Take Steps Now to Establish Quality Systems for LDTs
Strengthened oversight of laboratory developed tests is drawing nearer as the U.S. Food and Drug Administration has predicted a 2016 release of a finalized framework for that oversight. While opposition is strong and legislation could impose an alternative to the FDA’s proposal, it is still wise for laboratories to begin taking steps to prepare for heightened scrutiny and increased compliance requirements for LDTs. Impending regulation of LDTs was one of the challenges discussed at G2 Intelligence’s Lab Revolution held last month at the Sheraton Wild Horse Pass Resort and Spa in Chandler, Ariz. (April 6-8). At that conference, a panel highlighted the FDA’s proposal and its impact on laboratories. Michael Murphy, president of Conatus Consulting, and Richard S. Robinson MT (ASCP) from the American Red Cross Biomedical Headquarters Regulatory Affairs reviewed the current status of the FDA proposal and provided some practical advice to help labs prepare for anticipated new oversight. Murphy emphasized the importance of developing quality systems and noted that in the 20 cases the FDA mentioned in their recent report concerning problematic LDTs, errors were due to “extremely deficient” quality control. In the short term, he recommended labs focus on quality systems, design controls and document controls. […]
Strengthened oversight of laboratory developed tests is drawing nearer as the U.S. Food and Drug Administration has predicted a 2016 release of a finalized framework for that oversight. While opposition is strong and legislation could impose an alternative to the FDA’s proposal, it is still wise for laboratories to begin taking steps to prepare for heightened scrutiny and increased compliance requirements for LDTs. Impending regulation of LDTs was one of the challenges discussed at G2 Intelligence’s Lab Revolution held last month at the Sheraton Wild Horse Pass Resort and Spa in Chandler, Ariz. (April 6-8).
At that conference, a panel highlighted the FDA’s proposal and its impact on laboratories. Michael Murphy, president of Conatus Consulting, and Richard S. Robinson MT (ASCP) from the American Red Cross Biomedical Headquarters Regulatory Affairs reviewed the current status of the FDA proposal and provided some practical advice to help labs prepare for anticipated new oversight. Murphy emphasized the importance of developing quality systems and noted that in the 20 cases the FDA mentioned in their recent report concerning problematic LDTs, errors were due to “extremely deficient” quality control. In the short term, he recommended labs focus on quality systems, design controls and document controls. To begin establishing a quality system he recommended laboratories take four steps: 1) conduct a gap analysis, 2) get management buy in, 3) develop SOPs, and 4) train employees. Rather than taking a wait and see approach and having to play “catch up” to comply with increased regulation, laboratories would be wise to begin structuring quality systems now.
Editor’s Note: For more guidance on how to prepare for LDT regulation, G2 Intelligence will be presenting a 90-minute webinar, FDA Regulation of Laboratory-Developed Tests: What to Expect, How to Prepare, on May 24, 2016, at 2 p.m. EST, with Mahnu Davar and Jen Madsen, MPH of Arnold & Porter’s Life Sciences and Healthcare Regulatory Practice. For more information, visit www.g2intelligence.com/web/
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