TAG:
clia
Understanding Differences Between 2 CLIA Accreditors
MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Some health systems representing hundreds of hospitals have shifted from using the College of American Pathologists (CAP) to using The Joint Commission (TJC) to meet the accreditation …
CMS Sends Cease/Desist Letters to Labs Lacking CLIA Certificates
CLINICAL LABORATORIES DOING COVID-19 TESTING and lacking the proper CLIA certificates to do so are receiving cease-and-desist letters from the federal Centers for Medicare and Medicaid Services (CMS). The first letters were sent on Aug. 12 and le…
FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says
This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…
HHS ‘Stands Down’ FDA on Its Oversight of LDTs
CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…
Houston Errors Are Every Clinical Pathologist’s Fear
Due to medical errors, three patients died in three Houston hospitals in a short period of time. Each adverse event led to inspections by the federal Centers for Medicare and Medicaid Services (CMS) and sanctions as tough as revocation of deemed status for participation in the Medica…
CMS Sanctioned Three Houston Hospitals, Labs
CEO SUMMARY: At MD Anderson Cancer Center and Baylor St. Luke’s Medical Center, blood transfusion errors led to two patients’ deaths in separate incidents last fall. Then, this spring, a patient died in the emergency department of Ben Taub Hospital following “an ineffective process …
Attorney Explains Risks from New ‘Support Act’
CEO SUMMARY: Legislation signed into law on Oct. 24 was designed to stem the nation’s opioid crisis. But in addition to applying to sober homes and addiction treatment centers, the law also applies to clinical laboratories. Called the ‘Support for Patients and Communities Act,’ the …
FDA Issues Response to Draft Legislation to Regulate LDTs
DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA…
Dartmouth-Hitchcock Builds Strong Lab Outreach Business
CEO SUMMARY: As health networks and hospitals consider outsourcing their lab outreach programs, the lab team at Dartmouth-Hitchcock Medical Center (D-H) offers lessons about the value of retaining outreach. D-H is now in the eighth year of a sustained expansion of its laboratory outreach …
In Lawsuit Against HHS, ACLA Has Strong Positions
CEO SUMMARY: Rulings from Judge Amy Berman Jackson of the U.S. District Court in Washington, D.C., are expected soon in the ACLA’s lawsuit against HHS concerning the PAMA final rule that set the course for the new Medicare CLFS rates implemented in January 2018. One lawyer following the…
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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