Revvity Launches AI-First Platform to Coordinate Lab Workflows from Discovery to Manufacturing
The Signals LabGistics tool translates standard operating procedures into scientific workflows and supports GxP compliance across laboratory environments.
Category: Compliance
Compliance
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Compliance
Latest
SHEA Framework Shows Diagnostic Stewardship Can Save Hospitals Up to $2.8M Annually
A new SHEA framework outlines how targeted diagnostic stewardship interventions could save a 200-bed hospital up to $2.8 million annually.
Compliance
Latest
Joint Commission Launches System Survey Option for Laboratory Accreditation
The new concurrent survey model aims to reduce administrative burden and promote operational consistency across healthcare systems.
Senator Honored for Efforts to Improve Pediatric Lab Testing
The ADLM honored senator Shelley Moore Capito for advancing pediatric reference intervals, citing her support for related provisions in Senate appropriations bills for FY 2025 and 2026.
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House Committee Approves $5 Million to Improve Pediatric Lab Testing
The funding, allocated to the Centers for Disease Control and Prevention, aims to establish more accurate normal ranges for children’s medical results.
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CMS Transitions CLIA Program to Paperless Operations
Laboratories must now pay fees online and access certificates electronically as the program ends paper mailings.
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DELFI Diagnostics Receives New York State Approval for Lung Cancer Blood Test
The authorization from the New York State Department of Health makes the screening test available in all 50 states.
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US Settles Genetic Testing Fraud Case Against Laboratory Owner
The settlement follows a criminal conviction and addresses more than $174 million in fraudulent Medicare claims involving multiple laboratories.
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CMS Opens Data Collection Module for Clinical Laboratory Fee Schedule Reporting
Applicable laboratories are required to report information to CMS for each clinical diagnostic laboratory test that the laboratory furnishes.
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Policy and Payment Gaps Limit Access to Critical Diagnostic Testing
A new analysis finds that policy and payment gaps are limiting access to diagnostics, with nearly half the world lacking adequate testing and reimbursement lagging behind advances in precision therapies.
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FDA Issues Draft Guidance for Gene Therapy Genome Editing Safety
The recommendations focus on using next-generation sequencing to evaluate off-target editing risks and chromosomal integrity.
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Lab Owner Charged with $46 Million Medicare Billing Fraud for Tests Never Performed
The owner of an Oregon clinical laboratory allegedly submitted tens of millions in fraudulent claims to Medicare Advantage plans for laboratory testing services that were never ordered or performed.
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Alabama Doctor Sentenced to Prison in $2.7 Million Telemedicine and Genetic Testing Fraud
An Alabama-based physician received a 16-month prison sentence for signing off on medically unnecessary genetic tests and durable medical equipment orders, resulting in millions in false Medicare claims.
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New Jersey Lab Must Repay $3.4 Million to Medicaid for Billing Violations
State audit finds the lab billed for drug tests without required physician signatures in nearly a quarter of reviewed instances.
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Hawaii Dept of Health Issues Violations to Four Companies Over Illegal Direct-to-Consumer Lab Testing
State regulators say the companies collected specimens without authorized provider orders, violating Hawaii law.
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Proscia Earns SOC 2 Type II Certification for Digital Pathology Platform
The compliance milestone adds to the company’s existing ISO certifications as enterprise deployments accelerate across pharmaceutical and diagnostic laboratory customers.
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AMP Awards Pathologist for Role in Laboratory-Developed Test Litigation
The pathologist served as joint plaintiff in successful lawsuit challenging FDA regulation of LDTs as medical devices.
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FDA Issues Finalized Guidance on Emergency Use of Unapproved Diagnostic Tests
The guidance establishes a formal framework for how the FDA will exercise enforcement discretion regarding unapproved diagnostic tests in the event of future public health emergencies.
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