Contents: POCT Program Massachusetts General Hospital - Pathology Service 55 Fruit Street, Boston, MA 02114

Transcription

1 Title: i-stat Operations and Testing Procedure Cross References: i-stat Operator Training Checklist i-stat INR Fingerstick Training and Assessment Record i-stat Competency Assessment 6-month and Annual i-stat Instrument Competency-Written Test i-stat Cartridge Temperature Storage Log i-stat Instrument Corrective Action Log i-stat Instrument Validation Log i-stat Record of Receipt-QC Documentation Log i-stat Training Guide POCT Inter-Laboratory Correlation Procedure POCT QC Storage Ordering and Documentation Guide POCT Proficiency Testing Procedure POCT Proficiency Testing Evaluation Worksheet i-stat CLEW update form POCT EPIC Results Reporting Audit Guidelines POCT Program Massachusetts General Hospital - Pathology Service 55 Fruit Street, Boston, MA Contents: Purpose... 2 Scope... 2 Policy and Procedure Statement... 2 Proficiency Testing (ACT, PT/INR, CG4, CG8 Cartridges)... 2 Regulatory Requirements... 3 Competency Assessment... 3 Limitations/Interferences... 4 Test Kit/Supplies/Equipment... 7 Calibration... 7 Calibration Verification/Correlations... 8 Electronic Quality Control... 8 Liquid Quality Control... 9 Barcode Scanning Calculations Reporting results Preventive Maintenance Instrument Replacement Policy Troubleshooting Alternative method References Reference Ranges ACT (Kaolin) Cartridge Procedure CG8+, CG4+, and G3+ Cartridges Procedure Creatinine Cartridge Procedure PT/INR Cartridge Procedure Chem 8+ Cartridge Procedure Written By: Kim Gregory MT(ASCP) Date: 7/08 Nancy Toscano MT (ASCP) Date: 12/09 Caylee Cunningham, M (ASCP) Date: 6/16 1

2 Purpose This document outlines policies and procedures pertaining to testing on the i-stat. In an effort to be concise, some information from the manufacturer s recommended procedure may be excluded. It is recommended that operators familiarize themselves with the manufacturer s product information that accompanies each package and their manual, if one exists. Scope Level of Personnel: All RN s, Catheterization lab techs, Perfusionists, Respiratory Therapists, Radiology Technologists, Laboratory Technologists, and MD s who have successfully completed initial training and fulfilled the specific competency requirements for the complexity level of each cartridge. Testing Site: Clinical sites approved and on file with the Pathology service s POCT Division. Approved Cartridges: G3+, CG8+, CG4+, Creatinine, ACT (Kaolin), PT/INR, Chem 8+ Policy and Procedure Statement The i-stat is a portable clinical analyzer used in conjunction with i-stat cartridges to obtain definitive quantitative measurements of ACT, blood gas parameters, lactate, creatinine, PT/INR and electrolytes utilizing i-stat cartridges. The disposable cartridge contains all of the system s components (reagents, sensors, and waste container). Proficiency Testing (ACT, PT/INR, CG4, CG8 Cartridges) The College of American Pathologists (CAP) sends unknown samples, Proficiency Tests, to the laboratory for analysis of primary testing methods several times per year. Results are submitted to the CAP for scoring and peer comparison. If a site fails 2 out of 3 events or two consecutive events according to federal law, it may be required to discontinue testing. All Survey results are to be handled and reported in the same manner as clinical results following the directions on the CAP PT Survey package insert. The samples are not to be analyzed in duplicate unless clinical specimens are analyzed in duplicate. Actions or decisions must be documented. PT samples are not to be tested on multiple instruments and should only be tested on what is designated as the Primary Testing Method under an individual CLIA License. All other instruments used for the same test should utilize in house correlations for instrument comparisons and operator competency assessment. See the Calibration Verification and Correlations section for more information. Participation must be random and not assigned to specific individuals. Successful participation may be used as demonstrating successful competency for that year. Upon receiving the PT survey: The POCT program will contact the participating departments regarding the survey and the timeline of the survey to be performed. The departments must be available within the period identified by POCT. The Key operators must make sure of the following: o Instruments are in good working order. o Randomly select staff to participate, but ensure that subsequent surveys are rotated among different staff (e.g. document in a log) o Maintain original CAP survey form with the results documented. o Maintain the signed Attestation form. o In addition, retain copies of above in the files of testing personnel. Once results are obtained, they should be given to the POCT Coordinators who will send them to CAP via electronic entry on the CAP website. Site Director and CLIA certificate Director or designees shall review survey results to assess performance and ensure compliance with the standard and comment. Scores of 100% minimally requires documentation of review by the Director or designee. 2

3 Scores between 100% and 80% requires a comprehensive investigation and remedial action documented of unsuccessful challenges. Scores less than 80% requires a comprehensive investigation and documentation of remedial action of unsuccessful challenges. Scores of less than 80 percent may jeopardize a sites ability to continue to perform testing. Should a site fail proficiency, they will be required to immediately perform a comprehensive investigation and document remedial action. Operator re-training may be required. In order to avoid cessation of testing, a site failing a challenge will be expected to develop and implement a more aggressive plan for performance improvement Each site is responsible for completing survey challenges when they arrive. Anticipated Survey Periods: WP3 (PT/INR) CT-1/CT5 (Activated Clotting Time) AQ/AQI (CG8 and CG4) Product Receipt Evaluation receipt Product Receipt Evaluation receipt Product Receipt Evaluation receipt February March January February February March May June July August June July October November Regulatory Requirements I. Each testing site must have a documented quality control program, which is developed in collaboration with or has been approved by the MGH Pathology Service. II. All test results must be maintained in patient records with all required information for four years Required information: 1. Patient s name 2. Medical Record Number 3. Patient s gender 4. Patient s age or date of birth 5. Date & time test collected, performed and reported 6. Ordering Physician 7. Responsible physician (if not 6) 8. Reference or Target Range 9. Test Performed 10. Test units 11. Lab name III. Additional information that must be retained for four years: 1. Testing personnel records 2. Quality control results 3. Product information (i.e. serial number, lot numbers, expiration dates, etc.), information on quality control and any remedial action 4. QC charts, maintenance sheets, reference and critical ranges IV. Other 1. Universal precautions must be observed when handling any patient specimen. 2. A physician s order or standing order is required prior to performing test. 3. The Hospital Hand Hygiene policy must be adhered to at all times. 4. Transcription review for manually documented results one patient result/test performed/day. V. Linearity/Calibration Verification The POCT program will perform and document linearity/calibration verification checks every six months for non - waived cartridges if applicable. Competency Assessment Testing personnel must demonstrate competency prior to direct patient testing. Refer to the individual cartridge procedures for specific competency requirements. All operators must read the procedure manual and complete the 3

4 Operator Training Checklist after initial training and Competency Assessment Checklist after completing the competency assessment. Expired Operators: Operators will receive a warning of their competency expiration date on the istat device once they log in. This warning will be displayed every time they log in to the istat until their expiration date and are locked out. Operators that fail to meet competency requirements within 365 days will be locked out of the system. Depending on the amount of time their competency has lapsed, the user may have to undergo retraining and competency assessment per above. Limitations/Interferences Interferences An interferent is a substance, which, if present at significant levels in the blood specimen being analyzed, will produce an error in the result of the analyte being measured. The below table lists common interference; however full details may be found in the i-stat manual. Analyte Interferent Details/ Concentration Effect on Analyte Result Sodium Potassium Chloride BUN/Urea Glucose Bromide 37.5 mmol/l Increased ( ) i-stat Sodium results Nithiodote (sodium thiosulfate) 16.7 mmol/l Increased ( ) i-stat Sodium results Bromide 37.5 mmol/l Increased ( ) rate of star (***) outs Nithiodote (sodium thiosulfate) 16.7 mmol/l Decreased ( ) i-stat Potassium results Acetylcysteine 10.2 mmol/l Increased ( ) i-stat Chloride results. Bromide 37.5 mmol/l Increased ( ) i-stat Chloride results. Use another method. Bromide (therapeutic) 2.5 mmol/l Increased ( ) i-stat Chloride results. Use another method. Salicylate 4.34 mmol/l Increased ( ) i-stat Chloride results. Use another method. Thiocyanate 6.9 mmol/l Increased ( ) i-stat Chloride results. Use another method. Nithiodote (sodium thiosulfate) 16.7 mmol/l Increased ( ) i-stat Chloride results. Bromide 37.5 mmol/l Increased rate of star (***) outs Hydroxyruea 0.92 mmol/l Increased ( ) i-stat BUN/Urea results Nithiodote (sodium thiosulfate) 16.7 mmol/l Decreased ( ) i-stat BUN/Urea results Acetaminophen 1.32 mmol/l Increased ( ) i-stat Glucose results Acetylcysteine 10.2 mmol/l Decreased ( ) i-stat Glucose results Bromide 37.5 mmol/l Decreased ( ) i-stat Glucose results Bromide (therapeutic) 2.5 mmol/l Decreased ( ) i-stat Glucose results Hydroxyurea 0.92 mmol/l Use an alternative method to measure when patients have been administered hydroxyurea. PH Values < 37 C Decrease ( ) glucose by 0.9 mg/dl per 0.1 ph units 4

5 Hematocrit Ionized Calcium (ica) PCO2 PO2 TCO2 Creatinine Values > 37 C PO2 PO2 less than 20 C Decrease ( ) glucose by 0.8 mg/dl per 0.1 ph units Decreased ( ) i-stat Glucose results Thiocyanate 6.9 mmol/l Decreased ( ) i-stat Glucose results Nithiodote (sodium thiosulfate) 16.7 mmol/l Decreased ( ) i-stat Glucose results WBC Grossly elevated Increased ( ) i-stat hematocrit results Total Protein/Lipids Nithiodote (sodium thiosulfate) Increased TP or Lipids Decreased TP Decreased ( ) i-stat hematocrit results 16.7 mmol/l Increased ( ) i-stat Sodium results Bromide 37.5 mmol/l Increased rate of star (***) outs Sample Handling Sedimentation or fluid dilution Erroneous results Acetaminophen 1.32 mmol/l Decreased ( ) i-stat ica results Acetylcysteine 10.2 mmol/l Decreased ( ) i-stat ica results Bromide 37.5 mmol/l Increased ( ) i-stat ica results Magnesium 1.0 mmol/l Increased ( ) i-stat ica results by up to 0.04 mmol/l. Lactate 6.6 mmol/l Decreased ( ) i-stat ica results by up to 0.07 mmol/l. Nithiodote (sodium thiosulfate) 16.7 mmol/l Decreased ( ) i-stat ica results Salicylate 4.34 mmol/l Decreased ( ) i-stat ica results Salicylate (therapeutic) 0.5 mmol/l Decreased ( ) i-stat Ionized Calcium results by up to 0.03 mmol/l Thiocyanate 6.9 mmol/l Decreased ( ) i-stat Ionized Calcium results - use another method Propofol (Diprovan ) Thiopental Sodium For patients administered propofol or thiopental sodium, i-stat recommends the use of G3+, CG4+, CG8+, EG6+, and EG7+ cartridges, which are free from clinically significant interference at all relevant therapeutic doses. i-stat does not recommend the use of EC8+ cartridges for patients receiving propofol or thiopental sodium. Exposure to air >150 mmhg Decreased ( ) i-stat PO2 results <150 mmhg Increased ( ) i-stat PO2 results Iced samples Increased ( ) i-stat PO2 results Cold cartridge Decreased ( ) i-stat PO2 results Exposure to air Decreased ( ) i-stat TCO2 results Delayed testing Increased ( ) i-stat TCO2 results Acetaminophen 1.32 mmol/l Increase ( ) Creatinine results Acetylcysteine 10.2 mmol/l Increase ( ) Creatinine results Ascorbate 0.34 mmol/l Increase ( ) Creat by 0.3 mg/dl Bromide (therapeutic) 2.5 mmol/l Increase ( ) Creatinine results 5

6 Lactate ACT PT/INR CO2 When Creat < 2mg/dL: pco2 >40 mmhg pco2 < 40 mmhg When Creat >2mg/dL: pco2 >40 mmhg pco2 < 40 mmhg Increased ( ) Creat by 6.9%/10mmHg Decrease ( ) Creat by 6.9%/10mmHg Decrease ( ) Creat by 3.7%/10mmHg Increase ( ) Creat by 3.7%/10mmHg Creatine mmol/l Increase ( ) Creat by 0.3 mg/dl Increase ( ) Creat by 0.20 mg/dl Increase ( ) Creat by 0.4 mg/dl Glycolic Acid 10.0 mmol/l Decreased ( ) i-stat creatinine result - use another method Hydroxyurea 0.92 mmol/l Use an alternative method to measure creatinine when patients have been administered hydroxyurea. Nithiodote (sodium thiosulfate) 16.7 mmol/l Increased ( ) i-stat Chloride results. Bromide 37.5 mmol/l Decreased ( ) i-stat lactate result Glycolic Acid 10.0 mmol/l Decreased ( ) i-stat lactate result - use another method Hydroxyurea 100 μmol/l Use an alternative method to measure when patients have been administered hydroxyurea. Incorrect handling Exogenously added heparin, citrate, oxalate or EDTA Cubicin (daptomycin for injection) Analyzer not maintained on a level surface during testing Heparinized syringe Results may be affected by >10% Will interfere with results This antibiotic has been found to cause a concentration-dependent false prolongation of prothrombin time (PT) and elevation of INR when using the i- STAT PT/INR test. Use another method. Chlorhexidine Gluconate Lupus Anticoagulant Antibodies Incorrect handling Analyzer not maintained on a level surface during testing The i-stat PT/INR test may report false prolongation of the prothrombin time (PT) and an elevation of the INR on samples contaminated with Chlorhexidine Gluconate. If the presence of lupus anticoagulant antibodies is known or suspected, use an alternate testing method. Erroneous results 6

7 Test Kit/Supplies/Equipment Calibration Product Vendor Manufacturer # Tests Storage requirement I-STAT TRI Controls Level 1 Level 2 Level 3 i-stat TRI Controls Calibration Verification Hyperbaric QC i-stat 05P P P i-stat 05P70-01 Eurotrol/ Fisher NC CG8+ Cartridge i-stat 03P88-25 CG4+ Cartridge i-stat 03P85-25 G3+ Cartridge i-stat 03P78-25 Chem 8+ Cartridge i-stat 03P Na, K, Cl, BUN, Glu, Crea, ica, Lactate, ph, PCO2, PO2, TCO2, Hematocrit Na, K, Cl, BUN, Glu, Crea, ica, Lactate, ph, PCO2, PO2, TCO2, Hematocrit High PO2 Creatinine Cartridge i-stat 03P84-25 Creatinine ACT Liquid Controls Level 1 Level 2 i-stat 06P P17-16 Na, K, ica, Glucose, ph, PCO2, PO2, calculated parameters: TCO2, HCO3, BE, so2 Lactate, ph, PCO2, PO2, calculated parameters: TCO2, HCO3, BE, so2 ph, PCO2, PO2, calculated parameters: TCO2, HCO3, BE, so2 Na, K, Cl, BUN, Glu, Crea, ica, TCO2, Hematocrit calculated parameters: Anion Gap, Hgb ACT (Kaolin) ACT (Kaolin) Cartridge i-stat 03P87-25 ACT (Kaolin) PT/INR Cartridge i-stat 03P89-24 PT/INR INR Liquid Controls Level 1 Level 2 i-stat 06P P17-14 PT/INR Electronic simulator i-stat 06F11-01 N/A Syringes 1 ml BD Syringes 3 ml Portex 4041 Luerlock syringe Portex I-STAT1 9V NiMH Battery I-STAT 06F23-55 Store at 2-8ºC Store at 2-8ºC Room temperature storage See individual cartridge procedure See individual cartridge procedure See individual cartridge procedure See individual cartridge procedure See individual cartridge procedure See individual cartridge procedure See individual cartridge procedure See individual cartridge procedure See individual cartridge procedure Room Temperature Room Temperature Room Temperature Room Temperature Room Temperature Calibration is performed automatically as part of the test cycle on each cartridge type. Operator intervention is not necessary. 7

8 Calibration Verification/Correlations Calibration Verification (CAL VER) using the CAL VER solutions (low, medium, and high levels) is performed to confirm the stability of the istat throughout the reportable range of analytes on non-waived cartridges (i.e. CG4+, CG8+). CAL VER is required on all non-waived sensors in the following circumstances: 1. With each new instrument 2. With each instrument that required major maintenance 3. Every 6 months 4. After each CLEW software update (which can be used as the 6 month CAL VER check) 5. As part of the troubleshooting process when controls reflect an unusual trend or are consistently out of range. Since the cartridges, and more specifically the sensors, are subject to the CAL VER check and not the istats themselves, all analyzers that pass the Electronic Simulator test are equivalent, which should eliminate the testing of three levels, twice a year, on each and every analyzer. Two instruments should be used in any performance verification study, to represent the larger MGH istat system. If the Calibration Verification fails, repeat testing and further investigation may be necessary. To perform CAL VER on i-stat: Press Menu. Press 3 to select Quality Tests. Press 3 to select CAL VER. Scan the CAL VER lot number Choose Level 1-5 Scan Cartridge Lot Number When test is finished, PASS/FAIL will be displayed at the top of the screen. Along with CAL VER, correlations between analytes need to be performed every 6 months, when more than one methodology or instrument is being used, or if the analytes are being tested in different locations. Note: This is not applicable if both the testing is being performed under a separate CLIA certificate and the tests are used for a separate patient population. Instrument correlations can be done using either patient samples or QC materials. For more information regarding instrument and specific analyte correlations and acceptability criteria, refer to the Inter-Laboratory Correlation Procedure in SoftTech. Electronic Quality Control Electronic Simulators: The Electronic Simulator (both external and internal) is a quality control device for the analyzer. It simulates two levels of electrical signals that stress the analyzer s signal detection function both below and above measurement ranges. It provides an independent check on the ability of the analyzer to take accurate and sensitive measurements- of voltage, current and resistance from the cartridge. An analyzer will pass or fail this test depending on whether or not it measures these signals within specified limits. The Electronic Simulator will fail if high relative humidity interferes with the measurements, making separate recording of humidity unnecessary. A. Internal Electronic Simulator: The Internal Electronic Simulator runs every 8 hours for blood gases and for all the analytes every 24 hours. Inserting a cartridge triggers the internal simulator. When 8 hours has elapsed since the last Electronic Simulator test (internal or external), it will automatically perform the internal test before the sample is tested, adding about seconds to the testing cycle. 1. If it fails, the testing cycle stops and FAIL displays on the screen. Immediately rerun the cartridge in the same analyzer to confirm the FAIL. If the cartridge fails again rerun the cartridge in a different analyzer (if less than three minutes has lapsed from the time of cartridge filling.) If the cartridge fails in more than one analyzer, use a different cartridge. 2. If it passes, the cartridge cycle continues to completion and the user receives the test results. B. External Electronic Simulator: The External Electronic Simulator is a stable electronic device, which is inserted into the cartridge port of the analyzer as described above. It should be run when: 8

9 1. The analyzer has been dropped 2. Every six months after the CLEW software update 3. After major malfunction 4. Replacement analyzer received from i-stat To run external Simulator: Press the Menu key to access the Administration menu. Press the #3 for Quality test Press the #4 for Simulator Scan Operator ID Scan Simulator ID 1. Insert the simulator into the analyzer with the I facing up. (Do not touch the contact pads). Cartridge Locked is displayed indicating that the simulator should not be removed. DO NOT ATTEMPT TO REMOVE THE SIMULATOR WHILE THE Cartridge Locked MESSAGE IS DISPLAYED. AN ATTEMPT TO REMOVE FORCIBLY THE SIMULATOR DURING THIS CYCLE MAY DAMAGE THE ANALYZER. 2. If PASS is displayed on the analyzer screen, remove the simulator after the Cartridge, Locked message disappears from the display screen. 3. If FAIL is displayed on the analyzer screen: Repeat the procedure with the same Electronic Simulator. If PASS is displayed, use the analyzer as required. If FAIL is displayed, repeat the procedure with a different Electronic simulator, if available. 4. If PASS is displayed with the second simulator, use the analyzer as required. 5. If FAIL is displayed with the second Electronic simulator: C. Thermal Probe Check Do not analyze patient samples with the analyzer. Transmit the result to Precision Web. Record the failure in the Instrument Corrective Action Log, along with action taken. i-stat analyzers contain a thermal control subsystem consisting of two thermal probes with thermistors and heating contact wires. When measurements are performed at a controlled temperature, the thermal probes in the analyzer contact the metalized area under the chips in the cartridge and maintain the temperature of the sensors and the fluids that come into contact with these sensors at the required temperature of 0.10C. The thermal probe check must be verified twice each year, after i-stat software update. Check the thermal probes as follows: 1. If the analyzer and simulator have been stored separately in areas where the ambient temperature differs by more than 3C (5F), allow the simulator and analyzer to stand in the same place, out of drafts, for 30 minutes before inserting the simulator into the analyzer. Handle the simulator as little as possible to maintain its thermal uniformity and stability. 2. Insert the simulator into the analyzer. 3. When the results are displayed, press the period button and the difference between the thermal probes can be viewed on the analyzer s screen. (Acceptable: a value equal to or less that 0.1) 4. If a FAIL message with t Quality Check Code, or a value greater than 0.1 displays repeat the procedure. Repeat the procedure if is displayed. Call Technical Support for repeated failures. 5. Documentation of results appears electronically in Precision Web under the test detail of the electronic simulator. 6. The results of the Thermal Probe Check for each analyzer are documented on the Thermal Probe Check Log. Liquid Quality Control Liquid Quality Control must be performed: 1. On every analyzer prior to initial placement for patient testing 2. On every new lot number and every new shipment of cartridges 3. When there s a suspected cartridge or storage problem 4. On any back up analyzer placed in use before patient testing 5. On all cartridge/reagent types as well as all analytes. If the same analyte occurs on multiple cartridge/reagent types, it must be tested on every cartridge/reagent type 9

10 6. Monthly to check storage conditions of cartridges Note: Implementing a new or replacement device that uses non-waived cartridges: i-stat protocols are followed when approving a new device for use. Failure of an instrument to meet protocol requirements will require further evaluation. Barcode Scanning To scan a barcode Hold the analyzer approximately 3-12 inches and at a 10 degree angle from the barcode to be scanned. Press and hold down the Scan key to start the barcode scanner. When the analyzer accepts the barcode, it will beep in acknowledgment and automatically turn off the beam. The beam will also turn off after 3 seconds. You may view the data that scanned on the analyzer After viewing the data, release the Scan key. The meter contains a laser. DO NOT stare into the laser light or point it toward anyone. Failure to scan the cartridge pouch lot number will result in error code 69 or 147 instead of a test result Calculations The i-stat analyzer contains a microprocessor that performs all calculations required for reporting results. Reporting results The handheld analyzer will display test results once the cartridge has been unlocked and the Cartridge Locked prompt disappears. Results display for 2 minutes. Recall results to the display screen by pressing the Menu key. For dark units where it is difficult to view the display, pressing and holding the 0 (zero) key will turn the backlight on. A. Suppressed Results The i-stat will not display results under three conditions: 1. Results outside of the system s reportable ranges are flagged with a < (less than) or > (greater than) indicating that the result is below the lower limit or above the upper limit of the reportable range respectively. See Analytical Range under Reference Ranges for these values. If a flag of < (less than) or > (greater than) occurs, SEND A SPECIMEN TO THE CLINICAL LABORATORY FOR ANALYSIS. Action: Follow unit protocol for critical results. 2. A result that is flagged with *** means that: a. There is an interfering substance in the sample. b. An individual sensor for that test has been compromised. c. This particular test is a calculated result that depends on the results of another test that has ***. d. The first time *** appears when a sample is tested, retest the sample using a new cartridge (certain tests such as ACTk and PT/INR require fresh samples). e. If *** appear again when the sample is tested a second time on the i-stat SEND A SPECIMEN TO THE CLINICAL LABORATORY FOR ANALYSIS. f. If *** reappears on multiple patient samples, call Point of Care Testing for assistance. 3. Results will not be reported if a test cycle has a problem with the sample, calibrant solution, sensors, mechanical, or electrical functions of the analyzer. Action: Take the action displayed with the message that identifies the problem. Refer to the i-stat system manual s troubleshooting section if necessary. Use a backup analyzer if necessary. B. Transmitting Results to the Electronic Medical Record 1. Place the analyzer in the Downloader. The Power light must be green and the blue proximity light will turn on automatically. When properly aligned, all unsent results will be automatically transmitted. The analyzer does NOT need to be turned on. The message Communication in progress is displayed. Verify that the display is turned off before removing from Downloader. 2. If unable to resolve data transmission issues, notify the Point of Care Testing Program. mghpoctcoordinators, pager: Preventive Maintenance A. Rechargeable battery: A nickel-metal-hydride (NiMH) rechargeable battery powers the analyzer. The battery recharges when the analyzer is placed in a Downloader/Recharger. The battery pack can also be removed from the analyzer and placed in the separate recharging compartment on the Downloader/Recharger. Full recharge from a 10

11 discharged state takes approximately 40 hours. The analyzer will display Low Battery when battery recharge is needed. Spare batteries may be acquired from the POCT program staff. B. Disinfect exterior of analyzer between each patient with hospital-approved disinfectant, e.g. Sani wipe cloths or Virex 256. C. CLEW/JAMS software updates: Software updates performed twice per year re-establishes standardization values and incorporates refinements to the internal quality monitoring system. External Quality Control and the Thermal Probe Check are performed along with the CLEW update. The POCT Program will ensure CLEW updates are implemented prior to software expiration. Instrument Replacement Policy A. The replacement instrument policy applies to the following situations: 1. Any malfunction of the instrument 2. Any new instrument 3. Any major maintenance B. The POCT program will perform the following before the replacement instrument is installed: 1. External Simulator (Refer to the procedure for external Simulator) 2. Thermal probe check (Refer to the procedure for Thermal probe check) 3. CAL VER (Refer to the procedure for performing CAL VER) 4. Liquid Quality control (Refer to the procedure for performing liquid controls) 5. Follow i-stat protocols on analyzers used for non-waived testing 6. Document all the results. 7. Inform the POCT sites regarding the replacement of the instrument. 8. Edit instrument information in Telcor for proper configuration and results transmission. 9. All the reports must be approved and signed by the Medical Director or designee. Troubleshooting A. Analyzer: 1. No display: Either if the display screen remains blank, after a cartridge has been properly inserted or after the On/Off key has been pressed, the batteries should be replaced. 2. Cartridge Locked: Cartridge Locked appears on the screen during the testing cycle to indicate that the cartridge or simulator is locked in the analyzer and should not be removed. A cartridge or simulator must be removed only after the Cartridge Locked prompt disappears from the screen. Normally the analyzer will reset and release the cartridge after the testing cycle is completed. If the analyzer cannot reset, the Cartridge Locked prompt will remain on the screen. If this occurs, wait until the analyzer deactivates (display screen blank) and press the On/Off key. The analyzer will try to reset. If the Cartridge Locked prompt does not disappear, do not attempt to remove the cartridge. Contact the Point of Care Testing program: mghpoctcoordinators, pager: Low Battery: Recharge battery in Downloader/Recharge or swap with extra rechargeable battery. 4. Electronic simulator fail will appear if the analyzer has not successfully completed the electronic simulator test. Refer to ELECTRONIC QUALITY CONTROL section. 5. CLEW expiring, Upgrade required, Point of Care Testing would need to perform a software update. 6. Messages and Quality Check Codes: If a problem is detected during a testing cycle, the cycle will be stopped and a message box will appear on the screen. The messages will identify the code number. Refer to i-stat s technical bulletin(s) to determine the meaning of the code number and the suggested action. If the analyzer deactivates before the detected problem is addressed, the message box will reappear the next time the On/Off key is pressed. Document all problems on the Instrument Corrective Action Log and notify Point of Care Testing. Temperature out of Range error message: The analyzer must be moved to an area where the temperature is between C. Equilibration can take up to 30 minutes. Other error messages: Refer to the i-stat System Manual s Troubleshooting section for more information. 7. i-stat Dropped: Run simulator prior to patient testing. 11

12 8. Power Outage or Disaster scenario: Adaptors are available from the POCT program to allow i-stat to run on regular 9V batteries. Contact the POCT program for assistance. B. Cartridge: 1. *** Instead of Results: Test the patient specimen with a new cartridge. a. If *** reappears, send the sample to the Clinical Laboratory for analysis. The sample may contain a substance that interferes with the test. b. If *** are obtained for the same test performed on an additional (different) patient, contact Point of Care Testing for assistance: mghpoctcoordinators, pager: (This problem may have been caused by improper cartridge storage). Technical support may be contacted 24 hours x 7 days at Alternative method Should the i-stat System become inoperable for any reason, specimens should be collected and submitted to the laboratory in accordance with the Laboratory Procedure Manual. References A. i-stat1 System Manual, i-stat Corporation, Princeton, N.J., May 2016 B. Gornall, A.G.: Applied biochemistry of clinical disorders, Chapter 6, Respiratory Disorders, p. 94, C. Gradwohl s Blood gas analysis and acid-base balance: Principles & Techniques, Chapter 17, p. 351, Fleisher & Schwartz. D. Pesce, A. and Kaplan, Methods in Clinical Chemistry, C.V. Mosby Co., St. Louis, MO, E. Tietz, Norbert W., Editor, Fundamentals of Clinical Chemistry, W.B. Saunders Co., Philadelphia, PA, Reference Ranges The tested ranges are those ranges that were tested during functional sensitivity and linearity testing. 12

13 Test Reference Range Critical Value Range (Approved by Med Poll Committee)* Analytical Range Calcium, ionized mmol/l <0.8 or >1.54 mmol/l PCO2 (arterial, venous, mix, capillary) mmhg ph (arterial, venous, mix, capillary) PO2 (arterial, venous, mix, capillary) mmhg Art: 14D, Art: Ven: Mix: Cap: Art: Ven: Mix: Cap: Art: 0-14 D: Art: >14 D: Mix: Ven: Cap: <20 or >75 mmhg, first only (within past 24 hours) <7.10 or >7.59 units, first only (within past 24 hours) <40 mmhg Glucose (Adult) mg/dl <50 or > Glucose, plasma (newborn) mg/dl <40 or >500 mg/dl Potassium Adult: mmol/l <1 mo: mmol/l <2.8 or >6.0 mmol/l 2-9 Sodium mmol/l <120 or >160 mmol/l Chloride mmol/l None Lactate mmol/l None TCO2 Adult: mmol/l 14 days-1 yr: mmol/l <14 days: mmol/l <11.0 or >40.0 mmol/l 5-50 Urea Nitrogen/BUN 8-25 mg/dl None Hematocrit % >56% within 30 days < or = 20% within 30 days %PCV Hemoglobin (calculated) gm/dl < Anion Gap (calculated) mmol/l None (-10) (+99) HCO3 (calculated) > 1 year: mmol/l 14 days-1 yr: mmol/l 0-14 days: mmol/l None BE (calculated) None None (-30) - (+30) SO2 (calculated) None None PT/INR Creatinine PT sec (age 6 months to adult); PT-INR values for Warfarin Anti-Coag Therapy: Standard Intensity ; High Intensity EP Lab: Cardio aversion INR >2.0 All other EP procedures <3.5 Cath Lab: <1.5 Internal jugular approach <1.7 Femoral approach <2.0 Radial approach mg/dl <10 yr: mg/dl INR >5 POCT INR >5 Core Lab None *Clinical policy and Procedure Manual Laboratory Results: Guidelines for Retrieving and Reporting. 13

14 Addressograph Patient Activated Clotting Time Target Ranges The Institution's Medical Staff believe Reference Ranges are not appropriate for Activated Clotting Time (ACT), instead Target Values or Ranges that vary with procedures, protocols. In some cases, physician clinical preferences may be appropriate. The following table provides guidelines that have been established by site Medical Directors and staff and is intended to take the place of Reference Ranges. ACT ranges are for heparin unless otherwise specified. Location Neuro-Radiology EP laboratory Respiratory: Catheterization Lab Cardiac Surgery: Qualifier or Description Target Range is patient-specific and subject to physician s discretion during the case. The Target Range is determined for each patient in the doctor s order. The Target Range is procedure and patient-specific. Interventional Catheterizations: Patients undergoing Diagnostic Catheterizations Target ranges may vary with procedure. Typical Target Range Used at MGH times the baseline value seconds seconds with an upper limit of 240 seconds (upper limit 230) for patients on platelet G2b-3a inhibitors and (upper limit 240) for patients off platelet G2b-3a inhibitors Patient will receive units heparin, regardless of ACT level. Baseline: seconds Therapeutic heparin drip: On Cardiopulmonary bypass regardless of the surgical procedure: Off Cardiopulmonary bypass CABG: Therapeutic bivalirudin for CPB: seconds (or control aptt seconds to convert to an ACT value) >450 seconds >400 seconds Initial ACT: >400 seconds To remain in the Medical Record Reviewed by: K Lewandrowski, MD Date: 2/2/10 14

15 ACT (Kaolin) Cartridge Procedure The Activated Clotting Time (ACT) is a measure of the time required for complete activation of the coagulation cascade. The endpoint is indicated by the conversion of a thrombin substrate other than fibrinogen and an electrochemical sensor is used to indicate that conversion. The ACT is primarily used to monitor a patient s state of anticoagulation due to heparin administered during a medical or surgical procedure (e.g. cardiac catheterization, renal dialysis, Percutaneous Transluminal Coronary Angioplasty). Specimen Collection Suitable Specimens for ACT: Fresh whole blood (venous or arterial) without anticoagulant collected in a plastic syringe properly labeled with the patient name, date of birth, or medical record number. If from an in-dwelling line, flush the line with 5 ml saline and discard the first 5 ml of blood or three to six dead space volumes of the catheter. Fresh whole blood (venous or arterial) collected in a plastic tube properly labeled with the patient name, date of birth, or medical record number without anticoagulant, clot activators, or serum separators. Device used to transfer sample to cartridge must be plastic. If a repeat measurement is needed, a fresh sample must be obtained Criteria for Specimen Rejection: Evidence of clotting Other sample types such as urine, CSF and pleural fluid Specimen collected in a glass syringe or tube or with anticoagulant of any kind NOTE: Avoid the Following Circumstances Drawing a specimen from an arm with an I.V Stasis (tourniquet left on longer than one minute before venipuncture) Extra muscle activity (fist pumping) Hemolysis (alcohol left over puncture site or a traumatic draw) Icing before filling cartridge Time delays before filling cartridge Reagent Storage Requirements Verification of Cartridge Storage Conditions during Shipment On receipt of new cartridges, verify that the transit temperatures were satisfactory using the fourwindow temperature indicator strip included with the cartridge boxes. Read the temperature strip immediately since it will change with exposure to room temperature. Record observations on the Record of Receipt that comes with each box and attach the receipt with strip in the space shown on the Record of Receipt /QC Documentation Log. Perform liquid QC on the cartridges and document results on the Record of Receipt /QC Documentation Log. A. Refrigerated Cartridges Store at 2-8 C. Do not allow cartridges to freeze. Verify that the cartridges stored in the refrigerator are all within the expiration date printed on the boxes. Do not use after expiration date. Verify that the refrigerator did not exceed the limits of 2 to 8 C (35 to 46 F). Record the temperature of refrigerator on temperature log sheet. Cartridges must remain in pouches until time of use. Do not use cartridge if pouch has been punctured. Individual cartridges may be used after standing five minutes at room temperature. An entire box of cartridges should stand at room temperature for one hour. Remedial Action: If the temperature is outside the range of 2 to 8 C (35 to 46 F), quarantine the cartridges in the storage refrigerator. Notify the Site Coordinator of the temperature failure. DO NOT USE the cartridges from this refrigerator. 15

16 B. Room Temperature Cartridges: Cartridges at room temperature 18 to 30 C (64 to 86 F) are good for 14 days. Mark the room temperature expiration date on each cartridge. Do not return cartridges to the refrigerator once they have been at room temperature. Record the daily room temperature on temperature log sheet Return any cartridges that are beyond the 14-day room temperature stability to the site coordinator for tracking purposes. C. i-stat ACT Liquid Controls, Levels 1 and 2 Store at 2 to 8 C. Do not use after expiration date on box and ampoules. Record date and time removed from refrigeration. Control solutions may be stored at room temperature for up to 4 hours. If left out longer than 4 hours at room temperature, they should be discarded. Competency Assessment All operators must read the procedure manual and complete the Operator Training Checklist after initial training. The competency assessment process is done following initial training, after six months during the first year, then annually thereafter. Competency is assessed using six methods, examples of which are below: 1. Successful performance of routine patient testing, verified by direct observation 2. Supervisor monitoring of the recording and reporting of test results 3. Supervisor review of intermediate test results, QC, proficiency tests, and preventative maintenance performance 4. Successful performance of instrument maintenance function checks and calibration, verified by direct observation 5. Testing previously analyzed samples, proficiency testing samples, internal blind testing samples 6. Assessment of problem-solving skills Quality Control Prior to performing quality control, determine if additional preparation is required. Liquid Control preparation: ACT Coagulation Control Level 1 and Level 2 1. i-stat ACT controls are contained in 6-ml vials. Separate 6 ml vials contain 103 ml of calcium chloride solution for reconstitution. 2. Prior to testing, vials containing the lyophilized plasma and CaCl 2 reconstituting fluid should stand at room temperature for a minimum of 45 minutes. 3. Reconstitute only one level of control plasma at a time. CONTROL SOLUTIONS MUST BE USED IMMEDIATELY (less than 30 seconds) AFTER COMPLETING THE RECONSTITUTION AND MIXING STEPS. Pour the entire contents of the calcium chloride vial into the lyophilized human plasma control vial. 4. Allow the vial to sit at room temperature for 1 minute 5. Mix the contents by swirling gently for 1 minute, then inverting slowly for 30 seconds. 6. Visually inspect the control vial to ensure that the sample is fully reconstituted. If not, discard the reconstituted fluid and start over with fresh vials. 7. Using a plastic transfer pipette, plastic syringe, or plastic capillary tube with no anticoagulant, immediately transfer the solution from the vial into the ACT cartridge. NOTE: additional ACT cartridges may be tested with the remaining fluid if used within 30 seconds of complete reconstitution of the sample. Running the controls: 1. Put on gloves. 2. Press the On/Off key 3. Press the Menu key 4. Press 3 to select Quality Tests. NOTE: Always remember to analyze control materials in the Control pathway under the Quality Tests option of the i-stat 1 Analyzer Administration Menu. Do not analyze controls under the Patient Test pathway. This must be done before inserting the test cartridge into the analyzer. The analyzer allows 15 minutes to insert the cartridge after the last keystroke. 16

17 5. Press 1 to select Control. 6. Press Scan to scan Operator ID 7. Press Scan to scan Control Lot number 8. Press Scan to scan the cartridge lot number from cartridge pouch. 9. Fill cartridge with the control (see below). Insert cartridge. 10. Enter 1 for i-stat Level 1. Enter 2 for i-stat Level Results will appear. At the bottom of one of the result pages, you will see 1- Test Options Select You will now have the following options: 1- Next level 2- Repeat level 3- History Control Evaluation: Using these options will allow you to continue your Quality Control testing without having to start again at the top of the QC menu. 1. Document results on the Record of Receipt /QC Documentation Log and compare results to the ranges to determine acceptability. 2. The operator performing the quality controls is responsible for evaluating the controls and performing any necessary corrective actions. If the results are out of range, corrective action must be documented on the Record of Receipt /QC Documentation Log. 3. If all results are within expected ranges, use the cartridges as needed. Transmit the results when finished. 4. The result statistics will be reviewed monthly by the Medical director or Designee. Quality Control Corrective Action: 1. If any liquid control result is unacceptable, patient testing can not be performed until the problem has been resolved. Use another analyzer or send the specimen to the Clinical Laboratory. 2. Repeat any out of range control, verifying that the control procedure above has been followed carefully. 3. Document all the results and corrective actions on Record of Receipt /QC Documentation Log. 4. If new control solutions fail a second time, analyzer, control solutions and cartridges should be pulled from use and the POCT program notified mghpoctcoordinators, pager: An investigation will be done to determine the cause of failure. Testing Procedure 1. Follow hand hygiene protocol and put on gloves. 2. Turn the analyzer on and press 2 for i-stat Cartridge. 3. Scan or enter the operator ID and patient CSN. Repeat if prompted. 4. Press Scan to scan the cartridge lot number from cartridge pouch. 5. Remove the cartridge from its pouch. Avoid touching the contact pads or exerting pressure over the calibrant pack in the center of the cartridge. 6. Following thorough mixing of the sample, direct the dispensing tip or capillary tube containing the blood into the sample well and dispense the sample until it reaches the fill mark on the cartridge and the well is about half full. 7. Close the cover over the sample well until it snaps into place. (Do not press over the sample well.) 8. Insert the cartridge into the cartridge port until it clicks into place. When using an ACT cartridge, the analyzer must remain horizontal during the testing cycle. 9. Select tests to be reported. 10. Enter additional parameters on the Chart page if required: Choose the number corresponding to the type of sample used when prompted at the Sample Type field. Press the key to return to the results page. 11. View results shown on the analyzer s display screen. 12. Remove the cartridge after Cartridge Locked message disappears. The analyzer is ready for the next test. 13. Remove gloves and perform hand hygiene. 17

18 Documentation Dock meter after each test performed to transmit results. During network downtime, results are held in analyzer until they can be transmitted to patients electronic medical record. CG8+, CG4+, and G3+ Cartridges Procedure The CG8+ cartridge is designed to directly measure glucose, sodium, potassium, ionized calcium, Hematocrit, ph, pco 2, and po 2, while calculating values for hemoglobin, TCO 2, HCO 3, BE and so 2. The CG4+ cartridge directly measures ph, pco 2, and po 2, and lactate and calculates values for TCO 2, HCO 3, BE and so 2. The G3+ is similar to the CG4+, except that lactate is not measured. Sodium, Potassium, Ionized Calcium, ph, and pco 2 These analytes are measured potentiometrically by ion-selective electrode. Concentrations are calculated from the measured potential through the Nernst equation. 1. Sodium and potassium test results are important in the diagnosis and treatment of patients suffering from hypertension, renal failure or impairment, cardiac distress, disorientation, dehydration, nausea and diarrhea. 2. Ionized calcium is the biologically active fraction of calcium. Through its role in a number of enzymatic reactions and in membrane transport mechanisms, ionized calcium is vitally important in blood coagulation, nerve conduction, and neuromuscular transmission and in muscle contraction. Measurements of ionized calcium may be particularly useful under these clinical conditions: transfusion of citrated blood, liver transplantation, open-heart surgery, neonatal hypocalcaemia, renal disease, hyperparathyroidism, malignancy, hypertension and pancreatitis. 3. ph is an index of the acidity or alkalinity of the blood. 4. pco 2, along with ph, is used to assess acid-base balance. pco 2 is the respiratory component of acid-base balance. pco 2 represents the balance between cellular production of CO 2 and ventilatory removal of CO 2. Causes of primary respiratory acidosis (increase in pco 2 ) are airway obstruction, sedatives and anesthetics, respiratory distress syndrome, and chronic obstructive pulmonary disease. Causes of primary metabolic acidosis are ketoacidosis, lactate acidosis and diarrhea. Causes of primary respiratory alkalosis (decrease in pco2) are hypoxia due to chronic heart failure, edema and neurological disorders, and mechanical hyperventilation. Causes of primary metabolic alkalosis are vomiting and antacid treatment. 5. po 2, a measurement of the pressure of oxygen dissolved in the blood, is measured amperometrically. The oxygen permeates through a gas permeable membrane from the sample into an internal electrolyte solution where it is reduced at the cathode. The oxygen reduction current is proportional to the dissolved oxygen concentration. Decreased po 2 may be caused by ventilation problems or by alteration in the flow of blood within the heart or lungs. 6. Glucose is measured amperometrically. Hydrogen peroxide, produced by the oxidation of glucose, is oxidized at an electrode to produce an electric current proportional to the glucose concentration. Glucose is the primary source of energy for the body and the only source of energy for brain tissue. Measurements of blood glucose levels are important for identification of both hypo- and hyperglycemia, as well as for managing patient treatment to maintain glucose within designated limits. 7. Lactate is measured amperometrically. The enzyme lactate oxidase, immobilized in the lactate biosensor, selectively converts lactate to pyruvate and hydrogen peroxide. The liberated hydrogen peroxide is oxidized by the platinum electrode to produce a current that is proportional to the sample concentration. Elevated levels of lactate are mainly found in conditions of hypoxia such as shock and hypovolumia; in conditions associated with diseases such as diabetes mellitus, neoplasia, and liver disease. Note: The i-stat will not be used for Hematocrit and/or hemoglobin determinations in the operating rooms. Specimen Collection Suitable Specimens for Cartridges for Blood Gases, Electrolytes, and Chemistries: 18