i -STAT Training Module

1. i-STATTraining Module Created by: Laboratory Services, Point of Care Coordinator May, 2011

2. Introduction • The i-STAT Analyzer provides patient blood analysis at the point of care. The i-STAT system is a battery powered portable analyzer that utilizes single-use disposable cartridges to analyze a whole blood sample. Authorized tests which can be performed using the i-STAT are • lactic acid (CG4 cartridge) • Chem 8(Na, K, Cl, iCa, CO2, GLUC, BUN, Creatinine) with hemoglobin and hematocrit • PT/INR • blood gas testing including pH, PCO2 , PO2, TCO2 • (CG8 cartridge used in the OR only!) • ACT (Activated Clotting Time)

3. Introduction, continued The purpose of this learning module is to: • Re-educate users of the i-STAT instrument on the proper operation and procedures. • Serve as an annual competency for the use of the i-STAT instrument. • Be used as a resource for questions about the i-STAT instrument .

4. Learning Objectives At the completion of this module the learner will be able to: • Describe how to locate Point of Care Testing (POC) testing policies and procedures on Peninsula Regional’s iPortal. • Describe the following for i-STAT testing: • The parts of the i-STAT analyzer and cartridges, • Proper handling and storage of cartridges, • How to perform, transmit, and retrieve patient tests • What quality controls are in place • Describe how to troubleshoot potential problems and where to find help. • Identify critical values. • Describe how to enter your operator and patient ID with the built in bar code scanner of the i-STAT. • Describe how regulations impact use of the i-STAT.

5. How to Find the POC Testing Procedures • From the Medical Center’s iPortal site, select Policies and Procedures from the column on the right hand side of the page. Click on the “Point of Care” heading on the left side of this page, then choose i-STAT and then the i-STAT procedure you wish to review. • If the intranet is not functioning, there is a hard copy of the POC testing manual in the Point of Care Testing office in the main laboratory which any lab supervisor may access.

6. Analyzer Components Laser scanner Infrared screen on top “scan” key keypad Menu key Enter key ON/OFF button Cartridge goes here “print” key

7. Keypad Functions • SCAN - Activates the barcode scanner - Remember to hold it down until beep sound is heard or you see the laser. • ← → The arrow keys are used as a page key to move from one screen to the next screen. The left arrow key is used to backspace and clear keypad entries, and to move backward through the screens within a menu. The right arrow will page you forward to more information. • ABC - Used to enter alpha characters on data entry screens. When the ABC key is pressed the letter A is entered. The arrow keys are used to move up and down the alphabet. To enter a second letter press the ABC key once to move to the next position and again to enter an A. To enter a number after a letter, press a numbered key. To erase a letter, press the ABC key to move to the next position, and then use the left arrow (←) to backspace and clear the letter.

8. Keypad Functions, continued • 0 – 9 - Used to enter digits on data entry screens and to select menu options and stored records. • Enter (ENT) - Used to respond to a prompt to complete an action, such as entering an operator ID, patient ID, or comment code via the keypad. • MENU - Used to return to the previous menu and switch between the test menu and administration menu. • Print Key - Used to print results directly to the portable printer. • On/Off - Turns the analyzer on or off. When the analyzer is on, the On/Off key must be pressed /held for a second to turn the analyzer off. This key is inactive when a test is in progress and when the analyzer is prompting for mandatory data.

9. Cartridge Parts and Handling • Always check expiration date before using a cartridge. • Use the cartridge immediately once removed from the pouch. • Do not put pressure over the center of the cartridge, hold by the sides only. *There is a pouch containing fluid in the center of the cartridge that will burst if pressured. Bursting this fluid pouch will require a new cartridge for testing. • Do not remove the cartridge from the iSTAT when “Cartridge Locked” is displayed at the bottom of the screen. The cartridge is locked in place and attempted removal will cause irreparable damage to the instrument. • Do not touch the sensors on the end of the cartridge.

10. Cartridge Storage • The main supply of cartridges are stored in the lab between 2–8oC. Never freeze. Never expose to temperatures above 30°C (86°F). • Those that will be used for patient testing must be at room temperature 18–30oC. (Errors will occur during testing due to condensation if cold cartridges are used.) • A single cartridge taken from a refrigerator will take 5 minutes to reach room temperature and must remain in it’s pouch during this time. • An entire box of cartridges taken from a refrigerator will take 60 minutes to reach room temperature. • Cartridges brought to room temperature can not be returned to the refrigerator. • The temperature of the refrigerator that stores the cartridges is monitored and recorded on a daily basis using a certified thermometer by the laboratory.

11. IMPORTANT! Cartridge Expiration and Dating Once cartridges are removed from the refrigerator ,the NEW room temperature expiration date must be written on each individual cartridge. Room temperature storage requirements can be found on the back side of each cartridge. • PT/INR, ACT and Chem 8 cartridges brought to room temperature that are not for immediate use expire in 14 days. • CG4 and CG8 cartridges brought to room temperature that are not for immediate use expire in 2 months.

12. Acceptable Blood Specimens Standard precautions must be used when collecting blood samples. • Suitable specimens for Chem8cartridge: Fresh whole blood (arterial or venous) collected in lithium heparin anticoagulant collection (light green topped) tube filled to capacity . Specimen should be tested within 10 minutes. Fresh whole blood (arterial or venous) collected in a plain plastic syringe. Specimen should be Tested within 2 minutes. • Suitable specimens for CG4 and CG8 cartridges: Fresh whole blood without anticoagulant collected in a plastic syringe or plain plastic evacuated tube, no additives. Specimen should be tested immediately.

13. Suitable specimens (continued) • Suitable specimens for PT/INR cartridges: Note: Patient must be on Coumadin to have an istat PT/INR performed. Fresh whole blood without anticoagulant collected in a plain plastic syringe or plain plastic evacuated tube, no additives. Specimen must be tested immediately. • Suitable specimens for ACT cartridges: •  Fresh whole blood collected in a plain, plastic syringe with no additives. Specimen must be tested immediately. (If specimen is collected from an indwelling line it is important to flush line with 5 mL saline and discard the first 5 mL blood or six dead space volumes of the catheter).

14. Acceptable Specimens, continued • If specimen is collected from an indwelling line, flush line with 5 mL saline and discard the first 5 mL blood or six dead space volumes of the catheter. • If the specimen is collected into a lithium heparin tube, it must be labeled with a patient label or with the following information if the sample is saved for any reason : the patient name, patient ID number and time/date of collection. Note: . (OR use only) If a cartridge containing a Hematocrit sensor is being used, i.e.CG8 and Chem8 cartridge, and the patient is undergoing cardiopulmonary bypass (CPB) the operator should select “CPB”. CPB can be selected on the same screen as the sample type is entered.

15. Unacceptable Specimens • Specimens with any evidence of clotting • Partially drawn vacutainertubes can NOT be used for any i-STAT testing • Specimens collected in vacuum tubes with anticoagulants, other than lithium heparin (light green top tube) • Syringes for pH, PCO2, and PO2 with air bubbles in the samples • No other sample types such as urine, CSF, and pleural fluid are acceptable.

16. Unacceptable Specimens, continued The following circumstances can lead to erroneous results: • Drawing a specimen above an I.V. • Inadequate flushing of indwelling catheters • Stasis (tourniquet left on longer than one minute before venipuncture) • Extra muscle activity (fist pumping) • Hemolysis (alcohol left over puncture site, tourniquet left on >2 minutes or a traumatic draw) • Icing (putting the tube on ice) of the sample before filling the cartridge • Time delays before filling cartridge, especially lactate, ACT, and PT/INR • Exposing the sample to air when measuring pH, PCO2 , and PO2 • Air bubbles trapped in the sample chamber

17. Helpful Tips • Should the i-STAT System become inoperable for any reason or the result does not agree with the patient’s clinical condition, new specimens should be collected and submitted to the main laboratory and the POCC should be notified. • NEVER share your operator ID with others. Doing so will result in suspension of testing privileges and possible termination. • If the cartridge is overfilled (past the blue arrow) it may not seal properly. Do not wipe off the excess or draw it back into the syringe. You must obtain a new cartridge and start over. • Analysis times- • PT/INR cartridge: to detection of end point – up to 300 seconds (5 min.) • Chem8, CG4 and CG8 cartridges: 2-4 mins • ACT cartridge: to detection end point- up to 1000 sesconds (16.7 min.)

18. Helpful Tips, continued  • Remove the cartridge from the analyzer when the cartridge is unlocked. Do not removed while the “locked” indicator is on or irreparable damage can occur. • Always ensure the specimen is mixed well, patient has been identified with 2 patient identifiers and the cartridge is filled within the recommended time frame. • During testing, the handheld must not be moved and remain flat, especially during caogulation testing (PT/INR and ACT). • Some of the most common testing problems include: • Insufficient sample • Overfilled cartridge • Under-filled cartridge • Failure to adequately mix specimen before testing • Specimen clotted • Air bubbles trapped in the sample chamber • Pre-burst calibrant on the top of the cartridge • Touching the sensors on the cartridge • Sample lid not closed • A new sample should be drawn and a new cartridge used with any of the above problems are identified.

19. Entering Information • Information can be entered into the i-STAT analyzer by using the built in barcode scanner. The operator ID, patient ID, and lot numbers should be scanned. • Numbers and letters can be entered in some cases. To enter alpha characters press the ABC button and follow the prompts on the screen as detailed earlier in this module. • To scan information, press and hold the SCAN button and point the laser at the top of the i-STAT analyzer at the barcode. Laser scanner Scan button

20. Patient Test Procedure The following screens provide an overview of the procedure. See the i-STAT procedure for more specifics. • Have blood drawing supplies, i-STAT, and appropriate cartridges ready for use. • It is necessary to properly identify the patient per protocol(2 patient identifers) • Enter your operator ID and patient ID when requested. Continue to follow the prompts on the screen. • Obtain acceptable blood sample and mix well. • Remove cartridge from pouch without touching the sensors at the tip or pressing the calibrant pouch in the center. • Slowly dispense blood into the sample chamber of the i-STAT cartridge until it reaches the fill mark (blue arrow) without spilling over and without air bubbles in the chamber.

21. Patient Test Procedure, continued • Close the sample port on the i-STAT cartridge (do not push on the center when closing the cartridge; push on side). • Immediately place i-STAT cartridge into the i-STAT analyzer. • The analyzer must not be moved and kept flat during testing. • If prompted, select the sample type (arterial, venous, or if patient is undergoing CPB in OR, only). • After results appear on the analyzer screen, review for acceptability. When the istat is placed back in the docking cradle, the results will be sent to the patient’s medical record. If the value is critical, you must enter comment code 1 (press “1” then “enter”) and notify the provider. Next, the provider or doctor’s name, date, and time of who is notified MUST be documented in the patient’s medical record! • If necessary, you many print results by aligning the i-STAT with the laser on the printer and pressing print.

22. PPID (Positive Patient ID) • PPID: The istat will display the patient’s account number, name, DOB, and gender when the patient’s barcoded armband is scanned. You will then be asked to either: 1-Reenter the ID (if it is incorrect) or you may 2- Continue if it is correct. • NOTE: In many instances, the patient’s information will not be available in the istat. You may override this by choosing to Continue , but note when doing so, the scanned barcode number on the armband MUST match what is on the meter’s screen!! 1200000001 Flintstone, Wilma 08July1935

23. Quality Control (QC) Testing The iSTAT has 2 types of QC requirements: 1) Electronic (which is done automatically every 8 hours). You will not see it unless there is an error). Notify the POCC if problems/errors occur. • Two levels of liquid QCthat must be tested weekly for EACH kind of cartridgethat is used. Battery and Temperature Checks must be documented daily!

24. Quality Control Procedure • Turn on the i-STAT and touch MENU key- this takes you to the Administrative Menu • Touch 3 - Quality Tests • Touch 1 - Control • Scan the your Operator ID. • Scan the barcode for the control lot #. (NOTE: You must scan this number directly from the control vial. • Scan the cartridge lot number that you are using. • Invert the control ampoule for 5-10 seconds to equilibrate the liquid and gas phases. Tap the top of the ampoule to send solution back to the bottom section.

25. Quality Control Procedure, continued • Be sure to hold the ampoule at the tip and also at the bottom with forefinger and thumb to minimize increasing the temperature of the solution. • Protect fingers with gauze or tissue and snap off the ampoule at the neck. • Transfer the solution from the ampoule to the cartridge using a pipette. (Do not over or under fill the cartridge). • Close/seal the cartridge, being careful to not press down over the center of latch, and insert in into the analyzer. (Remember: Do not press on the center of cartridge as this could burst calibrant pack.). • Upon completion, check to ensure that QC results PASS, print/document result on QC Log sheet, remove cartridge, and dispose in biohazard container.

26. Automatic Pass/Fail of QC: • *To use this feature, YOU MUST SCAN THE BARCODEon the CONTROL VIAL when running controls! • *If QC fails, you must repeat it. When it passes, you will print the results and move to the next required level. If QC is not performed by the end of each week –Saturday by 7 a.m.- the iSTAT will NOT allow patient testing until QC requirements are met. Automatic QC Pass/Fail Determination: Automatic display of QC test pass or fail.

27. Out of Range QC  CORRECTIVE ACTION - If acceptable results are not obtained: • Check Technique- repeat controls using correct technique. If correct results are not obtained, continue with Step b. Record these results as documentation of the problem. (Required by accrediting agencies). • Check Control Material and Test Cartridge – Check expiration dates to verify that they are current. If outdated, obtain new controls and/or test cartridges and repeat. If still out of range ,call POCC or your supervisor/manager. Document all corrective action steps on the i-STAT 1 Quality Control Log. NOTE: Do not use i-STAT for patient testing until Quality Control results are withing acceptable range. Send all specimens to Lab until QC issues are resolved.

28. Critical Results Critical results will display with an arrow after the result - ↓ or ↑ “Action Range Flag” will appear in a black bar at the top of the screen. • Hand written documentation of physician notification of i-STAT patient result form is mandatory.This includes date and time of notification. • If the value is critical, you must press/enter the number 1 (comment code 1)and notify the provider. Next, the provider or doctor’s name of who is notified MUST be documented in the patient’s medical record with the date and time. • After results appear on the analyzer screen, review for acceptability. When the i-STAT is placed back in the docking cradle, the results will be sent to the patient’s medical record.

29. Interfering Substances Substances that can interfere with i-STAT results include:

30. Interfering Substances, continued Substances that can interfere with i-STAT results include:

31. Suppressed Results There are 3 conditions under which the iStat will not display results: 1. Results outside (above or below) the i-STAT’s measurable ranges are flagged with < or >, respectively. The < > flag indicates that the result for this test is dependant on the out of range result flagged < or >. ACTION: Send an acceptable specimen to the main laboratory for analysis if indicated by provider in accordance with proper specimen collection. 2. Cartridge results which are not reportable based on Internal QC rejection due to a possible interfering substance in the blood sample or a bad sensor are flagged with ***. ACTION: Test the specimen again using a fresh sample and another cartridge. If the specimen integrity is not in question, the results that are not suppressed should be reported in the usual manner. If the result is suppressed again, send a specimen to the laboratory for analysis if indicated by provider in accordance with proper specimen collection. Should you encounter numerous *** flags, contact the POC department in he Lab. This may indicate a bad lot of cartridges.

32. Suppressed Results, continued • 3. A Quality Check message will be reported instead of results if the analyzer detects a problem with the sample, calibrant solution, sensors, mechanical, electrical functions, or if the incorrect barcode is scanned for a cartridge during the test. • ACTION: Take the action displayed with the message that identifies the problem. Notify the Point of Care Coordinator (POCC) in the main laboratory if the problem persists. • Remove the analyzer from service and contact POCC at x4968 if you have any concerns with the functioning of the analyzer.

33. Procedure for Reviewing i-STAT Results • Turn on analyzer. • Press Menu key. • Select option #2 – Data Review. • Select option #1 – Patient ID. • Enter the patient ID. • Enter your operator ID. • The patient results will display. • If there is more than one page of results ,you can navigate between the pages using the arrow keys. • If there are results from more than one cartridge, for the same patient, you can navigate between the pages using the #1 and #2 keys.

34. Printing Test Results 1) Turn printer on if green power light is not lit. 2) Align infrared windows of analyzer and printer. 3) Display results on the i-STAT screen. 4) Press the Print key. 5) Do not move analyzer or printer until printing is complete. 6) Printed results from the i-STAT printer should be placed in the patient’s chart immediately.

35. Annual Operator Competency Notification Annual competency is required for all iSTAT testing operators. In addition, upon initial training, all users are required are required to be recertified again (meet with the trainer in their department or the POC department) 6 months into their 1st year of using the device (regulatory requirement). The iSTAT will notify operators of their annual recertification date 30 days prior.

36. Result Transmission to Patient’s Record- • Results should be transmitted after every patient or batch of patients. This is done by docking the i-STAT in it’s cradle. The iStat is not wireless. • The message “Upload Required” will display on the i-STAT screen when there is information (results) ready to transmit. • Ensure that the analyzer is DRY and Turned OFF BEFORE it is placed in the downloader/Recharger. Power light will be green when plugged in. Proximity light turns red when i-STAT is placed in downloader

37. Transmitting Results, continued • The first message to appear on the analyzer screen should be “Waiting to Send”. • Once a connection is made “Communication In Progress” displays. • Do not move analyzer while the message “Communication in Progress” is displayed. * If unable to transmit results, contact the Point of Care Coordinator in the main lab.

38. Analyzer Batteries • The analyzer will display “Low Battery” when the batteries need to be replaced. • The i-STAT requires two 9 volt LITHIUM batteries that can be obtained from the POC Department. NOTE: 9 volt alkaline batteries are not recommended for use due to decreased battery life. • The battery compartment is located at the end of the analyzer next to the laser barcode scanner window. To open, slide the compartment door to the left -shown below. Glucose Test Strip Port Infrared Communication Window Battery Compartment Laser Barcode Scanner Window

39. Cleaning the i-STAT • Disinfect analyzer after every patient with a PDI Super Sani-Cloth wipes or PDI Sani-Cloth Bleach wipes for C. Diff isolation patients. • Do not allow cleaning solution get into to the cartridge port port. *for C.Diff *allow to air dry for proper disinfection FDA,CDC and CMS state that we must clean the istat between each patient test. Allow 2 min. for proper disinfection Allow 3 min. for proper disinfection

40. Congratulations! You are now ready to take the i-STAT post-test. Click on the “Take Test” button located on the top of this screen. Please note: You must print a copy of the completed quiz AND perform one patient test (with your trainer/designee or POCC) for FULL credit and compliance.