By Dale Hockel
Understanding and achieving regulatory compliance
can be a daunting, but a necessary task. Rigorous requirements from the Centers for Medicaid & Medicare Services, accreditation requirements, state department of health compliance, and recalls/ alerts from the FDA and OEMs demand a full-time professional to understand all standards and regulations for every device in a hospital. Instead, many hospitals rely on already taxed clinical engineers to do the job. Although capable, CEs lack the time required to effectively engage with each regulatory body or stay current with every device.
Let’s examine a few regulatory requirements for documenting medical maintenance and determine if you have compliance covered.
Compliance starts with a medical equipment management plan. A MEMP includes the following:
- Written plan and supporting policies and Procedures
- Process of selecting, planning, acquiring equipment
- Process of addressing equipment use errors and patient risks
- Preventive Maintenance of life and non-life support equipment and documentation
- Maintenance strategies and intervals
- Alerts, recalls
- Safe Medical Device Act requirements
- Process for evaluating effectiveness
The MEMP starts with accurate inventory management — knowing what you have, its PM schedule, how it’s utilized, etc. Not knowing this critical information puts you and the facility at risk. The regulations state:
1. CMS Regulations 482.53 “An equipment inventory and incident history is maintained.”
2. The Joint Commission, EC02.04.01, EP2 “The hospital maintains either a written inventory of all medical equipment or a written inventory of selected equipment … and equipment incident history.” Regulations require hospitals to establish a precise inventory of all medical equipment and to document maintenance and PM regardless of ownership. Although regulatory bodies do not specify how the inventory is documented, the best practice is a computerized maintenance management system that stores information in one location, allows you a complete list of inventory and its history on file, and is easily accessible.
The next important step to staying compliant is the management of PM frequencies. The regulations state:
1. The Joint Commission, EC02.04.01, EP3 & EP4 “The hospital identifies the activities, in writing, for maintaining, inspecting and testing for all medical equipment on the inventory. The hospital identifies in writing, frequencies for inspecting, testing and maintaining medical equipment on the inventory based on criteria such as manufacturers’ recommendations, risk levels or current hospital experience.”
These regulations are left to the interpretation of the beholder, which is risky. For instance, recent changes with the CMS PM directive now make the interpretation of whether a device is considered life support, critical care or general based on where that device is located in the hospital and how it’s used. Consider AED defibrillators in a medsurg unit: some OEMs don’t have a designed PM or frequency, therefore some CEs don’t put it on schedule. However, it’s now considered life support, meaning twice a year PM, otherwise risk a citation. Best practices for PM frequencies include developing, documenting and working a plan, and updating it based on federal and state changes.
The responsibilities of documenting medical maintenance require more than asking a seasoned CE to “help out” when time permits. It requires a full-time risk manager that works in tandem with CE to develop an MEMP plan, document inventory and create a PM frequency plan for every device in the hospital. They should know when surveys will take place so you’re prepared. State surveys occur every year, the Joint Commission surveys occur every 18 months-three years, and CMS occurs every 15 months. Each state and regulatory body has their own requirements, so your risk manager must understand the process for each. If hiring a full-time professional isn’t in the budget, consider partnering with a service provider who can help prepare for the surveys and stay compliant year-round.
About the Author: Dale Hockel is the Senior Vice President of Operations at TriMedx, an Indianapolis-based health care equipment services provider. Dale is a senior executive with more than 20 years of strategic and operational leadership experience. Dale earned a BA in Management Science from Buena Vista University and an MBA from Indiana Wesleyan University.