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POCT
Date of issue 02/11/2011
Standard Operating Procedure (SOP) for the operation of
the Roche Accu-Chek® Performa glucose meter
This SOP has been compiled by the POCT committee to provide a template
compatible with Clinical Pathology Accreditation standards, containing information
users need to achieve consistently reliable and accurate results. This SOP should
be read in conjunction with the manufacturer’s manual and strip insert which are
available on the trust intranet site.
Clinical relevance/ purpose of examination
POCT Glucose meters are portable, hand held, battery operated instruments used in
conjunction with disposable test strips to rapidly measure glucose concentrations in a
small sample of whole blood.
POCT glucose measurement provides a convenient alternative to the laboratory
measurement as a monitoring/ screening tool but should not be used in the following
conditions:
 In the acute management of unstable diabetic states i.e. diabetic ketoacidosis,
hyperosmolar non-ketotic coma, hypoglycaemia
 To make a diagnosis of diabetes mellitus
 To make a diagnosis of hypoglycaemia
 Where the observed result is not in keeping with the patient’s clinical status
In these circumstances diagnosis and treatment decisions should only be made after
laboratory confirmation of screening results.
Principle of examination
When blood is applied to the electrode the glucose in the blood is converted to
gluconolactone by the action of glucose dehydrogenase. This reaction produces a
harmless electric current that the meter interprets as the blood glucose
concentration.
Specimen requirements and means of identification
Fresh capillary, arterial, or neonatal blood, as well as heparin (lithium or sodium)
anticoagulated venous blood may be used.
Required volume is 1-2 drops (0.6µL)
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POCT
Date of issue 02/11/2011
Sample Rejection Criteria
Due to the effect of glycolysis, venous or arterial blood glucose tests should be
rejected if not performed within 30 minutes of drawing the blood samples.
Take caution to clear arterial lines before the blood sample is drawn and applied to
the test strip.
Do not use blood sample collection tubes that contain EDTA because they may
interfere with the test.
Sample collected in bottles containing Iodoacetate or fluoride-containing
anticoagulants should not be analysed.
Refrigerated/cold samples should not be analysed but be brought to room
temperature slowly prior to testing.
Avoid air bubbles when using pipettes.
Any sample reading below 2.8 mmol/L or above 20 mmol/L, or which is not in
keeping with the clinical picture, should be verified by sending a venous specimen of
blood to the laboratory.
Equipment
Accu-Chek® Performa Meter
Log book
Lancet device
Cotton wool
Handle the meter carefully; avoid dropping or banging it.
Store the meter away from direct sunlight and extreme temperatures.
Avoid spilling liquids on the meter.
DO NOT immerse the meter in liquid.
Do not expose the meter to excessive sources of heat for prolonged periods of time
while obtaining a blood glucose result.
Reagent, standards or calibrators and IQC material
Accu-Chek® Inform 11 test strips.
Store the test strips at 2 °C to 30 °C. Do not freeze. Do not store the test strips in
high heat and humidity.
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POCT
Date of issue 02/11/2011

Use the test strips at temperatures between 8 °C and 44 °C and between 10 %
to 90 % relative humidity.
 Store unused test strips in their original container with the cap closed.
 Close the container tightly immediately after removing a test strip to protect the
remaining test strips from humidity.
 Use the test strip immediately after removing it from the container.
 Discard the test strips if they are past the expiry date.
 Expired test strips can produce incorrect results.
The expiry date is printed on the package and on the test strip container label next to
. The test strips can be used until the printed expiry date when they are stored
and used correctly. This applies for test strips from a new, unopened test strip
container and for test strips from a test strip container that has already been opened.
Healthcare Professional Information
Calibration code key
Always discard old calibration code keys in the empty strip container.
Accu-Chek® Performa Glucose Controls (Control 1 and Control 2).
 Store the control solutions at 2 °C to 32 °C. Do not freeze. Do not store the test
strips in high heat and humidity.
 Control solutions are stable if stored correctly until the expired date printed on the
vial or 3 months after opening.
 Mark the date of expiry on first opening the bottle i.e. 3 months from day of
opening.
Calibration
Roche test strips are batch matched. There may be batch variations, so to ensure the
accuracy of the system a code number which is printed on the test strip vial and a
code key are supplied with each pack of strips.
Before you use your meter for the first time and every time you open a new box of
test strips, you need to code/calibrate the meter to match the strips. Each
code/calibration key provides your meter with the specific information it needs to
accurately measure blood glucose.
Do not use any other code/calibration key, except the one that arrives in the
box with the pot of test strips. If you use the Accu-Chek® Performa while
incorrectly calibrated, inaccurate blood glucose readings could result.
It is important to note two things that appear on the label of the vial:


Expiry Date
Lot number
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POCT
Date of issue 02/11/2011
Installation of Code/Calibration Key
A code key is properly installed when it snaps into place.
You will need to insert a new code key:
• Whenever one of these displays appear
• Whenever you open a new box of strips:
1. Make sure meter is turned OFF.
2. Turn meter over so that you are looking at the back.
3. Remove old code key if one is installed and discard.
4. Insert new code key until it snaps into place.
5. Turn meter ON. A 3-digit code number appears. This
number must match the code number on your vial of
test strips. If it does not, repeat steps 1-5.
Instructions for the performance of the
examination
Capillary sampling
1. Wash hands thoroughly. Put gloves on.
2. Clean the side of the patients’ finger using soap and
water (rinse well) or gauze swabs. Ensure that the
finger is thoroughly dry.
3. Promote blood flow to the site by allowing the arm to
hang down by the side for a few seconds and then
flex arm and fingers. If the hand is very cold, allow it
to warm up before trying to obtain a blood sample.
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POCT
Date of issue 02/11/2011
4. Check expiry date of strips. Press power ON/OFF button.
5. Check that the code on the meter matches the code on the vial of test strips you
are using.
6. Open test strip vial and remove the test strip. Replace vial cap.
7. Within 30 seconds, insert test strip (yellow window facing up) into test strip slot.
The test strip symbol stops flashing and a blood drop will appear on the display.
8. Twist off protective cap until loose (do not pull off until loose).
9. Firmly place lancet against side of finger and press firing button.
10. Once used, the lancet will permanently retract into its protective case.
11. Lancets are single use devices; dispose of whole device into a sharps bin.
12. Allow 5 seconds to elapse after pricking the finger and then rather than squeeze
at the site of puncture, milk the blood down the hand towards the finger.
13. Touch the drop to the front edge of the yellow window of the test strip.
14. Do not put blood on top of the test strip. When you see the flashing hour glass
you have enough blood on the test strip.
15. If you applied blood, but do not see the flashing hour glass you may reapply more
blood within five seconds.
NOTE: If you can still see yellow on the test strip after a second drop of blood is
applied, remove the strip and repeat the test with a new strip. If the test pad is not
completely covered with blood you may get an inaccurate result.
16. Record result immediately using appropriate documentation.
If "LO" is displayed on your meter, the blood glucose may be below 0.6 mmol/L
If "HI" is displayed on your meter, the blood glucose may be 33.3 mmol/L.
17. Remove and dispose of test strip and any soiled materials in yellow clinical waste
bag.
18. Switch off meter.
For instruction on glucose measurement in non-capillary samples please refer to the
manufacturer’s manual available on the trust intranet.
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POCT
Date of issue 02/11/2011
Recording and calculation of results
Results along with the patient and user identifiers must be recorded either in the
Roche log book or on the POCT log sheet in addition to the patient notes.
Results should be recorded immediately, before the strip is removed from instrument.
Once the strip is removed the result will only be displayed for 3 seconds.
In the event that a result is not taken down before the screen clears the test should
be repeated. NO ATTEMPT SHOULD BE MADE TO RETRIEVE THE RESULT
FROM THE INSTRUMENT MEMORY.
The log of specimens analysed should be retained for at least the lifetime of the
instrument, minimum 10 years.
Limitations of examination (interferences, cross reactions
reportable intervals)
System measurement range: 0.6-33.3 mmol/L
The new generation strips identified by a green box
on packaging have been
modified such that there is no interference with maltose.
Glucose test strips are prone to the following interferences:
Substance
Galactose
Lipemic samples
(triglycerides)
Ascorbic acid
Hematocrit
interference level
>0.83 mmol/L
>20.3 mmol/L
>0.17 mmol/L
<10% or >65%
overestimation
overestimation
overestimation
If peripheral circulation is impaired, collection of capillary blood from the approved
sample sites is not advised as the results might not be a true reflection of the
physiological blood glucose level. This may apply in the following circumstances:
severe dehydration as a result of diabetic ketoacidosis or due to hyperglycemic,
hyperosmolar nonketotic coma, hypotension, shock, decompensated heart
failure NYHA Class IV, or peripheral arterial occlusive disease.
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POCT
Date of issue 02/11/2011
Internal Quality Control
IQC ensures that your system is working properly, that you
are doing a test correctly, and the meter is providing
accurate and reliable results.
Quality control tests must be carried out:
- before using your meter for the first time
- each day the meter is used for patient tests
- when starting a new pack of Roche test strips
- if you leave the cap off the vial of test strips
- after changing the meter’s batteries
- if you drop the meter
- after unexpected results, to check technique
- at least once a week, even is meter is not used for
patient tests
Performing IQC
1. Insert a test strip into the meter. The meter turns
on.
2. Make sure the code number on the display
matches the code number on the test strip
container. If you miss seeing the code number,
take the test strip out and reinsert it into the
meter.
3. Select the vial of control solution you want to
test. You will enter the level later in the test.
4. Put the meter on a flat surface, like a table.
5. Gently mix samples, remove the control bottle
cap, discard first drop and wipe the tip of the
bottle with a tissue.
6. Squeeze the bottle until a tiny drop forms at the
tip. Touch the drop to the front edge of the
yellow end of the test strip. When you see the
hour glass flash, you have enough control
solution in the test strip. Wipe the tip of the
bottle with a tissue then cap the bottle tightly.
7. A result appears on the display, along with a
control bottle symbol and a flashing “L”. Do not
remove the test strip yet. Press the left arrow
button once to mark it as Level 1. If you tested
the Level 2 control, press a second time.
8. Press the ON button to set the level in the
meter.
9. “OK” and the control result alternate on the display if the result is in range. The
range is printed on the test strip container label. “ERR” and the control result
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POCT
Date of issue 02/11/2011
alternate on the display if the result is not in range. Remove the test strip and
discard it.
10. Record result in Roche QC/patient log book.
11. If the result is outside the expected range:
 Check user technique
12. If the result is still outside the expected range:
 Check expiry date of strips and Performa Glucose Control solution (NB.
Once the solutions are opened they expire after three months). If either or
both of these are out of date, change them and then repeat the test.
 Did you leave the cap off the vial of test strips or glucose control
solutions?
 Did you use the correct QC solution (L1 with Control 1 or L2 with Control
2)?
 Did you select the appropriate control result level (L1 or L2)?
 Did you wipe the tip of the QC solution bottle before use?
13. If the result is still outside the expected range:
 Do not use the Accu-Chek® Performa. Contact the POCT team
External Quality Control
External quality assurance (EQA) is a program that allows testing sites to assess the
quality of their performance by comparing their results with those of other units.
Samples are sent from Welsh External Quality Assurance Scheme (WEQAS) to the
POCT Team on a bi-monthly basis. WEQAS provide aqueous solution that contains
an unknown concentration of glucose. The sample will be forwarded to each
registered participant by the POCT team. Every meter should be registered on the
EQA scheme.
These WEQAS samples should be tested exactly the same way as a sample from a
patient. IMPORTANT: For best performance perform test and return results on the
same day as receipt.
Apply the sample in a similar manner to the IQC solutions.
The return form should be completed and returned to the POCT Team. Log the result
in the Roche log book. If using internal mail please allow sufficient time to ensure the
contact receives the results prior to the deadline stated on the return form.
When the results are returned to the POCT team and logged on the WEQAS
website, the accuracy of your meter can be checked. This then forms part of the audit
of the blood glucose testing procedure.
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POCT
Date of issue 02/11/2011
Your performance will be communicated to you by the POCT team.
Please note it is good practise to maximise over the yearly EQA cycle the number of
users involved in EQA sample analysis. EQA performance can be used as part of
the annual assessment of competency.
Maintenance
Cleaning/disinfecting
The meter should be cleaned regularly:
• Always switch the meter off before cleaning.
• Gently wipe the surface with a soft cloth slightly dampened with one of the following
cleaning solutions:
Recommended cleaning agent: Mild soapy water, 70% (or less) solution of
isopropyl alcohol in water, 0.625% (or less) of solution sodium hypochlorite (bleach)
in water.
Recommended disinfecting agent: 0.625% (or less) of solution sodium
hypochlorite (bleach) in water,
Do not let liquid drip into the meter and take special care to keep moisture out of the
code key slot and the test strip guide.
Battery replacement
When a battery symbol appears on the display, your battery is weak and has only
enough power to run a few more tests.
Push the recessed plastic tab of the battery compartment forward (in the direction of
the arrow) to flip open the battery door.
Insert the battery into the compartment with “+” side facing you.
Snap battery cover back into place.
For trouble shooting and non-routine maintenance refer to the operators’ manual and
strip insert located in the POCT section of the laboratory web site.
Reporting reference limits
These test strips are calibrated to deliver plasma results. The normal fasting blood
glucose range for an adult without diabetes as related to plasma is 4.1-7.8 mmol/L.
Please note: Blood glucose varies widely even within the individual patient depending
on the time of the last meal, and this is especially the case in diabetes and in
neonates.
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POCT
Date of issue 02/11/2011
Alert critical values
Results <2.8 mmol/L and >20 mmol/L must be verified by the Clinical Biochemistry
Department. Please send a blood sample in a grey topped tube for glucose
confirmation.
All tests not in keeping with the patient presentation should be verified by sending a
venous specimen of blood to the laboratory.
Local protocol in relation to the reporting of critical results should be adhered to.
Responsibilities of personnel in authorising, reporting and
monitoring reports
Following the death of a patient, attributed to the inadequate use of a glucose meter,
the DOH issued a hazard notice in 1987. This and a more recent notice (1996)
highlights the need for a formal staff training programme for meter use together with
a strict quality control programme. Meters should only be used with the approval of
the laboratory.
Staff responsibilities are outlined in the Trust POCT policy.
All staff working in a healthcare environment have a responsibility to report any
incident that occurs involving POCT devices to the ward manager and POCT
coordinator.
Manufacturer will provide the following support
 Initial training
 Audit
The laboratory POCT Team (CAH ext 2660) will provide the following support
 Replacement meters
 Replacement log books
 Replacement batteries
 Schedule training
 Audit
 Advice on POCT QMS
Pharmacy will provide the following support
 Accu-Chek® Inform 11 glucose test strips.
 Accu-Chek® Performa control solutions.
 Lancet device
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POCT
Date of issue 02/11/2011
Hazards and safety precautions
Universal precautions must be observed when collecting blood specimens.
All samples should be handled as potentially infectious for hiv, hepatitis b and c, and
other pathogens.
Gloves should always be worn when collecting biological specimens.
Refer to COSHH assessment.
Performance criteria
Reportable Range (Dynamic Range)
0.6 – 33.3 mmol/L.
If LO is displayed on the meter, blood glucose may be below 0.6 mmol/L.
If Hi is displayed on the meter, blood glucose may be over 33.3 mmol/L.
For a full list of performance parameters see the kit insert and manual which can be
found on the POCT section of the laboratory web site.
Uncertainty of measurement
mean
Standard deviation
0.4
15.44
Uncertainty
14.64-16.24
The uncertainty is based on the variation of 36 results obtained for distribution 0311
(March 2011) of the WEQAS glucose scheme using strip lot 470011 for multiple
wards and operators.
Comparability with laboratory
On 07/04/11 the blood glucose level was determined 5 times on a patient lithium
heparin sample using the Roche Performa and Inform II laboratory meter before
being immediately spun down and the plasma glucose measured 5 times on the
Roche modular system.
1
2
3
4
5
mean
SD
% bias
Roche Modular
6.88
6.85
6.90
6.91
6.93
6.89
0.03
MP00154417
Roche inform II
7.3
7.3
7.4
7.3
7.3
7.34
0.055
106.5
UU11008424
Roche Accu-Chek® Performa glucose meter
Roche Performa
7.3
7.3
7.2
7.2
7.2
7.24
0.055
105.1
54201174191
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POCT
Date of issue 02/11/2011
Any other details
The COSHH assessment, user manual and strip insert can be located on the POCT
section of the Pathology web site http://10.142.1.242/cahgt/Depts/Labs/webhb/Default.htm
References
Blood Glucose Management System Accu-Chek® Performa. User manual for
healthcare professionals
Accu-Chek Inform 11 test strip package insert 05892872001 – 0510.
Roche Accu-Chek® Performa glucose meter
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