ISO 22870- Are you meeting expectations?

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Quality control has recently become crucial in the Point-of-Care (POC) field due to the introduction of ISO 22870 regulations and increased focus in patient safety. Quality control is critical in reducing turnaround time and saving money.

There is now an international standard specifically for POC testing, ISO 22870. This standard is intended to be used in conjunction with the standard for medical laboratories, ISO 15189. This means that aspects relating to Point-of-Care such as training, competence and documentation should be carefully planned, implemented and governed by a quality management system and there is a requirement for QC and EQA to be performed, where available.

POCT is typically carried out by non-laboratory staff, therefore when selecting the appropriate IQC material for POCT there are a number of key characteristics you must consider;

  • Format of the material – QC material employed should be liquid stable, requiring no preparation, reducing the likelihood of human error and increasing convenience.
  • Value assignment – all values must be accurately assigned. Look out for suppliers who use a large number of independent labs to determine the target value.
  • Third party controls – manufactured independently from any specific instrument or method third party controls are designed to deliver unbiased performance assessment.
  • Storage – for convenience controls should be liquid stable, as these can be easily stored in a fridge at 2oC – 8oC and won’t need to be shipped on dry ice.
  • Stability – a control with a good open vial stability will mean that it can be used for longer with less waste produced, meaning it is more convenient for the medical professional to use.
  • Transportation– the liquid stable controls can be conveniently stored at 2oC – 8oC reducing the need to ship on dry ice
  • Minimal training– easy to use with little training required, therefore suitable for use by non-laboratory personnel

In addition to IQC, External Quality Assessment (EQA) must also be employed to ensure a comprehensive review of test system performance. It is best to select a programme that offers frequent reporting with a large database of users. This will enable rapid error identification and ultimately accurate and reliable patient testing.

Our Acusera liquid ready-to-use controls include:

  1. Blood Gas ControlA liquid stable control provided in easy to open ampoules for added convenience and ease-of-use. Assayed, method specific target values are provided for the most common blood gas instruments.
  2. Liquid Cardiac ControlThis is a highly convenient liquid stable cardiac control offering excellent consistency. Assayed, instrument specific target values are provided for 8 cardiac markers, enabling flexibility and consolidation.
  3. Liquid Urinalysis ControlLiquid control that is compatible for use with both manual and automated methods of dipstick analysis. Available in convenient 12ml vials or 25ml dropper bottles with assayed ranges provided for 13 parameters covering the chemical examination of urine specimens.
  4. Liquid HbA1c ControlThis is another highly convenient liquid ready-to-use control. With an open vial stability of 30 days, keeping waste and costs to a minimum.

Complementary EQA programmes are also available to meet the needs of ISO 22870.


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