The standards promulgated by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) are one of the primary drivers of clinical engineering programs. There are, however, several other organizations, including federal and state agencies, that set standards and regulations regarding the use of medical equipment in hospitals.
JCAHO is an independent, not-for-profit organization. When congress passed the Social Security Amendments of 1965 (Public Law 89-97), there was a provision in the law that permitted hospitals accredited by the JCAHO to be “deemed” in compliance with the Medicare Conditions of Participation for hospitals. This provides hospitals with an alternate path that many consider preferable to a survey done by the individual state survey agencies on behalf of the Centers of Medicaid and Medicare Services (CMS) to qualify for Medicare and Medicaid reimbursement. The Conditions of Participation for hospitals are contained in 42 CFR 482.
JCAHO Medical Equipment Standards
The two main JCAHO medical equipment standards—EC.6.10 and EC.6.20—are in the “Management of the Environment of Care (EC)” chapter. This article will review the requirements in standard EC.6.10. The next article will review the requirements in standard EC.6.20.
Each JCAHO standard is divided into requirements called elements of performance (EP). EC.6.10 has eight EPs, which are discussed individually below.
1) Medical Equipment Management Plan
This EP requires the hospital to have a written plan that describes the processes for managing the effective, safe, and reliable operation of medical equipment. The plan should provide an overview of how the equipment is managed at the hospital, not simply a recitation of the medical equipment standards. It should also be a link between the JCAHO medical equipment-related standards and the function of managing medical equipment at the hospital. Applicable hospital policies, procedures, and standards should be referenced in the management plan.
The plan should be tailored to the type of organization (hospital, ambulatory, long-term care, etc, or multiple settings like hospital and ambulatory), the patient services provided (dialysis, nuclear medicine, surgery, etc), and the medical technology used (lasers, dialysis units, MRIs, etc). It should briefly describe how each EP that is relevant to the medical equipment and how the requirements in other JCAHO standards that have a link to the medical equipment program—such as IC.4.10, LD.4.10, and HR.2.20—are carried out. The management plan is the “linchpin” in complying with the medical equipment management standards, and is one of the key documents reviewed by the JCAHO surveyors.
2) Selection and Acquisition of Medical Equipment
This EP requires the hospital to describe its process for selecting new equipment. This should include a needs assessment, selection criteria, comparative evaluations, and a life-cycle cost analysis. The acquisition process would include evaluating the medical equipment for clinical effectiveness, patient safety, and human factors before final selection. It should also include initially evaluating the condition and function of the equipment after delivery and evaluating the training of the users, before it is used on the patients.
3) Inclusion of Risk Criteria
This EP gives the hospital a choice to either include all of the equipment in the program, or to select certain types of equipment to be included in the program based on equipment function; physical risks with use; and incident history, which are called inclusion or risk criteria. There are various versions of the equation used to combine these numerical criteria based on the original Fennigkoh and Smith model. There can be considerable variation between the risk rankings resulting from the different versions of risk-based calculators. The factors used in the various risk-based approaches, their weighting, the value above which one decides to include the device in the management program, and what preventive maintenance (PM) interval to use have been described as somewhat arbitrary. The risk-based subinventory allows the hospital to exclude PM completion rate reporting, for the so-called low-risk items. However, the all-inclusive inventory approach is less confusing and allows you to control equipment-management functions for all of the devices in your maintenance program.
4) Maintenance Strategies
This EP requires the appropriate selection of maintenance strategies for all of the equipment in your medical equipment management plan inventory. The strategies listed in the JCAHO standards include predictive maintenance (using the concepts of reliability-centered maintenance), interval-based inspections, corrective maintenance (that is, repair or replace if defective), and metered maintenance (hours of run time or number of images processed, for example).
5) Maintenance Intervals
This EP requires the hospital to define appropriate maintenance intervals for their equipment based on manufacturers’ recommendations, risk levels, and the organizational experience. In 2001, JCAHO removed the annual performance and safety testing requirement for medical equipment. This change signaled recognition that the safety and reliability of medical equipment has improved significantly in recent times.
6) Hazard Notices and Recalls
This EP requires the hospital to establish a process for monitoring and acting on hazard notices and recalls that pertain to their medical equipment. The process would include reviewing and acting on recalls and alerts from the manufacturers and others.
7) Incident Reporting and Monitoring— Safe Medical Devices Act (SMDA) of 1990
This EP requires a description of the hospital program for monitoring and reporting incidents as required by the SMDA. The SMDA requires user hospitals and other health care facilities to report device-related deaths to the US Food and Drug Administration (FDA) and the device manufacturer, report device-related serious injuries to the manufacturer or to the FDA (if the manufacturer is not known), and to provide a summary of all reports submitted during the year to the FDA on an annual basis.
8) Emergency Procedures
This EP requires the hospital to develop emergency procedures that identify the roles and responsibilities of users and maintainers, with respect to equipment disruption or failure; procedures on when and how to perform emergency clinical interventions when the medical equipment fails; and provisions for backup equipment and how to obtain repair services. The users and maintainers should evaluate the medical services provided by the hospital to determine which types of equipment are critical for patient care and to prepare a list of the critical equipment. After this, the hospital should develop procedures for managing the clinical consequences of critical equipment failure and for obtaining repair services during regular and after-hours, or replacement/loaner equipment from storage or outside suppliers.
Arif Subhan, MS, CCE, is senior clinical engineer, Masterplan, Chatsworth, Calif; and chair, CCE education committee, ACCE.For more information, contact us at [email protected].
1) The JCAHO medical equipment standards can be found in the chapter:
a) Management of the Environment of Care
b) Management of Information
c) Improving Organization Performance
d) Management of Human Resources
e) None of the above
2) The two main JCAHO standards pertaining to medical equipment are:
a) EC.6.10 and EC.6.20
b) EC.6.10 and EC.7.10
c) EC.6.20 and HR.2.20
d) HR.2.20 and HR. 3.20
e) None of the above
3) The Elements of Performance for the JCAHO standard EC.6.10 include:
a) Developing a management plan
b) Establishing a PM program
c) Developing emergency procedures for equipment failure
d) Monitoring hazard notices/recalls
e) All of the above
4) How many Elements of Performance require- ments are there in the JCAHO standard EC.6.10?
e) None of the above
5) The JCAHO standards require the maintenance intervals on medical equipment to be:
a) Every 6 months
b) Every 12 months
c) As specified by the manufacturer
d) Based on manufacturers’ recommendations, risk levels, and current hospital experience
e) None of the above
6) The “maintenance strategies” the JCAHO standards require the hospital to identify for different items in the inventory are:
a) Predictive maintenance
b) Interval-based inspections
c) Corrective maintenance
d) Metered maintenance
e) All of the above