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Reducing Errors During Patient-Controlled Analgesia Therapy Through Failure Mode and Effects Analysis

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Background:Despite the technologic advances in design, resulting in the development of "smart" pumps to help deliver analgesia more safely, patient-controlled analgesia (PCA) is still involved in a significant proportion of the medication errors ascribed to intravenous (IV) drug administration, many of which have harmed patients. In 2003, Failure Mode and Effects Analysis (FMEA) was used to assess the PCA process at a 695-bed teaching and research tertiary hospital.

Identifying and Addressing Failure Modes: For the three processes with hazard scores > 8—patient selection, prescribing, and medication administration—the potential cause(s) were identified, allowing the process to be redesigned to eliminate the potential cause(s).

Results: In January 2003 to May 2003, before the FMEA process began, there were 11 PCA errors (extrapolated to 26 for the entire 2003 calendar year). In 2004, when most of the corrective actions were taken, there were 22 reported PCA errors. In October 2007, a new online occurrence-reporting program was implemented, making reporting much easier. From October 2007 through September 2008, there were only 8 reported PCA errors, representing a 69% reduction from baseline. No serious adverse events were associated with any of these PCA errors.

Discussion: Despite the reduction in PCA errors since the FMEA was conducted, misprogramming of drug concentration remains a common PCA error. Solutions include safety software for IV infusion pumps, an integral bar-code reader for detecting concentration errors, and interoperability of the software with other hospital information systems. One lesson learned was that an FMEA can lead to resolution of problems beyond the scope of original intent—in this case, the development of a new system for identifying all broken equipment.

Document Type: Research Article

Publication date: August 1, 2010

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  • Published monthly, The Joint Commission Journal on Quality and Patient Safety is a peer-reviewed publication dedicated to providing health professionals with the information they need to promote the quality and safety of health care. The Joint Commission Journal on Quality and Patient Safety invites original manuscripts on the development, adaptation, and/or implementation of innovative thinking, strategies, and practices in improving quality and safety in health care. Case studies, program or project reports, reports of new methodologies or new applications of methodologies, research studies on the effectiveness of improvement interventions, and commentaries on issues and practices are all considered.

    David W. Baker, MD, MPH, FACP, executive vice president for the Division of Healthcare Quality Evaluation at The Joint Commission, is the inaugural editor-in-chief of The Joint Commission Journal on Quality and Patient Safety.

    Also known as Joint Commission Journal on Quality Improvement and Joint Commission Journal on Quality and Safety
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