Manage the Chain of Custody

Learning Objectives

After completing this unit, you’ll be able to:

Explain the importance of the chain of custody for Advanced Therapy Management.
Describe the differences between chain of custody and chain of identity in Life Sciences Cloud.
Explain how to customize chain of custody events.

Ensure Integrity and Safety

In the previous units, you explored how to use powerful tools such as Therapy Orchestration and Multi-Step Scheduling to manage a patient's advanced therapy journey. But ensuring the integrity and safety of these treatments goes beyond efficient coordination; it demands meticulous tracking and accountability.

Think of a patient’s cells as precious cargo on a complex journey from collection to infusion. Every step must be meticulously documented in a chain of custody, a continuous record showing the whereabouts and handling of each patient’s unique biological material. Regulatory bodies worldwide mandate this process to ensure transparency, accountability, and, ultimately, patient safety.

Advanced Therapy Management provides life sciences organizations with robust chain of custody and chain of identity features to meet this crucial requirement. The chain of custody records every handoff, modification, and signature, creating an irrefutable record of the therapy’s journey. Meanwhile, the chain of identity assigns a unique identifier to the collected biosample, ensuring the appropriate treatment reaches the patient. Admins can configure which events trigger chain of custody updates and the level of electronic signature required, offering both control and flexibility.

Secure the Chain of Custody

To illustrate how Advanced Therapy Management maintains the critical chain of custody, revisit Charles Green. His CAR T-cell therapy is now in the apheresis stage.

The data model for the chain of custody is quite straightforward. Study the key objects involved.

The relationship between chain of custody objects and care program objects.

Here’s a summary of the objects.

Object

Description

Scenario

Custody Item (1)

This object represents information about an item in the custody chain. Add a unique identifier to maintain a unique chain of identity throughout the process.

Charles enrolls in the Oncarta Therapy program and is assigned a unique identifier that links to his care program enrollee record.

This identifier serves as a digital fingerprint, ensuring that his cells are never confused with those of another patient.

Custody Chain Entry (2, 3, 4)

These objects represent information about an entry or event in the chain of custody.

During the apheresis stage, the StayHealthy team completes Charles’s serology report, records his apheresis collection, and produces a collection summary.

You can create custody records automatically as part of your therapy orchestration, greatly enhancing the intricacy and flexibility of the chain. Use prebuilt flows to seamlessly link your therapy orchestration with chain of custody requirements.

Here are a few key flows and how they relate to your chain of custody. Click each flow to learn more.

Customize Chain of Custody Events

Not every event needs a chain of custody record. Advanced Therapy Management teams can designate precisely which stages, steps, and tasks in the therapy orchestration trigger a chain of custody event. This level of granularity ensures that the chain of custody captures only the most critical information, avoiding unnecessary clutter while maintaining regulatory compliance.

For example, during the apheresis stage, StayHealthy creates two steps, Before Collection and After Collection, each with its own set of tasks.

Step	Task	Chain of Custody Event?
Before Collection	Serology Report	Yes
Before Collection	Print Documents	No
During Collection	Collection Start	Yes
	Collection End	Yes
	Collection Checklist	Yes
	Collection Summary	Yes

The Before Collection step contains two tasks, but only the Serology Report task requires a custody chain entry. The During Collection step contains four tasks. However, the Start, End, and Checklist tasks combine into a single custody chain entry, while the Collection Summary task requires its own custody record.

You can further customize flows and decision tables for scenarios requiring signatures to verify the chain of custody. For each work order, work order step, or task where the custody item requires verification, create a digital verification setup. The record serves as a signature trail, setting up the number of required signatures and determining if designated verifiers must sign the records in a specific order. For example, this screenshot shows the setup for confirming Charles’s identity during apheresis collection.

Digital Verification Setup for confirming patient identity.

To record apheresis collection, StayHealthy sets up a parallel verification requiring dual signatures. This means that two signatures are required and they must be signed in a specific order.

Next, create a custody verification type override record that links the signature trail to the appropriate work type details and, by extension, custody chain entry. For example, StayHealthy creates an override record for recording the apheresis collection.

The Custody Verification Type Override record specified for confirming patient identity.

This record links to the verification setup record for recording apheresis. And it links to the appropriate work procedure, work type, and work type step related to the task. When the nurse and treatment center physician verify the apheresis collection, a dedicated custody chain entry stores all the details about the verification.

Here’s a sample chain of custody configuration for two steps in the apheresis stage with the signature type added.

Step	Task	Signature Type	Signer 1	Signer 2
Before Collection	Serology Report	Single	Apheresis Nurse	—
Before Collection	Print Documents	—	—	—
During Collection	Collection Start	Dual	Apheresis Nurse	Treatment Center Physician
	Collection End	Dual	Apheresis Nurse	Treatment Center Physician
	Collection Checklist	Dual	Apheresis Nurse	Treatment Center Physician
	Collection Summary	Dual	Apheresis Nurse	Treatment Center Physician

Notice the signature configurations for each task.

The serology report requires only a single signature, which is assigned to the apheresis nurse.
The Print Documents task doesn’t require any signatures.
Three collection tasks combine into a single chain of custody event and require dual signatures from both the apheresis nurse and treatment center physician.
The collection summary task also requires dual signatures from the nurse and physician.

To satisfy local regulations without needing separate workflows, organizations can also specify country-specific overrides for chain of custody events and signature requirements. For example, a label verification stage requires dual signatures in one country but doesn’t even require a chain of custody event in another. You can easily customize decision tables to manage these rules.

Explore Compliance and Reporting

Finally, to ensure compliance and audit readiness, Advanced Therapy Management provides the ability to generate detailed patient chain of custody reports. These reports consolidate all the chain of custody records, presenting a comprehensive overview of the entire therapy journey. With customizable reporting options, you can tailor the information displayed to meet specific regulatory requirements or internal needs.

Wrap Up

For Charles, from the moment his cells were collected to the final infusion, every detail of his CAR T-cell therapy journey was carefully tracked and verified. Thanks to the seamless coordination of Therapy Orchestration, the efficient scheduling of his complex treatment plan, and the precise documentation of the chain of custody, Charles received his life-saving treatment safely and effectively.

By maintaining an unbroken and adaptable chain of custody, Advanced Therapy Management ensures transparency and fosters trust. It provides assurance that every step of a patient's treatment is meticulously documented, every handoff is secure, and the integrity of their therapy is never compromised.

Across the entire badge, you’ve covered a lot of ground, from understanding coactive treatment to exploring the Therapy Orchestration framework, Multi-Step Scheduling, and now, the chain of custody. Check out the Resources section for more specific setup and implementation details.

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