DARK Daily Laboratory and Pathology NewsDARK Daily is an e-briefing service providing up-to-the minute news of relevance for anyone working in diagnostic medicine, from clinical laboratories and pathology groups to lab industry suppliers and diagnostic technology companies. DARK Daily is part of The Dark Intelligence Group, Inc. and is dedicated to bringing useful business and management intelligence to laboratory managers, pathologists and diagnostic executives. Our recognized expertise in the strategic direction of laboratory medicine and the management of laboratories is available through DARK Daily, The Dark Report, free White Papers, Lab Resource Directory, the Executive War College on Laboratory and Pathology Management, Lab Quality Confab, and strategic consulting services.
FDA Looks to Clamp Down on Laboratory-Developed Tests and Put an End to ‘Wild West of Medicine’: Might CLIA Problems at Theranos Support FDA’s Position?
The Wall Street Journal examines the FDA’s position on LDTs and looks at the pros and cons of LDT regulation by the federal agency
National news coverage over the deficiencies uncovered by Clinical Laboratory Improvement Amendments (CLIA) inspections of the clinical laboratory operated by Theranos in Newark, Calif., may have an interesting consequence that affects all medical laboratories and pathology groups.
Over the past 30 months, Theranos has regularly asserted that its laboratory-developed tests (LDTs) were under review by the Food and Drug Administration (FDA). For example, in an interview published in the December 14, 2014, issue of The New Yorker, Theranos Founder and CEO Elizabeth Holmes stated, “We believe that to realize our vision we must operate at the highest levels of excellence… And the FDA’s stamp of approval is seen as an indicator of the quality of a product.”
Thus, it would be ironic if the problems in the quality of clinical laboratory tests uncovered by federal CLIA inspectors at the Theranos lab facility in Newark was used by the FDA to justify their intent to regulate LDTs. The FDA has already released a report to the public that identified instances where laboratories running LDTs were alleged to have reported inaccurate lab test results to patients and their physicians. continue reading
World’s Two Largest Whole Genome Sequencing Programs Give Pathologists and Clinical Laboratory Managers an Intriguing Look at New Diagnostic Opportunities
At Human Longevity, Inc. and the United Kingdom’s 100,000 Genome Project, knowledge gained from whole-genome sequencing is starting to be used to improve patient care
NEW ORLEANS, LA—Whole-human gene sequencing is poised to provide significant contributions to improving clinical care. That was one conclusion from expert speakers at the 21st annual Executive War College on Medical Laboratory and Pathology Management that happened here this week.
How fast knowledge from whole-human gene sequencing finds its way into clinical diagnostics and healthcare can be debated. But what is unquestioned, based on these presentations, is that insights gained from the analysis of large numbers of human genomes will trigger a revolution in how pathologists and physicians diagnose, treat, and care for patients. continue reading
Critical Shortage of Pathologists in Africa Triggers Calls for More Training Programs and Incentives to Increase the Number of Skilled Histopathologists
A critical shortage of pathologists in southern Africa is hindering the ability of medical laboratories in the region to properly diagnose and classify diseases
Countries in the Southern Africa Development Community (SADC) are currently dealing with a severe scarcity of pathologists. More pathologists are needed in the region to examine samples and interpret medical laboratory tests in order to ensure patients receive proper treatment.
There are a total of fifteen countries in SADC: Angola, Botswana, Democratic Republic of the Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia, and Zimbabwe.
Dark Daily has regularly written about the issues affecting medical laboratory testing in developing nations throughout the world. There are three challenges that are common to most of these countries: continue reading
Binder argues that groups opposing ‘value’ often diminish clinicians’ role in hospital quality and patient outcomes; clinical labs often have the data on the outcomes generated by different clinicians
As healthcare moves steadily toward a value-based reimbursement model, Leapfrog Group CEO Leah Binder is urging healthcare providers to rethink their opposition to quality measures and criteria that reward improved medical outcomes.
“Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder stated in an editorial she penned for Modern Healthcare. “Value will succeed either way, but it will be so much better infused with the knowledge and gifts of practicing providers.”
Many clinical laboratory managers and pathologists know that the Leapfrog Group carries quite a bit of clout in healthcare. Its members include some of the largest corporations in the United States. Collectively, Leapfrog’s members provide health benefits to more than 37 million Americans in all 50 states, and spend tens of billions of dollars on healthcare each year, according to this 2009 Leapfrog Group Fact Sheet. This is why health insurers, hospitals, and physicians pay attention to Leapfrog’s programs and public statements.
“If all hospitals implemented just the first three of Leapfrog’s four ‘leaps’ (our recommended quality and safety practices): over 57,000 lives could be saved, more than 3 million medication errors could be avoided, and up to $12.0 billion could be saved each year,” states the fact sheet.
Physician Opposition to Value-based Reimbursement Models Will Backfire
Leapfrog’s Binder argues the value-based reimbursement movement will succeed for three reasons:
1. “Value” is enshrined in the Affordable Care Act, with the Centers for Medicare and Medicaid Services (CMS) now tying almost 6% of hospital Medicare reimbursement to performance, and Congress replacing the sustainable growth-rate (SGR) with a value-based formula.
2. Private insurers also are transitioning their payment models, with 40% of commercial payments linked to value, up from 9% a year earlier. In addition, consumers, who are paying more out of pocket, are increasingly sensitive to value.
3. Big data is enabling quality to be quantified. Binder pointed to the leadership of the National Quality Forum (NQF) and others in showing “we can defensibly measure the quality side of the value equation.”
Binder warns that arguments made in the name of clinicians to denounce specific quality measures can backfire. In particular, she pointed to a study published in the BMJ that concluded clinicians have little impact on the “standardized mortality ratio,” therefore they should not be held accountable for it.
“Here’s the damaging assumption in the study: The only way physicians or nurses improve patient survival is by avoiding killer mistakes. Surely clinical skill impacts mortality more than that,” Binder stated in her Modern Healthcare editorial.
Similarly, Binder pointed to a study published in the Journal of the American Medical Association (JAMA) that also minimized the impact of clinicians. The study compared how United States hospitals scored on CMS composite safety measures versus alternative measures the researchers invented based on process quality composites. She summarized the findings as stating, “Some hospitals excel on the invented quality composites but fail on the CMS safety composite. Illogically, the researchers conclude that the CMS safety composite is flawed. One might just as well conclude that the researchers’ composites are flawed.”
“Ultimately, this paints a dismal portrait of individual clinicians. … If you excel on some but not all measures, the measures are wrong and you don’t excel at anything,” she stated.
Leapfrog Group Advocates Transparency for Both Insurers and Patients
The Leapfrog Group was formed in 2000, a year after the Institute of Medicine’s (IOM’s) landmark report on medical errors, “To Err Is Human: Building a Safer Health System,” in which the IOM estimated that preventable medical errors caused 44,000 to 98,000 deaths annually, with an associated cost of $17 billion to $29 billion.
The watchdog organization operates out of Washington, D.C. and is made up of more than 170 of the nation’s largest purchasers of healthcare, including:
• University of Michigan; and
• the Florida Healthcare Coalition.
Through its annual hospital surveys and research, the non-profit urges insurers and patients to use transparency to improve the safety and quality of the healthcare system.
The Leapfrog Group’s movement for transparency has grown to include more than 1,700 hospitals that participate in its annual survey on safety, quality, and resource use. In 2015, a record 1,750 hospitals submitted a survey, representing 46% of hospitals nationwide. It also has focused attention on reducing early elective deliveries, launched a pay-for-performance program, and designed a Hospital Safety Score to help consumers to make better healthcare decision.
Providers Should Seek Transparency
While negotiations about quality measures have reached a fever pitch, Binder would like to see providers insist on transparency and accountability for their patients, a step she says would validate clinicians’ work and expertise.
“While thoughtful critiques of measures are important, politically-motivated denial of measures is destructive in unintended ways,” Binder stated in her editorial for Modern Healthcare. “It often follows the unfortunate pattern of these studies in assuming that providers perform at essentially the same level of quality and/or their actions can’t be linked to patient survival or healing,” she observed.
“If all physicians and nurses believed their work had such modest impact, the burnout problem might be even worse,” continued Binder. “People who choose a career in healthcare tend to be bright, competitive and caring, and they won’t last long if they believe their talents make virtually no difference.”
As noted above, since the Leapfrog Group represents many of the major purchasers of healthcare, Binder’s recent comments should grab the attention of pathologists and clinical laboratory executives. They would do well to anticipate continued calls for more quality and more measurement of quality in healthcare as the movement toward value-based reimbursement marches on. Contributing value to hospitals, physicians, and payers is quickly becoming the new paradigm for clinical laboratories and pathology groups.
—Andrea Downing Peck
Trading in Medical Data: Is this a Headache Or An Opportunity for Pathologists and Clinical Laboratories
Legislation has been introduced that, if passed, would ensure health consumers have the opportunity to see and correct information held by data brokers
When it comes to patient privacy, pathologists and clinical laboratory managers may be spending more time addressing a growing issue with the patient data their labs create and store. Third-party data brokers want to position themselves to collect healthcare data at the source so can they de-identify it and sell it to interested parties.
Data brokers are commercial entities that collect, assemble, and/or maintain personal information about individuals. They also sell or provide third-party access to the information, explained the Congressional Research Service, a Legislative Branch Agency that provides policy and legal analysis to both House and Senate members and committees of the U.S. Congress, regardless of party affiliation.
Pharmaceutical companies, medical device manufacturers, and other businesses can purchase said data from various types of data brokers, such as information, analysis, and technology companies. The purchased data then can go on to guide industry investments or launch drug marketing campaigns. continue reading
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