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College of American Pathologists
January 3, 2023, Intelligence: Late-Breaking Lab News
At the moment, it appears that the controversial Verifying Accurate Leading-edge IVCT Development (VALID) Act will have a hard time passing in Congress. The bill, which is intended to shift regulation of laboratory-developed tests (LDTs) to the federal Food and Drug Administration…
Analytics Lets Labs Offset Staffing Woes
CEO SUMMARY: For hospital laboratories confronting worker shortages, data analytics can be useful for improving workflows and determining effective staffing levels. This information can also induce changes that may improve employee morale. Two experts discuss three analytics reports…
VALID and SALSA Acts Still Pending in Congress
CEO SUMMARY: Both the pending VALID Act and SALSA Act continue to push ahead as 2022 comes to an end. Meanwhile, a new bill centered on the Physician Fee Schedule may protect pathologist payments. These three different proposals share something in common:…
Use This Five-Step Process to Implement a New LIS
CEO SUMMARY: Rolling out a new laboratory information system (LIS) is a costly, time-consuming project. One expert outlines five steps that clinical labs can take to alleviate pressures while ensuring the right people are onboard to help the endeavor move forward. Among the steps is…
Texas Lab Details Dual Accreditation Journey
CEO SUMMARY: In seeking dual accreditation for CLIA and ISO 15189, Advanced Diagnostic Laboratory of San Antonio adapted existing processes to meet accreditor expectations. The result was stronger staff empowerment to suggest improvements in quality, combined with increased recognit…
In Post-COVID-19 Market, IVD Manufacturers Face Supply, Staff Challenges
CEO SUMMARY: After making billions during the COVID-19 pandemic, in vitro diagnostics (IVD) manufacturers must now adjust their strategies and relationships with clinical laboratory customers. Because many contracts for automated instruments are coming due, some IVD companies have t…
How to Better Recruit Millennial Pathologists
CEO SUMMARY: With the Great Resignation…
Passage of FDA Regulation of LDTs Inches Closer in the Senate
CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …
California Agency Problems Deepened Valencia Branch Laboratory Saga
CEO SUMMARY: Adding a new twist in the ongoing saga of the CLIA compliance failures at the Valencia Branch Laboratory in California are insights from a former clinical laboratory director familiar with the industry in California. He observed that problems at California’s Laborator…
COLA Re-enters CLIA Accreditation for Pathology
CEO SUMMARY: COLA again h…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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