Andrea Seykora (andrea.m.seykora@kpchr.org) is the Research Compliance Manager and Melinda Allie (melinda.j.allie@kpchr.org) is the Quality Improvement Compliance Coordinator at the Kaiser Permanente Center for Health Research in Portland, Oregon.
Internal monitoring and auditing is well-recognized as one of the seven elements of an effective compliance program outlined in the Federal Sentencing Guidelines for Organizations.[1] A robust monitoring and auditing plan ensures that the compliance program is functioning effectively and can help identify compliance concerns and their root causes before they become serious or are discovered in external audits.
As a focus group of the Health Care Compliance Association (HCCA) and Association of Healthcare Internal Auditors (AHIA) has articulated, auditing and monitoring are two different things.[2] Auditing is a more formal, periodic review of processes and controls, governed by professional standards and conducted by individuals independent of the operation. Monitoring, in contrast, involves less formal, ongoing evaluation to ensure that processes are working as intended. It is often not conducted by individuals who are independent of the operation and may include operations and compliance staff. This feature of monitoring makes it a great opportunity to build partnership between Compliance and the operational departments.
Best practices
When a monitoring strategy is approached as a collaboration between Compliance and operational business partners, it can boost other elements of the compliance program, such as maintaining open lines of communication and providing effective training and education.[3] This article outlines the key characteristics of monitoring programs and practical implementation strategies that foster the partnership between Compliance and operations.