TAG:
clia regulations
Patient Privacy Laws Create Legal Risk for Labs
CEO SUMMARY: Before the nation’s healthcare system can achieve the integrated universal EHR, it must fix the crazy contradictions in state and federal laws governing patient privacy. There is discordance between federal law and state law that defines the role and responsibility…
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…
Need Rigorous Validation For Home Brew Assays
CEO SUMMARY: National headlines about erroneous Vitamin D results are a reminder to the lab industry of the imprecision and risks associated with home brew testing. According to one laboratory expert, every laboratory-developed test (LDT) must meet two high standards. On…
Labs Should Prepare for Tighter CLIA Enforcement
CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of p…
Urology Revenue Loss Drives AP Lab Condos
CEO SUMMARY: Urologists are motivated to operate anatomic pathology laboratory condominiums as a way to replace lost income after Medicare imposed a major reimbursement cut for a key urology procedure. Capturing revenue from ancillary services is a hot topic within the urology profession….
AACC and CAP Meetings Generate Useful Insights
IT WAS A BUSY TIME LAST WEEK on the lab industry meeting circuit. THE DARK REPORT made the rounds and uncovered some valuable intelligence for lab directors and pathologists. First on the meeting tour was Philadelphia, site of the American Association of Clinical Chemistry (AACC) a…
California Is Lab Industry’s Bellwether Again
IT’S NO COINCIDENCE THAT two recent lab industry developments are centered around lab companies in California. Repeatedly that state has proven to be a valuable bellwether of lab industry trends for the nation. On the lab regulatory front, state officials from the California Department of …
State, Federal Regulators Target Specialty Labs
CEO SUMMARY: Specialty Laboratories, Inc. has earned the dubious honor of being the first-ever publicly-traded laboratory to have its CLIA-88 license revoked by federal regulators, terminating its right to payment for services covered by Medicare and Medicaid. The revocation is slated to …
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.
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.