SOP for Abbott Precision Xceed Pro + FreeStyle Precision Pro Meter

SOP for Abbott Precision Xceed Pro + FreeStyle Precision Pro Meter
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
Effective date: 07/02/2017
COPY
Summary of Significant Changes at this Revision
Update Approver/checker
Purpose and Scope
Items Required
1. The Abbott Precision Xceed
Pro/FreeStyle Precision Pro
(PXP/FPP) meter is a batterypowered device designed for the
measurement of blood glucose and
β-ketone (beta-hydroxybutyrate) in a
Point of Care setting.
2. The meter uses single-use test
strips to measure the concentration
of β-ketones in fresh capillary and
venous whole blood samples.
1. Abbott Precision Xceed
Pro/FreeStyle Precision Pro Meter
2. Abbott Precision Xceed Pro Blood βketone Test Strips
3. MediSense Glucose & Ketone
Control Solutions
4. WEQAS glucose/ketone EQA sample
5. 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
β-OHB = β-hydroxybutyrate
Nursing Staff: All Trained operators
Health Care Assistants: All trained
operators
Biomedical Scientists – all grades
Supervised Trainee BMS Staff
Competencies Required:
Current Version of: QMS/FM/TRG/77
Risk Assessment:
Current Version of: QMS/RA/CH/29
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 1 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
Effective date: 07/02/2017
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 .................................................................................................................. 5
8. Clinical Interpretation of Ketone Results .......................................................................... 6
9. Recalling Patient Results ................................................................................................. 6
10. External Quality Assurance (EQA) ................................................................................. 7
11. Limitations of Procedure ................................................................................................ 7
12. Maintenance .................................................................................................................. 8
13. COSHH and Health and Safety ..................................................................................... 8
14. Adverse Incidents .......................................................................................................... 9
15. Operators ....................................................................................................................... 9
16. Data Upload ................................................................................................................... 9
17. Docking Station ............................................................................................................ 10
18. References .................................................................................................................. 10
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 2 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
Effective date: 07/02/2017
1. Principle
Ketones: The β-hydroxybutyrate (β-OHB) in the blood sample is catalysed to acetoacetate
by β-hydroxybutyrate dehydrogenase. The co-enzyme (NAD) undergoes reduction in the
process. When the reaction is complete, electrons generate a small current. The current is
measured through built in electrodes. The size of the current is proportional to the amount
of β-OHB in the blood sample.
This POCT device must be used in accordance with the Trust POCT Policy.
2. Precision Xceed Pro/FreeStyle Precision Pro System
Components
- Workstation
- Precision Xceed Pro/FreeStyle Precision Pro meter
- Precision Xceed Pro β-ketone 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 β-ketone test strip foil packet prior to use
automatically calibrates the meter and checks the expiry date.
β-ketone test strips are stable up to the expiry date stated on the packaging - stored
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 – write opened and expiry date on
bottles.
Both Lo and Hi controls must be assayed.
IQC must be performed on each individual PXP/FPP meter daily.
The PXP/FPP meters are formatted to request QCs every 24 hours – the message
‘Ketone 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: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 3 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
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Effective date: 07/02/2017
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 β-ketone 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 – the display will alternate between Insert
Strip and Ketone.
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 10 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.
If proceeding to a patient test, press Menu and the screen will return to the main
menu
Press On/Off to turn off the meter when all tests are completed.
N.B. When the PXP/FPP meter is enabled for both glucose and ketone testing, prompts will be
given for both glucose and ketone QCs.
If Glucose QC is run first, then following a complete set of Glucose controls, 1-Next Level
becomes 1-QC Ketone.
If β-ketone QC is run first, then following a complete set of β-ketone controls, 1-Next Level
becomes 1-QC Glucose.
If there are no patient ketone samples to be run, then the ketone QCs do not need to be run.
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
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 4 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
Effective date: 07/02/2017
7. Patient testing
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All point of care testing devices have limitations – see Section 11 for the limitations
Only fresh capillary or whole blood venous samples should be used with the βketone test strips – venous samples should be collected into lithium heparin tubes
and used within 30 mins
The minimum sample volume is 1.5 µl
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 β-ketone test strip barcode.
Insert Strip is displayed.
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 10 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
It is possible to use venous samples for β-ketone analysis – N.B. they must be
collected into lithium heparin tubes, well mixed, and used within 30 mins
If it is not possible to obtain an adequate venous blood sample for testing,
then this must also be recorded in the patient’s notes - and recorded as an incident
in Datix if appropriate
See Section 8 for Clinical Interpretation of Ketone Results
The lower analytical range for the meter is 0.0mmol/l
The upper analytical range for the meter is 8.0mmol/l – results greater than this will
be displayed as > 8.0mmol/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.
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 5 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
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Effective date: 07/02/2017
Record the β-ketone result in the patient’s case notes – N.B. also include the
date/time performed, the device (including location), the test strip number and the
operator identity (of person performing the test and the person transcribing the
result).
8. Clinical Interpretation of Ketone Results
Exact guidelines on the interpretation of and response to blood β-hydroxybutyrate levels
have not yet been established. However, the current consensus of opinion suggests the
following interpretation:
Blood Ketone level
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Below 0.6mmol/L
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Between 0.6 and 1.5mmol/L
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Above 1.5mmol/L
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Advice
Readings below 0.6 mmol/L are
in the normal range
No need to change anything
When a blood Ketone reading is
between 0.6 and 1.5mmol/L and
the blood glucose reading is
higher than 16.7mmol/L, this
may indicate the development of
a problem that may require
medical assistance.
When a blood Ketone reading is
higher than 1.5mmol/L and the
blood glucose reading is higher
than 16.7mmol/L, there is a risk
of developing diabetic
ketoacidosis (DKA).
Take appropriate action.
N.B. Management of a patient with DKA is outlined in the departmental protocol.
9. 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
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 6 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
Effective date: 07/02/2017
10. 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 β-ketone
concentration at the time of analysis and the results are assessed independently.
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An EQA sample is distributed to all authorised PXP/FPP meter users every three
months by biochemistry with a result sheet.
Children’s Ward is the only RUH department with PXP/FPP meters enabled for βketone analysis as well as glucose analysis
The sample must be analysed (as per Patient Testing) on every PXP/FPP meter
located on the ward/department enabled for β-ketone analysis
Record the serial number of each individual meter that is used and record the βketone result for the EQA sample.
Return the result sheet to the biochemistry department.
11. Limitations of Procedure
All point of care testing devices have limitations and these should be remembered at all
times:
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PXP β-ketone test strips are designed for use with fresh capillary and venous
whole blood samples strips only – venous samples should be collected into lithium
heparin tubes, well mixed, and used within 30 mins
The β-ketone test strip has not been evaluated for arterial and neonatal samples,
or for alternative site testing
The strip is not designed for use with serum or plasma samples
Do not use tubes containing fluoride or oxalate
The minimum sample volume is 1.5 µl.
Blood β-ketone results are displayed as mmol/l.
Use the meter between 180and 300C.
Store the test strips between 40 and 300C.
Haematocrit range is 30%-60%.
Test results may be erroneously low if the patient is severely dehydrated, severely
hypotensive, in shock or in a hyperglycaemic-hyperosmolar state
The following have no significant effect on blood β-ketone results:
Substance
Acetoacetate
Acetone
Bilirubin (unconjugated)
Cholesterol
Triglycerides
Concentration Up To
0.6 mmol/l
10.3mmol/l
342µmol/l
12.95mmol/l
21.19mmol/l
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 7 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
Uric acid
Paracetamol
Ascorbic acid
Effective date: 07/02/2017
1.42mmol/l
1.7mmol/l
227µmol/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.
• 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. COSHH and Health and Safety
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Precision Xceed Pro Test Strips: No Hazard
Medisense Lo and Hi Control solutions: No Hazard
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 8 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
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Effective date: 07/02/2017
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.
14. Adverse Incidents
Any adverse incidents regarding the use of the PXP/FPP meter must be reported via the
ward manager to the Point-of-Care testing committee for evaluation and reporting on to the
MHRA.
15. Operators
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Only staff that are trained in accordance with the PXP/FPP meter Training
Programme for the Trust, and are certificated, are authorised to use the PXP/FPP
meter.
Training is provided by an Abbott Nurse Educator, Diabetes Liason Nurses or by
Link Nurses.
Refresher training may be provided by a Link Nurse.
Refer to the NMC Professional Conduct Code 2008 and RUH Policies.
16. 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.
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 9 of 10
RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE
SOP/POCT/50/4
Title: Abbott Precision Xceed Pro/FreeStyle
Precision Pro Meter – Ketone Analysis
Effective date: 07/02/2017
17. Docking Station
The Abbott docking station provides a means for hands-free, automatic data transfer
(upload/download) between the PXP/FPP meter and a PC running the data management
application software.
There is a docking station attached to a PC in each department using a PXP/FPP meter.
18. References
1. Abbott Precision Xceed Pro Blood/FreeStyle Precision Pro Glucose and βKetone Monitoring System – Operator’s Manual (PDF)
2. Package insert for Abbott Precision Xceed Pro Blood β-ketone Testing Strips
3. NMC Professional Conduct Code 2008
4. RUH Medical Equipment Policy
Copy number
1
2
Location held
Glucose Meters SOP File – Manual Lab
POCT section of intranet
Printed copies are uncontrolled unless there is an allocated Copy Number on page 1
Author: H.Witham
Checked by: E.Macdonald
Approved by: E.Macdonald
Page 10 of 10
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