By K. Richard Douglas
Among AAMIs many offerings is its role as a standards development organization, so a standard for AEM is clearly within its wheelhouse. While very well known for certifications and education, AAMI, in collaboration with other organizations, develops standards recognized across HTM.
Since 2014, AEM programs have been developed based on internal data sets developed by HTM departments using evidence-based maintenance. The goal has been to determine the most reasonable frequency for maintenance and testing based on data sets that also track failure rates.
The Centers for Medicare and Medicaid Services (CMS) allowed HTM departments to deviate from OEM maintenance recommendations, with some categories of equipment, when the HTM department has evidence that their alternate schedule does not impact patient safety or equipment function.
The interpretation of what is suitable in these programs, along with the best approach to the development of a compliant AEM program, has been the subject of debate and discussion.
Healthcare systems must meet the CMS Conditions of Participation. A healthcare delivery provider must meet these standards to receive compensation from Medicare and Medicaid. The standards must be met for every patient, even if that patient was not a Medicare or Medicaid patient.
Although efficiency and cost savings might be a part of an AEM program, the regulators are not interested in efficiency or cost savings; they are only focused on patient safety. Although, in CMS’s 2013 memo titled “Hospital Equipment Maintenance Requirements,” the agency did state that hospitals: “may through experience have identified more efficient or effective maintenance activities which do not reduce the safety of the equipment.”
CMS also expects that the standards of accrediting organizations meet or exceed those same standards.
Healthcare providers must comply with federal, state and local laws.
Against this backdrop is the issue of AEM programs that satisfy the exacting standards of the regulators. AAMI’s expert working group focused on this specific area of concern to develop a standard to help align AEM programs and allow them to stand up against scrutiny.
The EQ103 standard provides clarification in order to respond to accrediting bodies with justification and explanation for an AEM program’s parameters and guidelines.
CREATING THE ANSI/AAMI EQ103 STANDARD
The process of creating a standard requires discussion, debate, research, consensus, feedback and documentation.
The ANSI/AAMI EQ103: 2024 standard on alternative equipment management (AEM) programs in healthcare delivery organizations resulted from that process. The standard attempts to bring more broad standardization to AEM programs. The new standard was developed by a diverse group of participants in the working group, bringing a number of perspectives and experience to the process.
EQ103 provides a structured framework for what equipment should be eligible for the program, a risk-based assessment and the correct way to document the program. It includes sections on types of AEM activities, evaluating the performance of an AEM program, evaluating the safety and effectiveness of an AEM program and the decision to place equipment in an AEM program.
It lays out a best-practices approach for the management of an AEM program.
AAMI’s Medical Equipment Management Committee (EQ) develops standards on aspects of medical equipment management for healthcare technology managers. The EQ committee includes five working groups. The working groups include subject matter experts. There is cross-collaboration between the groups.
Many of the locally developed internal AEM programs have had a lot of thought and data put into their creation to produce greater levels of efficiency, but the paradigm developed through a national standard would offer a framework as guidance.
To provide more solid guidelines that can be implemented across the healthcare continuum and to satisfy CMS as well as those HTM professionals implementing an AEM program, the AAMI Alternate Equipment Management Working Group developed the EQ103 standard.
The two co-chairs of the committee, who spearheaded the effort, are Maggie Berkey, biomedical equipment specialist at Bio-Electronics, and Colleen Haugen-Ortiz, healthcare technology management quality specialist at GE HealthCare.
In developing the standard, the working group compared their framework to “what’s currently out there, including requirements from CMS and The Joint Commission, and other AAMI standards such as EQ56 and EQ89.”
The standard was approved by the American National Standards Institute (ANSI) in November of 2024; an important goal of the AAMI EQ103 working group.
Berkey says that there are many ways to implement an AEM program and the standard “makes it as easy as possible to get it right.”
Haugen-Ortiz says that uniformity is important in the new standard so that there is no conflicting information so that comparing the standard to existing standards like EQ56 or EQ89 does not result in any conflicts. Also, reviewing what CMS or The Joint Commission has published on the topic of AEM programs, was reviewed to avoid any conflict.
ANSI/AAMI EQ56 is an HTM-specific standard to create a robust maintenance program.
NO CONFLICTS
Elements of the standard, which will be important to those obtaining a copy, include its guidance for dealing with regulators, consistency with other standards and ANSI approval.
What will be some of the most important standardized practices to come out of EQ103?
“The annual evaluation to ensure that safety has not been compromised,” Berkey says.
“A better definition of what new equipment is, such as new tech versus new to that hospital,” says Haugen-Ortiz.
She says that the standard will provide direction for what equipment is usable for AEM and how it’s used for AEM. Berkey says that the standard is useful when HTM is talking to an accreditation body in order to point to the standard as a reference for why an action was determined.
The co-chairs say that it is important to be able to defend your AEM program. Was a risk-assessment carried out and how is the program maintained? These elements allow an AEM program to be more robust and, as a consequence, more defendable.
The co-chairs say they are developing a technical information report (TIR) to support the new EQ103 standard. Training on the new standard is also being developed. That effort would be aided by feedback from the regulators.
AEM programs must be continuously re-evaluated and tweaked as time goes on.
How does the standard comply with CMS requirements?
“The CMS S&C: 14-07-Hospital was our main source of information and we built this standard to provide clarity on everyday processes in HTM,” Haugen-Ortiz says.
How does the standard allow for variations/divergences from the OEM recommendations? What are some examples?
“We used CMS’ ‘S&C: 14-07-Hospital’ memo as our guide. We didn’t want to contradict the current guidelines but expand on them to help answer some of the burning questions that tend to bubble up. In the section titled ‘Elements of an AEM Program,’ we included several notes that delve into various scenarios,” Haugen-Ortiz says.
ANSI approves AAMI standards and the previous experience of many in the AAMI AEM working group, who worked on other standards, had input.
“While creating this standard, we followed ANSI guidelines to build a consensus document. The definitions are consistent with current standards as we didn’t want to include any conflicting information. Many of the participants were also involved in creating or very familiar with EQ56 and EQ89 which helped ensure all the information was current,” Berkey says.
ACCELERATED TIMELINE
The process for developing a standard like EQ103 can take years. How were the committee and stakeholders able to accelerate this timeline? Many in the AAMI alternate equipment management (AEM) working group put in lots of time and energy and worked tirelessly to bring the standard to fruition. Haugen-Ortiz described members of the group as a “passionate group of people.”
“We had an awesome group of professionals who donated so much of their time, knowing that this standard was needed some time ago. We had multiple meetings per week and people willing to meet rigorous deadlines. They were the true drivers of this standard. Yes, there were hours when we would argue over one word or a sentence. It’s unavoidable but that is the point of having a consensus body, to make sure there is representation and that everything is worded correctly,” she says.
There were stakeholders who had a history in standards development who lent their AEM experience and their standards experience to the group’s work.
Berkey said the goal was to create a standard that “would make sense to everybody, anybody, everywhere, anywhere.” The insights of the experienced group members ensured this outcome.
CREATED FOR EXISTING OR NEW AEM PROGRAMS
How difficult will the standard be to implement for those who have set up parameters and criteria based around their own AEM programs, and will it potentially require major changes to documentation, inputs, procedures and timetables?
“If you already have a great AEM program, you’ll see where you stand and be confident when your surveyor comes. For those who are not sure, or are just getting started with AEM and want help or clarification, this standard is a great tool for them to make their program more robust, knowing all the t’s are crossed and i’s dotted,” Berkey says.
Does the new standard offer any flexibility?
The co-chairs say that the flexibility is with the authorities having jurisdiction such as state and local laws.
“We wrote this with a group of people from various backgrounds and job titles to ensure that there was representation to meet the needs of the entire HTM community,” Haugen-Ortiz says.
Adoption of the standard by CMS or The Joint Commission, and feedback from those bodies, would reinforce the confidence that AEM programs have in bringing their programs in line with the new standard.
Aligning the elements of an AEM program into commonly accepted standards that satisfy surveyors and others, while assuring the highest degree of patient safety and equipment performance is a big lift. ANSI/AAMI EQ103 endeavors to make that feat possible.
