From the January/February 2020 issue of HealthCare Business News magazine

“The St. Luke’s Health System Internal Audit team investigated the need for a systemwide recall program,” said Geibel. “Variable response practices were found throughout the health system that weren’t serving our patients’ need, nor systematically providing the documentation we needed for Joint Commission’s Element of Performance EC.02.01.01 EP 11 requirement that we respond to all types of items, identify responsible parties, and document actions taken. This documentation is also important for FDA audits and responding to supplier audits.”

Lambert says when they realized they needed an automated, centralized program for managing recalls, they took several steps to make it happen. “We hired a competent analyst, investigated industry best practices, created the recall program model, communicated with system leadership, chose a recall software program, onboarded end-users to the recall program, defined roles in a RACI matrix, created a reporting dashboard, and produced a system recall policy,” he said.


“Once we had the software, people, governance, and standards in place we focused on the five levers for employee engagement: competent manager, contextual goals, objective metrics, resources, and autonomy,” Geibel added. “Centralization is important for standardization, including communication, response standards, and escalation, so the information can be accessed for an audit. It’s also important that the information from recalls is automatically shared with local employees who can take action. We use an already developed software program to coordinate the publication, assignment, and storage of alerts and their responses. We also partner with our software provider to help them continue developing the software program we will need.”

Gaining full support and involvement from leadership was also imperative to the program’s success. St. Luke’s chief quality officer and program sponsor Dr. Bart Hill is fully engaged and invested in the initiative, as is the organization’s chief executive officer Dr. David Pate. “For a health system of over 14,000 employees it is impressive he not only knows our program and our standards but has also had goals for us,” said Geibel.

Lambert and Geibel point to purchase order spending and standardization of product acquisition as key focus areas for enhancing recall readiness. “Without full integration of purchase history, health systems must address product recalls that may not impact their facilities,” Geibel explained. “Once we have full purchase history integration, we can focus on how we can assign recalls by the location that purchased the item, potentially reducing the workload by more than 85 percent.

January/February 2020 Magazine

Read more stories from the January/February 2020 issue

More Supply Chain

More Industry Headlines