Responding to Government Inspections
February 1, 2017 | Aging Services Risk, Quality, & Safety Guidance
Federal, state, and local governments regularly inspect continuing care facilities for many reasons, such as to routinely monitor the organization’s compliance with the governing entity’s regulations; to investigate complaints by employees, residents, family members, or other organizations; or to probe into an adverse event resulting in resident harm. Some inspections occur annually within a predictable time frame; others are unannounced. And just as the reasons for an inspection can vary, so can its scope. The inspection might involve one inspector who spends only a few hours at the facility or a team of inspectors that spends several days or even longer at the organization.
A visit from government inspectors often causes anxiety and stress for those at the organization who must respond to the investigators. However, a government inspection “need not be a traumatic event” if the organization has a plan in place for dealing with these inspections (Findlaw.com). With planning and preparation of key players, organizations can manage a government inspection and limit missteps that could affect the outcome. The need for planning is underscored by the fact that any follow-up civil or criminal proceedings pursued by the government entity are often based on the practices observed or evidence obtained during inspections. No organization should wait to put a plan in place until the inspector arrives at the facility. By then, it is too late.
Risk managers have a responsibility to ensure that their organizations have policies and procedures in place for responding to government inspectors and that the organization’s employees—from the receptionist who greets the inspector to the administrator and director of nursing who may respond to the inspector’s questions—are familiar with the policy and the organization’s approach to government investigations. Risk managers, often in consultation with the organization’s legal counsel, also have a responsibility to evaluate the inspector’s request for information in order to protect the confidentiality of resident records and other resident information and to guard the legal protections (e.g., confidentiality and privilege) that may be available to other documents, such as peer review materials and event reports.
This guidance article* provides general principles of readiness for government inspections. It cannot cover all the specific inspections a facility will undergo with local, state, and federal agencies. At the federal level, for example, a wide range of agencies are authorized to conduct inspections of continuing care organizations, and each agency has its own approach, spelled out in regulations and guidance documents. Facilities must be familiar with the inspection process followed by federal agencies such as the Centers for Medicare and Medicaid Services (CMS), the Department of Health and Human Services’ (HHS) Office of Inspector General, the Department of Housing and Urban Development, the Food and Drug Administration (FDA), and the Occupational Safety and Health Administration (OSHA). * Continuing Care Risk Managementgratefully acknowledges the input of the following individuals who reviewed the previous version of this guidance article: Laura Lally, J.D., vice president, chief claims officer, Caring Communities (Libertyville, Illinois), and Robert K. Neiman, J.D., principal at Much Shelist, P.C. (Chicago, Illinois).