LEAP Consulting Group, a specialized digital consultancy for the clinical laboratory sector, is thrilled to introduce a new service designed to assist CLIA-certified labs in navigating the FDA’s updated requirements under the LDT Final Rule announced in May 2024. This service helps laboratories understand their compliance risks, explore the best paths to meet new regulations, identify gaps in their current compliance status, and develop and implement effective remediation plans. LEAP’s support includes advising on compliance strategies, budgeting for remediation efforts, and ensuring that labs meet each phase-in deadline effectively.
Since 2012, LEAP Consulting Group has been serving clinical laboratories and has extensive experience with GXP and FDA regulations for medical devices since 2015. LEAP’s deep expertise in diagnostics, technology, process design, implementation, and FDA compliance enables a smooth transition for labs to meet FDA LDT medical device compliance requirements, building upon their existing systems and processes. The company employs a collaborative approach, adapting SOPs and, when necessary, assisting clients in acquiring or developing digital solutions tailored to meet regulatory obligations.
Josh Kramer, Founder and Managing Partner of LEAP Consulting Group, stated, “We take great pride in supporting our laboratory clients through their complete digital transformation journeys, from digital front-doors to results delivery, revenue cycles, and beyond. We are honored to guide them through the new requirements set by the FDA’s LDT Final Rule.” Raina Kiviat, Healthcare Practice Lead at LEAP, added, “Our specialized knowledge in diagnostics, technology, and FDA compliance positions us uniquely to help labs understand their risks, explore compliance options, and implement effective remediation plans.” Antony Galdi, Delivery Head for LEAP’s implementation practice, remarked, “We are dedicated to ensuring our clients achieve compliance efficiently and effectively, turning regulatory obligations into opportunities for commercial growth. It’s been a rewarding process to develop this new practice rapidly and work through the new ruling with our clients.”
LEAP’s compliance process for the new FDA ruling involves a streamlined, five-step approach:
- Information Request: Summarize current lab systems, electronic records, change control, and reporting procedures.
- Technology Analysis: Evaluate systems to determine their open/closed status and identify required security protocols.
- Gap Analysis: Identify and analyze compliance gaps in current processes and systems.
- Action Plan: Develop a plan for system configurations, policy updates, and process improvements, with a timeline and resource allocation.
- Remediation and Adaptation: Implement changes, create policies, and conduct training sessions.
LEAP offers tailored advice on people, processes, and platforms, with flexible scope and pricing options to provide as much or as little support as needed by each organization.
