A DRAFT STANDARD FOR INTERFACES BETWEEN BLOOD ESTABLISHMENT

COMPUTER SYSTEMS AND INSTRUMENTS

Paul Ashford, Renny Skagestad, Pia Bruce
ISBT Working Party on Information Technology - Interfaces Task Group

Why Standardise?
Reliable electronic communication between blood establishment computer systems (BECS) and the specialist instruments used in the collection, processing
and analysis of blood and blood products is essential to ensure the safety of the blood supply, however lack of standardization of the computer/instrument
interface has been a long-standing problem for the transfusion community. Instruments provide their electronic outputs in a plethora of formats each
requiring a specially tailored interface, and the need to have these interfaces written and validated for use is costly to both suppliers and customers. Limited
interfacing standards have been available for some years, most notably the ASTM-1394E standard (now known as the CLSI LIS2 Standard), and some
instruments do base their output on this structure, but even so there remains significant scope for variation that makes developing a generic interface
almost impossible.
A common and open definition for the instrument interface, and a common conceptual framework for data interchange between systems and instruments
is needed.
Developing a solution
The ISBT Working Party on Information Technology established an Interface Task Force in 2006 to develop a solution to the problem (P. Bruce, ISBT Science
Series (2008) 3, 185-188). The Task Force is open to experts in the field and currently has about 15 active members including BECS and instrument suppliers
and users, and IT experts. The aim of the project is to provide a degree of standardization that will ensure critical data fields are transmitted in a tightly
defined format allowing a generic interface to correctly receive and interpret this information. Existing electronic information standards were evaluated.
None provided the necessary degree of standardisation required for plug and play functionality, but two well established standards, LIS2-A2 and HL7 were
seen to be able to provide a messaging infrastructure that could support further transfusion specific enhancement.

LIS2-A2 is the current version of what was formerly the ASTM E-1394 Specification for Transferring Information Between Clinical Instruments and Computer
Systems. This particular standard was withdrawn by ASTM in 2002 when responsibility for the standard was handed over to NCCLS (now CLSI). The
standard was re-named LIS2-A, issued as an approved standard in 2003, and was updated and issued as a second edition, LIS2-A2, in 2004 (see LIS2-A2
Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard Second edition, NCCLS
document LAS2-A2, ISBN 1-56238-550-X).

HL7 is a well established messaging standard used widely in system to system messaging in the healthcare field2. The current standard is v 2.6 with v 2.7 in
ballot, however in practice many previous versions continue to be used with v 2.3 still particularly popular (HL7 Version 2 Messaging Standard Application
Protocol for Electronic Data Exchange in Healthcare Environments see www.hl7.org). Although HL7 has developed a version 3 of its standard this is
conceptually very different to version 2 and is not as widely used. HL7 have confirmed their long term commitment to supporting version 2 in the following
statement: Due to its widespread use, Version 2 will, no doubt, continue to play an integral part in healthcare messaging, even with the HL7 Version 3
Normative Edition. HL7 is committed to supporting and extending Version 2 in parallel with Version 3, providing continuity for current installations.

The structure of messages in these two standards is very similar and both support the concept of Universal Test Identifiers which allow approved external
agencies to specify the context and format requirements for information related to particular defined tests using coded reference tables. Such an approach
builds on these well established messaging standards and is the preferred option of the Interfaces Task Group.

Proposed Solution
The proposed solution is based upon two existing messaging standards, LIS2 (formerly ASTM E-1394) and HL7. Interfacing using these standards ensures
compatibility at the messaging level, but not at the individual field level. For example the following fields from a result message are both valid in HL7:
|^Donation weight||0.545|kg|
|^Weight of unit||472|g|
However, they are clearly not the same. The description of the result is different, the units are different, and quite probably the definition of weight differs,
the former being the weight of collected blood plus anticoagulant, the latter just being the blood collected. This degree of variability is not compatible with
interface standardisation.
To ensure that the content of these fields achieves the necessary level of conformity ISBT can define universal test and observation identifiers for use within
HL7 and LIS2 messages. An example universal reference table is shown below.
Using such definitions the name of the result field, the format and units of the result, and a clear statement of what the reading actually represents is pre-
determined. For the above example, the result fields would be standardised to:
|1236^Weight of donation^IBT0200||472|g|

Ref Name Definition

1235 Draw duration The time taken for the blood to be collected from the moment of needle insertion to the clamping off
of the unit, expressed in seconds using 3 digits and no decimal places

1236 Weight of donation Net donation weight (excluding weight of container and anticoagulant,) collected at the bedside at
completion of the donation event and specified in grams using a three digit number with leading zeros
if required and no decimal places

1237 Volume of donation Net weight of the blood collected, calculated from the weight using an appropriate ratio for specific
gravity of blood, expressed in millilitres using a three digit number, no decimal places

1238 Collection bag type ISBT 128 data structure [017] for the Container Manufacturer and Catalogue Number expressed in full
but excluding the data identifier characters

1239 Collection bag lot ISBT 128 data structure [018] for the Container Lot Number expressed in full but excluding the data
identifier characters

Next Steps
The Task Force is currently working in two areas:
building the full list of instruments that need to be interfaced, and the critical data items for each instrument type;
developing the reference table entries required for blood grouping machines.
The group is keen to involve all interested parties. Please contact paul.ashford@iccbba.org if you wish to participate in this work.