This article will review how to attain continuous compliance with a new Element of Performance (EP)—EC.02.04.03, EP 14, maintenance of nuclear medical equipment, which was added as a requirement in January 1, 2010—and two other Joint Commission medical equipment standards: EC.01.01.01 EP 7, Medical Equipment Management Plan; and EC.02.01.01 EP 11, Management of Recalls.
In order to receive Medicare and Medicaid payment, hospitals are required to be in compliance with the Medicare Conditions of Participation (CoP). The CoP is outlined in the Code of Federal Regulations (CFR) Title 42 Part 482. Last year, the Centers for Medicare & Medicaid Services (CMS) required The Joint Commission to compose its standards to be more specific so it can demonstrate equivalency with the Medicare hospital requirements. To accomplish this, The Joint Commission created new EPs and revised others.
CFR Title 42 Part 482.53 deals with “Nuclear Medicine Services.” CFR Title 42 Part 482.53(c) states “…The equipment must be maintained in safe operating condition and inspected, tested, and calibrated at least annually by qualified personnel.”
EC.02.04.03 EP 14
In order to be more specific to CFR Title 42 Part 482.53(c), this EP requires that those hospitals that use Joint Commission accreditation for deemed status purposes inspect, test, and calibrate nuclear medicine equipment annually and document these activities. As stated in the previous “CCE Prep” article in 24×7, May 2010, all the EPs in this standard (EC.02.04.03) require keeping and maintaining documentation of maintenance records. For continuous compliance with this EP, follow the guidelines outlined in the May 2010 article for keeping accurate maintenance records.
EC.01.01.01 EP 7
This EP requires the hospital to have a written plan for managing the medical equipment. The plan should briefly describe how all the different medical equipment standards and EPs are addressed. In summary, the medical equipment standards require that the medical equipment be safe to use, perform reliably, users know how to use it, and those who maintain the equipment know how to do so. The plan should describe the processes to achieve this. The management plan is a key document reviewed by The Joint Commission surveyors.
Medical Equipment Management Plan Checklist
1) The plan should not just restate The Joint Commission medical equipment standards and EPs. Each relevant standard and EP should be briefly described as to how it is implemented in the facility. The relevant standards and EPs should be referenced in the plan to show that they have been addressed.
2) Relevant hospital policies, procedures, and relevant standards/regulations—NFPA 99, College of American Pathologists (CAP), and Clinical Laboratory Improvement Amendments (CLIA), for example—should be referenced in the plan.
3) The unique requirements for each type of health care setting (hospital, long-term care, ambulatory, home care, etc) or multiple settings, such as the hospital and laboratory, should be described in the plan. For example, The Joint Commission home care standards require documented inspection of medical equipment between use by different patients, and laboratory standards require the maintenance frequency of laboratory equipment to be at least those established by the manufacturer.
4) The management plan should be current and reflect the existing practice of managing the medical equipment in the hospital. It should be reviewed periodically and updated during the year if there are changes in the management of medical equipment.
5) The plan should list the performance standards established for the current year based on the review of last year’s performance.
6) The relevant staff should be familiar with the contents of the management plan in the facility.
EC.02.01.01 EP 11
This EP requires the hospital to have a procedure for monitoring and acting on all product hazard notices and recalls, including medical equipment.
Recall Readiness Checklist
1) There should be a designated person who receives monitors and acts on recalls for medical equipment.
2) The FDA Web site for the “List of Device Recalls” should be monitored. It provides information about Class I medical device recalls (the most serious medical device recall) and some Class II and III recalls.
3) Biomedical/clinical engineering should internally coordinate with other departments (materials management, radiology, laboratory, etc) to ensure that all the recalls received by other departments directly are coordinated and acted upon.
4) Consider subscribing to some of the commercially available services that provide a periodic summary of recalls on medical equipment.
5) Conduct periodic audits for a particular medical equipment recall to ensure that all affected equipment has been addressed.
Arif Subhan, MS, CCE, is the chief biomedical engineer, VA Nebraska-Western Iowa Health Care System, Omaha, Neb; adjunct assistant professor, biomedical engineering, University of Connecticut; 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 or the University of Connecticut. For more information, contact .