A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
January 3, 2013
View Previous Issues - Healthcare News Archive
HHS Health IT Safety Plan Open for Public Comment
The U.S. Department of Health and Human Services (HHS) released the Health IT Patient Safety Action and Surveillance Plan which is open for public comment through Feb. 4, 2013 and addresses recommendations made in the 2011 Institute of Medicine (IOM) Report, Health IT and Patient Safety: Building Safer Systems for Better Care. “This report will help all of us better use health IT to deliver high quality care and improve patient safety,” said National Coordinator for Health IT Farzad Mostashari, M.D.
The Office of the National Coordinator for Health IT (ONC) will propose using electronic health record certification criteria to make it easier for clinicians to report patient safety events. Working with ONC, the Centers for Medicare & Medicaid Services (CMS) will align its health and safety standards and guidance for providers and suppliers. CMS will also develop training for surveyors that enhances their ability to identify safe and unsafe practices associated with health IT.
CMS Releases New DRG Manual
The Centers for Medicare and Medicaid Services has released the ICD-10-CM/PCS MS-DRG v30 Definitions Manual. It's not a final version of the Medicare Severity Diagnosis Related Groups (MS-DRG). It's important to stay on top of how ICD-10 codes will be grouped because the MS-DRGs drive reimbursements. If you're looking to build conversion apps or functions, check out these files:
- ICD-10-CM/PCS MS-DRG v30 Definitions Manual Table of Contents- Full Titles – Text Version [ZIP, 3MB]
- ICD-10 Medicare Code Editor v30 (MCE v30 to be used with v30 Definitions Manual) [ZIP, 1016KB]
- ICD-10 MS-DRG v29 & v30 Comparison Files [ZIP, 26KB]
You can learn more about the updates at CMS' ICD-10 MS-DRG Conversion Project page. Ron Mills writes at 3M Health Information Systems that CMS is working on a PC version of the groupers for early next year.
FDA Needs Mobile Health IT Office, Lawmaker Says
A California congressman introduced a bill... to promote health IT innovation, in part by creating a Food and Drug Administration office to oversee mobile health technology. U.S. Rep. Mike Honda, a Democrat, said in a news release that his Healthcare Innovation and Marketplace Technologies Act would foster innovation through marketplace incentives, challenge grants and more workforce retraining opportunities.
“Why have the principles of Silicon Valley, which I represent – competition, innovation, and entrepreneurship – not fully manifested themselves in the health-care information technology space? This bill gets us closer to that space,” Honda said in a statement. The measure would establish an Office of Wireless Health at the FDA to “develop and maintain a consistent, reasonable and predictable regulatory framework” for mobile-health technology issues.
Pathologists May Be Healthcare’s Rock Stars of Big Data in Genomic Medicine’s ’Third Wave’
Pathologists and clinical laboratory managers may be surprised to learn that at least one data scientist has proclaimed pathologists the real big data rock stars of healthcare. The reason has to do with the shift in focus of genomic medicine from therapeutics and presymptomatic disease assessment to big data analytics. “Big data analytics” will be required for translational medicine to succeed in the Third Wave of Genetic Medicine. That’s the opinion of Mark S. Boguski, M.D., Ph.D., who is a pathologist-informatist at Harvard Medical School and Beth Israel Deaconess Medical Center.
“Our notions about how genome science and technology would improve health and healthcare have changed,” Boguski wrote in an editorial published at Future Medicine. He then noted that the focus has shifted to big data analytics. “This is where genomics is likely to bring the most direct and sustained impact on healthcare for several reasons,” stated Boguski. “Genomics technologies enable disease diagnosis of sufficient precision to drive both cost-effective [patient] management and better patient outcomes. Thus, they are an essential part of the prescription for disruptive healthcare reform.”
Boguski reiterated the case for the value of laboratory medicine. He stated the following critical—but often overlooked—points....
- Pathologist-directed, licensed clinical laboratory testing has a major effect on clinical decision-making.
- Medical laboratory testing services account for only about 2% of healthcare expenditures in the United States.
- Medical laboratory services strongly influence the remaining 98% of costs through the information they provide on the prevention, diagnosis, treatment, and management of disease.
NCQA Announces First ACO Accreditation
Kelsey-Seybold Clinic, a Houston physician group, is the first healthcare provider to be accredited as an accountable care organization by the National Committee for Quality Assurance, according to a news release. The 350-doctor, 20-location clinic was one of six organizations that first applied for ACO accreditation after the NCQA began taking submissions in March of this year. The assessment focused on characteristics such as structure and operations; access to providers; patient rights and responsibilities; and performance reporting.
Medicare Discloses Hospitals' Bonuses, Penalties Based On Quality
Medicare on Thursday disclosed bonuses and penalties for nearly 3,000 hospitals as it ties almost $1 billion in payments to the quality of care provided to patients. In all, Medicare is rewarding 1,557 hospitals with more money and reducing payments to 1,427 others, according to a Kaiser Health News analysis of records released by the Centers for Medicare & Medicaid Services. The maximum amount any hospital could gain or lose was 1 percent of its regular Medicare payments.
Seventy percent of the scores are based on how frequently hospitals followed 12 basic clinical standards of care, such as controlling heart surgery patients' blood sugar levels and giving them beta blockers to lower their blood pressure. The other 30 percent is determined by how well hospitals were rated by former patients in surveys asking about the communication and responsiveness of doctors and nurses and the cleanliness and quietness of their environment.
Over the next four years, the program will expand to encompass 2 percent of all Medicare payments. Next year Medicare is adding death rates of heart and pneumonia patients, and for future years it is considering other measures, including the cost-efficiency of hospitals; the frequency of infections; and wait times in emergency rooms.
- Interactive Chart: Bonuses And Penalties For U.S. Hospitals
- Download Hospital Data: PDF File [608.69KB] | CSV Spreadsheet [403KB]
- By State: Hospital Quality Bonuses and Penalties
- Methodology: How Hospitals’ Quality Bonuses And Penalties Were Determined And How To Use The Data
Pfizer, Collaborators Developing NanoString ALK Test as Lower-Cost Alternative to FISH, IHC
Using NanoString's nCounter technology, researchers from Pfizer and Seoul National University have developed an ALK test they hope will be as accurate as the gold standard fluorescence in situ hybridization test for identifying patients who could benefit from Pfizer's Xalkori (crizotinib) and other ALK inhibitors used to treat non-small cell lung cancer, but at a lower cost. The team published the results in The Journal of Molecular Diagnostics last week, showing the method was highly concordant with both FISH and immunohistochemistry results.
Mao Mao, a researcher at Pfizer Oncology and a co-author of the study, told PGx Reporter that in general, the cost of a NanoString assay is "a fraction" of a FISH test, though he didn't provide specific cost estimates. "On the reagent side, NanoString is roughly 10-fold less costly than FISH. It also offers a digital reading, so there is no need for a pathologist to grade the result," he said.
FDA Clears New Testosterone Test
Abbott announced FDA clearance for a new testosterone test, the Architect 2nd Generation Testosterone Assay. The new assay is a chemiluminescent microparticle immunoassay for the quantitative determination of testosterone in human serum and plasma. The test will help diagnose and treat disorders like primary and secondary hypogonadism, delayed or precocious puberty and impotence in men, as well as hirsutism, virilization due to tumors, polycystic ovaries and androgenital syndromes in women. The assay is more sensitive, accurate and precise than previous versions of the assay....
FDA Approves Dual Vacuum-Assisted Biopsy System
Mammotome revolve (Devicor Medical Products), a dual vacuum-assisted biopsy system, has been approved by the US Food and Drug Administration for clinical use in the diagnosis of breast disease. According to a written release from the manufacturer, the device adds to the features of existing devices by incorporating an advanced specimen management system that can collect and organize "high quality individual tissue samples in numbered, specimen radiograph and pathology-ready chambers that preserve tissue integrity."
Better Prostate Cancer Diagnosis - Image-Guided Biopsy
Magnetic resonance ultrasound fusion targeted biopsy is a better way to accurately diagnose prostate cancer, scientists from the University of California, Los Angeles, have found. The biopsies were carried out in under 20 minutes, under local anesthesia. Of the 171 men, 90 were diagnosed with prostate cancer.
Leonard S. Marks, MD, lead investigator, professor of urology and director of the UCLA Active Surveillance Program, said: "The study yielded three key findings. First, it demonstrated the ability to target and biopsy lesions in an office-based setting with the patient under local anesthesia. Second, adding targeted biopsies to systematic biopsies increased the rate of diagnosis of all cancers and, more importantly, Gleason 7 or greater cancer.... Third, the level of suspicion on MRI correlates with cancer diagnosis overall and diagnosis of Gleason 7 or greater prostate cancers."
Dr. Bradford Hood and colleagues at the National Cancer Institute, NIH, said: "MR-US fusion guided biopsy unblinds the 'blind' biopsy and has great potential to supplement or replace 'blind' TRUS prostate biopsies. However, significant hurdles remain to broad adoption and the best approach is yet to be determined."
DoD Dangles $1M Prize for Swift Pathogen Detection Algorithm
The US Department of Defense is launching a competition that will provide $1 million to individuals or teams that develop an algorithm for swiftly and accurately characterizing clinical pathogen samples based only on raw DNA sequence data.
Run by the Defense Threat Reduction Agency (DTRA) and the US STRATCOM Center for Combating Weapons of Mass Destruction, this challenge was created to spur development of fast new methods for identifying pathogens in complex mixtures from clinical samples.
More broadly, DoD hopes that DNA sequencing and analysis technologies will enable it to diagnose a range of pathogenic threats in the field or in areas with low resources.
Federal, State Officials Widen Meningitis Probes
Lawmakers and state authorities have expanded their investigations in the multistate meningitis outbreak to other compounding pharmacies and the industry's trade group. Members of the House Energy and Commerce Committee requested information from the International Academy of Compounding Pharmacists about communication the trade group provided to compounding pharmacies that were dealing with federal and state authorities. “Allegations that your association may have encouraged compounding pharmacists to attempt to impede the FDA from evaluating the efficacy and safety of their products, if true, raise serious concerns about your actions,” the lawmakers said in the Dec. 7 letter. In a statement, the group said it would cooperate with the committee's request.
As of Dec. 10, there have been 37 deaths and 590 infections as a result of the tainted vials of preservative-free methylprednisolone acetate, according to the Centers for Disease Control and Prevention.
Finding the Answer
When Children's Mercy Hospital and Clinics in Kansas City, MO, first started down the road to developing the Center for Pediatric Genomic Medicine in 2011, administrators were originally looking to launch a new carrier test in a CLIA setting. "They needed a clinical lab director, so I joined the team as a clinical molecular geneticist," explained Carol Saunders, PhD, FACMG, clinical laboratory director of the Center. But the focus quickly changed to using NGS for diagnostic purposes, instead of carrier screening. The Center's specialty is inherited pediatric diseases, and its laboratorians help to ease the frustration of young patients and their families by finding diagnostic answers to their often hard-to-identify illnesses. Check out the equipment the Center for Pediatric Genomic Medicine uses:
- two Illuminna HiSeq 2000 DNA sequencers (soon to upgrade to HiSeq 2500)
- one Illumina cBot,
- one Illumina MiSeq,
- one Ion Torrent DNA sequencer,
- two custom-designed Perkin Elmer Sciclone G3 liquid handling robots,
- incorporating Agencourt SPRI magnetic bead separation,
- a Perkin-Elmer Janus liquid handling robot,
- a Bio-Rad CFX96 real-time PCR detection system,
- Caliper Lab Chip GX,
- Agilent Bioanalyzer 2000,
- Covaris LE220 96-well plate DNA sonication system, and
- Nanodrop S2000 spectrophotometer.
Food Allergy Smartphone Dock Brings Laboratory to a Restaurant Near You
People with acute food allergies live in a world where any dish can be tainted with poison – but not everyone can afford a slave food taster with the same allergy profile. Resorting to using technology, researchers at UCLA developed a small device that works along with a smartphone to detect common food allergens. It weighs less than 2 ounces (60 grams) and can detect chemical traces of peanuts, almonds, eggs, gluten and hazelnuts.
To use it in a restaurant will require a bit of laboratory field work to grind the ingredients and mix them with hot water and a solvent. The device not only provides positive/negative results, but even displays allergen concentrations in parts per million (ppm).
Fragile X Newborn Screening Feasible, but Caveats Exist
Newborn screening for fragile X syndrome (FXS) is feasible, but a higher-than-expected prevalence of premutation and "gray zone" alleles may complicate analysis of the public health burden of testing, according to results from a study by Flora Tassone, PhD, from the University of California, Davis, and colleagues, published online [PDF 403.68KB] December 21 in Genome Medicine. Most people have 29 or 30 CGG repeats in the gene. In individuals with the full mutation, exceeding 200 repeats, extended methylation turns off the gene, which adversely affects synaptic plasticity. Affected children have ID, behavior problems, social deficits, and ASD.
"It's not surprising that the study found a higher prevalence of the premutation than has been previously reported, because the screening method allowed more precise quantification of the alleles using a next-generation [polymerase chain reaction] patented by Asuragen," Dejan Budimirovic, MD, director of the Fragile X Clinic at the Kennedy Krieger Institute in Baltimore, Maryland, told Medscape Medical News. He agrees with the researchers' call for more studies of clinical outcomes associated with the premutation. Dr. Budimirovic was not involved in the study.
An Early Blood Test for Autism Shows Promise: Interview with Sek Won Kong, MD
Such early diagnosis is essential because pharmacologic and non-pharmacologic interventions made when children are younger have been shown to lead to positive effects on habilitative progress, functional outcome, and quality of life. Since imaging may be costly and ineffective, and a brain biopsy is infeasible, developing a sensitive blood-based genetic test has been a major effort. Recently, a team of researchers at Boston Children’s Hospital, led by Sek Won Kong MD, conducted the largest blood transcriptome study to date to evaluate the utility of gene expression profiling as a tool to aid in the diagnosis of ASD. The team developed a prototype blood test for autism that was able to predict—with up to 70 percent accuracy—whether a boy was at risk for autism, a marked improvement upon other blood tests. The results of the study were published in PLoS One.
New Test Offers More Information on Genetic Causes of Stillbirth
Karyotyping requires cells to be grown in culture, which is often not possible in a stillbirth. So the researchers sought a technique that would be more reliable. "Previous studies suggest that 25 to 60 percent of stillbirths are unexplained," said the article's first author, Uma Reddy, M.D., of the Pregnancy and Perinatology Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the NIH institute leading the research. "Microarray may explain genetic causes of stillbirths that previously were not identifiable by karyotype." Microarray analysis detected more abnormalities (29.9 percent) than did karyotype analysis (19.4 percent) in stillbirths with a major birth defect - a 53.8 percent increase in the detection rate. The microarray analysis also revealed genetic variations that have not previously been classified as either harmless or disease-causing. Future research is needed to determine if these variations are related to stillbirth, Dr. Reddy explained.
Dr. Reddy collaborated with 17 co-authors.... Their findings appear in the New England Journal of Medicine.
Kawasaki Disease Diagnosed by Urine Proteins?
Of thousands of protein molecules found within urine, researchers using recently developed technologies have identified 2 proteins that hold promise as biomarkers of Kawasaki disease (KD), a rare disease that is the most common cause of acquired pediatric heart disease in the developed world. Alex Kentsis, MD, PhD, from the Division of Hematology/Oncology, Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston Children's Hospital, and Harvard Medical School, Boston, Massachusetts, and coauthors report their findings in an article published online December 20 in EMBO Molecular Medicine.
"The work presented here opens many potential approaches for improving the diagnosis of Kawasaki disease, elucidating its pathophysiology and directing therapy," the authors conclude. "In particular, validation of meprin A and filamin C as specific and sensitive markers of Kawasaki disease using commonly available [enzyme-linked immunosorbent assays] enables their clinical use to improve the accuracy and timeliness of diagnosis of KD."
Clotting Disorders: Studies Challenge Standards to Improve Treatment Outcomes
Studies presented at the 54th Annual Meeting of the American Society of Hematology (ASH) examine current treatment standards for patients with clotting disorders in an effort to improve outcomes. In the first randomized clinical trial assessing the proper target hematocrit level, or percentage of red blood cells that should be maintained in patients with polycythemia vera (PV).
Patients with PV usually have elevated hematocrit levels (approximately 50 to 70%, compared with less than 50% in the general population), which puts them at a higher risk of suffering heart attacks, strokes.
”These data validate the notion that it is important to keep hematocrit levels below 45 percent for this population of patients who are at a high risk of developing clotting complications," said Tiziano Barbui, MD, lead author and Professor of Hematology and Scientific Director of the Research Foundation at Ospedali Riuniti di Bergamo in Italy.
HPV Infections May Return to Haunt Older Women
Reactivation of latent human papillomavirus (HPV) infection in older women could obscure an age-related increase in HPV detection at menopause, data from a prospective cohort study suggested. The age-specific prevalence of 14 high-risk HPV genotypes decreased in women with fewer than 5 lifetime sexual partners but not women with five or more partners, as reported online in Journal of Infectious Diseases. The findings have substantial epidemiologic, behavioral, and clinical implications, according to the authors of an accompanying editorial.
"Older women should not be told that detection of HPV always indicates a new infection, but rather that detection of HPV could result from an infection acquired many years ago," wrote Darron R. Brown, MD, and Bree Weaver, MD, of Indiana University in Indianapolis. "Further research is needed to help better understand the natural history of HPV infection in older women and to understand the importance of HPV persistence and reactivation in all women."
New Unified Language for HPV Biology Endeavors to Reduce Miscommunication in Anogenital Cancers and Precancers
The confusion over terminology used by different medical specialty groups has caused miscommunication among clinicians involved in diagnosing HPV-associated anogenital cancers and precancers, resulting in misdiagnoses and mistreatment. In response, an influential group of specialists from a variety of backgrounds interested in this subject convened two years ago to study whether to create a standardized terminology for these lesions. The current terminology used for these biologically similar lesions varies tremendously across body site, pathology specialty, and clinical subspecialty. In January, ASCP will offer a two-part webinar course, “The Lower Anogenital Squamous Terminology (LAST) Project: Why and How We Can Talk As One,” which presents the LAST Project’s recommendations. The course will be held on Jan. 7 and Jan 14, and will be presented by Mark H. Stoler, MD, FASCP, who participated in the LAST Project.
New Coronavirus Different From SARS in Key Ways
The novel coronavirus that made headlines earlier this year has some important – and possibly dangerous – differences from the virus that caused the deadly 2003 SARS outbreak, researchers reported. The new virus – dubbed hCoV-EMC – appears to be able to infect a wide range of mammalian cells, including those of bats, according to Christian Drosten, MD, of the University of Bonn Medical Center in Bonn, Germany, and colleagues. That could mean it has a natural host in the wild and a relatively low barrier against cross-species transmission, Drosten and colleagues reported online in mBio.
As of Nov. 30, the agency said, there have been nine cases – two in people from Qatar, five in residents of Saudi Arabia, and two in Jordan. Of those, five ended in death. "This virus is closely related to the SARS virus, and looking at the clinical picture, it causes the same pattern of disease," Drosten said. The ability of the virus to infect bats "was a big surprise," Drosten said. "It's completely unusual for any coronavirus to be able to do that – to go back to its original reservoir."
Although Ebola viruses can cause fatal disease in humans and other primates, pigs can carry the infections with few ill effects. Now, Canadian scientists have shown that apparently healthy pigs can pass the deadliest species of Ebola to monkeys, even without ever coming into contact with them. The study, published November 15 in Scientific Reports, marks the first time that the virus has spread between different species in a lab experiment, and suggests that pig farms could be facilitate such species-hopping in more natural conditions.
“An epidemiological survey of wild and domestic pigs in sub-Saharan Africa is now necessary,” agreed Shigeru Morikawa from the National Institute of Infectious Diseases, Japan, who was not involved in the research.
Cause of the Global Epidemic of Clostridium Difficle Identified
New research reveals that there were two different strains of bacterium that caused the global epidemic of Clostridium difficile between 2002 and 2006, not just one. Global outbreaks of C. difficile
- Outbreak starting in the USA - outbreaks began appearing all over the world, the first outbreak of the strain of C. difficile, FQR1 occurred in the USA and quickly spread all over the country.
- Outbreaks starting in Canada - the first outbreak of the other strain C.difficile, FQR2, occurred in Canada and quickly spread worldwide. The finding highlights how interconnected the global healthcare system is.
- Outbreaks in the UK - large scale outbreaks across the UK began after long-range geographical transmission events from other countries.
Dr Trevor Lawley, lead author from the Wellcome Trust Sanger Institute, said, "We have exposed the ease and rapidity with which these fluoroquinolone-resistant C. difficile strains have transmitted across the world. Our research highlights how the global healthcare system is interconnected and how we all need to work together when an outbreak such as this occurs.”
Staphylococcus Aureus: Why It Just Gets Up Your Nose
A collaboration between researchers at the School of Biochemistry and Immunology and the Department of Microbiology at Trinity College Dublin has identified a mechanism by which the bacterium Staphylococcus aureus (S. aureus) colonizes our nasal passages. The study, published December 28 in the open access journal PLOS Pathogens, shows for the first time that a protein located on the bacterial surface called clumping factor B (ClfB) has high affinity for the skin protein loricrin.
Interestingly, S. aureus persistently colonizes about 20% of the human population by binding to skin-like cells within the nasal cavity. Being colonized predisposes an individual towards becoming infected so it is vital that we understand the mechanisms involved. This discovery therefore opens new avenues for developing therapeutic strategies to reduce the burden of nasal carriage and consequently infections with this bacterium. This is particularly important given the difficulties associated with treating MRSA infections.
Unique Microscope Enables Biophysicists to Unravel Cellular 'Traffic Jams' in Active Transport
Inside many growing cells, an active transport system runs on nano-sized microtubule tracks that resemble a highway, complete with motors carrying cargo quickly from a central supply depot to growing tips or wherever materials are needed. A team of biophysicists at the University of Massachusetts Amherst, using a special technique and unique microscope, have improved upon earlier studies that used too-simple models not able to account for the densely crowded, dynamic conditions in a real cell. The new work, led by biophysicist Jennifer Ross, greatly advances understanding of how active transport proceeds smoothly, particularly in long cells such as neurons where it is vital to their survival. Findings appear in the current early online edition of Proceedings of the National Academies of Science. A key to Ross and colleagues' experimental system is a custom-built, single-molecule total internal reflection fluorescence (TIRF) microscope she built for her laboratory. It is much brighter than commercially available instruments and gives researchers the remarkable ability to see and photograph individual molecules in real time.
Amgen Buying Decode Genetics for $415M
Biopharmaceutical firm Amgen is acquiring genomic research products firm Decode Genetics for $415 million. The all-cash deal has been approved by Amgen's board and is expected to be completed before the end of the year. In a statement Amgen President and CEO Robert Bradway said the deal "fits perfectly" with the company's goal of pursuing the rapid development of relevant molecules for disease targets without wasting money on targets that aren't as well validated. Reykjavik, Iceland-based Decode was founded in 1996 and [in 2009] was forced to file for Chapter 11 bankruptcy protection. Decode was relaunched as a privately held company focused on research in rare variants associated with common conditions.
Stanford Launches New Center to Advance 'Information Age of Genomics'
In an effort to harness vast amounts of genomic data that can benefit human well-being, Stanford's School of Humanities and Sciences and School of Medicine have launched the Stanford Center for Computational, Evolutionary and Human Genomics. The center plans to attract faculty and students from Stanford's seven schools to engage in interdisciplinary collaborations that will catalyze discovery in emerging fields of research.
After two decades of sequencing the human genome and other organisms, the field is transitioning into an "information age of genomics," said center Co-Director Marcus Feldman, a biology professor. The center, which is open to all university faculty and labs, aims to promote interaction and collaboration. Planned activities include:
- Support for graduate and postdoctoral students.
- Support for small project grants, including student-initiated research.
- Computational genomics analysis service to support member labs and faculty, students and staff.
- Public outreach. During the first year, the center will present programs on "Genomics and Social Systems," "Agricultural, Ecological and Environmental Genomics" and "Medical Genomics."
- Consulting with academic institutions, industry, government and nonprofit organizations to facilitate collaboration and transfer knowledge.
Sanofi Funds New Patient-centered Disease Registry Project
Sanofi US has awarded $300,000 to a group of patient advocacy organizations, including Genetic Alliance, to create a crowd-sourced disease registry that will enable patients to store and share their medical data and biological samples for use in research. The Registries for All Diseases proposal was awarded the funding through the Sanofi US Collaborate Activate Innovation Challenge, a competition run by Sanofi's Partners in Patient Health designed to promote the sharing of complementary resources among diverse organizations.
The secure registry will engage participants through a survey that takes up their clinical information, a virtual research network that asks them a hundred clinical questions to characterize them for potential research, and a detailed questionnaire drafted by the disease advocates. It also will provide the opportunity to bank biological samples.
German Researchers Create ’Smart Test Tube’ That Can Revolutionize Automated Clinical Pathology Laboratory Specimen Processing
Researchers at the Fraunhofer Institute for Biomedical Engineering (IBMT) in Saarland developed a test tube that interacts with a central control network, according to a press release. Their primary goal is to enable specimen data to be processed automatically, particularly with regard to documentation.
Eliminating Need for Medical Laboratory Techs to Manually Enter Data—Barcoding and scanners have speeded up the specimen tracking process. However, barcoding has a drawback—information contained in the barcode cannot be edited. Researchers at IBMT developed a test tube with a tiny microchip embedded into the plastic. When the test tube is placed in an analyzer, equipment can record details onto the embedded chip. In this way, the chip can store a specimen’s entire history. That means there is no need for a clinical laboratory technician to write up a laboratory report on the sample. This new technology... is particularly useful in remote areas.... An example is the transport of blood infected with HIV from Africa for use in AIDS research.
Pathology Study Team Recommends Replacing Traditional Autopsies With Non-invasive, Imaging-based Alternative for the United Kingdom
Evolving imaging technology could begin to replace some traditional autopsy methodologies and encourage an increase in the number of autopsies performed
New imaging technology may give pathologists in the United Kingdom a new way to perform non-invasive autopsies. It is another example of how long-standing clinical practices can be transformed by the capabilities of newly developed technologies. Leading experts within the field of post-mortem cross-sectional imaging in Britain have recommended that England’s National Health Service (NHS) introduce alternative techniques for performing non-invasive autopsies. In some circumstances, the non-invasive approach could replace traditional autopsy methods.
Pathologist Conducted the Review of the New Technology— “There are important religious, cultural and humanitarian benefits offered by non-invasive autopsies,” observed Guy N. Rutty, M.D., Chief Forensic Pathologist to the East Midlands Forensic Pathology Unit (EMFPU) at the University of Leicester. Rutty, who chaired the sub-group that prepared the report, said “It is recognized that there is no longer the need to undertake invasive autopsy examinations in certain types of death.”
Trends for Early Detection of Aneuploidy and Trisomy
Aneuploidy is the most frequent genetic disorder observed in live births and miscarriages; trisomies are the most prevalent, accounting for approximately 53% of all chromosome abnormalities. The techniques for aneuploidy detection have evolved from cytological approaches prior to the 1990s, to molecular DNA tests (Qualitative Fluorescence Polymerase Chain Reaction, or QF-PCR) in the mid-1990s, to exciting, new techniques utilizing next generation sequencing that are currently under development for improvement of early aneuploidy detection.
Next-generation (NGS) DNA sequence analysis of cell-free fetal DNA (cffDNA) obtained from maternal blood is a promising upcoming technology. Many amplicons across the chromosome are sequenced; providing more detailed results from deep sequencing. Barcoding will enable processing hundreds of samples, increasing efficiency and decreasing cost of aneuploidy screening with the high-throughput capabilities of NGS.
Anatomic Pathology Today and Tomorrow
Most pathology departments are typically organized around the following service lines: clinical, anatomic, molecular, research, education, and informatics. The boundary lines among these different services are starting to blur... pathology labs and pathologists are going to need new proficiencies in three areas:
- Utilizing appropriate molecular and genomic techniques as part of their diagnostic process to enhance patient outcomes.
- Relying on software applications and electronic images of slides (also known as digital pathology) to perform diagnosis and collaborate with peers.
- Operating in a highly sub-specialized team environment and integrating various clinical data points in order to form a diagnosis.
“The throughput and safety of specimen handling has been greatly improved with the institution of tracking systems,” notes Dr. Michael Berman, Vice Chairman of Pathology at Jefferson Regional Medical Center in Crystal City, MO. “In addition to help in auditing and tracking, their greatest benefit may be in error reduction. They use barcode technology to better ensure correct tissue pass-off from specimen container to paraffin block to glass slide to pathologist desk.”
With greater reliance on complimentary molecular testing, the need for specimen handling now extends beyond the four walls of histology. Paper-based manual processes become very hard and error prone, especially as volumes go up.
In some developing nations, the lack of reliable, accessible medical laboratory testing is getting wide coverage in the local press. This is true of recent events involving pathology laboratories located in India, Nepal and Sri Lanka.
Reliability and Accuracy of Medical Laboratory Test Results—In India, the convergence of two trends is spurring government action. First, both patients and their physicians are losing confidence in the reliability of medical laboratory test results. The Wall Street Journal recently published a story titled, “Woman’s Drug-Resistant TB Echoes Around the World”. The story suggested that India’s failures in medical laboratory testing, misdiagnosis, and mistreatment of regular cases of tuberculosis have led to multiple drug-resistant strains.The situation has escalated to the point where government agencies have had to take action, according to a recent story published in The Times of India. Private laboratory owners are “at war” with policy makers and government agencies. Health officials in Thiravananthapuram, Kerala, in south-west India have been conducting raids on private clinical laboratories.
Nepal Study Confirms Majority of Labs Fail to Meet Government Criteria—The Nepal Association for Medical Laboratory Science (NAMLS) conducted a study from August 2008 to January 2009, journalist Sunawar reported. The study was titled “Status of Private Clinical Laboratory Medicine Service”. It showed that 84% of the pathology labs in and around Kathmandu Valley did not meet core governmental standards.
Monitoring of Sri Lanka’s Medical Laboratories Is Overdue—Sri Lanka’s Daily News opined that government action to regulate and monitor medical laboratories is long overdue.
Budget Cuts Mean More Clinical Pathology Laboratory Closures in Some Developed Countries
These moves are intended to further consolidate medical laboratory testing into larger regional lab facilities and achieve lower costs through economies of scale.
According to a recent story published in Lynn News, Queen Elizabeth Hospital is applying for a contract to analyze blood at a “super lab” in Norwich, the county seat, about 44 miles to the southeast. The change will mean the transfer of 96 pathology laboratory workers to the Norfolk and Norwich University Hospital (NNUH), beginning in December. In 2006, one government report, called the Carter Review, recommended that clinical pathology laboratories in England be run as “managed pathology networks.”
In Maryborough, Queensland, Australia, about 160 miles north of Brisbane, the pathology laboratory at Maryborough Base Hospital is due to close by the end of the year. This was reported in a story published by The Frazer Coast Chronicle. The closure will mean the loss of six medical laboratory jobs. Statewide, 105 clinical laboratory FTEs are to be axed by the end of the year, the story stated.
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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