News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Latest White Papers

Best Practices in Molecular Assay Validation for Laboratory-Developed Tests

This comprehensive white paper is designed to be your go-to guide, providing invaluable insights into critical success factors and essential functions crucial for maintaining compliance and delivering reliable results. Tailored for clinical molecular laboratory staff, this resource delves into the tangible aspects of compliant method validation, offering practical strategies for proving the accuracy and efficacy of laboratory-developed tests (LDTs).

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Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality

This white paper serves as a practical guide to enhance the understanding of the POCT team regarding critical success factors and essential functions needed to sustain compliance and produce reliable results. It focuses on the tangible aspects of good laboratory practice and regulatory compliance in routine and urgent patient care settings. This resource will be particularly beneficial to nursing and other clinical staff involved in patient testing.

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The Case of the Missing Mole: When costly Lost or Missing Laboratory Test Samples Instigate Courier Management Redesign

Incidents of lost or missing laboratory test samples carry heavy consequences. Yet, many laboratories find that accountability, reconciliation, and tracking persist as issues. This white paper will be useful for laboratory directors, lab managers, courier managers, logistics managers, and outreach managers—whether in hospital-based laboratories or independent medical laboratories working as outreach labs—who employ and manage couriers in-house.

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Latest E-Briefings

Former FDA Director to Speak at Executive War College on FDA’s Coming Regulation of Laboratory Developed Tests

Tim Stenzel, MD, PhD, will discuss what clinical laboratories need to know about the draft LDT rule, FDA memo on assay reclassification, and ISO-13485 harmonization Many clinical laboratories anxiously await a final rule from the US Food and Drug Administration (FDA)...

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Swiss Research Study into Long COVID Promises New Diagnostic and Therapeutic Possibilities

New biomarker may lead to new clinical laboratory testing and treatments for long COVID Researchers studying long COVID at the University Hospital of Zurich (UZH) and the Swiss Institute of Bioinformatics (SIB), both in Switzerland, have discovered a protein biomarker...

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Scientists at UT Health San Antonio Discover New Biomarker for Diabetic Kidney Disease

Biomarker may lead to clinical laboratory testing that enables clinical pathologists and urologists to diagnose risk for diabetic kidney failure years before it occurs Clinical laboratories working with nephrologists and urologists to diagnose patients experiencing...

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Rice University Researchers Develop ‘Molecular Jackhammer’ That Kills Cancer Cells

Research could lead to similar treatments for other diseases, as well as creating a demand for a new line of oncology tests for clinical labs and pathology groups Cancer treatment has come a long way in the past decades, and it seems poised to take another leap...

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Private Equity Firm General Catalyst to Buy Integrated Delivery Network Summa Health as Testing Ground for New Venture

Switching from non-profit to for-profit may affect how clinical laboratories operate in the new healthcare system Shifting away from fee-for-service payment models and towards value-based healthcare is the goal of many non-profit hospital systems. One such...

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Perfect Storm of Clinical Lab and Pathology Practice Regulatory Changes to Be Featured in Discussions at 29th Annual Executive War College

Forces in play will directly impact the operations and financial stability of many of the nation’s clinical laboratories With significant regulatory changes expected in the next 18 to 24 months, experts are predicting a “Perfect Storm” for managers of clinical...

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Increased Testing Demands from Physicians is Putting New Zealand Clinical Laboratories Under Severe Stress

Following the loss of its histology accreditation, pressure on APS laboratory continues to mount Government-run healthcare systems around the world often under-invest as demand grows and new healthcare technologies enter clinical practice. One such example is taking...

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AXIM Biotechnologies Develops Diagnostic Test for Parkinson’s Disease That Uses Tear Drop Specimens and Returns Results in Less than 10 Minutes at the Point of Care

New non-invasive test could replace traditional painful spinal taps and clinical laboratory fluid analysis for diagnosis of Parkinson’s disease Scientists at AXIM Biotechnologies of San Diego have added another specimen that can be collected non-invasively for rapid,...

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Scientists Close in on Elusive Goal of Adapting Nanopore Technology for Protein Sequencing

Technology could enable medical laboratories to deploy inexpensive protein sequencing with a handheld device at point of care and remote locations Clinical laboratories engaged in protein testing will be interested in several recent studies that suggest scientists may...

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Upcoming Webinars

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STIs and Resistant Organisms: Causes, Prevalence, Treatments
and Tests

Airing April 10, 2024

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Maximizing Financial Outcomes: Data-Driven Strategies for RCM Workflow Prioritization

Airing April 17, 2024

Latest Webinars

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Reimbursement Strategies for Denials Management: To Appeal or Not to Appeal?

Aired on March 27, 2024

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The Triple Threat: Has it changed since the last respiratory season?

Aired February 28, 2024

prevent financial losses due to Z-codes

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New Solutions in Laboratory Supply and Logistics Management that Cut Costs, Improve Compliance, and Boost Revenue

Aired February 21, 2024

prevent financial losses due to Z-codes

PREMIUM WEBINAR

SPECIAL REPORT Premium Webinar: Essential Guide to Obtaining Z-Codes for Molecular and Genetic Tests

Aired June 29, 2023

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From Market Access Through Reimbursement: Your Playbook to Maximize Revenue and Cash Flow

Aired December 12, 2023

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FREE WEBINAR

Best Practices in Molecular Assay Validation for Laboratory-Developed Tests

Aired November 8, 2023

CLIA INSPECTION READY

Better CLIA Compliance Reviewing Top Deficiencies from CAP, COLA, A2LA, The Joint Commission, CMS and Looking to Future CLIA Reform

SPECIAL REPORT | Better CLIA Compliance: Reviewing Top Deficiencies from Accreditors and Looking to Future CLIA Reform

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