TAG:
laboratory proficiency testing
Inadvertent PT “Errors” Trigger CLIA Sanctions
CEO SUMMARY: Despite taking appropriate steps to complete proficiency testing (PT), in recent years an unknown number of labs were determined to be in violation of CLIA requirements. Federal regulators are enforcing penalties ranging from suspension of the labs’ licenses to transition t…
Analysis of Lab Test Error Offers Lessons for Labs
CEO SUMMARY: As happens now and again, a rather typical example of an error in lab testing has made the nightly news in Indianapolis because of one justifiably irate patient who got a false positive test report for an STD. One pathologist, asked by THE DARK REPORT to assess the p…
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…
ER/PR Testing in Canada Continues to Make News
CEO SUMMARY: In Canada, the story about inaccurate breast cancer testing just won’t go away. In March, the Cameron Report was made public with its assessment of lab testing failures in Newfoundland and Labrador. In April, the health system in those provinces admitted that it ne…
Labs in British Columbia Meet Tough PT Standards
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…
First U.S. Labs Nearing ISO:15189 Accreditation
CEO SUMMARY: Laboratories, hospitals, and other health-care providers in the United States will increasingly be required to adopt quality management systems (QMS) as part of their regular operational routine. This is consistent with trends in other developed countries. Several U.S. labora…
Canadian Pathologists Start PT Testing for ER/PR
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…
“July 11, 2005 Intelligence: Late Breaking Lab News”
There’s been strong growth at two companies featured in Fortune Magazine’s 2005 list of “America’s Fastest-Growing Small Public Companies.” Ventana Medical Systems, Inc. earned a ranking as number 28 on the list. Bio-Reference Laboratories, Inc. was ranked …
International Tempest in Lab Industry Teapot
MAYBE ALL OF US IN THE LABORATORY PROFESSION GOT A GOOD LESSON in the deficiencies of the national and international media during the past month. I am referring to the screaming headlines last month about how four laboratory proficiency testing (PT) programs sent 4,000 laboratories virology PT kits w…
Ramifications From The “H2N2 Virus Affair”
CEO SUMMARY: Here’s the story, with new details, about how a patient sample, cross-contaminated with a “deadly” strain of influenza virus from a proficiency test kit, triggered alarm bells at the highest levels of public health in Canada, the United States, and the World Health Orga…
CURRENT ISSUE
Volume XXXII, No. 1 – January 6, 2025
The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.
The Dark Report • 21806 Briarcliff Dr • Spicewood, TX 78669
Phone: 512-264-7103
Email: info@darkreport.com
© 2025 The Dark Report. All rights reserved.