Risk management and improvement science – lessons learned from Massachusetts' response to the New England compounding center multi-state fungal meningitis outbreak

To protect the public, regulators need a framework and culture grounded in improvement science. We led the investigation of the New England Compounding Center (NECC) during the 2012 fungal meningitis outbreak, which revealed lapses in judgment and disregard for best practices by both NECC and staff at the regulatory agency. NECC knew about environmental contaminants and other regulatory deficiencies and failed to act. And the regulator did not have a comprehensive risk management framework to guide its operations. This failure in public and private sector systems and lack of an improvement framework offers lessons relevant to organizations engaged in the provision or oversight of health care. The disregard for best practices by NECC, coupled with insufficient oversight by regulators, and absence of comprehensive risk management in both organizations, resulted in a preventable tragedy. Any of the issues identified at NECC should have triggered internal investigation and regulatory action. Regulators relied on reputation and perceived intent instead of appropriate triage systems to prioritize investigations, and strong, deliberative enforcement actions. Development of mechanisms such as transparent response to complaints will increase accountability of regulators. Establishment of tools such as whistleblower protections will facilitate reporting by licensees. Regulators must harness the lessons learned from the NECC tragedy to drive internal and systemwide improvement. Strengthening legal frameworks is important and is underway in Massachusetts, but shifting culture is critical. In some health care sectors, there is an increasing focus on quality and safety. In settings where those principles have not been adopted, regulators should harness improvement science to lead cultural and operational transformation in both their organizations and those that they oversee. Investment in this domain is lacking, and the results are apparent. Rethinking approaches to focus on improvement and to foster accountability among licensees and regulators alike is essential to ensuring public safety.