Capillary Glucose Testing Recommendations
Definitions
Quality Control (QC) – part of quality management focused on fulfilling quality
requirements (ISO9000)7; NOTE 1: In healthcare testing, the set of procedures
designed to monitor the test method and the results to ensure test system
performance; NOTE 2: QC includes testing control materials, charting the results
and analyzing them to identify sources of error, and evaluating and documenting any
remedial action taken as a result of this analysis
(Clinical and Laboratory Standards Institute. Point-of-Care In Vitro Diagnostic (IVD)
Testing; Approved Guideline—Second Edition. CLSI document POCT4-A2 [ISBN 156238-618-2]. Clinical and Laboratory Standards Institute, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.)
External Quality Assurance (EQA)– an external program in which samples are
periodically sent to testing sites for analysis; NOTE: Usually, the results are
tabulated by the program and a participating site can compare its results with those
of other sites that use a similar method.
(Clinical and Laboratory Standards Institute. Point-of-Care In Vitro Diagnostic (IVD)
Testing; Approved Guideline—Second Edition. CLSI document POCT4-A2 [ISBN 156238-618-2]. Clinical and Laboratory Standards Institute, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.)
Background
Glucose meters are widely used in many areas including hospital wards and clinics,
general practice, operating theatres, ambulances, pharmacies, aboriginal health care
centres and by patients at home for self-monitoring. Such testing involves the use of
a glucose measuring meter, a specific blood glucose test strip and appropriate
quality control material. This will be referred to here under as the Glucose system
While the analytical performance of glucose systems has improved since they were
first introduced over 30 years ago, it is important that the following are taken into
account when using these devices:

The limitations of the system when used in specific settings such as critical
care units, obstetric wards and neonatal units

The effects of physiological and pathological interferences such as
haematocrit, various drugs and various intravenously administered solutions

Other potential interfering substances
The analytical performance (precision and bias) of glucose systems should be
designed to match the clinical application of the test. This document outlines
recommendations aimed at improving the use of glucose systems for patient care in
Australasia.
These recommendations are a consensus of attendees at a workshop devoted to
glucose systems organised by the Point of Care Committee of the Australasian
Association of Clinical Biochemists. The attendees were from a range of health
professionals including medical scientists, pathologist, health care industry, diabetes
nurses and a consumer representative.
SCOPE
This document refers to capillary glucose testing using glucose systems in hospital
wards and clinics, operating theatres, general practice, ambulances, pharmacies,
aboriginal health care centres and by patients with diabetes at home for selfmonitoring.
Outside of the scope of this document are:

Performance of glucose systems for self-testing of glucose at home and

Analytical devices such as transcutaneous meters and continuous monitoring
devices including those attached to patients to monitor levels of glucose,
oxygen etc.
Recommendations
1. All glucose systems used by health professionals for patient management should
participate in an EQA program. Review and communication of the performance
of each meter in such programs should become a routine practice for each site.
2. It is highly desirable to run a quality control sample daily. This ensures ongoing
validation of the test strips.
3. It is recommended that glucose systems which have features designed for
professional use are implemented in acute hospital facilities, not systems
designed for home use. This will allow results to be downloaded to patient
information systems so results are part of the patient record. This ensures more
effective use of results in patient management. Improved patient management
for diabetes will justify increased capital outlay for professional glucose meters.
4. Glucose systems used in hospital facilities should allow patient identification as
well as the capacity to be connected to other systems and/or networks.
5. The health care professional managing the patient should decide on the glucose
system most suitable to the patient setting, taking into account the relevant
professional scientific advice available for each device.
6. Glucose estimations performed in Intensive Care Units should be performed on
a blood gas machine or device of similar analytical performance.
7. It is highly desirable that the tolerance for analytical bias (accuracy) and
imprecision of glucose systems in other hospital areas should be less than 10%
variance from the true value.
8. Glucose systems accuracy should be confirmed by an accredited laboratory
method at least once every 12 months. If analytical performance is less than
that required, the glucose system should be replaced.
9. A standardised training package for health professionals and patients is
essential. As a minimum health care professionals should complete an online
competency program such as that provided by The Australian Point of Care
Practitioner’s Network (APPN) which is currently funded by the Australian
Government through the Quality Use of Pathology Program (www.appn.net.au).
10. It is recommended that all incidents and adverse events are reported to TGA
through the IRIS system (http://www.tga.gov.au/safety/problem-device.htm)
11. The performance of capillary blood glucose system should be validated by an
appropriately accredited clinical laboratory. Such validation should follow the
protocol published by the AACB PoCT Committee. This validation report must be
a minimum requirement prior to the introduction of a ward based glucose testing
system in a hospital.
12. Glucose meters designed for self-monitoring at home should not be used to
monitor tight glycaemic control.
13. It is desirable to assess performance glucose systems designed for selfmonitoring in the hands of patients as well as health care professionals.