By Heidi Horn, MA, AAMIF
One of every healthcare technology management (HTM) department’s most important responsibilities is to ensure the hospital is compliant with all laws and regulations impacting its medical equipment management program. And, let’s face it, there are a lot of them, and they change every few years.
HTM organizations use their computerized maintenance management system (CMMS) as the primary tool to document regulatory compliance. However, what the HTM industry has discovered is that CMS, the Joint Commission, and other regulatory bodies change their standards faster than legacy CMMS providers can update their programming to conform to the new requirements.
I brought this conundrum up to a high-ranking Joint Commission leader a few years ago after that organization announced its new alternative equipment maintenance (AEM) elements of performance (EP). While I applauded the concept, I told him that none of the existing CMMS platforms were able to accurately track compliance to the new rules. His reply was that they make the standards, but it’s not their responsibility to figure out how hospitals adhere to them, just to ensure that they do. Touché.
Fortunately, newer, more nimble CMMS providers have emerged in recent years who are able to configure their platforms more easily to adhere to the changing regulations.
Following is a summary of some of the January 2020 medical equipment-related Joint Commission elements of performance and the data your CMMS must be able to capture and report on to be compliant. It’s also important that your policies and procedures are aligned with your CMMS and Joint Commission requirements.
EC.02.04.01 EP 2—The hospital maintains a written inventory of all medical equipment.
The key to this EP is the word “all.” Many hospitals don’t keep or have access to all their medical equipment inventory, especially equipment that is maintained by the manufacturer or a third party or that is not owned by the hospital. However, the Joint Commission is very clear that ultimately the hospital—not its vendors—is responsible for this inventory.
Having a complete and accurate inventory of all your medical equipment in your CMMS is necessary. In the past, the Joint Commission did allow for some exceptions for devices that are exchanged frequently (such as rigid scopes)—hospitals were allowed to inventory only the manufacturer/model and amount of those devices (versus every individual device). However, I have heard of some surveyors holding to the letter of the EP.
EC.02.04.01 EP 3—The hospital identifies high-risk medical equipment on the inventory for which there is a risk of serious injury or death to a patient or staff member should the equipment fail. High-risk equipment includes life-support equipment.
Identifying high-risk equipment has been a Joint Commission requirement for a while, but to ensure you are consistent in what equipment is so designated, your CMMS should automatically identify applicable equipment as high risk when it is added to the inventory. To do this, the HTM department—working with clinicians—should identify high-risk equipment at both the device-type level and, if needed, the model level, and set those defaults in the CMMS. This ensures the accuracy of your high-risk inventory.
To automate this process further and make it more objective, it is a good idea to build a risk-scoring system into your CMMS that will calculate the risk of the equipment based on predetermined criteria, one of which should be, “there is a risk of serious injury or death to a patient or staff member should the equipment fail.”
Many hospitals still differentiate between high-risk and life-support equipment and need to understand that all life-support devices are high risk, but not all high-risk devices are life support, so it’s important not to confuse this.
EC.02.04.01 EP 4—The hospital identifies the activities and associated frequencies, in writing, for maintaining, inspecting, and testing all medical equipment in the inventory. These activities and associated frequencies are in accordance with manufacturers’ recommendations or with strategies of an AEM program.
While it sounds simple enough, when you dig into this EP, it requires a lot from your CMMS to document compliance. The most basic requirement is that your CMMS must have a way to identify every device that is on an AEM and be able to run an AEM inventory report if requested by the Joint Commission. To be clear, if you are not following every maintenance activity and every planned maintenance (PM) frequency in the manufacturer’s service manual, by definition, that device is on an AEM (whether it is identified properly or not).
While it is not required by the Joint Commission, a best practice is to have the PM tasks built into the CMMS and available in the PM work order. This not only makes it much easier for your techs to quickly locate every task that must be completed and thus ensures they are following all the required activities, but it also provides quick access to the required written activities if the Joint Commission asks to see them.
This EP also requires that the strategies of an AEM program must not reduce the safety of equipment and must be based on accepted standards of practice. The implication here is that you need a baseline of the equipment’s safety performance before you put it on an AEM and then the ability to measure changes in the equipment’s performance after it’s on an AEM. This typically is measured through mean time between failure (MTBF).
Also implied in this EP is the ability to differentiate in your CMMS those equipment failures that were PM preventable from those that were not. Anyone who has worked in the HTM industry for a few years understands that most equipment failures are not PM preventable. For example, you do not want to include failures like physical damage or user error in your MTBF calculation since they are not PM-preventable.
Logically, you also want your CMMS to alert you when performance starts to decline on individual device types or models so that you can make changes to your AEM strategy in real time. Most CMMS systems are unable to do this, which makes properly managing an AEM program very difficult and labor-intensive.
In order to ensure your AEM inventory is accurate, at the time a new device is added a high-functioning CMMS should automatically:
- Identify whether the device type or model has been approved to be on an AEM.
- Assign the appropriate PM frequency and activities to the asset.
- Be able to differentiate those devices that have their AEM eligibility set at the device-type level from those that are set at the model level.
- Exclude inappropriate devices. Per EC.02.04.01 EP 5, you want your CMMS to ensure the following equipment are not put on an AEM: lasers, imaging and radiologic devices, and new equipment with insufficient maintenance history to support the use of an AEM.
Finally, EP 4 also dictates that all medical equipment must have 100% completion rate of the activities and frequencies of either the manufacturer’s recommendations (for devices not on an AEM) or the written AEM activities and frequencies (for devices on an AEM).
This means your CMMS must generate the PM work order at the required intervals. It is common for some devices to require different activities at varying frequencies (such as annual battery changes versus semiannual calibrations). Your CMMS should have the ability to generate these different PM work orders as well as track compliance.
The 100% completion rate requirement is generally interpreted to mean that for every device that has a PM, you must complete all the required PM activities by the due dates as frequently as the written guidelines dictate. When this EP was introduced, there was a huge outcry from the HTM community.
The belief was that it is nearly impossible to have 100% PM completion due to devices that aren’t available. So the Joint Commission has allowed PM grace periods as well as two other exceptions to this rule: If the device cannot be located or is in use for its scheduled PM, and reasonable attempts have been made to find or gain access to the device, it will not count against the hospital.
These exceptions introduce the concept of PM compliance (not to be confused with PM completion). Whereas PM completion is the percentage of PMs that were actually completed compared to the number that were due, PM compliance subtracts the devices that could not be found or were in use from the denominator so that they don’t count against your compliance rate and 100% compliance is achievable.
Unfortunately, here again, most CMMS systems are not set up to accurately track these exceptions and can report only PM completion percentage.
Furthermore, hospitals will want to define in a policy and procedure what it considers a reasonable attempt to find or gain access to a device that has a PM due. For example, if the hospital’s policy requires a technician to make at least two attempts to locate a device that is scheduled for its PM, then those attempts need to be documented in the PM work order, and the CMMS should be able to identify that two attempts were made prior to the PM due date and automatically count the PM as compliant. If on the other hand two attempts were not made prior to the PM due date, then the CMMS should count the PM as not compliant.
High-performing CMMS systems should not only be able to track whether the PM is compliant or not compliant based on the hospital’s policies, it should also have dashboards and reports that can track this information at the technician and hospital levels in real time.
Hospitals should also have policies and procedures that define when a device is considered “missing” and when it is assumed to be “lost” and no longer in the facility. For example, if the device cannot be found for its first PM, you may want your CMMS to flag it as “missing” (which assumes it’s still somewhere in the facility but can’t be found at the moment) and then generate the next PM work order.
If the device cannot be found at its second consecutive PM, then you may want your CMMS to automatically change the status to “lost” (which assumes it’s no longer in the facility) so no further PM work orders are generated. This prevents your technicians from wasting time repeatedly trying to find equipment that was removed from the facility years ago.
While this sounds simple, most CMMS’ cannot handle the concept of consecutive “PM Not Performed–Not Found” work orders. To complicate matters, you also want your CMMS to automatically change the asset to active again if the device is later found and a work order is opened for it.
Many hospital policies require the PM work order to remain open if the device is in use. This is a best practice because it ensures the PM will get done sooner versus waiting for the next PM cycle. However, this practice can wreak havoc on your PM compliance rate if your CMMS cannot properly calculate that the PM is compliant when the device is in use, even though the PM due date is past.
EC.02.04.01 EP6 goes into more detail about what devices can be on an AEM program. A common myth is that high-risk devices cannot be on an AEM. The Joint Commission does not exclude them. However, it does require that the severity and probability of failure be reviewed, along with the history of like devices and whether there are backup devices available. For that, your CMMS needs to calculate risk and PM-preventable MTBF.
There are many more regulations that apply to medical equipment. Fortunately, newer, more nimble CMMS providers have emerged in recent years who are able to more easily configure their platforms to adhere to the changing regulations. Modern-day CMMS systems automate many data entry processes that we once had to rely on technicians to remember to do.
As those of us who have managed HTM technicians know, accurate data entry is not usually at the top of their priority list, and this can put you at risk for a poor regulatory survey. The more your CMMS can simplify the data entry process for your technicians and even automate it, the more accurate your data will be and the easier it will be for your department to be compliant with regulations.
Heidi Horn, MA, AAMIF, is vice president of global enablement-healthcare at Nuvolo. She has more than 20 years’ experience leading HTM organizations and writing regulatory-compliant policies for hospitals. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at [email protected].