SOP for Abbott Precision Xceed Pro/FreeStyle Precision Pro Glucose Meter

SOP for Abbott Precision Xceed Pro/FreeStyle Precision Pro Glucose Meter
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
Effective date: 4/9/15
COPY
Summary of Significant Changes at this Revision
Add Freestyle Precision Pro (FPP) glucose meters to SOP.
These are the next technical version of glucose meters after the PXP - but they operate in the same way.
The FPPs will be introduced gradually alongside the PXPs.
Purpose and Scope
Items Required
1. The Abbott Precision Xceed
Pro/FreeStyle Precision Pro meter is
a battery-powered device designed
for the measurement of blood
glucose in a Point of Care setting.
2. The meter uses single-use test
strips to measure the concentration
of glucose in fresh capillary, venous,
arterial or neonatal whole blood
samples.
1. Abbott Precision Xceed Pro Meter
2. FreeStyle Precision Pro Meter
3. Abbott Precision Xceed Pro Blood
Glucose Test Strips
4. MediSense Glucose & Ketone
Control Solutions
5. WEQAS External glucose EQA
sample
6. Lancing Devices
Definitions and Abbreviations
Grade / Qualifications Required
PXP = Precision Xceed Pro
FPP = FreeStyle Precision Pro
POCT = Point of Care Testing
NPT = Near Patient Testing
IQC = Internal Quality Control
QC = Quality Control
EQA = External Quality Assurance
Nursing Staff: All Trained operators
Health Care Assistants: All trained
operators
Biomedical Scientists – all grades
Supervised Trainee BMS Staff
Copy number
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2
Location held
Manual Lab – Glucose Meters SOP File
Electronic Copy – POCT section of intranet
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
Checked by: H Witham
Approved by: H Witham
Page 1 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
Effective date: 4/9/15
Contents
1. Principle ........................................................................................................................... 3
2. Precision Xceed Pro/FreeStyle Precision Pro System Components................................ 3
3. Calibration........................................................................................................................ 3
4. Internal Quality Control (IQC) .......................................................................................... 3
6. Patient Preparation .......................................................................................................... 4
7. Patient testing .................................................................................................................. 4
8. Recalling Patient Results ................................................................................................. 6
9. External Quality Assurance (EQA) ................................................................................... 6
10. Limitations of the Precision Xceed Pro/FreeStyle Precision Pro Meter .......................... 6
11. Limitations of Procedure ................................................................................................ 7
12. Maintenance .................................................................................................................. 7
13. Audit............................................................................................................................... 8
14. COSHH and Health and Safety ..................................................................................... 8
15. Adverse Incidents .......................................................................................................... 8
16. Operators ....................................................................................................................... 9
17. Data Upload ................................................................................................................... 9
18. Docking Station .............................................................................................................. 9
19. References .................................................................................................................... 9
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
Checked by: H Witham
Approved by: H Witham
Page 2 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
Effective date: 4/9/15
1. Principle
Glucose measurement: Bioamperometry
Glucose in the blood reacts with the enzyme NAD-glucose dehydrogenase on the test
strip. The chemical reaction releases NADH, which then reduces Phenanthroline Quinone.
A voltage is applied across the test strip. The current generated from the sample is
proportional to the concentration of glucose in the sample and is expressed in mmol/l.
2. Precision Xceed Pro/FreeStyle Precision Pro System
Components
- Workstation
- Precision Xceed Pro/FreeStyle Precision Pro glucose meter
- Precision Xceed Pro glucose test strips
- Medisense High and Low Control Solutions
- Docking station
When not in use, always store the meter in the workstation.
3. Calibration
Scanning the barcode label on each glucose test strip foil packet prior to use automatically
calibrates the meter and checks the expiry date.
Glucose test strips are stable up to the expiry date stated on the packaging - store
between 40 and 300C.
Retain package insert until box of test strips has been used.
4. Internal Quality Control (IQC)
IQC solutions – Abbott Medisense Glucose & Ketone Control Solutions – Lo and Hi.
Stability: Unopened – up to expiry date stated on bottles/box.
Opened – 90 days from time of opening – expiry date to be noted on bottles.
Both Lo and Hi controls must be assayed.
IQC must be performed on each individual Precision Xceed Pro/FreeStyle Precision Pro
glucose meter daily.
The Precision Xceed Pro/FreeStyle Precision Pro glucose meters are formatted to request
QCs every 24 hours – the message ‘Glucose QC Due Now’ will be displayed, and the
system will be locked out until acceptable results for both Lo and Hi QCs have been
obtained:
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
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RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
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Effective date: 4/9/15
Press On/Off to turn on the meter – the Abbott logo and software version will be
briefly displayed.
Press 2. Control Test.
Press SCAN to scan the Operator ID barcode.
Press SCAN to scan the low control solution lot no. barcode.
Press SCAN to scan the glucose test strip barcode.
Open the foil test strip packet at the notch and tear down to remove the test strip.
With the black contact bars facing up, insert the strip into the test strip port until it
stops and Strip Inserted is displayed.
Gently invert the required control solution bottle 3-4 times.
Remove the cap and wipe the nozzle with a clean gauze or tissue.
Apply a small drop of solution to the test strip target area, allowing the target area
to fill completely.
Wipe the nozzle of the control solution bottle before replacing the cap.
N.B. Apply the QC solution with the meter in a horizontal position to avoid it
entering the strip port.
When sufficient sample has been applied, the meter bleeps, displays Sample
Accepted, and automatically starts the test.
Control results appear as PASS or FAIL after a 20 second countdown.
If a PASS result is obtained for the Lo QC press 1. Next Level, and repeat the
procedure using the Hi QC.
If a FAIL result is obtained for the Lo QC press 2. Repeat Test, and repeat the
procedure with the Lo QC.
The system will be locked out until acceptable results have been obtained for both
Lo and Hi QCs.
After the Hi QC select 1. Exit, then 1. Patient Test – then follow the patient testing
procedure.
Press On/Off to turn off the meter when all tests are completed.
6. Patient Preparation
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Wash your own hands and put on gloves prior to patient testing
The site of sampling should be chosen to cause minimum discomfort and skin
damage.
The site of the puncture must be cleaned before collecting the sample
7. Patient testing
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Press On/Off to turn on the meter – the Abbott logo and software version will be
briefly displayed.
Press 1. Patient Test.
Press SCAN to scan the Operator ID barcode.
Manually enter the Patient ID via the keypad and press Enter.
Press SCAN to scan the glucose test strip barcode.
Insert Strip is displayed.
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
Checked by: H Witham
Approved by: H Witham
Page 4 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
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Effective date: 4/9/15
Open the foil test strip packet at the notch and tear down to remove the test strip.
With the black contact bars facing up insert the strip into the test strip port until it
stops and Strip Inserted is displayed.
Apply Sample is then displayed.
Apply a drop of blood from the patient’s finger to the strip with the meter in a
horizontal position to avoid it entering the strip port.
When sufficient sample has been applied the meter beeps, displays Sample
Accepted and automatically starts the test.
The result, date and time are displayed after a 20 second countdown.
N.B. If insufficient sample has been obtained, then no beep will be heard and
Sample Accepted will not be displayed – in this case a repeat blood sample will
have to be obtained from the patient in order to repeat the test – and this must be
recorded in the patient’s notes – and recorded as an incident in Datix if appropriate
If it is not possible to obtain an adequate blood sample for testing by the finger
prick method, then this must also be recorded in the patient’s notes - and recorded
as an incident in Datix if appropriate - and a venous sample should be collected
and sent to the biochemistry laboratory for confirmation of the glucose.
The action range is set at 4.0 – 15.0 mmol/l on all PXP/FPP meters - except
NICU
N.B. The action range for NICU PXP/FPP meters is 2.8 – 10.0 mmol/l (at request
of NICU consultant Bernie Marden)
Results above the action range will be displayed with ▲ next to the result
Results below the action range will be displayed with ▼ next to the result.
If results are above or below the action range then a blood sample should be
collected into a fluoride oxalate tube and sent to the biochemistry laboratory for
confirmation of the glucose.
The lower analytical range for the meter is 1.1mmol/l – results less than this will be
displayed as <1.1 mmol/l
The upper analytical range for the meter is 27.8 mmol/l – results greater than this
will be displayed as >27.8 mmol/l.
Remove the test strip from the test strip port and dispose of appropriately.
The following options will then be displayed:
- 1. Next Patient – Select to run another patient sample.
- 2. Patient History – Select to display the last test result for this patient as well
as allowing previous results to be viewed.
If all tests are completed press On/Off to turn off the meter.
Record the glucose result in the patient’s case notes.
As well as recording the result in the patients notes also record the date/time
performed, the device (including location), the test strip number and the operator
identity (of person performing the test and person transcribing the result - if
different).
N.B. If any blood glucose result is <4mmol/l the patient must be treated as per
the RUH hypoclycaemic protocol (except neonates on NICU – refer to
departmental protocol)
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
Checked by: H Witham
Approved by: H Witham
Page 5 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
Effective date: 4/9/15
8. Recalling Patient Results
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Press On/Off to turn on the meter – the Abbott logo and software version will be
briefly displayed.
Press the Menu button.
Press 1. Data review.
Press SCAN to scan the Operator ID barcode.
The options in data review are:
- Patient by Operator ID
- Patient by Patient ID
- All Patient Data
9. External Quality Assurance (EQA)
External Quality Assurance/Control differs from IQC in that the accuracy of the procedure
is not known until after the results have been issued. The user does not know the glucose
concentration at the time of analysis and the results are assessed independently.
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An EQA sample is distributed to all authorised Precision Xceed Pro/FreeStyle
Precision Pro meter users every three months by biochemistry with a result sheet.
The sample must be analysed (as per Patient Testing) on every Precision Xceed
Pro/FreeStyle Precision Pro meter located on the ward/department.
Record the serial number of each individual meter that is used and record the
glucose result for the EQA sample.
Return the result sheet to the biochemistry department.
10. Limitations of the Precision Xceed Pro/FreeStyle Precision
Pro Meter
All point of care testing devices have limitations and these should be remembered at all
times.
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The blood glucose meter alone cannot make a diagnosis of diabetes or
hypoglycaemia and a confirmatory sample must be sent to the laboratory.
All results must be interpreted with respect to the patient’s condition.
If an unexpected high or low glucose result is obtained, a repeat test must be
performed and a venous sample sent to the biochemistry laboratory.
If a glucose result is <4.0 mmol/l or >15.0 mmol/l a venous sample should be sent
to the biochemistry laboratory for confirmation.
Blood Glucose Action Limits by Non - Qualified Staff : Blood Glucose results
<4 mmol/l or >15 mmol/l must be reported to a trained member of the
nursing/medical staff.
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
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Approved by: H Witham
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RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
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Effective date: 4/9/15
The glucose test strip has been evaluated with neonatal blood. As a matter of
good clinical practice, caution is advised in the interpretation of neonate glucose
values <2.8 mmol/l.
11. Limitations of Procedure
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Precision Xceed Pro test strips are designed for use with fresh whole blood.
The minimum sample volume is 0.6 µl.
The system is not designed for use with serum or plasma samples.
Do not use blood collected into fluoride or oxalate.
Venous and arterial whole blood samples collected into lithium heparin and EDTA
may be used if analysed within 30 minutes.
Care should be taken to clear arterial lines before blood is drawn and applied to the
test strip.
Blood glucose results are displayed as mmol/l.
Use meter between 150and 400C.
Store the test strips between 40 and 300C.
Haematocrit range is 20%-70%.
Test results may be erroneously low if the patient is severely dehydrated, severely
hypotensive, in shock or in a hyperglycaemic-hyperosmolar state (with or without
ketosis).
Do not use during intravenous infusion of high dose ascorbic acid or during xylose
absorption testing.
The following substances have no significant effect on blood glucose results:
Substance
Bilirubin (unconjugated)
Cholesterol
Triglycerides
Uric Acid
Maltose
Galactose
Paracetamol
Ascorbic Acid
Concentration Up To
684µmol/l
12.95mmol/l
16.95mmol/l
1.39mmol/l
3.21mmol/l
2.50mmol/l
1.3mmol/l
284µmol/l
12. Maintenance
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Store the meter in the workstation case.
Cleaning the exterior surface of the monitor:
• Clean surface of meter with damp cloth and mild soap.
• Turn off the meter prior to cleaning.
• It is acceptable to clean the surface with hospital detergent wipes, 70% Alcohol or
10% Ammonia.
• Do not clean the strip port.
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
Checked by: H Witham
Approved by: H Witham
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RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
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Effective date: 4/9/15
Do not pour liquid into the strip port or buttons.
Do not place the meter in water.
Replacing the Batteries:
• Batteries: The meter will display an empty battery icon and Low Battery when a
battery change is required.
• Replacement batteries are available from biochemistry Ext. 4712.
Replacing the Port Protector:
Should blood or control solution come into contact with the port protector, the meter should
be cleaned and dried, and the port protector replaced.
• Replacement port protectors are available from Biochemistry Ext 4712.
• Lift the port protector from its left or right edge – using a flat tool device e.g. small
screw driver – N.B. Do not insert tool into strip port opening.
• Carefully pry the protector until it separates from the meter.
• Discard the port protector as a biohazard.
• Rest the flat bottom of the new port protector on the ledge of the test strip port.
• Push both sides of the port protector until the tabs snap into place.
• There should be no gap between the port protector and the meter around the
edges.
13. Audit
It is the laboratory’s responsibility to carry out regular audits of the Precision Web system
and the various aspects of glucose meter usage within the RUH.
14. COSHH and Health and Safety
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Precision Xceed Pro test strips: No Hazard
Medisense Lo and Hi Control solutions: No Hazard
External Quality Assurance (EQA) samples: Treat as Biohazard
Gloves must be worn at all times when processing controls, EQA and patient
samples.
Dispose of all test strips, finger pricking device, port protectors, control solutions
and EQA in a sharps bin or yellow bag for incineration as appropriate.
15. Adverse Incidents
Any adverse incidents regarding the use of the Precision Xceed Pro/FreeStyle Precision
Pro blood glucose meter must be reported via the ward manager/practice manager to the
Point-of-Care testing committee for evaluation and reporting on to the MHRA.
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
Checked by: H Witham
Approved by: H Witham
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RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
Effective date: 4/9/15
16. Operators
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Only staff that are trained in accordance with the Precision Xceed Pro/FreeStyle
Precision Pro blood glucose meter Training Programme for the Trust, and are
certificated, are authorised to use the Precision Xceed Pro/FreeStyle Precision Pro
glucose meter.
Training is provided by an Abbott Nurse Educator, Diabetes Liason Nurses or by
the Link Nurse.
Refresher training may be provided by a Link Nurse.
Refer to the NMC Professional Conduct Code 2008 and RUH Policies.
17. Data Upload
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Data uploading is required once every 24hrs.
Upload Due Now message will be displayed when this is required and the meter
cannot be used until this has been completed.
To start the upload of data place the meter into the docking station.
The monitor will first turn on, if it isn’t already, and then automatically upload data
to the management system.
During communications, the Data Uploading screen appears, with rotating arrows
to indicate that the system is working.
The arrows may occasionally pause.
Data transfer takes approximately 10 – 20 seconds.
During data upload the meter cannot be used for testing.
After upload is complete, the meter will display Upload Successful, Turning Off
and then shut down.
If an error occurs with the data upload – retry. If the problem persists contact
Biochemistry Ext 4712.
18. Docking Station
The Abbott docking station provides a means for hands-free, automatic data transfer
(upload/download) between the Precision Xceed Pro/FreeStyle Precision Pro meter and a
PC running the data management application software.
There is a docking station attached to a PC in each department using a Precision Xceed
Pro/FreeStyle Precision Pro glucose meter.
19. References
1. Abbott Precision Xceed Pro/FreeStyle Precision Pro Blood Glucose Monitoring
System – Operator’s Manual (PDF)
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
Checked by: H Witham
Approved by: H Witham
Page 9 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/45/6
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Glucose Meter
Effective date: 4/9/15
2. Package insert for Abbott Precision Xceed Pro Blood Glucose Testing Strips
3. NMC Professional Conduct Code 2008
4. RUH Medical Equipment Policy
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: M Stubberfield
Checked by: H Witham
Approved by: H Witham
Page 10 of 10
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