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continuous improvement
Level Two of Value Pyramid Defines Internal Benchmarks
By Robert Michel | From the Volume XXI No.16 – November 24, 2014 Issue
CEO SUMMARY: In this second installment of our series on the laboratory value pyramid, we introduce “Level Two: Establish and Meet Standards of Value.” This second level continues the lab’s focus on its internal operations and activities. The goal is for the lab to develop the working cultu…
Defining a Path to Clinical Laboratory Best-in-Class via Benchmarks
By Robert Michel | From the Volume XXI No. 13 – September 22, 2014 Issue
CEO SUMMARY: With the American healthcare system undergoing a major transformation, it is essential that all clinical laboratories and pathology groups recognize this transformation and effect the right strategies to meet the needs of physicians, patients, and payers. A g…
One Key to Lab Success Is Daily Performance Metrics
By Joseph Burns | From the Volume XXI No. 7 – May 19, 2014 Issue
CEO SUMMARY: Every clinical lab today must deal with the twin challenges of performing an increased volume of tests while being paid less money. That’s why a handful of innovative lab organizations now use management information systems with analytics that provide detailed, real-time me…
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…
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…
Quality Assurance Regs to Tighten for UK Labs
By Robert Michel | From the Volume XXI No. 2 – February 3, 2014 Issue
CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” w…
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…
Sonora Quest Builds EMPI To Serve Patients and ACOs
By Joseph Burns | From the Volume XXI No. 1 – January 13, 2014 Issue
CEO SUMMARY: Probably no state has seen a faster transition to ACOs, medical homes, and other types of integrated clinical care organizations than Arizona. Recognizing that this change created a new opportunity to add more value with clinical lab testing services, Sonora Quest Laboratorie…
2013’s Top Ten Lab Stories Point to Tougher Times
By Robert Michel | From the Volume XX, No. 17 – December 23, 2013 Issue
CEO SUMMARY: For 2013, the big story was money—or, more accurately, less money for providers. This was not limited to clinical labs and pathology groups, but was equally true of hospitals and physicians. In THE DARK REPORT’S annual lookback at the year’s 10…
Boosting the Lab’s Role in Collaborative Care
By Joseph Burns | From the Volume XX No. 1 – January 22, 2013 Issue
CEO SUMMARY: Collaborative care is an essential element of accountable care organizations (ACO) and other emerging models of integrated clinical care. At MedCentral Health System, one clinical chemist has held a key place on the physician team that develops order sets and clinical alerts….
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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