Tag: laboratory accreditation program

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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December 14, 2009 “Intelligence: Late Breaking Lab News”

In Nigeria, there is an aggressive effort underway to raise the quality of medical laboratory testing. One major element involves inspection of clinical laboratories throughout the nation by teams of laboratory professionals working with the Medical Laboratory Science Council of Nigeria (MLSCN). During 2009, MLSCN has closed 938 substandard and unregistered medical laboratories in all

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June 29, 2009 “Intelligence: Late Breaking Lab News”

In recent weeks, the laboratory at Blanchard Valley Hospital in Findlay, Ohio, received its accreditation for ISO 15189: Medical Laboratories. With this achievement, Blanchard Valley becomes only the third lab in the United States to become ISO 15189-accredited. Blanchard Valley’s laboratory used the ISO 15189 accreditation services provided by the College of American Pathologists (CAP).

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There is Steady Convergence In Lab Operations Worldwide

IS THERE AN ACCELERATING CONVERGENCE OF LABORATORY OPERATIONS by major clinical laboratories throughout the world? In recent weeks, THE DARK REPORT has seen tantalizing evidence that the answer to this question should be “yes.”

This trend has strategic implications for independent commercial laboratories and hospital-based laboratories in the United States. It also has implications for in

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