Joint Commission Ups Expectation for Medical Device Maintenance Activities
Posted December 19, 2016
Starting in January, The Joint Commission (TJC) will expect hospital healthcare technology management (HTM) departments to complete all planned maintenance activities in line with manufacturer recommendations or the policy set by their organization 100% of the time.
This change to the Environment of Care (EoC) standards found in the Comprehensive Accreditation Manual for Hospitals is part of TJC’s project REFRESH, which George Mills, the commission’s director of engineering, described during a presentation at the AAMI 2016 Conference & Expo in June. A main goal of this project is to develop a single, comprehensive method of categorizing the risk associated with TJC standards. As a result, the “A” and “C” scoring categories previously applied to the elements of performance (EP) for each standard were eliminated.
Since these categories were introduced in 2003, HTM professionals have been required under TJC standards EC.02.04.01 and EC.02.04.03 to complete 100% of scheduled maintenance on high-risk equipment, such as bypass machines, ventilators, and anesthesia machines, which pose a risk of serious injury or death to a patient or staff member if they were to fail. Compliance for this type of high-risk equipment was judged under the previous “A” scoring category, so you either met the standard or you didn’t.
Compliance for scheduled maintenance on non-high-risk equipment was judged under the “C” scoring category, which meant you could miss one scheduled maintenance in a sample of 10 and still be considered in satisfactory compliance. Hence, at least 90% of scheduled maintenance had to be completed for a random sampling of non-high-risk equipment.
“With the removal of these two categories, The Joint Commission will now survey to a ‘see it—cite it’ methodology,” Mills wrote in a post published in AAMI’s online discussion group, AAMI Connect. “This is consistent with the previous A category’s pass/fail.”
This means that under the new EPs, all planned maintenance activities on medical equipment—regardless of risk—must be completed and completed on time, Mills explained in an interview. The frequency of these activities should be based on the manufacturer’s recommendations or an organization’s alternative equipment maintenance (AEM) program.
“The Joint Commission has supported AEM programs, provided the alternative equipment management decisions are made by a qualified individual using written criteria. … However, if equipment has not been evaluated by the written criteria of the AEM, [an organization] would need to follow the manufacturer’s recommendations [for scheduled maintenance activities and frequencies] at 100% compliance. An advantage to the AEM is the flexibility in managing equipment activities and frequencies. But without the structure of the AEM, alternatives to equipment management are not defensible,” Mills wrote.
What this boils down to is:
- Scheduled maintenance of all high-risk, life-sustaining devices that previously would have been scored under category A still must be completed at 100% compliance in accordance with either the manufacturer’s recommendations or an AEM approach approved by the organization.
- All equipment that has not been evaluated and included in an AEM program must follow the manufacturer’s recommendations for activities and related frequencies 100% of the time because, according to TJC, there is no justification for not following what the manufacturer has stipulated.
- All non-high-risk equipment found in an AEM must be maintained according to the organization’s policy 100% of the time.
It is the last two requirements that have many HTM professionals concerned.
“Given the size and portability of today’s equipment, given the possible storage/hiding areas in most hospitals, and given the limits of the majority of hospitals’ HTM resources, we believe achieving 100% completion rate of scheduled maintenance on 100% of the inventory to be a practical impossibility,” said Stephen Grimes, managing partner at Strategic Healthcare Technology Associates, LLC. “We are concerned that the vast majority of hospitals will find it impossible to meet ‘the letter’ of those new EoC standards that require 100% compliance of their established scheduled maintenance requirements.”
For Mills, compliance with the new standards is about setting and following―to the letter―your organization’s policies. “You’ve got to do what you say,” Mills said, reiterating that the frequency is determined by the organization.
So, let’s say a hospital has an AEM program for its inventory of infusions pumps, and its policy states that 90% of these pumps must be serviced annually using a set of 13 steps (with annually defined as every 9–15 months, which is similar to how NFPA defines it). When it comes time for a TJC survey, as long as the HTM department is able to prove through its documentation that it never deviated from this policy, it would be compliant with the new standard. The department completed 100% of what it said it would do.
“Hospitals need to clearly identify the written criteria as the guiding documentation for an AEM program and apply that strategy to their equipment. Then, they should follow that strategy and be able to defend through their written criteria the decisions that were made,” Mills advised hospital HTM professionals.
To further complicate the matter, the expectation of a 100% completion rate for AEM inventory is not reflected in the prepublication requirements TJC released in October. In the prepublication document, EC.02.04.01 EP 4 states: “Scheduled maintenance activities for non-high-risk medical equipment in an alternative equipment maintenance (AEM) program inventory may be deferred as defined by organization policy, provided the completion rate is not less than 90%.”
According to Mills, the discrepancy between the prepublication version and the version that will be implemented in January occurred after the Center for Medicare & Medicaid Services (CMS) reviewed the proposed language.
“According to the response we received, the 90% language was technically not compliant with CMS. The new EP language aligns with input from CMS,” Mills said.
TJC, as well as other accrediting bodies such as DNV and the American Osteopathic Association’s Healthcare Facilities Accreditation Program, have “deemed status” from CMS. This means that healthcare organizations that achieve accreditation through a “deemed status” survey are determined to meet or exceed Medicare and Medicaid requirements. Because of that, TJC standards must meet or exceed those published by CMS.
Under 42 CFR 482.41 (c)(2) of the CMS State Operations Manual, “Hospitals comply with this regulation when they follow the manufacturer-recommended maintenance activities and schedule. … A hospital may, under certain conditions, use equipment maintenance activities and frequencies that differ from those recommended by the manufacturer. … The hospital is expected to adhere strictly to the AEM activities or strategies it has developed.” “Strict adherence” is generally interpreted by CMS to mean completing 100% of the activities in a frequency identified by the organization.
At the time of publication, CMS was still in the process of reviewing the updated EPs; however, hospitals are still expected to comply in January, even though the updated language won’t appear in the EoC chapter—either online or in print—until July, according to TJC sources.
“The new language that is going to be included in July is what we are going to be surveying to starting in January,” Mills confirmed.
To help HTM professionals better understand the new requirements and share strategies for compliance, both Mills and Grimes will be leading an AAMI webinar on Jan. 6 from 11:00 a.m. – 12:00 p.m. ET. Registrants for Demystifying the Changes to Joint Commission and CMS Standards will be able to submit their questions in advance for the Q&A portion of the event.