Abbott | Precision XceedPro | Abbott Precision XCeedPro Blood Glucose Meter

Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Title:
Abbott Precision XCeedPro Blood
Glucose Meter
Code:
Point of Care 171
Authors:
Mark Gilmour
Version:
1.1
Document Category:
Point of Care
Authorised By:
Mark Gilmour
Authorised On:
30-May-2013
Review On:
30-May-2015
Location Of Copy:
Intranet
Section:
All Areas NHS Forth Valley
Date Time Of Last Update:
30-May-2013 12:02
Date Time Printed:
30-May-2013 12:04
Document Status:
Authorised
Ou Name:
Point of Care Testing
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
1 PURPOSE OF EXAMINATION
This document outlines the policies and procedures that should be followed
when using the Abbott Precision XceedPro Blood Glucose Meter. Full
instructions on the use of these meters are provided in the Abbott Precision
XceedPro Operators Manual (available on CD-Rom & Intranet). These
instructions must be followed at all times.
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
2 PRINCIPLE OF METHOD
The Precision XceedPro Blood Glucose System has been developed to allow
rapid measurement of blood glucose (D-glucose) using an electrochemical
detection technique. The biosensor employs a disposable dry reagent
electrode technology based on the glucose dehydrogenase method for
glucose determination. When a drop of blood is applied to the target area of
the test strip, the glucose dehydrogenase catalyses the oxidation of glucose in
the drop to produce gluconic acid. During the reaction, electrons are
transferred by a co-enzyme and an electrochemical mediator to the electrode
surface. This generates a current that is measured by the system. The size of
the current generated is proportional to the
amount of glucose present in the specimen, and will give an accurate reading
of the blood glucose concentration.
3 SPECIMEN REQUIREMENTS AND MEANS OF IDENTIFICATION
Patient identification should be verified before attempting to take a sample for
use on the Abbott Precision XceedPro glucose meter. Use only fresh whole
blood. Venous, capillary or arterial whole blood can be used. Arterial
specimens: caution should be taken to clear arterial lines before blood is
drawn and applied to the electrode. Venous specimens: may be collected into
lithium heparin or EDTA collection tubes. DO NOT use fluoride oxalate
collection tubes as these interfere with the method. Serum and plasma
samples are also unsuitable. Capillary specimens: ensure the patient’s hands
are clean and dry before sampling. A Virtex lancet device should be used.
Neonatal specimens: a heel prick specimen can be applied directly to the
target area on the test strip. Alternatively, blood can be collected in a capillary
tube coated with heparin or EDTA, and then applied to the test strip.
4 EQUIPMENT, REAGENTS AND CONSUMABLES
EQUIPMENT AND SPECIAL SUPPLIES
Abbott Precision XceedPro Glucose Meter
Abbott Precision XceedPro Docking Port
Abbott Precision XceedPro Workstation
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
Page 1 of 9
4.1 REAGENTS
4.1.1 Abbott Precision XceedPro test strips.
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Abbott Precision XceedPro Blood Glucose Test strips are sealed in individual
foil packets. Each packet is bar-coded. The barcode, once scanned, provides
the meter with information for calibration and test strip expiry date. The meter
will not accept a test strip that is out with has exceeded the expiry date.
Test strips should be stored at a temperature between 4 and 30°C. When
stored correctly, the unopened test strips remain stable until the expiration
date printed in the barcode label. Consult the kit insert for further information if
required.
5 STANDARDS, CALIBRATORS AND QUALITY CONTROL MATERIALS
5.1 Abbott Medisense Internal Quality Control Solutions
Store between 4 and 30°C. Internal quality control (QC) checks ensure that
your system is working properly and that you are performing the test correctly.
QC solutions are provided at low and high levels. Each bottle is bar-coded
which, once scanned, provides the meter with the manufacturers’ expiry date
and lot number. Each bottle is stable for 90 days after opening or until the
expiry date printed on the label, whichever comes first. Do not use solutions
past this date. QC solutions are ordered through Central Stores as required.
When opening a new bottle, the 90-day discard date should be clearly written
on the label.
5.2 External Quality Assurance
All wards are required to participate in the regular external quality assessment
of analytical performance. The hospital participates in a CPA registered
External Quality Assurance (EQA) scheme which is provided by WEQAS.
External quality assessment is undertaken at 3-month intervals. The
Laboratory Quality Manager distributes one sample per meter to each ward
area concerned. A trained operator should perform the analysis as if the
sample were from a patient. The meter should be docked after the EQA
specimen has been analysed to enable the results to be transferred to the
server.
The Laboratory Quality Manager will record and analyse all results and
provide regular performance data. A performance report will be issued to each
ward manager. Poor performance (including no returns) will be identified and
investigated. Persistent non return of EQA results will result in an incident
being raised on the Safeguard system.
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
Page 2 of 9
6 CALIBRATION
Calibration information is contained within the test strip barcode. Information
provided includes the test strip lot number, expiration date and IQC ranges.
The equipment has been validated against the YSI model 2300 glucose
analyser (YSI inc). The values are multiplied by 1.12 to provide plasmaequivalent glucose values for the calibration of the Abbott Precision XceedPro
Blood Glucose Test Strips.
7 PROCEDURE
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
7.1 Staff Training
Only staff whose training and competence has been established and recorded
are permitted to carry out point of care testing. Each staff member must
attend a training session or have training provided in the clinical area by a
cascade trainer to enable them to be a registered user of the device. Each
user will receive a unique barcode (Operator ID), which must NOT be shared
with other staff members. The unique Operator ID allows auditing of the
system, and traceability of results. To maintain registration on the system,
each operator must perform a successful QC test at least once a year. Failure
to do so will result in them being removed from the operator list. A successful
QC test demonstrates continued competency, and will renew the users’
registration for a further 12 months. Users can be removed from the
system for noncompliance.
Each staff member is responsible for maintaining the skills they require to
follow the policy and procedures required for this device. Staff members may
attend for re-training as necessary.
A complete list of trained personnel will be held by the Laboratory Quality
Manager. This is a requirement to fulfil MDA DB2010 (02)’Management and
Use of IVD Point of Care Test Devices’.
7.2 Instructions for Use
7.2.1 Performing a QC test:
• Check discard date and expiry date on the QC solution bottle.
• Press on/off to switch on meter.
• Press 2 to select Control Test.
• Press scan to scan your Operator ID (your barcode).
• Press scan to scan the low QC solution barcode.
• Press scan to scan the test strip. Insert Strip will appear on the
screen.
• Open the foil test strip packet at the notch and tear down to remove
the test strip. Do NOT touch the test area of the test strip as this can
cause erroneous results.
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
Page 3 of 9
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
• With the contact bars (electrodes) facing up, insert the test strip into
the test strip port. Strip Inserted should appear on the screen, followed
by Apply Low Solution.
• Gently invert the solution a few times to mix.
• Ensure the meter is placed on a flat surface then apply a drop of
solution to the target area of the test strip (note: applying the sample
whilst the meter is in a vertical position will lead to the sample dripping
into the port and damaging the meter). Sample Accepted will appear on
the screen. NOTE: Alternatively a drop of QC solution can be placed
on the back of a gloved hand and the strip introduced to the sample.
• Wait for the monitor to analyze the specimen and display the test
result.
• The result will be displayed as a Pass or Fail.
• Press 1 to select next level, and repeat with the high level QC. If QC
fails, select 2 to repeat the test.
• Press on/off to switch of the meter or 1 to return to menu.
• Waste QC materials and test strips used for QC testing may be
discardedin general waste bins.
A QC check should be performed daily. The meter has a ‘lock out’ function,
which will prevent users performing a patient test if a QC check has not been
performed in the last 24 hours. Once a QC test has been completed
successfully, the meter may be used again for patient testing.
A QC check should also be performed when:
o Using a new meter for the first time.
o Starting a new pack of test strips.
o The meter is dropped.
o Changing the batteries.
o Unexpected results are obtained.
If the QC test fails:
o Repeat the test.
o Check the discard date of the QC solutions (NB shelf life of 90 days
once open).
o Change QC solutions if required.
o Repeat the test.
o If the QC results are still outside the expected range, contact
Biochemistry for advice.
7.2.2 Performing a Patient test
Patient identification barcodes must be used.
Follow the procedure below (for capillary specimens):
• Ensure the patient’s finger is clean and dry.
• Press on/off to switch on meter.
• Press 1 to select Patient test.
• Press scan to scan your Operator ID (your barcode).
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
Page 4 of 9
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
• Press scan to scan Patient ID (patient’s barcode). This can be
entered manually using the alphanumeric keypad if necessary.
• Press 2 to continue testing or 1 to re-enter ID.
• Press scan to scan the test strip. Insert Strip will appear on the
screen.
• Open the foil test strip packet at the notch and tear down to remove
the test strip. Do NOT touch the test area of the test strip as this can
cause erroneous results.
• With the contact bars facing up, insert the test strip into the test strip
port. Strip Inserted should appear on the screen. Followed by Apply
Sample.
• Obtain capillary blood specimen using a Virtex lancet.
• Ensure the meter is placed on a flat surface then apply a drop of
blood to the target area of the test strip. (Note: applying the sample
whilst the meter is in a vertical position will lead to blood dripping into
the port and damaging the meter). Sample Accepted will appear on
the screen.
• Wait for the monitor to analyze the specimen and display the test
result. This may take up to 20 seconds.
• Write the test result directly in the patient notes
• Discard clinical material and potentially contaminated waste in an
appropriate clinical waste bin. Lancet devices must be discarded in a
clinical waste sharps container.
• Press 1 to select next patient if required.
• Press on/off to switch of the meter.
7.2.3 Patient test: emergency protocol
Selected ward area have been provided with a patient ID barcode for
emergency situations only, where patient ID is unavailable. The use of these
barcodes is monitored. The Laboratory Quality Manager has authority to
remove emergency barcodes if they are misused.
8 LIMITATIONS OF PROCEDURE
8.1 Interferences
Maltose, icodextrin and other common substances at normal therapeutic
levels do NOT affect the glucose result. There is also minimal measurement
bias from oxygen, haematocrit and other physiological variables.
8.2 Indications
It is appropriate to use the Abbott Precision XceedPro glucose meter in
the following circumstances:
• Initial assessment of patient with collapse/loss of consciousness with
separate specimen always being sent to laboratory.
• Initial assessment of known diabetic patient.
• Initial assessment of patient with glycosuria.
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
Page 5 of 9
• Monitoring of stable diabetic patients.
• Screening patients in whom abnormal blood glucose levels may
occur,
with laboratory confirmation where abnormal results are found:
o TPN therapy
o Liver disease (although not if severely jaundiced)
o Suspected hypoglycaemia/funny turns (if result less than 3.0
mmol/l, send specimen to laboratory)
o High dose steroid treatment
o Neonates at risk of hypoglycaemia
o Miscellaneous circumstances
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
8.3 Contra-indications
It is inappropriate to use the Abbott Precision XceedPro glucose meter
in the
following circumstances:
• In the acute management of acute unstable diabetic states: diabetic
ketoacidosis, hyperosmolar non-ketotic coma, and hypoglycaemia.
• To make a diagnosis of diabetes mellitus.
• To make a diagnosis of hypoglycaemia.
• In severely anaemic patients.
• Where the observed result is not in keeping with the patient’s clinical
status.
• Where the blood glucose result is less than 4.0 mmol/l or greater
than 20 mmol/l.
• Patients with peripheral circulatory failure (e.g. severe dehydration,
hypotension, shock). Severely anaemic patients.
In the above circumstances, diagnosis and treatment decisions should only be
made after the laboratory has confirmed the blood glucose on a venous blood
sample. Contact Clinical Chemistry for advice if required.
8.4 Haematocrit Range
The haematocrit range for the use of this meter is 20-70%
Care should be taken when using the meters on patients with a high or low
haematocrit. If in doubt, a specimen should be sent to the laboratory.
9 PATIENT RESULTS/REFERENCE LIMITS
The assay is valid between 1.1-27.8 mmol/L. If a patient’s result is less than
4.0mmol/L or greater than 20mmol/L, a venous specimen should be sent to
the hospital laboratory for analysis and confirmation of the result.
If a patient’s glucose result is inconsistent with the clinical picture, check the
result with a new test strip. If in doubt, send a venous specimen to the lab.
10 THE DOCKING STATION
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
Page 6 of 9
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Test results and information are transferred to a data management system
using a docking station. To allow communications, the meter must be
mounted on the docking station. Once connected, information will be
transferred and Data Uploading will appear on the screen. The arrows on the
meter display should rotate. Once complete, upload successful will appear
on the screen. This may take up to 20 seconds. The information received is
collated and reviewed by the Diabetes Team. The meter must be docked
every 24 hours to allow transfer of data. It is recommended that the meter is
docked after performing the daily QC check and after external QA specimens.
Please note that the docking station does not recharge the meter. The meter
should NOT be stored on the docking station as this can reduce the life
of the batteries.
If data fails to upload on docking, the following message will appear on the
screen: ‘Last upload incomplete. Re-dock meter’. Check the following:
• PC is switched on.
• All connections are secure
• Has the PC been changed.
For further advice, contact the Laboratory Quality Manager.
11 TEST HAZARDS AND PRECAUTIONS
• Always were gloves and follow health and safety policies.
• Make sure the monitor and test strips are at room temperature.
• Do not use test strips beyond expiry date.
• Do not use QC solutions which have expired, or have been open for
more than 90 days.
• Do not use test strip if foil packet has been punctured or torn.
• Do not use test strips that are wet, bent, scratched or damaged.
• Do not use a test strip more than once.
• Do not handle a test strip with wet or dirty hands.
• Do not scan a test strip barcode then use a different test strip. This
may cause inaccurate results.
• After blood has been applied, do not remove or disturb test strip.
• Do not use serum or plasma specimens.
• Do not use fluoride oxalate specimens.
• Store meters in the provided workstations when not in use to prevent
damage.
• All sharps should be disposed of in a sharps bin and not in the Abbott
Precision XceedPro Workstation
• It is dangerous, unhygienic and an infection risk to store used sharps
in the Abbott Precision XceedPro Workstation
• Haematocrit range is 20-70%.
Care should be taken when using the meters to test patients with a
high or low haematocrit. If in doubt, a specimen should be sent to the
laboratory.
12 HEALTH AND SAFETY
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
Page 7 of 9
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
• All users of near-patient testing equipment must comply with all Local
Health and Safety Policies.
• There is a risk of infection from any patient sample. Protective gloves
should be worn when taking samples (a fresh pair used for each
patient).
• Virtex lancets should be used.
• Used strips and sharps must be disposed of safely in a sharps bin.
• Gloves must be worn when performing maintenance on instruments
that are potentially contaminated.
• Consult the Operator’s guide for the manufacturer’s instructions on
the safe use of these meters.
• Consult the Abbott Precision XceedPro COSHH form for full details of
hazards.
13 MAINTENANCE
This is the responsibility of all users. Regular maintenance involves ensuring:
• The strip port cover is always present when using the meter. If the
blue strip port cover is not present do not use the meter. Contact
Laboratory Quality Manager for a replacement meter.
• Correct storage of strips.
• Correct storage of meters and regular checks of cleanliness and
battery life.
• Correct disposal of used strips and sharps.
The meter can be cleaned with a damp cloth and mild detergent. Ensure that
no moisture/liquid enters the sample port when cleaning as this can damage
the meter. Acceptable cleaning solutions include alcohol and ammonia based
cleaners. Bleach should not be used.
Any faults or errors should be reported to the Laboratory Quality Manager.
14 RECORD KEEPING
A complete record of test results, patient ID, operators, quality control, and
trained users is held electronically on a central database.
This information is necessary for use by other healthcare professionals
and for the purposes of clinical review, workload analyses and audit. It
may also be required for legal purposes in the future.
The Laboratory Quality Manager will perform regular audits of the system.
15 ADVERSE INCIDENT REPORTING
An adverse incident is any incident that produces, or has the potential to
produce, unwanted effects involving the safety of patients, users and others.
Adverse incidents in POCT devices may arise from shortcomings in the
device, its operating instructions, user practices or conditions of use.
Unwanted effects may include misdiagnosis or inappropriate treatment.
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
Page 8 of 9
Any adverse incidents involving these meters must be logged on the
Safeguard system and reported to the Laboratory Quality Manager and the
Lead Diabetes Nurse immediately.
16 TROUBLE SHOOTING
The main error messages that may occur are detailed in the Abbott XceedPro
Troubleshooting Guide Suggested causes and remedies are given.
Consult the Operators Guide or contact the Laboratory Quality Manager for
further advice.
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
17 SUPPLIES/SERVICE PROVISION
The Diabetes Department supplies replacement batteries. Test strips and QC
Material can be obtained from Central Stores. All ordering and returning of
faulty equipment is carried out through the Laboratory Quality Manager.
Abbott Precision XCeedPro Blood Glucose Meter - Version: 1.1. Index: Point of Care 171. Printed: 30-May-2013 12:04
Authorised on: 30-May-2013. Authorised by: Mark Gilmour. SOP Unique Reference: 112-26570897. Due for review on: 30-May-2015
Author(s): Mark Gilmour
Page 9 of 9
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