Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone ...

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Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18 Edition No. 1.0 Copy No. 1 Page 1 of 21 Replaces : n/a Review date: 11/06/20 SOP CDEC007 Clinical Chemistry Department Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter Emergency Section CONTROLLED DOCUMENT

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Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

Edition No. 1.0 Copy No. 1

Page 1 of 21 Replaces : n/a Review date: 11/06/20

SOP CDEC007

Clinical Chemistry Department

Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Emergency Section

CONTROLLED DOCUMENT

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

Edition No. 1.0 Copy No. 1

Page 2 of 21 Replaces : n/a Review date: 11/06/20

Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

This document describes the Standard Operating Procedure for the Abbott Freestyle Precision Pro (FPP) Blood Glucose and Blood Ketone Meter. This procedure has been implemented to measure Point of Care (POCT) blood glucose and ketones in patients across Wye Valley NHS Trust (Hereford County Hospital) using networked meters. Within Hereford County Hospital, all meters are set up for glucose measurement. A small number of wards/departments also require ketone measurement and in these areas, the meters are also set up to measure ketones. In addition, in low usage areas, hand-held, non-networked Abbott Neo H glucose meters have been installed (see separate SOP). This S.O.P. relates to the networked Freestyle Precision Pro meters only.

CLINICAL BACKGROUND

Glucose - Measurement of a patient's glucose concentration is useful on many occasions, including the monitoring of the diabetic patient, the acutely ill patient and the neonate. Measurement of capillary, arterial and venous blood glucose by the use of the Freestyle Precision Pro Blood Glucose Monitoring System meter test strips with the meter gives a reasonably accurate result for monitoring purposes: the measurement should not be used for diagnosing Diabetes Mellitus. The measuring range is 1.1 – 27.8 mmol/L but values below 4.0 mmol/L and greater than 15 mmol/L should be checked by sending a fluoride/oxalate sample urgently to the laboratory for measurement of glucose.

Ketones – Measurement of a patient’s ketone level using the Freestyle Precision Pro Blood Ketone Monitoring System is a simple and quick method to measure the ketone level in peripheral blood. It may be used in screening for diabetic ketoacidosis and following treatment. This method is not suitable for arterial samples.

ANALYTICAL PRINCIPLE

Glucose –The Abbott Diabetes Care Blood Glucose System has been developed to allow rapid measurement of blood glucose using an electrochemical detection technique. The biosensor employs a disposable dry reagent 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, glucose dehydrogenase catalyses the conversion of glucose in the drop to 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 system and will give an accurate reading of the blood glucose concentration. Maltose, isodextrin and other common substances at normal therapeutic levels do not affect the glucose result. There is also minimal measurement bias resulting from oxygen, haematocrit and other physiological variables.

Ketones – β-Hydroxybutyrate in the blood specimen reacts with a nicotinamide adenine dinucleotide (NAD) co-enzyme β-hydroxybutyrate dehydrogenase (HBDH). This chemical

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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reaction releases electrons which result in a small current proportional to the concentration of β-hydroxybutyrate in the specimen.

Conworx Unipoc – Unipoc is the software used to monitor the use of the meters and to provide passwords for users. See Appendix 2 for instructions on how to add Operators.

The FPP can measure both glucose and ketones but must be enabled for both if required. Care must be taken to ensure you know if you are measuring glucose or ketones.

EQUIPMENT AND MATERIALS

FreeStyle Precision Pro Blood Glucose and Blood ß-Ketone Meter - Purchased from Abbott Diabetes Care. Keep the meter dust free in the workstation and protect from extremes of temperature and humidity i.e. do not store on window ledges.

AA batteries - obtained from Blood Sciences (x4040).

Docking Station – connected to a pc within the department. Please do not disconnect.

FreeStyle Precision Pro Glucose Strips (71281-70) – 100 strips per pot, obtained from Pharmacy Dept., Wye Valley NHS Trust. Stable until expiry date when stored at 4 – 300C.

FreeStyle Precision Pro ß-Ketone Strips (71287-70) – 50 strips per pot, obtained from Pharmacy Dept., Wye Valley NHS Trust. Stable until expiry date when stored at 4 – 300C.

MediSense Glucose & Ketone Control Solutions – 1 x 4 ml Lo and 1 x 4ml Hi Control. Stable until expiry date when stored at 4 – 300C. Once opened, stable for 90 days from the date of opening. Obtained from Blood Sciences (x4040).

Infection Control Single Use sleeves – obtained from Blood Sciences (x4040).

Weqas POCT Glucose and Ketone EQA samples – 0.5 ml sterile plastic dropper bottles, sent out by Blood Sciences.

SAMPLE REQUIREMENTS

One drop of whole blood. Blood should be analysed immediately, avoiding air bubbles.

Arterial samples (for glucose testing only) – Use only fresh whole blood samples. Clear the arterial line before blood is collected into a heparinised syringe. Use the sample within 30 minutes of collection. Please ensure that a drop of blood is suspended vertically from the syringe and move the meter and testing strip horizontally towards the drop. Avoid injecting samples horizontally into the strip port as this will damage the port and / or meter.

Venous samples (for glucose or ketone testing) – Use only fresh whole blood samples. The sample may be collected into collection tubes containing heparin or EDTA. Do not collect into collection tubes which contain fluoride or oxalate as these interfere with the method. Use the sample within 30 minutes of collection.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

Edition No. 1.0 Copy No. 1

Page 4 of 21 Replaces : n/a Review date: 11/06/20

Capillary samples (for glucose or ketone testing) – Use only fresh whole blood samples. When a drop of blood has formed, apply directly onto the target area of the test strip. Alternatively, the blood may be collected into a capillary tube coated with heparin and then applied to the target area of the test strip within 30 minutes of collection.

Neonatal samples (for glucose testing only) - Use only fresh whole blood samples. When a drop of blood has formed on the patient’s heel, always wipe away the first drop. Allow blood to flow again and apply this sample directly onto the target area of the test strip. Alternatively, the blood may be collected into a capillary tube coated with heparin and then applied to the target area of the test strip immediately.

Table 1. Sample Requirements

Sample type

Arterial Venous Capillary Neonatal

Whole blood /

Heparinised syringe

Whole blood /

Heparin / EDTA

Whole blood /

Heparinised capillary

Whole blood

(heel prick) /

Heparinised capillary

Glucose Suitable Suitable Suitable Suitable

Ketone NOT SUITABLE Suitable Suitable NOT SUITABLE

INTERFERENCES

Glucose

Do not use for serum or plasma samples.

Use between 15 and 40° C and between 10 and 90 % relative humidity.

Haematocrit must be between 15 and 65%.

Do not use during intravenous infusion of high-dose ascorbic acid or during xylose absorption testing.

Test results may be erroneously low if the patient is:

- severely dehydrated – see note 1

- severely hypotensive – see note 1

- in shock – see note 1

- hyperglycaemic-hyperosmolar state (with or without ketoacidosis) – see notes 2/3

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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Note 1 – Capillary and neonatal (heel prick) – severe dehydration, severe hypotension and shock are clinical conditions where the circulation is affected. In these conditions, the glucose concentration in capillary blood can be different to that of other blood types. It is recommended that venous or arterial samples are used in these situations.

Note 2 – All sample types – For a patient in a hyperglycaemic-hyperosmolar state, the physiological effects associated with this clinical condition (increased viscosity of sample due to dehydration, reduced pH, and increased haematocrit) are observed with all blood sample types, therefore, these aspects of the limitation refer to all sample types

Note 3 – Patients in a hyperglycaemic-hyperosmolar state (with or without ketoacidosis) – it is recommended that laboratory methods are used for the treatment decisions. For patients with suspected Diabetic Ketoacidosis, it is recommended that blood ketone testing is used to screen patients and track their treatment.

INTERFERENCES

Ketones

Do not use with arterial, neonatal, serum or plasma samples.

Use between 18 and 30°C and between 10 and 90% relative humidity.Haematocrit must be between 30 and 60%.

PERFORMANCE CHARACTERISTICS

Glucose – Reference: Blood Glucose Test Strips Package Insert -Instructions for Use (LF_POCT_001)

Precision – For within-run precision using blood samples, results typically vary by no more than 4.8% - see Table 2 below.

Table 2. Precision

Level Low Mid-low Mid-high High

Mean (mmol/l) 2.5 5.1 12.3 20.2

SD (mmol/l) 0.12 0.18 0.36 0.58

CV (%) 4.8 3.6 2.9 2.9

Accuracy/Bias – Capillary blood glucose results obtained by trained operators at two clinical centres were compared with those obtained using the YSI glucose analyser. (See Blood Glucose Test Strips Package Insert for results).

Limit of Detection – 1.1 mmol/l.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

Edition No. 1.0 Copy No. 1

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Range of Measurement 1.1 mmol/l to 27.8 mmol/l.

Ketones – Reference: Blood ß-Ketone Test Strips Package Insert -Instructions for Use (LF_POCT_002)

Validation and Verification

Precision – For precision using venous whole blood samples (20 per level), results typically vary by no more than 3.9% - see Table 3 (below).

Table 3. Precision

Low Medium High

Mean (mmol/l) 0.34 2.36 6.32

SD (mmol/l) 0.03 0.09 0.2

CV (%) - 3.9 3.1

Accuracy/Bias – Whole blood ß-ketone results were compared with plasma results obtained using a reference laboratory instrument at four hospitals. (See Blood Ketone Test Strips Package Insert for results).

Assay Range 0.0 – 8.0 mmol/l. Limit of detection 0.01mmol/l.

This centre is currently conducting in-house verification for the meter.

CALIBRATION PROCEDURES

Each FreeStyle Precision Pro test strip (glucose and ketone) has a barcode which contains lot-specific calibration information. The FreeStyle Precision Pro test strip is referenced against the YSI Analyser. YSI whole blood values are multiplied by 1.12 to provide plasma-equivalent values for the calibration of FreeStyle Precision Pro test strips. (Test strip insert).

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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EXTERNAL DOCUMENTS

External Documents Name / Number

Version Location Document Manager

FreeStyle Precision Pro Operators Manual

(Abbot Diabetes Care Ltd. 2012)

POCT A. McTiernan

Cascade Training FreeStyle Precision Pro Blood Glucose and Blood ß-Ketone Meter

Abbott Diabetes Care Inc. 2014

Link Trainers (POCT)

A. McTiernan

FreeStyle Precision Pro Blood Glucose Package Insert

LF_POCT_001 With Strips

Antony Griffiths

FreeStyle Precision Pro Blood Ketones Package Insert

LF_POCT_002 With Strips

Antony Griffiths

METHOD

RISK ASSESSMENT

All materials/equipment have been considered and the following may present risks

Material Risk

Test Strips

Quality Controls Lo & Hi

Non-reactive substances. If ingested seek medical advice Avoid contact with eyes, skin and clothing. Do not ingest. In case of eye contact irrigate thoroughly with water for 10 minutes.

QUALITY CONTROL

Internal Quality Control (IQC) ensures that the system is working properly and that the test is being performed correctly. QC solutions for glucose and ketones are provided at low and high levels. Each bottle is barcoded. This provides the meter with the manufacturer’s lot number and expiry date. 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 for each area are distributed by the Biochemistry Department. They are sent out on request. When opening a new bottle, the 90-day discard date should be written clearly on the label. The QC solutions should be stored between 4°C and 30°C. Wear gloves when analysing Quality Control solutions.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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PERFORMING AN INTERNAL QUALITY CONTROL TEST FOR GLUCOSE.

Glucose Quality Control Solution testing should be performed daily. The meter has a ‘lock-out’ function, which will prevent users performing a patient test if a glucose QC check has not been performed in the last 24 hours.

1. Press the On/Off button to turn on the meter.

2. Press 2 to select Control Test.

3. Hold the meter facing the Operator ID barcode and press Scan.

4. Check both vials of QC solution are within the 90 day expiry date (from date of opening).

5. Hold the meter facing the low control solution lot number and press Scan.

6. Hold the meter facing the test strip barcode and press Scan. (*If a ketone strip lot isrequested, present and scan the blue glucose strip and press 2 - Continue).

7. With the blue side facing you, open the foil test strip packet at the notch and tear downto remove the test strip.

8. With the contact bars facing up and towards the test strip port, insert the test strip intothe test strip port until it stops and Strip inserted is displayed, followed by ‘Apply LowSolution’.

9. Gently invert the required control solution bottle 3 - 4 times to mix the solution. Removethe cap of the control solution bottle and wipe the nozzle with a clean gauze or tissue. Applya small drop of solution to the test target area. Wipe the nozzle of the control solutionbottle before replacing the cap.

10. Wait for the meter to analyse the sample and display the test result. Remove the teststrip from the meter.

11. If the result is a pass, press 1 – Next Level and carry out the procedure again from 5, thistime with the high control solution. (When the strip is inserted, the message ‘Apply HighSolution’ will be displayed).

12. If the result for the high solution is a pass, press 1 – Exit.

Note – If either the low or high control fails, press the option 2 – Repeat Test and follow the instructions on the meter display.

Once a QC test for glucose has been successfully completed, the meter may be used to perform a patient blood glucose test.

A Quality Control check should also be performed when:

Using a new meter for the first time.

Starting a new lot of test strips.

The batteries have been changed.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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The sample port has been replaced.

The meter has been dropped.

Unexpected patient results are obtained.

*Over-riding Ketone Quality Control Lockout to Perform Glucose Quality Control (seeAppendix 3)

Where meters are enabled for glucose and ketone testing, both tests have a 24 hour QC ‘lock-out’ (see Appendix 1).

In these clinical areas:

THE GLUCOSE QC MUST BE CHECKED EVERY 24 HOURS.

THE KETONE QC SHOULD ONLY BE CHECKED BEFORE A PATIENT TEST AND IS VALID FOR 24 HOURS.

This means that when the ketone QC lockout has expired, the meter will prompt you for a ketone strip after scanning the low control solution (step 5 above).

If you do not have a patient requiring ketone testing, you do not need to run the ketone QC at this point.

To run a glucose quality control instead:

a. Scan the blue glucose strip as per step 6. Unexpected strip – Ketone expected, Glucoseentered will be displayed.

b. Press 2 - Continue and proceed as per step 8. above and onwards to test your low andhigh glucose Quality Control for glucose.

To perform a patient blood test instead (following glucose Quality Control):

a. Press the menu button to take you to the front menu.

b. Press 1 for Patient Test and follow the procedure for performing a glucose blood test.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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PERFORMING AN INTERNAL QUALITY CONTROL TEST FOR KETONES.

Only run the ketone QC (steps 1 – 12 below) before testing the patient for ketones. Patient ketone levels can then be tested for the following 24 hours before another QC test will be required.

1. Press the On/Off button to turn on the meter.

2. Press 2 to select Control Test.

3. Hold the meter facing the Operator ID barcode and press Scan.

4. Check both vials of QC solution are within the 90 day expiry date (from date of opening).

5. Hold the meter facing the low control solution lot number and press Scan.

6. Hold the meter facing the test strip barcode and press Scan.

7. With the blue side facing you, open the foil test strip packet at the notch and tear downto remove the test strip.

8. With the contact bars facing up and towards the test strip port, insert the test strip intothe test strip port until it stops and Strip inserted is displayed, followed by ‘Apply LowSolution’.

9. Gently invert the required control solution bottle 3-4 times. Remove the cap of thecontrol solution bottle and wipe the nozzle with a clean gauze or tissue. Apply a small dropof solution to the test target area. Wipe the nozzle of the control solution bottle beforereplacing the cap.

10. Wait for the meter to analyse the sample and display the test result. Remove the teststrip from the meter.

11. If the result is a pass, press 1 – Next Level and carry out the procedure again from d, thistime with the high control solution. (When the strip is inserted, the message ‘Apply HighSolution’ will be displayed.

12. If the result for the high solution is a pass, press 1 – Exit.

Note – If either the low or high control fails, press the option 2 – Repeat Test and follow the instructions on the meter display.

A Quality Control check should also be performed when:

Using a new meter for the first time.

Staring a new lot of test strips.

The batteries have been changed.

The sample port has been replaced.

The meter has been dropped.

Unexpected patient results are obtained.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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EXTERNAL QUALITY CONTROL (EQA)

EQA samples (dropper vials containing pink test solution) will be distributed to all meters on a monthly basis for glucose and bi-monthly for ketones (from the laboratory POCT team). This will usually be on the Thursday of the first full week of the month. Results for these samples MUST be returned by the cut-off date indicated on the results sheet, so that they can be entered onto the external WEQAS database.

Repeated failure to return EQA results could result in deactivation and / or removal of the meter. As many operators as possible in any given ward or department should be encouraged to take part in the quality assessment process, as well as all the meters allocated to the ward / department. The test on the sample is carried out as for a patient, the results are recorded on the results sheet and returned to POCT, Blood Sciences by post or by e-mailing

NON-RETURN OF EQA RESULTS

A participation rate of 100% is expected for the EQA scheme.

All meter operators should endeavour to complete and return the EQA results by the cut-off date. It is not the responsibility of the link trainer or one individual within each department.

The following steps will be taken for up to 3 non-returns during a 12 month period. The POCT team will:

1. Inform the Ward Manager by letter.2. Inform the Ward Manager by letter and report to the Blood Sciences Team meeting.3. Inform the Ward Manager by letter, report to the Pathology Board and complete

DATIX incident form

POOR PERFORMANCE EQA RESULTS

The following steps will be taken for up to 2 returns during a 12 month period showing poor performance. The POCT team will:

1. Inform the Ward Manager by letter, review QC performance for that meter and senda repeat sample wherever possible.

2. Inform the Ward Manager by letter, check the conformity of the meter and / or liaisewith the Ward Manager to arrange operator re-training. Following this, a repeatsample will be issued and a report sent to the next Pathology Board.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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PERFORMING A GLUCOSE / KETONE BLOOD TEST

SCANNING PATIENT BARCODES

The Freestyle Precision Pro can scan 1D or 2D barcodes but cannot be programmed to do so simultaneously. All meters used with in-patients (i.e. wearing wristbands) will be set to scan the 2D barcode on the wristband except ITU, Theatres and Eye Unit. All meters used with out-patients will be set to scan the 1D barcode contained within the patient notes.

If the meter cannot scan the 1D or 2D barcodes, the RLQ number can be entered manually using the alphanumeric keypad. Press the A/a button to toggle between numeric, uppercase alpha mode and lowercase alpha mode i.e. press once for capitals and enter RLQ on the keypad, press twice more to toggle back to number entry and complete the patient RLQ number and press enter.

Unregistered patients (e.g. collapsing relative) can be given 7777777777 as a registration number. The RLQ number should be entered against all other patients.

PROCEDURE

1. Wash hands and put on latex gloves. Clean site for piercing with water only and then dry.Do not use alcohol wipes (Warning: skin contamination may result in false results).

2. Press the On/Off button to turn on the meter.

3. Press 1 to select Patient Test.

4. Press Scan to scan your Operator ID when prompted. Your 6 digit operator ID can also beentered manually using the alpha numeric keypad.

5. Press Scan to scan the patient’s ID (RLQ number) when prompted. (See preceding sectionon scanning patient barcodes).

6. Press Scan to scan the test strip.

7. Open the foil test strip packet at the notch and tear down to remove the test strip.

8. With the contact bars (black and white strips) facing up, insert the test strip into the teststrip port. ‘Strip inserted’ should appear on the screen followed by ‘Apply sample’.

9. Puncture the chosen area of skin to form a drop of blood.

10. If testing a neonate, always wipe away the first drop from the patient. Allow blood toflow again and use this sample for testing.

11. Keeping the meter horizontal, 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 blooddripping into the port and damaging the meter). ‘Sample accepted’ will appear on screen.

12. Wait for the meter to analyse the specimen and display the test result (5 seconds forglucose and 10 seconds for ketones).

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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DATA UPLOAD

Data is uploaded to the Data Management System (UniPOC) wirelessly if the wireless function is enabled. Data can also be uploaded to UniPOC by placing the meter in the Docking Station. During communications, the ‘Data Uploading’ screen appears and the arrows rotate to indicate that the system is working. The arrows may occasionally pause. After upload is complete, the message ‘Upload Successful, Turning Off’ will appear on the meter which will then turn off.

It is recommended that meters are docked every 24 hours.

Please note: the docking station does not charge the batteries.

RECORDING AND TRANSCRIPTION OF RESULTS

Patient results should be written with positive identification such as initials and unit number in the patient notes.

The meter will read glucose results between 1.1 and 27.8 mmol/l and ketone results between 0.0 and 8.0 mmol/l.

Any abnormal or unexpected result must be communicated to a doctor. Repeat the test and get a laboratory check.

If a numerical result is not obtained for glucose, i.e. the result lies outside the range (1.1 - 27.8 mmol/l ) a venous fluoride sample (yellow tube) must be sent to the laboratory for analysis.

Adult Patient Glucose Results only

Results less than 4 – treat as per hospital hypoglycaemic bundle and send a venous sample to the laboratory.

Results greater than 15 – treat as per hospital hyperglycaemic bundle.

If results persistently fall between 11 – 14.9 mmol/l, inform the Ward Team.

FAULTY METERS

In the first instance contact the POCT team during routine working hours (Monday to Friday 9am to 5pm). Out of hours a meter may be borrowed from a nearby location, or the laboratory THIS MUST BE RETURNED. Glucose measurement is available from the laboratory 24/7.

1. If the meter appears to be faulty, first consult the error codes at the back of the usermanual.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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2. If you cannot find a solution to the problem, contact the POCT team by emailing

3. If the fault cannot be rectified and a replacement meter is required or if the strip port needs to be replaced, clean the meter using a Clinell sanitising wipe. Complete the form in Appendix 4 and send to the laboratory with the meter by porter. Do not send through the pod system.

4. If a replacement meter is required due to avoidable misuse, the cost of repair will be charged to the relevant department.

5. The laboratory will contact Abbott to report the problem and arrange repair.

6. The POCT will remove all patient data prior to dispatch to Abbott.

7. The laboratory is responsible for returning faulty meters with an accompanying Incident Report Form.

8. All meters should be decontaminated by the Trust before meters are returned to Abbott. Decontamination documentation should accompany the meter(s).

STRIP PORT MODULE

The strip port module should be replaced if the meter becomes disabled as a result of liquid or other contaminant entering the strip port. Avoid getting dust, dirt, blood, control solution, water or any other substance in the meter’s test strip port.

Replacement is also indicated in the case of repeated strip port module errors.

Follow the instructions for returning a faulty meter to the laboratory. (see section on faulty meters)

CHANGING A STRIP PORT MODULE

For laboratory staff only.

1. Turn the meter off using the power button.

2. Place the meter (display screen down) on a flat surface. Use a Phillips screwdriver toremove the single screw on the back of the strip port module and place it aside.

3. Carefully slide the strip port module away from the meter and discard in the biologicalwaste.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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4. Slide a replacement strip port module into position on the meter and use the new screwto secure the replacement strip port module.

5. Check both high and low QC and dock the meter before returning it to it’s originallocation.

INFECTION CONTROL

Cleaning the exterior surface of the meter daily is recommended (see below) and whenever the meter is soiled.

Single-use, plastic meter sleeves for use with barrier-nursed patients are available from Blood Sciences upon request (x4040).

CLEANING THE METER

1. Turn off the meter.

2. Wipe all surfaces until the meter is visibly clear of soil.

3. Use a pre-packaged wipe e.g. Clinell wipe, squeeze out excess fluid prior to use. Do notapply cleaning solution directly to the meter.

Do not immerse or autoclave the meter or flood it with any liquid.

OPERATOR BARCODES

Operator barcodes will be issued at the point of training by the link trainer.

Barcodes listed on the training registers will be activated once the training register is sent to the POCT Blood Sciences and the operator information is entered onto the Conworx Unipoc system by laboratory staff (Appendix 3).

Staff must not use other Operator’s barcodes under any circumstances.

NEVER SHARE YOUR BARCODE WITH ANYONE. You may be subject to disciplinary action if you do so.

If you suspect that your barcode is being misused, please email to deactivate the suspect barcode and request a new one.

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

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Appendix 1

POCT distribution list for Freestyle Precision Pro Glucose and Blood β-Ketone Meter

Location Glucose Ketone-enabled

A&E - Majors (k) 1 1

A&E - Majors 2 1

A&E - Minors 1

A&E - RAA 1 1

A&E - Resus (k) 1 1

A&E - Triage 1

Fred Bulmer Departure Lounge 1

Age Care Clinic / OP - Fred Bulmer 1

Arrow Ward 2

Blood Sciences Department 1 1

CAU 1 1

CCU 1 1

Children's Unit 1 1

Paediatric Outpatients 1

DCU 1

Delivery Suite 1

Diabetic Centre 1 1

Endoscopy 1

Endoscopy Recovery 1

Frome Ward 2 2

ITU 1 1

Leadon Ward 1

Lugg 2 2

Macmillan Renton Unit 1

Maternity 1

Monnow 2

Gilwern Assessment Unit 1

Outpatients (Oxford Suite) 1

Pre-op Assessment LGFT-DGPT 1

Professional Development Centre 1

Redbrook Ward 2

SCBU 1

Surgical Admissions Unit 1

Teme Ward 2

Triple Theatres 1

Victoria Eye Unit 1

Victoria Eye Ward 1

Women's Health 1

Wye Ward 2 1

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

Edition No. 1.0 Copy No. 1

Page 17 of 21 Replaces : n/a Review date: 11/06/20

Appendix 2

How to Add New Operators to Conworx Unipoc (Lab staff only)

1. Find Unipoc on the favourites bar, shortcut key or type the following into your browser:

http://wvt-bgdata-prd/qcm3/

2. Enter your user ID and password and press logon.

3. Press on the operators tab (top left) and scroll to new.

4. Complete all fields with an asterix:

* First name

* Last name

* Operator ID (6 digit number on their barcode).

* Home location (go to the location tree on the left hand side and press on the plus to openthe appropriate location e.g. for Leadon, open up wards).

5. Go to recert interval and change from expired; click on the down arrow and change tospecify. Enter the date 3 years from the date of training.

6. Click on ‘Add Operator.’ The new record should now be listed in the table of operatorsbelow.

7. Initial and date the hard copy of the training record.

The operator will be now be able to use any Freestyle Precision Pro meter within the County Hospital as soon as that meter has undergone data upload i.e. by docking in the docking station or wireless transfer.

Please note: Link trainers will be added by the POCT team.

CONTROLLED DOCUMENT

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

Edition No. 1.0 Copy No. 1

Page 18 of 21 Replaces : n/a Review date: 11/06/20

Appendix 3

Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Performing Internal Quality Control Tests for Glucose

GLUCOSE TO BE CHECKED EVERY 24HRS.

KETONES TO BE CHECKED PRE-USE.

Because the software expects ketones to be checked every 24hrs also, it is suggested (until

software changes can be effected) that the following process is followed:

1. Turn on unit and wait for pre-use checks to complete.

2. Scan operator ID when prompted.

3. Scan low level solution lot when prompted.

AT THIS POINT, THE METER WILL ASK FOR A KETONE STRIP TO BE SCANNED, AS THE

KETONE QC WILL BE OVER 24HRS SINCE LAST TEST. IGNORE THIS PROMPT!!

4. Scan glucose strip lot instead.

MESSAGE DISPLAYED “UNEXPECTED STRIP – KETONE EXPECTED, GLUCOSE ENTERED”

5. Select option 2 – continue.

6. After pass, select option 1 for next level.

7. Scan or enter high solution lot.

8. The meter should now ask for a glucose strip to be scanned.

COMPLETE QC TESTING, AND PLACE METER IN DOCKING STATION TO UPLOAD DATA.

CONTROLLED DOCUMENT

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

Edition No. 1.0 Copy No. 1

Page 19 of 21 Replaces : n/a Review date: 11/06/20

Appendix 4

Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Incident Report Form

A separate form must be completed for each piece of equipment to be returned to Abbott Diabetes Care.

Meters must be cleaned and sent to the laboratory for assessment and decontamination and return to Abbott Diabetes Care (where appropriate).

Contact Name

Phone No:

Site

Location

Cleaned by

Date of Return

Meter Type

Serial Number

Description of Incident / Error

CONTROLLED DOCUMENT

Wye Valley NHS Trust Use of the Freestyle Precision Pro Blood Glucose and Blood β-Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 11/06/18 Effective Date : 11/06/18

Edition No. 1.0 Copy No. 1

Page 20 of 21 Replaces : n/a Review date: 11/06/20

Date Modification Signature

Wye Valley NHS Trust Use of the Nova Ketone Meter

Blood Sciences Department - Clinical Chemistry Date of Issue: 01/11/16 Effective Date : 01/11/16

Edition Number 1 Copy Number 1

Page 21 of 21 Replaces n/a Review Date : 01/11/18

Amendment Discard Insert Section(s) involved

No. Date Page(s) Issue No. Page(s) Issue No.