A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
June 25, 2015
- State Legislation, Regulations, and Hospital Guidelines for Newborn Screening for Critical Congenital Heart Defects — United States, 2011–2014
- HPV Vaccination Tied to Drop in Precancerous Cervical Lesions in U.S.
- Free Webinar Introducing IQCP Workbook for CLIA Laboratories
- AACC Urges Development of and Coverage for Innovative Personalized Medicine Lab Tests
- ‘Smarter’ Ordering of Breast Biomarker Tests Could Save Millions in Health Care Dollars
- A New Device Could Diagnose Malaria in a Matter of Minutes
- New Tool Identifies Novel Compound Targeting Causes of Type 2 Diabetes
- New Biomarker Identified in Women with Mental Illness
- Scientists Reverse Depression in Mice by Reactivating Happy Memories
- The 100-Year-Old Scientist Who Pushed the FDA to Ban Artificial Trans Fat
- New Anti-Malaria Drug Developed at Dundee University
- Pollution May Age the Brain
- GSA Seeks Feedback on Proposed Health IT Offerings
- Healthcare Cybersecurity Primer Outlines Defensive Strategies
- EXTREME Essentials for Interoperability
View Previous Issues - Healthcare News Archive
State Legislation, Regulations, and Hospital Guidelines for Newborn Screening for Critical Congenital Heart Defects — United States, 2011–2014
Forty-three states have taken action on newborn screening for critical congenital heart defects (CCHD) through statute, regulations, or hospital guidelines. Of those 43 states, 32 (74 percent) are collecting or planning to collect CCHD screening data. Through these actions, more newborns with CCHD may be detected, treated and able to live fully. CCHDs are birth defects that require treatment during the first year of life. Without timely detection, CCHDs could lead to disability or death. Newborn screening for CCHD allows for the possibility of early identification and treatment. State mandates for newborn screening for CCHD will likely increase the number of newborns screened and cases detected, leading to more lives saved. In 2014, CDC collaborated with key partners to assess states’ actions for adopting newborn screening for CCHD. Data collection at the state level is important for surveillance, monitoring outcomes, and evaluation of CCHD newborn screening programs.
HPV Vaccination Tied to Drop in Precancerous Cervical Lesions in U.S.
A new study offers more evidence that the advent of vaccines to fight human papillomavirus (HPV) could reduce cervical cancer in American women. While it's still too early to say that vaccines such as Gardasil and Cervarix are lowering cases of cervical cancer, the new study finds a recent decline in the number of young American women with cervical tissue changes that can lead to cancer. However, researchers led by Susan Hariri of the U.S. Centers for Disease Control and Prevention stressed that another factor may be driving the trend: changes made to cervical cancer screening recommendations in recent years. HPV vaccination was introduced in the United States in 2008, and the CDC currently recommends vaccination of girls ages 9 through 12, to help prevent infection with the sexually transmitted virus.
Free Webinar Introducing IQCP Workbook for CLIA Laboratories
Wednesday, July 15, 2015, 1:30 PM - 3:30 PM Eastern Time
Wednesday, July 15, 2015, 1:30 PM - 3:30 PM Eastern Time
Individual Quality Control Plan (IQCP) is a Quality Control (QC) option for Clinical Laboratory Improvement Amendments (CLIA) laboratories performing non-waived testing. IQCP will provide laboratories with flexibility in customizing QC policies and procedures. IQCP is currently being implemented through and education and transition period that will conclude on December 31, 2015. As of January 1, 2016, laboratories may choose to implement IQCP or must meet general CLIA QC requirements.
Learn how to customize an IQCP for your laboratory. This MLN Connects® Event will introduce participants to “Developing an IQCP, a Step-by-Step Guide,” a new workbook developed by CMS and the Centers for Disease Control and Prevention (CDC). A question and answer session will follow the presentation.
CMS will use webcast technology for this event with audio streamed through your computer. Please note, if you are unable to stream audio through your computer, phone lines are available.
This MLN Connects Event is being evaluated by CMS for CME and CEU continuing education credit (CE). Refer to the event detail page for more information.
- IQCP Workbook
- Example scenario and forms for performing a Risk Assessment
- Creating a QC Plan
- Identifying Quality Assessment monitors
Laboratorians, professional organizations, quality improvement experts and other interested stakeholders.
Laboratorians, professional organizations, quality improvement experts and other interested stakeholders.
Registration will close at 12:00 p.m. ET on the day of the call or when available space has been filled.http://www.eventsvc.com/blhtechnologies/register/e0553869-1d51-40e3-bc20-3cdc3d30cc14
Genome Studies Show How Ebola Spread Initially
After tracking tiny mutations in the genome of Ebola, scientists from around the world are developing a fuller picture of how the virus spread and evolved genetically during the world’s worst outbreak of the disease. The latest studies, which reported the genetic sequences of viruses from more than 400 patients in Sierra Leone, Guinea and Liberia, suggested that early efforts to combat the epidemic in the spring of 2014 nearly stamped it out in the forested border region of Guinea where the outbreak started. But before those efforts even began, sick people from the area had already crossed the border into Sierra Leone. And at least one of them infected other people, who then crossed back into Guinea and into Liberia, reigniting the epidemic. “That second wave was a much bigger wave than the first one,” said Miles W. Carroll of Public Health England, the lead author of a paper published in the journal Nature, which analyzed 179 Ebola virus sequences from Guinea. Although officials in Guinea and with the World Health Organization knew that sick people had crossed into Sierra Leone by March 2014, the illness continued to spread silently in Sierra Leone for two more months before the outbreak was detected there. “It does seem to be what has seeded the rest of the outbreak,” said Pardis Sabeti, a Harvard professor and computational biologist at the Broad Institute who helped write a study published in the journal Cell.
NIH Expands Testing of Ebola Drugs and Vaccines into New Countries
The National Institutes of Health has expanded its research of Ebola vaccines and drugs into Sierra Leone and Guinea, a move that increases the chances of getting definitive results from clinical studies. The NIH’s National Institute of Allergy and Infectious Diseases, along with the Food and Drug Administration and other U.S. agencies, has insisted that the fastest way to get a precise scientific answer about whether drugs and vaccines work is to conduct a randomized clinical trial. In this “gold standard” of medical research, patients are randomly assigned to a new drug or vaccine while other patients get a placebo or standard care. But the effort to produce definitive answers has been stymied for several reasons. One is that NIH was initially confined to Liberia, where Ebola now appears eradicated. In Guinea and Sierra Leone, Ebola cases have ticked up in recent weeks, with 10 confirmed cases in Guinea and 14 in Sierra Leone in the week ended June 14.
Laboratory Testing / Diagnostics
AACC Urges Development of and Coverage for Innovative Personalized Medicine Lab Tests
The American Association for Clinical Chemistry (AACC) has released a position statement endorsing efforts within the healthcare community to improve patient outcomes by personalizing medical care. The statement emphasizes the central role that innovative laboratory tests play in precision medicine, and stresses the need for policymakers and insurers to adopt policies that ensure access to and appropriate reimbursement for these tests so that patients can benefit from targeted treatments. In the statement, AACC details the challenges that policymakers must tackle before the field of personalized medicine can fulfill its potential. One major roadblock is that Medicare and other insurers do not cover many tests that are integral to personalized medicine because these tests are specific to diseases or conditions that affect small subsets of the population, making it difficult for test developers to amass sufficient data to comply with research requirements.
‘Smarter’ Ordering of Breast Biomarker Tests Could Save Millions in Health Care Dollars
A review of medical records for almost 200 patients with breast cancer suggests that more selective use of biomarker testing for such patients has the potential to save millions of dollars in health care spending without compromising care, according to Johns Hopkins researchers. Specifically, waiting to perform these tests until a patient has a full excisional biopsy instead of “reflexively” or automatically testing for them on initial small “core” biopsies could save as much as $117 million, according to a report on the study published in the July issue of The American Journal of Surgical Pathology. On repeat testing after excisional biopsy, researchers noted that three of the 18 cancers (17 percent) that were ER-negative in core biopsy samples were now found to be positive on excision, and one of the 24 (4 percent) cancers that was PR-negative in core biopsy samples was now positive on the excision. On repeat Her2 testing, one of the 42 cancers (2.4 percent) that was Her2-negative in the core biopsy was positive on the excision. These results are consistent with those of other research groups, indicating that testing the larger sample helps pick up tumors that carry biomarkers in some areas but not others and that are eligible for targeted therapy, says senior study author Pedram Argani, M.D., director of the Breast Pathology Service at The Johns Hopkins Hospital and a professor of pathology and oncology at the Johns Hopkins University School of Medicine.
A New Device Could Diagnose Malaria in a Matter of Minutes
Every year, 3.2 billion people worldwide are at risk of being diagnosed with malaria, according to the World Health Organization. This high risk leads to about 198 million cases a year — so many that a child dies from the disease every minute, WHO says. People in developing countries are at the highest risk of becoming infected, and an inability to detect the disease quickly and at a low cost contributes to its spread. John Lewandowski, co-founder and CEO of Disease Diagnostics Group, has invented a new way to diagnose the disease that addresses these problems. With two magnets and a laser pointer, he hopes to eradicate malaria from the globe. Because the parasites that cause malaria consume red blood cells but are unable to digest the iron in them, Lewandowski created a test that shows whether or not there is iron in the bloodstream. The iron can be easily detected using magnets, and the results are much faster than current diagnostic methods.
Serial CA-125 Measurements Better for Ovarian Cancer Screening
A cancer risk algorithm using serial measurements of serum cancer antigen 125 (CA-125) detected more cases of ovarian cancer than did a single-threshold rule, according to a large, prospective screening study published in the Journal of Clinical Oncology. The findings “highlight the need to examine serial change in biomarker levels in the context of screening and early detection of cancer. Reliance on predefined single-threshold rules may result in biomarkers of value being discarded,” wrote Dr. Usha Menon, professor of gynecological cancer at University College London (J. Clin. Oncol. 2015 June 20.
Clinical Value of Roche’s Cintec PLUS Cytology Test Confirmed for Women with Abnormal Cervical Cytology Screening Results
Ventana Medical Systems, Inc., a member of the Roche Group, has announced the publication of further results from the Primary ASC-US LSIL Marker Study (PALMS) in this month’s issue of Cancer Cytopathology. In this latest publication based on the PALMS study results, the CINtec PLUS Cytology test was compared to pooled, high-risk HPV DNA testing as a triage or follow-up screening method for mildly abnormal Pap cytology results. The study confirmed that the CINtec PLUS Cytology test had high specificity and was effective in identifying women with precancerous lesions. These results suggest that if implemented as a triage test in a cytology-based screening program, the CINtec PLUS Cytology test may lead to a reduction in the overtreatment of women screened for cervical disease. The CINtec PLUS Cytology test was developed to help identify the subgroup of women with underlying transforming HPV infections that may lead to cancer and distinguish them from those with mostly transient infections.
Research and Development
New Tool Identifies Novel Compound Targeting Causes of Type 2 Diabetes
A new drug screening technology developed at the Harvard T.H. Chan School of Public Health has identified a new potential anti-diabetes compound—and a powerful way to quickly test whether other molecules can have a positive effect on a critical molecular pathway believed to be central to diseases ranging from diabetes to retinitis pigmentosa, cystic fibrosis, Huntington’s disease, and Alzheimer’s. The study appears in the June 17, 2015 issue ofScience Translational Medicine. The study describes the development of two complementary assays that allow scientists to directly monitor ER function in live cellular systems in culture in the lab. This screening system enables measurement of the amount of chaperones, molecules that patrol and promote ER function, as well as the capacity of the ER to properly fold proteins into their three-dimensional shapes.
New Biomarker Identified in Women with Mental Illness
Psychiatric disorders can be difficult to diagnose because clinicians must rely upon interpreted clues, such as a patient's behaviors and feelings. For the first time, researchers at University of California, San Diego School of Medicine report identifying a biological marker: the over-production of specific genes that could be a diagnostic indicator of mental illness in female psychiatric patients. The study was published in the journal EBioMedicine. Researchers found that the gene XIST, which is responsible for inactivating one of the two copies of the X chromosome in cells that store genetic material, works overtime in female patients with mental illnesses, such as bipolar disorder, major depression and schizophrenia. The study suggests that over-production of XIST and genes from the inactive X chromosome are common denominators in the development of psychiatric disorders in patients with rare chromosome disorders, such as Klinefelter syndrome and Triple X syndrome, and in the general population of female psychiatric patients. "There has been an utmost urgency to identify biomarkers for mental illness that could significantly impact research and drug development," said Xianjin Zhou, PhD, assistant professor in the Department of Psychiatry at UC San Diego School of Medicine and lead author.
Scientists Reverse Depression in Mice by Reactivating Happy Memories
Earlier this year, French neuroscientists achieved a remarkable feat. Hacking into the brains of mice, they switched the emotional character of their memories, turning a neutral recollection into a positive one. Now, neuroscientists at the Massachusetts Institute of Technology's Tonegawa Lab have taken another major step forward in the science of memory manipulation. In a study published this week in Nature, the researchers succeeded in reversing depression-like behavior in mice by artificially reactivating happy memories. The findings could have some exciting implications down the road for the treatment of depression in humans. If scientists are able to manipulate the brain cells where memories are housed, we may one day be able to develop pharmaceutical therapies for depression that are more targeted than antidepressants, which work across the entire brain.
Blood Chemical Predicts Brain Decline
Scientists have discovered a chemical in blood that indicates whether people will have declining brain function. Looking for the earliest signs of Alzheimer's disease, they analysed levels of 1,129 proteins circulating in the blood of more than 200 twins. These were compared with data from cognitive-function tests over the next decade, in Translational Psychiatry. And levels of one protein, MAPKAPK5, tended to be lower in those people whose brains declined. MAPKAPK5 is involved in relaying chemical messages within the body, although its connection with cognitive decline is unclear. Dementia cases are expected to treble globally by 2050, but there is no cure or treatment. It can take more than a decade from the first changes in the brain to culminate in symptoms such as memory loss, confusion and personality change. And drug companies believe they need to treat patients, years before symptoms appear in order to protect the brain.
Fish Oil in Diet Promotes Blood Cell Growth in Mice
A diet rich in fish oil appeared to promote blood cell production partly by altering the hematopoietic niche in bone marrow, a recent study in mice suggested. Researchers demonstrated that a fish oil rich diet, but not high in other fats, promoted extramedullary hematopoiesis in the spleen and increased hematopoietic stem-cell (HSC) self renewal in bone marrow. The diet appeared to alter hematopoietic niche and induce the expression of matrix metalloproteinase 12 (MMP12) in bone marrow. The study may broaden the understanding of how diet -- specifically dietary fatty acid intake -- influences blood cell formation, researcher Sheng Xia, PhD, of Jiangsu University in Zhenjiang, China, and colleagues wrote in the journal Endocrinology.
Protein Plays Unexpected Role in Embryonic Stem Cells
The finding, published June 16 in the journal Genes & Development, shows that nucleoporins play an important role in maintaining embryonic stem cells before they begin to develop into specific tissues. This discovery gives a new understanding to genetic diseases that are caused by mutations in these proteins. One nucleoporin protein in particular has a dramatic -- and unanticipated -- function in the formation of neurons from stem cells. 'We've shone a new light on this class of proteins,' says Martin Hetzer, a professor in Salk's Molecular and Cell Biology Laboratory and senior author of the new paper. 'I hope researchers start to accept and realize that nucleoporins are more than just transport proteins.'
Researchers Design Placenta-on-a-Chip to Better Understand Pregnancy
National Institutes of Health (NIH) researchers and their colleagues have developed a “placenta-on-a-chip” to study the inner workings of the human placenta and its role in pregnancy. The device was designed to imitate, on a micro-level, the structure and function of the placenta and model the transfer of nutrients from mother to fetus. This prototype is one of the latest in a series of organ-on-a-chip technologies developed to accelerate biomedical advances.
Seeking a Smarter Way to Diagnose Prostate Cancer
Hans Schmitthenner, a research scientist at Rochester Institute of Technology, hopes to make detecting prostate cancer — the second leading cause of cancer deaths among men — less of a guessing game. Non-cancerous cells as well as cancerous cells can produce elevated PSA levels in the test for prostate-specific antigens commonly used to find signs of prostate cancer. Just a quarter of those patients who have a biopsy taken because of heightened PSA levels actually have prostate cancer, according to the National Cancer Institute. Schmitthenner's diagnostic procedure — still in its early stages of development — attempts to take a lot of the uncertainty out of prostate cancer detection by using targeting agents that seek out any cancer cells in the prostate and make them stand out with dyes that stick to their membranes. "By using targeted dyes, we can say, 'These cells light up, so there is a high likelihood of disease in those cells,' " said Schmitthenner, who is an associate research professor in chemistry and imaging science. A follow-up biopsy could then be taken with a much greater certainty of finding cancer because the dyes would have already pointed to tissues likely to be cancerous.
Public Health and Patient Safety
The 100-Year-Old Scientist Who Pushed the FDA to Ban Artificial Trans Fat
No one was more pleased by the Food and Drug Administration's decision to eliminate artificial trans fats from the U.S. food supply than Fred Kummerow, a 100-year-old University of Illinois professor who has warned about the dangers of the artery-clogging substance for nearly six decades. "Science won out," Kummerow, said in an interview from his home in Illinois. "It's very important that we don't have this in our diet." In the 1950s, as a young university researcher, Kummerow convinced a local hospital to let him examine the arteries of people who had died from heart disease. He made a jarring discovery. The tissue contained high levels of artificial trans fat, a substance that had been discovered decades earlier but had become ubiquitous in processed foods throughout the country. Later, he conducted a study showing that rats developed atherosclerosis after being fed artificial trans fats. When he removed the substance from their diets, the atherosclerosis disappeared from their arteries.
New Anti-Malaria Drug Developed at Dundee University
Researchers at Dundee University have discovered a new compound which could treat malaria while protecting people from the disease and preventing its spread, all in a single dose. The compound, DDD107498, was developed by the university's Drug Discovery Unit and the Medicines for Malaria Venture. Scientists said the "exciting" new drug could work well against parasites resistant to current treatments. Concerns have been growing about strains of malaria which are resistant to current treatments, which have already appeared on the border between Myanmar and India. Details of the discovery have been published in the journal Nature.
Pollution May Age the Brain
Researchers studied 1,403 women without dementia who were initially enrolled in a large health study from 1996 to 1998. They measured their brain volume with M.R.I. scans in 2005 and 2006, when the women were 71 to 89 years old. Using residential histories and air pollution data, they estimated their exposure to air pollution from 1999 to 2006. They used data recorded at monitoring sites on exposure to PM 2.5 — tiny particulate matter that easily penetrates the lungs. Each increase of 3.49 micrograms per cubic centimeter cumulative exposure to pollutants was associated with a 6.23 cubic centimeter decrease in white matter, the equivalent of one to two years of brain aging. Previous studies have shown that air pollution can cause inflammation and damage to the vascular system, but this study, in The Annals of Neurology, showed damage to the brain itself.
Will a Surgical Mask Keep You Safe in a Viral Outbreak?
An outbreak of Middle East respiratory syndrome in South Korea has sent sales of surgical masks soaring. But do these masks work? Here's what we do — and don't — know about how well surgical masks help prevent the spread of diseases at clinics, as well as in crowded malls and subways.
1. Masks can be helpful for protecting health workers from a variety of infectious diseases, including MERS. The U.S. Centers for Disease Control and Prevention recommends health care workers wear a mask with a respirator, called an N95 mask, to protect against MERS. N95 masks filter out 95 percent of infectious particles, the CDC says. In health care settings, these masks are individually fitted to the wearer to make sure the fit is tight. But the effectiveness of regular surgical masks against MERS is still up for debate. At least one study found surgical masks to be just as good at stopping influenza as N95 masks are. A head-to-head comparison, published in JAMA, the journal of the American Medical Association, found both masks worked equally well in preventing transmission of the flu in a hospital, when the masks were also used with disposable hospital gowns, gloves and other protections.
2. But either type of mask is less likely to do much good for the average person on the street.
3. If you're sick yourself, wearing a mask might be a good idea.
4. If you find yourself in a situation where MERS is spreading, there are other strategies.
GSA Seeks Feedback on Proposed Health IT Offerings
To attract health information technology vendors and buyers to the federal marketplace, the General Services Administration plans to include a special item number (SIN) for health IT offerings on its IT Schedule 70—the largest, and most widely used acquisition vehicle in the federal government. GSA published a request for information on June 16 to seek public and private sector input on the proposed health IT SIN. These numbers are designed to group similar technology offerings for the government and to make it easier for buyers to compare product costs and features. According to GSA, the health IT market is “sufficiently mature” for this SIN to attract both vendors and government buyers to its IT Schedule 70, which provides technology products and services to federal, state, and local governments.
Healthcare Cybersecurity Primer Outlines Defensive Strategies
A new primer on cybersecurity outlines the challenges that healthcare organizations face and steps they can take to defend themselves against cyberattacks. The Workgroup for Electronic Data Interchange's (WEDI) "Perspectives on Cybersecurity in Healthcare" covers three prime areas of cybersecurity: the lifecycle of cyberattacks and defense; the anatomy of an attack; and building a culture of prevention. To build that culture of prevention, the report recommends a strong cyberdefense strategy that addresses how to prepare for and monitor attacks and recover from breaches. At a minimum, security architecture should be able to stall adversarial efforts, thwart attacks at each phase and facilitate a rapid response.
The report outlines three strategies:
- Mitigate threats before they enter a network with basic controls, such as ensuring that operating systems and anti-malware, Web filtering and antivirus software on servers and endpoints are updated and patched to reduce the risk of vulnerabilities and infections.
- Discover threats that have entered or tried to enter systems. No organization can prevent every cyberattack, but it is important to build a response system that can alert your security staff, rapidly identify a breach and its scope, and notify other enforcement points so that a breach can be contained without extensive collateral damage.
- Respond to any threats that have breached the network. In addition to deploying sandbox appliances, which can test and detect novel threats, organizations might need to deploy internal network firewalls and mitigate an attack once a network has already been breached.
EXTREME Essentials for Interoperability
Writing in the Journal of the American Medical Informatics Association, two health IT researchers put forth five use cases that help define what an "open" electronic health record should really look like. Dean F. Sittig, professor of biomedical informatics at the University of Texas Health Science Center at Houston, and Adam Wright, medical informatics researcher in the Department of General Internal Medicine, Brigham & Women’s Hospital, use the term EXTREME – it stands for EXtract, TRansmit, Exchange, Move, Embed – to shape a definition of useful interoperability.
- An organization should be able to securely extract patient records while maintaining granularity of structured data.
- An authorized user can transmit all or a portion of a patient record to another clinician who uses a different EHR or to a personal health record of the patient’s choosing without losing the existing structured data.
- An organization in a distributed/decentralized health information exchange can accept programmatic requests for copies of a patient record from an external EHR and return records in a standard format.
- An organization can move all its patient records to a new EHR.
- An organization can embed encapsulated functionality within their EHR using an application programming interface. Goals: access specific data items, manipulate them, and then store a new value.
Healthcare Security: Adapt or Die
When examining the rapid speed at which the threat landscape for healthcare is changing and combining it with the traditionally slow-to-adapt nature of the healthcare industry in general, the problem's pretty clear. It's a different threat world nowadays. Think about it. Every 60 seconds, 232 computers are infected with malware; 12 websites are successfully hacked, with 416 attempts; more than 571 new websites are created; 204 million emails are sent, and 278,000 tweets are sent out into the twittosphere – all in a single minute. Combine this with the fact that on the black market, medical records are worth $60, compared to credit card data, which typically sells for $20. So, what are the implications for a healthcare security professional? When examining the rapid speed at which the threat landscape for healthcare is changing and combining it with the traditionally slow-to-adapt nature of the healthcare industry in general, the problem's pretty clear.
ATA: 3 Priorities for Broadband Policy in Healthcare
In comments to the National Telecommunications and Information Administration, the American Telemedicine Association urged the support for and consideration of broad band as a key component to improving healthcare services. "Broadband advances enable telemedicine supply, and telemedicine demand enables broadband advances," the ATA wrote in its letter. The ATA outlined the following three priority areas of focus for federal broadband policy as it relates to healthcare.
1. Coordinate federal funding to support local health broadband usability.
2. Create and maintain health service networks via broadband.
3. Incentivize investments in broadband by reimbursing for services.
Healthcare to Enter 'Third Wave of Digital'
They're calling it the "third wave of digital." And it's coming to the healthcare industry first. In the 1990s, it was the Internet. In the early 2000s, it was about mobility. Now, it's the era of "living services." At least that's according to Accenture officials, who citing their new report published June 15, say organizations – including healthcare organizations – will be soon providing a "new wave of transformative digital services." And the one area where this wave will appear first? It's the healthcare industry, officials point out. Think quantified self-health tracking devices. Think wearables and mobile health platforms that are helping consumers manage myriad chronic diseases and wellness.
Creating Added Value from Clinical Pathology Laboratory Testing Produced Improved Outcomes at University of Mississippi Medical Center and Broward Health
One big challenge facing medical laboratories and anatomic pathology groups in the United States today is the need to transition from a transaction-based business model (increasing specimen volume leads to increasing revenue) to a value-based business model (helping providers improve their use of clinical laboratory tests in ways that measurably improve patient outcomes while controlling or reducing the cost of care.) Two trends reinforce the need for clinical laboratories to craft strategies to develop new ways to add value to lab testing services.
One trend is the move by Medicare and private health insurers to shift reimbursement for providers away from fee-for-service and toward bundled reimbursement and budgeted reimbursement.
The second trend is the emergence of integrated clinical care organizations. The most visible of these are accountable care organizations (ACO) and patient-centered medical homes (PCMH). What these care delivery organizations have in common is that they require hospitals, physicians, clinical laboratories, imaging centers, nursing homes and other types of providers to work together more effectively so that patients receive healthcare in a seamless fashion because there is a continuum: primary care to specialty care to acute care and back again.
E. coli Testing Market Expected to Reach $2.1 Billion by 2022
The global market for E. coli testing is expected to reach $2.1 billion by 2022, up from $1.2 billion in 2013, according to a new report from market research company Transparency Market Research. Thanks in part to major federal efforts to combat more foodborne illness in the U.S. via the Food Safety Modernization Act (FSMA), analysts expect environmental and clinical laboratory testing for E. coli to significantly increase over the next decade — to the tune of 6-7 percent growth each year.
Individuals with Social Phobia Have Too Much Serotonin
Previous studies have led researchers to believe that individuals with social anxiety disorder/social phobia have too low levels of the neurotransmitter serotonin. A new study carried out at Uppsala University, however, shows that the situation is exactly the opposite. Social phobia is commonly medicated using SSRI compounds. These change the amount of the neurotransmitter serotonin in the brain. Based on previous studies, it was believed that individuals with social phobia had too little serotonin and that SSRIs increased the amount of available serotonin. In a new study published in the scientific journal JAMA Psychiatry, researchers from the Department of Psychology at Uppsala University show that individuals with social phobia make too much serotonin. This discovery is a major leap forward when it comes to identifying changes in the brain's chemical messengers in people who suffer from anxiety.
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