A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
October 4, 2012
ABC's to Public Health
As Doctor May Chu, PhD Director of LSPPPO and the Laboratory Science Connectivity Workgroup (LSCW) describes, CDC’s mission depends critically on laboratory testing- not only in our laboratories, but in the many public health laboratories throughout the U.S. These laboratories in turn depend upon testing done in hospitals and laboratories of all kinds. None of this can happen without the skilled and careful work of thousands of laboratory scientists, technologists and technicians.
There are many career opportunities in these laboratories and there is no doubt that the need will continue to grow. We invite you to learn about these laboratories and the heroes who staff them, all working to protect our health.
Growing Patient Access to Test Results
The Department of Health and Human Services (HHS) is clarifying final rules for patients to obtain their laboratory test results directly from the lab. Drivers of this final decision include lack of timely follow-up by healthcare providers, the need for patients to be more engaged in and accountable for their own health information, and since the results belong to the patient there is a consensus among leaders that patients should have a right to have them.
The rule will ensure that all CLIA and CLIA-exempt clinical laboratories, which abide by regulations under the Health Insurance Portability and Accountability Act, adopt IT standards enabling patients to gain access to their protected information.
Proposed: FDA Office of Mobile Health
There are already tens of thousands of mobile health applications available for download on smart phones and tablets, allowing consumers to do anything from count calories to monitor their blood sugar level and fight depression. But it can be hard to know which ones actually deliver on their health claims and provide accurate information.
The Food and Drug Administration, the agency in charge of regulating mobile health apps, has evaluated a few apps so far, but it still has not made clear which apps will require approval. Some app developers have raised concerns about whether the FDA can keep up with the fast-paced innovations of Silicon Valley.
But a bill set to be introduced in the U.S. House of Representatives later this month aims to smooth the agency’s evaluation process. The Healthcare Innovation and Marketplace Technologies Act (HIMTA) would establish a special Office of Mobile Health at the FDA to provide recommendations on mobile health app issues. It would also create a mobile health developer support program at the Department of Health and Human Services to help app developers make sure they are operating within privacy regulations, including the federal law HIPAA that sets privacy standards.
FDA to Re-Examine Medical-Device Security Risks
The Food and Drug Administration will begin looking at external security vulnerabilities of the software in medical equipment after inquiries from congressional investigators.
A report issued by the Government Accountability Office (PDF) found that for wireless medical devices, the FDA “did not consider information security risks from intentional threats as a realistic possibility until recently.”
Agency officials told the authors of the GAO report that they plan to re-examine their evaluations of software used in medical devices and add an assessment of “information security risks.”
“Although researchers have recently demonstrated the potential for incidents resulting from intentional threats in two devices—an implantable cardioverter defibrillator and an insulin pump—no such actual incidents are known to have occurred, according to the FDA,” the report noted.
CMS Provides Pathologists Temporary Relief from Meaningful Use Penalties
The U.S. Centers for Medicare and Medicaid Services (CMS) will shield pathologists, at least temporarily, from the Meaningful Use program’s noncompliance penalties that go into effect in 2015. The relief was provided as part of the agency’s Meaningful Use Stage Two Final Rule, released in late August at ASCP’s urging. The rule also provides protection for radiologists and anesthesiologists.
Pathologists should be aware that CMS can only provide temporary relief. For pathologists to secure permanent relief, Congress must enact legislation. Currently, the Health Information Technology Reform Act (H.R. 4066) has been introduced, which would exempt pathologists from eligibility for both Meaningful Use penalties and incentives.
Source: Source: http://www.ascp.org/
The American Society for Clinical Pathology (ASCP) recently chose 32 ASCP Career Ambassadors for 2012-2013. Sponsored by Roche, the program is a collaborative effort to address a laboratory science workforce shortage by placing dedicated, recently certified ASCP members into classrooms nationwide to promote the profession to pre-college students. In 2011-2012, ASCP Career Ambassadors reached almost 8,000 students through classroom presentations and career fairs.
CCHIT: 2014 EHR Certification Will Focus on Care Quality, Delivery
As providers look ahead to Stage 2 of the meaningful use electronic health records incentive program, they will see a greater emphasis on quality of care and improved patient outcomes, according Alisa Ray, executive director of the Certification Commission for Health Information Technology (CCHIT). With this in mind, Ray said, the new 2014 criteria for certifying EHR technology to federal standards have been designed to support delivery of safer care.
"We are getting feedback that [the Office of the National Coordinator for Health Information Technology] has really, really raised the bar this time," Ray said at the American Health Information Management Association (AHIMA) annual convention. In its recently published 2014 criteria for certification of health IT technology, ONC called for "safety-enhanced design" in eight EHR functions, such as order entry, drug-drug and drug-allergy checking, clinical decision support and electronic medication administration records.
That program officially begins October 4, though the federal government will not finalize testing procedures until late December or early January, Ray said.
Electronic Standing Orders Increase Delivery of Preventive Services
A new study funded by the Agency for Healthcare Research and Quality (AHRQ) and published in The Journal of the American Board of Family Medicine, found that implementing electronic standing orders for preventive services increased service delivery. Implementing and Evaluating Electronic Standing Orders in Primary Care Practice: A PPRNet Study discusses how electronic standing orders, established rules that allow qualified staff to deliver certain types of care, can be used in primary care practices with an electronic health record (EHR). By checking the rules established by the standing orders against the patient’s prior record of care, the EHRs were able to produce a list of necessary preventive services. Since Americans receive approximately half of all recommended preventive services, increasing preventive service delivery is an important goal. Using their EHRs, the eight primary care practices that participated in this study developed standing orders for health screenings, immunization and diabetes management. As a result, all of the practices improved delivery of six specific services and medical assistant’s workflow and morale were optimized. To highlight the success of this initiative, the AHRQ developed a video that details how this project improved service delivery, staff moral and clinical workflow.
NIH Buying Power Keeps Francis Collins up Nights
In an interview, National Institutes of Health director and Human Genome Project veteran Francis Collins opens up to Nature's Meredith Wadman on his four years leading the NIH as one-time windfalls from the American Recovery Act have withered into what he calls "about a 20 percent loss in buying power over the last ten years."
Collins says biomedical scientists are working in an "exhilarating" yet "paradoxical" time, with research "rocketing forward," even while success rates for NIH grant applications have sunk down to 17 percent and lower.
"A great many scientists, including those just starting out, are having trouble getting their ideas supported and getting increasingly frustrated. That is what wakes me up at night," Collins says.
Large-Scale Testing Errors
Thanks to automated systems and other advancements, the number of errors occurring today in the analytical phase of laboratory testing has been drastically reduced. While these advancements in laboratory testing have led to rapid reporting of large numbers of patient samples, laboratories now face a new type of problem: systemic errors that could impact many patient results before the laboratory even detects the error. In this interview, Nikola Baumann, PhD, director of the Central Clinical Laboratory and Central Processing at the Mayo Clinic in Rochester, Minn., offers ideas and suggestions on how to prepare for and recover from large-scale testing errors.
There are two practices in the laboratory that make us more vulnerable to large-scale testing errors.
The first is performing QC for the sake of performing QC. We should remind ourselves and our laboratory staff that we use QC to ensure stable operation. Running controls until “they come in” or repeating between instrument comparisons “because the first one didn’t match” are red flags. To detect errors, we need to trust our quality control processes and react to failures.
The second practice that makes us vulnerable is not openly communicating with our end users. Clinicians are robust error detectors. They will notice a questionable result, repeat the test, and if the repeat test result makes sense in the clinical context, all is well in their mind. But the clinician may never tell the laboratory about the error, which means that the problem may continue. Open dialog between the laboratory and clinical services should be cultivated and encouraged as an additional valuable quality assurance (QA) tool.
Beau Gunderson's fascinated by what he might learn from his DNA. "I'm curious about what makes me tick, essentially," says Gunderson, 29, who writes code for a Silicon Valley startup. So Gunderson has signed up for every genetic test he's been able to afford. And he can't wait for the price of getting his entire genetic code—his genome—to drop to about $1,000, as many are predicting is imminent.
"Yeah, if the price does drop—to a thousand bucks for example—I might pay that. That's a good personal price point for me," Gunderson said.
"The early adopters that are getting this done now are those who have this incredible curiosity about their genetic makeup, about their potential genetic destiny," said Jay Flatley, who heads Illumina Inc., of San Diego.
Illumina even recently started offering an iPad app that people can use to learn more about whole genome sequencing and their own genomes. In September, the company announced a new service that could deliver a genome in two weeks.
Source: Source: http://www.npr.org/
Genomics Shapes the Future of Laboratory Medicine
As genomic testing is rapidly changing patient care, pathologists need to take a leading role.
“We have the expertise to ensure accurate testing and interpret the results,” said Richard L. Haspel, MD, FASCP, Assistant Professor of Pathology at Harvard Medical School, Boston, and Director of the Laboratory Medicine Residency Training Program at Beth Israel Deaconess Medical Center, Boston. “We are the healthcare professionals who diagnose cancer and provide staging and grading information to guide treatment. For the best possible patient care, we need to be at the forefront as genomic technologies enter the clinical arena and learn how to integrate this testing into our current practice.”
Innovative Glasses Enable Clinical Laboratory Phlebotomists to See Vasculature Through the Skin
New technology now makes it possible for the wearer of a special pair of glasses to detect hidden vasculature and changes in the blood through the skin. Some experts predict that this innovative technology might be used by medical laboratory phlebotomists to improve the collection of blood—thus raising patient satisfaction with phlebotomy services.
Eyewear Technology Shows Serious Potential for Medical Use
Developed by 2AI Labs, a company based in Boise, Idaho, the glasses amplify fluctuations of oxygen levels in hemoglobin just beneath the skin. The story was reported in Technology Review.
The technology has important potential in a variety of medical applications, not the least of which would be use, in clinical laboratory phlebotomy departments. The patented eyewear is reportedly in phase testing at two regional hospitals.
Here’s how Changizi describes his three different patented eyewear technologies on his website’s medical applications page:
- The Oxy-Iso isolates and enhances perception of blood oxygenation under the skin. This is useful for phlebotomists, nurses, and other clinical personnel involved in medical procedures where perception of vasculature is important.
- The Hemo-Iso isolates and enhances perception of blood concentration under the skin. This is useful for emergency departments, operating theaters, intensive care, and paramedics.
- The Oxy-Amp amplifies perception of health and emotion signals on the skin while maintaining full perception of the natural world. This is useful for medical procedures, urgent care, anesthesiology, surgery, as well as assessment and diagnosis.
Key Step Lacking in Preventing Perinatal Hep B Transmission
Most babies born to mothers with hepatitis B (HBV) appear to get post-exposure prophylaxis as well as the full three-dose series of vaccine against the virus, the CDC is reporting. But adherence to a key follow-up step – post-vaccination serologic testing – seems less complete, the agency reported in the Sept. 28 issue of Morbidity and Mortality Weekly Report. About 25,000 infants are born every year in the U.S. to mothers who test positive for the hepatitis B surface antigen (HBsAg), the CDC report noted, and without intervention up to 90% of infants can become infected, increasing their risk for cirrhosis or early death.
For that reason, the CDC's Advisory Committee on Immunization Practices urges post-exposure prophylaxis with hepatitis B vaccine and hepatitis B immune globulin within 12 hours of birth. Exposed infants should also complete the three-dose HBV vaccine series. To evaluate the effect of the treatment, the committee has recommended, babies should be tested – a month after the last dose of vaccine -- for the HBV surface antigen and for the antibodies against it.
Biomarker Panel Separates Alzheimer's From Other Dementias
Using a panel of 5 biomarkers may help provide a differential diagnosis of patients with dementia or parkinsonian disorders, new research suggests.
The study showed that 4 of these biomarkers — T-tau; P-tau; Aβ1-42; and a relatively new biomarker, α-synuclein — can differentiate patients with Alzheimer's disease (AD) from those who have dementia with Lewy bodies (DLB) or Parkinson's disease with dementia (PDD). Another biomarker, neurofilament light chain (NF-L), used alone can separate patients with PD from those with atypical parkinsonism, such as progressive supranuclear palsy, multiple-system atrophy, and corticobasal degeneration, the researchers also report.
The study is the first to assess the added value of combining several cerebrospinal fluid (CSF) biomarkers simultaneously in the differential diagnosis of all these disorders, said study author Annika Öhrfelt, PhD, a neurochemist researcher at the Sahlgrenska Academy, University of Gothenburg, Sweden.
Molecular testing has evolved to the point where molecular testing, particularly quantitative real-time PCR, has become a de rigueur tool for diagnosing infectious diseases — and now core laboratories are looking for ways to move molecular testing to the point of care and eliminate slow and inefficient centralized testing.
As such, North Shore-LIJ has now begun decentralizing its respiratory virus testing using the FilmArray system and respiratory panel assay from BioFire Diagnostics, which changed its name from Idaho Technology. The FilmArray platform currently detects and distinguishes between 20 respiratory pathogens, viral and bacterial, by automatically extracting and purifying nucleic acids from an unprocessed sample, amplifying pathogenic nucleic acids using a two-step nested PCR process, and comparing endpoint melting curve data to generate a result. The system is highly accurate, covers most of the respiratory pathogens frequently encountered in a hospital setting, and, importantly, can provide a result in about an hour and a half with two minutes of hands-on technician time, Ginocchio says.
A Bloomberg Terminal for DNA Sequencing
Knome, a small, Cambridge, Mass., startup, announced that in the fourth quarter it will begin selling a $125,000, 600-pound supercomputer to hospitals to allow them to analyze the data contained in one human DNA sequence in as little as a day, at a time when the cost of that data is dropping toward $1,000.
Right now, there are about 2,000 next-generation DNA sequencing machines out there. That vast majority are made by Illumina (total sales: $1.0 billion) and have a list price of about $700,000.
Leco, Berkeley National Lab Partner on Metabolomics
Analytical instrument firm Leco announced an agreement with the US Department of Energy's Lawrence Berkeley National Laboratory to develop metabolomic applications and tools. The deal provides Berkeley Lab's Life Sciences Division access to Leco's Citius LC-High Resolution TOF-MS. The instrument provides acquisition speeds of up to 200 spectra per second, mass resolution up to 100,000 full width at half maximum (FWHM) and mass accuracy less than 1 parts per million, Leco said.
Source/full article: http://www.genomeweb.com/
Sexually Abused Women Skip Pap Smears
Sexually-abused girls appear more likely to skip cervical cancer screening as adults, according to an exploratory study suggesting that the exam brings back the feeling of victimization for some.
Only 49% of British women abused as children or young adults had gotten a recommended Pap smear in the prior 5 years as compared with a general population rate of 79% there, Anne Szarewski, MD, of the Queen Mary University of London, and colleagues found.
UV Device Erases Superbugs from Hospital Rooms
Nasty microorganisms lurking on bed rails, tables, doorknobs and other surfaces in hospitals are causing a more than $30-billion problem for the U.S. healthcare system. Now, a new device is one of many trying to hunt down these microorganisms in an effort to reduce healthcare-associated infections such as methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile.
Xenex Healthcare Services LLC's portable disinfection system pulses bursts of the inert gas xenon at a rapid speed and high intensity in an ultraviolet flash lamp, producing UVC radiation. At certain wavelengths, UV light penetrates the outer coatings of bacteria, viruses, mold and spores. "The light acts like a needle – it pierces the cell walls and prevents them from replicating," CEO Morris Miller said.
It's used in addition to traditional surface cleaning. Hospital staff members clean the surfaces of the room as they usually would, to get rid of surface dirt, and then bring in the machine, open drawers and expose other surfaces that are likely to be contaminated. They turn on the device with a remote control and leave the room. The entire process takes about 10 minutes and leaves no residue or gas in the room, Miller said.
The key finding of researchers Bryan Yipp and Bjoern Petri from the Snyder Institute for Chronic Diseases in the Faculty of Medicine at the University of Calgary is what happens to the white blood cells, or neutrophils, after they attack an infection. It was believed that the cell would cover the bacteria with a net-like material and then die.
"This process was thought to involve an explosive cell death or a beneficial suicide so the way these cells could get the contents out is to explode so they would be dead," said Yipp.
"It actually turns out that is not true and that these cells can actually release their internal contents and survive. They can actually continue to function and perform a very valuable function in order to get rid of the bacteria."
HIV 'Made' New Deadly Salmonella – Study
An epidemic of a deadly strain of Salmonella has swept across the whole of Africa by "taking advantage" of the spread of HIV, according to an international team of researchers. Their study, published in Nature Genetics, is the first to identify the separate cases as a single epidemic.
One in four people in Africa infected with the strain died. It is thought to be the first time a single strain of an infection has spread so widely in the wake of HIV.
HPV Vaccine gets a (mostly) Clean Bill of Health
A large study of the safety of the HPV vaccine has turned up no unexpected side effects.
The study, published in the journal Archives of Pediatrics & Adolescent Medicine, did find that the vaccine caused some women to faint the day they received it, and some recipients also developed skin infections. Both problems are believed to be general side effects of vaccines, and unrelated to anything specific about the HPV shot.
Researchers Tackle Age-Related Decline in Immune Response
Blocking a single protein might stop the age-related decline of the immune system that reduces people's ability to benefit from vaccinations and leaves them vulnerable to infectious diseases and cancer, a preliminary new study says.
Levels of the protein, called DUSP6, steadily rise as people age and interfere with the ability of an important class of immune cells to respond to invading germs or vaccines designed to protect against those harmful germs, researchers from the Stanford University School of Medicine found. They also pinpointed a potential compound that may inhibit DUSP6 and turn back the clock on the immune system's decline and reinvigorate its response to vaccines.
The study was published online Sept. 30 in the journal Nature Medicine.
Gut Bacteria are Different in People with Diabetes
There’s a lot of talk these days about the role of gut bacteria in disease and health. The latest report in that area: a study in Nature that finds differences between the bacteria growing in the guts of people who have diabetes and those who don't.
The Chinese and European authors of the study used DNA analysis to figure out the bacterial populations inside 345 Chinese people.
They found that people with diabetes had mild gut disturbances. They had fewer bacteria that make a compound called butyrate, for example. And they had higher levels of various bacteria that can increase in number when opportunity strikes and thereby cause disease.
Reduced numbers of butyrate-producing bacteria are also seen in people who are older and in people who have colorectal cancer -- implying that these bacteria could play a generally protective role in the gut, the authors wrote.
A genetically modified cow that produces milk less likely to cause allergic reactions has been engineered by New Zealand scientists. Up to 3% of infants are allergic to cows' milk in their first year of life.
The modified cow produced milk without beta-lactoglobulin - a whey protein to which some people are allergic. The study has been labelled a "milestone" by one scientist, but some campaign groups say it raises ethical concerns. There are important differences between a woman's breast milk and cows' milk, such as beta-lactoglobulin, which is found in milk from cows but not people.
Cloud Computing Saves Health Care Industry Time and Money
The cloud's vast computing power is making it easier and less expensive for companies and clinicians to discover new drugs and medical treatments. Analyzing data that used to take years and tens of millions of dollars can now be done for a fraction of that amount. Companies can rent massive computer resources by the hour, and the cost is relatively little. The ability to analyze vast amounts of data in this way is changing lots of industries — including health care.
Think of the cloud as a giant warehouse full of computers of all sizes and shapes. Matt Wood, head of scientific and technical computing at Amazon Web Services, says pharmaceutical companies are saving money by renting only the computing power they need, and paying for it by the hour. "So you can imagine 50,000 laptops running this experiment. They didn't have to buy or provision or manage or cool or power any of those laptops, or set them up. They could just provision what they needed at a scale that they needed it," Wood says.
Shortage of Health IT Workers Worsens
The health IT staffing shortage is getting worse, most acutely for technicians qualified to implement and maintain clinical software, a new survey shows.
The survey, conducted in July by the College of Healthcare Information Management Executives, found that 67 percent of health IT executives reported staffing shortages, compared with 59 percent two years earlier. For clinical software implementation, the figure was 76 percent, up from 70 percent in 2010.
Only 12 percent of chief information officers responding to the survey reported hiring graduates of the new Health IT Workforce Development program, under which students can achieve non-degree health IT training in six months or less at community colleges and universities
Two Leading Health Care Quality Organizations Hold National Summit to Build Consensus around Ways to Minimize Overuse of Five Treatments
To help reach a consensus on ways to reduce the occurrence of medical treatments that are commonly used but not always necessary, the American Medical Association (AMA)-convened Physician Consortium for Performance Improvement (PCPI) and The Joint Commission co-sponsored the National Summit on Overuse, September 24, 2012, to discuss strategies to improve the quality and safety of patient care.
A variety of key stakeholders, including representatives from physician organizations, medical specialties, government agencies, research institutions and patient groups, came together at the National Summit on Overuse to discuss the appropriate use of the following treatments and procedures:
- Heart vessel stents (percutaneous coronary intervention or PCI)
- Blood transfusions (blood management)
- Ear tubes (tympanostomy tubes) for brief periods of fluid behind the ear drum
- Antibiotics for the common cold (viral upper respiratory infections)
- Early scheduled births (early induction) without medical need
Despite Lists, Experts Disagree on the 'Best Hospitals'
Nearly 40% of consumers surveyed last year said they use hospital ratings to choose a health care facility, but there's little agreement between the lists, raising questions about their value.
Consumers pore over reviews and ratings of everything from cars to washing machines, but it is doctor and hospital rankings that may be the most confusing and controversial. At least 15 different groups rank health care organizations, but no two judge them the same way, which leads to widely divergent results, says Brent James, a medical doctor who is chief quality officer at Intermountain Healthcare in Salt Lake City.
"On some of those, we look pretty bad and on others we're golden; the best in the nation," James says. "All of us publish newspaper ads that say we're the best on one or another."
California and Washington State will require coverage of acupuncture. Arkansas wants prevention counseling for women at high risk of breast cancer but not coverage of expensive infertility treatment. Oregon opted against covering bariatric surgery for obesity but insurers will have to cover cochlear implants for hearing.
These are some of the decisions states have made as they determine what minimum insurance benefits millions of their residents will be entitled to in 2014 under the federal health law.
The decisions – which affect people who will buy individual and small group policies -- are being closely watched because they’ll determine how comprehensive the plans are and affect how much they cost.
Insurers Latest to Champion Medical Homes
With evidence mounting that patient-centered medical homes can reduce costs and improve outcomes, more insurers are pushing them. That means primary care physicians will be under increasing pressure from payers to adapt their practices to the model.
“This type of clinical integration really cannot be ignored,” said Mary Campagnolo, MD, president of the Medical Society of New Jersey. “Physicians need to ask how to join forces with like-minded physicians to develop the infrastructure to deal with this new environment.”
Programs supported by commercial and government insurers now exist in nearly every state, according to a report issued Sept. 7 by the Washington-based Patient-Centered Primary Care Collaborative, an organization supportive of the medical home model.
Doctor Visits Dropping, New Census Figures Show
Americans of working age are going to the doctor less frequently than they were 10 years ago, according to a new report by the Census Bureau.
In 2010, people age 18 to 64 made an average of 3.9 visits to doctors, nurses and other medical professionals, down from 4.8 visits in 2001, said the report [PDF 486.71KB].
The precise reasons for the decline were unclear, said Brett O’Hara, an official at the Census Bureau and a co-author of the report. But the changing demographics of the American population most likely had something to do with it.
Sleepy Workers Make Costly Mistakes
Insomnia may exact an expensive toll in on-the-job errors and accidents, a survey suggested.
The sleep disorder was linked to a 40% elevated risk of workplace incidents that cost a company $500 or more, Ronald C. Kessler, PhD, of Harvard, and colleagues found.
In fact, insomnia is estimated to be the cause of about 7% of workplace accidents that lead to a financial loss and 24% of all related costs -- more than any other chronic condition, the group reported in the October issue of the Archives of General Psychiatry.
The total cost to U.S. businesses is likely in the range of $31 billion a year, they projected.
Serco Takeover of NHS Pathology Labs 'Led to Clinical and Financial Failures'
The takeover of the NHS's biggest pathology laboratories by the multinational Serco has led to a series of clinical and financial failures and saw London hospitals being forced to lend money to the company, it has emerged. GSTS Pathology, a joint venture between Serco and King's College and St Thomas' hospitals, described itself as "an exemplar of public private partnership in the health sector", when it took over the hospitals' pathology services in 2009 – deals worth £800m over the next decade.
Pathology laboratories are a key part of the health service – analysing blood and tissue for doctors across the NHS and involved in 70% of all patient diagnoses. But documents obtained under the Freedom of Information Act by Corporate Watch, a not-for-profit research group, detail 400 clinical incidents in 2011 – including losing and mislabelling samples – at GSTS's St Thomas' labs. The service exceeded the agreed monthly turnaround times for tests 46 times in 2011, with critical risk levels breached 14 times.