Codes and Standards Interpretation
By Matthew F. Baretich, P.E., Ph.D.
Healthcare delivery is a highly-regulated business. The same is true for medical devices and healthcare facilities that are integral components of the healthcare delivery system.
Examples of applicable codes are the National Electrical Code (NFPA 70), the Life Safety Code (NFPA 101), and the Health Care Facilities Code (NFPA 99). There are regulations from the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and other federal agencies, plus regulations from states and other government agencies. There are also accreditation standards from organizations like the Joint Commission, DNV-GL, HFAP, CAP, AABB, and other ingredients in the alphabet soup of regulation.
The first step toward compliance is to determine which requirements apply in your setting. Some of these requirements have the force of law in your jurisdiction. Some of them are voluntary (e.g., accreditation standards) albeit essential for participation in the healthcare system. There are formal definitions for the term “Authority Having Jurisdiction” but to me, an AHJ is any entity with requirements that I need to meet.
I still run across statements like “NFPA requires this and that.” The National Fire Protection Association has dozens of codes and standards (voluntary unless required by your AHJ) that are updated regularly. At a minimum, you have to specify which publication you’re referring to and which edition. For example, NFPA 99 (2018) is the current edition of the Health Care Facility Code. You’d think that would settle the matter but, for example, CMS and the Joint Commission enforce the 2012 edition of NFPA 99 and your state may enforce a different edition (with or without amendments).
Similarly, the Joint Commission has a variety of accreditation programs that address various healthcare facilities and services: hospitals, critical access hospitals, ambulatory health care, behavioral health, and so on. The requirements are updated annually – and sometimes more often. Sorting it out and determining what applies (and how to apply it) can be challenging.
One way that Baretich Engineering helps with compliance is by developing guidance material. The 2015 edition of the Electrical Safety Manual collects healthcare-specific material from numerous codes and standards. The manual then provides practical recommendations for compliance, including sample policies.
Our AEM Program Guide clarifies the sometimes-confusing requirements for “Alternative Equipment Maintenance” programs now authorized by CMS and the Joint Commission. The publication offers guidance for reducing maintenance costs while maintaining equipment safety.
In our Clinical Engineering practice, we conduct formal assessments of medical equipment management programs. These assessments have been conducted across the United States in healthcare facilities and systems of all sizes. After reviewing compliance levels, we make recommendations for improvement and, as needed, help implement change.
In our Forensic Engineering practice, we are often asked about what codes and standards were applicable at the time of an adverse event and how the level of compliance might have had an effect on the incident.
Electrical Safety Manual (2015). Association for the Advancement of Medical Instrumentation. AEM Program Guide (2017). Association for the Advancement of Medical Instrumentation. How to Meet CMS and TJC Power Strip Requirements. AAMI News. November 2017.
How to Write a Medical Equipment Management Plan. 24x7. March 2016.
© 2018 Baretich Engineering, Inc. This article was first published as a blog post at baretich.com.