PROCEDURE NO. POC LBH. Printed copies are for reference only. Please refer to the electronic copy for the latest version.

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1 Department Of Pathology POC Blood Glucose Monitoring Accu-Chek Inform II Procedure-LBH Version# 1 Department PROCEDURE NO. PAGE NO. Point-of-Care Testing POC LBH 1 OF 7 Printed copies are for reference only. Please refer to the electronic copy for the latest version. 1. Purpose The Accu-Chek Inform II system is used to quantitatively measure glucose in fresh venous, arterial and capillary(fingerstick and neonatal heelstick) whole blood. The system is used as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes meillitus, nor for testing neonate cord blood samples. 2. Principle The system is calibrated with venous blood containing various glucose concentrations and is calibrated to deliver plasma-like results. This test method is referenced to the hexokinase method and is traceable to an NIST standard. 3. Specimen 3.1..The following fresh whole blood sample types may be used: a. Venous whole blood b. Arterial whole blood c. Capillary(non-neonate fingerstick and neonate heelstick)whole blood 3.2 The following anticoagulants are acceptable(do not use any other anticoagulants for meter testing): a. Lithium or Sodium Heparin; EDTA 4. Equipment And Materials 4.1. Accu-Chek Inform II 4.2. Accu-Chek Inform II test strips 4.3. Accu-Chek Inform II controls Effective Date: 08/12/2014 1

2 4.4. Single use, disposable lancets 4.5. Alcohol swab 4.6. Cotton ball, tissue or gauze for wiping finger after stick 4.7. Gloves are required for universal blood collection precautions. 5. Calibration Each box of strips contains a code key. Each code key belongs to a single lot and provides important information about the lot-specific properties of the Accu-Chek Inform II test strip. The properties of each lot number are downloaded (as a code file) from the code key into the Accu-Chek Inform II system by means of the code key reader. The code key lot information will be downloader by the point of care department when a new not number is introduced into the hospital. 6. Test Strip Storage and Handling: Use the test strips at temperatures between F (16-35 C). Use the test strips between % relative humidity. Humidity is the amount of dampness in the air. Store the test strips at temperatures between F (2 30 C).Do not freeze. Store unused test strips in the original container with the cap closed. Do not remove test strips from the test strip container and put them into another container such as a plastic bag or pocket, etc. Close the container tightly immediately after removing a test strip to protect the test strips from humidity. Use the test strip immediately after removing it from the container. Discard the test strips that are past the expiration date printed on the test strip container. If the expiration date is missing or illegible, do not use the test strips. Do not apply blood or control solution to the test strip before inserting it into the meter. If a result appears before applying blood or control solution, do not act on that result. Test strips bottle do not need to be dated when opened. 7. Quality Control 7.1.Supplies required: Inform II controls (level 1 and level 2) Inform II test strip vial Inform II meter 7.2 Controls need to be labeled with the 3 month discard date upon opening. 7.3 Liquid Quality Controls (Levels 1 & 2) are to be performed once every 24 hours and must be in range before patient testing can be performed. 7.4 Good Laboratory Practice is to perform controls when opening a new vial of strips or when unexpected results are obtained. Effective Date: 08/12/2014 2

3 8. Quality Control (Procedure) 8.1. After logging in the meter by scanning your operator barcode, select Control Test from Main Menu Hold down the scan button and scan the barcode on the bottle of control. Make sure the control is not out of date. 8.3 Hold down the scan button and scan the barcode on the glucose strip bottle. Once the meter displays a picture of a test strip with a downward flashing arrow, insert strip into the meter in the direction of the arrows and with the Accu- Chek lettering facing upward. 8.4 Wait for the flashing drop icon and then dose the control at the front edge of the test strip. Once sufficient sample has been detected, the measurement begins. An hourglass icon indicates that the measurement is in progress. You will get an error message if the sample is insufficient. If this occurs, you will need to repeat the test. Keep the meter in a horizontal position during testing. 8.5 When measurement is complete, you will receive a Pass or Fail message. 8.6 You will need to select the comment button and select one comment if you receive a fail message. 8.7 Touch the button to confirm result and send to data management system. 8.8 If you have persistent issues, please contact your POC office. Note: Patient testing may not be performed if quality control testing results are not within acceptable limits and the meter will not display the patient testing option if scheduled quality control results exceed acceptable limits. 9. Procedure (Patient Testing) Policies with patient testing: Blood glucose must be ordered by the physician/pa. Blood glucose determinations using venous and arterial blood specimens should be performed within 30 minutes of specimen collection to minimize the effects of glycolysis. Do not use test strips after their expiration date. Immediately cap vial after opening. Only LifeBridge Certified operators may perform a blood glucose test on the Inform II. Follow universal blood collection precautions when collecting specimens, performing test procedures, and cleaning blood glucose equipment. 9.1 Don gloves and any other protective equipment as required by LifeBridge infection control and isolation procedures. Perform fingerstick using the LifeBridge Fingerstick Procedure. Hand hygiene must be performed before after each procedure. (See procedure Hand Hygiene and Skin Protection, found in Infection Prevention and Control Manual. 9.2 Identify patient by name and date of birth. 9.3 Turn meter on and scan operator barcode to log into meter. 9.4 From the Main Menu, select Patient Test. Effective Date: 08/12/2014 3

4 9.5 Scan only the patient s barcode on the wrist band. This should be the Account number for Northwest and Sinai Hospital. 9.6 Scan the barcode on the Inform II strip bottle. 9.7 When you see a picture of a test strip with a downward flashing arrow on the screen, insert the test strip into the meter. Immediately recap the vial of strips. 9.8 The meter will display a flashing drop above the test strip icon when the test strip is properly inserted. 9.8 Collect an acceptable blood sample according to LifeBridge Health Fingerstick Procedure. Fingerstick or neonate heelstick samples: Test immediately as the sample is collected. Venous, arterial or line draw samples: Test as soon as possible and no later than 30 minutes following collection. Be sure they are well mixed and that line draw samples have been thoroughly cleared of line fluids. Do not allow bubbles to enter the test strip-sampling chamber. Keep the meter in a horizontal position during the testing process Wipe away the first drop or two of blood with a clean piece of gauze Apply blood to the front edge of the test strip. The sample will fill the yellow sample chamber by capillary action. Do not apply the sample to the top of the test strip Once sufficient sample has been detected, the measurement begins. An hourglass icon indicates that the measurement is in progress. 9.13After the sample has been obtained, apply gentle pressure to the puncture with A clean gauze square for several minutes Once a result is obtained, remove the strip and dispose of it into a biohazard container Meter should be wiped with PDI Sanicloth wipes or Bleach wipes following The wet and dry times of the wipes (found on the product label on container) Personal protection equipment should be disposed of properly Touch the comment icon to select a comment if necessary. LifeBridge approved Comments will be available for selection Touch the button to confirm the result and send the result wirelessly. If wireless is not working, dock in a docking station that can transmit results Return meter to docking station. 10. Reference Ranges Adult: mg/dl PEDS: PICU: NICU: (<24 hours) (>24 hours) 11. Critical Values Adult : 50 mg/dl or 400 mg/dl PEDS: 50 mg/dl or 400 mg/dl Effective Date: 08/12/2014 4

5 PICU: 50 mg/dl or 400 mg/dl NICU: 30 mg/dl or 199 mg/dl (<24 hours) NICU: 50 mg/dl or 199 mg/dl (>24 hours) Repeat testing is recommended for critical results or any result that does not correlate with the patient clinical condition to ensure patient safety. Note: CR HI or CR LO indicates a critical value. For values below or above the reportable limits ( mg/dl), it is recommended that the Provider send a specimen to the lab for verification. Note: RR HI or RR LO indicates a value beyond the reportable limits. Critical value notification to provider needs to be documented. This should include name of provider, date and time of notification and value that was notified. 12. Reporting Results/ Transferring data Data is transferred wirelessly to Cerner. Results will automatically transfer wirelessly when the operator selects the check button after testing. In case the wireless network is down, please dock the meter on the appropriate docking station that is identified by a blue dot. The following series of screen displays will appear to confirm that data transfer is occurring: Connecting (meter is establishing connection) Transferring (meter is transferring information) Idle( meter has finished communications and is ready to use) 13. Troubleshooting 13.1 General guidance for interpreting on-screen message and error codes: If the error message Strip Defect Error appears on the display, the test strip may be defective or the blood glucose result may be extremely low and below the meter s measurement range. Refer to the test strip package insert, perform a quality control test using a new test strip, review proper testing procedure, and repeat the blood glucose test, or follow your facility s testing policy. If the meter displays Type Bad Dose, there may be insufficient amount of blood on the test strip. Repeat the test using a new test strip, ensuring proper sample application, or refer to the test strip package insert For technical help call: 1. Sinai: Ann Bengzon (beeper#1546) or Pauline Kamenyi (vocera 21000) 2. Northwest: Call Point of Care office: Extension x Roche technical help line Maintenance and Handling Effective Date: 08/12/2014 5

6 Meter and Base Unit Storage, Maintenance and Handling 14.1Keep meter in base unit when not in use 14.2Handle the meter and its system components carefully. Avoid dropping or banging. 14.3Protect the base unit from dripping liquid. 14.4Do not immerse the meter or base unit in any liquid. 14.5Do not expose the meter to excessive sources of heat for prolonged periods of time when performing a test. Potential sources of heat include but are not limited to: Leaving the meter under a bilirubin light or photo therapy light Leaving the meter on a bed warmer Leaving the meter in an isolette 14.6 General Cleaning and Disinfecting Procedural Considerations: Do s Don ts Disinfect meter after every patient. Disinfect carrying case after taking out of patient s room. Use Sanicloth wipes at NW and Sinai. Use Bleach wipes at NW for suspected or known C. Difficile patients Follow wet and dry times on package of wipes being used. Do Not clean or disinfect the meter while performing any type of test. Do Not allow pooling of liquid on the touchscreen. Do Not spray anything onto the meter or base unit. Do Not immerse the meter or base unit in liquid. Do Not get liquid into the strip port! If liquid does get into the test strip port, immediately dry the components with a dry cloth or gauze pad. If solution is allowed to collect in any meter opening, severe damage to the system can occur. If you suspect that moisture may have entered the strip, perform glucose control testing. Do Not wipe the electrical connectors on the back of the base unit. Do Not use any cleaning and disinfecting product other than that which is recommended by the hospital. 15. Limitation of Procedure Effective Date: 08/12/2014 6

7 The ACCU-CHEK Inform II test strips are for testing fresh capillary, venous, arterial, or neonatal whole blood. Cord blood samples cannot be used. Note: No maltose inference with this strip Hematocrit should be between % Lipemic samples (triglycerides) in excess of 1800 mg/dl may produce elevated results Blood concentrations of galactose >15 mg/dl will cause overestimation of blood glucose results. 15.4Intravenous administration of ascorbic acid which results in blood concentrations of ascorbic acid >3 mg/dl will cause overestimation of blood glucose results If peripheral circulation is impaired, collection of capillary blood from the approved sample sites is not advised as the results might not be a true reflection of the physiological blood glucose level. This may apply in the following circumstances: severe dehydration as a result of diabetic ketoacidosis or due to hyperglycemic hyperosmolar non-ketotic syndrome, hypotension, shock, decompensated heart failure NYHA Class IV, or peripheral arterial occlusive disease This system has been tested at altitudes up to 10,000 feet Manufacturer states, This system should not be used for patients who are critically ill. Lifebridge lab tested this meter on critically ill patients and found the results to correlate with lab results within acceptable CLIA standards. It is up to the provider to decide whether to use this meter for critically ill patients. 16. References 1 FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication, (2010). MedicalDevices/Safety/AlertsandNotices/ucm htm, accessed 03/02/12. 2 CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens, (2010). accessed 03/ Roche procedure and policy manual(2012). Roche Diagnostics 9115 Hague Road, Indianapolis, IN Roche Accu-Chek Inform II package inserts for strips (2013) 17. Attachments N/A Departments: POCT Effective Date: 08/12/2014 7

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