Laboratory Specimen Handoff

Summary

Passing of specimens between Laboratory Automation Systems (LAS) and Specimen Processing Devices (SPD) is an integral part of clinical laboratory operation. In the absence of any industry guidance, such handoffs are currently defined on an ad hoc basis. Implementers naturally turn to predecessor products for guidance. This approach causes similar interfaces to be created within each organization, 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 managing sample handoff in 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 LAS and SPD to implement specimen handoff using standardized protocols, reducing the new product design burden for all parties.

The Problem

Current LAS and SPD vendors have little guidance on how to implement specimen handoff interfaces between their equipment. HL7 and CLSI AUTO3-A provide some direction, but do not provide specific guidance for individual handoff workflows.

Proposed Solution

The proposed solution is a Laboratory Specimen Handoff (LSH) Profile. The LSH Profile facilitates laboratory specimen passing by providing detailed message transactions used during handoff.

The LSH Integration Profile will cover the two most common handoff use cases in the clinical laboratory. The LSH Profile will be implemented in phases, by use case, in order of commonality.

Phase 1	Single-Specimen Point-in-Space Acquisition
	STM notifies SPD that a specimen container is en route to the SPD. The SPD prepares for specimen arrival, typically receiving work order steps (by some means other than LSH). Upon arrival, the STM presents the specimen for acquisition. Acquisition is typically aspiration. The SPD acquires the specimen from the container, without taking possession of the container. Automation removes the specimen from the aspiration position.
Phase 2	Single-Specimen Container Transfer
	SPD takes posession of specimen container. Workflow TBD

Additional phases may address other handoff use cases. A likely addition is "Multi-Specimen Container Transfer".

Benefits

The LSH Profile will advance the IVD industry by providing a common, fully specified framework for the most common specimen handoff use cases, based on the collective experience of active participants from across the IVD industry.

Promoting a consistent understanding of specimen handoff will have a number of benefits.

1. Reduced design burden for individual product interfaces
2. Reduced design burden for equipment to which a variety of products may be attached
3. Comprehends common pitfalls that may not be apparent to a particular development team
4. Provide a generally accepted foundation upon which the industry can build

Systems Affected

Actors & Transactions

Order Filler	Receives the laboratory work for each patient. Produces Work Orders.
Automation Manager	Container for all lab automation features, inclusive of Analyzer Manager, Process Manager and Specimen Transport Manager The internals of this actor are intentionally vague, as they are out of scope for IHE-LAB activities.
Analyzer	Instrument that automates IVD testing.
Pre/Post Processor	Device that automates specimen preparation.

Three actors will be affected by the LSH Integration Profile - Specimen Transport Managers (STM), Analyzers and Pre/Post Processors (PPP). Examples of STM Actors are laboratory automation tracks and sample transport robots. Analyzer Actors are typically in-vitro diagnostic devices. Examples of PPP Actors are centrifuges and aliquotters.

Standards and Systems

Profile Status: Preliminary (Pre-Supplement)

Documents: IHE Laboratory Technical Framework:

• Vol. 1
• Vol. 2

Underlying Standards:

• HL7
• CLSI AUTO5-A (HL7 Chapter 13)

Use Cases

Single-Specimen Point-in-Space Acquisition