Jul 25, 2012 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory News, Laboratory Operations, Laboratory Pathology
Some medical laboratories may be exposed to malpractice suits involving prenatal genetic testing associated with “wrongful birth” claims
Genetic testing is creating a new source of medical malpractice liability and early cases have generated substantial settlements for the plaintiffs. Any clinical laboratory organization or pathologist involved in genetic testing should pay serious attention to this emerging field of malpractice law.
In particular, the media is reporting on malpractice lawsuits that involve prenatal genetic testing that was performed on behalf of parents who were attempting to determine the possibility of serious inheritable diseases in their unborn children.
In these cases, parents of a child born with a debilitating—and frequently financially-devastating—disease that could have been detected by accurate genetic testing are suing their healthcare providers, including medical laboratories. These plaintiffs claim that, through inaccurate genetic testing or lack of available testing, they were denied the choice of terminating a pregnancy that tested positive for serious inherited disease. (more…)
Jul 23, 2012 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory News, Laboratory Operations, Uncategorized
New database of diabetes patients opens door for pathologists to improve existing medical laboratory testing algorithms
Integration of healthcare informatics is proceeding at a brisk pace. The latest evidence comes from 11 highly-respected integrated health systems that are pooling data to create the largest, most comprehensive private-sector diabetes registry in the country. It will contain information from 1.1 million diabetic patients.
For clinical laboratory managers and pathologists, this “super diabetes database” demonstrates that many multi-hospital health systems are now willing to pool patient data to make it easier to identify clinical trends. This data will also be used to develop more sophisticated evidence-based medicine (EBM) guidelines—many of which will involve better utilization of medical laboratory tests.
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Jul 20, 2012 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Hiring & Human Resources, Laboratory News, Laboratory Operations, Management & Operations, News From Dark Daily
New lab test market could open up if research findings lead Consumer Reports and nine medical specialty associates join forces to target the overuse of certain diagnostic procedures, including some medical laboratory tests
For years, pathologists and physicians have spoken out about the overuse of medical laboratory tests and other diagnostic procedures. Now an interesting alliance of a medical specialty association and Consumer Reports has come together with a highly-publicized plan designed to reduce unnecessary or inappropriate testing by encouraging physicians to more deeply involve patients in the process.
It is the American Board of Internal Medicine Foundation (ABIMF) that is working with Consumer Reports. Their common goal is to stanch the overuse of unnecessary healthcare tests and procedures that do not improve patient outcomes and do run up healthcare costs. Experts estimate the wasteful use of healthcare resources accounts for as much as 30% of current healthcare costs in the United States.
The program is called “Choosing Wisely” (CW). According to a story in Modern Healthcare (MH), “Choosing Wisely” is a campaign to get physicians and patients to discuss whether a particular test is likely to improve patient health or outcome.
Pictured above is the press conference conducted by the American Board of Internal Medicine Foundation (ABIMF) to announce the launch of the “Choosing Wisely” campaign. The goal of this campaign is to reduce overutilization or unnecessary ordering of diagnostic procedures. Each of nine medical specialty associations has put forth a list of specific diagnostic procedures that should be part of this campaign and a number of clinical laboratory tests are on these lists. (Photo copyright by American Society of Nephrology.)
Participating in this initiative are about 375,000 physicians in nine specialty societies. Each of these nine medical specialty groups has identified five diagnostic tests or procedures within their specialty area that warrant re-evaluation by physicians and patients as to whether they will provide useful information or lead to a positive outcome. Clinical laboratory managers and pathologists will be interested to learn that a number of these medical specialty associations have included clinical laboratory tests on their respective lists.
“What we’re asking for is for people to have a conversation,” stated Daniel B. Wolfson, M.H.S.A., ABIM Foundation Executive Vice President and Chief Operating Officer, in the MH story. “These are not rules; they are guidelines used to guide most—but not all—cases,” he explained.
Writing in a commentary in The Huffington Post (HP), Donald M. Berwick, M.D., Chief Executive Officer of the Institute for Healthcare Improvement and former Administrator of the U.S. Centers for Medicare & Medicaid Services, called the program a game-changer. The physician specialty societies support their claims of overuse with copious scientific citations, Berwick noted.
“These societies have shown tremendous leadership in starting a long overdue and important conversation between physicians and patients about what care is really needed,” said Christine K. Cassel, M.D., President and Chief Executive Officer of the ABMF. “Physicians, working together with patients, can help ensure the right care is delivered at the right time for the right patient.” She was quoted in a Choosing Wisely press release.
According to the release, Consumer Reports is working with American Association of Retired People (AARP) and other organizations representing the lay public to get the word out about the “Choosing Wisely” campaign.
Specialist Physicians Identify Some Medical Laboratory Tests for Review
Below are listed the recommendations made by the different medical specialty associations that identify a clinical laboratory test:
American Academy of Allergy, Asthma & Immunology
- Don’t perform unproven diagnostic tests, such as immunoglobulin G (IgG) testing or an indiscriminate battery of immunoglobulin E (IgE) tests, in the evaluation of allergy.
- Don’t routinely do diagnostic testing in patients with chronic urticaria.
- Don’t recommend replacement immunoglobulin therapy for recurrent infections unless impaired antibody responses to vaccines are demonstrated.
American Academy of Family Physicians
- Don’t perform Pap smears on women younger than 21 or who have had a hysterectomy for non-cancer disease. read article.
American College of Physicians
- In patients with low pretest probability of venous thromboembolism (VTE), obtain a high-sensitive D-dimer measurement as the initial diagnostic test; don’t obtain imaging studies as the initial diagnostic test.
American Society of Clinical Oncology
- Don’t perform surveillance testing (biomarkers) or imaging… for asymptomatic individuals who have been treated for breast cancer with curative intent.
- Don’t use white cell stimulating factors for primary prevention of febrile neutropenia for patients with less than 20% risk for this complication.
American Society of Nephrology
- Don’t perform routine cancer screening for dialysis patients with limited life expectancies without signs or symptoms.
- Don’t administer erythropoiesis-stimulating agents (ESAs) to chronic kidney disease (CKD) patients with hemoglobin levels greater than or equal to 10g/dL without symptoms or anemia.
In its coverage of the “Choosing Wisely” initiative, Clinical Laboratory News, a publication of the American Association for Clinical Chemistry, (AACC) reported that the utilization changes CW seeks may sound like bad news for the lab,. But sometimes these types of program can end up promoting appropriate clinical laboratory testing over other options, the writer noted.
Medical laboratories should emphasize making sure the right clinical lab tests are used at the right time, suggested Stephen E. Kahn, Ph.D., Chair of AACC’s Evidence-Based Laboratory Medicine Committee.
The “Choosing Wisely” initiative, at a minimum, does provide another opportunity for pathologists and clinical laboratory managers to add value to physicians and their patients by helping clinicians have confidence they they are ordering the right test at the right time, supported by evidence-based medicine (EBM) guidelines.
—Pamela Scherer McLeod
Related Information:
U.S. Physician Groups Identify Commonly Used Tests or Procedures They Say Are Often Not Necessary
“Choosing Wisely”: Physicians Step to the Front in Health Care Reform
June 2012 Clinical Laboratory News: Screening Tests in the Age of Austerity
Jul 16, 2012 | Laboratory Hiring & Human Resources, Laboratory News, Laboratory Operations, Laboratory Pathology
It’s been a challenging year for this New Zealand city’s medical laboratory testing professionals
CHRISTCHURCH, NEW ZEALAND—Two private clinical laboratory companies in this city have had quite a roller coaster ride during the past 18 months. Included in the ups and downs were a series of destructive earthquakes, a new contract bidding cycle that eliminated one of the two existing private medical laboratory companies, and a lab acquisition.
For pathologists and clinical lab administrators in other countries, there are useful lessons to be learned in the aftermath of the Christchurch earthquakes. Among other things, one clinical laboratory company needed to move its testing facility six different times in a year! That’s because aftershocks and ongoing engineering inspections revealed significant damage to these different buildings at different points in time.
Two Major Earthquakes within Six Months in Christchurch
It was September 4, 2010, when a magnitude 7.1 earthquake rocked the city, causing considerable damage but no fatalities. Just six months later, on February 22, 2011, a magnitude 6.3 earthquake hit Christchurch. This second earthquake caused substantial damage and loss of life. For this event, experts noted that the “intensity and violence of the ground shaking was measured to be… among the strongest ever recorded globally in an urban area.” (more…)
Jul 11, 2012 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
Both pathology profession and biotech industry have much at stake in how Supreme Court rules in this important case involving the patentability of genes
Legal challenges to gene patents are a high interest topic among pathologists and clinical laboratory scientists who perform genetic testing. Two high profile cases involving gene patents were accepted by the Supreme Court. A ruling was made in one case and the second case is continuing.
The Supreme Court issued a ruling in one case, titled Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Prometheus). The dispute centered upon Prometheus’ method patents to testing for metabolites of the drug thiopurine in patients with gastrointestinal disease.
In a unanimous opinion, the Supreme Court ruled that these patents were invalid. Some medical laboratory scientists believe that the ruling could ultimately result in the invalidation of the even more significant gene patents, including those gene patents at issue in Association for Molecular Pathology, et al. v. Myriad Genetics (Myriad)..
New Ruling Has Huge Significance for Pathology and Lab Medicine
According to a story in CAP Today, in the Prometheus case, the court reasoned that a process of recognizing and reciting a law of nature is not patentable because laws of nature are not patentable.
This summer, the Supreme Court will hear oral arguments in the case of Association of Molecular Pathology vs. Myriad Genetics. At issue is the patentability of genes. In March, the Supreme Court ruled unanimously against Prometheus in another case involving gene patents. (Image by PSmag.com)
“We have the first clear statement by the Supreme Court—and by a unanimous Supreme Court—that laboratory testing really amounts to nothing more than an observation about the correlation between an analyte and a particular medical condition is not patentable,” stated Jack Bierig, JD, Partner with Sidley Austin in Chicago, in the CAP Today article.
Bierig observed that the key question presented by Prometheus is where to draw the line between a law of nature and an application of the law. “There is a well-known distinction between laws of nature—which are not patentable; and applications of laws of nature—which are patentable,” he stated. “This is the first Supreme Court case that has addressed that question in the context of laboratory testing.”
The ruling overturned the U.S. Court of Appeals for the Federal Circuit (CAFC) decision which upheld the Prometheus patents.
Prometheus Decision May Render Myriad Gene Patent Claims Invalid
Important questions still remain about the patentability of genes. Just six days following the March 20, 2012, ruling in Prometheus, the Court remanded Myriad to the CAFC for reconsideration under the new ruling. In 2011, the CAFC found in favor of Myriad.
The Myriad case originated in 2009 when several plaintiffs, including the American Civil Liberties Union, filed a lawsuit challenging seven of Myriad Genetics’ (NASDAQ: MYGN) patents on the BRCA1 and BRCA2 genes and methods for interrogating the genes.
The question of gene patentability is of critical importance to pathologists, according to Roger D. Klein, M.D., J.D., a molecular pathologist and Chair of the Professional Relations Committee of the Association for Molecular Pathology (AMP). Klein observed in CAP Today that enforcement of gene patents in Myriad has interfered with pathologists’ ability to provide comprehensive interpretations involving multiple diagnostic test procedures. He asserted that the patents have also prevented pathologists from implementing cost-saving algorithms that reduce unnecessary testing.
“It’s the gene patents that are so universal,” agreed Wayne W. Grody, M.D., Ph.D., Professor of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics at the University of California School of Medicine. “We really care much more about the impact of this case on Myriad and other cases that may come later,” stated Grody, who is also President of the American College of Medical Genetics and Genomics.
Biotechnology in a “Minor Panic” Following Prometheus Ruling
According to a story in The Economist, the biotechnology industry is in a “minor panic” at the implications of the high court’s unexpected ruling in Prometheus.
Klein rejects the biotechnology industry’s argument that patent invalidation will jeopardize the advancement of personalized medicine. “I think it will produce tremendous advancement and accelerate progress,” he stated.
John H. Noseworthy, M.D., President and Chief Executive Officer of Mayo Clinic, agreed. “[The new ruling] will favorably impact patient care because it provides broad access to good-quality bedside testing,” he stated in a story published by The Wall Street Journal.
At this point, oral arguments in the Myriad case are scheduled for this summer. In reconsidering the Myriad case, the CAFC may reverse its previous ruling upholding the BRCA gene patents, Bierig speculated. Or, the case may end up in the Supreme Court for final determination.
“I think there’s a chance that the Supreme Court could now rule that the product of the genome is basically a natural phenomenon,” observed Bierig. Klein agreed, suggesting that the Prometheus decision probably renders the Myriad patent claims invalid.
Pathologists and clinical laboratory managers will want to continue to follow the surprising developments in these clinically-relevant patent cases. The Prometheus decision sent a clear message that the Supremes are positioned on the side of the “medical” rather than “commercial” ethic in the area of genetic patents.
For its part, the biotechnology industry may ultimately have to resort to seeking relief through congressional revision of patent law as it pertains to genes. Of course, it can be expected that the clinical laboratory testing profession would be actively educating Congressman should there be consideration of such legislation.
—Pamela Scherer McLeod
Related Information:
For background on the patent cases:
Decisions in Prometheus, Myriad, and Classen Cases Help Clarify Patent Eligibility Requirements for Genetic Lab Tests and Molecular Diagnostics
By Zeus! Prometheus ruling checks patents
Prometheus unsound: America’s Supreme Court wallops the biotech industry
Top Court’s Patent Rejection Alarms the Biotech Industry
Jul 2, 2012 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, News From Dark Daily
Nanosphere’s Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) gives pathologists and clinical laboratory managers a new tool in the diagnosis of septicemia
One of the more challenging diseases to diagnose and treat is septicemia. Traditional microbiology methods typically require two or three days before an accurate diagnosis can be made. Now there is news of a rapid test for bloodstream infections that can allow a hospital clinical laboratory to deliver an answer to physicians in as little as two hours.
It was just last week when the Food and Drug Administration LINK (FDA) granted a de novo petition to allow Nanosphere, Inc., of Northbrook, Illinois, to market its Gram Positive Blood Culture Nucleic Acid Test (BC-GP). This assay is design to be run on Nanosphere’s Verigene automated system. Because the time-to-answer is as little as two hours, this diagnostic technology has the potential to trigger swift changes in the current standard of care for diagnosing and treating blood infections.
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