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College of American Pathologists
What if Congress Chooses to Pass an LDT-Specific Law?
CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed test…
How Private Health Insurers May Respond to FDA LDT Regulation
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Congressional Subcommittee Hears Testimony on FDA LDT Rule
DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…
Examining the Worldwide Pathologist Shortage
CEO SUMMARY: Demand for pathology services is growing faster than the number of pathologists available to meet that demand. This is true for the United States and most other nations. Consequently, efforts are underway to more accurately measure the number of pathologists practicing in eac…
March 18, 2024, Intelligence: Late-Breaking Lab News
In California last month, Quest Diagnostics entered into a settlement agreement with California Attorney General Rob Bonta and nine local district attorneys. KCRA News of Sacramento reported that the “settlement resolves allegations that the company unlawfully disposed of …
CLIA Lab Directors Must Watch Delegated Duties
CEO SUMMARY: Laboratory accredito…
How Certain Labs Can Crack into Health Plans’ Closed Networks
EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed…
Proficiency Testing Ranks High as a CLIA Violation
CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scr…
Actions Pathologists Can Take to Protect Their Income
CEO SUMMARY: Pathology groups may feel their income is under attack from lower Medicare reimbursement rates and rising practice costs. But steps to protect that income can include carefully determin…
Competency Assessments Prove To Be a Nagging CLIA Deficiency
CEO SUMMARY: Competency assessment problems rank high among frequently cited deficiencies during CLIA inspections. Representatives from the CAP, COLA, and The Joint Commission explain what areas to…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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