Vendor Quality Assurance

At Trinity Health, we are committed to delivering safe, high-quality care to our patients. This includes ensuring the safety and reliability of the medical products and services we use every day. Product disruptions and recalls present growing challenges for healthcare providers, both operationally and financially. In recent years, there has been a significant increase in the frequency, complexity, and cost of managing supplier disruptions and recalls. It involves substantial resources, including time spent by staff to identify and quarantine affected products, system or process updates, and coordinating with various departments to ensure patient safety. These activities are essential to maintaining the quality of care and compliance with regulatory requirements.

The FDA, through 21 CFR Part 7, places responsibility on manufacturers and suppliers to ensure product safety and to take appropriate action when a product is defective or presents a risk to patients. When a manufacturer initiates a recall, it implicitly acknowledges responsibility for the underlying issue and its consequences. Healthcare providers can reasonably assert that costs incurred to protect patients, manage recalled inventory, and comply with recall requirements and processes are a direct consequence of the failed service or defective product and should be reimbursed by the responsible supplier or manufacturer.

To address the financial impact of these activities, Trinity Health has engaged Optima Supply Partners to administer the recovery of costs associated with supplier disruptions and recalls.

We expect that suppliers will take responsibility not only for the cost of affected goods but also for these additional costs incurred in managing supplier disruptions and recalls. Optima Supply Partners will work directly with our suppliers to quantify and communicate these costs, and to ensure that recovery is handled in a fair and transparent manner.

Thank you for your continued collaboration and commitment to quality and patient care.

For any questions, please contact: HQTHSupplierQualityandPerformance@trinity-health.org