TAG:
laboratory quality
ISO 15189 Is the Goal at Avera McKennan Lab
CEO SUMMARY: Now entering its ninth month on the path to accreditation under ISO 15189:2007 Medical Laboratories, Avera McKennan’s lab recently completed its “gap analysis.” This important step prepared the laboratory for the pre-assessment and assessment steps that will result in a…
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…
Key Trends Drive Change for Clinical Laboratories
CEO SUMMARY: Technology plays an ever-growing role in reshaping the organization and operation of clinical laboratories. New technologies figure prominently in THE DARK REPORT’S 2007 list of key trends in the clinical laboratory industry. Technological advances in instr…
Picking Top Ten Stories Of 2005 for Lab Industry
CEO SUMMARY: THE DARK REPORT offers its pic…
“Coming Out” Party In Atlanta for IQLM
CEO SUMMARY: It was like a debutante ball for the fledgling Institute for Quality in Laboratory Medicine (IQLM). Over three days, thought leaders in healthcare and laboratory testing tackled the issue of how laboratory medicine can improve patient safety and contribute to higher-quality h…
Doctor “Pay to Perform” Launched by Medicare
CEO SUMMARY: Medicare’s just-announced physician “pay-for-performance” program will be a positive development for laboratories and pathologists. One consequence is that physicians will be measured on how effectively they use recommended lab tests in certain areas of care. This will …
2003’s Big Lab Stories Reflect Health Trends
CEO SUMMARY: At a minimum, 2003 proved to be a year of relative stability for the laboratory industry, as demonstrated by THE DARK REPORT’S “Ten Biggest Lab Stories of 2003.” The year was free of industry-wide crises and scan- dals. That allowed most laboratory administrators and pa…
Major Events Hit Pathology Profession
ACROSS THE AMERICAN HEALTHCARE SYSTEM, numerous trends tug at pathologists and the laboratory medicine services they provide. Both clinical pathologists and anatomic pathologists find themselves confronted with a growing number of demands for change. Increasingly these demands can no longer be ignore…
National Lab Standards Coming For Patient Safety
CEO SUMMARY: Because lab test data plays such an important role in medical decision-making, the Centers for Disease Control and Prevention (CDC) has launched a national effort to evaluate the quality of clinical and public health laboratories. In forming a Quality Institute, the goal is t…
Gauging The Impact Of Lab Patient Safety
CEO SUMMARY: Within 18 months, the Laboratory Quality Institute plans to issue a national report on the quality of laboratory services. Not only will this bring a new level of public attention and scrutiny to clinical laboratory operations, but it will require everyone involved in deliver…
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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