Tag: quality laboratory

Court Dismisses ACLA Claims in PAMA Case

CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims for lack of “subject matter jurisdiction.” While not dismissing it outright, the judge

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FDA Issues Response to Draft Legislation to Regulate LDTs

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At

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Brooklyn Toxicology Lab Suspended for 30 Days by NY Department of Health

IN BROOKLYN, N.Y., a toxicology laboratory has been shut down temporarily since Sept. 9 by order of the New York State Department of Health. The lab was cited for failing to perform calibration and quality control procedures properly,

The lab company is Advanced Clinical Laboratory Solutions Inc., which describes itself as, “a physician-driven, patient-minded, client-focused clinical

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Public Comment Started on FDA LDT Regulations

CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased

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Mid America Clinical Laboratories Discusses Recent Lab Errors

IN FOLLOWING UP THE DISCOVERY of false positive results for Chlamydia tests it had performed on a limited number of patients, Mid America Clinical Laboratories (MACL) found itself the subject of news coverage.

This included interviews with an irate patient who told one television news reporter that, after receiving a positive result for her Chlamydia test,

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Pennsylvania Lab Earns ISO 15189 Accreditation

CEO SUMMARY: Clinical laboratories often promote themselves as being able to deliver quality results. But simply saying so is not the same as having an outside organization audit the laboratory to accredit its analytical processes and its other operational activities. NMS Labs in Willow Grove, Pennsylvania, pursued accreditation to ISO 15189 Medical Laboratories to gain

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