viernes, 10 de octubre de 2014



Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services


October 09, 2014

  • Adults Over Age 45 Should be Screened for Diabetes
  • FDA Issues Draft Guidance on LDTs
  • Laboratories Must Comply With new HIPAA Patient Access Rules by October 6, 2014
  • Putting Waived Testing Under the Microscope
  • The New International Recommendations for Chronic Kidney Disease
  • Novel Blood Test Shows Who Has and Who May Get Cancer
  • Study of Identical Twins Reveals Type 2 Diabetes Clues
  • 3D Technologies Poised to Change How Doctors Diagnose Cancers
  • Tobacco Tied to Higher Risk of Oral HPV Infection, Study Finds
  • Enterovirus D68 in the United States, 2014
  • New FDA Strategic Roadmap Includes Health IT-related Goals
  • 25 Years of Health IT: Highs & Lows


View Previous Issues - Healthcare News Archive


Leading News

Adults Over Age 45 Should be Screened for Diabetes
Primary care physicians should screen all adults over age 45 for diabetes, according to new recommendations proposed by a government-sponsored panel of experts. The US Preventive Services Task Force, composed of primary care providers, base their new advice on evidence suggesting that diagnosing elevated blood sugar levels before people develop full-blown diabetes can reduce their risk of getting the condition and also developing heart disease. Evidence from several recent large clinical trials suggest that those who have moderately elevated blood sugar, a condition called prediabetes, detected on a routine blood test and treated through a diet and exercise program have a 47 percent reduced risk of developing diabetes over the next several years. The Task Force’s previous recommendations from 2008 only recommended diabetes screening in those at increased heart disease risk due to high blood pressure because studies were lacking to show benefits for screening the general population. “More evidence has emerged since then on the benefits of lifestyle interventions,” said Task Force member Dr. Michael Pignone, a professor of medicine at the University of North Carolina at Chapel Hill School of Medicine. “Our feeling is that you need to have an effective intervention available for people that you screen.” People who are overweight, have a family history of diabetes, or are African-American, Asian, or Latino, likely need to be screened earlier than 45, the Task Force recommended, because they’re at higher diabetes risk. Women who have polycystic ovarian syndrome or who developed gestational diabetes during pregnancy also fall into the high-risk category.

FDA Issues Draft Guidance on LDTs

Laboratories Must Comply With New HIPAA Patient Access Rules by October 6, 2014
HIPAA covered laboratories and hospitals with laboratories subject to the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) must comply with changes to the HIPAA Privacy Rule that provide patients with direct access to laboratory test results by October 6, 2014.  Earlier this year, the Centers for Medicare & Medicaid Services, the HHS Office for Civil Rights and the Centers for Disease Control and Prevention published a final rule amending the CLIA regulations and the HIPAA Privacy Rule to provide patients with greater access to their lab test results. As amended, the CLIA regulations, which are now effective, permit a CLIA lab to provide, upon request, a patient and/or his/her personal representative (and any person designated by the patient) with access to completed test reports that, using the lab’s authentication process, can be identified as belonging to that patient.  Beginning October 6, 2014, the Privacy Rule amendments (which eliminated an exemption for PHI held by CLIA labs) require HIPAA covered CLIA labs to provide individuals and/or their personal representatives with access to protected health information (“PHI”) about the individual maintained in a designated record set under the Privacy Rule provisions establishing the individual’s right of access to PHI (“access rights”).  Thus, the combination of the two provisions now require most CLIA labs to provide test results (and any other PHI they maintain) when requested by the patient.  Labs that are not covered by HIPAA may provide a patient and/or his/her personal representative (and any person designated by the patient) with access to completed test reports, but are not required to do so.

Ebola Outbreak: Spain Investigates New Case
Investigations are under way at a hospital in Madrid after a Spanish nurse became the first person known to have contracted the deadly Ebola virus outside West Africa. The nurse had treated two Spanish missionaries who died of the disease after being flown home from the region. The European Commission has asked Spain to explain how the nurse could have become infected. Some 3,400 people have died in the outbreak - mostly in West Africa. 

AIDS: Origin of Pandemic 'was 1920s Kinshasa' 
The origin of the AIDS pandemic has been traced to the 1920s in the city of Kinshasa, in what is now the Democratic Republic of Congo, scientists say. An international team of scientists say a "perfect storm" of population growth, sex and railways allowed HIV to spread. A feat of viral archaeology was used to find the pandemic's origin, the team report in the journal Science. They used archived samples of HIV's genetic code to trace its source, with evidence pointing to 1920s Kinshasa. Their report says a roaring sex trade, rapid population growth and unsterilised needles used in health clinics probably spread the virus. Meanwhile Belgium-backed railways had one million people flowing through the city each year, taking the virus to neighbouring regions. Experts said it was a fascinating insight into the start of the pandemic.
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Laboratory Testing / Diagnostics

Putting Waived Testing Under the Microscope
The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) remains the most sweeping federal law affecting the laboratory industry. Its purpose is to safeguard the “accuracy, reliability, and timeliness” of patient test results. 
Today, the number of labs with direct oversight under CLIA 88’s purview is shrinking due to the rise of so-called “waived testing” – point-of-care-performed tests exempted from most federal and state regulations. These tests can be performed by individuals with little or no laboratory background, in a bedside or chair side setting.  They are simple to conduct, do not require staff with specialized training, and have a reputation for being relatively error-free.  In 1993, only nine waived testing analytes, and 203 waived testing systems, were waived. Today there are now 120 waived analytes, and more than 4,000 waived testing systems are listed on the FDA website. Waived tests now include HIV tests, tests for drugs of abuse, glucose, pregnancy tests, tests for Lyme disease, infectious diseases like influenza A and B, and many others. Further, according to CMS, more than 165,000 clinical laboratories in the United States now have certificates of waiver. That means that 70 percent of laboratories performing work that ultimately impacts millions of patients across the United States have little to no federal regulatory oversight.

The New International Recommendations for Chronic Kidney Disease  
What laboratorians need to know about the 2012 KDIGO Clinical Practice Guideline
Chronic Kidney Disease (CKD) is a common clinical condition with significant adverse effects for patients. Since 2002, CKD has had strictly defined criteria for diagnosis and staging based almost entirely on clinical chemistry laboratory results. The 2002 guideline produced by the Kidney Disease Outcomes Quality Initiative (KDOQI) was very influential on laboratory and clinical practice, both in scope—for example with the introduction of routine reporting of the estimated Glomerular Filtration Rate (eGFR)—and in reach, affecting clinical practice throughout the world.  In late 2012, this guideline was superseded by the 2012 Kidney Disease, Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. A product of large scale international collaboration, the KDIGO guideline builds on many of the initiatives of the previous version and also introduces new recommendations for laboratory testing and interpretation. This guideline has already made a significant impact in the global setting. As laboratory medicine professionals, we need to understand the needs of requesting clinicians and provide results which support decisions based on evidence-based clinical guidelines. To do so, we must understand both the guideline and its optimal implementation in our local settings. 
The KDIGO recommendations for laboratory practice are summarised here, along with additional information and discussion.

Novel Blood Test Shows Who Has and Who May Get Cancer
Scientists at the University of Bradford in West Yorkshire, U.K. say they have developed a new blood test that can determine if an individual has cancer. The lymphocyte genome sensitivity (LGS) test could not only detect some cancers earlier than ever before, but it may eventually eliminate the need for some types of biopsies, as well as identify those more likely to develop cancer in the future, according to the research team. The study (“Sensitivity and specificity of the empirical lymphocyte genome sensitivity assay: implications for improving cancer diagnostics”) was published in the FASEB Journal. To develop this test, Diana Anderson, Ph.D., and colleagues took blood samples from a group of people that included healthy individuals, cancer patients, and people believed to be at a higher risk than normal to develop cancer. Lymphocytes in these samples were examined in a comet test, by embedding the cells in agar on a microscope slide. In this test, damage to the DNA of the cells was caused by treatment with ultraviolet (UVA) light. This damage was observed in the form of DNA pieces being pulled within the agar in an electric field toward the positive end of the field. This caused a comet-like tail, and the longer the tail, the more DNA damage.

Blood Markers Predict CKD Heart Failure
Elevated levels of high-sensitivity troponin T (hsTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) strongly predicted heart failure in patients with chronic kidney disease followed for a median of close to 6 years, researchers reported. Compared with patients with the lowest blood levels of hsTnT, those with the highest had a nearly five-fold higher risk for developing heart failure and the risk was 10-fold higher in patients with the highest NT-proBNP levels compared with those with the lowest levels of the protein, researcher Nisha Bansal, MD, of the University of Washington in Seattle, and colleagues wrote online in the Journal of the American Society of Nephrology.

Researchers Discover Potential Biomarker to Detect ‘Bubble Boy’ Disorder 
A genetic disease called SCID, short for severe combined immunodeficiency, forces patients to breathe filtered air and avoid human contact because their bodies’ natural defenses are too weak to fight germs. Although it affects fewer than 2,000 new births each year worldwide, SCID is a cousin to acquired immune deficiency syndrome triggered by a human immunodeficiency virus — HIV/AIDS. Now, using a mouse model, Virginia Tech researchers in the September issue of The ISME Journal describe a potential biomarker to detect SCID by analyzing for a microbe in the fecal matter of infants.

Researchers Hope to Diagnose Deadly Ebola Virus With Nanotech
Scientists have built a prototype of a device that can diagnose the deadly Ebola virus by shining light on viral nanoparticles on silicon. A team of researchers at Boston University's College of Engineering and its School of Medicine has been working for the past five years to develop a portable device that uses a silicon chip to diagnose a patient with Ebola, or other hemorrhagic fever diseases like the Marburg virus or Lassa Fever. What's potentially important about this diagnostic device is that it could easily be used in remote areas with limited electrical and medical resources. "What motivates us is that there are some really good tests to diagnose these diseases but none of these tests are easily transported where they are needed," said John H. Connor, an associate professor in BU's Department of Microbiology and a virologist on the research team. "They have to fly in heavy, electricity-requiring machines that require specialized training and special ingredients to make the diagnostics work properly. They're expensive, time intensive and, most importantly, they're pretty much locked to a clinical lab."

Researchers Use Synthetic Biomarkers to Catch A Clot
Tests that look for biomarkers could help physicians diagnose disease before symptoms present themselves. But it’s difficult to find the right protein, metabolite, or other molecule in the body that signals the start of a disease. Now researchers have described a sensitive new assay that generates its own synthetic biomarkers to detect harmful blood clots in mice (J. Am. Chem. Soc. 2014, DOI: 10.1021/ja505676h). To create the assay, the scientists combined technologies their two groups had been working on: Bhatia’s group had synthesized worm-shaped iron oxide nanoparticles that they decorated with molecules to home in on diseased cells, while Walt’s team had developed single-molecule arrays (SiMoA) that allowed them to detect extremely low quantities of biological compounds of interest. For the new assay, the two teams decorated the nanoworms with a peptide that can be cleaved by thrombin, an enzyme activated at high levels in clotting disorders. When the nanoparticles bump into active thrombin in a mouse with clotting problems, the enzymes clip off a labeled peptide that the mice then excrete in their urine. The researchers then treat the urine with an antibody-labeled microbead and a reporter protein conjugated to streptavidin. The antibodies on the beads bind to one end of the excreted peptide, while the streptavidin conjugate binds to the other end. So in the presence of the synthetic biomarker, the microbeads end up decorated with the reporter protein. The scientists then distribute the beads in an array of microwells only large enough for one bead to fit in each. They treat the wells with a compound that glows when cleaved by the reporter protein and then count glowing wells. The team can then relate this number to the degree of clotting in the mouse.

GE Healthcare to Collaborate With GlaxoSmithKline on Commercial Oncology Testing
GE Healthcare has announced an agreement between its affiliate, Clarient Diagnostic Services, Inc., (Clarient) and GlaxoSmithKline (GSK). The collaboration aims to improve access to diagnostic testing for cancer patients by establishing a network of clinical laboratories to identify genetic mutations associated with different tumor types. The collaboration will enable GE to develop a broader laboratory and data analytics service that will foster better efficiency in the healthcare market related to oncology precision medicine. This will be made available as a subscription-based service and operated by GE Healthcare.

Quest Diagnostics Unveils New State-of-the-Art Clinical Laboratory in Marlborough, Massachusetts 
When fully operational, the facility is expected to employ 1,350 health care professionals – 100 more than originally projected by the company in 2013 when it announced plans to establish a major laboratory in Marlborough to serve New England.  The facility will house operations and employees from approximately half a dozen of the company's clinical laboratories spread across Massachusetts and Connecticut. It will also provide the base for Quest's first diagnostic research and development (R&D) center in New England and only its third in the United States. The R&D center will focus on advanced technologies, including next generation sequencing, as well as neurology, reproductive genetics and other specialized medical fields. Additional capabilities will include bioinformatics and population-health analytics to mine the company's national testing data to uncover insights that will help clinicians and health systems identify gaps in care.
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Research and Development

Study of Identical Twins Reveals Type 2 Diabetes Clues
By studying identical twins, researchers from Lund University in Sweden have identified mechanisms that could be behind the development of type 2 diabetes. This may explain cases where one identical twin develops type 2 diabetes while the other remains healthy. The study involved 14 pairs of identical twins in Sweden and Denmark. One twin had type 2 diabetes and the other was healthy. "Twins are a good model for finding mechanisms, but the results are applicable to all", said Emma Nilsson, who carried out the study with Charlotte Ling. We know that fat tissue can release hormones and regulate metabolism in different organs in the body. The question the researchers posed was whether epigenetic* changes in the DNA lead to changes in the fat tissue that in turn can lead to the development of type 2 diabetes. The researchers investigated DNA methylation* at 480 000 points on the DNA and looked at how it affected the expression of the genes in the identical twins. They found that genes that are involved in inflammation were up-regulated and that genes involved in the fat and glucose metabolism were down-regulated in those who had diabetes. "This means that they are not able to process fat as well, which leads to raised levels of fat in the blood and uptake of fat by other organs instead, such as the muscles, liver or pancreas. This causes insulin resistance, which leads to type 2 diabetes", said Emma Nilsson.

3D Technologies Poised to Change How Doctors Diagnose Cancers
Scientists at the Food and Drug Administration are studying the next generation of screening and diagnostic devices, some of which borrow from the world of entertainment. Soon, three-dimensional (3D) images in actual 3D might help your doctor find hidden tumors and better diagnose cancers, thanks to the regulatory work being done by a team at FDA’s Division of Imaging, Diagnostics, and Software Reliability. The team is led by Division Director Kyle Myers, a physicist with a Ph.D. in optical sciences. It includes Aldo Badano, Ph.D., a world-renowned expert in display evaluation technology, and Brian Garra, M.D., a diagnostic radiologist doing research in regulatory science at FDA. They are studying how clinicians receive visual information and analyze it to diagnose a disease. At the center of their research are breast cancer screening devices, which are making the leap from traditional two-dimensional (2D) screening such as mammography to 3D breast tomosynthesis, 3D ultrasound and breast computerized tomography (CT). This technology is very exploratory and years away from becoming standard in your doctor’s office.

Stem Cell Discovery Could Lead to Better Treatments for Blindness 
Scientists at the University of Southampton have discovered that a region on the front surface of the eye harbours special stem cells that could treat blinding eye conditions. This part of the eye is called the 'corneal limbus' and is a narrow gap lying between the transparent cornea and white sclera. The research, published in PLOS ONE, showed that stem cells can be cultured from the corneal limbus in vitro. Under the correct culture conditions, these cells could be directed to behave like the cells needed to see light - photoreceptor cells.

Scientists Explain How Rabies 'Hijacks' Neurons to Attack the Brain
Rabies causes acute inflammation of the brain, producing psychosis and violent aggression. The virus, which paralyzes the body's internal organs, is always deadly for those unable to obtain vaccines in time. Some 55,000 people die from rabies every year. For the first time, Tel Aviv University scientists have discovered the exact mechanism this killer virus uses to efficiently enter the central nervous system, where it erupts in a toxic explosion of symptoms. The study, published in PLOS Pathogens, was conducted by Dr. Eran Perlson and Shani Gluska of TAU's Sackler Faculty of Medicine and Sagol School of Neuroscience, in collaboration with the Friedrich Loeffler Institute in Germany. "Rabies not only hijacks the nervous system’s machinery, it also manipulates that machinery to move faster," says Perlson. "We have shown that rabies enters a neuron in the peripheral nervous system by binding to a nerve growth factor receptor, responsible for the health of neurons, called p75. The difference is that its transport is very fast, even faster than that of its endogenous ligand, the small molecules that travel regularly along the neuron and keep the neuron healthy."

Scientists Identify Rare Stem Cells in Testis That Hold Potential for Infertility Treatments
Rare stem cells in testis that produce a biomarker protein called PAX7 help give rise to new sperm cells — and may hold a key to restoring fertility, research by scientists at UT Southwestern Medical Center suggests. Researchers studying infertility in mouse models found that, unlike similar types of cells that develop into sperm, the stem cells that express PAX7 can survive treatment with toxic drugs and radiation. If the findings hold true in people, they eventually could lead to new strategies to restore or protect fertility in men undergoing cancer treatment.
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Public Health and Patient Safety

Tobacco Tied to Higher Risk of Oral HPV Infection, Study Finds
Tobacco use in any form appears to be linked to an increased risk of infection with oral human papillomavirus type 16 (HPV16), a virus that can cause cancers of the mouth and throat, according to Johns Hopkins University researchers. The odds of being infected with HPV16, a sexually transmitted disease, rise as tobacco use increases, the researchers said. As few as three cigarettes a day can increase the risk of infection with HPV by almost one-third, according to the study. How tobacco use might influence HPV16 infection isn't clear, said lead researcher Dr. Carole Fakhry, an assistant professor of otolaryngology-head and neck surgery at Johns Hopkins University School of Medicine. "We don't fully understand oral HPV16," she said. "People exposed to tobacco could be more likely to become infected after exposure to HPV16 or less likely to get rid of the infection."

New HPV Vaccine Could Prevent 90% of Cervical Cancers
An in-the-works HPV vaccine could prevent against up to 90% of cervical cancers, according to new research in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research. The majority of cervical precancers are caused by nine subtypes of the human papillomavirus (HPV). A vaccine is currently being developed by Merck to be effective against those nine HPV types. The current HPV vaccine, Gardasil, which is also made by Merck, fights four subtypes of HPV and protects against 70% of cervical cancers.
Merck funded this new study.

Enterovirus D68 in the United States, 2014
What We Know
  • EV-D68 infections have recently been documented across the United States.  
    • From mid-August to October 6, 2014, CDC or state public health laboratories have confirmed a total of 594 people in 43 states and the District of Columbia with respiratory illness caused by EV-D68. Learn about states with confirmed cases. This indicates that at least one case has been detected in each state listed but does not indicate how widespread infections are in each state.
    • Enteroviruses commonly circulate in summer and fall. We’re currently in middle of the enterovirus season, and EV-D68 infections are likely to decline later in the fall.

UC Santa Cruz Ebola Genome Browser Now Online to Aid Researchers' Response to Crisis
The UC Santa Cruz Genomics Institute released a new Ebola genome browser to assist global efforts to develop a vaccine and antiserum to help stop the spread of the Ebola virus. The team led by University of California, Santa Cruz researcher Jim Kent worked around the clock for the past week, communicating with international partners to gather and present the most current data. The Ebola virus browser aligns five strains of Ebola with two strains of the related Marburg virus. Within these strains, Kent and other members of the UC Santa Cruz Genome Browser team have aligned 148 individual viral genomes, including 102 from the current West Africa outbreak. UC Santa Cruz has established the UCSC Ebola Genome PortalExternal Web Site Icon, with links to the new Ebola genome browser as well as links to all the relevant scientific literature on the virus. 

Heroin Overdose Deaths Increased in Many States Through 2012
Still twice as many people died from prescription opioid overdoses
Heroin deaths increased sharply in many states, according to a report of death certificate data from 28 states published by the Centers for Disease Control and Prevention in this week’s Morbidity and Mortality Weekly Report. Despite these findings, still more than twice as many people died from prescription opioid overdoses as died from heroin in these states in 2012. Though not directly addressed by this study, two things appear to be driving the increase in heroin overdoses: (1) widespread prescription opioid exposure and increasing rates of opioid addiction; and (2) increased heroin supply. While the majority of prescription opioid users do not become heroin users, previous research found that approximately 3 out of 4 new heroin users report having abused prescription opioids prior to using heroin. This relationship between prescription opioid abuse and heroin is not surprising; heroin is an opioid, and both drugs act on the same receptors in the brain to produce similar effects. Heroin often costs less than prescription opioids and is increasingly available.

Nodding Syndrome May be Spread by Blackflies 
Despite decades of research, scientists have yet to pinpoint the exact cause of nodding syndrome (NS), a disabling disease affecting African children. A new report suggests that blackflies infected with the parasite Onchocerca volvulus may be capable of passing on a secondary pathogen that is to blame for the spread of the disease. New research is presented in the International Journal of Infectious Diseases.  "We hypothesize that blackflies infected with Onchocerca volvulus microfilariae may also transmit another pathogen," notes lead investigator Robert Colebunders, MD, PhD, who is head of the HIV/STD Unit, Department of Clinical Sciences at the Institute of Tropical Medicine, and Professor of Infectious Diseases at the University of Antwerp. "This may be a novel neurotropic virus or an endosymbiont of the microfilariae, which causes not only NS, but also epilepsy without nodding."
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Health IT

New FDA Strategic Roadmap Includes Health IT-related Goals
The U.S. Food and Drug Administration unveiled a new roadmap that outlines its strategic priorities through 2018. According to FDA Commissioner Margaret Hamburg, the plan--which includes many health IT-related goals--was in development for more than a year. "More often than not today, a drug or medical product that ends up on the shelves of an American drugstore or in our hospitals will come, at least in part, from some foreign source," Hamburg said in a blog post touting the roadmap. "Nearly 40 percent of finished medicines that Americans now take are made elsewhere, as are about 50 percent of all medical devices. … These and other new challenges and transformative developments in global science, technology and trade are rapidly altering the environment in which we work to fulfill our broad public health mission. 

25 Years of Health IT: Highs & Lows
"The industry has rapidly deployed the dramatic changes and innovated as a result of the last several years after the Affordable Care Act," said Ash Shehata, partner in the Global Healthcare Center of Excellence at KPMG. "IT has been at the center of the transformation." Take a look back at some of the key ways health IT has achieved its early promise, and still has a long way to go.
5 Highs
  • Electronic health records
  • Rise of the healthcare CIO
  • Democratization of healthcare
  • Analytics
  • Electronic data interchange
5 Lows
  • Breaches
  • Lack of interoperability
  • Telemedicine adoption
  • Preventable errors
  • Mixed messages

Will EHR Data Stand Up in Court?
While healthcare stakeholders naturally focus on the medical reliability of data recorded in EHRs, there's another question worth asking: Would the information EHRs contain stand up in a court of law? According to a new analysis published in the Ave Maria Law Review, the answer is a pretty clear "No."
There has been no shortage of debate among healthcare stakeholders concerning whether EHRs are reliable and, if not, how to make them so. But the three authors of the Ave Maria piece take, not surprisingly, a lawyer's view on the question of reliability. And almost from the beginning they point to some significant problems. For example, they cited the fact that the data in EHRs are used, naturally, to determine payments to providers. Consequently, "there is a substantial financial incentive to attuning (sic) the record systems' functional priorities to assure that the resulting record artifact leverages the maximum payment, dissociated from its accuracy and reliability as a business record of patient care events."
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Other News

Most Clinical Laboratories and Pathology Groups are Under Pressure to Cut Costs and Deal With Shrinking Budgets for 2015
The challenge facing medical lab managers and pathologists is to intelligently cut costs in their labs without laying off med techs, histotechs, and other lab scientists By any measure, this year’s budget season is a tough one for the nation’s clinical laboratories and pathology groups. Most labs are scrambling to adjust to reduced reimbursement and directives from their parent hospitals and health systems to shrink their lab budgets for 2015. It’s why smart cost-cutting tops the list of challenges at all medical laboratory managers and pathologists. Lab leaders need effective approaches to trim spending in their lab without the need to lay off skilled medical technologists and other experienced lab scientists.

FDA: Warning Letters Hit 5-year Low in 2013
The number of warning letters sent by the FDA to medical device companies dipped for the 1st time since 2009, according to a report from the agency's Center for Devices & Radiological Health. The CDRH sent 144 warning letters to medtech makers in 2013, according to the report, compared with 164 last year, a 12.2% decline, according to the report. Of the U.S. firms inspected by the agency, 4% received warning letters, the agency said.

Washington Hospital Prices Vary Broadly
As is the case in most parts of the country, hospital prices in Washington state are all over the map, with multiples of three or four between facilities for the same procedure. A knee or hip replacement surgery, for instance, costs $92,000 at Multicare Good Samaritan Hospital in Puyallup--four times the cost of the identical surgery at Wenatchee Valley Hospital, according to the Washington Health Alliance, a not-for-profit advocacy group, which released the price data for the state's hospitals. The data was culled from Medicare reports from 2011 and 2012.
"Understanding hospital sticker prices in advance of a hospital stay can help both insured and uninsured patients reduce sticker shock," John Gallagher, a spokesperson for the organization, told theSeattle Times.

The Future of Nursing: An industry in Flux
Like the healthcare industry as a whole, the nursing profession constantly evolves and adapts to meet new demands and changes. Amid debates about the nursing shortageExternal Web Site Icon, changes to nurses' scope of practiceExternal Web Site Icon and educational requirements, only one thing is certain--the future of nursing remains in flux. In this special report, FierceHealthcare talks exclusively with Beverly Malone, Ph.D., R.N., CEO of the National League for Nursing, about the issues, expectations and challenges nurses of the future will face, from an aging workforce to a shortage of nurse educators to overcoming a lack of diversity in the field.
Source: Web Site Icon

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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