Len Lewis Email & Phone Number

Detroit, Mi, Us

Ann Arbor, Mi

Oversees the controlled substances compliance program for the University of Michigan Health System (UMHS), Reviews and evaluates compliance issues/concerns within the organization. Ensures that all levels of the organization are in compliance with the rules and regulations of regulatory agencies (including the U.S. Drug Enforcement Administration and the State of Michigan) and that appropriate institutional policies and procedures are in place and are being followed.Collaborates and coordinates with both leadership and operational personnel across the hospitals and health centers relating to controlled substance control.Develops & maintains controlled substances and medication management policies and procedures in accordance with federal, state and local laws and regulations, as well as The Joint Commission. Ensure that all internal policies and procedures related to controlled substances and medication management are consistent with current laws and regulations; and are understood and implemented.Develop audit processes and conduct audits for the purchasing, receipt, distribution and administration of controlled substances and the entire medication use process.Perform regularly scheduled trend analyses and data base assessments in order to identify drug diversion activities.Ensure that all documentation required by federal, state and local agencies is, completed, maintained, and stored in a readily retrievable manner. This includes prior approval of any new sites for controlled substance use for patient care or research.Develop, maintain, and routinely evaluate a multidisciplinary approach to proactive drug diversion as well as the medication use process. This includes evaluation of new technology utilized in proactive prevention and detection of controlled substances diversion.Provide reports to various hospital committees when required, including the Controlled Substances Safety and Compliance Oversight Committee.

Ann Arbor, Mi

Responsible for Regulatory Compliance suspicious ordering monitoring, investigations and operational compliance functions.

Lead a team of Quality Engineers in investigations of incidents (deviations) and writing incident reports. Maintain data base of in incidents. Maintain CAPA program. Introduce process improvements and evaluate validation protocols.

Mba, Business Management And Strategy

Education record

Education record

Education record

Education record