A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
December 13, 2012
View Previous Issues - Healthcare News Archive
TEST Act Signed by President Obama, Provides Regulators Discretion When Clinical Laboratories Mistakenly Violate CLIA PT Requirements
On December 4, 2012, President Barack Obama signed into law the bill titled “Taking Essential Steps for Testing (TEST) Act of 2012.” This brings important regulatory relief to clinical laboratories by amending the language of the CLIA statue of 1988, as it pertains to the penalties that may be assessed following an instance of an inadvertent referral of a proficiency test specimen. This new law was welcomed by pathologists, who serve as laboratory directors for CLIA-licensed medical laboratories.
“The TEST Act will ensure that laboratories are not unfairly punished when they follow the usual practice and refer a specimen to another laboratory,” commented Alan Mertz, President of the American Clinical Laboratory Association. The legislation permits the federal Centers for Medicare & Medicaid Services (CMS) to impose alternative sanctions in cases in which a PT sample is referred to another laboratory for confirmatory testing or because the laboratory does not offer a specific test.
Clinical Lab Coalition to Congress: ‘Protect Medicare Lab Services’
In a Nov. 29 letter to House and Senate leaders in both parties, the Clinical Laboratory Coalition urged them to protect patients’ access to lab services as they grapple with tax increases and spending cuts looming on Jan. 1, 2013, along with a 26.5 percent cut scheduled for physician fees. The letter asked that while Congress pursues deficit reduction, it should not seek savings by further cuts to the Medicare lab fee schedule or by introducing cost sharing, which would hit beneficiaries’ pocketbook. The letter had 50 signers, including national clinical lab and pathology associations, scientific societies, independent lab companies, and medical device makers.
Bill Would Make Drug Compounders Register With FDA
A bill that would require compounding pharmacies to register with the Food and Drug Administration was introduced in the House, according to a news release from the two sponsors of the bill, Reps. Rosa DeLauro (D-Conn.) and Nita Lowey (D-N.Y.).
The bill, called the Supporting Access to Formulated and Effective Compounded Drugs Act, or SAFE Compounded Drugs Act, would establish an FDA database on the pharmacies for use by the FDA and states in oversight of drug compounders, according to the news release. In addition, it would require the FDA to set minimum production standards and direct the FDA to offer training to state regulators.
NIH Proposes Critical Initiatives to Sustain Future of U.S. Biomedical Research
Actions would aim to strengthen the biomedical research workforce and manage deluge of data
The National Institutes of Health is seeking to launch multiple initiatives designed to help strengthen the biomedical research enterprise and sustain the global competitiveness of the U.S. scientific community well into the future. Faced with significant challenges affecting the biomedical research workforce and the storage and use of large biomedical datasets, the NIH Director charged the Advisory Committee to the Director (ACD) to develop recommendations. The ACD used three specialized committee working groups, each of which included additional outside experts on the relevant topics.
The ACD presented its recommendations to the NIH director in June 2012. NIH leadership further deliberated on the recommendations and presented its implementation plan at the 105th meeting of the ACD on Dec. 6 and 7. The actions that NIH is seeking to implement are:
- Diversity in the Biomedical Research Workforce:
- The Future Biomedical Research Workforce:
- Data and Informatics:
With Impending GeneTests Phaseout, NIH Urges Labs to Sign Up With Genetic Testing Registry
With the GeneTests database slated to be phased out by the middle of next year, the National Institutes of Health is encouraging labs to register their marketed genetic tests with the new Genetic Testing Registry if they have not yet done so. After going live with the beta version of the GTR in February this year, the NIH populated the new site with test information from GeneTests in an effort to reduce the burden on labs and allow users to test out the new registry. However, NIH informed labs in a letter that although this information has been included in GTR, "this was only a temporary solution to allow display of data from GeneTests through GTR during the transition period." Labs that wish to continue to have their information listed in GTR must "take specific action by registering" the lab and the test with the new registry.
B12 Assays May Be Missing Anemia
Newer assays for measuring vitamin B12 levels may miss more than a third of pernicious anemia cases, researchers found. Between 22% and 35% of saved samples from confirmed pernicious anemia patients showed false normal results using three different assays, Ralph Carmel, MD, of New York Methodist Hospital, and Yash Pal Agrawal, PhD, of Weil Cornell Medical College, reported in a letter to the editor in the New England Journal of Medicine. The results "suggest widespread malfunction" of the newer competitive-binding luminescence assay (CBLA), they wrote.
Diagnostic sensitivity of the older microbiologic and radioisotope-dilution assays have been estimated to be about 95%, the researchers said, but since CBLAs have replaced these assays, few studies have compared their sensitivity and specificity with older methods. Since 2006, they reported, five case reports have identified false-normal cobalamin levels in seven patients with pernicious anemia, with errors in the Immulite 2000, Abbott Architect, and Siemens Dimension Vista CBLAs.
Some speculate that these failures have something to do with the newer tests being unable to inactivate serum anti-intrinsic factor antibodies, which can confound test results.
New Test Offers More Information on Genetic Causes of Stillbirth
NIH network study confirms more detailed information from microarray analysis. A more precise method for examining a fetus’ genetic material may help detect abnormalities in 40 percent more cases of stillbirth than does the traditional method, according to a National Institutes of Health network study.
A stillbirth occurs when a baby dies in the womb prior to delivery at or after 20 weeks of gestation. In the United States, stillbirth occurs in 1 of every 160 births. When pregnancy ends in stillbirth, doctors may attempt to examine the baby’s chromosomes with a technique known as a karyotype. The karyotype is an image of an individual's chromosomes and is used to look for an abnormal number of chromosomes or for abnormally shaped chromosomes. However, 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.
The researchers compared the results of karyotypes from more than 500 stillbirths to results from microarray analysis, a genetic method which detects small segments of missing parts of chromosomes (deletions) or additional sections of genetic material (duplications) that cannot be seen by karyotype. "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." The research was coordinated through the Stillbirth Collaborative Research Network (SCRN), supported by the NICHD.
Cancer Screening Via Blood Test and Gene Sequencing
Scientists at the Johns Hopkins Kimmel Cancer Center have combined the ability to detect cancer DNA in the blood with genome sequencing technology in a test that could be used to screen for cancers, monitor cancer patients for recurrence and find residual cancer left after surgery. "This approach uses the power of genome sequencing to detect circulating tumor DNA in the blood, providing a sensitive method that can be used to detect and monitor cancers," says Victor Velculescu, M.D., Ph.D., professor of oncology and co-director of the Cancer Biology Program at Johns Hopkins. A report describing the new approach appears in Science Translational Medicine.
Breath Test Could Possibly Diagnose Colorectal Cancer
A new study published in the British Journal of Surgery has demonstrated for the first time that a simple breath analysis could be used for colorectal cancer screening. The study is part of the journal’s “Improving Outcomes in Gastrointestinal Cancer” supplement. Cancer tissue has different metabolism compared to normal healthy cells and produces some substances which can be detected in the breath of these patients. Analysis of the volatile organic compounds (VOCs) linked to cancer is a new frontier in cancer screening.
Studies: Assays Can Help Distinguish Cervical Disease From Clinically Insignificant Infection
OncoHealth Corporation, a protein biomarker diagnostics company, has announced three new studies demonstrating the effectiveness of assays using its proprietary HPV E6 and E7 biomarkers to differentiate clinically meaningful cervical disease from insignificant HPV infections. Previous studies have demonstrated that Pap testing lacks sensitivity, while testing for high-risk human papillomavirus (HPV), the cause of cervical cancer, lacks specificity. OncoHealth’s tests are based on E6 and E7 oncoproteins, which are known to be associated with progression of HPV infection to cervical cancer.
New Super-Sensitive Clinical Lab Test Technology Combines ELISA and Nanotechnology for Simpler, Cheaper and Earlier Detection of Disease
Pathologists and clinical laboratory managers can expect to see new technology translated to a wide variety of diagnostic tests Researchers claim a new diagnostic technology for detecting the HIV virus is 10 times more sensitive than traditional techniques. More remarkable is the fact that this new technology enables analyte detection at very low concentrations with the naked eye!
Pathologists and clinical laboratory managers won’t see this technology enter clinical use for some time. That is because the developers hope to deploy the accurate, fast, and very cheap HIV medical laboratory tests in Africa first. Once validated in actual clinical use, this radically innovative technology could be adapted for use in a wide variety of clinical laboratory tests.
Nucleic Acid Based Tests
There is a list of nucleic acid-based tests that have been cleared or approved by the Center for Devices and Radiological Health. These tests analyze variations in the sequence, structure, or expression of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in order to diagnose disease or medical conditions, infection with an identifiable pathogen, and determine genetic carrier status.
This list excludes nucleic acid-based companion diagnostic tests. Those tests are listed at In Vitro Companion Diagnostic Devices1.
Nanosphere Gets FDA OK for C. Difficile Test
Nanosphere said that the US Food and Drug Administration has granted 510(k) clearance for the firm's Clostridium difficile molecular test.
The test, which runs on Nanosphere's Verigene system, detects the toxin A and B gene sequences of C. difficile and identifies the PCR ribotype 027 strain, which is associated with increased severity of disease. The test automates the steps of bacterial DNA extraction, amplification, hybridization, and target detection on the Verigene system.
Feds Scrutinize Genomics Merger
A Chinese biotech company is angling to buy California-based Complete Genomics, but federal regulators are expressing security concerns and may scuttle the deal. BGI Shenzen (formerly known as the Beijing Genomics Institute), one of the world's foremost sequencing centers, has offered $118 million for the purchase of American sequencing company Complete Genomics, but federal authorities in the United States are raising concerns about the security of the data should the sale proceed. According to Politico, federal officials have cited the potential for the deal to compromise national security as a reason for their deliberations, which stalled the transaction after BGI Shenzen made its initial offer in September.
Standardized Blood Culture Process Reduces Contamination
Introduction of a standardized sterile collection process for blood cultures can reduce peripheral blood culture contamination rates and hospital charges, according to research published online Dec. 3 in Pediatrics. Randon T. Hall, M.D., from the Vanderbilt University Medical Center in Nashville, Tenn., and colleagues designed a sterile blood culture collection process for use in the pediatric emergency department, information about which they disseminated using a Web-based educational model. All members of the nursing staff were subsequently expected to use the modified sterile technique to perform peripheral blood cultures. The researchers found that, during the intervention period, the peripheral blood culture contamination rate dropped significantly, from 3.9 percent at baseline to 1.6 percent. This was accompanied by estimated yearly savings of about $250,000 in hospital charges.
HPV Tied to Throat Cancers: Study
A sexually transmitted infection usually thought of in connection to cervical cancer is also tied to a five times greater risk of cancer of the vocal chords or voice box, a new report suggests. Combining the results of 55 studies from the past two decades, Chinese researchers found 28 percent of people with laryngeal cancers had cancerous tissue that tested positive for human papillomavirus (HPV). But that rate varied widely by study, from no throat cancer patients with HPV to 79 percent with the infection. "We're finding that HPV appears to be linked to a number of squamous cell carcinomas of the head, neck and throat," said Dr. William Mendenhall, a radiation oncologist from the University of Florida in Gainesville who didn't participate in the analysis.
Promising New Technique for Creating Stem Cells Using a Routine Blood Sample
Scientists - funded by the British Heart Foundation (BHF), Medical Research Council (MRC) and Wellcome Trust - have published a patient-friendly and efficient way to make stem cells out of blood, increasing the hope that scientists could one day use stem cells made from patients' own cells to treat cardiovascular disease. Dr Amer Rana, of the University of Cambridge, said of the research: "We are excited to have developed a practical and efficient method to create stem cells from a cell type found in blood. Tissue biopsies are undesirable - particularly for children and the elderly - whereas taking blood samples is routine for all patients.
Altered Immune Cells Beat Leukemia
It is hard to believe, but last spring Emma, then 6, was near death from leukemia. She had relapsed twice after chemotherapy, and doctors had run out of options.
Desperate to save her, her parents sought an experimental treatment at the Children’s Hospital of Philadelphia, one that had never before been tried in a child, or in anyone with the type of leukemia Emma had. The experiment, in April, used a disabled form of the virus that causes AIDS to reprogram Emma’s immune system genetically to kill cancer cells.
The treatment very nearly killed her. But she emerged from it cancer-free, and about seven months later is still in complete remission. She is the first child and one of the first humans ever in whom new techniques have achieved a long-sought goal — giving a patient’s own immune system the lasting ability to fight cancer.
Brain Cells Made From Urine
Some of the waste that humans flush away every day could become a powerful source of brain cells to study disease, and may even one day be used in therapies for neurodegenerative diseases. Scientists have found a relatively straightforward way to persuade the cells discarded in human urine to turn into valuable neurons.
The technique, described online in a study in Nature Methods, does not involve embryonic stem cells. These come with serious drawbacks when transplanted, such as the risk of developing tumours. Instead, the method uses ordinary cells present in urine, and transforms them into neural progenitor cells — the precursors of brain cells. These precursor cells could help researchers to produce cells tailored to individuals more quickly and from more patients than current methods.
Honey Bees' Genetic Code Unlocked
Researchers say they have unlocked the genetic secrets of honey bees' high sensitivity to environmental change. Scientists from the UK and Australia think their findings could help show links between nutrition, environment and the insects' development. It could, they suggest, offer an insight into problems like Colony Collapse Disorder, a mysterious cause of mass bee deaths globally. The findings appear in Insect Biochemistry and Molecular Biology.
Florida Asks FDA Approval to Eliminate Dengue Fever With Genetically Modified Mosquitoes
Mosquito control officials in the Florida Keys are awaiting approval from the federal government to begin releasing hundreds of thousands of genetically modified mosquitoes to stop the spread of dengue fever. The experiment will be the first of its kind in the United States. The goal is to eliminate the Aedes aegypti mosquito population in and around Key West.
"We cannot speculate as to when a decision will be made," Shelly Burgess, a spokesperson for the Food and Drug Administration, told ABCNews.com. "But no genetically engineered animals of any species that FDA regulates will be released in the United States, including for the purposes of field trials, without appropriate regulatory oversight."
If approved by the FDA, the British biotech company Oxitec would release non-biting male mosquitoes that have been genetically modified. The hope is that they would mate with the wild females already in the Keys, passing along a birth defect that kills their offspring before they can reach maturity. After a few generations, the population in the Keys would die off.
Female Malaria Parasites Should be Targeted to Eradicate Disease
Fresh insight into the parasite that causes malaria suggests a new way to develop drugs and vaccines to tackle the disease. Research into malaria parasites - which exist in male and female forms, and mate to spread the disease - suggests that treatments would be more likely to succeed if designed to target female forms of the parasite. Scientists found that male parasites can adapt to new surroundings faster than the females. Targeting the females would be more likely to succeed in killing the infection in the long term and would prevent the parasites from breeding and spreading.
Iron May Give Small Babies Behavioral Boost
Giving babies born with a low birth weight iron supplements during the first 6 months of life appears to improve their behavior around preschool age, a randomized trial showed. Compared with infants receiving placebo, those who received 1 or 2 mg/kg of ferrous succinate drops per day were significantly less likely to exceed the subclinical cutoff for behavioral problems around age 3.5 (2.9% and 2.7% versus 12.7%, P=0.027), according to Staffan Berglund, MD, PhD, of Umeå University in Sweden, and colleagues.
Interactions Increasing Between Medications and Grapefruit
The number of prescription drugs that can have serious adverse effects from interactions with grapefruit are markedly increasing, yet many physicians may be unaware of these effects, states an article published in CMAJ (Canadian Medical Association Journal). The article, a review by the researchers who discovered the interactions more than 20 years ago, summarizes evidence to help clinicians better understand the serious effects this common food can have when consumed with certain prescription drugs. "Many of the drugs that interact with grapefruit are highly prescribed and are essential for the treatment of important or common medical conditions," writes Dr. David Bailey, Lawson Health Research Institute, London, Ont., with coauthors. "Recently, however, a disturbing trend has been seen. Between 2008 and 2012, the number of medications with the potential to interact with grapefruit and cause serious adverse effects...has increased from 17 to 43, representing an average rate of increase exceeding 6 drugs per year. This increase is a result of the introduction of new chemical entities and formulations."
Cedars-Sinai Surgery Infections in Five Patients Caused by Tears in Surgeon's Gloves, Hospital Admits
Five patients at Cedars-Sinai Medical Center contracted staph infections after a surgeon implanted replacement heart valves in them while he had bacteria on his hands. The surgeon wore gloves during the surgeries, which took place in June, but the gloves developed microscopic tears, NBC reports.
After five patients became infected with identical strands of the staphylococcus epidermidis bacteria, epidemiologists conducted an investigation that led them to the surgeon as the source, the Medical Daily reports.
CMS, ONC Propose Tweaks to EHR Regs
A proposed federal rule nips and tucks previously issued regulations governing the testing, certification and use of electronic health-record systems. The proposed rule, issued jointly by the CMS and the Office of the National Coordinator for Health Information Technology, tweaks several of the meaningful-use criteria that healthcare providers must meet to qualify for payment under the federal EHR incentive program. For example, it adds an alternative meaningful-use criterion for the electronic transmission of structured lab results from hospitals to ambulatory-care providers who ordered the lab test.
Under the new alternative criterion, hospitals must send structured electronic clinical lab results to the ordering ambulatory-care provider for more than 20% of total lab orders received from ambulatory providers, regardless of whether the orders were received electronically or by phone, fax or other communications method. The original meaningful-use criterion for lab orders requires hospitals to electronically send structured lab data only in response to 20% of the lab orders that it also receives electronically.
ONC, CMS Make Stage 2 Revisions
The Office of the National Coordinator for Health IT and the Centers of Medicare and Medicaid Services have revised aspects of their measures in the meaningful use Stage 2 final rule. The interim final rule allows for public comment and makes several changes that primarily affect hospitals. The changes offer more clarity for providers and better align standards to the timeframe.
ONC has updated the version of the data element catalog in its 2014 Edition EHR certification criteria final rule to better support the technical descriptions and capability for capturing data for the clinical quality measures that CMS released Oct. 25, according to an interim final rule with comment released Dec. 4 in the Federal Register. The rule will take effect 30 days after it is officially published Dec. 7. Comments will be accepted for 60 days.
3 Steps to HIPAA Security in the Cloud
The default response for those charged with HIPAA security is to say ‘no’ to cloud computing. Why? Clouds are not under direct control, they are not typically up on existing and emerging healthcare regulations, and, most importantly, they are new and scary. There is a clear need, however, to rethink the role of cloud computing by those charged with HIPAA security. The efficiencies that can be gained by leveraging public, private, and hybrid clouds are just too compelling. The trick is to understand the existing requirements, and then understand how the emerging use of cloud computing could provide compliant and secure HIPAA solutions. In many cases, leveraging cloud computing will improve upon the best practices and technology that exist today.
Here are three steps to using HIPAA in the cloud:
- Understand the details of the requirements.
- Understand the role of the cloud provider.
- Create a business case, and then map a path to the cloud.
Identity Theft Is a Growing Risk in Health Care: Ponemon Report
Identity theft is more rampant in health care than any other U.S. industry, according to the Ponemon Institute's third-annual report on patient privacy and data security. Medical identity theft is a real threat and is on the rise, according to an annual survey on health care data security by the Ponemon Institute, a company that conducts research on privacy and data in multiple industries.
"It hadn't been on the radar, and now suddenly health care providers are paying close attention to this issue," said Ponemon. Of health care organizations surveyed, 52 percent reported medical identity theft. Inaccuracies in patients' records were the cause according to 39 percent of this group, and 26 percent of this set of respondents said the identity theft affected patients' medical care.
Source: Source: http://www.eweek.com/
NHS Faces Privacy Storm over Plan to Store Thousands of Patients' DNA to Help Develop Life-Saving Treatments
Plans to create a database of the DNA records of thousands of Health Service patients were denounced by privacy campaigners. David Cameron, claims it would be a vital resource for scientists and allow them to develop life-saving treatments for cancer and other illnesses. But the campaigners warn it could lead to sensitive personal details being passed to private companies. An individual’s DNA can reveal whether they are at particular risk of certain illnesses, including breast cancer, heart disease and Alzheimer’s.
There are concerns that insurance companies will use these details to raise a customer’s premium and other firms will use them for marketing purposes. The Government insists the DNA records will be stored anonymously and patients will be able to opt out if they have concerns. But Nick Pickles, of civil liberties group Big Brother Watch, said: ‘If private companies want access to our medical records then they should ask. It’s wholly wrong for this to be an opt-out scheme.
David Cameron in the Lab
As part of a UK initiative announced today to sequence up to 100,000 patients within the National Health System, Prime Minister David Cameron popped by the genomics core facility at the Cancer Research UK Cambridge Research Institute. James Hadfield, who runs the lab, says on his blog that it was "a little nerve wracking having my boss, his boss and his boss's boss standing by while I was talking to the country's boss."
Hadfield says that Cameron asked him how easy is it to sequence a genome today, so he decided the best demonstration would be to have him do it himself. "We prepared a cartridge and flowcell ready to go. The Prime Minister took the sample through the set-up screen, waited for the flow check and kicked of the run by pressing start," proving that sequencing is so easy that "even political leaders can do it."
Project Sequencing 100 Canadians to Launch This Week
A project aimed at sequencing the genomes of 100 Canadians in the next year will launch at, the University of Toronto. The project, called the Personal Genome Project Canada (PGP-C), is a collaboration with Harvard Medical School's Personal Genome Project. Combined, the two projects seek to sequence 100,000 individuals in the next decade in order to achieve greater clarity on the genetic variants involved in diseases. The genetic information gleaned from the effort will be deposited in a public repository for use by researchers around the globe as control data.
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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