Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995

Issues Archive

The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.

Volume XXXI, No. 3 – February 26, 2024

In this issue:

A “perfect storm” of new developments in the clinical laboratory and pathology group industry is coming, and The Dark Report is analyzing these changes as well as preparing to present the details to attendees at the annual Executive War College. Also, HHS has published an important final rule for health IT Interoperability.

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Volume XXXI, No. 2 – February 5, 2024

In this issue:

The Dark Report takes a deep dive into the comments submitted on the FDA’s draft LDT rule, questioning the FDA’s transparency in publishing the comments. Also included is a report on a letter about LDT oversight issued jointly by the FDA and CMS. In addition, a major data breach at a European lab has lessons for American clinical labs.

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Volume XXXI, Number 1 – January 16, 2024

In this issue:

The Dark Report notes that British Columbia cervical cancer screenings will now be made via self-collected HPV testing, rather than Pap smears, in an effort to overcome medical personnel shortages. Also, a new deal between Google Cloud and Epic Systems aims to help hospitals move their EHR data to the cloud.

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Volume XXX, Number 18 – December 26, 2023

In this issue:

This issue examines the top 10 stories from 2023, which show no immediate threats to the clinical laboratory industry, but which were mostly about developments where the consequences will influence laboratory operations in coming years. In other news, a convicted fraudster earns an eight-year prison sentence for violating EKRA.

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Volume XXX, Number 17 – December 4, 2023

In this issue:

In this issue, The Dark Report discusses the impact of artificial intelligence-powered solutions. The Dark Report suggests that it is timely for lab managers at all levels of the organization to begin learning about the field of artificial intelligence. In addition to this topic, discover how labs should be prepared for data to dominate diagnostics, understand that CLIA lab directors must monitor delegated duties, and stay informed about the latest regulatory and IVD updates.

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Volume XXX, Number 16 – November 13, 2023

In this issue:

In this issue, Clinisys CEO Michael Simpson explains new developments in digital technologies that will expand the value and role of lab test data. Also, recent cases of healthcare fraud are examined, and whole genome sequencing for newborns is shown to be gaining favor with physicians and payers alike.

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Volume XXX, Number 15 – October 23, 2023

In this issue:

This issue explores the financial difficulties of many hospitals and retail pharmacy chains, and also the problems that clinical laboratories have with proficiency testing. In addition, the Clinisys CEO discusses strategic changes that labs need to make.

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Volume XXX, No. 14 – October 2, 2023

In this issue:

In the Oct. 2, 2023, issue of The Dark Report, we look at the Food and Drug Administration’s reasoning behind a proposed rule to more strictly regulate laboratory-developed tests. Other stories outline how the SALSA bill aims to combat PAMA cuts and what steps a clinical lab took to bring outreach services back in house.

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Volume XXX, No. 13 – September 11, 2023

In this issue:

Recent court rulings involving the No Surprises Act are putting the government on the defensive about provisions of the law. Also, the continued consolidation of the IVD and national laboratory company markets has brought more influence to those lab companies. In addition, learn how clinical labs can earn money from their diagnostic data by helping private insurers navigate Medicare Advantage’s risk adjustment model.

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Volume XXX, No. 12 – August 21, 2023

In this issue:

An industry expert outlines steps pathologists can take to protect their incomes from outside pressures. Also, self-insured companies and unions are suing payers over price transparency. In addition, guerrilla Kaizen events are described in detail to control lab waste and inefficiencies.

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