TAG:
laboratory accreditation program
July 31, 2023, Intelligence: Late-Breaking Lab News
Regulatory relief is on the way for clinical laboratories accredited by The Joint Commission. An overhaul of the Laboratory Accreditation Program’s standards, which goes into effect Aug. 27, will …
Public Comment Started on FDA LDT Regulations
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
Lab Testing, Pathology Is Fast-Growing in China
CEO SUMMARY: It was record attendance at the major pathology congress which took place in Hangzhou, China, last month. Because of the ongoing growth of China’s economy, the demand for healthcare—and for high-quality clinical lab and pathology testing—is rising at an accelerated pace…
Lab Industry Unprepared For FDA Action on LDTs
CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by …
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 …
June 29, 2009 “Intelligence: Late Breaking Lab News”
In recent weeks, the laboratory at Blanchard Valley Hospital in Findlay, Ohio, received its accreditation for ISO 15189: Medical Laboratories. With this achievement, Blanchard Valley becomes only the third lab in the United States to become ISO 15189-accredited. Blanchard Valley’s …
ISO 15189 Accreditation Program Offered by CAP
CEO SUMMARY: Two strong trends in laboratory management can be seen in the College of American Pathologists’ (CAP) move to offer accreditation to ISO 15189:2007. The first trend is the movement toward quality management systems such as Lean and Six Sigma. The second trend is the global …
There is Steady Convergence In Lab Operations Worldwide
IS THERE AN ACCELERATING CONVERGENCE OF LABORATORY OPERATIONS by major clinical laboratories throughout the world? In recent weeks, THE DARK REPORT has seen tantalizing evidence that the answer to this question should be “yes.” This trend has strategic implications for independent commercial lab…
Change Beneath Surface Marks 2004 Lab Stories
CEO SUMMARY: Presented here are THE DARK REPORT’S “Ten Biggest Lab Stories of 2004.” These are the events we consider most important to the lab industry during the year. However, in contrast to past years, 2004 lacked the types of blockbuster events which radically change and reshap…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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