Online Program

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

Tuesday, November 5, 2013 : 12:50 p.m. - 1:10 p.m.

Madeleine Biondolillo, MD, Director, Bureau of Health Care Safety & Quality, Massachusetts Department of Public Health, Boston, MA
Iyah Romm, Massachusetts Health Policy Commission, Boston, MA
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.

Learning Areas:

Administration, management, leadership
Public health administration or related administration
Public health or related laws, regulations, standards, or guidelines
Public health or related public policy

Learning Objectives:
Explain the importance of early warning indicators in regulatory agencies Discuss impact of improper organizational ethics and risk management systems Identify mechanisms for leveraging improvement resources to respond to a critical public health need

Keyword(s): Regulations, Quality Improvement

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am the Bureau Director for the lead health care safety and quality regulatory in Massachusetts. I directly oversaw the regulatory response to the New England Compounding Center, the source of the multistate fungal meningitis outbreak in 2012. I also directly oversaw operational and regulatory changes in Massachusetts subsequent to this outbreak.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.