TAG:
the laboratory
New Pricing Formula for Advanced Diagnostic Tests
By R. Lewis Dark | From the Volume XXI NO. 6 – April 28, 2014 Issue
CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diagnostic tests (ADTs) and directs CMS to assign a temporary HCPCS code and use list prices to pay labs for such tests …
Lab Serving Large MD Group Manages Quality and Costs
By Joseph Burns | From the Volume XXI NO. 6 – April 28, 2014 Issue
CEO SUMMARY: For decades, pathologists have pointed out that their expertise in laboratory medicine can be tapped by physicians to improve utilization of lab tests, contribute to improved patient outcomes, and reduce the overall cost of care. Exactly that is now happening at Atrius Heal…
New Skills Needed for Difficult Lab Job Market
By Joseph Burns | From the Volume XXI NO. 6 – April 28, 2014 Issue
CEO SUMMARY: Across the nation, a small but growing number of pathologists and lab directors has begun to engage career coaches and management recruiters specifically to sharpen their interviewing and career development skills, even though they are still employed. One expert says this tre…
CMS Gives Deemed Status to A2LA under CLIA Law
By Joseph Burns | From the Volume XXI No. 5 – April 7, 2014 Issue
CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…
New Federal Law Changes How CMS Sets Lab Prices
By Robert Michel | From the Volume XXI No. 5 – April 7, 2014 Issue
CEO SUMMARY: CMS wanted more power to cut the prices it pays for clinical lab testing. A significant part of the lab industry wanted more transparency and consistency in how CMS established coverage guidelines and prices for new lab tests. Congress appears to have attempted to craft a law…
April 07, 2014 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XXI No. 5 – April 7, 2014 Issue
In the United Kingdom, the National Health Service’s (NHS) biggest consolidation of clinical laboratory services is expected to take place in May, after the government’s Office of Fair Trading said it will conduct no further investigation into the project. Six health trusts are c…
Congress’ New SGR Law Has Mixed News for Labs
By Joseph Burns | From the Volume XXI No. 5 – April 7, 2014 Issue
CEO SUMMARY: Once again, the lab industry faces a mixed bag following passage of a new law by Congress last week. Besides the one-year fix for the SGR, H.R. 4302 also has language that may defer adjustments to Medicare Part B lab test fees until 2017 and creates a new procedure for Medica…
Better Data Needed to Support Pathologists as Consultants
By Joseph Burns | From the Volume XXI No. 4 – March 17, 2014 Issue
MULTIPLE TRENDS ARE UNFOLDING that mutually reinforce the need for pathologists and PhDs to be experts and consultants in how physicians order and follow up on molecular diagnostics assays and genetic tests. “Healthcare in the United States is approaching a tipping point that can greatly favor pat…
Eastern Canada’s Latest Lab Errors Get Attention
By Joseph Burns | From the Volume XXI No. 4 – March 17, 2014 Issue
CEO SUMMARY: Authorities for Eastern Health in Newfoundland and Labrador province in Canada are conducting a root cause analysis after finding discrepancies in breast cancer testing that affected nine patients. Health officials said these cases were discovered as a result of an improved q…
Lean Used to Lay Groundwork for Lab’s 15189 Accreditation
By Joseph Burns | From the Volume XXI No. 2 – February 3, 2014 Issue
CEO SUMMARY: Henry Ford Health System’s laboratory organization has become first in the nation to have all its laboratory sites “standardized under one source of leadership” and accredited to the standards of ISO 15189: Medical Laboratories. The journey to achieve this current state…
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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