Page 1 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
Purpose
To improve the clinical outcome of patient care by continuous real-time management of blood glucose
concentrations as well as to provide rapid detection of extreme blood glucose concentrations in patients
whose symptoms suggest hypoglycemia or hyperglycemia.
Principle



Glucose dehydrogenase in the strip converts the glucose in the blood sample to
gluconolactone
Electrons are transferred through a mediator, potassium ferricyanide.
The resulting current of electrons is proportional to the glucose level in the blood
Specimen
 A drop of fresh whole blood (0.6uL)
 Capillary blood from fingerstick or heel stick is the preferred and usual specimen
 Staff must follow safe working practices and wear disposable gloves when performing all

testing
The meter will report an error if the amount of sample introduced to the meter is insufficient
Instrumentation:
Accu-Chek Inform II meter
 Operating temperature is 12 to 47 degrees C, 90% relative humidity at 32 degrees C
 Intended for in vitro diagnostic use in the determination of blood glucose levels in
capillary whole blood samples.
 The meter can perform patient blood glucose tests and glucose control tests with control
solutions
 The system automatically records: the time and date of test, the identification data for
the operator, patient and samples, the control solution and test strip information and the
test results and comments
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 2 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
Battery Pack
 Meter contains a rechargeable battery pack and begins charging as soon as the meter is
docked in the base unit. Meters must be returned to the docking base unit for
recharging when the Battery Low warning is displayed or at least once in a 24hr period.
Base unit
 Status display window at the right hand side of the base unit will light up orange when
the supply is connected, green when ready and flashes orange when there is an error
Equipment and Materials:
Equipment:

Accu-Chek Inform II Glucose Meter

Accu-Chek Inform II meter docking station (base unit)

Cobas IT 1000 data management system

Blood Lancet Device

Disposable Gloves
Materials: All obtainable from Stores and will be charged to each location

Glucose Control Solutions

Test Strips

Lancets

Alcohol pads

Hospital approved disinfectant wipes

Operator ID barcode
Preparation and Storage

Glucose Control Solution (Level Low and Level High)
-
Ready to use; gently shake each vial of control solution before use
QC Material is stable unopened until the expiry date on the bottle when stored at
15-30 degrees C
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 3 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
-
-
The control material may be kept 90 days (3 months) after the date of opening or
expiry date, whichever comes first. Mark the bottle with this expiry date being
careful not to cover the barcode
Always wipe the tip with a tissue to prevent crystallization of the solution on the
outside of the bottle.
New QC lots are added by the laboratory POC coordinator or designate, not the
operators.
Frequency of use
-
-

Accu-chek Inform II Test Strips
-

Both levels of control will be run every 24 hours per meter. Patient testing will
not be allowed until both control tests are run and the results are in the
acceptable range
Additional Quality control checks must be performed each time a new bottle of
strips is opened, when the patient’s results obtained differ from those expected,
or to investigate possible instrument damage or strip deterioration after cleaning
the meter
Ready to use
Store test strips in their original bottle in a cool, dry place. Keep away from heat
and sunlight. Do no refrigerate or freeze
After removing a test strip from the bottle use immediately, and immediately
replace the bottle cap
Store test strips in their original container
Do not bend, cut or alter a test strip in any way
Strips can be used until manufacturer expiry when stored and used correctly
Do not use any test strips past their expiration date on vial. Expired test strips
can produce incorrect results
Test strips contains no interference from maltose
Safe-T-Pro Plus Lancet
-
-
Single-use lancet device with three depth settings (1.3, 1.8 and 2.3 mm)
The sample requirement is very small (0.6uL). It is recommended that the 1.3
mm setting be used
It consists of a thin, 23 gauge, silicone-coated needle with beveled tip which
automatically retracts after use
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 4 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013

Operator ID
-
Each operator is assigned a unique identifier. This identifier must be scanned
into the meter before any testing can be performed. It is a breach of security to
allow another person to use his/her operator ID. All results can be traced to the
end operator. Operator Barcode ID will be generated by the Laboratory.
Calibration

Calibration is performed by the laboratory POC coordinator or designate and then
downloaded to every Inform II meter. This calibrates the meters to the test strips.
Calibration by the operator is not required. The chip contained in each strip container can
be discarded
Procedure:
Powering up and Entering Operator ID:
1. Press the power on/off button located below the center of the touch screen. The power up screen
appears. This screen displays date, time, status of battery charge (when the battery symbol is
completely black, it is fully charged) and QC requirements. The Operator ID screen appears next
2. Scan your Operator ID (manual entry is not allowed or accepted by the meters)
- Press the Scan button (barcode symbol) on the upper right corner of the screen
- The black backlight of the scan button indicates that the scanner is activated.
- Position the scanning beam approximately 4-8 inches from your operator ID barcode. A
beep indicates a successful scan of the barcode
- Once you scan your operator ID barcode, the Main Menu screen will appear. Your name
will be displayed on the screen.
Quality Control Testing
3. Press Control Test from the Main Menu.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 5 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
4. The two control levels that are required will appear as icons on the display.
5. Press the icon for the first glucose control required for testing.
6. Push the scan icon and scan the level of control you are running.
7. The strip lot screen will appear.
8. Scan the barcode strip on the test strip container
9. Insert the strip when prompted.
10. Once the flashing drop appears on the “apply control solution screen”, add the appropriate level of
control solution to the end of the strip.
11. The meter will display “PASS” or ‘FAIL”
12. If PASS, proceed with the other level of QC.
13. If FAIL is displayed, you must select a comment that pertains to why the control failed. Press the
comment icon to display the preprogrammed comments. A failed control must be repeated.
14. Press the check mark √ to return to the result screen.
15. Remove the strip and dispose in biohazard waster container
16. Repeat steps 3 -16 with the second glucose control required for testing.
17. The inform II automatically downloaded the QC result into the laboratory’s Cobas IT 1000 database.
QC Troubleshooting (if QC FAILS)
 Repeat test and be sure the correct QC level was used
 Check expiry date of controls (control solution expires 3 months after opening)
 Try a different or new QC vial
 Try a different or new vial of test strips
 Should the meter continue to fail, contact the Laboratory for further assistance.
Additional QC testing
 Additional routine QC solution testing should occur when there is a circumstance that could
affect the performance of the meter, the strips or that operator such as:
- Meter dropped
- Cap left off test strip vial
- When a new vial of strips opened
- Should questionable patient results be displayed
18. Turn off the meter and place meter back in docking station to recharge for later use.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 6 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
Performing a Patient Test
The patient ID will always be the Meditech account number (exception: unregistered ER patients will
use a generic barcode). The account number (patient’s barcode arm band) must always be scanned
into the meter. Manual entry is not allowed.
1. Cleanse puncture site with soap and water on the “horseshoe” aspect of the digit (neonates:
refer to Newborn Capillary Blood Sampling – see N-OBS-IV-1307). The site should be warm,
not swollen or infected. Remember to rotate the sites. To ensure an adequate sample, the
patient’s hands may need to be warmed by hand washing or rubbing the fingers (Neonates:
ensure heel is warm).
2. Perform hand hygiene
3. Turn on the Inform II meter
4. Touch the barcode icon (top right hand) and scan your Operator ID tag. The Main menu screen
is now displayed
5. Select the Patient Test button
6. Using the patient wrist band, scan in the patient details to enter the patient identifier
7. Press √ to display the Strip Lot confirmation screen
8. Touch the barcode icon and scan the barcode on the test strip vial
9. Perform hand hygiene and put o personal protective equipment (protective gloves)
10. Remove the test strip from the test strip vial and close immediately with the cap
11. When prompted insert the test strip with the yellow target facing up. Once the meter has
detected the test strip, you are prompted to apply a blood sample (enough blood to cover the
yellow target area). Perform puncture as outlined below wearing protective gloves
Using the Accu-chek Safe-T-Pro Plus Lancets
a) Hold the lancet and twist off the sterility cap by twisting it in either direction
b) Turn the depth adjuster to the required depth – the lancets come pre-set at the medium
depth. There are 3 penetration depths available
- Low 1.3 mm depth (short marking)
- Medium 1.8 mm depth (middle marking)
- High 2.3 mm depth (long marking)
c) Hold the lancet device firmly against the side of the finger (avoid the thumb and
forefinger) and ensure it is above the nail bed.
d) Press the purple button to release the lancet
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 7 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
e) The lancet automatically retracts into the device casing.
f) Dispose the lancets into a yellow sharps container.
g) Do NOT squeeze the finger to obtain blood. Wait 5 seconds then massage blood into
the finger from the palm. Wipe away the first drop of blood. Use second drop. Erroneous
results may be obtained if excessive squeezing of the finger/heel is used to obtain the
blood sample
12. Add the patient sample to the front edge of the test strip until the yellow window is completely
filled with blood and no yellow is visible.
13. If any yellow is still visible within the target area, a second drop of blood may be applied within 5
seconds. An hourglass appears on screen until the measurement is completed and the result is
displayed.
14. A result comment for critical/out of range results is required. Press the comments button to
display the pre-programmed result comments and choose the appropriate comment
15. If a critical level is obtained (<3.0 mmol/l or >25.0 mmol/l), repeat steps using a different
puncture site.
16. For critical results > 25.0 mmol/, order an urgent venous glucose draw.
17. Documenting Results:
-
-
At the BGH site, in-patient glucose results are documented on the patient’s chart using
the PCS software program. The yellow Emergency/Triage form is to be used for all ER
patients.
At the Willett site - Urgent Care, all patient glucose results are documented on the
patient’s chart using a “Glucometer” stamp. Enter the results, date and time, and
initialize
18. Dispose of soiled materials into a yellow clinical waste bag for incineration.
19. Dispose of used test strips into a sharps container.
20. Turn meter off.
21. Clean the meter with a 70% alcohol swab or hospital approved disinfectant wipe. Ensure that
no cleaning fluid gets into the test strip port on the front of the meter and return to docking
station.
Emergency Triage Meter patient entry if a Hospital ID number is not available
a)
b)
c)
d)
e)
f)
Refer to form POCT.GEN.4200 Anonymous Barcode form
Scan generic barcode “GM009999/10” as the patient ID
Complete testing
Record results on the Anonymous Barcode form
Send to Lab “Attention POCT” ASAP upon completion
Do not file in patient’s chart
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 8 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
Proficiency Testing

Performed by Nursing Staff on the Direction of Laboratory Staff
Cleaning and Maintenance:
The Glucose Meter




Personal protective equipment must be worn when performing any maintenance
procedure
The Meter must be kept clean at all times
Any blood splashes must be removed immediately using a Disinfectant wipe (e.g. PCS
wipe or 70% isopropyl wipe)
Wipe down the outside of the meter with a damp (not wet) 0.1% Sodium Hypochlorite
wipe (e.g. PCS Wipe) or 70% isopropyl alcohol swab between patients. Be sure the
wipes are not too wet prior to use. Do not allow liquid to enter the strip slot or collect on
the connectors
Cleaning the scanner window

Use a clean, dry cloth to wipe the scanner window
Cleaning the accessory box

Wipe with hospital approved disinfectant wipe after each use
Health and Safety
The Accu-Chek Inform II System or its components must be treated as potentially bio-hazardous waste.
Users must be aware that any object being exposed to human blood is a potential source of infection.
To reduce the risk of infection users must:
 Use gloves
 Use a new lancet for each patient. Dispose of used lancets in yellow sharps container
 Dispose of used test strips into a yellow sharps container
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 9 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
Isolation Precautions

Outside the isolation room:
o if necessary perform Quality Control
o Scan in your operator ID
o Perform Hand Hygiene and put on PPE
o Remove strip from vial; it is very important to remove the strip prior to
entrance to room to insure the entire vial of strips do not become
contaminated

Inside isolation room:
Note: Depending on the frequency of tests, consider keeping a test strip bottle
with a limited supply of strips in the isolation room
o Wipe surface with hospital approved disinfectant wipe
o Place test strip/vial on the clean dry surface
o Confirm patient identification and scan armband
o Scan strip vial barcode
o Insert strip into meter, obtain capillary sample and perform testing

Before exiting the room:
o Remove the test strip and discard
o Wipe meter with a Disinfectant cleaner Wipe
o Discard isolation glove. Remove PPE

Perform personal hand hygiene

Outside the isolation room:
o Wipe the meter and strip vial with a wipe and allow appropriate disinfectant
time for the wipe being used. See instructions on disinfectant wipe container

Perform personal hand hygiene
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 10 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
Reference Range:
Random:
Adult
Pediatric
3.8 – 8.9
3.3 – 8.9
Critical
Adult
Pediatric
<3.0 or >25.0 mmol/l
<2.6
mmol/l
mmol/L
mmol/l
Limitations:
 Results may be affected and must be interpreted according to the patients’ clinical
condition, whenever patients’ present the following conditions:
o Galactose greater than 0.83 mmol/L
o Triglyceride greater than 20.3 mmol/L
o Intervenous ascorbic acid greater than 0.17 mmol/L
o Hematocrit greater than 0.65 or less than 0.10 L/L. Low hematocrits may
cause higher results. High hematocrits may cause lower results
o Severe dehydration as a result of diabetic ketoacidosis or due to
hyperglycemic hyperosmolar non-ketotic syndrome, hypotension, shock,
decompensated heart failure, or peripheral arterial ocllusive disease
Procedural Notes:



Patient’s with medical conditions as stated above must be collated with laboratory
results before deemed acceptable for glucose monitoring
Glucose meter testing and venous draw to be done within 5-10 minutes of each other
on a Fasting Blood Glucose
For test results, the discrepancy between the glucose meter and the laboratory result
should be less than 15%
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 11 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
Troubleshooting
 All error messages displayed are accompanied by a description of the error and a
possible solution
Display
Test Result LO/HI
Possible Solution
The glucose result may be below (LO) or above
(HI) the measurement range of the meter. Lower
than 0.6 mmol/l or higher than 33.3 mmol/l
 Repeat test to confirm result
 Request a venous sample for confirmation
Test Result CR LO/CR HI
The glucose result may be below/above the critical
range
 Repeat test to confirm result
 Request a venous sample for confirmation
of High critical results
 Notify physician
Bad Strip
The test strip is defective or the blood glucose
result is extremely low and below the meter’s
measurement range
 Repeat test to confirm result
 Request a venous sample
Battery Low/Battery Critical Low
Charge the battery by placing the meter in the
base unit
Base Unit Light flashes
Charging contacts may be shorted
 Disconnect and connect the power supply
again
 If error persists contact HELP desk
Meter Screen Freezes
Meter needs to be re-set
 Press small round circle in middle of back
of meter with paperclip – may take a few
minutes to re-set.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 12 of 12
Title: Bedside Ancillary Blood Glucose Testing – Accu-Chek Inform II Glucose Meter
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3101
Version:
Date Issued: Mar 2013
References:





Roche Diagnostics Ltd. Package, ACCU-CHEK Inform Blood Glucose Monitoring
System, Operator’s Manual 2010
Roche Diagnostics Ltd. Package Insert 2011, Accu-Chek Inform II, Performa Test Strips
and Performa Control Solutions
Quality Management Program. Laboratory Services, Ontario Laboratory Accreditation.
Division, Requirements and Guidance Information. Dec 2012
CLSI Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities: C30A2 – Second Edition
Point of Care Testing, Christopher P. Price, Jocelyn M Hicks, AACC 1999
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled