The EC.9.10 Standard

The January and March 2007 “CCE Prep” articles in 24×7 reviewed the requirements of the two main Joint Commission medical equipment standards, EC.6.10 and EC.6.20. This article will review the EC.9.10 Joint Commission standard that links with the medical equipment management program.

Managing a comprehensive medical equipment program requires knowing more than the two main Joint Commission standards, EC.6.10 and EC.6.20. There are other standards in the chapters covering the Environment of Care (EC), Human Resources, Infection Control, Performance Improvement, and Management of Information that have an impact on the medical equipment program.

Environment of Care Standards

The EC.9.10 standard applies to all of the seven EC programs and requires the hospital to monitor conditions in the environment. There are three elements of performance (EP) in the standard EC.9.10 that pertain to medical equipment.

The first EP requires the organization to establish and implement a process of reporting medical equipment management problems, failures, and user errors to the facility’s safety/EC committee. This requires an ongoing collection and dissemination of information about the deficiencies and opportunities for improvement in the medical equipment management program. The report is prepared periodically, quarterly for example, by the manager/director of biomedical/clinical engineering, and includes information on medical equipment maintenance completion, user errors, recalls, incidents, and other equipment management issues.

The second EP requires an annual evaluation of the medical equipment management plan. The third EP (a detailed version of the second) requires an annual evaluation of the scope, objectives, performance, and effectiveness of the medical equipment management plan.

The annual evaluation is an important document that is reviewed by The Joint Commission surveyors. The annual evaluation should be divided into four sections—objectives, scope, performance, and effectiveness. Be sure that you include these four key words explicitly in the annual evaluations. It is reported that The Joint Commission surveyors look for these key words during the survey.

Objectives

When evaluating the objectives of the plan, ensure that they still apply to the hospital and represent the medical equipment program’s concerns. The objectives of a medical equipment program could include “ensuring that medical equipment performs properly and does not create hazards that may endanger the health and safety of either patients or staff”; and “the equipment is used and maintained to ensure full compliance with the regulatory requirements of the relevant local, state, and national authorities having jurisdiction”; and “the equipment is available for the appropriate clinical service that the hospital provides.” Usually these objectives, which are general, can be carried forward from year to year. If the objectives do not change then it should be noted in the annual evaluation that there are “no changes” in the objectives.

The Scope

The scope is the breadth of the medical equipment management plan and should include how medical equipment is managed in the entire organization. The scope includes the hours of operation, equipment included, services provided, and the facilities covered by the plan. The evaluation should assess whether the scope outlined in the plan is appropriate or whether something has changed in the structure of the organization. For example, perhaps an ambulatory care center has been added to the hospital and now requires the managing of its medical equipment. If the scope did not change, then it should be noted in the annual evaluation that there are “no changes” in the scope. These two areas—objectives and scope—usually do not change in most organizations.

Performance Indicators

Monitoring and reviewing the established performance indicators assist in evaluating the performance of the program. The performance evaluation should be data driven and focused on the major elements of the medical equipment program. Performance indicators should be established to monitor the important medical equipment program processes. Based on the evaluation of the program, new indicators may have to be developed “to monitor response time on service requests,” for example. Also, an existing indicator may have to be revised, for example, “95% of the users are aware of the emergency procedures to be followed in the event of equipment failure,” may have to be raised to 98%.

Assessing Effectiveness

The effectiveness of the program is assessed to determine what went well during the year, what was accomplished, and the areas that need improvement. The effectiveness of the program should be assessed based on how the medical equipment program performed during the year and how it compares with the performance of the prior year.

Next month, we will review the other Joint Commission standards that have links with the medical equipment management program.

Arif Subhan, MS, CCE, is a senior clinical engineer, Masterplan, Chatsworth, Calif; and chair, CCE education committee, ACCE. For more information, contact .