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DARK Daily Laboratory and Pathology News

DARK 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.

Latest E-Briefings

Several Studies Identify Problems in Reporting of Clinical Trial Data; HHS and NIH Propose Tougher Requirements for Reporting Clinical Trial Results

Even federal agencies are feeling the consequences of increased transparency as studies uncover serious problems in how data from clinical trials is made available to the public

Increased transparency is coming to clinical trials because of proposed new federal rules. Although the greatest impact will be on drug trials and pharmaceutical research, experts believe that developers of new diagnostic technologies and clinical laboratory tests will benefit as a result of easier access to the public data filed by researchers. Two government agencies published notices announcing their intention to stiffen requirements for greater transparency in clinical trials. The proposed changes are significant for pathologists and medical laboratory professionals because, more stringent requirements for registration and dissemination would make more data from clinical studies available for researchers who develop clinical laboratory tests.

HHS and NIH Publish Notice of Proposed Changes

In November 2014, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM). The same month, its research agency, the National Institutes of Health, announced a draft policy regarding required dissemination of NIH-funded clinical trial information.

The goal of the proposed changes is to ensure that summary results for drugs that fail in trials, or are dropped for other reasons, still make it into the public database,, according to a story published in Science.
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JAMA Report Highlights Inaccuracies in Pathologists’ Breast Cancer Diagnoses

Study done by researchers at the University of Washington determined that diagnostic concordance with consensus expert panel missing in nearly 25% of breast cancer cases studied

Standards of quality in clinical care are increasing at a steady pace and anatomic pathology is no exception. The most recent example is the publication of a study in a respected national medical journal that revealed how pathologists participating in the study produced an unexpectedly high rate of diagnostic inaccuracy for certain types of breast cancers.

This situation did not go unnoticed by the national media. On March 17, no less than The New York Times headlined their story on the findings of this story with the title: “Breast Biopsies Leave Room for Doubt, Study Finds.”

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Obama’s $215 Million Precision Medicine Initiative: Will Congress Fund It and Can It Advance Genetic Testing and the Value of Clinical Laboratory Services?

As proposed, the President’s Precision Medicine Initiative would incorporate a large, volunteer study cohort in innovative ways

Even as a new presidential initiative to boost precision medicine makes headlines, there is uncertainty as to how the program can be funded. The Precision Medicine Initiative was announced by President Obama on January 30, 2015.

Many pathologists, clinical chemists, and medical laboratory scientists recognize that such a program would pump additional funds into the research and development of new diagnostic tests that are designed to aid physicians in their practice of precision medicine.

The big question is how to pay for this initiative. President Obama proposed budgeting $215 million to fund this effort. But such funding must be approved by a Congress that is at odds with the President on nearly every issue. Additionally, The American Clinical Laboratory Association (ACLA) warns that the Food and Drug administration’s (FDA) 2014 announcement to regulate laboratory developed testing services (LDTs) is in conflict with the President’s initiative. continue reading

California Regulators Find Many Problems with the Provider Directories That Health Insurers Make Available to Consumers

In California, a survey found significant inaccuracies in provider directories posted online—may trigger action by regulators to have insurers address this problem

Transparency in healthcare is an important trend. In recent years, much attention has been given to increasing the transparency of the prices charged to patients by hospitals, physicians, and medical laboratories. But now the transparency trend is about to drive change in the provider directories that health insurance plans make available to their beneficiaries and consumers.

When choosing a health plan, many people look for insurance that includes their own physician, or at least a doctor close to home. That is why an accurate and up-to-date provider list is essential to consumer choice and access.

But many health insurers fall short in this regard. California recently released chastising reports on two of its major health plans, Anthem Blue Cross and Blue Shield (ABCBS) (NYSE:WLP) and Blue Shield of California, (BSCA) for publishing inaccurate provider lists on the state’s California Covered insurance exchange. continue reading

Most Clinical Laboratories and Pathology Groups Unprepared to Help Client Physicians Meet Meaningful Use Stage 2 Criteria

Because of the failure of many EHR products to obtain MU Stage 2 certification, physicians using those EHRs are being forced to buy and implement a different EHR

Like the jaws of a vise squeezing together, the nation’s clinical laboratories and pathology groups now find themselves caught in the jaws of the federal government’s complex program to encourage providers to adopt and use electronic health record (EHR) systems.

One jaw is the failure of many EHR systems to certify to Meaningful Use Stage Two requirements, thus exposing physicians using those EHRs to substantial Medicare penalties as early as this year.

The other jaw of this proverbial vise is the need—for the second time—for many medical laboratories to spend substantial amounts of money to create a new LIS-to-EHR interface to those client physicians who are replacing their first EHR system, because it is not certified to Meaningful Use Stage 2 and they want to avoid Medicare penalties for use of a non-certified EHR. continue reading

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