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New Service FMEA: Developing high reliability

Patient Safety Quality Monthly, January 11, 2008

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As a former director of quality and risk management, and in my current position as a quality consultant for The Greeley Company, I find that many organizations employ the failure modes and effects analysis (FMEA) methodology to analyze specific problems to prevent or reduce the likelihood of a recurrence and/or to meet the Joint Commission (formerly JCAHO) requirement of an annual FMEA.

However, using FMEA tools and methods proactively to prevent potential problems could reduce the risk to patients and liability to staff, physicians and the hospital. As an example, using the FMEA prior to the implementation of a new service will lead to a more robust and reliable service.

During the strategic planning process, the new service has been evaluated for cost efficiency and marketability. The next step is to identify potential failure modes in the operational phase of the service. The objective of a New Service FMEA is to implement a safe, effective, and cost-efficient new service line.

The following are requirements of success for a New Service FMEA:

• Intrinsic safety of the new service
• Effective planning for interfaces with other services
• Effective process control loop in place

What are some of the potential failure modes during the implementation phase of the new service?

• The service is proven but the facility does not have comprehensive procedures to control the process
• There are procedures but the staff members have not been fully trained and lack the competencies to carry out the procedures
• The new service may put an excessive burden on interfacing services (e.g., a new interventional cardiology service could affect ER volume and acuity, inpatient volume and acuity, or anesthesia time demands), and the issues are not resolved
• The new service is not implemented into emergency management plans (codes, rapid response, fire, evacuation) and the infection control plan
• There is a lack of clear performance expectations for equipment and technology (quality control) and process reliability and patient outcomes (performance improvement)

Planning ahead and taking the time to do a new service FMEA will result in an efficient and reliable service that integrates easily into current operations.

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