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Clinical governance

The MHRA ([117]) has highlighted the need for standardization in training (including regular updates) and for reliability and quality control of blood glucose testing. In order to achieve these, careful and systematic selection of appropriate equipment must occur. The following aspects must be considered when selecting monitoring devices:
  • The equipment must be designed for use by non‐laboratory staff.
  • The equipment must be suitable for use in the intended setting (e.g. in a critical care unit or in an ambulance).
  • It must be clear whether the meter or lancing device is for single patient use or can be used on multiple patients.
  • The design must suit the needs and requirements of the patient or user.
  • The equipment must be CE marked under the IVD directive (MHRA [119]).
  • Support and advice must be provided by the hospital laboratory on device purchase, interpretation of results, troubleshooting, quality control, and health and safety.
  • The equipment should be easy to use and an appropriate service co‐ordinator should be identified.
  • Written standard operating procedures should be available and kept with the device.
  • Training must be given to the operators of the equipment and refreshed appropriately. The training should include:
    • basic principles of measurement
    • expected results in normal and pathological states
    • demonstration of the proper use of the equipment in accordance with the manufacturer's specification
    • demonstration of the consequences of improper use
    • knowledge of operator‐dependent steps
    • instruction in the collection of appropriate blood samples
    • health and safety aspects
    • instruction in the importance of complete documentation of all data produced
    • appropriate calibration and quality control techniques
    • practical experience of the relevant procedures, including a series of analyses to satisfy the instructor that the trainee is competent
    • information regarding contraindications
    • information on basic troubleshooting, error messages and potential sources of error (MHRA [117]).
It is recommended to keep records of training and quality testing results. The frequency of these quality control tests may vary according to manufacturer or hospital policy (MHRA [117]).
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