Department Of Pathology POC.514.06- Blood Glucose Monitoring Accu-Chek Inform II Procedure-LBH Version# 6 Department PROCEDURE NO. PAGE NO. Point-of-Care Testing POC.514.05 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 (finger stick and neonatal heel stick) 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 mellitus, 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. Patients in whom finger stick sampling is contraindicated: Use Inform II meter on venous or arterial samples only: Systolic BP < 80 Patient requiring pressor support Acute decompensated heart failure 3+ edema or greater of the upper extremities Severe DKA or HHNS Patients in whom the Inform II meter is not approved for use: use central laboratory method or EPOC: Hct <10 or >65 Triglycerides > 1800 mg/dl Galactosemia > 15 mg/dl Concurrent IV administration of ascorbic acid Effective Date: 10/07/2017 1
Umbilical cord samples 3. Specimen 3.1 The following fresh whole blood sample types may be used: 3.1.1 Venous whole blood 3.1.2 Arterial whole blood 3.1.3 Capillary (non-neonate finger stick and neonate heel stick) whole blood 3.2 The following anticoagulants are acceptable (do not use any other anticoagulants for meter testing): 3.2.1 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 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 5.1 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 downloaded by the point of care department when a new lot number is introduced into the hospital. 6. Test Strip Storage and Handling: 6.1 Use the test strips at temperatures between 61-95 F (16-35 C). 6.2 Use the test strips between 10-80 % relative humidity. 6.3 Store the test strips at temperatures between 36-86ºF (2-30ºC). Do not freeze. 6.4 Store the test strips at temperatures between 36 86 F (2 30 C).Do not freeze. 6.5 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. 6.6 Close the container tightly immediately after removing a test strip to protect the test strips from humidity. 6.7 Use the test strip immediately after removing it from the container. 6.8 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. Effective Date: 10/07/2017 2
6.9 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. 6.10 Test strip bottle does 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 run controls when opening a new vial of strips or when unexpected results are obtained. 8. Quality Control Procedure 8.1. After logging in the meter by scanning your operator barcode, select Control Test from Main Menu. 8.2. 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) 9.1 Policies with patient testing: 9.1.1 Blood glucose must be ordered by the physician/pa. Effective Date: 10/07/2017 3
9.1.2 Blood glucose determinations using venous and arterial blood specimens should be performed within 30 minutes of specimen collection to minimize the effects of glycolysis. 9.1.3 Do not use test strips after their expiration date. Immediately cap vial after opening. 9.1.4 Only Lifebridge Certified operators may perform a blood glucose test. 9.1.4 Follow universal blood collection precautions when collecting specimens, performing test procedures, and cleaning blood glucose equipment. 9.2 Procedure 9.2.1 Don gloves and any other protective equipment as required by Lifebridge infection control and isolation procedures. 9.2.2 Perform finger stick using the Lifebridge Finger stick Procedure. Hand hygiene must be performed before and after each procedure. (See procedure Hand Hygiene and Skin Protection, found in Infection Prevention and Control Manual. 9.2.3 Identify patient by name and date of birth. 9.2.4 Turn meter on and scan operator barcode to log into meter. 9.2.5 From the Main Menu, select Patient Test. 9.2.6 Scan only the patient s barcode on the wrist band. This should be the account number for Northwest, Levindale and Sinai Hospital. 9.2.7 Scan the barcode on the Inform II strip bottle. 9.2.8 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. 9.2.9 The meter will display a flashing drop above the test strip icon when the strip is properly inserted. 9.2.10 Collect an acceptable blood sample according to Lifebridge Health Finger stick Procedure. Finger stick or neonate heel stick 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. 9.2.11 Keep the meter in a horizontal position during the testing process. 9.2.12 Wipe away the first drop or two of blood with a clean piece of gauze. 9.2.13 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. 9.2.14 Once sufficient sample has been detected, the measurement begins. An hourglass icon indicates that the measurement is in progress. 9.2.15 After the sample has been obtained, apply gentle pressure to the puncture with a clean gauze square for several minutes. 9.2.16 Once a result is obtained, remove the strip and dispose of it into a biohazard container. Effective Date: 10/07/2017 4
9.2.17 Meter should be wiped with hospital approved wipes following the wet and dry times of the wipes (found on product label). 9.2.18 Personal protection equipment should be disposed of properly. 9.2.19 Touch the comment icon to select a comment if necessary. Life Bridge approved comments will be available for selection. Operator error Wrong ID will repeat Cleaned meter Informed Nurse Repeat Test Will doc Dr in Adhoc Insulin drip Sliding Scale Replaced strips DKA protocol (peds/picu) Pt refused rpt 24 to 48 hours old (NICU) Sent to lab 4 to 24 hours old (NICU) 9.2.20 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. 9.2.21 Return meter to docking station. 10. Reference and Critical Range 10.1 Reference Ranges and Critical Values for Northwest and Sinai Hospitals Age Critical Low Reference Range Critical High 0-4 hours old <25 mg/dl 30-99 mg/dl >200 mg/dl 4-24 hours old <35 mg/dl 35-99 mg/dl >200 mg/dl >24-48 hours old <40 mg/dl 50-99 mg/dl >200 mg/dl >48 hours to 28 days <50 mg/dl 50-99 mg/dl >200 mg/dl >28 days to 18 years <50 mg/dl 70-105 mg/dl >300 mg/dl* Adults >18 years 50 mg/dl 70-105 mg/dl 400 mg/dl Critical ranges for peds/nicu population established by Department chairs and Medical Director of POCT in Feb. 2017. *Glucose results >300 for Peds/PICU patients in DKA will be managed per their DKA protocol. 10.2 Reference Ranges and Critical Values for Levindale Hospital and Adult Day Care Age Critical Low Reference Range Critical High >18 years old 60 mg/dl 70-105 mg/dl >400 mg/dl Effective Date: 10/07/2017 5
*Note: Physician notification and treatment for hypoglycemia will be initiated if blood glucose level is < 70 mg/dl, per Department of Nursing. 10.3 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 indicated a critical value. 10.4 For values below or above the reportable limits (10-600 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. 10.5 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. This is documented by the nurse under nursing documentation adhoc section of power chart. Note: Some units in Levindale will require paper documentation critical result notification. 11. Reporting Results/ Transferring data 11.1 Data is transferred wirelessly to Cerner. Results will automatically transfer wirelessly when the operator selects the check button after testing. 11.2 In case the wireless network is down, please dock the meter on the docking station marked either hard wired or transmits results. 11.3 The following series of screen displays will appear to confirm that the date transfer is occurring: Connecting (meter is establishing connection) Transferring (meter is transferring information) Idle (meter has finished communications and is ready to use) 12. Troubleshooting 12.1 General guidance for interpreting on-screen message and error codes: 12.1.1 If the error message Strip Defect Error appears on the display, the strip may be defective or the blood glucose may be extremely low and below the meter s measurement range. Run a quality control using a new strip. If ok, repeat test and still low, send sample to lab. 12.1.2 If meter displays Type Bad Dose, there may be insufficient amount of blood on test strip. Repeat the test using a new test strip. 12.1.3 For technical help call: 1. Sinai: POC manager 25673 or vocera Point of Care Testing 2. Northwest: Call POC office: Extension X54371 3. Levindale: POC manager 25673 or vocera Point of Care Testing 4. Roche technical help line 1-800-440-3683 5. Point of Care staff are available Mon-Fri from 7am to 4pm. Messages left on vocera will be addressed next working day. 6. Broken meters are not handled by Bio Med. Effective Date: 10/07/2017 6
13. Maintenance and Handling 13.1 Keep meter in base unit when not in use to charge battery. 13.2 Handle the meter carefully. Avoid dropping or banging. 13.3 Protect the base unit from dripping liquid. 13.4 Do not immerse the meter or base unit in any liquid. 13.5 Do not expose the meter to excessive sources of heat for prolonged periods of time. Potential sources of heat include but are not limited to: Baby isolette or bilirubin light Hot/cold window or heating vent 14.0 General Cleaning and Disinfection Procedures: 14.1 Do s Disinfect meter after every patient. Disinfect carrying case if taken into patient s room. Use hospital approved wipes. Follow wet and dry time on package of wipes being used. 14.2 Do Not do: 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. Test with QC. Do Not wipe the electrical connectors on the back of the base unit. 15. References: 15.1 FDA Public Health Notification: Use of Fingerstick Devices on More than one Person Pose Risk for Transmitting. Bloodborne Pathogens: Initial Communication, (2010). 15.2 CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens, (2010). http://www.cdc.gov/injectionsafety/ Fingerstick-DevicesBGM.html, accessed 03/3012. 15.3 Roche procedure and policy manual (2012). Roche Diagnostics 9115 Hague Road, Indianapolis, IN 46256. 15.4 Roche Accu-Chek Inform II package inserts for strips (2017). 15.5 S&C 15-11 CMS Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS), March 13, 2015. 15. Attachments a. N/A Departments: POCT Effective Date: 10/07/2017 7