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.

Change Management

Laboratories are encouraged to adopt a change management strategy. 

An approach to change management documentation to comply with accreditation requirements:-

 Purpose of the proposed change:

This change in HbA_1c calibration is to conform to national and international best practice. The initiative will mean that HbA_1c is measured specifically and reproducibly. It also enables the use of international reference ranges and harmonisation of medical decision or ‘target’ values.

Brief description of proposed change:

Implementation of traceability to the IFCC reference system requires software upgrade, analyser and electronic validation to facilitate dual reporting of HbA_1c in IFCC (mmol/mol) and DCCT derived (%) units

Outline proposed steps that need to be completed pre-implementation:

1)     A risk assessment or updated risk assessment

2)     Provision of documentary evidence by the supplier on completion of the implementation of traceability to the IFCC reference system and completion of software, electronic, analyser and user training.

3)     Staff training and competency assessment is required.

4)     Standard Operating Procedure needs to be amended to reflect change.

5)     LIS: assessment of printed laboratory reports is required.

6)     Instrument assessment of printer reports is required.

7)     In-house verification exercise is required for the following post IFCC calibration:-

a)     Carry out within-run precision study using IQC materials (control targets are established from IFCC calibrated instruments);

b)    Analyse calibrators as if patient samples and check results against IFCC assigned values;

c)    Analyse a minimum of ten patient samples that have HbA_1c concentrations that cover the medically relevant range from the period when calibration was DCCT aligned and compare results to the IFCC-DCCT/NGSP master equation derived DCCT result (%);

d)   Check that the LIS is receiving the correct result and that the HbA_1c DCCT derived result (%) is correct. This can be done by checking the HbA_1c IFCC result on the instrument in mmol/mol against the result in the LIS and by manually calculating the HbA_1c DCCT derived result (%) using the IFCC-DCCT/NGSP master equation:

DCCT/NGSP (%) = [0.09148*IFCC (mmol/mol)] +2.152.

8)   All laboratories that transmit results electronically should validate and verify this transmission, both on screen and the printed report. Check that the HbA_1c derived DCCT result (%) is transmitted accurately eg HealthLink, DIAMOND etc.  This electronic transmission check needs to be done again on the 1^st July 2010 when dual reporting commences.

For further information please contact:

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

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

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