On March 31, 2014, the Joint Commission added a new element of performance (EP 24) to the primary medical equipment standard EC.02.04.03 for “deemed status” hospitals. This requirement was intended to go into effect on July 1, 2014.1 This additional requirement was in response to the Centers for Medicare and Medicaid Services (CMS) memo dated December 20, 2013 (S&C 14-07-Hospitals), which had relaxed some of the restrictive policies on preventive maintenance of medical equipment.2-4 The term deemed status is described in a previous CCE prep article.4
According to the Joint Commission, however, the CMS was of the opinion that this additional EP did not bring the Joint Commission standards in line with the CMS requirements for deemed status hospitals. Consequently, the Joint Commission has expanded and added EPs in the two main Joint Commission standards EC.02.04.01 and EC.02.04.03. The previously approved EC.02.04.03, EP 24, has been removed. These updated requirements went into effect on July 2, 2014.5
EC.02.04.01 EP 1
This EP is unchanged. It requires the hospital to seek input from individuals who operate equipment (clinicians and nurses) and those who service equipment (biomedical/clinical engineering) when the hospital chooses and purchases medical equipment.6
EC.02.04.01 EP 2
Key Joint Commission Definitions
Medical equipment: “Fixed and portable equipment used for the diagnosis, treatment, monitoring, and direct care of individuals.”
High-risk equipment: “Any device or components of building utility systems for which there is a risk of serious injury or death to a patient or staff member if the device or component fails. High-risk equipment includes life-support equipment.”
This EP was changed. It formerly required the hospital to maintain either a written inventory of all medical equipment or a written inventory of selected equipment which would be classified by physical risk associated with its use and equipment incident history. This requirement was retained for the hospitals that do not use Joint Commission accreditation for “deemed status” purposes.
However, “deemed status” hospitals must now include all medical equipment in their inventory. This new rule will require these hospitals to reassess their current medical equipment inventory based on the definitions of the term medical equipment, which can be found in the glossary of the Joint Commission standards.5,6 (See box for a summary of the definitions.)
EC.02.04.01 EP 3
This is a new EP. It requires the hospital to identify “high-risk” medical equipment in the inventory. This category of equipment includes items for which there is a risk of serious injury or death to a patient or staff if the equipment fails. The high-risk medical equipment encompasses life-support equipment, including items such as a robotic surgical system. The term high-risk is new to Joint Commission medical equipment standards and is considered comparable to the CMS term critical equipment. The term high-risk is defined in the glossary of the Joint Commission standards.5,6
EC.02.04.01 EP 4
This new, revised EP combines the concepts of maintenance activities and frequencies of the earlier EP 3 and EP 4. It now requires the hospital to identify the activities and associated frequencies, in writing, for maintaining, inspecting, and testing all medical equipment in the inventory.
In order to determine the frequencies of maintenance and testing, hospitals must follow manufacturers’ recommendations or develop strategies of an alternative equipment maintenance (AEM) program. This AEM program must not reduce the safety of equipment, and must be based on accepted standards of practice. For medical equipment, suggested accepted standards are the American National Standards Institute/Association for the Advancement of Medical Instrumentation handbook, ANSI/AAMI EQ56: 2013, Recommended Practice for a Medical Equipment Management Program.5,6
EC.02.04.01, EP 5
This is a new EP for “deemed status” hospitals. It requires the hospital to use manufacturer’s recommendations for maintenance activities and frequencies for the following types of equipment:
- Medical laser devices;
- Imaging and radiologic equipment (whether used for diagnostic or therapeutic purposes);
- Medical equipment that is subject to federal or state law or Medicare Conditions of Participation. It should be tested and maintained according to manufacturer’s recommendations or an approach that establishes more stringent maintenance requirements;
- New medical equipment that usually does not have adequate maintenance history to support the use of AEM strategies. The maintenance history must include records provided by the hospital’s contractors, information made public by nationally recognized sources, and records of the hospital’s experience over time.5,6
The next CCE Prep column will discuss other changes to the Joint Commission medical equipment standards.
(Answers at end of article)
1. The following element of performance (EP), which requires the hospital to solicit input from individuals who use and service equipment when it chooses and purchases medical equipment, was not part of the recent revision of the Joint Commission medical equipment standards.
a) EC.02.04.01 EP 1
b) EC.02.04.01 EP 2
c) EC.02.04.01 EP 3
d) EC.02.04.01 EP 4
2. The Joint Commission defines “medical equipment” as ________.
a) Fixed and portable equipment used for the diagnosis, treatment, and monitoring of individuals
b) Fixed and portable equipment used for the diagnosis, treatment, and direct care of individuals
c) Fixed and portable equipment used for the diagnosis, treatment, monitoring, and direct care of individuals
d) Fixed and portable equipment used for the treatment, monitoring, and direct care of individuals
3. The Joint Commission defines “high-risk” equipment as _________.
a) Any device for which there is a risk of serious injury or death to a patient or staff member if the device fails
b)Any device for which there is a risk of serious injury to a patient or staff member if the device fails
c) Any device for which there is a risk of death to a patient or staff member if the device fails
d) Any device for which there is a risk of serious injury or death to a patient if the device fails
4. According to the Joint Commission, the accepted standard for medical equipment is _______.
a) NFPA 99, 2015 Edition
b) ANSI/AAMI EQ56: 2013
c) NFPA 70, 2014 Edition
d) January 1, 2015
5. According to the Joint Commission “high-risk” equipment includes _____.
a) life-support equipment
b) non-life support equipment
c) all devices that are included in the Preventive Maintenance program
d) none of the above
Arif Subhan, MS, CCE, FACCE, is the chief biomedical engineer at VA Greater Los Angeles Healthcare System and a member of 24×7’s editorial advisory board. The suggestions and views expressed in this article are of the author. They do not represent the views of the Department of Veterans Affairs. For more information, contact [email protected]
1. Revised Requirements for the Environment of Care (EC) Chapter. Available at: http://www.jointcommission.org/assets/1/18/EC_PrepubReport_HAPandCAH_July2014release_20140304.pdf. Accessed October 11, 2014.
2. Biomeds Cheer CMS Change of Mind on Maintenance, December 27, 2013. Available at: https://24x7mag.com/2013/12/biomeds-cheer-cms-change-of-mind-on-maintenance/. Accessed October 11, 2014.
3. Hospital Equipment Maintenance Requirements, CMS Memo dated December 20, 2013. Available at: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf. Accessed October 11, 2014.
4. Subhan A. New Joint Commission requirement for medical equipment. 24×7. 2014;19(5):26.
5. Joint Commission. EC News. 2014;17(9).
6. 2014 Joint Commission Comprehensive Accreditation Manual. Available at: http://www.jcrinc.com/2014-comprehensive-accreditation-manuals. Accessed October 17, 2014.
1—A; 2—C; 3—A; 4—B; 5—A