Pathology Directorate / F Examination Process
F2 Examination procedures
Printed on : 04/08/2010 Page 1 of 4
Blood Sciences
Section : Point of Care
The Nova Glucose meter
Site/Area of application / Point of Care
Index code / BSF2POC006 v 3
Superseded documents / BSF2POC006 v 2
Implementation date of this version / 4th August 2010
Approver of content of SOP / Uche Okeahialam Author: Rob Coleman
Reason for change / Review and update to current SOP template
Keywords for search on EQMS / Poct, Nova, Glucose, Blood sugar.
This document is controlled using the Pathology EQMS software.
Controlled printed copies can be identified by the authorisation signature present in the space below. Upon request further authorised copies can be obtained through the department’s quality system.
Uncontrolled copies may be printed for an individuals use but should not be used after 1 week from the date of printing.
Signature
1. CLinical relevance/purpose of procedure
The device used to monitor blood glucose must be reliable, accurate, fast, easy and convenient to use. The glucose meters used by patients and hospital workers are for monitoring, not diagnosis. These meters should only be used by staff who have been trained and are aware of the contraindications to their use.
2. principle of procedure
Glucose dehydrogenase is impregnated into the test area of a reagent strip (also called an electrode). This reacts with the glucose present in a blood sample and produces an electrical signal. This is detected by the meter and translated into a glucose result in mmo/L. The strength of signal produced is directly proportional to the amount of glucose in the blood.
3. personnel / training requirements
OPERATORS:
Only staff who have received documented training (by Nova trainers or by ward Key Trainers) are authorised to use the meters. Copies of training records must be kept in clinical areas and be available for scrutiny if requested. Names of staff trained, trainer, date, location (ward/Hospital), and password must be sent to the Point of Care Manager in Biochemistry, LGI by e-mail - Group address “Point of Care”, for the password to be made active.
TRAINING: Training sessions will initially be run by Nova. Each area must have trained members of staff who are designated to cascade training to new/untrained staff.
4. specimen requirements
Sample type: - Whole blood. Finger prick, heel or earlobe sample. A fresh sample in a blood gas syringe (balanced Heparin) is suitable.
Minimum volume: - 1.2mL
Sample must be measured immediately
5. equipment
Stat Strip Connectivity Meter and Docking Station and Work Station
NB Connectivity Meters are not replaced free, so a new meter will have to be purchased to replace lost or damaged meters
6. health and safety/risk assessment
See the COSHH assessment BICOSHH153
Glucose Sensors The reagent area of each electrode contains:
Glucose Enzyme - No Risk
Non-reactive ingredients - No Risk
Glucose Control Solutions
Glucose - Low Risk
Non-reactive ingredients - Low Risk
Do not swallow or inject the solution. Wear gloves throughout.
7. reagents
Stat Strip Glucose Test Strips, 50 strips per vial . . . . …………………....42214
Stat Strip Glucose Control Solution, Level 1(low), one vial ...... 41741
Stat Strip Glucose Control Solution, Level 3(high), one vial ...... 41743
Batteries 42215
All above stored at room temperature (Below 30 degrees celsius).
The strips are obtained from Pharmacy. Control solutions are supplied by Pharmacy.
Users will also require equipment for obtaining a capillary finger or heel prick sample
8. Calibration
The method is calibrated at the time of manufacture.
9. quality control
See reagent section.
Records of quality control lot numbers are stored in the BioConnect software, to which the Stat strip meters are linked.
External Quality Assessment participation:-
WEQAS
One bottle of unknown Glucose concentrate solution is sent to each ward/dept every three months. Test is performed as per patient sample and the result obtained is returned to the Laboratory as directed. This is a mandatory requirement
10. computer / telepath codes
N/A
11. procedure or methodology
To analyse a Patient sample
Important: Only trained staff may use the glucose meters. Access to the meter is by scanning personal Trust ID badge. (Use of someone else’s password may result in disciplinary action.
· Remove meter from docking station.
· Press “Login”. Press “Scan” whilst pointing bar code reader at your own Trust ID badge barcode.
· From the Patient Test screen press “Accept”
· “Enter Strip Lot” screen is displayed. Scan the strip lot number from the side of the strip container. Press “Accept”
· Enter the patient’s ID by scanning their addressograph label ,wristband barcode, or enter Hospital Case note number using the keypad. If this is not available use the keypad to enter full patient name. Please be aware that glucose results from the meters are stored on computer and MUST be traceable to the patient. Press “Accept”
· Wash patients hand or heel with water and dry thoroughly. Alternatively use alcohol pads to clean area; dry thoroughly after cleaning.
· Holding hand downward, massage finger with thumb toward tip to stimulate blood flow.
· Use a safety lancet to puncture the finger and gently squeeze the finger to form a drop of blood. Prick the side of the patient’s finger. Remember not to use the thumb or index finger.
· Follow instructions on the screen to perform test.
· Result will appear in 6 seconds.
· To add a comment before accepting or rejecting the result, press the “Comment” key. Accept your comment and then accept or reject the result. A comment must always be added if rejecting a result.
· The result must be entered in the patient’s notes, and the appropriate action taken if any
· Return meter to the Docking Station.
To analyse Quality Control (QC) samples.
This procedure must be performed with the meter placed on a flat surface. Control solution must not be allowed to drip into the meter.
· Remove meter from docking station.
· Press “Login”. Press “Scan” whilst pointing bar code reader at your own Trust ID badge barcode.
· From Patient Test Screen press “QC” key.
· “Enter Strip Lot” screen is displayed. Scan the strip lot number from the side of the strip container. Press “Accept”
· Scan the QC lot no. Press “Accept”
· Follow the on-screen instructions to perform the test. Make sure the QC bottle is mixed thoroughly before sampling.
· Result will appear in 6 seconds, if test has “Passed”, press “Accept”.
· If test has “Failed” check your Strips and QC solution have not exceeded the 90 day expiry. If expired, run the test again with fresh test strips/QC solution. Make sure the QC bottle is mixed thoroughly before sampling. If it fails again, report failure to POCT 22338, bleep 2320, who will advise you further.
Disposal:
Particular care should be taken to ensure that lancets and used electrodes are disposed of in a sharps container.
Cleaning:
The Stat Strip meter should not require much cleaning, as with correct use, blood and control solutions do not enter the meter. However, if the meter does get dirty it can be wiped with a damp cloth and mild soap/detergent.
Do not immerse or place the meter in water.
Infection control:
Wear gloves
Disposable covers are available for meters in use for patients with infections
12. uncertainty of measurement
All POCT devices have limitations and this should be remembered at all times.
A diagnosis of diabetes or hypoglycaemia cannot be made by blood glucose sensor reading alone. A confirmatory fluoride oxalate (grey top) sample must be sent to the laboratory for analysis.
All results need to be interpreted in the light of the patient’s condition. If an unexpectedly high or low glucose concentration is obtained, a repeat test should be performed and a sample sent to the laboratory
SELF-MONITORING BY IN-PATIENTS
Patients with diabetes admitted to hospital may be monitoring their own blood glucose levels using one of a number of different systems.
However, the hospital and its staff have an over-riding duty of care to patients and they must be confident that the blood glucose results obtained are accurate so that they can act appropriately on them. For this reason only test results obtained using the ward Stat Strips must be used to modify treatment in any way.
Analytical range: - 0.6-33.3mmol/L
Reportable intervals for patient samples: - 0.6-33.3mmol/L
13. reference range / action limits
Reference range: - 3.5-6.0 mmol/L (Fasting)
Reference range derived from: - Tests and Tubes database
Action limits:-
Neonatal: Less than 3.0 or Greater than 11.0mmol/L
Non-neonatal: Less than 2.5 or greater than 20 mmol/L
14. referEnces
Nova Instructions for Use Manual Ref 41853
Kit inserts: - Ref 42214, 43282
Details of lot numbers of all reagents used in performing a glucose test are stored in the patient record in the Bioviewer server.
Training in this procedure is recorded using the generic training record BSF2POC020
15. APPENDICES
N/A
INDEX CODE: BSF2POC006 version 3 / TITLE: The Nova Glucose meter / Page 1 of 4Copies without an Authorised stamp or document manager signature are no longer valid after 7 days of this date 04/08/2010