CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health insurers. Meanwhile, respected laboratory scientists and physicians are using peer-reviewed medical journals to point out that Theranos has yet to publish details about the performance of its diagnostic technology to enable independent validation.
Tag: quality assurance program
CEO SUMMARY: Authorities for Eastern Health in Newfoundland and Labrador province in Canada are conducting a root cause analysis after finding discrepancies in breast cancer testing that affected nine patients. Health officials said these cases were discovered as a result of an improved quality assurance testing program and are unrelated to problems that plagued Eastern
CEO SUMMARY: As it developed a home brew mass spec assay for Vitamin 25(OH) D to meet the request of some client physicians, the laboratory at the University of Massachusetts Medical Center quickly recognized several challenges. First, there were fundamental differences in the numbers generated on the same population by the internally-developed LC-MS assay compared
CEO SUMMARY: Facing a crisis due to several highly publicized deficiencies in lab testing, pathologists in Canada are using proficiency testing (PT) to improve standards. In British Columbia, PT is mandatory and every lab is evaluated every quarter. Pathologists in BC recommend that every province and territory adopt mandatory proficiency testing. Currently only British Columbia
CEO SUMMARY: Experts point out that widely publicized episodes of lab testing deficiencies in several provinces are signs that chronic underfunding of lab testing services is a key factor in these failures. To restore public confidence in breast cancer testing, the Canadian Association of Pathologists is developing a voluntary proficiency testing system for hospital labs