LDA Update Proposal

Proposed Work Item: Laboratory Device Automation (LDA)

Proposal Editor: John Hopson, Abbott Laboratories
Work Item Editor: John Hopson
Date: 04/28/2015, last updated 04/28/2015
Version: 1.0 (draft)
Domain: Clinical Laboratory
Status: LDA Update Proposal Spring 2015.

Summary

Communication between IVD analyzers and Laboratory Automation Systems (LAS) is an integral part of clinical laboratory operation. In the absence of any industry guidance, such communication is currently defined on an ad hoc basis. Implementers naturally turn to predecessor products for guidance. This approach causes similar interfaces to be re-created over-and-over, even though such interfaces share features with products from a variety of vendors.

There clearly exists a need for fully specified interface protocols to reduce the time and costs associated with providing LAS-to-analyzer interfaces to clinical laboratories. The IHE-LAB Committee is the appropriate entity to create and promote such solutions. Prior work by the Committee on the LDA profile is evidence of that need.

This proposed profile will enable laboratory systems and IVD analyzers to communicate in with standardized interfaces, reducing the design burden for all parties for new product interfaces.

The Problem

Current IVD analyzer vendors and Laboratory Automation Systems (LAS) vendors have little guidance on how to implement software interfaces between their sample transport systems and IVD analyzers. HL7 and CLSI AUTO3-A provide some direction, but do not provide specific guidance for individual LAS-to-analyzer workflows.

Use Cases

1. Key Use Case

An IVD analyzer vendor creates an analyzer capable of interfacing with an LAS sample transport track with a point-in-space interface for direct track sampling. As they look for guidance on how to implement the interface, they realize that there is no detailed guidance from the IVD industry, only historical information from their own predecessor products, and perhaps some input from various LAS vendors.

Furthermore, an LAS vendor realizes that each new track-connected analyzer requires a unique driver development cycle, even though there are behavioral similarities between analyzers from various vendors.

Both parties notice that the LAS-to-analyzer development burden is incurred over-and-over, even though this type of interface is typical. Both would prefer to leverage an interface that is based on real world workflows, is built on existing standards, has been vetted by key industry representatives and is promulgated by a respected standards body.

Standards and Systems

Existing systems that could be involved in the solution.

1. IVD analyzer
2. Laboratory automation sample transport track system

Relevant standards upon which the solution might be based.

1. HL7
2. CLSI AUTO5-A (HL7 Chapter 13