Manufacturers' Maintenance Recommendations: Locked In or Not?

Abstract

The primary reason for hospital accreditation is supposed to be making sure that healthcare is provided safely and effectively. However, it often seems that hospital accreditation is more about making sure that healthcare providers can be reimbursed by the Centers for Medicare & Medicaid Services (CMS) and other third-party payers (insurance companies). Accreditation organizations obtain deeming status—the authority to judge an organization in compliance with requirements—with CMS conditions of participation by writing standards that are in compliance with CMS requirements. What, then, are the CMS requirements for medical equipment management? How closely do the medical equipment management standards written by organizations with deeming status match CMS’s requirements? CMS has three standards for the physical environment, including one for facilities. Under the facilities standard, there is a paragraph that reads: “Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.” This appears to give ultimate flexibility to healthcare organizations for designing and implementing medical equipment management programs. However, the reality is not that simple or straightforward. CMS is required to use state agencies to determine whether healthcare organizations meet its standards. CMS publishes the State Operations Manual with details and explanatory material for its standards. The appendices contain guidelines for interpreting the standards for different types of healthcare organizations. These appendices have “interpretive guidelines” and “survey procedures” for each of the requirements. Appendix A is for hospitals. In the interpretive guidelines for medical equipment, it says, “Equipment must be maintained to ensure an acceptable level of safety and quality.” It goes on to say, “There must be a regular periodical maintenance and testing program for medical devices and equipment. A qualified individual such as a clinical or biomedical engineer, or other qualified maintenance person must monitor, test, calibrate, and maintain the equipment periodically in accordance with the manufacturer’s recommendations and federal and state laws and regulations. Equipment maintenance may be conducted using hospital staff, contracts, or through a combination of hospital staff and contracted services.” This is significantly more restrictive. A scheduled inspection and maintenance program that uses manufacturers’ recommendations, as well as any applicable laws and regulations, is required. This then is the origin and the authority behind what is probably the most debated requirement of medical equipment management programs—that inspection programs have to follow manufacturers’ recommendations. The American Osteopathic Association (AOA) and DNV Healthcare, two of the three organizations with Manufacturers’ Maintenance Recommendations: Locked In or Not?