October 2023

Clinisys CEO Discusses Strategic Changes That Labs Need to Make

In an exclusive Q&A with The Dark Report, Clinisys CEO Michael Simpson describes the main forces transforming healthcare here in the United States and abroad. He connects these trends with advances in cloud-based technology, artificial intelligence, and machine learning. Simpson became CEO and President at lab informatics provider Clinisys in 2017. Since then, he has […]

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Why Many Patients Cannot Pay for Their Lab Tests

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

IT IS WIDELY RECOGNIZED THAT GOVERNMENT AND PRIVATE PAYERS STEADILY NIBBLE AWAY at what they reimburse clinical laboratories and anatomic pathologists. Lowering the prices paid for tests, excluding labs from networks, and declining to grant coverage for new lab tests are just a few of the tactics used by the health insurance industry to cut

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Hospitals, Pharmacies Struggle to Be Profitable

Lab Intelligence / Robert Michel

CEO SUMMARY: Pharmaceutical companies may be posting strong growth in revenue and profits. But that’s not true for the nation’s largest retail pharmacy chains. Rite Aid’s Chapter 11 bankruptcy filing earlier this month put a spotlight on financial stress at all the retail pharmacy chains. This news was matched by the release of a survey

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Proficiency Testing Ranks High as a CLIA Violation

Laboratory Compliance / Robert Michel

CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scrutinize every PT sample that does not pass muster. Editor’s note: This is

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Clinisys CEO Discusses Strategic Changes Labs Need to Make

IVD/Lab Informatics / Robert Michel

“Today, we predict that the next storm is about ready to happen, and it will involve clinical laboratories and anatomic pathology practices.” —Michael Simpson CEO SUMMARY: In this exclusive Q&A with The Dark Report, Clinisys CEO Michael Simpson describes the main forces transforming healthcare here in the United States and abroad. He connects these trends

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Gaining Network Access with Payers Is Often about Geography

Managed Care Contracts / Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. SMALLER LABORATORIES WANTING TO

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October 23, 2023, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Earlier this summer, a 16-year-old completed his bachelor of science degree, along with his certification as a Medical Laboratory Scientist (MLS). The faculty at LSU Health-Shreveport reported that Isak Schmidley, MLS (ASCP)BC is the youngest graduate of its Medical Laboratory Science Program to earn both the BS and the MLS certification. Schmidley earned his associate’s

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FDA Releases Proposed Rule to Further Regulate LDTs

TDR Insider / Robert Michel

The U.S. Food and Drug Administration (FDA) has taken the first step to regulate laboratory developed tests (LDTs). Many in the clinical laboratory oppose the FDA on this point. Last week, the agency made the draft rule public, prior to its official publication this week. This move by the FDA—which picked up significant momentum over

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Two Forces Push for More FDA Oversight of LDTs

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administration (FDA), is pulling on laboratories by proposing more stringent requirements for LDTs. Another force, this one by means of Congress, is attempting

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FDA Issues Proposed Rule to Further Regulate LDTs

Genetic Testing, In Vitro Diagnostics, Lab Intelligence, Lab Risk & Compliance, Laboratory Compliance / Scott Wallask

CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnostic devices, which then places many of these tests under increased regulatory review. Clinical laboratory managers and pathologists have until Dec. 2 to submit comments

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