Sep 4, 2012 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
Many products that medical laboratories use will be covered under the new UDI system
You’re reading it here first! UPCs—universal product codes—are coming soon to the medical laboratory analyzers and other products that your clinical laboratory purchases. Under a proposed rule published by the Food and Drug Administration (FDA), medical devices will soon have UDIs—universal device identifiers.
You know about UPCs. Those are the ubiquitous “universal product codes” that are found on literally every retail product. UPCs make scanning at the cash register possible. Now a similar system is coming to medical devices, including the lab analyzers, reagents, and other products used by medical laboratories and pathology. (more…)
May 6, 2011 | Laboratory News, Laboratory Pathology
It’s not just in the United States that Direct-to-Consumer (DTC) medical laboratory tests are coming under criticism, as reported in recent weeks by Dark Daily. Two prominent organizations in the United Kingdom (UK) have issued reports with serious criticisms of what are known as “Do-It-Yourself” (DIY) clinical laboratory tests in that country.
Researchers identified the several ways that DIY test in the UK, often bought over-the-counter in pharmacies, could mislead or harm consumers. In our earlier Dark Daily e-briefing titled “Medical Laboratory Tests for Consumers Under Investigation on Two Continents,” we presented pathologists and clinical laboratory managers with the results of a General Accountability Office (GAO) study that was critical of DTC medical laboratory tests.
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Apr 27, 2011 | Laboratory Pathology, News From Dark Daily
Government agencies in both the United States and the United Kingdom look at direct-to-consumer (DTC) tests
Direct-to-Consumer (DTC) medical tests are under attack by multiple federal agencies here in the United States, even as authorities in the United Kingdom (UK) similarly question the potential of these genetic tests and molecular diagnostic assays to harm and/or mislead consumers.
Of course, many pathologists and clinical laboratory managers here in the United States know that multiple government agencies have spent the last year scrutinizing the DTC market. There is the possibility that new regulations and laws enacted as a result of these investigations could not only bring DTC genetic testing under tighter government oversight, but these same regulations might also ensnare certain genetic tests and medical laboratory assays that have appropriate uses in clinical care.
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Mar 4, 2011 | Digital Pathology, Laboratory News, Laboratory Pathology
Pathologists likely to be surprised to learn that consumers reach objectively to the results of genetic tests
How consumers will react to the results of genetic tests is a subject of constant debate by many health policy wonks. This same debate has its counterpart in the clinical laboratory testing industry, as pathologists and PhDs discuss the pros and cons of allowing consumers to order their own predictive genetic tests and molecular diagnostic assays.
Rapid developments in whole human genome sequencing will soon make it affordable and fast for any consumer to run their entire genome and have the results analyzed and presented to them in a detailed, easy-to-understand manner. In practical terms, it means medical laboratories and anatomic pathology groups will need to be ready to respond to consumer demand for access to these tests.
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Dec 13, 2010 | Laboratory News, Laboratory Pathology
Researchers Offer Evidence that Hospitals and Pathology Labs Often Negotiate Lower Prices on Their Own
Even as Congress shines a spotlight on the business activities of group purchasing organizations (GPOs), the Medical Device Manufacturers Association (MDMA) has made public a research study it initiated about GPO contract practices. This report says an inherent conflict of interest prevents GPOs from obtaining the lowest possible prices for its hospital and clinical pathology laboratory members.
On December 3rd, Dark Daily reported on the report published by the General Accountability Office (GAO) in response to a Congressional directive. The GAO determined that, during 2008, sales made under GPO contracts by members, including hospitals, clinical laboratories, and other types of healthcare providers, totaled $109 billion.
The six GPOs studied by the GAO earned a bit more than $2 billion in revenue for 2008. Of this, $1.7 billion came from administrative fees generated by contract purchases. The balance of $320 million was from fees generated by supply chain outsources, revenue cycle management, and consulting.
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