Ensuring FDA Compliance with Real-Time Inventory Tracking at MTS

Case Study: Mid-America Transplant Services

Mid-America Transplant Services (MTS) is a community-based, not-for-profit organization dedicated to enhancing human life. MTS coordinates the procurement of vital organs, tissues, and eyes across eastern and southern Missouri, southern Illinois, and northeastern Arkansas. They operate a fully functioning eye and tissue bank and maintain their own rooms for organ and tissue procurement.

MTS was facing growing difficulty manually maintaining compliance records required by the May 2005 FDA regulatory requirements for Organ Procurement Organizations (OPOs). These regulations require:

tracking data for materials and supplies used in tissue and organ donations
traceability from point of receipt through final usage in a specific donor case
ensuring products are not available for use until certificates of analysis are received and inspection criteria are met

The Need for a Compliant, Integrated Solution

MTS contacted CliftonLarsonAllen LLP for help. Marilyn Lunnemann explains:

“MTS’s objective was to ensure operational excellence by implementing an inventory tracking solution to meet FDA standards. After researching potential solutions, MTS determined that customization and expansion of their existing Sage 300 ERP solution would help them achieve their goals.”

Their objectives included:

compliance with FDA Section 1271 regulatory requirements
full integration between purchasing, inventory, and accounting
bar-coded scanning to ensure accuracy
enhanced functionality for tracking goods from secured to unsecured locations

Sage 300 ERP Lot Tracking provided many required features, but lacked scanning and specific business logic needed for FDA compliance.

CliftonLarsonAllen recommended ACCU-DART to fill these gaps.

Why ACCU-DART Was the Ideal Choice

ACCU-DART is a real-time radio-frequency inventory control solution designed to integrate directly with:

Sage 300 ERP
Sage Pro ERP
AccountMate

Using radio-frequency scanners, ACCU-DART allows warehouse and clinical staff to instantly update the accounting system with accurate information.

Marilyn Lunnemann explains:

“The ACCU-DART bar coding solution provided the missing components to the core Sage 300 software to enable the scanning, tracking of additional data, and adherence to the business rules required to comply with FDA regulations.”

Customization to Meet Strict FDA Requirements

ACCU-DART is easily customized to fit specialized workflows. For MTS, customizations included:

recording whether certificates of analysis were received from suppliers
capturing detailed inspection criteria
printing FDA-compliant labels based on item type
additional enhancements to support regulatory compliance

The Result

With ACCU-DART in place, MTS:

improved processing efficiency
gained better access to case-related data
significantly increased accuracy for donor case tracking
reduced workload related to product utilization and manufacturer reporting

A representative from MTS noted:

“Under the old system, if there was a recall, medical records would have to scan through hundreds of charts trying to match a lot of supplies to a particular case. Now we can just run a report.”

MTS also shared:

“The system will allow us to better utilize our resources with more accurate inventory levels and less waste due to expiring products.”

Now, MTS can focus more of their resources on their mission: saving and improving lives through organ and tissue donation.