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Document title: fill in the title of your SOP
Luton and Dunstable University Hospital
Clinical Biochemistry
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STANDARD OPERATING PROCEDURE FOR THE ROCHE
ACCU-CHEK PERFORMA GLUCOSE METER
Q-PULSE FILE NAME
LI-BIO-POCTPerf
EDITION No
1.0
DATE OF ISSUE
23rd September 2013
REVIEW INTERVAL
2 Years
AUTHORISED BY
N A Vaughan
SIGNATURE
AUTHOR
D Cannon
COPY
1 of 3
LOCATION OF COPIES
1. Master file, Quality Officer Shelves
2. Point of Care Testing Shelves
3. Intranet / Point of Care Services
Electronic archives
Document review history
Review date
Reviewed by
Signature
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Author D Cannon
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Luton and Dunstable University Hospital
Clinical Biochemistry
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DOCUMENT AMENDMENT FORM FOR STANDARD OPERATING PROCEDURE
FOR THE ROCHE ACCU-CHEK PERFORMA GLUCOSE METER
Record Filename LI-BIO-POCTPerf
Number Date
Page
Amendment
Number
Authorised by
1
2
3
4
5
6
7
8
9
10
The amendment must be authorised by the POCT Manager to ensure all copies
including the electronic version are updated simultaneously
Any minor amendment must be handwritten without obscuring the previous text. An
asterisk is written in the adjacent margin to highlight the alteration and is signed and
dated by the POCT Manager
Amendments requiring immediate action must be handwritten without obscuring the
previous text. An asterisk is written in the adjacent margin to highlight the alteration
and is signed and dated by the POCT Manager
Ten or less minor amendments may be recorded before a new edition is issued.
Major changes must result in the immediate review of the procedure.
Document amendment does not replace the review process.
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Author D Cannon
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Luton and Dunstable University Hospital
Clinical Biochemistry
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HAZARDS AND PRECAUTIONS
For appropriate use of protective clothing, please refer to ‘Use of Personal Protective
Equipment (PPE) in Pathology and Phlebotomy
Substance
Blood
Hazards
Danger of infection
IQC
Danger of infection
EQA
Danger of infection
PDI Sanicloth 70
(cleaning wipe
containing 70%
isopropyl alcohol)
Irritating to eyes
(R36) Highly
flammable (R11)
Precaution
Follow standard
precautions. See
above. Dispose of
in orange clinical
waste bags.
Follow standard
precautions. See
above. Dispose of
in orange clinical
waste bags.
Follow standard
precautions. See
above. Dispose of
in orange clinical
waste bags.
Keep away from
sources of ignition.
No smoking
First aid Code*
A1, B, C, D
A1, B, C, D
A1, B, C, D
A, B, C
IF IN ANY DOUBT CONSULT A SENIOR MEMBER OF STAFF OR
YOUR SAFETY REPRESENTATIVE
*Key:
A1
Ingestion: wash mouth thoroughly with water and give plenty to drink. In severe
cases obtain medical attention.
B
Eye contact: irrigate thoroughly with water. Seek medical help.
C
Skin contact: wash off skin thoroughly with water.
D
Inhalation: remove to fresh air. If severe call a physician.
If First Aid treatment has to be given contact the nearest first aider but do not delay
treatment to the casualty.
If necessary, call the crash team 2222.
Treat all body tissue and waste as potential infective.
In all cases, an Incident form must be filled in and report to Occupational Health or
Accident Service if out of hours.
See Also Risk Assessments:
Blood or Body Fluid Analysis 47
Blood glucose, ketones and HbA1c measurement outside the laboratory 96
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Luton and Dunstable University Hospital
Clinical Biochemistry
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TABLE OF CONTENTS
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TABLE OF CONTENTS......................................................................................................... 4
0 INTRODUCTION................................................................................................................. 5
0.1 Purpose and Scope ......................................................................................................... 5
0.2 Clinical Indication .......................................................................................................... 5
0.3 Responsibilities ............................................................................................................... 5
0.4 References ....................................................................................................................... 6
0.5 Definitions ....................................................................................................................... 6
0.6 Related Documents......................................................................................................... 6
1 PRE-EXAMINATION PROCESS ...................................................................................... 7
1.1 Training & Competency ................................................................................................ 7
1.2 Patient Preparation ........................................................................................................ 7
1.3 Primary Blood Specimens ............................................................................................. 7
1.4 Spillage of Clinical and Non-Clinical Waste................................................................ 8
1.5 Retention of Clinical Material and Records ................................................................ 8
1.6 Disposal of Clinical and Non-Clinical Waste............................................................... 8
2 EXAMINATION PROCESS................................................................................................ 8
2.1 Analytical Principle........................................................................................................ 8
2.2 Limitations of Analytical Procedure ............................................................................ 9
2.2.1 The device................................................................................................................. 9
2.2.2 Cross-reactivity & interferences ............................................................................ 9
2.2.3 Specimens unsuitable for analysis ......................................................................... 9
2.2.4 Safety Notices........................................................................................................... 9
2.3 Central Database and Connectivity.............................................................................. 9
2.4 Equipment....................................................................................................................... 9
2.5 Reagents/Consumables ................................................................................................ 10
2.6 Calibration .................................................................................................................... 11
2.7 Quality Assurance Programme................................................................................... 11
2.7.1 Internal Quality Control (IQC) ........................................................................... 11
2.7.2 External Quality Assessment (EQA) ................................................................... 14
2.8 The Test Procedure ...................................................................................................... 15
2.10 Maintenance................................................................................................................ 16
2.10.1 As required........................................................................................................... 16
2.11 Troubleshooting.......................................................................................................... 17
3 POST-EXAMINATION PROCESS .................................................................................. 18
3.1 Reference Values .......................................................................................................... 18
3.2 Reporting the Results................................................................................................... 18
3.3 Interpretative Comments ............................................................................................ 18
3.4 Reviewing Previous Results......................................................................................... 18
3.5 Performance Criteria................................................................................................... 18
3.6 Documentation.............................................................................................................. 19
3.7 Audit of Results and Indication .................................................................................. 19
3.8 Comparability............................................................................................................... 19
3.9 Uncertainty of Results.................................................................................................. 19
4 SELF ASSESSMENT OF COMPETENCY FORM........................................................ 20
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Luton and Dunstable University Hospital
Clinical Biochemistry
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0 INTRODUCTION
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0.1 Purpose and Scope
The Roche Accu-chek Performa glucose meters are used for the determination of glucose
concentration, mainly in capillary specimens, although arterial or venous specimens can also
be used. This document describes the procedure to be followed to ensure the provision of
accurate and reproducible patient results for the clinician to act upon.
It is essential that all staff using this equipment are properly trained and that quality assurance
procedures are performed regularly. Consequences for patients can be very serious if an
incorrect result is acted upon.
These meters are used mainly by GP surgeries, mental health trust units and outreach clinics
of the hospital. As the GPs and Mental health units are outside our Trusts scope we have tried
not to refer to Trust policies but to refer users to their own local policies. Those from inside
the Trust should refer to Trust policies.
0.2 Clinical Indication
Glucose analysis plays an important role in the evaluation of patients with diabetes and in
other circumstances such as patients on steroids or patients with signs and symptoms of
diabetes.
Glucose meters can only be used as a monitoring or screening tool and should not be solely
used in the following conditions:
 The acute management of unstable diabetic states e.g. DKA, HONK or Hypoglycaemia
(venous or arterial specimens may be of benefit in these cases, see details in section 1.2
Patient Preparation);
 To make a diagnosis of diabetes mellitus;
 To confirm a diagnosis of hypoglycaemia;
 Where the observed result is not in keeping with the patient’s clinical status;
 Where the patient has peripheral shutdown.
In these circumstances, diagnosis and treatment decisions should only be made after
laboratory confirmation of screening results, except hypoglycaemia where treatment may be
given on the basis of Performa blood glucose results of <4mmol/L. However laboratory
testing is required to confirm hypoglycaemia or if a patient is hypoglycaemic repeatedly.
0.3 Responsibilities
POCT Management group ensure:
 The responsibilities, authority and interrelationships of all personnel involved in
POCT are specified and communicated within the organisation;
 Staff performing POCT receive appropriate training, supervision and competence
testing;
 All proposals to introduce any product, device or system for POCT are evaluated for
their clinical effectiveness and cost efficiency;
 The selection of POCT devices and systems includes their practicability and the
comparability of their results with those obtained in the laboratory;
 The reports of the POCT quality assurance programme(s) are reviewed by the group
and advice on improvement is provided and implemented.
Senior Clinical Biochemistry Management Staff ensure:
 Departmental policies and procedures are in accord with the requirements of the
MHRA bulletins, Trust Medical Device Management Policy and Pathology
Accreditation [CPA(UK)Ltd] standards and any other quality standards to which the
organisation subscribes;
 The needs and requirements of the users are reviewed regularly;
 Persistent problems are escalated to the relevant manufacturer and actioned;
 Determining and documenting back up plans if equipment is out of action;
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Luton and Dunstable University Hospital
Clinical Biochemistry
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Clinical Biochemistry Staff with POCT responsibilities ensure:
 Regular tasks in the management of the POCT service are carried out;
 Persistent problems are notified to senior departmental staff;
Users ensure:
 Their annual training is kept up to date and they are competent to practice;
 The correct specimen is obtained from the correct patient under the correct
circumstances and the correct specimen is tested;
 The specimen is collected with minimal discomfort to the patient;
 The test is carried out according to the manufacturer’s instructions;
 The test is correctly recorded in the device or record book and in the patient’s notes;
 The specimen is disposed of according to local Policy;
 Clinical biochemistry POCT staff are informed in the event of problems with the
device;
 The results are reported as appropriate.
Practice Managers ensure:
 Users of the equipment keep their training up to date and maintain their competency.
 Adequate supplies of consumables are maintained;
 Appropriate resources are available;
 Proper records of training and competency are maintained;
 Ensures that faulty equipment is taken out of use;
 Notifies the POCT team if equipment is obsolete or no longer required;
Infection Control Nurse / Safety representative ensures:
 Performs a risk assessment for handling biological material;
 Advises on precautions to be taken when handling biological material including
spillages, and safe disposal.
 Advises on safety of products before purchase;
 Updates COSHH details and advises on precautions to be taken when handling all
material including spillage, breakage and disposal.
Manufacturers ensure:
 The user is kept up to date with information regarding the device and the associated
products that they provide;
 Provide training sessions for the user in order to provide competent use of the
instrument;
 Fulfil the criteria agreed in the purchasing contract or tender.
0.4 References
 Management and Use of IVD Point of Care Devices, MDA Bulletin DB2010(02) PDGEN-MDAPOCTMg
 LDH Point of Care Testing Policy MP-GEN-LDHPOCTPo
0.5 Definitions
The USER - any person who handles the device whether it is used directly to produce results
or indirectly for maintenance and Quality Assurance Procedures. This includes Clinicians,
Nursing Staff, Healthcare Scientists and Medical Equipment Technicians as necessary.
EQAS – External Quality Assessment Scheme
POCT – Point of Care Testing
SOP – Standard Operating Procedure
IQC – Internal Quality Control
MHRA – Medicines and Healthcare Products Regulatory Agency
0.6 Related Documents
 Accu-Chek Performa Blood Glucose Meter Owner’s Booklet LI-BIO-PerfOpMan
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Author D Cannon
Authorised by N A Vaughan
Luton and Dunstable University Hospital
Clinical Biochemistry




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Accu-chek Performa Test Strip Insert LI-BIO-InformStp
Accu-chek Performa Control Insert LI-BIO-InformIQC
Glucose Meter Patient Results and Quality Control record book
Performa Training Presentation MI-BIO-POCGluCom
1 PRE-EXAMINATION PROCESS
1.1 Training & Competency
Blood glucose testing may only be carried out by trained and competent users. If no trained
users are available, a fluoride EDTA (yellow topped) specimen must be sent to the laboratory
with an ICE request or manual request form.
Blood testing shall only be performed by authorised personnel who must use appropriate
personal protective equipment.
Training is available from your local POCT team who can be contacted on 01582 497991.
For sites in our EQA scheme 1 hour of training is available a year.
1.2 Patient Preparation
When there is decreased peripheral blood flow (peripheral shutdown), capillary blood does
not represent the whole body situation and therapeutic decisions must not be based on
capillary specimens. Examples of such situations include, but are not limited to:
 Severe Dehydration
 Hypotension
 Shock
 Peripheral circulatory failure
 Hyperosmolar non-ketotic coma (HONK)
 Diabetic Ketoacidosis (DKA)
 Unconscious patients
 Peripheral vascular disease
 Decompensated heart failure (NYHA Class IV)
In the above situations, capillary blood may give much lower results than comparative venous
or arterial specimens and a fluoride EDTA specimen (yellow top) should be sent to the
laboratory for analysis (do not use this specimen on the Performa meter) or venous/arterial
blood can be used on the test strip. If using arterial or venous blood on the glucose meter
ensure there is minimal delay (less than 5 minutes) between the specimen being taken and it
being applied to the strip. If sampling from a venous or arterial line the line must be flushed
before drawing the specimen.
1.3 Primary Blood Specimens
Always remember to gain consent from the patient before taking a blood specimen.
To obtain a good capillary blood specimen the following steps should be followed:
1. Wear protective gloves
Reason – health and safety precautions for exposure to bodily fluids.
2. Prepare the patient’s skin
If mobile the patient should be encouraged to wash their hands with soap and water and
thoroughly dry them. If you can not wash the whole hand, ensure the site to be punctured
is clean and dry; damp gauze followed by dry gauze is recommended.
Do not use alcohol gel or any other alcohol containing product to clean the lancing
site as this will cause falsely low results by deactivating the enzyme used in the strip.
Reason – washing the site ensures that no contaminants (e.g. any food residues containing
glucose) transfer to the test strip leading to a falsely high result. Drying the site ensures
that a drop of blood forms and that the blood is not contaminated with any fluid on the
skin causing a falsely low result.
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Clinical Biochemistry
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3. Promote blood flow to the site
Try to ensure the patient’s hands are warm and have good blood flow (washing the hands
as above with soap and water can help with this). Allow the arm to hang down by the side
for a few seconds and flex the elbow and fingers.
Reason – promotes good blood flow towards the fingertips to produce a good specimen
for testing.
4. Prick the finger
When lancing the finger, use the side of the finger between the nail and the pad.
Avoid using the index finger and thumb or any finger with a ring on it. Prick the finger
using your lancet.
In the hospital we use Unistik 3 Comfort (purple) or Unistik 3 Normal (yellow).
To use the Unistik lancet, hold the body and twist off the lancet cap until it separates from
the device (do not pull) and dispose of it. Identify the lancing site and press the newly
revealed end firmly against the finger and press the release button. The single use needle
retracts immediately leaving the device safe for immediate disposal into a sharps bin.
It is important that you utilise a single use lancet to minimise the risk of infection.
Reason – the side of the finger is less painful as there are fewer nerve endings and it is
also where capillaries flow up the side of the finger. It is easier to apply the drop of blood
to the test strip from the side of the finger. The index finger and thumb are the most used
digits and so it is less painful to the patient if they are not used.
5. Wait a few seconds before milking the finger
Allow a few seconds to elapse after lancing the finger and rather than squeeze the
puncture site, milk the blood down from the hand through the finger by gentle massage.
After sampling ensure the patient applies pressure and some gauze to the lanced area to
staunch the blood flow.
Reason – Allow a few seconds after lancing the finger because the capillaries do not
bleed immediately. The blood will flow more easily if the lanced area is not squeezed; if
the finger is squeezed too hard, capillaries contract preventing blood flow and squeezing
the puncture site will contaminate the specimen with tissue fluid causing falsely low
results.
1.4 Spillage of Clinical and Non-Clinical Waste
Spillage of Clinical and Non-clinical waste must be dealt according to your local policy. The
meter, workstation and any other consumables must be cleaned regularly and particularly if
any spillages occur. Tissue and water should be used to remove blood spillages followed by a
PDI Sanicloth 70 (or other cleaning cloth/material containing 70% isopropyl alcohol). The
meter must be cleaned between every patient with a PDI Sanicloth 70 (or other cleaning
cloth/material containing 70% isopropyl alcohol).
1.5 Retention of Clinical Material and Records
The patient’s results should be immediately recorded in the Log Book and the patient’s
medical notes.
1.6 Disposal of Clinical and Non-Clinical Waste
Clinical and Non-clinical waste must be disposed of according to your local policy. Dispose
of used test strips as clinical waste. Dispose of used lancets as sharps.
2 EXAMINATION PROCESS
2.1 Analytical Principle
Glucose is analysed by amperometry. The enzyme on the test strip, a mutant version of
glucose dehydrogenase (Mut.Q-GDH), converts glucose in the blood specimen to
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gluconolactone. This reaction creates a harmless electric current that the glucose meter
interprets to give a blood glucose result. The specimen and environmental conditions are also
evaluated using a small electrical signal.
2.2 Limitations of Analytical Procedure
2.2.1 The device
Test strips: There are no effects when the test strips are stored between 2°C and 30°C.
Do not freeze. Test strips should only be used between 8°C and 44°C and between 1090% humidity. Do not store test strips in high heat or humidity atmospheres.
Strips must always be stored in their original container with the cap closed. When
removing a test strip from the container close the cap immediately and use the test
strip straight away.
Performa glucose meter: There are no effects on results when the Performa meter is
used at temperatures between 12oC and 47oC or at humidity levels <90% at 32oC.
For a complete list of interferences, limitations and cross reactivity refer to the test
strip insert. The measuring range of the device is 0.6 to 33.3mmol/L. Results less than
0.6mmol/L will be recorded as ‘LO’, results greater than 33.3mmol/L will be recorded
as ‘HI’.
2.2.2 Cross-reactivity & interferences
The following substances when in excess of the interference limit may produce falsely
elevated glucose results. For haematocrit; a low haematocrit can cause a falsely high
glucose result and a high haematocrit can cause a falsely low glucose result.
Substance
Interference Limit Example/Note
Galactose
>0.83 mmol/L
Galactosaemia
Triglycerides
>20.3 mmol/L
Extremely lipaemic blood (very high triglycerides)
Ascorbic acid >0.17 mmol/L
Intravenous administration of ascorbic acid
Haematocrit
<10% or >65%
Severe anaemia or polycythaemia
2.2.3 Specimens unsuitable for analysis
Anticoagulants containing fluoride or iodoacetate may interfere with test results, so
blood taken from a yellow topped specimen container cannot be used on the Performa
II meter as false results will be produced. Alcohol from alcohol wipes or hand rub will
also prevent the test from working properly. A list of common interferences is found
in the pack insert.
2.2.4 Safety Notices
There are no current safety notices for this device.
2.3 Central Database and Connectivity
There is currently no connectivity or central database for the Performa meters
2.4 Equipment
The Performa meters are supplied by Roche diagnostics and will be kept in a workstation in
your area of work. Replacement meters can be obtained via the POCT team on 01582 497991
if required.
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Clinical Biochemistry
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IR Window
On/Off/Set Button
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Code Chip Slot
Display
Right and
Left
Arrow
Buttons
Battery Door
Test Strip Slot
2.5 Reagents/Consumables
Item
Single use Lancets
Gauze
Cleaning materials
Internal Quality
Control (IQC)
External Quality
Assurance (EQA)
Batteries
Test strips
Workstations
Record books
Source
Local Supplies
Local Supplies
Local Supplies (cloth or similar must contain 70% isopropyl alcohol)
POCT team (supplied on an automatic rolling programme every 3
months)
POCT team (every 2 months)
POCT team
For GP surgeries a limited number of free of charge strips are
available through the POCT team.
For Mental Health Units/outreach clinics supplies are via L&D
Pharmacy
POCT team
POCT team
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Clinical Biochemistry
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2.6 Calibration
Roche test strips may experience 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.
You will need to insert a new code key:
 Whenever you open a new box of strips
 Whenever one of these displays appear:
No code key
Incorrect code key
Expired lot
To calibrate the meter:
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 with a code key that
matches your batch of strips.
.
2.7 Quality Assurance Programme
2.7.1 Internal Quality Control (IQC)
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
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 Each day before 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
We recommend that in low use areas IQC is carried out on a weekly basis regardless of
whether patient testing is taking place. IQC material is stable 3 months from the date of
opening. The POCT team therefore send out IQC on a 3 monthly basis to all the sites in
our EQA scheme. The bottles are labelled with the date of their expiry. No area should
therefore be without in date quality control material, however if these bottles are lost or
damaged replacements can be obtained from the POCT team.
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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.
5. Gently mix the IQC samples
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.
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 also printed on the
test strip container label. “ERR” and the control result
alternate on the display if the result is not in range.
Remove the test strip and discard it.
10. Record result in the record book.
11. If the result is within the expected range you can
continue with patient testing.
If the result is outside the expected range do not use
the meter for patient testing. Check expiry dates,
storage conditions and procedure, re-mix QC and retest
If results now in range – proceed with patient testing
If results still out of range – Refer to the
Troubleshooting guide (Section 2.10) for further
information. Or contact the POCT team on 01582
497991 for further information/discussion.
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Author D Cannon
Authorised by N A Vaughan
LI-BIO-POCTPerf
Edition Number 1.0
Page 13 of 21
Luton and Dunstable University Hospital
Clinical Biochemistry
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2.7.2 External Quality Assessment (EQA)
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 every two months. WEQAS provide aqueous solution that contains an unknown
concentration of glucose. The sample will be forwarded to each registered participant by
the POCT team. EQA should be tested on every meter in exactly the same way as a
sample from a patient. Each meter receives its own letter and the serial number of the
meter is noted and should be checked against the number on the reverse of the meter.
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 (also record the
results in your record book). When the results are returned to the POCT team they log the
results on the WEQAS website, the accuracy of your meter/test strips/operator is then
checked. A report of your performance is then returned to your area and should be kept
with your records. Performance is highlighted as green (good), yellow (acceptable) or red
(poor performance/unacceptable). It is important that the EQA results are returned as it is
the only true way to check the meters, consumables and operators performance. Poor
performance and non-returns will be followed up with each area individually. Poor
performance is defined as a result >15% from the mean. For Trust sites poor performance
or non-returns are recorded and managed as non-conformities.
Please note it is good practice to maximise the number of users involved in EQA sample
analysis in order to monitor the overall performance.
Example of our EQA distribution letter:
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Author D Cannon
Authorised by N A Vaughan
Luton and Dunstable University Hospital
Clinical Biochemistry
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2.8 The Test Procedure
Each user of the Performa meter must be trained and be assessed as competent (See
Appendix 1 – Self assessment competency form).
If the meter is not working report the problem to the POCT team on 01582 497119 (Mon-Fri,
9am-5pm) and/or follow the Troubleshooting guide (Section 2.11). If you have more than
one meter in your area please use an alternative, if this is not possible an ICE request form or
manual request must be made and accompanied by venous blood taken into a yellow topped
bottle and sent to the local laboratory.
Gloves must be worn when using the meter for patient testing.
Ensure the IQC has been performed prior to patient testing on this day.
Ensure the test strips are in date by checking the expiry date on the side of the pot.
Performing a patient test:
1. Open test strip pot and remove a test strip. Replace the cap on
the pot of strips ensuring you hear a click to show the lid is on
tightly. Insert the strip into the meter.
2. Check that the code on the meter matches the code on the vial
of test strips you are using.
3. Ensure the test strip symbol stops flashing and a blood drop
has appeared on the display.
4. Lance the finger according to the instructions in section 1.2
5. Touch the drop of blood to the front edge of the yellow window of the
3.
.
test strip (do not put blood on top of the test strip).
6. When you see the flashing hour glass you have enough blood
on the test strip. If you applied blood, but do not see the
flashing hour glass you may reapply more blood within five
seconds.
7. Your result appears on screen. Record result immediately in
your record book and in the patient’s notes.
5/6.
8. Remove and dispose of test strip, lancet and any soiled materials in line
with local policy on clinical waste.
9. Switch off the meter.
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Author D Cannon
Authorised by N A Vaughan
7.
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Luton and Dunstable University Hospital
Clinical Biochemistry
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2.9 Results
Record the results in the Patient Result and Quality Control Book and in the patient’s notes.
The Patient Results and Quality control book must contain the following:
 Date
 Time
 Quality Control Results
 Patient’s NHS number or DOB
 Patient’s first and last names in full
 Patient’s result
 Comments/Action taken
 User’s signature
 Print name of user
The book should be kept with the meter and when full kept in a secure place for the lifetime
of the meter (or if required by other guidelines for the longest time period necessary). Any
problems, error codes or breakdowns should be recorded in the book.
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. Do not attempt to
review the result in the meter memory; this is unsafe as they are not linked to patient
demographics.
2.10 Maintenance
The user is responsible for the routine maintenance of the meter
2.10.1 As required
 Cleaning
The meter should be cleaned regularly, always clean the meter if there is visible
soiling and preferably clean the meter additionally once a week.
Wear gloves to clean the meter and always switch the meter off before cleaning.
Wipe with a slightly moist cloth and mild cleaning agent. We recommend PDI
Sanicloths or similar cleaning cloth containing 70% isopropyl alcohol. Do not use
regular alcohol wipes. 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
The meter uses one 3-volt lithium battery that lasts for approximately 2000 tests.
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, remove the battery.
Insert the new battery with the + side up i.e. visible to you.
Put the battery door back in place and snap it closed.
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Author D Cannon
Authorised by N A Vaughan
Luton and Dunstable University Hospital
Clinical Biochemistry
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2.11 Troubleshooting
Should you have any queries or problems please feel free to contact the POCT team for
advice on 01582 497991. Some additional useful information is detailed below.
Repeated IQC Failures:
In no circumstances should the Performa meter be used if the QC does not pass as incorrect
patient results will be produced. If IQC fails, repeat the QC and check the following:
 Ensure you use the correct QC solution (L1 with Control 1 or L2 with Control 2)
 Ensure you select the appropriate control result level (L1 or L2)
 Ensure you gently mix the QC solution before processing the test
 Check expiry date of strips and Performa Glucose Control solution (NB. Once the
solutions are opened they expire after three months but should be labelled with the
date of expiry). If either or both of these are out of date, change them (you may
need to call the POCT team to get replacements) and then repeat the test.
If the QC still fails:
 If you have more than one meter at your site try the QC solutions from the other
meters box, if this passes, the QC solutions which have been failing are probably
at fault. This can occur if the lids of the bottles are swapped over or if the lids are
left off the solutions. Call the POCT team to get the solutions replaced.
 If you have a spare box of test strips open these, calibrate the meter using the
code/calibration key and run QC. If the QC then passes it is likely the old test
strips were at fault. This can happen if the lid is left open on the test strips as they
absorb moisture from the atmosphere and deteriorate. Call the POCT team to get
a new pot of strips.
 Very rarely there may be a problem with the meter and this may need to be
replaced. Call the POCT team to arrange this.
Error codes:
A list of error codes and suggested actions is included in your user manual, but a summary is
detailed below:
E1 – The test strip is damaged. Remove the test strip and reinsert it, or replace it if damaged.
E2 – The code chip is incorrect. Turn off the meter and insert a new code chip.
E3 – An error occurred during the test. Discard the test strip and repeat the test.
E4 – Not enough blood or control solution was drawn into the test strip for measurement or
was applied after the test has started. Discard the test strip and repeat the test.
E5 – The code chip is from an expired lot of test strips. Ensure the code chip number matches
the code number on the test strip container. Make sure the time and date in the meter are
correct (see user manual).
E6 – Blood or control solution was applied to the test strip before the flashing drop appeared
on the display. Discard the test strip and repeat the test.
E7 – An electronic error occurred or, in rare cases a used test strip was removed and
reinserted. Turn the meter off and on, or take the battery out for a few seconds and reinsert it.
Perform a control test.
E8 – The temperature is above or below the acceptable range for the meter (6-44oC). Move to
an area with a temperature within the range and wait five minutes before repeating the test.
Do not artificially heat or cool the meter.
E9 – The battery is almost out of power. Change the battery now.
E10 – The time and date settings may be incorrect. Make sure the time and date are correct
and adjust if necessary (see user manual).
In any case if you can not solve the problem contact the POCT team on 01582 497991.
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Author D Cannon
Authorised by N A Vaughan
Luton and Dunstable University Hospital
Clinical Biochemistry
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3 POST-EXAMINATION PROCESS
LI-BIO-POCTPerf
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3.1 Reference Values
There is no stated reference range for a random glucose result.
Blood glucose varies widely even within the individual patient depending on the time of their
last meal, especially in known diabetics.
3.2 Reporting the Results
The person performing the test is responsible for the results.
If the result is unexpected or very abnormal please check all procedures and re-check IQC.
Repeat patient test if IQC is within range. The requesting Doctor should be informed
immediately of any unexpected or clinically significant results. If there is concern over the
results contact senior staff in your area or the POCT team for further advice.
3.3 Interpretative Comments
Alert critical values - Results <2.5 mmol/L and >20 mmol/L should be confirmed by the
Clinical Biochemistry Department. Please send a blood sample in a yellow topped tube for
glucose confirmation. All tests not in keeping with the patient presentation should be
confirmed by sending a venous specimen of blood to the laboratory.
Decisions on treatment should be made by appropriate staff in your area taking into account
the limitations of the device and remembering factors such as:
 Failure to wash the hands can result in falsely high results if the hands are
contaminated with glucose
 Washing the hands with alcohol can cause falsely low results
 When there is decreased peripheral blood flow (peripheral shutdown), capillary blood
does not represent the whole body situation and therapeutic decisions must not be
based on capillary specimens. Examples of such situations include, but are not limited
to:
o decompensated heart failure (NYHA Class IV).
o diabetic ketoacidosis (DKA)
o peripheral vascular disease
o shock
o severe dehydration
o hypotension
o peripheral circulatory failure
o hyperosmolar non-ketotic coma (HONK)
o unconscious patients
In the event of peripheral shutdown venous or arterial blood from a plain syringe can be used
on the meter.
For patients with known diabetes and glucose results <4mmol/L consider treatment
appropriate for hypoglycaemia.
3.4 Reviewing Previous Results
No attempt should be made to retrieve the result from the instrument memory.
Previous results can only be reviewed in the patient’s notes or from the Patient Results and
Quality Control Record Book.
3.5 Performance Criteria
The system is calibrated with reference to the glucose hexokinase method and is traceable to a
NIST standard. The r2 correlation value in comparison studies range between 0.94 and 1.06.
The system accuracy according to EN ISO 15197 showed that 199 out of 200 specimens
(99.5%) are within the minimum acceptable performance criteria.
The mean within series imprecision is <3.5%, CV 3.3%.
The mean day-to-day imprecision is <1.7%, CV 1.6%.
The detection limit is 0.6mmol/L.
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Author D Cannon
Authorised by N A Vaughan
Luton and Dunstable University Hospital
Clinical Biochemistry
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3.6 Documentation
Patient results are documented according to Section 2.7
3.7 Audit of Results and Indication
EQA results are used to audit this process. In addition all POCT is subject to periodic
horizontal and vertical audits and spot checks.
3.8 Comparability
Comparability data between the Performa test strips and the laboratory method is available
from the POCT team on request. It is logged on the QPulse document control system in the
laboratory.
3.9 Uncertainty of Results
The degree of uncertainty for results is expected to be within acceptable limits provided all
calibration and control procedures have been followed correctly and that the sample
collection, identification and processing has been followed correctly.
See section 2.2 Limitations of Analytical Procedure and 3.5 Performance Criteria
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Author D Cannon
Authorised by N A Vaughan
Luton and Dunstable University Hospital
Clinical Biochemistry
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4 SELF ASSESSMENT OF COMPETENCY FORM
POCT Annual Self-Assessment Competency Statement for
Glucose testing using the Roche Performa Glucose Meter
Do not use this device unless you are competent to do so
Surname: …………………………….
Forename(s): ………………………….
Location: …………………….........
Job Title: ………………………………..
Self-verification of competence is undertaken by assessment against the statements below.
These statements are designed to help you assess your competency to use this POCT (Point of
Care testing) equipment. Responsibility for safe use remains with you, so if you are in any
doubt regarding your competence to use the device, you should seek guidance.
You must be able to answer yes to all the questions before considering yourself competent
and completing the competency statement in section B overleaf. If you are in any doubt or
feel that you are not competent please complete section A over leaf and contact the POCT
team (Ext 7991) or your manager to instigate further learning or training.
Ask yourself the following general questions:
1. Have I attended a training session about the device in the last year?
2. Have I performed a patient test under supervision by a competent
practitioner?
3. Have I read the Standard Operating Procedure (SOP) for the device?
(These can be found on the Intranet under Point of Care Services)
4. Do I know what infection control precautions to take when using the
device?
5. Do I know the circumstances when the device should not be used
including test interferences and limitations?
6. Do I know what action to take based on the results, including if the
result is unexpected or suspicious?
7. Do I know when and where to seek help, or how to report an error or
incident?
Ask yourself the following device specific questions:
8. Do I know how and why the finger must be cleaned before testing?
9. Do I understand that glucose testing should not be carried out on a
finger prick sample in patients who are peripherally shutdown?
10. Do I know when and how to carry out a Quality Control (QC) test?
11. Do I know when and how to carry out Calibration on the meter?
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Author D Cannon
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Response
Yes / No
Yes / No
Yes / No
Yes / No
Yes / No
Yes / No
Yes / No
Yes / No
Yes / No
Yes / No
Yes / No
Luton and Dunstable University Hospital
Clinical Biochemistry
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POCT Annual Self-Assessment Competency Statement for
Glucose testing using the Inform II Glucose Meter
Do not use this device unless you are competent to do so
Surname: …………………………….
Forename(s): ………………………….
Location: …………………….........
Job Title: ………………………………..
Complete either Section A or B whichever is appropriate to you.
Section A
I require further training before I can use the Inform II glucose meter for testing in a
competent manner.
Signed:……………………………….
Date:…………………………………….
Section B
I certify that I am aware of my responsibility for continuing professional development and I
understand that I am accountable for my actions. With this in mind I make the following
statement:
I am competent to use the Inform II glucose testing POCT device
Signed:……………………………….
Date:…………………………………….
Please return this form to the POCT team, Clinical Biochemistry, Luton & Dunstable
Hospital. Telephone Ext 7991. We suggest you also keep a copy for your personal records.
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