LDT Regulation: New Survey Asks Readers for Their Views About Two Bills Before Congress

Survey respondents can give their opinions about the proposed VALID and VITAL acts Two bills are pending in Congress, and each is written to change the current regulatory scheme for laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). The bills go by the acronyms of the VALID Act and VITAL Act. Many clinical laboratories offering LDTs today may be unaware of the details within each bill as currently written. An LDT is a proprietary diagnostic test developed and performed by...

Pew and Massachusetts eHealth Collaborative Find the Frequency of Patient Mismatches Exceeds ‘Desirable Levels for Effective Data Exchange’

EMPIs may help clinical laboratories ensure their patients and medical records are properly matched with medical laboratory test results and specimens Mix-ups between patients and their medical records, known in the healthcare industry as “patient mismatching,” happen far too frequently in hospitals and clinics worldwide. When surgery is involved, such mismatches can lead to deadly errors. However, clinical laboratories and pathology groups also must take steps to ensure patients, their...
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