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. Sample Presentation Use Case

Automation notifies the IVD analyzer that a sample is en route to the IVD analyzer. The IVD analyzer prepares for sample arrival. Upon arrival, automation presents the sample for aspiration. IVD analyzer aspirates from the sample and notifies automation when sampling is complete. Automation removes the sample from the aspiration position.

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

Technical Approach Overview

Actors

The proposed LDA actors are shown below.

1. Order Filler - Receives the laboratory work for each patient
2. Analyzer/Automation Manager - Manages analytical work for the instrument based on the Work Order. Produces AWOS’s. Also, manages specimen (automation) work for pre/post processing. Produces SWOS’s
3. Analyzer - Instrument that automates IVD testing
4. Track - Manages specimen container transport and handoff
5. Pre/Post Processor - Device that automates specimen preparation