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To implement changes to an existing process of donor organ packaging and labeling in order to eliminate packaging errors.

•  Collaboratively, the Quality and Recovery departments developed and implemented a new step-by-step verification process for the labeling and packaging of organs for transplant.

•  Through effective education, training, testing, and reassessment, the new labeling and packaging verification system has been hardwired and audited for compliance.

•  The new procedures were effective in reducing labeling and packaging errors, reducing the incidence from 16 labeling-related occurrence reports from April 2009-2011 to zero significant errors since implementation.

•  New staff coming in to the OPO is trained the same way each time to maintain consistency in practice and minimize future errors.

In March 2011, a labeling and packaging error occurred following the recovery of a liver for transplant. Because of this, the quality and safety of a transplantable liver was compromised and the recipient’s safety was put at risk.

In response to this error, Louisiana Organ Procurement Agency (LOPA) began a detailed analysis of their packaging and labeling practices. They initiated a Kaizen event with an expert team of Quality staff and Clinical staff to assess the entire procedure and make recommendations for improvement.

This Storyboard details the process that followed. It outlines the steps that were taken to implement this revised organ verification protocol as recommended. This process can serve as an illustration to any modification of Standard Operating Procedures in healthcare.

Implementing a Revised Organ Verification Protocol

Timothy Lindsay1, Alexandra Dixon1,2, Tiffany Haydel, RN, CPCT3, Michelle Cavett, MBA3, Anil Paramesh, MD, FACS1,3,4

1Tulane University School of Medicine, 2 Tulane University School of Public Health and Tropical Medicine, 3Louisiana Organ Procurement Agency, 4Louisiana State University Health and Sciences Center

Context

Aim

Methods

Process

Members of the expert team at LOPA decided to implement the revised packaging and labeling protocol through a system of education, training, testing, and reassessment (Fig. 1). This four step process was used to address the three main issues raised by the Kaizen event: Labeling and Packaging Errors, Verification Errors, and Lack of Job Role Clarity.

Figure 1. Representation of the Four Step process for training clinical staff at LOPA

Conclusions Lessons Learned

Educate   Use  of  Didac-cs:  Presenta-ons  and  Assigned  Readings  (SOPs)  

Train   Hands-­‐on  and  Field  Training    

Test   Competency  assessment  for  all  recovery  staff  

Reassess   Use  of  audits  by  Quality  staff  to  ensure  compliance  and  performance  

New  Orleans  Healthcare    Improvement  Group  

A  joint  LSU  &  Tulane    IHI  Open  School  Chapter    

To address the issue of Verification Errors, LOPA created a “Valid Source Document,” serving as the primary source of donor information (Fig. 2). Standard Operating Procedures (SOP) were revised to mandate that all labeling be verified by two individuals equally focused on the task.

(a)  

(c)  

Figure 2. Valid Source Document

Figure 4. Demonstration of Employee Training and Field Experience. All photos were taken during a simulation exercise that was used for training. (a) Valid source being utilized for comparison of information in the verification process. (b) Valid source being utilized for completion of the organ label. (c) Comparison of internal and external organ labels by two OPO staff members.

Figure 5. Representation of the new packaging materials for donor organ. Different organs are represented by different colors of labels and ice bags. Not shown above is the packaging for kidneys (blue or yellow), pancreas (black), liver (green), or intestines (pink).

Figure 3. Representation of process used to implement the revised Labeling and Packaging Procedure of Organs at LOPA.

*Well-respected, experienced employees were recruited first and trained on the new procedures. Their input and support greatly aided the transition to a new system.

 =  Procedures  to  Address  Exis-ng  Habits  

 =  Procedures  to  Address  Factors  Outside  of  LOPA  

 =  Procedures  to  Address  the  Future  

The issue of unclear Role Responsibilities was primarily addressed through education.

The new Labeling and Packaging procedure was revised and implemented by the process that addressed existing habits, outside factors, and future training circumstances.

Implementa8on:  Old  Habits,  External  Challenges,  and  Consistent  Progress  for  the  Future  

(b)  

•  Education (classroom-style and required-reading) is enhanced by hands-on training and simulation prior to implementation of new procedures.

•  Changes to procedures are best initiated through a respected group of individuals who understand and agree with importance of the change. They can act to facilitate the change and train new employees (through preceptorship) on proper practices.

•  In the future, employee satisfaction and feedback surveys may be valuable to help judge the attitudes and receptivity of employees to policy change.

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