A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
November 21, 2012
Nearly everyone ages 15 to 64 should be screened for HIV even if they're not at great risk for contracting the virus, according to new guidelines proposed by an influential panel of medical experts. If the panel ultimately adopts those recommendations, Medicare and most private health insurers will be required to pay for the tests. The draft guidelines were written by the U.S. Preventive Services Task Force, an independent group that operates under the auspices of the Department of Health and Human Services to advise the government and the nation's physicians on the medical evidence for preventive health measures. Posted online on the task force website for a four-week period of public comment, the guidelines also recommend that doctors offer HIV tests to people under 15 or over 64 if they are at high risk for contracting HIV and — in advice that has not changed — to all pregnant women.
House Panel Grills FDA About Compounding Pharmacies
The head of the Food and Drug Administration said the agency needs new authority over compounding pharmacies in order to prevent disasters like the ongoing outbreak of meningitis linked to tainted custom-made drugs. The current system in which state and federal agencies share oversight — and courts disagree on their lines of authority — has “hampered our ability to act to protect patients and prevent, rather than just react to, safety concerns,” Commissioner Margaret A. Hamburg told members of the House Energy and Commerce subcommittee on oversight and investigations.
HHS Extends Deadline to Announce Exchange Plans
HHS Secretary Kathleen Sebelius said that states would have four more weeks to decide whether to operate their own health insurance exchanges under the healthcare reform law.
In a letter to Republican Govs. Bob McDonnell of Virginia and Bobby Jindal of Louisiana and the Republican Governors Association, Sebelius said states could express their intent at the same time they submit a blueprint for how they would operate the exchange, which they must do by Dec. 14. Last week HHS said states would have to say by Nov. 16 if they intended to set up an exchange rather than have one operated by, or in partnership with, the federal government.
FDA Panel Backs Avian Flu Vaccine
A Food and Drug Administration advisory panel gave its unanimous support Nov. 14 to an H5N1 influenza vaccine designated for a national stockpile, where it would be reserved for use during an avian influenza pandemic or outbreak. The advisory committee agreed that immunogenicity and safety data on the "Q-Pan H5N1" vaccine support licensure for use in adults at increased risk of exposure or during a pandemic. The proposed indication is for the "active immunization for the prevention of disease in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine." The vaccine is administered in two doses about 21 days apart.
Legislation giving the Centers for Medicare and Medicaid Services (CMS) leeway in enforcing sanction on clinical laboratories for violating proficiency testing (PT) referral rules was approved by the Senate Nov. 14 and now heads to the president for his signature. The Taking Essential Steps for Testing (TEST) Act (H.R. 6118; S. 3391) passed the House in September. The measure amends the Public Health Service Act to revise sanctions for clinical laboratories that unintentionally refer PT samples to other laboratories. It allows CMS discretion to make the one-year certificate revocation for such a laboratory optional rather than mandatory and the flexibility to levy intermediate sanctions instead of the two-year prohibition against ownership or operation of a lab.
ACLA to FDA: Exclude Lab-Developed Tests from Unique Device ID Rule
The American Clinical Laboratory Association (ACLA) wants to make sure that laboratory-developed tests (LDTs) will not be subject to a unique device identifier (UDI) system proposed by the Food and Drug Administration (FDA).That system would require most medical devices, such as analyzers and in vitro diagnostic test kits, to carry a UDI, a numeric or alphanumeric code containing basic information as the type of device and its manufacturer or its expiration date and batch or lot number.
A group of seven professional societies led by the American College of Cardiology has released a consensus statement to help doctors know when to order a troponin test and how to interpret the results . The statement is published online November 12, 2012 in the Journal of the American College of Cardiology. Troponin testing is most often ordered to diagnose or rule out MI in patients with possible symptoms of MI. The new consensus document, written by a committee led by Dr L Kristin Newby (Duke University, Durham, NC) and Dr Robert Jesse (Virginia Commonwealth University, Richmond), stresses that "the most important nuance to understand is that an elevated troponin is a finding that represents the likely occurrence of myocardial necrosis and does not in and of itself provide any indication of the etiology.
The consensus document references the recently completed third universal definition of MI, which establishes the levels of cardiac troponin required to diagnose MI
As lab medicine grows more complicated and busy physicians have less time to review and interpret test results, many experts have called for improved lab reports that employ graphics and layout to improve physicians' understanding of results. This issue of Strategies explores a recent study that examined how physicians made use of enhanced graphical reports. A limited number of studies have shown that improved formatting and templates can boost the quality of lab reports, but not many have evaluated physicians' use of enhanced reports or the impact of these reports on care management and outcomes. Recently, researchers at ARUP Laboratories examined how often clinicians took advantage of enhanced graphical reports available online (J Pathol Inform 2012;3:26). The research follows-up on a pilot project ARUP began in 2009 that gives clinicians access to special supplemental reports for certain tests.
AAO: Gene Tests Not Shown Helpful for Eye Diseases
Ophthalmologists should steer clear of recommending genetic tests for complex diseases like age-related macular degeneration (AMD) because the evidence for their utility just doesn't exist. Direct-to-consumer gene tests currently on the market offer little insight into a patient's predisposition to disease, Edwin Stone, MD, PhD, chair of the genetic testing task force for the American Academy of Ophthalmology, said during a press briefing at the organization's annual meeting.
Genomic Tests Show Promise for MRSA Control
An apparent outbreak of methicillin-resistant Staphylococcus aureus (MRSA) in a special-care baby unit (SCBU) could have been identified and controlled much sooner with the use of whole-genome sequencing, which tracked carriage to the infants' mothers and persistence to a hospital employee, British investigators reported.
A new approach to tracking of MRSA transmission pathways between healthcare facilities and the community may include genotyping of MRSA isolates, which would allow inferences on transmission on the basis of their genetic relatedness. This report demonstrates the value of whole-genome sequencing to provide rapid, accurate, and comprehensive identification of bacterial transmission pathways in hospital and community settings, with concomitant reductions in infections.
New Blood Test Helps Identify Babesiosis in Donated Blood
Initial results of Imugen’s new investigational blood tests to screen blood donors for babesiosis were presented at the annual scientific sessions of the American Association of Blood Banks (AABB), held in Boston in October. Data from the Imugen studies were summarized at several podium presentations. Susan Stramer, PhD, current president of the AABB and the executive scientific officer of the American Red Cross, Erin Moritz, MS, PhD, of the American Red Cross, and Philip Molloy, MD, medical director of Imugen, presented some study findings. At the time of the 2012 AABB meeting, approximately 20,000 blood donors had been tested for Babesia microti parasites by nucleic acid tests and also by a new serologic test method.
Metastatic Breast Cancer Survival Predicted by Nodal Ki-67?
Assessment of the Ki-67 antigen has proven to be a simple and dependable method for indirectly measuring cell proliferation, and studies have demonstrated a positive relationship between cell proliferation in breast cancer and tumor grade and size, mitotic activity, hormonal and Her-2 status, and tumor progression, according to Kareem Tawfik, MD, lead author and resident of the University of Cincinnati, Ohio.
Laser-light Testing of Breast Tumor Fiber Patterns Helps Show Whose Cancer is Spreading
New diagnostic tool could lower numbers of unnecessary lymph node surgeries.
Using advanced microscopes equipped with tissue-penetrating laser light, cancer imaging experts at Johns Hopkins have developed a promising, new way to accurately analyze the distinctive patterns of ultra-thin collagen fibers in breast tumor tissue samples and to help tell if the cancer has spread. In what is believed to be the first study to measure minute changes in tumor connective tissue fibers, researchers found that eight women whose cancers had spread beyond the breast through the body's lymphatic system had about 10 percent more densely packed and radially spread-out collagenous structural proteins than six women whose cancers had not yet spread.
Potential Blood Test to Reveal Diabetes Risk Many Years in Advance
When a patient is diagnosed with type 2 diabetes, the disease has usually already progressed over several years and damage to areas such as blood vessels and eyes has already taken place. To find a test that indicates who is at risk at an early stage would be valuable, as it would enable preventive treatment to be put in place.
Researchers at Lund University have now identified a promising candidate for a test of this kind. The findings have been published in the journal Cell Metabolism.
RADTs May Be Missing Clinically Important Streptococci.
Researchers trying to find a way to treat multiple sclerosis think they’ve come up with an approach that could not only help patients with MS, but those with a range of so-called autoimmune diseases, from type-1 diabetes to psoriasis, and perhaps even food allergies. So far it’s only worked in mice, but it has worked especially well. And while mice are different from humans in many ways, their immune systems are quite similar.
The approach uses tiny little balls called nanoparticles made of the same material used to make surgical sutures that dissolve harmlessly in the body. They’re attached to little bits of the protein that the immune cells are attacking, the researchers report in issue of the journal Nature Biotechnology.
New Micropumps for Hand-held Medical Labs
In an advance toward analyzing blood and urine instantly at a patient’s bedside instead of waiting for results from a central laboratory, scientists are reporting development of a new micropump capable of producing pressures almost 500 times higher than the pressure in a car tire. Described in ACS’ journal Analytical Chemistry, the pumps are for futuristic “labs-on-a-chip,” which reduce entire laboratories to the size of a postage stamp.
Animal Testing May Be Overtaken by "Organ-on-a-Chip"
A US study that successfully used a "lung-on-a-chip" to mimic a chemotherapy drug side effect brings closer the day when drug developers use "organ-on-a-chip" methods to replace more traditional approaches like animal testing and cell cultures, which are costly and time consuming.
Senior author Donald Ingber, founding director of the Wyss Institute for Biologically Inspired Engineering at Harvard University in Boston, and colleagues, write in the 7 November online issue of Science Translational Medicine, how they developed their "lung-on-a-chip" to study pulmonary edema, a major toxic side effect of the cancer chemotherapy drug interleukin-2 (IL-2).
Indiana University Researcher to Study Effectiveness of Blood Test to Detect Recent Drinking
An Indiana University researcher has received a $1 million grant to study whether a blood test could be used to determine whether people have been drinking heavily in recent weeks. IU School of Medicine professor Dr. Suthat Liangpunsakul says such a test is needed when a patient is being considered for a liver transplant, when alcohol consumption is a concern. Liangpunsakul says patients almost always under-report their drinking to their physicians. The test would measure levels of certain phospholipids, molecules that function as components of cell membranes. A preliminary study found elevated levels of phospholipids in mice and humans who had consumed alcohol. The grant came from the Department of Defense.
FDA Clears Nanosphere’ s CYP2C19 Test to Guide Therapeutic Strategy, Not Predict Response
The US Food and Drug Administration has granted 510(k) marketing clearance for Nanosphere's CYP2C19 mutation test for use in guiding treatment with drugs metabolized by the CYP450 2C19 genetic pathway, including the antiplatelet agent clopidogrel. The FDA indicated that the test, marketed as the Verigene CYP2C19 Nucleic Acid Test, be used "in clinical laboratories upon prescription by the attending physician as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP450 2C19 gene product, specifically *2, *3, and *17."
The agency states, however, that "the Verigene CYP2C19 Nucleic Acid Test is not indicated to be used to predict drug response or non-response."
UnitedHealthcare Sees Need for National Registry to Track Use, Set Coverage of Molecular Tests
Insurer UnitedHealthcare is keeping a close watch on efforts by the Centers for Medicare & Medicaid Services to track the use of molecular diagnostics and set reimbursement policy based on the value these tests add to patient care. UHC would be interested in using a national test registry to track the diagnostics it pays for, according to Lee Newcomer, senior vice president of oncology services at the firm. However, in the event that no such resource emerges soon, UHC is currently considering its options in this regard. UHC believes that payors are in dire need a program under which they can review the analytical and clinical validity of molecular diagnostics and compare them to the standard of care
Lab groups don't like the MolDx program because they fear that the effort will be used to deny payment or cut reimbursement rates. Moreover, they are concerned that the program may compromise the privacy of test data that is proprietary to labs.
United Healthcare Expands to Brazil
The largest American insurer is spending $4.9 billion to acquire 90 percent of Brazil’s Amil Participacoes, which has about 5 million members, a provider network of 3,300 hospitals and 44,000 doctors, and also owns 22 hospitals and about 50 clinics, reported the Associated Press.
Kaiser Permanente Taps Tyson for CEO Post
Kaiser Permanente President and Chief Operating Officer Bernard Tyson will replace retiring CEO and board chair George Halvorson, the Oakland, Calif.-based company said. Halvorson, 65, last year announced his intentions to retire, and in October said he would leave Kaiser in December 2013. Halvorson has been CEO since 2002. “The board made an excellent choice,” Halvorson said in the release. “Bernard has done an extremely good job as president and COO of Kaiser Permanente, and I am confident he will continue to perform at the same level as chairman and CEO.”
WellStar Buys Gingrich Think Tank
WellStar Health System, Marietta, Ga., has bought the Center for Health Transformation, the healthcare think tank established by former House Speaker Newt Gingrich, out of bankruptcy. The purchase price was $20,000, according to WellStar President and CEO Reynold Jennings. The system plans to use the same name for the center, and has also bought its trademark and website.
Mucus Is Beneficial in the Fight Against Bacteria
A possible new protection against biofilm formation, polymers found in mucus, have been discovered by a team of researchers from MIT. Katharina Ribbeck, the Eugene Bell Career Development Assistant Professor of Biological Engineering and senior author of the paper says: "Mucus is a material that has developed over millions of years of evolution to manage our interactions with the microbial world. I'm sure we can find inspiration from it for new strategies to help prevent infections and bacterial colonization."
Antibiotic Overuse Remains a Problem in the U.S., Researchers Say
Patterns of antibiotic overuse vary in the U.S. vary by region, with residents of some Southeastern states taking about twice as many antibiotics per capita as residents in some Western states. According to the Washington-based Center for Disease Dynamics, Economics and Policy, Kentucky, West Virginia, Tennessee, Mississippi and Louisiana were the states with the highest rates of antibiotic use in 2010. Those states had more than one antibiotic prescription per capita in 2010. The states with the lowest use of antibiotics that year were Alaska, Hawaii, California, Oregon and Washington, with just over one prescription for every two people.
Overall, the rate of antibiotic prescriptions in the U.S. declined from 966 prescriptions for each 1,000 residents in 1999 to 801 in 2010.
DR-TB: Urgent Need to Respond to Growing Global Crisis
Results from the largest multi-country implementation of the new rapid tuberculosis (TB) diagnostic test reveal an urgent need to address the growing global crisis of drug-resistant TB (DR-TB), according to Médecins Sans Frontières/Doctors Without Borders (MSF).
New TB test
It shows an overall 50 percent increase in laboratory-based diagnosis of TB using Xpert MTB/RIF compared to the TB test still most commonly used, sputum smear microscopy, with a high variability across projects (increase in lab confirmation ranged from 10 percent to 115 percent).
“This new TB test is helping expose the true size of the drug-resistant TB epidemic and get people on treatment faster,” said Dr Helen Bygrave, HIV/TB Specialist with MSF in South Africa.
New TB drugs
Two new drugs to treat TB - the first to be developed for the disease in almost 50 years - are expected to come to market in 2013 and are both active against drug-resistant forms of the disease.
Alzheimer’s Tied to Mutation Harming Immune Response
But now, in a surprising coincidence, two groups of researchers working from entirely different starting points have converged on a mutated gene involved in another aspect of Alzheimer’s disease: the immune system’s role in protecting against the disease. The mutation is suspected of interfering with the brain’s ability to prevent the buildup of plaque.
The discovery, researchers say, provides clues to how and why the disease progresses. The gene, known as TREM2, is only the second found to increase Alzheimer’s risk substantially in older people. “It points very specifically to a potential metabolic pathway that you could intervene in to change the course of Alzheimer’s disease,” said William Thies, chief medical and scientific officer of the Alzheimer’s Association.
A Root Cause of Parkinson’s
Aggregates of misfolded α-synuclein proteins are not just hallmarks of Parkinson’s disease, they actually initiate pathology, according to a report out (November 15) in Science. A single injection of the aggregated proteins, known as Lewy bodies, into the brains of healthy mice caused the propagation of such aggregates across networks of brain cells as well as the destruction of dopaminergic neurons, a key feature of Parkinson’s disease.
Paralyzed Dogs Walk Again With Nose Cell Transplant
May Hay, a dog lover, used to cart her 10-year-old dachshund, Jasper, around in a trolley because his short hind legs were paralyzed after he was hit by a car. But after researchers took some cells from the dog's nose -- that's right, his nose -- and implanted them in his injured spine as part of a new study, Jasper could walk again. "Now, he whizzes around the house and garden and is able to keep up with the other dogs," Hay told BBC. "It's wonderful."
'Calm Down' Genes Treat Epilepsy in Rats
Adding "calm down" genes to hyperactive brain cells has completely cured rats of epilepsy for the first time, say UK researchers. They believe their approach could help people who cannot control their seizures with drugs. The study, published in the journal Science Translation Medicine, used a virus to insert the new genes into a small number of neurons.
Now, Injectable Sponge to Deliver Drugs and Cells Inside Body
A gel-based sponge that can be molded to any shape, loaded with drugs or stem cells, compressed to a fraction of its size, and delivered via injection has been developed by Harvard bioengineers. Once inside the body, it pops back to its original shape and gradually releases its cargo, before safely degrading. The biocompatible technology amounts to a prefabricated healing kit for a range of minimally invasive therapeutic applications, including regenerative medicine.
Regular Exercise May Help Seniors Stave Off Heart Failure
Study found reduced levels of certain indicators for heart injury with moderate physical activity
Older adults who exercise regularly, even at a moderate level, are less prone to key biological indicators of heart failure risk, a new study finds. "We're not talking about seniors trying to run half-marathons. We're talking about the impact of much more typical and achievable behavior among older individuals, like walking five times a week for 30 minutes or more, and other kinds of similar leisure-type activities," said study lead author Dr. Christopher deFilippi, of the University of Maryland School of Medicine at Baltimore. A simple blood test can detect levels of the indicators of risk, or "biomarkers," known as highly sensitive troponin T (cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
Excess Lupus Cases Found Near Uranium Plant
People living in an area contaminated by a uranium processing plant had up to a 5-fold risk of developing systemic lupus erythematosus, researchers found. In scrutinizing health issues among participants in the Fernald (Ohio) Community Cohort, 5 lupus cases occurred among the 4,187 individuals with low uranium exposure; 7 cases occurred among the 1,273 with moderate exposure, and 12 cases occurred among the 2,756 individuals with high exposure, said Pai-Yue Lu, MD, of Cincinnati Children's Hospital Medical Center. Following logistic regression modeling, lupus was found to be associated with high exposure (OR 4.81, 95% CI 1.38–16.75, P=0.043), Lu reported at the annual meeting of the American College of Rheumatology. There was no association between low or moderate uranium exposure and lupus, she said.
FDA Investigating Deaths, Possible 5-Hour Energy Link
The distributor of 5-Hour Energy insists the caffeine-loaded “shot” is safe when used as directed following news that the U.S. Food and Drug Administration had received reports from the company that the product may be linked to 13 deaths in recent years.
The FDA confirmed a New York Times report that it is investigating the deaths, which occurred in the last four years. The investigation is similar to one the agency has launched targeting Monster Energy drink and reports of five possible deaths related to that product.
New AHRQ Guide Identifies Successful Design Methods for Development of Consumer Health IT
A new AHRQ guide, Designing Consumer Health IT: A Guide for Developers and Systems Designers, presents suggested recommendations for designers and developers of consumer health IT products. Recommendations include general guidance for designers and design teams on the process of designing and developing a product and guidance that is specific to a design phase such as idea generation, identification of end users, testing, and commercialization. The guide includes results of an environmental scan and grey literature review along with expert interviews to improve consumer health IT design to increase effective use. Select to access this report (PDF file PDF 2.99MB).
Medical laboratory professionals will be surprised to learn that some experts claim American healthcare will not see a return on investment from use of EHR systems It is the popular wisdom today that universal adoption of electronic health record (EHR) systems will lead to significant improvements in patient outcomes, while also delivering substantial cost savings to the American health system. However, this trend also requires clinical laboratories to spend substantial amounts of money to provide electronic interfaces between their laboratory information systems (LIS) and EHR systems of their client physicians. Until recently, very little criticism of these federal EHR subsidies has appeared in the media. However, some experts now assert that tens of billions of dollars hospitals and physicians are spending to implement EHRs and integrate their information systems will never be recouped by downstream savings.
A federal health information technology committee released its proposed rules for Stage 3 meaningful use of electronic health records -- the first step in a long public process of reviewing how the government assesses whether EHRs qualify for incentive payments under Medicare and Medicaid.
The committee said Stage 3 objectives should:
- Support new models of care;
- Address national health priorities;
- Have broad applicability to different medical specialties, patient health needs and regions of the country;
- Promote advancement of EHR capabilities; and,
- Be achievable and feasible.
A 45-day comment period is under way, to be followed by the committee’s review in the first three months of 2013. Stage 2 guidance is final, but the deadline for compliance isn’t until 2014. The tentative date for Stage 3 compliance is in 2016.
Five Ways Speech Will Transform Medicine
Here are five innovations coming to healthcare that will take the meaning of efficiency and documentation to a whole new level with core speech and NLP/CLU technology:
- Cloud-based speech recognition
- Navigation and control using speech intelligence
- Cloud-based medical intelligence
- Medical intelligence from the narrative note
- Analytics, alerts and tracking from narrative dictation
Today, speech recognition offers efficiencies, but recent technological advancements will expand the horizon of medical opportunity. Speech recognition will change the human/computer interface by reducing the administrative burden, decreasing costs and, most importantly, increasing the efficiency and safety of healthcare delivery.
NFL Medical Records Go High-Tech
Given the increased interest in providing better care for players, including more emphasis on concussions, National Football League officials announced a new way to track and treat injuries.
The NFL said it is implementing an electronic health records system that will eventually be adopted by all 32 teams. The system, which will be phased in over two seasons, will take the place of paper medical records and will be completely transportable, from hand-held devices to hospitals, tracking a player’s injury and medical history, and even providing medical personnel video footage of player injuries. That will make is easier for doctors to have access to a player’s complete record, especially if they are injured while playing on the road.
Medical Schools Now Advertising Overseas to Fill Classes
Senior administrators at Harvard Medical School have launched what they describe as a "last ditch effort" to fill classes for 2013 by purchasing advertisements in a variety of overseas publications, including the Kampala Evening Gazette, the South Vanuatu Advertiser, and the Bhutan Times. According to Vice-Dean of Admissions, Gary Gilman, the advertising campaign was planned only recently. "Frankly, we were getting desperate," said Gilman. "With only 3 weeks before the admission deadline, we have had only 87 applications for our 165 slots, and at least 20 of those were from students with GPAs less than 2.5."
Laboratory Worker Files Lawsuit Claiming Employer Violated Federal Wage Laws
A clinical laboratory worker has filed a lawsuit against his employer claiming he was fired for complaining about the company violating federal wage laws. Bradley W. Pruden filed suit against Med Fusion on Nov. 7 in the Eastern District of Texas, Sherman Division.
Owners of Regional Independent Clinical Pathology Laboratory Companies Gather in Washington DC with Plans to Visit Senators and Representatives
An intrepid group of clinical laboratory owners gathered in the nation’s capital specifically to visit their Senators and Representatives. The goal was to educate these elected officials about the tenuous financial condition of independent medical laboratory companies. In particular, ongoing budget cuts to the Medicare Part B Clinical Laboratory Test Fee Schedule are undermining the ability of medical laboratories to deliver top-flight lab test services. This is particularly true for smaller independent clinical laboratories, particularly these located in communities not well-served by national lab companies. This activity was organized by the National Independent Laboratory Association (NILA), an organization whose membership consists of many local medical lab companies.
HQCA Review Results in Recommendations for Health System Iimprovements in the Practice of Anatomical Pathology
The Health Quality Council of Alberta (HQCA) has released its independent review of events that occurred in anatomical pathology in Calgary in 2010 and 2011, and in Edmonton in 2011. The Calgary events that were reviewed concerned problems in the preparation of 31 tissue specimens at the Calgary Laboratory Services Diagnostic and Scientific Centre (CLS DSC) and Rockyview General Hospital (RGH). The Edmonton events that were reviewed concerned the misinterpretation of 159 prostate tissue samples by a locum (temporary) pathologist at the Royal Alexandra Hospital (RAH).
The HQCA's review took a systemic view of the events, meaning that all findings and recommendations in its final report are related to system-level improvements associated with the practice of anatomical pathology in Alberta. The HQCA conducted the review at the request of Alberta Health Services (AHS) and based on concerns raised by the Minister of Health regarding assurance of medical quality in anatomical pathology. Following immediate corrective actions taken, AHS wished to determine if any further steps were required to reduce the likelihood of similar events occurring in the future.
GHP’s First Visit to Malawi Reveals Laboratories in Desperate Condition
When CLSI’s Global Health Partnerships (GHP) traveled to Malawi for the first time in the program’s seven-year history, the staff encountered laboratories that were ill-equipped and technicians who were improperly trained and/or lacked the tools to follow basic safety guidelines. Their goals included assessing the transportation networks that carried samples from health centers to district laboratories to the central TB reference laboratory, and examining the internal and external quality improvement system for the district microscopy network.
Public Outcry Over Inaccurate Medical Laboratory Test Results and Misdiagnoses Spurs Government Action in Developing Countries
News accounts of medical laboratory test errors is one reason why patients and clinical laboratory professionals in developing nations are calling for corrective action From Kenya to the Caribbean, clinical laboratory testing failures are making national news. It is both patients and professional associations of laboratory workers who are fueling public debate and government action in response to public disclosures about patient harm as a consequence of errors in medical laboratories testing.
Clinical Laboratory Stakeholder Conferences Calling For Change
In Nairobi, Kenya, pathologists and clinical laboratory professionals gathered recently for a first-of-its-kind meeting of the Medical Laboratory Stakeholders Forum (MLSF). “Country statistics [in Kenya] show four in 10 lab results are erroneous,” the MLSF stated on its website. This means that only about 60% of patients in Kenya get accurate diagnosis of their diseases. “It is therefore paramount that a deeper understanding of the role that medical laboratories play in the overall health sector is realized,” stated the authors.
Sham Labs Playing With Health of Khyber Tribesmen
More than 50 medical laboratories in Khyber Agency operate without qualified staff and play with the lives of tribal patients by using substandard equipment and chemicals, sources say. Sources privy to the ‘business’ in Landi Kotal said that illegal laboratories registered a sharp increase during the recent months as there was no regulatory authority to check the qualification of the staff working in those laboratories.
Out of the total 56 clinical laboratories, 46 have been set up in Landi Kotal while the rest operate in Jamrud. “Only three out of the total 56 laboratories possess legal documents and these are run by qualified staff,” sources said. They said that most of the staffers working in those illegal laboratories were technically as well as educationally unqualified. “In Landi Kotal some of these laboratories are run and owned by Afghan nationals, who have not attended school let alone getting medical or technical training,” sources said.