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OIG Reports Its Findings about CDC’s First COVID Test Problems

By Robert Michel | From the Volume XXXI, Number 1 – January 16, 2024 Issue

ONE MAJOR FAILURE BY FEDERAL AGENCIES in the first days of the COVID-19 pandemic was the development and release of an inaccurate and unreliable SARS-CoV-2 test, intended for use by public health labs. This was the finding of the U.S. Department of Health and Human Services (HHS) …

July 30, 2018 Intelligence: Late Breaking Lab News

By Robert Michel | From the Volume XXV No. 11 – July 30, 2018 Issue

Clinical labs and physicians can soon say goodbye to “meaningful use.” Federal officials are proposing a significant change to the Medicare and Medicaid EHR Incentive program for certified EHRs that has been in existence since 2011. In a press release issued last spring, the Centers for M…

New Business Models for Pathology, Clinical Labs

By R. Lewis Dark | From the Volume XXIV No. 7 – May 15, 2017 Issue

EXPERTS OFTEN PROCLAIM THAT THE U.S. HEALTHCARE SYSTEM is slow to change and slow to adopt the management approaches, operational innovations, and new technologies that other industries use. One example is adoption of the quality management techniques that W. Edwards Deming and the Japanese develope…

ARUP Laboratories Earns CAP’s ISO 15189 Accreditation

By Joseph Burns | From the Volume XXIV No. 5 – April 3, 2017 Issue

CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitmen…

Much Disruption for Labs In 2016’s Top 10 Stories

By Robert Michel | From the Volume XXIII, No. 17 – December 19, 2016 Issue

CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…

Henry Ford Health System Labs Show How Lean Methodology in Healthcare Increases Revenues

By Mary Van Doren | From the Volume XXIII No. 3 – February 29, 2016 Issue

EXECUTIVE SUMMARY: Here’s a major accomplishment by the lab division of a nationally-recognized health system that has gone unreported until this DARK REPORT intelligence briefing. This article explains how using the quality management system of ISO 15189 and the Lean methodology in …

Henry Ford Health System Laboratory Division Combines Lean with ISO 15189

By Joseph Burns | From the Volume XXIII No. 3 – February 29, 2016 Issue

CEO SUMMARY: As healthcare transitions away from fee-for-service payment and adopts new models of reimbursement, every clinical lab will need to deliver more value with its lab testing services. At Henry Ford Health System in Detroit, the laboratory division has blazed a path of improving…

December 7, 2015 Intelligence: Late Breaking Lab News

By Robert Michel | From the Volume XXII, Number 17 – December 7, 2015 Issue

Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accredit…

Achieving CLIA, ISO 15189 at Same Time with A2LA

By Joseph Burns | From the Volume XXII No. 3 – February 17, 2015 Issue

CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…

Gearing Up the Laboratory to Exceed Expectations of External Customers

By Robert Michel | From the Volume XXII No. 3 – February 17, 2015 Issue

CEO SUMMARY: This is the third installment of THE DARK REPORT’S description of the Laboratory Value Pyramid. It describes “Level Three: Deliver Value that Exceeds Expectations.” This is the level where the laboratory organization now shifts its emphasis from internal operation of…

Volume XXXI, No. 16 – November 25, 2024

Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.

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