PEC is a successful and modern blood donor center located in the northeastern region of the United States. Its management style has always stood out among other blood centers in the United States because of its modern and progressive views. The blood center is known for embracing changes in manufacturing with a positive approach by appropriately planning and allocating resources to ensure things are done the right way. However, in the last few years, both employees and customers have noticed a steady decline in control and quality. The number of manufacturing errors and product and service complaints reported by customers has drastically increased. PEC has tripled in size in the last 3 years, after the acquisition of several small blood banks in the state. Changes have occurred quickly to accommodate this growth, and thorough planning before the implementation of these changes has not always been possible. Among many of its growing pains, PEC employees finally realized that their blood bank computer system was outdated and unable to handle the workload volume increase in the last few years. Management at PEC selected EJO, Inc., as the new software vendor. Although EJO’s experience, reputation, expertise, and client support were well known, its new blood banking software was not. However, the cost of implementing this new software fit well within the approved fiscal budget. With full management support, validation and training efforts began early in the year with a proposed “live” date for September of that year. By June, multiple “bugs” had been identified during system testing. EJO’s technical support was excellent, but with so many problems to be addressed and corrected, management was getting anxious. They wanted the new system to go “live” before their next FDA inspection. September came and went, and the system was not ready for implementation. Finally, in March of the following year, parallel testing was completed. Because of time constraints, not all functions were tested, in particular, functions pertaining to the issue of products. Management was aware but decided to go ahead with implementation of the system. In April, the new system at PEC was implemented with no major problems. Everything was okay until 3 months later, when the distribution supervisor noticed that the system had allowed the release of human T-cell lymphotropic virus (HTLV) I/II repeatedly reactive donor units. The PEC
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