Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
- Assessment of problem solving skills.
The Fourth Annual Laboratory Safety Survey
Last year we happily reported that “despite continuing economic pressures that might have made lab health and safety a ‘nice to have’ rather than a ‘must have,’” there had been substantial improvements in lab health and safety practices. Unfortunately, we cannot report the same trend this year. In fact, what we learned from this year’s survey is that there has been a significant across-the-board decrease in all aspects of laboratory safety practices, which begs the question “Why?”
This year we found that laboratory safety and hygiene practices from 2012 to 2013 had taken a serious turn in the wrong direction. For example, this year 59 percent of respondents said their labs have designated chemical hygiene officers compared to 75 percent last year. And 4 percent fewer respondents said that their labs had a designated safety officer (77 percent versus 81 percent last year.) But these are just two examples of this downward trend Equally troubling were reported declines in laboratory recordkeeping practices. This year’s survey reports a 15 percent decrease in the number of respondents current in their annual chemical and hygiene planning and training (71 percent versus 86 percent), an 8 percent decrease in those having a complete and current chemical inventory (83 percent versus 91 percent), and a whopping 17 percent fewer labs having a current biological safety manual (56 percent versus 73 percent). As for materials safety data sheets and the UF Laboratory Safety Manual being available to lab personnel, both remained constant year over year.
CDC: Injection Guidelines Target Safety
With the stated goal of increasing injection safety, the CDC unveiled a new set of guidelines powered by a catchy phrase -- "the four Es".
The "Es" in question are:
- Epidemiologic surveillance of unsafe injection
- Enforcement of safe practices
- Engineering devices to reduce risks
"The U.S. experience with outbreaks attributed to unsafe injection practices has grown substantially over recent years," the authors said, noting at least 49 outbreaks since 2001 attributable to "extrinsic contamination of injectable medical products at the point of administration," the majority of which involved hepatitis B or C, but also included bacterial and invasive bloodstream infections.
The guidelines classified unsafe injection practices into two categories: reuse of syringes and mishandling of injectable drugs.
Public Gains Access to Medicare Physician Data
A federal judge's decision to end a 33-year ban on public access to a confidential database of Medicare insurance claims means patients can find out how much Medicare paid their doctors and may open the door to closer scrutiny of how much physicians charge for their services. The injunction was put in place in 1979 after a federal court in Florida ruled in favor of the American Medical Association's argument that physicians' right to privacy outweighed the public's interest in how much tax dollars were spent on the program, The Wall Street Journal reports.
The Obama administration designated a respiratory disease now found in the Middle East a threat to public health and national security. The move gives officials the authority to fast-track the approval of treatments and tests for Middle East respiratory syndrome coronavirus (MERS-CoV), which causes flu-like symptoms and has killed 30 people since April of last year. Department of Health and Human Services Secretary Kathleen Sebelius made the designation, allowing the Food and Drug Administration (FDA) to quickly approve testing devices for U.S. citizens living overseas without going through the normal process.
Overview of MERS
What is CDC doing about MERS?
CDC works 24/7 to protect people’s health. It is the job of CDC to be concerned and move quickly whenever there is a potential public health problem. CDC is closely monitoring the MERS situation and working with WHO and other partners to understand the risks of this virus. CDC is engaged in the following ways:
- CDC developed molecular diagnostics that will allow scientists to accurately identify MERS cases. CDC also developed assays to detect MERS-CoV antibodies. These lab tests will help scientists tell whether a person is, or has been, infected with MERS-CoV. CDC will evaluate genetic sequences as they are available, which will help scientists further describe the characteristics of MERS-CoV.
- As part of routine public health preparedness in the United States, CDC is providing MERS-CoV testing kits to state health departments. CDC is also updating guidance for public health departments, healthcare providers, and laboratories.
- CDC is offering recommendations to travelers when needed. CDC is also helping to assess ill travelers returning from affected areas.
- In addition, CDC participated in international public health investigations of past MERS cases in Saudi Arabia (October 2012) and Jordan (May 2013). CDC continues to provide advice and laboratory diagnostic support to countries in the Arabian Peninsula and surrounding region.
Health Law Is Fostering Competition, U.S. Says
The new health care law is injecting more competition into health insurance markets nationwide, drawing additional insurance companies into states long dominated by a few carriers, Obama administration officials said. Such competition offers the prospect of more choices for millions of consumers who will be shopping for insurance this fall. Companies entering the market could also put downward pressure on prices, partly offsetting factors that tend to increase premiums. The competition could pose new challenges to Blue Cross and Blue Shield plans, which dominate the individual insurance markets in many states.
GOP Stalemate may Give Sebelius Control of IPAB
Congressional Republicans continue to oppose the Medicare Independent Payment Advisory Board (IPAB), but their refusal to submit possible candidates to the new cost-control panel may give the U.S. Department of Health & Human Services secretary the power to determine Medicare cuts. In a May 9th memo, the Congressional Research Services told Sen. Tom Coburn, M.D., (R-Okla.) that if no one is appointed to the IPAB, HHS Secretary Kathleen Sebelius would be responsible for cutting the $586 billion Medicare program when projected per capita spending outpaced growth targets. "In short, should the IPAB fail to submit a package of recommendations in a required submission year, the secretary is obligated by law to do so," the memo said.
Supreme Court Rules DNA Can Be Taken After Arrest
The U.S. Supreme Court ruled that police can routinely take DNA samples from people who are arrested but not yet convicted of a crime, and see if the DNA matches any samples from unsolved crimes in a national database. The 5-to-4 decision split the court's conservative and liberal blocs, with conservative Justice Antonin Scalia authoring a fiery dissent. Twenty-eight states and the federal government have enacted laws that provide for automatic DNA testing of arrestees.
Feds Move Nearer to Patient-Safety Framework for Health IT
Now that a majority of healthcare providers have installed electronic health-record systems, the federal government is inching closer to adopting a regulatory and patient-safety framework for computerized healthcare devices. The latest move comes more than a year and a half after an Institute of Medicine report pointed out “unacceptable risks” posed by health IT systems under the status quo. The Office of the National Coordinator for Health Information Technology at HHS published a request for comments from the public as part of a joint effort it and the Food and Drug Administration and the Federal Communications Commission are undertaking to develop a congressionally mandated report on possible regulations “for health IT, including mobile medical applications.”
ASCP to Congress: Repeal SGR, Fix Stark and Meaningful Use
Earlier this month, ASCP advocated that the powerful U.S. House of Representatives Ways & Means and Energy & Commerce Committees, both of which have oversight over Medicare, repeal the Medicare Physician Fee Schedule’s flawed Sustainable Growth Rate (SGR). This advocacy was in response to a recent joint committee report recommending the repeal and reform of the SGR, the flawed formula used to calculate the annual update in the Medicare Physician Fee Schedule
Miss. to Require Cord Blood Testing on Babies Born to Some Teenage Moms
Mississippi lawmakers have embarked on a novel campaign to discourage older men from having sex with teenagers: Starting July 1 doctors and midwives will be required to take umbilical cord blood samples from babies born to some women under the age of 16 so officials can try to identify the father through a match from the state’s DNA database. "It is our hope that we can deter men over the age of 21 from having sex, particularly with girls 16 years and younger, particularly if they know we are going to pursue them," said Jim Hood, the state’s Democratic attorney general who helped draft the bill. Officials said Mississippi is the first state in the country to implement such a program.
A Call for Better Estradiol Measurement
Research over the decades has demonstrated that the sex steroid hormones, primarily estradiol and testosterone, not only exert control over the development and maintenance of reproductive capacity but also have a guiding hand on a good many other biological processes. The evolving understanding of these latter functions has placed new measurement demands on both estradiol and testosterone, particularly at low levels that reflect non-reproductive physiology. In the case of testosterone, a concerted effort during the past 5 years by a broad public-private consortium has made great strides in achieving more robust and standardized measurements. Now, an Endocrine Society panel has turned its sights on estradiol measurement, calling for a universally recognized traceable standard, age- sex- and biologically-specific reference ranges, and more. “We have the same problem with estradiol as we’ve had with testosterone, which is that the current assays, particularly direct immunoassays, are inadequate for many of the purposes we need estrogen measurements for.
Prostate Cancer: Can New Tests Reduce Unnecessary Treatment?
Two new genetic tests may help better predict which prostate cancers are aggressive and need immediate treatment, and which do not need treatment right away, researchers say. One test, called Prolaris and manufactured by Myriad Genetics, looks for specific genes that control a cancer cell's abilities to divide and multiply. Patients receive a score (between -3 and 3) that indicates how aggressive their cancer is. The other test, called Oncotype DX Prostate Cancer Test and manufactured by Genomic Health, was released earlier this month and is also marketed as a test to predict prostate-cancer aggressiveness. Both tests have the potential to reduce the overtreatment of prostate cancer. Many men with the disease undergo surgery or radiation therapy despite having low-risk cancers that likely would not have been fatal. But experts say that although these tests do seem to help predict cancer outcomes, their usefulness to doctors and patients remains to be seen. Researchers still need to determine "how much added information these tests really provide, and how often it's going to really change how we manage a patient," said Dr. Judd Moul, director of the Duke Prostate Center in Durham, N.C.
A first-trimester blood test may predict gestational diabetes later in the pregnancy, Japanese researchers found. Women in the top quartile for serum soluble (pro)renin receptor before 14-weeks' gestation were nearly three times more likely to develop gestational diabetes than those with the lowest levels in the prospective cohort study. The test plus other clinical risk factors had fairly good predictive accuracy, Atsuhiro Ichihara, MD, PhD, of Tokyo Women's Medical University, and colleagues reported online in the Journal of Clinical Endocrinology & Metabolism. The group previously showed that the biomarker, which reflects activation of the renin-angiotensin system, also predicted development of hypertension in pregnancy.
Blood Test May Identify Fibrosis, Cirrhosis in People With Hep C.
Blood testing can accurately identify clinically significant fibrosis and cirrhosis in people with hepatitis C virus (HCV) infection and may be an alternative to liver biopsy in some patients, a new study found. The analysis of 172 studies comparing various blood tests to biopsy in HCV patients revealed that some of the simplest, cheapest blood tests performed as well as more expensive, complex tests, reported Roger Chou, MD, and Ngoc Wasson, MPH, from the Evidence-Based Practice Center at Oregon Health and Science University in Portland.
Ridge Diagnostics Announces Launch of Proteomic Test for Major Depressive Disorder
Ridge Diagnostics announced the launch of its MDDScore product, a proteomic test for aiding diagnosis of major depressive disorder. The launch follows the presentation by the company at last week's Annual Scientific Convention and Meeting of the Society of Biological Psychiatry of data from a recent clinical study demonstrating that the test when combined with patient gender and body mass index was able to diagnose MDD with 94 percent sensitivity and 92 percent specificity.
Quest Diagnostics to Close Wallingford Lab
Medical testing services provider Quest Diagnostics announced plans to shut its centralized processing laboratory in Wallingford over the next two years as it shifts to a different business model. Wendy Bost, a spokeswoman for the Madison, N.J.-based company, said the closing of the Wallingford laboratory, which is being combined with several other moves, will result "in a small percentage" of Quest's 650 employees losing their jobs. Bost would not say how many jobs would be lost, but sources with knowledge of the plan say about 70 people will be laid off once the laboratory closing is complete.
MedTech Veterans Program Expands, Launches Online Mentoring Program
An initiative to match veterans with career opportunities in the medical device industry, the Medical Technology Veterans Program, expands its footprint online. The Medical Technology Veterans Program, launched in 2012 as a joint effort between Abiomed and medical device lobby AdvaMed, has since enlisted the help of more than 30 other medtech players and raised about $150,000. The program is hoping the new portal will harness the power of social networking to expand its network of veterans and medical device industry insiders.
A radio frequency identification tagging system for blood products, allowing them to be tracked through the supply chain, has won FDA approval, the agency said. Called iTrace for Blood Centers, the system consists of small memory chips placed on blood component bags and readers to download the data stored on the chips -- radio frequency identification (RFID) technology. SysLogic, of Brookfield, Wis., manufactures the system.
FDA Limits Magnesium to Prevent Preterm Labor
The FDA advised clinicians not to give pregnant women magnesium sulfate to prevent preterm labor for more than 5 to 7 days because it may harm developing fetal bones. Longer off-label administration of magnesium for tocolysis, which is approved only for the prevention of seizures in preeclampsia, can lead to low calcium levels and osteopenia or fractures in the baby, the agency explained. A warning to this effect is being added to the drug's labeling, and the teratogenicity category is being changed from Pregnancy category D rather than A.
NIH, ONC, and EPA Award $100,000 to Winner of Health and Technology Challenge
New technology that creates a personal, portable, and wearable air pollution sensor, developed under the My Air, My Health Challenge, was announced at the Health Datapalooza in Washington, D.C. The grand prize of $100,000 was awarded to Conscious Clothing. The challenge was held by the National Institutes of Health, the Office of the National Coordinator for Health Information Technology (ONC) of the U.S. Department of Health and Human Services, and the U.S. Environmental Protection Agency (EPA).
The winning team created the Conscious Clothing system, a wearable breathing analysis tool that calculates the amount of particulate matter that is inhaled. The system uses groove strips, stretchy, conductive strips of knitted silver material wrapped around the ribcage, to measure breath volume, and collects and transmits data in real time, via Bluetooth, to any Bluetooth-capable device. David Kuller of AUX, Gabrielle Savage Dockterman of Angel Devil Productions, and Dot Kelly of Shearwater Design, developed the Conscious Clothing system.
US Researchers Reported That They had Turned Human Skin Cells Into Embryonic Stem Cells Contained Errors
Shoukhrat Mitalipov nevertheless adamantly stood by the conclusions of the study published last week in journal Cell, which reported that human stem cell lines for the first time had been created via cloning. The journal Nature contacted Mitalipov after an anonymous online critic on PubPeer spotted four separate problems in the paper. In an interview with Nature, Mitalipov confirmed that three errors were made in the rush to publish -- but denied the fourth issue raised was an error and said the overall conclusions were unaffected. "The results are real, the cell lines are real, everything is real," said Mitalipov, a reproductive biology specialist at the Oregon Health and Science University in Beaverton.
"I personally made the cells," he said. "I saw them grow into colonies." He blamed the errors on his rush to publish the research, which he hoped to present next month at the International Society for Stem Cell Research meeting. "Maybe it was rushed," he said. "It was my mistake."
Harvard Researchers Find that 83% of Radiologists Fail to See Gorilla in the Midst—of a Lung Scan!
Pathologists and clinical laboratory managers should be aware of the possibility of ‘inattentional blindness’ as a potential cause for diagnostic and laboratory error Pathologists and clinical laboratory professionals who regularly analyze images will be interested in the findings of a research study designed to assess how the phenomenon called “inattentional blindness” among radiologists could cause them to possibly miss things hiding in plain sight.
‘Inattentional Blindness’ Occurs Even Among Highly-trained Radiologists
Listeria sickened 1,651 people from 2009-2011, the Centers for Disease Control and Prevention in Atlanta said in a report. Twenty percent of those stricken died, primarily the elderly and prenatal babies who were stillborn or miscarried. “No progress in reducing the overall incidence of listeriosis has occurred in over a decade,” the CDC said. “Renewed prevention efforts are needed from farm to table.”
Scientist at MIT Raises Hope of Creating Artificial Human Liver
Dr Sangeeta Bhatia, who is presently professor of health sciences and technology has identified a dozen chemical compounds that can help liver cells not only maintain their normal function while grown in a lab dish but also multiply to produce new tissue. The liver is the only major organ in the human body that can regenerate itself if part of it is removed. However, researchers trying to exploit that ability in hopes of producing artificial liver tissue for transplantation have repeatedly been stymied.
Scots Scientists to Trial Synthetic Human Blood
Scottish scientists have been given the go-ahead for the world’s first trials in humans of synthetic blood, The Scotsman can reveal. Researchers based at the Scottish Centre for Regenerative Medicine (SCRM) in Edinburgh hope to use stem cells to manufacture blood on an industrial scale to help end shortages and prevent infections being passed on in donations. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has now granted a licence so scientists can make blood from stem cells which can be tested in humans – the first step towards large-scale clinical trials, which will hopefully lead to the routine use of blood created in this way. The researchers also revealed they will now turn their attention to using stem cells – early cells capable of turning into different types of tissue – from adult donors as opposed to the more controversial embryonic ones which have so far formed the basis of their work.
Protection Against E. coli O157:H7 Provided by Intestinal Bacteria
A cocktail of non-pathogenic bacteria naturally occurring in the digestive tract of healthy humans can protect against a potentially lethal E. coli infection in animal models according to research presented at the 113th General Meeting of the American Society for Microbiology. The research, conducted by scientists at the University of Michigan Medical School in Ann Arbor, could have important implications for the prevention or even treatment of this disease. "EHEC is of primary concern because HUS, the most severe outcome, preferentially targets young children," says Kathryn Eaton, a researcher on the study. "The discovery that normal intestinal bacteria can prevent intestinal Stx accumulation and disease in an animal model may have important implications for prevention of HUS in people infected with EHEC," says Eaton.
New Compounds Found to Curb Staph Infection
In an age when microbial pathogens are growing increasingly resistant to the conventional antibiotics used to tamp down infection, a team of Wisconsin scientists has synthesized a potent new class of compounds capable of curbing the bacteria that cause staph infections. Writing online in the Journal of the American Chemical Society, a group led by University of Wisconsin-Madison chemistry Professor Helen Blackwell describes agents that effectively interfere with the "quorum sensing" behavior of Staphylococcus aureus, a bacterium at the root of a host of human infections ranging from acne to life-threatening conditions such as pneumonia, toxic shock syndrome and sepsis. Interfering with bacterial quorum sensing to stymie disease is considered a promising new antibiotic strategy, says Blackwell.
Simple Strategy Works Best to Reduce Infections, Study Finds
Using germ-killing soap to wash the sickest patients every day and applying antibacterial ointment inside their noses turns out to be the most effective way to reduce deadly hospital bloodstream infections, according to a study published that has broad implications for practical use. The study, published in the New England Journal of Medicine, found that daily application of mupirocin ointment inside the nose and daily washing with a cloth soaked in chlorhexidine soap reduced bloodstream infections by up to 44 percent and significantly reduced the presence of drug-resistant bacterium known as MRSA, or methicillin-resistant Staphylococcus aureus.
Transfusions With Heart Surgery Might Raise Infection Risk
Delicate balance exists between treating anemia, avoiding side effects from infusion of red blood cells, study says. Patients who receive a red blood cell transfusion during or after heart surgery may be at greater risk for infection, according to a new study. However, the use of platelets during transfusions does not appear to carry a similar risk. Limiting red blood cell use could result in fewer major postoperative infections, the researchers suggested. The study is published in the June issue of the Annals of Thoracic Surgery.
Mosquitoes With Altered Gene Can't Sniff People Out
Scientists have discovered that mutating a smell-related gene in mosquitoes hinders their ability to sniff out humans from other warm-blooded prey. Researchers said the findings, published May 27 in the journal Nature, clearly show how important scent is to mosquito "hunting preferences." And they hope the results will pave the way to better weapons against the mosquitoes that transmit diseases including malaria and dengue fever. It's well known that certain mosquitoes "specialize in humans," said Leslie Vosshall, a professor at Rockefeller University, in New York City, and senior researcher on the study.
Women May Have Natural Defense Against Common STD
'Trich' causes discomfort for some, but is symptomless in others
Women appear to have a natural defense against the world's most common sexually transmitted infection, a new study says. This natural protective barrier consists mainly of lactic acid bacteria -- called lactobacilli. The finding appears online May 29 in the journal Sexually Transmitted Infections. The discovery could lead to new treatments for "trich," which affects an estimated 174 million women and men around the world each year, according to a journal news release. Trich is caused by the parasite Trichomonas vaginalis or T. vaginalis. Symptoms of the infection include pain, irritation and discharge. About 50 percent of all people who have this condition, however, don't develop symptoms and are unaware that they are infected.
Veggies Are Key to Long Life
People who followed a vegetarian diet had a lower risk for death from any cause, and men in particular also saw benefits for cardiovascular mortality, a large prospective study found. Among individuals who adhered to any type of vegetarian diet, the adjusted hazard ratio for all-cause mortality was 0.88 (95% CI 0.80-0.97), according to Michael J. Orlich, MD, and colleagues from Loma Linda University in California.
"Vegetarian dietary patterns have been associated with reductions in risk for several chronic diseases, such as hypertension, metabolic syndrome, diabetes mellitus, and ischemic heart disease, which might be expected to result in lower mortality," they wrote. However, previous mortality studies have had contradictory results, so Orlich and colleagues sought to clarify the uncertainty by analyzing outcomes for 73,308 participants in the Adventist Health Study 2.
High adherence to a Mediterranean diet appears to slow the progression of carotid plaque, a PREDIMED substudy suggests. Of note, investigators found an attenuation of plaque progression in the Mediterranean diet arm of the study that included supplementation with nuts and no such change in the other intervention arm, which included supplemental extra virgin olive oil. This difference, however, may simply have been a product of limited sample size, Dr Aleix Sala-Vila (Institut d'Investigacions Biomèdiques August Pi Sunyer, Barcelona, Spain) said at the European Atherosclerosis Society (EAS) 2013 Congress.
That Employee Who Smokes Costs the Boss $5,800 a Year
Figures on the cost of smoking have been rough estimates at best, with a very general estimate of $193 billion a year nationwide. Researchers now say they're got much tighter focus on the number: $5,800 per smoker per year. And the biggest chunk of that comes not in health care costs, but in work lost during all those smoke breaks. That came in at $3,077, based on an estimate of five smoke breaks during the work day. "The smoking breaks added up to a lot more than we expected," says Micah Berman, an incoming assistant professor of law and public policy at Ohio State University, who led the study, which was published in Tobacco Control.
Failure to Use Linked Health Records May Lead to Biased Disease Estimates
Up to half of all heart attack cases are missed using just one data source. Failure to use linked electronic health records may lead to biased estimates of heart attack incidence and outcome, warn researchers in a paper published on bmj.com. They show that up to 50% of all heart attack cases are missed using just one data source. These findings may be relevant to other common conditions, such as stroke, and support the wider use of linked multiple record sources by clinicians, policy makers and researchers, say the authors.
Primary care records were the single most complete source of non-fatal myocardial infarction records (not recording one quarter), hospital records missed one third and the disease registry nearly half. In other words, acute myocardial infarction was underestimated by 25-50% using one source compared to using all three.
Most Doctors Don’t Meet U.S. Push for Electronic Records
Fewer than 1 in 10 doctors used electronic records last year to U.S. standards, according to a survey that shows the challenge facing a multibillion-dollar effort to digitize the health system for improved patient care. Only 9.8 percent of 1,820 primary-care and specialty doctors said they had electronic systems that met U.S. rules for “meaningful use,” a list of tasks such as tracking referrals or filling prescriptions online. Less than half all those surveyed, or 44 percent, had any system in place, according to the report published by the journal Annals of Internal Medicine.
For New Doctors, 8 Minutes Per Patient
Researchers from Johns Hopkins University and the University of Maryland shadowed interns at two different internal medicine training programs over the course of almost 900 hours. They recorded the time the interns spent talking with and examining patients, meeting with families, attending educational conferences, discussing treatment plans with other doctors, sleeping, eating and even walking around the hospital. As in earlier studies, the researchers found that current interns spend the majority of their time in activities only indirectly related to patient care, like reading patient charts, writing notes, entering orders, speaking with other team members and transporting patients. But when they calculated the amount of time spent face to face with patients, the researchers found that interns were devoting about eight minutes each day to each patient, only about 12 percent of their time.
“We have to ask ourselves if spending more time on electronic medical records than with patients is time well spent,” said Dr. Leonard S. Feldman, senior author of the study and assistant professor of medicine and pediatrics at the Johns Hopkins School of Medicine. “If you’re only spending eight minutes talking to and examining a patient, something is certainly going to be missing.”
The policy about online medical professionalism was issued April 11 by the American College of Physicians and the Federation of State Medical Boards. The guidance was presented at the ACP annual scientific meeting in San Francisco on April 11-13 and published in the April 16 issue of Annals of Internal Medicine.
Key recommendations for physicians and medical students include:
- Keep professional and personal online personas separate by creating a site exclusively for community outreach and networking.
- Don't “friend” patients or contact them through social media.
- Before posting information online, consider how the public might perceive the content.
- Don't vent about work issues on the Web.
- Only email and text message patients who have agreed to such communication methods and with whom you have an established relationship.
- Regularly search for your name online and correct inaccurate information when possible.
Patients Should Be More Involved in Medical Decision Making
A new study published in the journal JAMA Internal Medicine revealed that the level of shared decision making among adult patients who had discussed medical tests, medications and procedures with their doctors was not as high as expected. A national survey was conducted in 2011 by Floyd J. Fowler, Jr., Ph.D., from the Informed Medical Decisions Foundation and the University of Massachusetts, Boston The survey also revealed whether the patients were told they had a choice and whether they were asked for any input by their doctor.
The importance of involving and discussing with patients.
A team of experts from University College London, published a study in the British Journal of General Practice, that revealed before visiting your doctor, searching on the Internet to try and find out what is wrong can actually help patients benefit more from the consultation.
Serious Work Put Into Making Primary Care Fun Again
Amid alarming rates of physician burnout, hundreds of clinics nationwide are redesigning their practices with a goal in mind beyond improving the quality of care. They are aiming to make life as a primary care doctor enjoyable once more. Twenty-three of these clinics are profiled in a report in the May/June Annals of Family Medicine that describes practice innovations that can ease the chaos, administrative overload, miscommunication and computerized busy work that too often characterize primary care. These clinics find that planning visits ahead of time, delegating more tasks to nurses and medical assistants, holding daily meetings and using standing orders for recurring items not only improves patient satisfaction but also creates happier doctors.
Empowerment Is Not a Zero Sum Game
The key to developing and maintaining this environment is the empowerment of staff to make decisions at the level nearest to where the work is performed. Empowerment is not only the delegation of responsibility, but the creation of a culture where staff feel that they are respected for their knowledge, experience and dedication; where they know that their work-related concerns will be listened to, and given serious consideration. However, we all know managers who do not share power easily; who have problems delegating decision making, and who may micromanage competent employees out of the laboratory.
Hospital CEOs See Double-Digit Pay Hikes
Trimming medical costs is the latest mantra among hospital executives, government bureaucrats, insurers and benefit managers as they grapple for ways to contain U.S. health care spending. But executive compensation in the health care industry shows few signs of hitting a ceiling. One sure bet: The salaries and benefits for hospital administrators will continue to rise. A recent survey by Equilar, an executive compensation data firm based in Redwood City, Calif., found that — for the fourth time in five years — health care chief executives commanded the highest pay packages last year among publicly traded companies.
Federal Prosecutors Get Guilty Pleas From Three Clinical Laboratory Executives in Two Different Anti-Kickback Cases, One in New Jersey and one in North Carolina
Former executives at two different clinical laboratories pleaded guilty in two separate cases of fraud, but physicians who accepted illegal payments have yet to be named or charged. Three, former executives at two clinical laboratory companies pleaded guilty recently in two separate cases of fraud brought by U.S. district attorneys in New Jersey and North Carolina.
First Case involves Biodiagnostic Laboratory Services
In one case, two former salesmen for Biodiagnostic Laboratory Services, LLC, (BLS) of Parsippany, New Jersey, pleaded guilty to conspiracy to violate the Anti-Kickback Statute and the Federal Travel Act while working at BLS, according to a statement from the U.S. District Attorney’s Office for the District of New Jersey.
Second Case Centers Upon Wilkesboro Clinical Laboratory
In a separate case in U.S. District Court in Charlotte, North Carolina, Louis Francis Curte, 49, the former owner of Wilkesboro Clinical Laboratory (WCL), in Wilkesboro, North Carolina, pleaded guilty to four counts of health-care fraud and one count of filing a false tax return, according to a statement from U.S. Attorney Anne M. Tompkins in the Western District of North Carolina. Curte and the WCL billed Medicare for services not rendered.
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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