Roche ACCU-CHEK Inform II Manual do Utilizador descarregar pdf (Página 7)

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Accu Chek Inform II Blood Glucose Meter Standard Operating

Procedure.

Version 1.50

Author:S.Phillips

Doc Manager: K.Ashton

Authorised by: K. Ashton

Signature : ………….

Ver Date:

15/09/14

Do not photocopy this document

Page 7 of 14

Last printed: 13 May 2015 ( ward-jones julie (rq6) rlbuht )

Acceptance of quality control

The acceptable limits for the quality control solution are provided by the manufacture for each lot of control

solution and strip lot and are stored on the meter.

The meter will automatically detect if the quality control result is within acceptable limits and displays the

result as PASS (within acceptable limits) or FAIL (outside acceptable limits).

The meter will lockout and will not permit patient testing after a FAILED quality control test. The test must

be repeated and PASS before patient testing is permitted.

Procedure if the Quality Control Test FAILS:

Check user technique

Repeat the test

Change the strips and/or control solution and repeat the test. REMEMBER Control solutions

expire 3 months after opening.

If the result is still outside the expected range DO NOT use the Inform 11 meter. Contact the POCT team.

2. EXTERNAL QUALITY CONTROL (EQA) – Bimonthly

Blood Glucose EQA tests are run on samples whose values are unknown to the operator performing

the test.

Participation in External Quality Control is Mandatory.

The Blood Sciences department will deliver an EQA sample to each ward or department for analysis

of blood glucose. Samples should be tested as per a patient sample. Results will be automatically

downloaded into the laboratory cobas IT database.

The ward sister or diabetes link nurse should decide which members of staff (trained on the meter)

should perform the External Quality Control Test.

Performance characteristics

Manufacturers’ Data

Linearity: 0.6 to 33.3 mmol/L

Detection limit: 0.6 mmol/L

Precision: Within batch <3.5% CV

Between batch <1.7% CV

In house data

Precision: within batch <4.0 % CV (range 2.9 – 22.1 mmol/L)

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