A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
July 30, 2015
- Change in 'Pap' Test Rules Linked to Drop in STD Testing
- Risks of Screening Mammography Overestimated: Large Study Shows Women Receive About 30 Percent Less Radiation Than Previous Believed
- Leading Experts Prescribe How to Make Cancer Drugs More Affordable
- Finding and Following Bugs
- ASM, CAP, and CLSI Collaborate to Prepare Materials to Address New Regulations in the Laboratory
- FDA Mulls Expansion of Diagnostic Test Oversight
- Saliva May Help Distinguish Between Forms of Cognitive Impairment
- Preliminary Guidance for Newborn Blood Spot Work
- Moffitt Cancer Center Researchers Develop First Genetic Test to Predict Tumor Sensitivity to Radiation Therapy
- Adjuvants Improve Immune Response to H7N9 Flu Vaccine
- Scientists Test Universal Flu Vaccine in Mice
- Study: Daily Soda Could Increase Diabetes Risk by 18%
- AACC Emphasizes Need for Quality Results and Patient-Friendly Reports in Direct-to-Consumer Testing
- Senate Committee Seeks EHR Interoperability Investigation
- Got Scribes? Study Says They Could Make ED Testing More Exact
View Previous Issues - Healthcare News Archive
Change in 'Pap' Test Rules Linked to Drop in STD Testing
A major change in Pap test guidelines introduced in 2009 may have had an unintended consequence: Some young women are missing out on screening for chlamydia -- a common sexually transmitted disease that can cause infertility if left untreated. That's according to a small, new study that discovered chlamydia screening among 15- to 21-year-olds plummeted after national guidelines were changed to discourage routine Pap screening for cervical cancer before age 21, because of evidence that showed it did not benefit young women. Those guidelines have nothing to do with chlamydia -- a bacterial STD that infects nearly 3 million Americans each year, according to the U.S. Centers for Disease Control and Prevention. But researchers suspect that as fewer young women got Pap tests, chlamydia screening also fell by the wayside. However, the CDC and other groups advise all sexually active women younger than 25 to get an annual chlamydia screening test.
Risks of Screening Mammography Overestimated: Large Study Shows Women Receive About 30 Percent Less Radiation Than Previous Believed
Screening mammography is safer than previously thought, suggests a large study that determined women receive about 30 percent less radiation during the test than assumed. The research is being presented at the 57th Annual Meeting of the American Association of Physicists in Medicine (AAPM). "Our findings suggest that the harms of screening mammography are smaller than perceived by a significant amount and its efficacy therefore is that much greater," said Andrew Hernandez, BS, a PhD candidate in biomedical engineering at the University of California Davis. "Our large study confirms smaller studies that found the levels of radiation women receive during screening mammography are overestimated. The decision to screen is a computation based both on benefit and risk. We know what the benefits are, and our research now suggests that the risk of developing cancer from screening mammography is 30 percent lower than previously thought," said Hernandez. "The next step is to update the radiation dose methods relevant to mammography to reflect the real distribution of glandular tissue."
Leading Experts Prescribe How to Make Cancer Drugs More Affordable
A group of 118 of the nation's leading cancer experts have drafted a prescription for reducing the high cost of cancer drugs and voiced support for a patient-based grassroots movement demanding action on the issue. Their recommendations and support are outlined in a commentary, co-authored by the group, in the journal Mayo Clinic Proceedings. The group says these actions would improve the situation and allow market forces to work better. The group also supports the patient-based, grass-roots movement on change.org that advocates against high cancer drug prices with the goal of drawing the attention of pharmaceutical companies and elected representatives to this issue.
Finding and Following Bugs
Genomic tools are helping researchers and clinicians detect pathogens, the Journal of the American Medical Association reports. For instance, JAMArecounts, next-generation sequencing of a blood sample from a Kansas man with a mysterious and eventually lethal infection uncovered a novel virus, now dubbed the Bourbon virus for the county in which he lived. Similarly, genomic tools have enable researchers and clinicians to track a Klebsiella pneumonia outbreak at the NIH Clinical Center. As such tools are becoming faster and cheaper, JAMA says they may become more common in tertiary medical centers, but that everyday clinical care will likely rely on rapid PCR. "We don't need to do genome sequencing for a patient who comes in with an E. coli urinary tract infection, but we do need it in the context of an ICU that cares for, say, a critically ill patient who has had a bone marrow transplant, to find out what [microbes] that person was colonized with," Julie Segre from the National Human Genome Research Institute tells JAMA. Others caution that issues like sample contamination underscore the need to test the validity of genomic approaches.
ASM, CAP, and CLSI Collaborate to Prepare Materials to Address New Regulations in the Laboratory
Representatives from American Society for Microbiology (ASM), College of American Pathologists (CAP), and the Clinical and laboratory Standards Institute (CLSI) have jointly prepared materials for laboratories to use as a guide in development of an antimicrobial susceptibility testing (AST) Individualized Quality Control Plan (IQCP) for a commercial automated AST system. The IQCP is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) policy that will become effective as an alternative QC option for all laboratory tests on January 1, 2016. For IQCP compliance, laboratories can either develop an IQCP or perform daily QC as described in current CLIA regulations. It will no longer be acceptable for laboratories to follow CLSI AST guidelines alone for converting from daily to weekly testing of QC strains. Laboratories will be required to develop an IQCP (or perform CLIA mandated QC) regardless of when weekly QC of AST was implemented. Specifically, the following materials are available:
- Template (PowerPoint®) that describes the components that should be included in an IQCP for a commercial MIC AST system
- Example of a completed IQCP (tabular format)
- Listing of Q&A's
The materials can be found on each organization’s website. Additional materials will be developed through this collaboration to assist addressing IQCP for other tests in clinical microbiology laboratories.
FDA Mulls Expansion of Diagnostic Test Oversight
At a time when physicians are complaining about the coming "tsunami" of regulations they'll have to follow for quality reporting and electronic health records, federal officials are considering increasing regulations in another area: laboratory-developed tests. Currently, LDTs are regulated by the Centers for Medicare and Medicaid Services (CMS) under a law known as the Clinical Laboratory Improvement Amendments of 1988, or CLIA. CLIA regulates the tests' "analytic validity," Rachel Sachs, JD, an academic fellow at Harvard Law School in Boston, explained at the school's "Health Law Year in P/Review" conference last January. But that may be changing. Last October, the agency issued a draft framework for regulating LDTs. In the framework, the agency said it was concerned that although CLIA regulation helps ensure "that laboratories and their personnel maintain standards of high quality, FDA is concerned that compliance with CLIA regulations alone does not ensure that the diagnostic devices themselves are safe and effective."
Not surprisingly, the American Clinical Laboratory Association (ACLA) is not happy with the idea. In a white paper issued in January, the association explains why the tests shouldn't be seen as medical devices. "In common usage, a 'device' is a physical article or product ... Laboratory-developed testing services are self-evidently not 'devices,'" wrote attorneys Paul Clement, JD, and Laurence Tribe, JD, the authors of the white paper. The College of American Pathologists, on the other hand, seems to take a more nuanced approach. In its own proposal for regulating LDTs -- outlined in aJune 19th letter to the Energy and Commerce Committee -- the college suggests "A tiered risk-based regulation that would focus FDA oversight to the tests that currently have the least transparency and highest potential patient risk."
Centrifuges: Labs Unsung High Performance Instruments
Centrifugation and centrifuge maintenance may not be the most exciting topics in laboratory medicine, but they are central to much of the testing we do and important in the quality of tests we provide, as an inadequate instrument or poor procedure can affect test results. Though their care is often neglected, the very high speeds at which centrifuges operate make them high performance instruments that need to be monitored and maintained. The College of American Pathologists (CAP) only has limited requirements for centrifuge maintenance. The CAP checklists GEN.41017 and COM.30600 require documentation that centrifuge performance is verified at least annually by manufacturer service representatives or a clinical engineer, or more frequently as defined by the manufacturer. Clinical and Laboratory Standards Institute (CLSI) guidelines in GP31A go into more detail about centrifuge care and maintenance. This document sets out the general recommendations for maintenance, but specifically cites the need for accuracy in centrifuge timers and speed control. Annual performance verification is well and good, but for optimal sample processing, lab staff should be prepared to do routine maintenance and function checks. Laboratorians should all be familiar with the basic operation of centrifuges and the need to check several factors with each run.
Testing for ESBL: Do We Have It All Wrong?
The recent study by Tamma and colleagues and another from 2012 provide insight on whether beta-lactam/beta-lactamase-inhibitor combination antibiotics (BLBLIs) have a role in treating infections caused by extended-spectrum beta-lactamase (ESBL) producers. In 2010, the Clinical & Laboratory Standards Institute lowered the breakpoints of third-generation cephalosporins to improve the detection of ESBLs and AmpC beta-lactamases. As a result, microbiology laboratories are no longer required to test for the presence of ESBLs in Enterobacteriaceae. Proponents of this "new" approach argue that when BLBLIs are active against ESBL producers in vitro, they should also be active in vivo. The presence of an ESBL is therefore less important than the actual minimum inhibitory concentration (MIC). Opponents argue that clinicians need to know when an ESBL is present, because carbapenems would be the preferred agents. They point to the limited clinical data on using BLBLIs for ESBL infections, the potential presence of undetected resistance mechanisms, and the possibility of an inoculum effect when BLBLIs are used. Who is correct? An ongoing multicenter, randomized trial is comparing meropenem with piperacillin-tazobactam for ceftriaxone nonsusceptible E coli and K pneumoniae infections. After years of debate, a definitive answer on the need for routine ESBL testing may be just around the corner.
Saliva May Help Distinguish Between Forms of Cognitive Impairment
A saliva test successfully predicted whether patients had Alzheimer's disease, mild cognitive impairment (MCI), or normal cognitive aging, suggesting to researchers that it may hold promise and have implications for future Alzheimer's research. The early results of the study were presented at the Alzheimer's Association International Conference here. In the study, Shraddha Sapkota, MSc, of the University of Alberta, Canada, and colleagues aimed to fully discriminate between Alzheimer's disease, MCI, and normal cognitive aging based on metabolomic signatures; determine the top discriminative metabolites; and evaluate these metabolites as biomarkers for predicting neurocognitive performance. According to results, researchers detected 1,515 metabolites in each pairwise comparison. After linking data back to each patient's clinical diagnosis, researchers observed a strong link between certain substances and a person's cognitive abilities.
Preliminary Guidance for Newborn Blood Spot Work
The US National Institutes of Health has released preliminary guidance informing study investigators that they'll need to get parental permission before using newborn dried blood spots for government-funded research. The NIH guidance reflects Section 12 of the "Newborn Screening Saves Lives Reauthorization Act of 2014," which went into effect March 18. Under a last-minute amendment to this legislation, NIH-funded research using dried blood spots derived at the time of newborn screening on or after that date is considered non-exempt human subjects research and must abide by regulations under 45 CFR part 46. "Waiver of parental permission for such research is not permitted under this legislation," NIH states. NIH advises investigators conducting government-funded research involving newborn dried blood spots to keep informed of developments in this regard, and says that the Department of Health and Human Service Office for Human Research Protections will also issue additional guidance on this law.
Moffitt Cancer Center Researchers Develop First Genetic Test to Predict Tumor Sensitivity to Radiation Therapy
Recent advances in the understanding of cancer have led to more personalized therapies, such as drugs that target particular proteins and tests that analyze gene expression patterns in tumors to predict a patient’s response to therapy. Moffitt Cancer Center researchers have contributed to these advances by developing the first test that analyzes the sensitivity of tumors to radiation therapy. They discovered that colon cancer metastases have varying sensitivity to radiation therapy based on their anatomic location. Researchers from Moffitt previously developed a radiation sensitivity index (RSI) that predicts how sensitive tumors are to radiation based on expression patterns of different genes. In a paper published July 15 in The International Journal of Radiation Oncology, Biology and Physics, they used the RSI to determine the radiation sensitivity of 704 metastatic and 1362 primary colon tumors.
New Compound May Prevent Beta Amyloid, Tau Misfolding
Data presented at the Alzheimer's Association International Conference 2015 suggest that a new compound TRV 101 may inhibit protein misfolding of beta amyloid and tau peptides, which contribute to the pathology of Alzheimer's disease. After screening more than 11 million compounds in a computer model and creating a library of compounds that may prevent toxic protein-protein interactions, they identified a family of novel compounds, of which TRV 101 was a representative compound. Results suggested that TRV 101 prevents oligomerization activity against both beta amyloid and tau, and selectively binds to the target protein. Researchers also concluded that TRV 101 has optimum drug-like properties — exhibiting favorable in vitro ADMET, high-brain penetrance, and oral bioavailability — and is benign, according to a 44-receptor panel test.
Genomic Fingerprint May Predict Aggressive Prostate Cancer in African Americans
African American men are more likely to develop prostate cancer than European American men, and are also more than twice as likely to die from it. Although there are many reasons that contribute to this health disparity, new research shows that African American men may have a distinctly different type of prostate cancer than European American men, according to new genomic fingerprinting results. Researchers at Thomas Jefferson University have identified biomarkers that define a genomic subtype of prostate cancer that is more common in African American men, and which signals a more aggressive disease.
DNA and Cellular Damage Observed Following Cardiac CT Scans
Low-dose radiation from cardiovascular computed-tomography (CT) angiography results in DNA and cellular damage, as well as increased expression of cells involved in the regulation of cell repair and apoptosis, according to the results of a new study. Most of the cells damaged by the CT angiogram were repaired, but a small percentage of cells died, according to researchers. The results raise the possibility that radiation exposure from CT angiography can cause DNA damage that leads to cellular mutations if these damaged cells are not repaired or eliminated, according to lead investigator Dr Patricia Nguyen (Stanford University, CA) and colleagues. Moreover, the study suggests that cumulative cell death after repeated exposure to radiation from CT could be "problematic."
Biomarkers in Blood Shown to be Highly Selective Indicators of Brain Damage
Researchers have shown that the levels of two proteins present in blood and cerebrospinal fluid increase significantly at different time points following traumatic brain injury (TBI), confirming their potential value as biomarkers of trauma-related brain damage. The researchers linked the changes in circulating UCH-L1 and GFAP proteins in rats to brain tissue damage and neuronal degeneration seen on examination of the rat brains, and present their findings in an article published in the Journal of Neurotrauma.
Glasses That Make Cancer Glow
It's better than x-ray vision, according to Dr. Samuel Achilefu, a professor of radiology at Washington University, who developed the technology. "The primary goal of the technology is to make sure that the surgeon does not operate in the blind, it's to make the cancer cells light up like Christmas trees," said Achilefu. The system works by first injecting the patient with a cancer-targeting dye that attaches to abnormal cells. Then a near infrared light is beamed on the target area which allows a surgeon wearing specialized glasses to see cancer cells glowing. "What this does is conserve the healthy tissue and only go after the ones that are abnormal," added. Achilefu.Currently the cancer glasses are being tested on skin and breast cancer patients, but Dr. Achilefu says they could be used to visualize and remove a wide range of cancers. He says lighting up cancer means a brighter future for people diagnosed with the deadly disease.
Sound Waves Gently Cull Circulating Tumor Cells from Blood Samples
The capture and analysis of circulating tumor cells (CTCs) in the blood of cancer patients is a valuable tool for treatment decisions and therapy monitoring. Until recently, it was a huge challenge to capture these rare cells in a blood sample. In a new approach, researchers funded by the National Institute of Biomedical Imaging and Bioengineering have developed a system that efficiently isolates CTCs using sound waves, without physical contact or damage to the cells, assuring that their original characteristics are maintained. The contact-free nature of the method offers the potential for more precise cancer treatment and monitoring, and new discoveries on how cancer spreads. The low-cost acoustic cell-separation device was developed by a research team led by Tony Jun Huang, Ph.D., at Pennsylvania State University, and his collaborators at the Massachusetts Institute of Technology, Notre Dame University, Penn State Hershey Cancer Center, and Carnegie Mellon University. The work is described in the April issue of the Proceedings of the National Academy of Sciences.
Pill on a String Can Detect Cancer without Need for Biopsy
A ‘pill on a string’ has been developed by the University of Cambridge to detect the early signs of gullet cancer without the need for a biopsy. The pill is swallowed and when the outer case dissolves it reveals a sponge which can then be pulled up the throat lining, collecting cells. Researchers say the tiny sponge is more effective at picking up cancer because it takes a swab of the whole throat and not just a small area that a biopsy would examine.
Virus-Like Particle Vaccine Protects Mice from Many Flu Strains
A vaccine that protects against a wide variety of influenza viruses (a so-called universal flu vaccine) is a critical public health goal given the significant rates of illness and death caused by seasonal influenza and the potentially devastating effects of a pandemic influenza strain. Now, researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, have devised a way to induce protective immunity in mice against a wide array of influenza viruses. The experimental vaccine is made from non-infectious virus-like particles (VLPs) that stimulate an immune response, but that cannot replicate or cause disease. In the new study, the NIAID scientists vaccinated mice with the VLP cocktail, then exposed them to lethal doses of several different influenza viruses. Importantly, in some of the experiments, mice were exposed to viruses from H subtypes not included in the cocktail vaccine. Vaccinated mice showed significant protection following challenge with influenza viruses expressing 1918 H1, 1957 H2, and avian H5, H6, H7, H10, and H11 H subtypes. The investigators are now testing the VLP cocktail in ferrets. If the results are similar to those seen in mice, they will advance the vaccine into early-stage human clinical trials.
Two Genomic Analyses of Native Americans Come to Differing Conclusions
A pair of genomic studies published today has come to conflicting conclusions as to how the Americas were peopled. One study, appearing in the online early version of Science from the University of Copenhagen's Eske Willerslev and his colleagues, reported that the ancestors of all present-day Native Americans came to the Americas in a single wave from Siberia no earlier than 23,000 years ago. The other study, published in the advanced online version of Nature from Harvard Medical School's David Reich and his colleagues, concluded that two migration streams were more likely, one of which was more closely related to ancestors of Australasian populations. In particular, the studies differed in their interpretation of genomic data suggesting that some Native American groups in South America, such as the Suruí of Brazil, were more closely related to ancestors of present-day Australasians.
Questionnaire Beats Blood Test in Identifying At-Risk Drinking among ER Patients
Emergency room physicians treating patients with alcohol-related trauma can better identify those at risk of future drinking-related trauma with a 10-point questionnaire rather than the standard blood alcohol content test, according to a study in The Journal of the American Osteopathic Association (JAOA). The questionnaire, known as the Alcohol Use Disorders Identification Test (AUDIT), was developed by the World Health Organization to address difficulties in identifying at-risk drinking behavior. It assesses alcohol consumption, drinking behaviors and alcohol-related problems. Researchers at Loyola University Medical Center found the 10-point questionnaire to be 20 percent more effective than measuring blood alcohol level in detecting patients with at-risk drinking behaviors likely to result in future ER visits.
Diagnostic Test Developed for Enterovirus D68
Researchers at Washington University School of Medicine in St. Louis have developed a diagnostic test to quickly detect enterovirus D68 (EV-D68), a respiratory virus that caused unusually severe illness in children last year. The outbreak caused infections at an unprecedented rate, with over 1,000 confirmed cases and 14 reported deaths nationwide, according to the Centers for Disease Control and Prevention (CDC). Results published in the August issue of The Journal of Clinical Microbiology demonstrate that the test is extremely effective at identifying various strains of EV-D68 and reduces the amount of time needed to detect the virus. Earlier procedures for identifying enterovirus strains involved sequencing a region of the virus’s genome, which is too cumbersome to perform on large numbers of patients. The new test can be completed in a few hours, while previous techniques took several days to process. The researchers also said the new test is more specific than commercially available diagnostic tests for enterovirus.
Saudi Study Finds Gene Panels Have Similar Dx Rate to Clinical Exomes at Lower Cost, Shorter Time
Gene panels have significant practical and cost advantages over clinical exome sequencing for diagnosing Mendelian diseases, according to researchers from Saudi Arabia. In a study published online in Genome Biology last month, the team found that 13 gene panels they developed covering about 3,000 Mendelian disease genes yielded a diagnosis in 43 percent of patients, a rate comparable to whole-exome sequencing but at a fraction of the cost and in a shorter timeframe. "We wanted something that's very practical, that any clinician can order," said Fowzan Alkuraya, a principal clinical scientist at King Faisal Specialist Hospital and Research Center in Riyadh and the study's author. "Exome sequencing is popular, but it's too expensive, and it takes time." The turnaround time for a panel is about 10 days compared to typically months for clinical exome tests, and the cost per panel is between $75 and $150, according to the study.
Adjuvants Improve Immune Response to H7N9 Flu Vaccine
In a phase 2 trial that included nearly 1,000 adults, the AS03 and MF59 adjuvants (a component that improves immune response of inactivated influenza vaccines) increased the immune responses to two doses of an inactivated H7N9 influenza vaccine, with AS03-adjuvanted formulations inducing the highest amount of antibody response, according to a study in the July 21 issue of JAMA. In March 2013 the first human infections with the avian influenza A(H7N9) virus were reported in China, and since that time hundreds of cases have been documented. While most infections are believed to result from exposure to infected poultry, the potential for viral adaptation that would facilitate person-to-person transmission is a major concern. Previous experience with an inactivated H7N7 influenza vaccine indicated that hemagglutinin (a substance on the outer coat of the influenza virus) H7 is poorly immunogenic, necessitating evaluation of adjuvanted H7N9 vaccines, according to background information in the article. “These results imply that, of the options currently available utilizing adjuvants included in the national stockpile, based on the immune response data, AS03 should be considered a first-line adjuvant for strategies incorporating an inactivated H7N9 vaccine in adults,” the authors write.
Scientists Test Universal Flu Vaccine in Mice
Scientists report that a universal flu vaccine in mice protected the animals against eight different flu strains. If the vaccine works in humans, scientists might not have to develop new flu vaccines every year, the researchers said. The findings were reported July 21 in the journal mBio. Currently, a vaccine is created each year to protect against the handful of flu strains that are predicted to be the most common during that flu season. And the vaccine makeup is determined months in advance so that manufacturers have time to make the millions of doses needed.
Study: Daily Soda Could Increase Diabetes Risk by 18%
While the consumption of SSBs [sugar-sweetened beverages] has been found to be associated with a greater risk of obesity, a major risk factor for type 2 diabetes, little data exists on the direct connection between SSBs and diabetes. In order to examine the effect of regular consumption of SSBs, ASBs, and fruit juice on the risk of developing type 2 diabetes, researchers conducted a systematic review and meta-analysis of 17 observational studies involving 38,253 individuals with type 2 diabetes. Overall, researchers found that higher consumption of SSBs raised the risk of type 2 diabetes development by 18% per one serving/day and 13%, before and after adjustments for adiposity. ASBs raised the risk by 25% and 8%, before and after adjustments, and fruit juice raised the risk 5% and 7%, before and after adjustment.
Survey: Only 48 Percent of Americans Wash Their Hands after Cracking Eggs
A team of researchers from RTI International, Tennessee State University, and Kansas State University have just published the findings of their surveyof handling practices and consumption of shell eggs in U.S. homes. The study was partially funded by the Department of Agriculture’s National Institute of Food and Agriculture. Only 48 percent wash their hands with soap and water after cracking eggs. Because hands are the primary vehicle for spreading pathogens in the kitchen, USDA and the Partnership for Food Safety recommend that consumers wash their hands before and after handling raw eggs. More than half of participants who fry or poach eggs leave the yolks soft or runny, something discouraged by the Food and Drug Administration. Thirteen percent reported rinsing or washing eggs before cooking them, another potentially unsafe practice because of the possibility of cross-contamination. According to the Centers of Disease Control and Prevention, Salmonella enteriditis is one of the most common serotypes of Salmonella bacteria reported worldwide, and eggs have been the most common food source linked to infections. An estimated 64 percent of outbreaks between 1998-2008 caused by Salmonella enteriditis were attributed to eggs.
South Korea Says MERS Outbreak That Hit Economy No Longer Worry
South Korea urged its people to put the outbreak of Middle East Respiratory Syndrome behind them after lifting the last quarantine over a disease that has hurt economic growth and public confidence in President Park Geun Hye. Since the first reported cases of MERS on May 20, the virus has infected 186 people and killed 36 in South Korea. It prompted thousands of schools to close at one point and led to the cancellation of concerts, trips and other public activities vital to growth in Asia’s fourth-largest economy. South Korea’s MERS outbreak was the second-largest after Saudi Arabia and almost all of its infections have taken place in hospitals, indicating the virus didn’t spread into the community. The World Health Organization advises a country to declare the end of a MERS outbreak after 28 days since the last case tested negative, even though it is up to the country to decide. South Korea has reported no new cases of MERS since July 5.
Helping Staff Who Are Traumatized by Errors
In 2001, when Cheryl Connors was just three years into her career as a nurse, an 18-month-old girl named Josie King died as a result of medical errors on Connors' unit at Johns Hopkins Hospital. In 2010, she teamed up with Dr. Albert Wu, a professor of health policy and management at Johns Hopkins, to find a way to offer hospital staff needed emotional support following adverse events. “What we ended up with was a volunteer peer-responder program whose sole mission was to provide timely support to staff who had encountered patient-related events and who could benefit from help,” Wu said. The program is separate from the hospital's root-cause analyses and other post-error patient-safety work, focusing solely on staff support. After a medical error, employees may suffer from anxiety, shame and depression. The symptoms, if left unchecked, can progress to post-traumatic stress syndrome, Wu said. “It's evident that some people, months and years later, are still trying to avoid trigger situations or certain kinds of patients.”
Support for Staff
- Get senior leaders on board: You'll need their support to make sure peer responders have time reserved to respond to calls,
- Invest in training: Peer volunteers need to learn very specific techniques to provide effective support,
- Reach out to hospitals that have done work in this area,
- Provide options for support: If you don't have the resources to start your own program, make sure employees know about the Medically Induced Trauma Support Service, which can provide telephone support to clinicians involved in medical errors.
AACC Emphasizes Need for Quality Results and Patient-Friendly Reports in Direct-to-Consumer Testing
Noting a paradigm shift among consumers who are seeking greater control over their own healthcare, AACC issued a position statement on direct-to-consumer laboratory testing, which allows people to order medical tests directly from a lab without having to work with their healthcare provider. The statement emphasizes direct-to-consumer test results must be accurate and easily understood—an area where laboratory medicine professionals play a vital role. Laboratory test results are key to patients getting the care they need, and in the past, state laws limited the ordering of these tests to physicians. However, as people have become more engaged in managing their own healthcare, this model has begun to change. Currently, 37 states and the District of Columbia permit consumers to order some or all of their laboratory tests without the involvement of a physician. Individuals can also buy over-the-counter test kits or get laboratory services from non-traditional settings such as retail centers.
Got Scribes? Study Says They Could Make ED Testing More Exact
Querying a health information exchange can lead to significant reductions in laboratory tests and radiology exams, according to a new study of more than 2,000 emergency department visits in three western New York hospitals. The study was published in the Journal of the American Medical Informatics Association, conducted by the Brookings Institution and supported by HealtheLink, the Buffalo, N.Y.-based health information exchange. According to the study results, usage of the HIE was associated with a 52% reduction in the expected total number of laboratory tests and a 36% reduction in radiology examinations ordered per patient at the ED.
Senate Committee Seeks EHR Interoperability Investigation
Members of the Senate Appropriations Committee this week sought an investigation into whether taxpayer-supported software is preventing the free exchange of patient records between non-partnering healthcare organizations. In the committee's response to the Department of Health and Human Services (HHS) fiscal year 2015 budget, the bipartisan group of senators pointed to so-called "information blocking," and detailed steps the Office of the National Coordinator for Health Information Technology (ONC) – which oversees EHRs – should take to ensure the free flow of patient data between healthcare organizations. In June, ONC unveiled a 10-year interoperability roadmap, building on a vision that National Coordinator for Health IT Karen DeSalvo began sharing soon after taking on the office's leadership role. Recently, the Rand Corporation released the report "Redirecting Innovation in US Healthcare," which found that several technologies would reduce costs and improve outcomes – if interoperability improved.
Initiative Aims to Ease Prenatal Testing Fears
A campaign launching Friday by the Perinatal Quality Foundation in conjunction with Quest Diagnostics aims to cut through that layer of anxiety by providing straightforward information to help families and health care providers make informed decisions about family planning and pregnancy management. The initiative will use a website, newsletter and events to help people understand the advantages and limitations of tests. At the core of the campaign: the creation of an online patient registry through which women who receive prenatal screening during pregnancy will be asked to report results of confirmatory diagnostic tests, which are screenings required to verify an analysis. Researchers can then use this information to assess how good the tests are at finding abnormal chromosomes in cells, which can indicate that a fetus has a birth defect. Determining a test’s predictive value – which measures the accuracy of positive or negative results – is crucial, says Douglas Rabin, medical director for women’s health at Quest, the first lab to join the initiative. Researchers can better make this assessment through data culled in the online registry, which will launch in 2016, he says.
Elderly Want to Control What Health Information Families See
"Respecting and preserving the autonomy of the elder is critical," said lead author Dr. Bradley Crotty. "Elders and families should have honest discussions about preferences for information sharing and decision-making, and share these conversations with healthcare providers." To understand how patients over 75 and the family members who care for them think about sharing medical information, Crotty and colleagues held separate focus groups in 2013 and 2014 with 30 elders and 23 caregivers. Most of the elderly patients were older than 81. A third of them rarely, if ever, used the internet, while 60% went online daily or almost every day. Many differences of opinion emerged as the two groups talked about sharing access to the elderly patients' health records, the researchers reported online July 6 in JAMA Internal Medicine. While the study is small, it points for the need for online patient portals to be designed with the needs of both elderly patients and their family caregivers in mind, said Crotty, who is director of patient portals in the division of clinical informatics at Beth Israel Deaconess Medical Center and an instructor at Harvard Medical School.
Risk Management for ICD-10: 3 Areas Worth Provider Focus
With the deadline to transition to ICD-10 rapidly approaching, providers must continue efforts to ensure the code set switch goes smoothly. The healthcare professionals, in a HIMSS News post, outline areas of risk management providers should focus on for ICD-10, which include.
- Sustainability: Providers should make sure stakeholders remain vigilant about the transition and sustain the level of attention ICD-10 is currently receiving as the deadline grows near.
- Engagement: Alongside sustainability is engagement, DiLuzio and Roach say. Providers need to ensure everyone remains engaged in the effort through enhanced communication.
- Practice: Making sure any issues or revenue impacts are realized or addressed before October is also important.
Despite years of delays, it's looking more like Oct. 1 will be the official date of implementation.
Many Americans Do Not Get Recommended Preventive Services
Many Americans did not receive some recommended preventive health services in 2011 to 2012, according to a report published in the July 17 issue of the Morbidity and Mortality Weekly Report. The report suggests the Affordable Care Act (ACA) may improve uptake of these services. "Rates of receipt of some clinical preventive services by adults are higher for persons with insurance coverage or higher incomes," write Jared B. Fox, PhD, and Frederic E. Shaw, MD, JD, from the Office of Health System Collaboration and Center for Surveillance, Epidemiology and Laboratory Services, CDC, Atlanta, Georgia. "The [ACA]'s expansions of health insurance access and coverage requirements for clinical preventive services were developed to increase access to health services to improve the health of the population." Preventive care can save lives and improve health by early detection of disease and appropriate intervention. The authors note that persons with health insurance are up to three times as likely to receive needed preventive care as uninsured persons. However, even many insured persons did not get receive recommended preventive services in 2011 to 2012, according to combined adult responses to the National Health Interview Survey in those years.
The Joint Commission Offers Integrated Care Certification
A new certification option from The Joint Commission is focused on helping health care organizations improve care coordination across the continuum of care, beginning with hospital and ambulatory care settings. The new Integrated Care Certification option assesses how well a health care organization integrates information sharing, transitions of care, hand-off communications and other key activities as a patient moves between the hospital and outpatient care settings. With a focus on leadership, clinical integration, patient and family engagement and other areas, this new certification is the starting point for improving patient outcomes with better coordinated care. The standards are designed to be flexible to accommodate different system types, from large hospital systems with multiple campuses to small independent hospitals and from small primary care practices to large multispecialty groups.
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