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DLS|HEALTHCARE NEWS|July 09, 2015

DLS|HEALTHCARE NEWS|July 09, 2015



CDC. Centers for Disease Control and Prevention. CDC 24/7: Saving Lives. Protecting People.

A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems

July 09, 2015

News Highlights

  • Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Enterovirus D68; Availability
  • Bring Back Prostate Screening
  • ICD-10: CMS Won't Deny Claims for First Year
  • Risks and Rewards on the Road to Value
  • Visuals to the Fore in New Histology Labeling Guideline
  • Field Evaluation of Rapid Ebola Immunoassay Reveals Limitations of PCR-Based Testing
  • UGA Researcher Leads Comprehensive International Study on Folate
  • Simple Test May Help Predict the Need for Repeat Colonoscopy
  • Simplifying Diagnosis of Diabetes in Remote Indigenous Settings
  • Giving Children Antibiotics 'May Cause Obesity and Diabetes'
  • Most U.S. Hepatitis C Infections May Be Missed
  • Emory University to Lead National Ebola Training and Education Center
  • FDA to Explore Use of EHRs to Aid in Drug Trials
  • Leapfrog Group CEO: HIT Funds Should Go toward Ensuring Systems Are Safe
  • Building Protocols into EHRs Can Help Cut Wasteful Care
  

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Leading News

Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Enterovirus D68; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for in an vitro diagnostic device for detection of Enterovirus D68 (EV-D68) strains detected in North America in 2014. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 6, 2015, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves EV-D68. On the basis of such determination, the Secretary of HHS also declared on February 6, 2015, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of EV-D68 subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. The Authorization is effective as of May 12, 2015.
Bring Back Prostate Screening
For years, research on prostate cancer has sought an approach to screening that is more individualized than a one-size-fits-all measurement of the level of prostate-specific antigen in a man’s blood. These efforts are now paying off. That’s why it’s time to re-evaluate the nation’s current approach to prostate cancer. Even though we anticipate 221,000 new diagnoses this year, and 28,000 deaths, recommendations drafted in 2010 and finalized in 2012 strongly discourage PSA screening men without symptoms for this disease. Those decisions didn’t take into account adaptations that urologists have made to help better identify patients likely to develop deadly prostate cancers. Some tools, called PSA derivatives, were being developed as early as the mid-1990s, and all have been refined since.
The result: Rather than use the historical arbitrary cutoff of a 4.0 PSA reading to define abnormal, we now have tools to adjust our interpretation of readings for age (PSA levels normally rise with age); for race (this, too, affects what is considered normal); and for the size of a man’s prostate, which affects how much PSA he produces. We can test for how fast PSA levels rise over time. And we can analyze how PSA circulates in the bloodstream (free or bound to serum proteins), which can predict prostate cancer risk. When we use these markers together, these varied interpretations of PSA levels give us a clearer picture of who does, or doesn’t, need further testing.
ICD-10: CMS Won't Deny Claims for First Year
In a surprise concession, the Centers for Medicare & Medicaid Services announced Monday that it would work with the American Medical Association on four steps designed to ease the transition to ICD-10. Despite longtime disagreements on the topic, CMS will now adopt suggestions made by none other than the AMA with regard to the code set conversion. Those changes concern:
1. Claims denials.
2. Quality reporting and other penalties.
3. Payment disruptions.
4. Navigating transition problems.
CMS and AMA Announce Efforts to Help Providers Get Ready for ICD-10
With less than three months remaining until the nation switches from ICD-9 to ICD-10 coding for medical diagnoses and inpatient hospital procedures, The Centers for Medicare & Medicaid Services (CMS) and the American Medical Association (AMA) are announcing efforts to continue to help physicians get ready ahead of the October 1 deadline. In response to requests from the provider community, CMS is releasing additional guidancethat will allow for flexibility in the claims auditing and quality reporting process as the medical community gains experience using the new ICD- 10 code set. The AMA also has a broad range of materials available to help physicians prepare for the October 1 deadline. To learn more and stay apprised on developments, visit AMA Wire. 
CMS also detailed its operating plans for the ICD-10 implementation. Upcoming milestones include:
  • Setting up an ICD-10 communications and coordination center, learning from best practices of other large technology implementations that will be in place to identify and resolve issues arising from the ICD-10 transition.
  • Sending a letter in July to all Medicare fee-for-service providers encouraging ICD-10 readiness and notifying them of these flexibilities.
  • Completing the final window of Medicare end-to-end testing for providers this July.
  • Offering ongoing Medicare acknowledgement testing for providers through September 30th.
  • Providing additional in-person training through the “Road to 10” for small physician practices.
  • Hosting an MLN Connects National Provider Call on August 27th.
CDC Awards $216 Million to Community-Based Organizations to Deliver the Most Effective HIV Prevention Strategies to Those in Greatest Need
The Centers for Disease Control and Prevention announced that it has awarded $216 million over five years to 90 community-based organizations (CBOs) nationwide to deliver effective HIV prevention strategies to those at greatest risk, including people of color, men who have sex with men (MSM), transgender individuals, and people who inject drugs. “Community-based organizations have been vital to our nation’s HIV prevention efforts since the earliest days of the epidemic,” said Jonathan Mermin, M.D., director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and Tuberculosis Prevention. “The organizations we’re funding have a strong foothold in the hardest-hit communities. They have the credibility and experience needed to deliver the most effective HIV prevention strategies to those who need them most.”
Genetic Testing for Developmental Disabilities, Intellectual Disability, and Autism Spectrum Disorder
Genetics research in recent decades has discovered numerous genetic variants that help explain the etiology of developmental disabilities (DDs). Genetic tests (e.g., array comparative genomic hybridization, sequencing) are rapidly diffusing into clinical practice for diagnosing DDs or, more often, for determining their genetic etiology. An urgent need exists for a better understanding of these tests and their clinical utility.
This Technical Brief collects and summarizes information on genetic tests clinically available in the United States to detect genetic markers that predispose to DDs. It also identifies, but does not systematically review, existing evidence addressing the tests’ clinical utility. We sought input from nine Key Informants to identify important clinical, technology, and policy issues from different perspectives. We searched the National Center for Biotechnology Information’s Genetic Testing Registry (GTR) to identify genetic tests. A structured search of studies published since 2000 was performed to identify available evidence that addresses genetic tests’ clinical utility.
Our search of the GTR database identified 672 laboratory-developed tests offered by 63 providers in 29 States. We also identified one test cleared by the U.S. Food and Drug Administration. Common genetic testing methods used include array comparative genomic hybridization, microarray, DNA sequencing (the Sanger method or next-generation sequencing), and polymerase chain reaction. We did not identify any studies that directly assessed the impact of genetic testing on health outcomes. Most of the clinical studies identified for indirect assessment of clinical utility are case series reporting on a test’s diagnostic yield.

Laboratory Testing / Diagnostics

Risks and Rewards on the Road to Value
Producing Test Results Is No Longer Enough
As federal and private payers increasingly demand a bigger bang for their buck, clinical laboratories must do more than just provide test results—they must show how they contribute to improved clinical outcomes while helping payers hold down costs. That’s a tall order for an industry that often struggles with change and that historically has tied increased test volumes to increased revenues. But the current transition from “volume to value,” driven by changes in how labs will be reimbursed going forward, is clearly picking up steam. In January, the Centers for Medicare and Medicaid Services (CMS) announced a new payment framework and ambitious new goals, designed to increase accountability for both quality and total cost of care and to place a greater focus on population health management versus fee-for-service. Due to the Affordable Care Act, by 2014, an estimated 20% of Medicare reimbursements had shifted to value-based alternative payment models, directly linking reimbursement to the health and well-being of patients, according to CMS. The agency has set a goal of having 30% of Medicare payments in alternative or population-based payment models by the end of 2016 and 50% by the end of 2018. For laboratories that have been continuing to operate under the old, volume-based model, these reimbursement shifts are a wake-up call to change the way they operate. Some laboratories have already started to make the move toward a value-based business model.
Visuals to the Fore in New Histology Labeling Guideline
Like laboratorians, filmmakers split their work-flow into three phases. In film, they are preproduction, production, and post-production. When flubs occur on a movie set, “We’ll fix it in post,” often said sardonically, is the fallback game plan to keep things on schedule and use visual and sound effects to cover up mistakes.
But you’ll never hear “We’ll fix it in post” in a laboratory, where errors have to be stemmed in the preanalytical phase, if not before. The mantra has to be “We’ll fix it in ‘pre.’” And that’s exactly the purpose of the new guideline that the College’s Pathology and Laboratory Quality Center and the National Society for Histotechnology have developed for accurate and consistent labeling of blocks and slides in surgical pathology (Brown R, et al. Arch Pathol Lab Med. Epub ahead of print April 21, 2015. doi:10.5858/ arpa.2014-0340-SA). In a quest to increase accuracy of patient identification and make labeling more standardized, the CAP and the NSH jointly convened an expert panel to produce the guideline. The panel’s main conclusion: Two human-readable, visual checks are needed.
Field Evaluation of Rapid Ebola Immunoassay Reveals Limitations of PCR-Based Testing
As part of their effort to battle the ongoing Ebola outbreak in Sierra Leone, researchers from Partners in Health and Public Health England (PHE), as well as their collaborators in Sierra Leone's Ministry of Health and Sanitation and Geneva's Foundation for New Innovative Diagnostics, recently performed a field validation of the Corgenix ReEBOV Antigen Rapid Test kit. Given that standard testing at the PHE field lab in Port Loko throughout the course of the outbreak in Sierra Leone had involved the use of Altona Diagnostics' RealStar Filovirus Screen RT-PCR kit, the team used that kit as a benchmark to validate the results of the Corgenix test. They found that the Corgenix test had 100 percent sensitivity and 92 percent specificity in detecting Ebola virus from patient blood samples. However, the team also found that the Altona assay itself performed less than optimally in the PHE lab. "Surprisingly, the findings also revealed that the standard Altona RT-PCR test, under the conditions deployed in the field, was itself an imperfect reference standard," the authors wrote in a press release. "The Altona RT-PCR assay failed to detect a small number of EVD cases that tested positive by both RDT and by an alternative RT-PCR test, all with relatively low amounts of virus." The results were unexpected, Boston Children's Hospital's Nira Pollock, the study's senior author, told GenomeWeb. The Altona test was not as sensitive as the team had expected, especially compared to the alternative assay, previously published by a team led by the US Army Medical Research Institute of Infectious Diseases (USAMRIID).
FDA Approves Theranos’ $9 Finger stick Blood Test for Herpes
Theranos announced that the U.S. Food and Drug Administration had approved the test for herpes simplex 1 virus and called the move a validation of the company's approach and technology, which strives to make blood testing cheaper and less painful than traditional blood draws. The test requires only a few drops of blood, which can be obtained with a finger prick. "It’s a milestone for us," said Elizabeth Holmes, Theranos' chief executive. "It demonstrates the quality and integrity of our work."
ABIM Grant Awarded to Reduce Unnecessary Pap Tests
In keeping with the national focus on reducing unnecessary medical care and getting the right test to the right patient at the right time, the American Board of Internal Medicine (ABIM) Foundation awarded a 34-month grant to a group of Washington state health care organizations. The grant will fund efforts in connection with the Choosing Wisely program—“a national initiative that encourages clinicians and patients to discuss which medical tests and procedures may be unnecessary for their condition, and in some instances can cause harm.”
 “Sometimes conducting another test is not the answer. Choosing Wisely is about doing the right thing for patients and avoiding care that could do harm,” said Brian Seppi, MD, President of the Washington State Medical Association, in a press release announcing the grant.  “It’s about open communication between physicians and their patients and improving patient outcomes.”
Wearable Health-Monitoring Devices Could Alter Traditional Role of Pathologists as Gatekeepers of Medical Laboratory Test Data
Traditionally, medical laboratories have been the gatekeepers for the lab test data of most patients. After all, it is regularly said that 70% or more of a patient’s permanent health record is made up of clinical laboratory test data. However, several market forces are at play that could eat away at the long-standing role of medical laboratories as the primary gatekeepers of patient test data. Today, consumers increasingly want to use wearable devices that not only track their health and fitness, but are designed to also eventually stream self-monitored health data directly into clinical data repositories. As these wearable devices are cleared to use the same biomarkers involved in clinical laboratory tests to monitor the wearer’s health condition, then these devices will stream that data into the electronic health records (EHR) of patients with chronic diseases.

Research and Development

UGA Researcher Leads Comprehensive International Study on Folate
A University of Georgia researcher is lead author on an international paper on folate biomarkers as part of an initiative to provide evidence-based guidance for the global nutrition and public health community. Lynn Bailey, head of the foods and nutrition department within the College of Family and Consumer Sciences, led a comprehensive study on folate, an essential B vitamin required for DNA synthesis and normal growth and development. The paper, published in the Journal of Nutrition, includes 18 authors from around the world and represents a consensus of the top folate scientists globally. The study's primary focus is information relative to folate biomarkers, or biological indices that predict an individual or population group's folate status. The paper conveys how a folate status biomarker can be used to assess risk for this type of birth defect and determine if intervention is needed on an individual or population basis. The paper is the product of nearly five years of collaborative work of an expert panel, chaired by Bailey and organized by the National Institute of Child Health and Human Development in 2010 as part of the international program Biomarkers of Nutrition for Development. The initial six nutrients selected for the program--iodine, vitamin A, iron, zinc, folate and vitamin B-12--were chosen for their high public health importance. The information has been incorporated into a recent World Health Organization publication to be used globally to assess risk for folate-related birth defects.
Simple Test May Help Predict the Need for Repeat Colonoscopy
A simple panel of genetic biomarkers may be able to predict which individuals are at high and low risk of developing colorectal cancer following screening colonoscopy, and therefore could identify those who should have repeat screening, say a team of researchers from Luxembourg. Presenting their data here at the 17th World Congress on Gastrointestinal Cancer (WCGC), the researchers say that a panel of eight genetic markers, derived from a simple comparison of case patients and control individuals, can identify patients at risk for colorectal cancer with a high sensitivity and specificity. Interestingly, a panel using just three of the studied markers was almost as good as the full set and may offer a low-cost solution for determining which patients should be recalled for repeat colonoscopy.
Simplifying Diagnosis of Diabetes in Remote Indigenous Settings
Researchers have found a way of simplifying the diagnosis of diabetes in Indigenous Australians living in remote health care settings, according to a study published in the Medical Journal of Australia. Early identification of diabetes is crucial to starting preventive treatment that would help close the gap between Indigenous and non-Indigenous health outcomes. However, the current diagnostic test - the assessment of blood glucose levels - is inefficient and time-consuming, particularly for those in remote settings, the researchers wrote.  "Delayed diagnosis is due in part to the use of an algorithm that relies on the assessment of glucose levels and, if the results are equivocal, a follow-up oral glucose tolerance test", the researchers, led by Dr Julia Marley from the University of Western Australia's Rural Clinical School, wrote. "This complicated algorithm can significantly delay informing and educating the patient. In contrast to glucose testing, assessment of glycated haemoglobin A (HbA1c) requires no fasting. This makes it more suitable for opportunistic testing, and results in fewer missed diagnoses."  Further, HbA1c tests detected diabetes in more people than did glucose testing. 
Source: Australian Medical Association
Spit-and-Stick Test Could Be Biomarker for HNSCC
It's early days yet, but a simple test that looks for tumor DNA shed in saliva and plasma could serve as a biomarker and screening tool for head and neck squamous cell carcinoma (HNSCC), reports a team of investigators. Somatic mutations or human papillomavirus (HPV) — collectively referred to as tumor DNA — were identified in saliva samples from 71 of 93 patients with HNSCC (76%) and in the blood of 41 of 47 (87%) of those who also provided plasma samples. Tumor DNA was detected in at least one of the samples of 45 of the 47 patients (96%) who provided both plasma and saliva samples. The study, by Nishant Agrawal, MD, from the Johns Hopkins University School of Medicine in Baltimore, and colleagues, was published online June 24 inScience Translational Medicine.
A Better Way to Spot Pulmonary HTN in Systemic Sclerosis?
Elevated cardiac troponin/probrain natriuretic peptide linked to risk of lethal complication
Common cardiac biomarkers could be used to identify patients with systemic sclerosis (SSc) at risk for developing pulmonary hypertension, French researchers reported. On a multivariate analysis, increased levels of both high-sensitivity cardiac troponin T (HS-cTnT) and N-terminal probrain natriuretic peptide (NT-proBNP) among SSc patients were associated with a 50-fold increase in the risk for precapillary pulmonary hypertension (OR 50, 95% CI 1.6-580.4, P=0.026) compared with healthy controls, according to Jerome Avouac, MD, PhD, of Paris Descartes University, and colleagues.
Researchers Identify Two Promising Therapeutics for Preventing and Treating MERS
As the South Korean epidemic of Middle East Respiratory Syndrome (MERS) continues, researchers have raced to find treatments for the deadly virus, which has killed more than 400 people since it was first discovered three years ago in Saudi Arabia. Now, scientists at the University of Maryland School of Medicine (UM SOM) and Regeneron Pharmaceuticals, Inc., have discovered and validated two therapeutics that show early promise in preventing and treating the disease, which can cause severe respiratory symptoms and has a death rate of 40 percent. These therapeutics are the first to succeed in protecting and treating animal models of the MERS virus. The study appears in the journal Proceedings of the National Academy of Sciences (PNAS).
Reaction to Smells May Help Diagnose Autism, Study Suggests
It may be possible to diagnose autism by giving children a sniff test, a new study suggests. Most people instinctively take a big whiff when they encounter a pleasant smell and limit their breathing when they encounter a foul smell. Children with autism spectrum disorder don’t make this natural adjustment, said Liron Rozenkrantz, a neuroscientist at the Weizmann Institute of Science in Israel and one of the researchers involved with the study. She and her colleagues report their findings in the journal Current Biology.
Artificial Platelets Promote Clotting, May Serve as Prophylactic for Soldiers in Battle
Artificial platelets that help with clot formation have been created in the past, but they’ve been limited in their ability to gather around the site where the coagulation cascade is taking place. Instead they tend to begin promoting the clotting process randomly, potentially creating dangerous blood clots. Moreover, these artificial platelets don’t contract the clot like naturally occurring ones do, probably because of their rigid nature. Now researchers at Georgia Tech and Chapman University in California have developed platelet-like particles (PLPs) that seem to overcome previous limitations, being able to move toward sites where clotting is occurring and contracting the clots much like natural platelets do.
Study Shows Diseases like Plague Can Perilously Evolve
Contrary to what was previously believed, the bacterium responsible for the Black Death probably caused small outbreaks of lung disease for many years before it evolved its better-known bubonic form, according to a new genetic study. Also, only one added gene was needed to turn the Yersinia pestis bacterium into a killer, and only one tiny mutation in that gene was needed to give it two ways of spreading — by cough or by flea bite, said Wyndham W. Lathem, a microbiologist at Northwestern University Feinberg School of Medicine who oversaw a team inserting genes into ancestral versions of Y. pestis in mice.
Human Cytomegalovirus Harbors Hot, Cold Spots of Genetic Diversity, Report Finds
A team led by University of Massachusetts Medical School researchers has characterized the genomic diversity of human cytomegalovirus, finding that it harbors hot and cold spots of variability. As they reported in the Proceedings of the National Academy of Sciences, Timothy Kowalik from UMMS and his colleagues analyzed the genomic diversity of the viruses infecting 17 infants and one adult to note that about a quarter of the HCMV genome is conserved and lacked any polymorphisms. These regions of low diversity included core herpesvirus — the viral family to which HCMV belongs — genes and genes encoding proteins involved in DNA replication and processing as well as genes encoding capsid, tegument, and regulatory proteins. Regions of high genomic diversity, meanwhile, included genes encoding glycoproteins, envelope protein genes, and genes linked to immune evasion. Understanding conserved sites in the viral genome could inform the selection of therapeutic targets, the researchers said. Currently, they noted, resistance has developed to all FDA-approved small molecule treatments for HCMV infection.

Public Health and Patient Safety

Giving Children Antibiotics 'May Cause Obesity and Diabetes'
Giving children common antibiotics may cause obesity by altering bacteria in their gut, according to new research. A study mimicking use of the drugs in babies found mouse pups put on weight and developed bigger bones. The make up of trillions of bugs in their intestinal tract, known as the microbiome and vital for a healthy immune system, also altered. The findings published in Nature Communications follows an analysis last year of more than 64,500 youngsters that found those receiving antibiotics at least four times before the age of two were more likely to be obese by the time they were five. The researchers administered three short courses of two of the most common antibiotics prescribed to children, including amoxicillin, to the mice - the same therapeutic dose the average human receives in the first two years of life. Professor Martin Blaser, of New York University, said although the study was limited to mice, the results agree with many others pointing toward significant effects on children over exposed to antibiotics.
Most U.S. Hepatitis C Infections May Be Missed
New cases of hepatitis C are drastically underreported to federal officials, researchers contend in a new study. And they suggest that may be hampering public health efforts to cope with the chronic infection that can lead to cirrhosis or liver cancer. The findings were published in the Annals of Internal Medicine. The new study found that only one out of 183 Massachusetts residents diagnosed between 2001 and 2011 with acute hepatitis C infection was reported to the U.S. Centers for Disease Control and Prevention (CDC). The rest went unreported, either because their test results didn't come back quickly enough or because the results didn't meet the strict CDC definition for hepatitis C infection, says senior study author Arthur Kim, MD, director of the Viral Hepatitis Clinic at Massachusetts General Hospital in Boston.
Emory University to Lead National Ebola Training and Education Center
After helping four U.S. patients recover from the Ebola virus in the past year, the U.S. Department of Health and Human Services on Wednesday named Emory University lead coordinating center of the National Ebola Training and Education Center (NETEC). The university will collaborate with the University of Nebraska Medical Center, the New York City Health and Hospitals Corp. (Bellevue Hospital), the Centers for Disease Control and Prevention and HHS Office of the Assistant Secretary for Preparedness and Response on the program, which will receive $12 million in funding over the next five years.
Cystic Fibrosis Might Be Deadlier for Hispanics, Study Suggests
Cystic fibrosis is deadlier for Hispanic patients than others, and genetic differences may make Hispanics less likely to benefit from new treatments for the disease, researchers report. "We need to ask if the care model for patients with [cystic fibrosis] is working for this minority group," study author Dr. MyMy Buu, an instructor in pediatric pulmonary medicine at Stanford University School of Medicine in Palo Alto, Calif., said in a university news release. "We want to make sure that what we are doing is not inadvertently causing disparities." The findings reflect an urgent need to identify the factors that contribute to this health disparity, the researchers noted.
Cuba Stamps Out Mother-to-Child HIV
Cuba has successfully eliminated mother-to-child transmission of both HIV and syphilis, the World Health Organization (WHO) says. The head of the WHO, Dr. Margaret Chan, called it one of the greatest public health achievements possible. It follows years of efforts to give pregnant women early access to prenatal care, testing and drugs to stop these diseases passing from mother to child. Every year, globally, around 1.4 million women living with HIV become pregnant. Untreated, they have a 15-45% chance of transmitting the virus to their children during pregnancy, labour, delivery or breastfeeding. That risk drops to about 1% if antiretroviral medicines are given to both mothers and their babies.
NIH-Funded Vaccine for West Nile Virus Enters Human Clinical Trials
A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The experimental vaccine was discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland. The scientists were funded with a $7.2 million grant from NIAID, awarded in 2009. The new vaccine is being tested in a Phase 1 clinical trial at Duke University in Durham, North Carolina, one of NIAID’s Vaccine and Treatment Evaluation Units (VTEUs).

Health IT

FDA to Explore Use of EHRs to Aid in Drug Trials
The U.S. Food and Drug Administration (FDA) has announced its interest in considering the use of electronic health records with electronic data capture (EDC) in order to improve clinical trials for new and investigational drugs. In an notice published in the Federal Register, the FDA's Center for Drug Evaluation and Research stated that it was interested in supporting demonstration projects to test the capability and evaluate performance of using an end-to-end EHR-to-EDC single-point data capture approach, using established data and implementation standards in a regulated clinical research environment.
Leapfrog Group CEO: HIT Funds Should Go toward Ensuring Systems Are Safe
Technology is meant to make work at hospitals easier and improve patient care, but often installing new systems can go awry and many health administrators lack experience with the new tools, according to Leah Binder, president and CEO of the nonprofit Leapfrog Group. Leapfrog Group offers a test for hospitals to see if their systems for processing medication orders work correctly. However, Binder says her organization finds that medication orders made in IT systems often don't alert to errors, and 1 in 6 of the orders that could kill a patient don't get stopped by the system.
Building Protocols into EHRs Can Help Cut Wasteful Care
UPMC health system in Pittsburgh after doctors started seeing reminders in the electronic health record that such tests can be unnecessary. UPMC incorporated the reminders into its EHR, drawing from the Choosing Wisely recommendations from the American Academy of Family Physicians and two neurological surgical societies to avoid spine imaging for “nonspecific acute low back pain and without red flags.” The pathway directs these patients to rest or physical therapy first, said Dr. Steven Shapiro, UPMC executive vice president and chief medical and scientific officer. At UPMC, it helps that the system owns a health plan and pays doctors based partly on how closely they stick to protocols, which include some Choosing Wisely recommendations. One-quarter of physician incentives are related to quality, and adherence to protocols is one measure of performance, Shapiro said. Too often, healthcare fails to follow strong evidence for good care, where such evidence exists. “That's not acceptable,” he said.
Healthcare Gets Poor Rating for Application Security
The healthcare industry fares poorly compared to other industries in reducing application security risk, according to a report from application security vendor Veracode. More than 200,000 application assessments from its customers over 18 months were analyzed using methods including static analysis, dynamic analysis or manual penetration testing. "Given the large amount of sensitive data collected by healthcare organizations, it's concerning that 80 percent of healthcare applications exhibit cryptographic issues such as weak algorithms upon initial assessment," the report states, referring to authentication protocols. In addition, healthcare is near the bottom of the pack when it comes to addressing remediation, with only 43 percent of known vulnerabilities being remediated.
IT Talent Shortage Hitting Healthcare Hardest
Healthcare is continuing to experience a shortage of qualified health IT staff that, in the view of some observers, is growing worse. But few healthcare organizations believe that the solution is to lure IT pros away from other industries. In fact, most hospital systems and large physician groups would prefer not to hire any IT person who doesn’t have extensive health experience.  "Healthcare organizations are looking for healthcare-experienced people," says Frank Myeroff, president of Direct Consulting Associates, a health IT staffing firm in Solon, Ohio.  Ernie Hood, senior research director for the Advisory Board Co., a large healthcare consulting firm based in Washington, D.C., agrees. In fact, he says, healthcare organizations are generally uninterested in graduates of health IT training programs, even if they have IT experience in other industries. "It doesn't substitute for the actual field experience working in healthcare," he says. 

Other News

New Global Health Site Launched
APHL launched a new Global Health site that provides partners with a single, current source for information on its activities worldwide. Peruse our countries map to see where we work, and check out our capabilities matrix and top achievements. You can also learn about our partnerships and resource materials, and view a short video on our program and services.

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