SOP FOR STANDARD GLUCOMETER | OPERATING PROCEDURE FOR MEASUREMENT OF BLOOD GLUCOSE LEVEL AND OPERATION OF GLUCOMETER (ROCHE ACCU-CHEK ACTIVE)

                   1.0                            OBJECTIVE

1.1                            To lay down a standard procedure to be followed for the measurement of Blood Glucose Level and operation of Glucometer (ROCHE ACCU-CHEK ACTIVE).

2.0                            SCOPE

2.1                            This Standard Operating Procedure (SOP) shall be applicable for measurement of Blood Glucose Level and operation of Glucometer (ROCHE ACCU-CHEK ACTIVE) in Animal House Facility.

3.0                            RESPONSIBILITY

3.1                            Head / Designee

3.2                            All Personnel involved in the measurement of blood glucose level and use of a Glucometer.

4.0                            DEFINITIONS

4.1                            Nil

5.0                            PROCEDURE

5.1                            Operating Procedure

                   5.1.1                       Preparing for a blood glucose test

                   5.1.1.1                 Open the test strip box and remove the code chip.

                   5.1.1.2                 Check that the code number on the code chip is the same as the code number on the label of the test strip container.

                   5.1.1.3                 Gently slide the code chip straight into the code chip slot on the side of the meter.

                   5.1.1.4                 Read the package insert which comes with the test strips.

                   5.1.2                       Testing blood glucose

                   5.1.2.1                 Take a test strip from the strip container. Close the test strip container again immediately.

                   5.1.2.2                 Without bending it, gently slide the test strip into the test strip guide in the direction of the arrows.

                   5.1.2.3                 Check that the code number on the display is the same as the code number on the label of the test strip container.

                    5.1.2.4                 Identify the cage number/animal number and take the animal out from its native cage and restrain gently.

                   5.1.2.5                 Prepare the blood collection site by wiping it with normal saline sterile swab.

                   5.1.2.6                 Lancing device or other acceptable technique can be used for blood drop collection.

                    5.1.2.7                 When the flashing drop symbol is displayed: apply the blood drop to the center of the green field.

                    5.1.2.8                 The flashing hourglass symbol indicates that the test is in progress. After approx. 5 seconds, the test result appears on the display and you hear a beep.

                    5.1.3                       Blood Collection Techniques

5.1.3.1 Lancing device

5.1.3.1.1 Remove the cap from the lancing device

5.1.3.1.2 Insert a new lancet in the lancet holder. The lancet must audibly click into place.

5.1.3.1.3 Remove the protective cap from the lancet with a twisting motion.

5.1.3.1.4 Place the cap back on the lancing device again. The cap must audibly click into place.

5.1.3.1.5 Rotate the cap until the desired penetration depth is set.

5.1.3.1.6 Start with a low penetration depth setting.

5.1.3.1.7 Press down the priming button as far as it will go. The lancing device is primed when the middle of the release button is yellow.

5.1.3.1.8 Press the lancing device firmly against the chosen puncture site.

5.1.3.1.9 Press the release button.

5.1.3.1.10 Disposing of the lancet: Remove the cap from the lancing device. Slide the ejector forward. The used lancet is ejected.

5.1.3.1.11 Dispose of used lancets in such a way that the needles cannot cause injury. Discard used lancets according to local regulations / Biomedical Waste disposal guidelines.

5.1.3.2 Alternate methods to collect blood drop

5.1.3.2.1 Retro-orbital puncture, tail vein nick and Saphenous vein for rodents, Saphenous vein and marginal ear for rabbits and saphenous vein for guinea pigs can be used as alternate methods for collecting small blood drop for blood glucose estimation.

Note: Wipe off first blood droplet and take 2nd drop for accurate estimation.


5.1.4 Error

5.1.4.1 For any type of error message displayed on the screen user manual.


5.2                            Calibration


5.2.1 Calibration of the Glucometer shall be carried out by the outside agency / Contracted biochemistry estimation laboratory by testing against calibrated instrument readings within the linearity range.

5.2.2 Calibration shall be done once in a year or as per requirement and the calibration label shall be updated subsequently.

6.0                            ENCLOSURES

6.1                            Format

Sr. No.

Format Title

Format No

No. of Pages

7.0                            ABBREVIATIONS


7.1 SOP : Standard Operating Procedure

7.2 QAD : Quality Assurance Department

7.3 AHF: Animal House Facility

8.0                            REFERENCES


8.1 Users Manual

8.2 In-house

9.0                            REVISION HISTORY

                                                                                                                 

END OF DOCUMENT

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