This SOP must be available at all glucose meter workstations.

Transcription

1 LEEDS TEACHING HOSPITALS NHS TRUST STANDARD OPERATING PROCEDURE (SOP) for use of Abbott Optium Exceed blood s. All staff using the meters must have read and understood this SOP. A copy must in all areas where Glucose meters are used. This Standard Operating Procedure explains the protocol for measuring blood glucose concentration using the Optium Exceed meter, with emphasis placed on the responsibility of nursing staff to ensure that the meter is used correctly and that a high standard of patient and control results is maintained. These procedures must be followed to protect patients. Failure to follow procedures may be detrimental to the user and Nurse Manager in the event of litigation. 1. OPERATORS: Only staff who have received documented training are authorised to use the Optium Exceed meters. Copies of training records must be kept in clinical areas and for scrutiny if requested. Names of staff trained by the Abbott representative will be sent to the Point of Care Manager and kept on a database. 2. TRAINING: Training sessions can be arranged through the Point of Care Manager, or the Abbott company representative. Each area should have a member of staff who is a designated cascade trainer. 3. EQUIPMENT: MediSense Optium Glucose Meter: The meter should be stored at room temperature, away from moisture, direct heat or sunlight. Return to Biochemistry Department for repair or replacement. MediSense Optium H Electrodes (Test strips): Electrodes should be stored at temperatures between 4 o C and 30 o C away from direct heart or sunlight. As each electrode is individually foil wrapped they will remain stable until the date printed on the box. Do not use bent, scratched, damaged or expired electrodes. Order from Pharmacy. MediSense Glucose Controls: Lo and Hi, should be stored at room temperature. They are stable until the expiry date printed on the vials, or for 90 days from the vials being opened, whichever comes first. The date new control solutions are opened should be written on the vials along with the new 90 day expiry date. Replacement solutions can be ordered from the Biochemistry department (x22338 or x64625). 3. OPERATION NOTE: In this Trust blood glucose concentration is reported in mmol/l, which will be set on the meters BIEEAOE1 v 1 Page 1 of 6

2 Calibration: To ensure accurate results the meter must be calibrated (coded) for each new box of strips before use to ensure that system accuracy is unaffected by batch to batch variations in strips. The calibrator stores information required by the meter to provide accurate results. The code key (calibrator) is stored in its own plastic container when not in use. 1. Remove the calibrator and Instructions for Use insert from the new box of electrodes. Check the 5 digit lot number on each following. the electrode box the calibrator each electrode packet Instructions for use insert Make sure that they all have the same lot number. Use ONLY Optium Xceed strips with Optium Xceed meters 2. Hold the calibrator with the contact bars facing upwards. Insert the contact bars into the test port meter. The lot number will be displayed. Check that the lot numbers match. Calibration is now complete. Remove the calibrator and store in its container. Do not discard it or the Instructions for Use insert until all the electrodes from that box have been used. The Optium meter must be calibrated: Before a meter is used for the first time Routinely after changing batteries Routinely when a new box of electrodes is opened If the code number displayed does not match the code number printed on the box of electrodes If the meter has been dropped, immersed in water etc On any occasion when there is a suspicion that the meter is not working correctly DO NOT MIX CALIBRATOR AND STRIP LOT NUMBERS Internal Quality Control Internal quality control checks ensure that the meter is working correctly at the time of testing. In order to do this, sample with known concentrations are run through the usual test procedure. 1. Open an electrode packet by tearing diagonally at the notches in the foil and then tearing down the side packet. 2. Remove the electrode form the packet. 3. Insert the contact bars, facing upwards, into the meter test port. The meter will turn on automatically. 4. Invert the control bottle 4 times to mix the solution thoroughly. Apply a drop to the electrode target area, the test will start when the sample is detected. 5. After the 20 second countdown, the glucose control result is displayed. Record the result in the green Quality Control Record Book. Compare the glucose control result to the Expected Result for Use with MediSense control solution printed on the Instructions for Use insert in the box of glucose electrodes currently in use. Make a note in the green Quality Control book that the result is Within range BIEEAOE1 v 1 Page 2 of 6

3 6. Remove the electrode and discard in a sharps container. If the control result is not within the acceptable range, repeat the test with a new electrode. If the result is still not in range, recalibrate the meter, checking all lot numbers. If the problem persists do not use the meter and contact the Point of Care staff. Once opened the quality control solutions are stable for 90 days. On opening the vials the expiry date should be written on the bottle. For legal reasons the quality control record book must be kept for 12 years from when it is completed. Completed QC record books must be returned to the Point of Care Manager. Replacement record books and QC solutions can be obtained from the Biochemistry department. Internal quality control must be performed on a daily basis, before the meter is used for monitoring patients. For sensors used less frequently QC must be performed on a weekly basis (minimum) or before the first patient test day is carried out. After any unexpected result Before a meter is used for the first time Routinely after changing batteries Routinely when a new box of test electrodes is opened If the meter is dropped, immersed in water etc. On any occasion when there is suspicion that the meter is working incorrectly. If the electrodes have been exposed to extreme temperature (less than 4 o c or greater than 30 o C). Blood glucose testing 1. Wash hands, (operator and patient) with warm soapy water. Dry thoroughly. Do not use alcohol wipes as this may affect the result. 2. Open a glucose electrode packet by tearing diagonally at the notches in the foil and then tearing up or down the side packet. 3. Remove the electrode from the packet and insert the contact bars, facing upward, into the test port. 4. Push the electrode until it stops. The meter will turn on automatically. Check that the lot numbers match on the calibrator and the box of electrodes currently in use. If the lot numbers do not match, recalibrate the meter. 5. Apply blood when prompted by touching the blood drop to the target area of the electrode. The test starts automatically when the sample is detected. Important: If the test fails to start, a second drop can be applied to the target areas within 30 seconds first drop. If the test fails to start after the second drop is applied, or if more than 30 seconds have elapsed, discard the electrode and repeat the test. 6. After the 20 second countdown the blood glucose result will be displayed. Record the patient s result on the appropriate document for the clinical area. This record MUST include unequivocal patient identify, date and time of test, the result and the identity operator. 7. Remove the electrode and discard the electrode in a sharps container. Important: If Lo appears, the sensor has determined that the blood glucose concentration is less than 1.1 mmol/l. Repeat the test. If the result is the same, send a sample to the laboratory for accurate confirmation. BIEEAOE1 v 1 Page 3 of 6

4 If Hi appears, the sensor has determined that the blood glucose concentration is greater than 27.8 mmol/l. Repeat the test, if the result is the same, send a sample to the laboratory for accurate confirmation. External Quality Assessment (WEQAS): This differs from internal quality control in that the accuracy procedure is not known until after the results have been issued. As the user does not know the glucose concentration at the time of analysis and the results are assessed independently, it allows confidence that the performance of meters and operators is not varying over time and that results are similar in different clinical areas. Vials of external quality control material are distributed bi-monthly by POCT staff. The sample must be tested as soon as possible and the result returned promptly to POCT Manager. 4. LIMITATIONS All POCT devices have limitations and this should be remembered times. A diagnosis of diabetes or hypoglycaemia cannot be made by blood glucose sensor reading alone. A confirmatory sample must be sent to the laboratory for analysis. All results need to be interpreted in the light 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. In any event, the result should be confirmed by the laboratory if a glucose result of less than 3.0mmol/l is obtained. The situation is more complex in neonates, so protocols produced by the neonatal areas should be consulted in conjunction with this SOP. 5. HEALTH AND SAFETY Particular care should be taken to ensure that lancets and used electrodes are disposed of in a sharps container. Cleaning: The Optium 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. Document any cleaning in the Quality Control Record Book. 6. COSHH REGULATIONS Glucose Sensors The reagent area of each electrode contains: Glucose Oxidase - 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. BIEEAOE1 v 1 Page 4 of 6

5 7. CONTRAINDICATIONS Glucose measurement (Sources: MDA SN 9616 and MediSense Literature) Contra-indication Examples and limits for MediSense Optium Peripheral Circulatory Failure Severe Dehydration Variations in Blood Oxygen Tension High Concentration of Non-Glucose Reducing substances in blood High Bilirubin Values Extremes of Haematocrit Severe dehydration, hyperglycaemic-hyperosmolar state, with or without ketosis, hypotension, shock, peripheral vascular disease. Vomiting or diarrhoea, prescription drugs eg. diuretics, inability to recognise or respond to thirst sensations, sustained uncontrolled diabetes. Patients receiving intensive oxygen therapy Intravenous infusion of ascorbic acid (>170 mmol/l), xylose absorption test Jaundice (Bilirubin >342 µmol/l) Neonatal blood samples (<20%, >70%) Hyperlipidaemia Triglycerides > 33.9 mmol/l Cholesterol >13.0 mmol/l Some Drugs Miscellaneous 8. TROUBLE SHOOTING Paracetamol (> 662 µmol/l (100 mg/l)) High Urate concentrations (>1.2 mmol/l) Never use a meter if there are concerns that it is not functioning correctly. If another sensor is not available, send samples to the laboratory. Quality control errors Most quality control errors can be resolved in the clinical area before contacting the laboratory staff about a quality control error : Carry out calibration, checking that the lot numbers on electrode packaging, and calibrator match. Check that the QC solutions were opened less than 90 days ago. (They are stable for only 90 days from the date opened). Invert QC bottles 4 times (the quality control solution sometimes crystallises around the neck bottle. BIEEAOE1 v 1 Page 5 of 6

6 Repeat the QC test If the error persists, contact the POCT Manager (ext , bleep 2320). 9. 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 MediSense Optium Meter using Optium H strips must be used to modify treatment in any way. This Standard Operating Procedure was prepared by Robert Coleman POCT Manager, and Dr Joan Pearson POCT Clinical Lead, Department of Clinical Biochemistry & Immunology. 15/2/2008 BIEEAOE1 v 1 Page 6 of 6