Tag: clia regulations

ISO 15189 Accreditation Requires Specific Steps For Global Recognition

CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical laboratories based on the ISO 9001 quality management system.

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Need Rigorous Validation For Home Brew Assays

CEO SUMMARY: National headlines about erroneous Vitamin D results are a reminder to the lab industry of the imprecision and risks associated with home brew testing. According to one laboratory expert, every laboratory-developed test (LDT) must meet two high standards. One, accuracy, reproducibility, and transferability of the test result number. Two, a reference range that

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Labs Should Prepare for Tighter CLIA Enforcement

CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of proficiency testing (PT) procedures. Revocation of lab’s CLIA certification lasts for one year, and also

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California Is Lab Industry’s Bellwether Again

IT’S NO COINCIDENCE THAT two recent lab industry developments are centered around lab companies in California. Repeatedly that state has proven to be a valuable bellwether of lab industry trends for the nation.

On the lab regulatory front, state officials from the California Department of Health Services (CDHS) have sanctioned Specialty Laboratories, Inc., based upon regulatory

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