A nationwide HSE lead initiative is currently underway to oversee implementation of the International Standardisation of HbA1c. Dual reporting will begin on July 1^st 2010.

The HSE is leading the national implementation of the International Standardisation of HbA_1c measurement.  The impetus for this initiative stems from the considerations of the HSE Diabetes Expert Advisory Group to follow international decisions that HbA_1c assay results be reported worldwide in IFCC units (mmol/mol) and derived DCCT/NGSP units (%) using the IFCC-DCCT/NGSP master equation.  The Project Team is chaired by Dr. Ned Barrett and includes health professionals and senior HSE management. 

The Project Team has reached agreement with all current equipment suppliers to the Irish market, in line with the internationally agreed Consensus Statement and the agreement reached at the IFCC meeting with Manufacturers (December 2007) in particular.  The terms of these agreements include the following:

· All Manufacturers should implement worldwide the traceability to the IFCC reference system for HbA_1c.  In the European Union (EU) the implementation of calibration traceability in laboratory medicine to higher-order standards is already mandatory.  The EU directive 98/79/EC on in vitro diagnostic (IVD) medical devices explicitly requires manufacturers to ensure and document metrological traceability of their products.

·         The deadline for implementing traceability to the IFCC reference system is December 31^st 2009 for all the instruments in current use.

·         The name (abbreviation) of the test in the laboratory reports and in the clinical setting should be “HbA_1c” (not “A_1c”).

·         All new instruments sold after January 1st 2011 will report (as a result of an HbA_1c test) both SI (mmol/mol – no decimals) and NGSP derived units (percentage – one decimal), in agreement with the Consensus Statement.

Click here to read the specification developed to support changes to GP Messaging Systems.

For further information please contact:

Loraine McGrattan, Project Manager, HSE – Palliative Care/Chronic Illness Care Group, Millennium Park, Naas, Co. Kildare

Tel: 045 882588
E-mail:fiona.gleeson1@hse.ie

Click here to read Frequently Asked Questions for Health Care Professionals.

Click here to read a list of publications by the IFCC Working Group on the International Standardisation of HbA1c