Title/Description: Point of Care Glucose Testing-Waived Department: Organization Wide Personnel: All Effective Date: November 29, 2016 Revised:

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1 Title/Description: Point of Care Glucose Testing-Waived Department: Organization Wide Personnel: All Effective Date: November 29, 2016 Revised: PURPOSE The Abbott FreeStyle Precision Pro (FSPP) Blood Glucose meter and test strips are intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh, capillary whole blood and from venous, arterial or neonatal whole blood. The results may be utilized in the clinical decision making processes involving a patient s blood glucose level. The system is not for use in diagnosing diabetes, but is used as an aid in monitoring the effectiveness of diabetes control programs. PRINCIPLE The Abbott FreeStyle Precision Pro (FSPP) system has been developed to allow rapid measurement of blood glucose (D-glucose) by using an electrochemical detection technique. The biosensor employs a disposable dry reagent strip technology based on the glucose dehydrogenase method for glucose determination. Each test strip features an electrode containing the enzyme glucose dehydrogenase (GDH-NAD), NAD Cofactor, and PQ mediator. When a drop of blood is applied to the target area of the test strip, the glucose dehydrogenase catalyses the oxidation of glucose in the drop to produce 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 blood glucose concentration. POLICY Task Classification/ Precautions: 1. CLIA Classification: Waived 2. Precaution Category: Universal Precautions a. Justification: High risk for exposure to blood/body fluids with visible blood b. Protective Wear: Gloves c. Disinfect meter after use on each patient to prevent transmission of potential pathogens Operator Certification 1. Only a Certified Operator will be allowed to perform the point-of-care glucose procedures. 2. A certified operator is an employee who has attended the initial training and successfully completed the competency performance for this procedure. 3. In order to maintain the status of Certified Operator, all operators are required to demonstrate continuing competency on an annual basis. 4. It is the Nurse Managers responsibility to ensure that all staff performing this procedure is currently certified. Non certified operators are locked out of the FSPP meter operation. 5. The Nurse Manager will notify the Point-of-Care Coordinator of additions or deletions of certified operators (i.e. new hires, termination of staff, etc.). Competency Verification 1. An operator must attend training on the FSPP glucometer offered by the Staff Development or by a FSPP trainer designated by the Nurse Manager or POC Coordinator and successfully pass a written test. 2. An operator must demonstrate competency during orientation through direct observation by the Nurse Clinical Educator, Nurse Manager, the POC Coordinator or designee.

2 Annual Competency Verification: 1. Demonstrate competency to a certified nurse/ Charge Nurse/Nurse Manager or POC Coordinator on Annual Competency Checklist, and 2. Complete CBL on ShareSafe and pass a test. Record of Certification 1. The Staff Development Department maintains education course records in the Staff Development Department for nursing staff and POC Coordinator for non-nursing staff. 2. Subsequent re-certifications will be noted on Annual Competency Checklists. 3. Individual educational files are also placed in the nurse's personnel file, if these are maintained by the Nurse Manager. EQUIPMENT 1. Foil-wrapped FreeStyle Precision Pro (FSPP) Blood Glucose Test Strips 2. MediSense Glucose Control Solutions (low & high) 3. Sterile disposable approved lancet 4. Alcohol Prep 5. 2 x 2 s or cotton swab 6. FSPP blood glucose analyzer 7. Alcohol or bleach disinfecting wipe FreeStyle Precision Pro Blood Glucose Test Strips Storage Requirements 1. Store in sealed foil packet between 4-30 degrees C (39-86 degrees F) prior to use. Keep away from direct sunlight and heat. Use the test strip immediately after opening the foil packet. Unopened strips are usable until expiration date published on packet. 2. Do not use wet, bent, scratched or damaged test strips. 3. Use the test strip only once and then discard. 4. Do not use the test strip if the foil pouch has a puncture or tear. Calibration 1. Scanning the barcode label on each test strip foil packet prior to use automatically calibrates the monitor and checks the expiration date helping ensure reliable and accurate test results. 2. Each test strip is wrapped in a foil packet with a barcode label. This label holds the calibration information about the test strip, including the lot number, the expiration date and expected control solution ranges. Do not scan one test strip packet's barcode and use a test strip from another packet, since incorrect assay results may be generated. New Strip Lots 1. New lots are evaluated by correlation of the new lot to the old lot by running a minimum of ten (10) runs of low and high level quality controls. This is performed by the POC Coordinator. Any discrepancies will be brought before the Laboratory Director. New Meters 1. A five (5) point linearity is performed on all meters before being put into use for patient testing. This is performed by and results reviewed by the POC Coordinator.

3 Data Transfer 1. Most of the FSPP meters will be configured to connect wirelessly to the network when they are turned ON, while others may require manual insertion into the Abbott Docking Station in order for data to be transferred between the meters and the Data Management System and into the LIS/HIS. Patient information is uploaded to the meter and test results are downloaded into the data management system when the analyzer is turned ON or docked into a docking station. 2. In the event the wireless network is non-functional, the FSPP meters may be placed into the Abbott Docking Station for data transfer to occur. 3. The docking station will automatically upload the data from the meter into LIS/HIS via a Data Management System. The information includes the reagent strip lot number, the date and time the test was performed, the operator who performed the testing, the serial number of the monitor used and the download location, and any operator comment codes, along with the results. For patient testing, the patient name, ID number, and Date of Birth are included. For controls, the control level and lot number is indicated. 4. To start the upload of data, simply place the FSPP analyzer into the Abbott Docking Station or turn the meter ON. Display 1. Menu options, error codes, and test results are viewed on the meter display. Press and hold Backlight/Alphanumeric on the keypad to turn on or off the backlight for the monitor display. Keypad 1. The keypad contains the following controls: a. On/Off: This button turns the monitor on or off. The monitor will automatically turn off after 4 minutes if the monitor is left on but has not been used. b. Scan: Press to use the laser barcode scanner. The scanner will automatically enter the test strip information (calibration, control range, lot number and expiration date), as well as the operator ID, patient ID, and control lot number. c. Numbers: The 10-digit keypad can be used to enter identification numbers or to select an option that appears in the display. d. Clear: Press clear to perform the following functions i. To back up one space while entering numbers on the keypad. ii. When clear is pressed two times, all entered numbers shown in the display will be cleared. iii. Clear a numerical code from the monitor after having pressed Enter. iv. Clear a barcode scanned by mistake. v. Return to a previous screen e. Menu: performs the following functions: i. Return to the top of the menu. ii. Switch between Test Mode and Menu Mode. iii. Enter confirms the information that was manually entered. iv. Backlight/Alphanumeric hold Backlight/Alphanumeric key to turn on or off the backlight for the monitor display

4 Barcode Scanner 1. The Barcode Scanner is used to scan barcode information into the monitor and can scan 1D and 2D barcodes. 2. Hold the barcode scanner 3-12 inches from the barcode to be scanned. 3. Place the object to be scanned on a flat surface, by itself. Press and hold down the scan button to start the barcode scanner. 4. A visible red/green beam will be emitted from the monitor. 5. Slowly move this beam over the entire barcode on the item to be scanned, ensuring the green beam covers the entire barcode. The beam will shut off after 3 seconds if no information is detected. Reposition the scanner and try again. 6. When the monitor accepts the barcode, it will beep in acknowledgement. 7. The operator can view the data that was scanned by the monitor. 8. Release the scan button to stop the scan and continue with the next step. CAUTION: Never look into the barcode scanner beam or point it toward anyone's eyes. The beam could cause damage to the eye. Battery Compartment 1. The monitor holds two AA batteries to power the monitor. Any type of AA battery may be used. Discard used batteries per facility policy. 2. If the monitor is left on and has not been used for 4 minutes, it will automatically shut itself off. Audible Indicator (Not Visible) The monitor will beep to indicate one of the following: 1. A successful barcode entry. 2. Sample detection. 3. At three seconds before the result is to appear. 4. When an error occurs. QUALITY CONTROL IMPORTANT: Do not allow blood or other solution to run down the test strip into the monitor's test strip port as it may cause irreparable damage to the monitor. Two levels of QC solution (LOW and HIGH) are performed on each meter every 24 hours when in use. Controls expire 90 days after opening date or at the manufacturer s expiration date, whichever occurs first. The meter is set to lock-out use if controls have not been performed within the specified time limit. Patient testing may not be performed until both the High and Low control solutions pass. For assistance in troubleshooting control testing, see the Operator s Manual or User s Guide. All QC and patient result data are stored in the meter and transferred to the LIS system once the meter is docked in a docking station or connected wirelessly. Storage Requirements 1. Store between 4-30 degrees C (39-86 degrees F). Unopened vials are usable until expiration date published on label. Once opened, vials are good for 90 days. 2. Record date opened and 90 day expiration date on vial. 3. DISCARD ALL UNUSED CONTROL SOLUTION 90 DAYS AFTER OPENING. Performing Quality Control 1. Press the ON/OFF key to turn on the glucometer.

5 2. The display will read Glucose QC Due Now if QC is due on the meter. You may not skip performing QC. The meter is set to lock-out mode and will not allow patient testing until both levels of QC are performed successfully. 3. Select option #2, Control test. 4. Scan or Enter Operator ID will be displayed. At this time, scan your badge or enter your personal operator ID and press ENTER. 5. Check the expiration date on the control bottles to ensure that the controls have not met an expiration date. 6. Scan or Enter LOW Level Solution Lot is displayed. Scan the barcode on the low level of the control. 7. Scan or Enter Strip Lot is displayed. Scan the barcode on the FreeStyle Precision Pro strip. 8. Insert strip is displayed. Open the strip intended to be used at the upper indentation and tear off the left end of the foil wrapping. Insert black and white stripe end of strip into the sample port face up. 9. Apply Low Solution is displayed. Dispense one drop of LOW Glucose Control solution onto white testing area of strip. You have 30 seconds to add an additional drop of control to the testing area if not detected 10. Sample Accepted is displayed. Analyzing Sample will follow with a countdown of 5 seconds. 11. PASS is displayed if the LOW level control is acceptable. 12. Select #1, Next Level and proceed to test the HIGH Glucose Control solution by following steps 1 through If the LOW or HIGH control FAILS, select #2, Repeat Test and repeat the test assuring that you test the correct level of control solution as prompted by the meter. 14. If the LOW or HIGH control fails a second time, repeat the test using a fresh bottle of control solution. 15. If repeat testing FAILS, take the glucometer out of use and return it to the lab for a replacement meter. 16. The POC Coordinator will review the Quality Control Records on the instruments at least monthly. BLOOD COLLECTION AND TESTING PROCEDURE Specimen 1. Use fresh, capillary whole blood from a finger stick or a heel stick in neonates. This is the preferred sample. Venous and arterial whole blood samples may be used if tested immediately and they are not clotted. Testing must be done immediately upon sample collection. Avoid squeezing the puncture site excessively. The puncture site must be cleaned by washing with soap and water and/or cleaned with alcohol and allowed to dry. 2. Caution should be taken to clear arterial lines before blood is drawn. 3. Apply the drop of blood directly to the target area of the test strip, covering the entire area until you hear a beep that sample has been accepted. 4. Whole venous blood anticoagulated with EDTA or heparin may also be used. Test within 30 minutes of collection and invert the tube several times before obtaining the sample. Do not use serum, plasma or blood anticoagulated with fluoride. 5. The minimum specimen volume is 0.6 microliters. Patient Identification, Preparation, Specimen Collection and Analysis 1. Press On/Off to turn on monitor. The Abbott logo screen will appear for a few seconds followed by the product name, software version screen and then the Test Mode menu. 2. If wireless is enabled, allow the double arrow icon to disappear.

6 3. Explain the purpose of the test and the steps of the testing procedure to reassure the patient. 4. Wash your hands and put on disposable gloves (universal precautions). 5. If possible, ask the patient to wash his/her hands with warm water and soap, rinse, and dry well. If patient is unable, cleanse the puncture site with an alcohol swab and allow to thoroughly dry (alcohol at the puncture site must be dry or an error code/inaccurate results may occur). 6. Press 1 to select Patient Test. The meter display will next prompt for an Operator ID to be entered. 7. Press SCAN to scan your barcode. The display will next prompt for a Patient ID to be entered. 8. Press SCAN to scan the patient ID barcode located on the white patient armband, or manually enter the patient s 10 digit visit number. Verify that the patient s name and ID# match the patient s armband. Confirm the patient ID by entering the last 2 digits of the year of birth (ex. 1963, enter 63). After entering the Patient ID, the test strip lot screen appears. 9. Press SCAN to scan the test strip barcode. 10. Open the foil test strip packet at the notch and tear up or down to remove the test strip. Avoid touching the test pad area of the test strip to avoid contamination during insertion. 11. With the contact bars facing up, insert the test strip into the test strip port until it stops. The apply sample screen will appear next. Using the Soft Touch Device: a) Hold the Accu-Check Safe-T-Pro lancet and twist off blue protective lancet cap. b) Lightly press the Accu-Check Safe-T-Pro lancet against the side of the fingertip and press the blue button. c) Wait a few seconds for the puncture to open and the blood to flow. You may hold the patient s hand down his/her side to increase blood flow. d) Apply the blood to the test strip and perform the blood glucose test. 12. Apply a drop of blood to the target area on the test strip. Apply the blood directly from the patient s finger to the test strip. The test starts automatically, as the sample is accepted. Important: If the test fails to start, sufficient blood sample may not have been applied to the test strip. Discard the current strip and repeat with new strip. 13. Wait the 5 seconds it takes for the monitor to analyze the sample and display the result. Note the result and whether it falls outside the action range. If the result is above or below the action range, an up or down triangle appears in front of the test result. Important: confirm that the correct unit of measure (mg/dl) shows on your meter with every test. 14. If an Action Value is determined, take appropriate action as defined by your unit procedure for Critical Values. Important: RESULTS OF LESS THAN <20 OR GREATER THAN >500 MUST BE REPEATED unless blood is being sent to lab for testing 15. If the analysis is determined to be invalid due to procedural error (test done on wrong patient, bad fingerstick, etc), enter: Comment Code number 99: Procedure Error, Do not send to LIS 16. If repeat testing is to be performed, Comment Code 05: Repeat/Verification, Do not send to LIS may be entered. This comment may be added to the initial test or the repeat test to prevent both results from being sent to the patient record. Important: High or low results that are incorrect may have serious medical consequences. If the blood glucose result is unusual or are not consistent with physical symptoms, repeat the test correctly with a new test strip.

7 17. Remove the test strip from the monitor when finished testing and place in a biohazard container. 18. Ensure that the wireless connection is functional or dock the meter on the appropriate docking device and make sure the screen shows the results are being uploaded (arrows are moving in counter-clockwise direction). Results will transmit to the Data Management System and then into the LIS/HIS. OPERATING GUIDELINES 1. Use only the MediSense control solution provided by the laboratory to verify performance of the FreeStyle Precision Pro Test strips and meter. 2. Use the strips before their expiration date. 3. Do not use test strips that are wet, bent, scratched, or damaged. Use the test strip immediately after opening its foil packet. 4. Do not scan a packet s barcode and use a test strip form another packet. This may cause incorrect assay results to be generated. 5. Cover the entire target area of the test strip with the blood sample. The test results will not be affected if the target area has been briefly touched with the patient s finger, a capillary tube or a pipette. 6. If the test fails to start, apply a second drop of blood to the target area within 30 seconds. If the test fails to start after the second drop is applied, or if more than 30 seconds have passed, discard the used test strip and repeat the test. 7. After the blood is applied to the test strip and the test starts, do not touch the test strip. 8. Use each test strip only once. 9. Refer to the package insert in the test strip box for specific directions on storage and use of the strips. 10. A more extensive description of operational features and troubleshooting is in the FreeStyle Precision Pro Glucose Meter Operator s Manual available in ShareSafe. 11. In the event of meter failure, meter errors, failure to download or other suspected issues, the meter should NOT be used for patient testing and should be returned to the POC Coordinator in the laboratory or left with the department supervisor for return to the POC Coordinator as soon as possible. Extra backup meters are kept in the nursing supervisor s office and can be obtained for use as necessary after business hours. MAINTENANCE 1. Clean and disinfect the meter with an approved disinfectant wipe after each patient use and when blood is visible on the instrument to prevent the transfer of infectious agents between patients and to avoid exposure to users. 2. Never let the meter get wet inside. 3. Keep the protective blue port cover in place at all times. Port replacements are available in the laboratory. 4. Check the clear coating over the meter optic (barcode scanner) to make sure it is not scratched or damaged. RESULTS Placing the meter into the Docking Station or uploading via the wireless connection, allows the results to crossover thru the interface into the HIS and LIS systems. The patient results are forwarded to the Result tab for the appropriate patient in Sunrise and are displayed under Point of Care Glucose. The test name is shown as Blood Glucose Fingerstick with the result, any low or high

8 indicator flags, the normal range and units, as well as the date and time. These results can then be pulled into the various nursing flowcharts. EXPECTED VALUES: The normal fasting blood glucose range for a non-diabetic adult is mg/dl. One to two hours after meals, normal blood glucose levels for a non-diabetic adult should be less than 140 mg/dl. CRITICAL VALUES: LOW: < 50 mg/dl HIGH: > 500 mg/dl Adults LOW: < 40 mg/dl HIGH: > 500 mg/dl Newborns 1. If a confirmation blood glucose preformed by the Clinical Laboratory is necessary, a specimen should be obtained from the patient (serum or plasma) and sent to the laboratory for STAT glucose testing. Do not use collection tubes that contain fluoride or oxalate. Use EDTA, Sodium Heparin, Lithium Heparin tubes within 30 minutes of collection. 2. If critical value is confirmed, laboratory will call result to nursing unit. Notify attending physician and begin treatment for hypo or hyperglycemia per nursing policy. ANALYTICAL MEASUREMENT RANGE (AMR): LOW: < 20 mg/dl HIGH: > 500 mg/dl A result falling outside of the AMR requires that the test be repeated for verification. A new specimen should be obtained. Consider sending a specimen to the Clinical Laboratory for confirmation if the patient s signs and symptoms do not agree with the result, especially if this is the first glucose result obtained on the patient. LIMITATIONS 1. This system has not been approved for use in the critically ill. Blood glucose monitoring should be performed using alternative method (lab testing) for these patients. 1. Hematocrit range is 15-65% for glucose measurements. Samples with hematocrits outside this range may give erroneous results. 2. For best results, use between 59 F and 104 F and 10-90% humidity. 3. Test results may be erroneously low if the patient is severely dehydrated or severely hypotensive or in a hyperglycemic-hyperosmolar state (with or without ketosis). Reasons Glucose Results May Be Higher Than Expected: Hematocrit is lower than 15%.. Serum or plasma samples were used instead of whole blood. Venous blood is tested in arterial/capillary mode when using FreeStyle Precision Pro test strips. 4. The glucometer has a measuring limit of 20 mg/dl and up to 500 mg/dl. Any value determined below these limits will be noted with a <20 mg/dl or >500 mg/dl on the meter display. Such results should be repeated for verification. 5. The test strip has been evaluated with neonatal blood. As a matter of good clinical practice, caution is always advised in the interpretation of neonate glucose levels below 50 mg/dl. 6. Do not use during intravenous infusion of high-dose ascorbic acid or during xylose absorption testing. REFERENCES: Abbott FreeStyle Precision Pro Blood Glucose and B-Ketone Monitoring System Manual, Abbott Diabetes Care Inc. Alameda, CA. Rev. C 07/16.