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 of the clinical laboratory which performs a laboratory test and reports those results
Tag: clia regulations
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 laboratories based on the ISO 9001 quality management system.
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. One, accuracy, reproducibility, and transferability of the test result number. Two, a reference range that
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 proficiency testing (PT) procedures. Revocation of lab’s CLIA certification lasts for one year, and also
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. Here are details about this exploding trend and why there is interest
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) annual convention, held July 21-25. The number of exhibitors and the size
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 take effect on April 26, but is subject to a court appeal that
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 Health Services (CDHS) have sanctioned Specialty Laboratories, Inc., based upon regulatory