viernes, 11 de abril de 2014



Healthcare News

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


April 10, 2014


View Previous Issues - Healthcare News Archive


First Look at Medicare Data in 35 Years

Reimbursements to doctors who provide Medicare services in 2012 ranged from nearly $21 million to a single Florida ophthalmologist to the $27,000 for the average anesthesiologist, according to the first look at government payment data in 35 years. The data were released this week by the Center for Medicare Services after a court order lifted an injunction sought by the American Medical Association had been in place since 1979. 
Health officials have debated releasing the data for decades, said Gail Wilensky, former Medicaid program director under President George H.W. Bush. Opponents of releasing the information said people may not understand how to use it. In the 1990s, she said, hospitals made the same argument when required to release mortality rates. "A lot of the same issues were raised; people wouldn't understand," Wilensky said. "That's always the first line of argument to data being released." Transparency outweighs potential damage, she said, adding there should be a fast way for providers to correct errors. "Making information public has a way of improving the accuracy and validity of information," Wilensky said. "Now there are a lot of parties interested in it being correct." The data show the providers' names, addresses, specialties, billing rates, the amount paid by Medicare, number of Medicare beneficiaries and number of services provided for every Medicare provider. Each provider lists a billing rate per service, and then what Medicare actually paid.

Be an Advocate – Promote the Profession During Medical Laboratory Professionals Week

Each year, a week is set aside to celebrate the numerous laboratory professionals around the nation. Fourteen sponsoring organizations collaborate to promote Medical Laboratory Professionals Week, which will take place April 20-26, 2014. It is during this time that we must take on the role of advocate for the profession to be the voice and provide the face to educate and inform others of the vital role played by each and every one of us. The people within the lab are highly skilled, dedicated professionals working together to provide high quality patient care. The lab is not buttons and machines, but highly trained individuals who collect specimens from you or your loved ones in the hospital; interpret the tests that bring relief to the families waiting for results; maintain instruments to provide state of the art analysis; perform quality control measures to ensure that the results provided for your family are as accurate as possible; correlate the clinical situation with the patient condition as a means of providing valuable information to physicians; and continue to collect, test and report vital information for your health and well-being.

Fixing the Problem of Mislabeled Specimens in Clinical Labs

The incidence of patient identification errors, including mislabeled and misidentified specimens, is much too high in clinical laboratories. The best data on errors in U.S. laboratories is derived from three separate College of American Pathologists (CAP) Q-Probe studies, in which the reported rates of mislabeled specimens were 0.39/1000 in 120 institutions (2006), 0.92/1000 in 147 clinical labs (2008), and 1.12% of blood bank specimens in 122 clinical labs (2010). These are sobering statistics, especially for professionals engaged in providing life-sustaining health services. None of us will disagree that the goal for all laboratories is zero misidentified specimens. But how to realize that aim is less clear. Some of the solutions are easy to implement and others are more costly and involved.
Specimen Labeling Problem Points:
  • Patient misidentification at the time of collection
  • Incorrect barcode reads on point-of-care devices
  • Use of handwritten labels at any point
  • Labeling mix-ups immediately before or after collection
  • Mislabeling during laboratory accessioning, aliquoting, and post-centrifugation pour-off
  • Relabeling specimens that already have an existing label from another system, such as may occur in a core laboratory or a reference laboratory

Fearing Punishment for Bad Genes

About 700,000 Americans have had their DNA sequenced, in full or in part, and the number is rising rapidly as costs plummet — to $1,000 or less for a full genome, down from more than $1 million less than a decade ago. But many people are avoiding the tests because of a major omission in the 2008 federal law that bars employers and health insurers from seeking the results of genetic testing. The Genetic Information Nondiscrimination Act, known as GINA, does not apply to three types of insurance — life, disability and long-term care — that are especially important to people who may have serious inherited diseases. Sponsors of the act say that they were well aware of the omission, but that after a 14-year effort to write and pass the law, they had to settle for what they could get. That leaves many patients who may be at risk for inherited diseases fearful that a positive result could be used against them.

Sidestepping the Biopsy With New Tools to Spot Cancer

For people with cancer or suspected cancer, the biopsy is a necessary evil — an uncomfortable and somewhat risky procedure to extract tissue for diagnosis or analysis. Lynn Lewis, a breast cancer patient in Brooklyn, has had her cancer analyzed an easier way: simple blood tests that are being called “liquid biopsies.” Telltale traces of a tumor are often present in the blood. These traces — either intact cancer cells or fragments of tumor DNA — are present in minuscule amounts, but numerous companies are now coming to market with sophisticated tests that can detect and analyze them. While the usefulness of the tests still needs to be proved, proponents say that because liquid biopsies are not invasive, they can be easier to repeat periodically, potentially tracking the disease as it evolves and allowing treatments to be adjusted accordingly.

Stool Test 'Accurate for Diagnosing Bowel Diseases'

UK scientists say they have found a way of diagnosing different types of bowel disease by testing the smells given off by patients' stools. The test analyses the chemical compounds emitted and recognises the profile of different diseases. In a study of 182 stool samples from patients with inflammatory bowel disease and irritable bowel syndrome, the results were 76% accurate. The research team said the test could provide more accurate diagnoses. The University of the West of England study, published in the Journal of Breath Research, used a testing system they built combining a gas chromatograph and a metal oxide sensor to recognise patterns specific to known diseases. These patterns are created by volatile organic compounds emitted from stool samples, which are a good indicator of the conditions in the patient's gastrointestinal tract.

Faster Genetic Testing Method Will Likely Transform Care for Many Patients With Breast Cancer

Faster and cheaper DNA sequencing techniques will likely improve care for patients with breast cancer but also create challenges for clinicians as they counsel patients on their treatment options. Those are among the conclusions of a study published recently in the BJS (British Journal of Surgery). The findings provide insights into how genetic advances will soon be affecting patient care. Next generation sequencing (NGS) is a newer method of sequencing DNA that processes large amounts of data. It's faster and more expensive than conventional sequencing, but in recent years it has become cheaper and more widely accessible by rapid advances in computing power. With the use of NGS, which will soon become the mainstay of clinical genetics, breast cancer units will likely be able to get the results of genetic testing before patients begin their breast cancer treatment.


Urine Test Could Help Predict Recurrence of Bladder Cancer

Individuals who have had bladder cancer in the past are at high risk of recurrence, but researchers publishing in the journal Clinical Cancer Research say a simple DNA methylation marker test in urine can predict tumor recurrence. The researchers were led by Gangning Liang, PhD, an associate professor in the Department of Urology at the University of Southern California Norris Comprehensive Cancer Center in Los Angeles. He says that non-muscle-invasive bladder cancer (NMIBC) comprises 80% of all bladder cancer cases. There is a high rate of recurrence with this cancer, which Liang says leads to high treatment costs. "The current standards for monitoring of bladder cancer recurrence are either unreliable or invasive," he adds. "We wanted to find reliable biomarkers to monitor recurrence of NMIBC using a noninvasive assay."

RPS In-Office Dry-Eye Test Gets CLIA Waiver

Rapid Pathogen Screening has received a Clinical Laboratory Improvement Amendments waiver from the Food and Drug Administration for InflammaDry—a rapid, disposable, in-office test to aid in the diagnosis of dry-eye disease. The InflammaDry test detects elevated levels of matrix metalloproteinase 9, a clinically relevant inflammatory marker, in the tears of patients with dry-eye disease. InflammaDry is a single-use test that requires no additional equipment to administer or interpret results. Using only a small sample of human tears, the four-step process takes less than two minutes to complete and results are available in 10 minutes.


Re-excision Unnecessary in Mild to Moderate Atypical Nevi

Re-excision of atypical nevi with microscopic margins on initial biopsy, currently a fairly common practice, might be unnecessary in mild or moderate cases, according to a retrospective analysis. "There's no consensus on what management of atypical nevi should be," said Michael Cashman, MD, a dermatology resident at Medstar Washington Hospital Center, Georgetown University Hospital, Washington, DC. "There should be practice guidelines, but we can't establish guidelines unless there's evidence-based research," he told Medscape Medical News.


Pathologists in Canada Address Handling and Use of Tissue Specimens for Clinical Diagnostic Purposes at IQMH Conference in Toronto

Two developments in healthcare and laboratory medicine underpinned the primary discussion that took place over the two days of this conference. The first development centered upon recognition by healthcare practitioners and patients that the quality and accuracy of anatomic pathology testing needs to improve continuously over time. In other words, the level of quality that may be acceptable today will not meet the expectations of patients in coming years.
The second development is the rapid take-up of molecular diagnostics and genetic testing for clinical purposes. Because of advances in molecular and next-generation gene sequencing technologies, anatomic pathology laboratories need to reassess long-standing practices in how tissue is collected, transported, processed, and diagnosed. Traditional steps in tissue handling and processing often fail to meet the quality and integrity requirements of ever-more sensitive and specific molecular assays and genetic tests.


Hopkins Looks at Screening for Postpartum Depression

An estimated 10 percent to 20 percent of pregnant women will develop postpartum depression, a condition that plagues new mothers with persistent feelings of sadness, hopelessness, exhaustion and anxiety that can last up to a year after giving birth. In women with a history of mood disorders such as depression and bipolar disorder, the rates rise to 35 percent to 40 percent. Until now, there has been no reliable way to screen for postpartum depression in advance. But new research by Zachary Kaminsky, Ph.D., an assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, may change that. A study of 50 women with a history of mood disorders revealed that a simple blood test during pregnancy can determine genetic predictors of postpartum depression with 85 percent accuracy. Kaminsky says the data indicated that women at risk were more sensitive to estrogen. This is determined by studying epigenetic codes — marks on DNA that affect how genes respond. “We can take blood during pregnancy, and we can look for these marks and have a pretty accurate guess as to whether a woman’s going to get postpartum depression or not,” he says.


Blood Clot Alliance Asks Congress for $4 Million to Save 100,000 Lives a Year

The National Blood Clot Alliance (NBCA) is calling on Congress for $4 million in each of the next five years to support better awareness and avoidance of blood clots. The Alliance maintains that this relatively modest spending could save as many as 100,000 lives a year - more than three times the number claimed by breast cancer each year - and as much as $10 billion annually in avoidable hospital readmissions by lowering the incidence of misdiagnosis and the failure to take preventative measures to avoid blood clots. Since 2010, funding to the Centers for Disease Control and Prevention (CDC) for education and prevention of blood clots has been cut by more than half, to less than $600,000. 


Red Blood Cell Diagnostic Testing Using Flow Cytometry

This guideline addresses the diagnostic red blood cell (RBC) assays performed as fluorescence-based assays on a flow cytometry platform; including testing procedures for fetomaternal hemorrhage detection, paroxysmal nocturnal hematuria screening, membrane defect anemia testing for hereditary spherocytosis, and nucleated RBC counting. Points of validation and quality control, and caveats of interpretation are also discussed.


Laboratory Testing for the Lupus Anticoagulant

This document provides guidance and recommendations regarding the proper collection and handling of the specimen; descriptions and limitations of screening and confirmatory assays, and mixing tests used to identify lupus anticoagulant (LA); determination of cutoff values and calculations associated with the various assays; and interpretation of test results in an LA panel.


After Stakeholder Comments, CMS Ups BRCA Testing Reimbursement

The Centers for Medicare & Medicaid Services has decided to revise the reimbursement for the CPT code describing BRCA testing from $1,438 to $2,184.  In public comments, industry stakeholders had criticized CMS for failing to follow gapfill procedures for establishing payment levels for molecular pathology codes when it finalized pricing in December for CPT code 81211 and 81214 at $1,438. Code 81211 describes a test for the full sequencing of the BRCA1/ 2 genes and code 81214 is for full sequencing of only the BRCA1 gene.


J&J Accepts $4B Carlyle Offer for Diagnostics Unit

Johnson & Johnson has accepted an offer of about $4 billion from the private equity firm the Carlyle Group to buy its Ortho-Clinical Diagnostics business. The Ortho-Clinical business serves hospitals, testing laboratories and blood banks. It supplies equipment and chemicals to screen donated blood for HIV, hepatitis C and other serious diseases. It also makes technology for advanced testing of blood to diagnose health conditions and to monitor medication effects.


Roche to Buy Testing Equipment Maker for Up to $450 Million

The Swiss drug maker Roche Group said that it had agreed to pay up to $450 million to acquire IQuum, a maker of medical testing equipment based in Massachusetts. The deal is expected to expand Roche’s offerings in its molecular diagnostic testing business.


NIH-funded Atlas Details Gene Activity of the Prenatal Human Brain, Offers Clues to Psychiatric Disorders

A comprehensive three-dimensional atlas of the developing human brain that incorporates gene activity along with anatomical reference atlases and neuroimaging data has released its first major report online in Nature. This National Institutes of Health (NIH)-funded resource, freely available to the public, enables researchers to answer questions related to the early roots of brain-based disorders such as autism and schizophrenia. The BrainSpan Atlas aims to inspire new hypotheses regarding human brain development, and has already led to some surprising findings. For example, the study authors found significant differences between mouse and human brains in the subplate zone, a developmentally transient structure critical for proper cortical development. On the other hand, the researchers expected to find a unique molecular signature for the outer portion of the subventricular zone, an area which is not found in mice and which contains a hugely expanded pool of neuronal stem cells that give rise to our greatly expanded neocortex. Surprisingly, despite its much larger size, no significant differences were found between this zone and the inner portion of this layer that is conserved from mouse to human.


Spinal Stimulation Helps Four Patients With Paraplegia Regain Voluntary Movement

Groundbreaking results bring new hope for those with spinal cord injury – NIH study
Four people with paraplegia are able to voluntarily move previously paralyzed muscles as a result of a novel therapy that involves electrical stimulation of the spinal cord, according to a study funded in part by the National Institutes of Health and the Christopher & Dana Reeve Foundation. The participants, each of whom had been paralyzed for more than two years, were able to voluntarily flex their toes, ankles, and knees while the stimulator was active, and the movements were enhanced over time when combined with physical rehabilitation. Researchers involved in the study say the therapy has the potential to change the prognosis of people with paralysis even years after injury.

Living Organ Regeneration 'First' by Gene Manipulation

An elderly organ in a living animal has been regenerated into a youthful state for the first time, UK researchers say. The thymus, which is critical for immune function, becomes smaller and less effective with age, making people more susceptible to infection. A team at the University of Edinburgh managed to rejuvenate the organ in mice by manipulating DNA. Experts said the study was likely to have "broad implications" for regenerative medicine. The thymus, which sits near the heart, produces T-cells to fight off infection. However, by the age of 70 the thymus is just a tenth of the size in adolescents. "This has a lot of impacts later in life, when the functionality of the immune system decreases with age and you become more vulnerable to infection and less responsive to vaccines," one of the researchers, Dr Nick Bredenkamp, told the BBC. The results, published in the journal Development, showed that boosting Foxn1 activity in elderly mice could give them the thymus of a much younger animal.  

Muscle Paralysis Eased by Light-sensitive Stem Cells

A genetic tweak can make light work of some nervous disorders. Using flashes of light to stimulate modified neurons can restore movement to paralysed muscles. A study demonstrating this, carried out in mice, lays the path for using such "optogenetic" approaches to treat nerve disorders ranging from spinal cord injury to epilepsy and motor neuron disease. Optogenetics has been hailed as one of the most significant recent developments in neuroscience. It involves genetically modifying neurons so they produce a light-sensitive protein, which makes them "fire", sending an electrical signal, when exposed to light.


Scientists Study Genome of Tamiflu-resistant Flu

Tamiflu is one of the few available treatments for those who come down with the flu. But the virus quickly develops resistance; multiplying at a rate of several generations a day, these tiny pathogens rapidly accumulate genetic mutations. Because of this, they have a good chance of developing counterattacks to the antiviral. How can these infinitesimal variations be identified within the immensity of the virus’ genetic code? EPFL researchers have created a computer tool that can shed light on the flu virus’ formidable adaptability. They were able to find mutations that conferred resistance that had up to this point not yet been identified. Their software has been made freely available to researchers everywhere, and is the subject of an article published in the journal PLOS Genetics.


FDA Panel Recommends 2 New Anti-MRSA Agents

The Anti-Infective Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted unanimously to recommend approval of 2 new antibacterial agents for the treatment of skin and skin structure infections caused by gram-positive pathogens, including methicillin-resistantStaphylococcus aureus (MRSA). The 2 drugs are tedizolid phosphate (Sivextro, Cubist Pharmaceuticals, Inc), and dalbavancin (Dalvance, Durata Therapeutics, Inc). Each drug has gone through two phase 3 noninferiority clinical trials and has been considered for approval under the Generating Antibiotic Incentives Now (GAIN) initiative signed into law in 2012 as part of the Food and Drug Safety and Innovation Act. The incentive was designed to support development of new antibacterial drugs.


FMT Colonoscopy Most Cost-Effective Treatment for Recurrent C. diff

When comparing four treatments for recurrent Clostridium difficile, researchers found fecal microbiota transplant colonoscopies may be the most cost effective, according to a study in Clinical Infectious Diseases. Researchers concluded FMT is the most cost-effective initial treatment for recurrent C. diff.


Two Major Studies Associate Cancer and Heart Disease With Vitamin D Deficiency

The two studies, both of which appeared in the journal BMJ, are meta-analyses, including data on more than a million people. They include observational findings as well as evidence from randomized controlled trials.
One study, conducted by Harvard and Oxford University researchers, along with members of other institutions, finds that adults with lower levels of vitamin D have a 35% greater chance of dying of heart disease and a 14% higher risk of dying of cancer. The researchers report that ingesting supplements of vitamin D2 confers no benefit, but that, for adults, supplementing diet with vitamin D3 is associated with an 11% reduction in death from all causes. The researchers conclude that Vitamin D deficiencies contribute to 13% of deaths in the United States.
The other study, conducted by researchers from Stanford and several European universities, is somewhat more conservative in its conclusions. While acknowledging “suggestive evidence” that high vitamin D levels have a protective effect against hypertension, diabetes, and other diseases, they assert that “highly convincing” evidence is lacking for the value of vitamin D supplementation. 

Aspirin Lacks Post-surgical Benefits and Raises Bleeding Risks, Study Finds

Giving aspirin to patients around the time of surgery may do them more harm than good, a large new study finds. Surgery of any kind – not just heart surgery – may raise a person's risk for having a heart attack, research has shown. Doctors often start patients on a low dose of aspirin shortly before and after their procedures to help prevent those events.


Can a Transplant Drug Help Eliminate Lingering HIV Infections?

Researchers studying the effects of immune suppressant drugs on transplant patients with HIV have made a surprising discovery: A drug intended to hobble the body's defense system may actually help destroy dormant reservoirs of the virus that causes AIDS. In a paper published in theAmerican Journal of Transplantation, authors found that when a small group of transplant patients received the drug sirolimus, they experienced a two-to-threefold drop in HIV levels, whereas patients who received other immunosuppressants did not.


Single Drug May Suffice for Gram-Negative Bacteremia in Kids

Routine addition of an aminoglycoside to a β-lactam as empirical therapy for children with Gram-negative bacteremia may not be helpful except in those with risk factors for multidrug-resistant (MDRGN) organisms; according to a retrospective cohort study published online April 7 in Pediatrics. "Existing data do not demonstrate a need for combination therapy after antimicrobial susceptibility data indicate adequate in vitro activity with β-lactam monotherapy," write Anna C. Sick, MD, MPH, from the Department of Pediatrics, University of Pittsburgh Medical Center in Pennsylvania, and colleagues. "However, the role of empirical combination therapy for the treatment of Gram-negative bacteremia in children remains unsettled."


Prevalence of Herpes Simplex Virus 1 Declining in Adolescents

New research indicates that in 2005–2010, fewer adolescents were seropositive for herpes simplex virus type 1 (HSV-1) in comparison to 1999–2004, signaling a change in epidemiology that has implications not only for disease patterns of both oral and genital herpes but also for HSV vaccine development, timing, and delivery strategies. Researchers at the Centers for Disease Control and Prevention and Emory University conducted the analysis using nationally representative data from the National Health and Nutrition Examination Survey (NHANES).


How Running 'May Preserve Thinking Skills'

Aerobic exercise in your 20s may protect the brain in middle age, according to a US study. Activities that maintain cardio fitness - such as running, swimming and cycling - led to better thinking skills and memory 20 years on. Scientists say the research, reported in Neurology, adds to evidence the brain benefits from good heart health. Cardio fitness is a measure of how well the body absorbs oxygen during exercise and transports it to the muscles. Researchers at the University of Minnesota, Minneapolis, tested almost 3,000 healthy people with an average age of 25.


How You Digest Carbs May Influence Weight Gain, Study Says

The way your body digests carbohydrates may affect your risk for obesity, a new genetic study indicates. Researchers focused on a gene called AMY1, which is responsible for an enzyme in the saliva called salivary amylase. When food enters the mouth, the enzyme begins the process of starch absorption that continues in the digestive system. Starches are a type of carbohydrate. People typically have two copies of AMY1, but the number of copies can vary widely. It's believed that higher numbers of the gene evolved in response to diets that contained greater levels of starch, the researchers said. They studied the number of copies of AMY1 in thousands of people from France, Singapore, Sweden and the United Kingdom, and found those with a low number of copies were more likely to be obese.


Diet Rich in Beans, Lentils, Peas Lowers LDL

People who consumed a serving a day of dietary "pulses" -- such as beans, chickpeas, lentils and peas -- significantly reduced their low-density lipoprotein (LDL) cholesterol, a meta-analysis concluded. Those whose diets included a median pulse intake of 130 g/d had lower LDL cholesterol levels than those on a control diet (mean difference -0.17 mmol/L, 95% CI -0.25 to -0.09), according to John L. Sievenpiper, MD, PhD, of the University of Toronto in Canada, and his co-authors. The results were "equivalent to a reduction of about 5% from baseline" and consistent with the results of two previous meta-analyses, they wrote online in CMAJ.


Do Fat Teens Face an Early Death?

Life expectancy gains seen over the last half-century do not appear to extend to adults who were overweight or obese in adolescence, according to a large study spanning several decades. Overweight and obese teens in the study were more likely to die before reaching the age of 50 than their normal-weight peers, and the mortality trends of those born between 1970 and 1980 were no better than for those born decades earlier, Amir Tirosh, MD, PhD, of Harvard Medical School and Brigham and Women's Hospital, and colleagues wrote in the Journal of Clinical Endocrinology and Metabolism.


Improving Patient Safety Systems for Patients With Limited English Proficiency

A Guide for Hospitals
Research suggests that adverse events affect patients with limited English proficiency (LEP) more frequently, are often caused by communication problems, and are more likely to result in serious harm compared to those that affect English-speaking patients. This guide focuses on how hospitals can better identify report, monitor, and prevent medical errors in patients with LEP.
The goal of this guide is to help hospital leaders better understand how to address the issue of patient safety for limited-English-proficient (LEP) and culturally diverse patients. The guide can help hospital leaders:
  1. Foster a Supportive Culture for Safety of Diverse Patient Populations.
  2. Adapt Current Systems To Better Identify Medical Errors Among LEP Patients.
  3. Improve Reporting of Medical Errors for LEP Patients.
  4. Routinely Monitor Patient Safety for LEP Patients.
  5. Address Root Causes To Prevent Medical Errors Among LEP Patients.


Anti-vaccine Movement is Giving Diseases a 2nd Life

Recent measles outbreaks in New York, California and Texas are examples of what could happen on a larger scale if vaccination rates dropped, says Anne Schuchat, the CDC's director of immunizations and respiratory diseases. Officials declared measles, which causes itchy rashes and fevers, eradicated in the United States in 2000. Yet this year, the disease is on track to infect three times as many people as in 2009. That's because in most cases people who have not been vaccinated are getting infected by others traveling into the United States. Then, Schuchat says, the infected spread it in their communities.

Pharmacogenomics' Global Failure

Pharmacogenomics has failed the global health community because it has not yielded new research that could be used to help treat people with rare, orphan, and tropical diseases in underdeveloped and developing countries, according to a new article in Global Public Health. After conducting a review of pharmacogenomics studies that were published between 1997 and 2010, University of Montreal's School of Public Health bioethicist Catherine Olivier found that the pharmacogenomics research community has neglected to pursue science in these disease areas.


US Seeks to Foster Development Innovation With $1B-a-Year Lab

Inspired by such epochal breakthroughs as the "green revolution", not to mention the advent of humbler technologies including the cow manure-powered fridge, the US agency for international development (USAid) is to sink almost $1bn (£602m) a year into a new global development laboratory. The scheme will bring together scientists, corporations, universities and charities in a collective that will dream up and test new tools to fight poverty.


Types of Communication During the Review of Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Types of Communication During the Review of Medical Device Submissions.” The purpose of this  guidance is to update the Agency's approach to Interactive Review and other additional types of communication, to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed to in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III). These new Agency communication commitments are to increase the efficiency of the review process.


HHS Publishes FDASIA Framework for Health IT

The U.S. Department of Health & Human Services published the long-awaited proposed strategy and draft recommendations for a health IT risk-based framework mandated by the Food and Drug Administration Safety and Innovation Act. The 34-page draft report—a collaborative effort by officials from the FDA, the Federal Communications Commission and the Office of the National Coordinator for Health IT—outlines a strategy that identifies three categories of health IT: administrative health IT functions; health management health IT functions; and medical device health IT functions. Risk and corresponding controls, the report's authors said, should focus on the functionality of health information technology, as opposed to the platforms on which that functionality lives. "The proposed strategy and recommendations reflect the Agencies' understanding that risks to patient safety and steps to promote innovation: 1) can occur at all stages of the health IT product lifecycle; and 2) must consider the complex sociotechnical ecosystem in which these products are developed, implemented and used," the authors said.


FDA Calls for Classifying Health IT Products by Patient-Safety Risk Level

The Food and Drug Administration proposed regulating health information technologies based on their potential risks to patient safety, rather than by the technology platform they utilize. The federal agency stayed close to recommendations made by stakeholders when developing the report (PDF Adobe PDF fileExternal Web Site Icon) outlining how health IT products should be regulated. 
Administrative health IT products, such as billing and claims software and inventory management systems, would fall into a low-risk category.  Medication management, provider order entry, most clinical-decision support software and other health management IT products would go into a second low-risk category. 

New Security Risk Assessment Tool Helps Providers Ensure HIPAA Compliance

HHS has released a new Security Risk Assessment (SRA) tool to help health care providers in small-to-medium sized offices conduct risk assessments of their organizations. The SRA Tool is the result of a collaborative effort by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Office for Civil Rights (OCR).  The CMS Security Risk Analysis Tipsheet helps providers understand:
  • Steps for conducting a security risk analysis
  • How to create an action plan
  • Security areas to be considered and their corresponding security measures
  • Myths and facts about conducting or reviewing a security risk analysis

Hospitals Mine Clinical Data to Help Reduce Costs and Avoid Readmissions, Creating Opportunities for Clinical Laboratory Pathologists to Contribute to Improved Patient Outcomes

Medical laboratory test data is one cornerstone of this data mining activity and pathologists are well-positioned to take a more prominent role in helping clinicians use lab tests more effectively Data mining has arrived at many hospitals and health systems. The goal is to mine large quantities of clinical data to identify useful patterns that can guide clinicians to intervene with specific patients. This trend creates a big opportunity for pathology informaticians to step forward and contribute to improved patient care in significant ways. Clinical laboratory test data will always play a role in this initiative. Pathologists can play essential roles in these efforts to analyze clinical data and identify useful clinical interventions.


Smart Data Key to Patient Engagement

We hear a lot about patient engagement these days. Certainly, the idea is a noble one. And the benefits it could bring when practiced on a wide scale are immense. But a lot of providers are still wondering: How do you do it? With Stage 2 meaningful use mandating that 5 percent of patients view, download, and transmit their own health data, many hospitals and practices are nervous about whether that threshold can be met.  But beyond the box-checking of MU, there's of course a much more compelling argument for getting people more involved in their own care.


Patients Nationwide Now Have Direct Access to Lab Test Results Through Quest Diagnostics

Quest Diagnostics has launched MyQuest by Care360 at, a secure patient portal that enables patients to view copies of their lab test reports from Quest Diagnostics. Quest Diagnostics provides direct patient access to lab information through a range of free channels which include a patient portal and mobile health app as well as traditional mail, fax and email. Quest has provided several channels for patients to request and receive their lab reports in select states where direct patient access had been allowed prior to the new federal rule. 


The Human Genome’s Secrets: Unlocked and Online

After spending decades helping unlock the secrets of the human genome, the National Human Genome Research Institute wants to unlock educational materials about the project from their home at the Smithsonian’s National Museum of Natural History. The museum and the genome research institute partnered on Genome: Unlocking Life’s Code, a 4,300 square-foot exhibition that launched in spring 2013. Now the institute, which is part of the National Institutes of Health, wants a contractor to transform a handful of interactive elements from that exhibit into similarly interactive experiences on the exhibition’s website


Trio of Health Data Breaches Rocks California Patients

Three major data breaches rocking the state of California made headlines recently--one involving a computer infected with malicious software, one involving a former employee's illegal access and one involving theft of medical data from a contractor's office. In Torrance, Calif., a total of 338,700 patients have been affected by medical data stolen from Sutherland Healthcare Solutions, a medical billing and collections company. The Los Angeles Times reports that the data was stored on eight computers taken during a February break-in, with information including patients' first and last names, Social Security numbers and certain medical and billing information. Birth dates, addresses and medical diagnoses also may have been included.


The Evolution of Medical Laboratory Technology in Pakistan

Clinical laboratories represent an area of health care that has undergone a great deal of improvement in recent years. The introduction of a variety of laboratory tests and diagnostic techniques in the wake of technological advancements has given a new perspective to the field of medical laboratory technology. Since the future role of medical laboratory technology is strongly challenged by new technological pressures, it is necessary to understand the evolution of this field of medical science in order to address curriculum- and training- related issues of the discipline, especially in a developing country like Pakistan where there is a need for continuous professional development and highly specialized training. This review highlights the history of medical laboratory technology in Pakistan and future recommendations that are imperative for bringing this important medical profession up to date.
Source: Adobe PDF fileExternal Web Site Icon

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