TAG:
medical laboratory test
In-Practice Histology Lab Splits Biopsies; ID’s Patient with DNA
In response to continuing requests by clients and readers of THE DARK REPORT, this issue institutes a new feature titled “Lab Fraud Watch.” It will provide information about activities in the medical laboratory testing marketplace which could be interpreted as violatin…
Will Lawsuits Re-shape Current Lab Practices?
CEO SUMMARY: Recent events in California, triggered by a lab whistleblower lawsuit filed in 2005 and unsealed in 2009, provide the latest example of how these lawsuits and related government enforcement actions can cause fundamental changes in the pricing and marketing p…
ISO 15189 Accreditation Earned by Spectra Labs
CEO SUMMARY: Spectra Laboratories Inc., recently announced that it had earned accreditation to the ISO 15189:2007 standard, following an assessment by a team from the Association for Laboratory Accreditation (A2LA). Spectra is a high-volume laboratory that serves renal patients. …
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…
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 …
ISO 15189 Work Advances at Meeting in Vancouver
CEO SUMMARY: Laboring quietly out of the public eye, an international work team of professionals, including representatives from the CDC, the FDA, and global in vitro diagnostics (IVD) manufacturers, has spent the past 14 years developing an important series of quality and safety standard…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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