Standards

Data & Interoperability

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Overview

The Master Data Repository is at the heart of DoseID and is the source of truth for all aspects of an item’s characteristics and history. It is the central database that all members can access to create new serialized items, log events and view an item's history. As a cloud based system it is accessible from anywhere in the world either by human or machine users.

Unit-dose drugs have had barcodes, and even serial numbers, to one degree or another, for years. But printed unit-dose labels are limited to a finite amount of information known at the time of printing. A dynamic drug record in the Centralized Registry can hold an infinite number of attributes, including ones that didn’t exist during manufacturing or which have since changed, such as refrigeration BUDs and recall statuses.

Architected as a high-availability cloud platform with access APIs and a standard object models, the Centralized Registry enable frictionless integration and usage with other systems.

Interoperable with GTIN, SGTIN, DSCSA, Blockchain, & Other Standards

The Centralized Registry can store and surface related item data such as…

  • Standard drug attributes, including NDC, Lot Number, and Expiration Date
  • GTIN-14, SGTIN, and other identifiers from major standards bodies at both item and outer package levels
  • DSCSA serial number from saleable-unit parent
  • Blockchain transaction addresses, block IDs, and hashes

It can also handle items not covered by these approaches, such as items compounded in a hospital that don't have an NDC.

Interoperable with Hospital Technology and Automation Systems

  • API endpoints for easy integration to lookup item history and record new events
  • Standard object & event models

Interoperable with Label Converters

  • API endpoints for easy item registration

Object & Event Data

At the heart of the Centralized Registry is Object and Event Data for each and every serialized item. From item registration during the manufacturing or compounding process, through decommissioning after a medication is administered to a patient, the Registry maintains a dynamic and real-time collection of information about each item that can easily be retrieved or appended.

Integrated partner systems can look up items with which they're interacting and get back data to enable richer, safer, and more efficient workflows. These systems are also expected to contribute key object and event data back into the repository. That participation and behavior is what enables interoperability for the hospital customer across their systems.

Object data for drug items can include:

  • Item Data — DoseID Serial Number, EPC, DSCSA Serial Number
  • Product Data — NDC, Manufacturer, Drug, Concentration, Package Size & Type
  • Batch Data — Lot Number, Expiration Date, Compound Date
  • Post-manufacturing Data — Beyond Use Dates and other date-based attributes

The Registry also supports other types of objects such as Accounts (IDNs, Hospitals, DoseID Partners), Orgs, Users, and Reference objects (hardware/enclosures).

Event Data includes:

  • Event Types: create, scan, decommission, other actions
  • Event Metadata: reasons, cGMP flags, user, account, timestamp, related reference objects

Rocuronium Example

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In this example, you can see a refrigerated item that generates a beyond use date ("BUD") upon removal from the refrigerator. Because the item is serialized, and both the refrigerator and ADC are integrated with the Centralized Registry, the ADC can be aware of both the manufacturer's expiration date and the BUD.