Procedure manuals containing the i-stat Processing Procedure are located at each download station and in the Respiratory Therapy department.

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1 Principle: The I-STAT system delivers quantitative results for a panel of tests on a small sample of whole blood in less than two minutes. Portability and simplicity of operation permit its use by qualified health care professionals at the point of patient care assisting in rapid evaluation of acid-base, oxygenation, and electrolyte status. The system can be implemented as a network to facilitate integration into the facility s patient reporting and billing system. A more detailed explanation is available for each analyte in the i-stat Operator s Manual. Available test cartridges: EG7+ G3+ CG4+ ph ph ph PCO2 PCO2 PCO2 PO2 PO2 PO2 BE (ecf) BE (ecf) BE (ecf) HCO3 HCO3 HCO3 TCO2 TCO2 TCO2 Na Lac K ica HCT Hb Procedure manuals containing the i-stat Processing Procedure are located at each download station and in the Respiratory Therapy department. Policy: Task Classification/ Precautions: 1. CLIA Classification: Moderate Complexity 2. Precaution Category: Universal Precautions a. Justification: High risk for exposure to blood/body fluids with visible blood b. Protective Wear: Gloves 1

2 Operator Certification 1. Only a Certified Operator will be allowed to perform the point-of-care Blood gas procedures. 2. A certified operator is an employee who has a minimum of a high school diploma or its equivalence, has reviewed the current testing policy and procedure, has attended the initial training and successfully completed the competency verification criteria for this procedure. 3. In order to maintain the status of Certified Operator, all operators are required to demonstrate continuing competency before running patient tests, at six (6) months, at 12 months, and annually thereafter. 4. It is the Supervisor s responsibility to ensure that all staff performing this procedure are currently certified. Non certified operators are locked out of the i- STAT meter. 5. The Supervisor will notify the Point-of-Care Coordinator of additions or deletions of certified operators (i.e. new hires, termination of staff, etc.). Competency Verification 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, or internal blind samples. 6. Assessment of problem-solving skills Record of Certification 1. Subsequent re-certifications will be noted on Annual Competency Checklists. 2. Individual educational files are placed in the operator s personnel file maintained by the Administrative Coordinator for Respiratory Therapy. Specimen Requirements: microliters of fresh whole blood from capillary, venous or arterial puncture. Every effort should be made to collect venous samples when IV lines are started. 2

3 2. Heparinized whole blood (green top tube). 3. Heparinized whole blood (syringe) for blood gas. Cautions: Observe standard precautions at all times. Materials: 1. I-STAT cartridge (EG7, G3+, or CG4+). 2. Heparinized blood gas syringe 3. Alcohol Pads. 4. Sharps container. 5. Gloves. 6. Capillary tubes. 7. Patient identification bracelet (arm band). See Patient Identification Specimen Collection: In-Dwelling Line Back flush line with sufficient amount of blood to remove intravenous solution, heparin, or medications that may contaminate the sample. Recommendation: three to six times the volume of the catheter, connectors, and needle. Arterial Specimens Allow alcohol to dry 30 seconds before sample obtained. Fill blood gas syringe to the recommended capacity or use the least amount of liquid heparin anticoagulant that will prevent clotting. Under-filling syringes containing liquid heparin will decrease ph results, increase PO2 results due to dilution and will decrease ionized calcium results due to binding. For ionized calcium, balanced or low volume heparin blood gas syringes are recommended. Mix blood and anticoagulant by rolling syringe between palms for at least 5 seconds and then inverting the syringe repeatedly for at least 5 seconds. Avoid or remove immediately any air drawn into the syringe to maintain anaerobic conditions. A blood gas sample should be tested within 30 minutes after it has been obtained (remix before testing). If lactate is performed, specimen must be run immediately after collection. 3

4 Venous Specimens Allow alcohol to dry 30 seconds before sample obtained. If a cartridge cannot be filled immediately, collect sample into an evacuated blood collection tube or a syringe containing heparin (sodium, lithium, or balanced) anticoagulant. For ionized calcium measurements, balanced heparin or 10 IU/ml of sodium or lithium heparin is recommended. Fill tubes to capacity; fill syringes for correct blood to heparin ratio. Incomplete filling causes higher heparin to blood ratio which will decrease ionized calcium results and may affect other results. Mix blood and anticoagulant by rolling tube between palm for at least 5 seconds and then inverting the tube repeatedly for at least 5 seconds. If possible, test samples immediately after draw; samples should be tested within 30 minutes (remix before testing). If lactate is performed, specimen must be run immediately after collection. See Venipuncture Procedure and Routine Collection of Laboratory Specimens Procedure in the Clinical Laboratory s procedure manual. Finger and Heelstick Specimens The least preferred sample, use only as a last resort. Allow alcohol to dry 30 seconds before sample obtained. Wipe away the first drop of blood, which contains excess tissue fluid which can increase potassium result and dilute other test results. Allow alcohol to dry 30 seconds before sample obtained. Avoid drawing air into the capillary tube. Heparinized capillary tubes are not suitable for ionized calcium due to the high concentration of heparin. Use balanced heparin or plain capillary tubes for collection. Test samples immediately to avoid clotting. Criteria For Specimen Rejection: Evidence of clotting. Specimens collected in vacuum tubes with anticoagulant other than lithium or sodium heparin. Syringe for ph, PCO2, and PO2 with air bubbles in sample. Incompletely filled vacuum tube for measurement of ionized calcium. See Supplemental Cartridge Information Sheets at the end of this procedure for a more detailed list of interfering substances. Storage Requirements: 4

5 Cartridges: Verify that the transit temperatures were satisfactory using the window temperature indicator included in the shipping container. Date the boxes of cartridges with the date of receipt. Store the main supply of cartridges at 2 to 8 C. Do not allow cartridges to freeze. Cartridges may be stored at room temperature 18 to 30 C for 2 months. Cartridges should never be returned to the refrigerator once they have been at room temperature, and should not be exposed to temperatures above 30 C. Mark the calendar on the box and date the individual cartridge packages to indicate the room temperature expiration date. Cartridges should remain in sealed pouches until time of use. Do not use after the labeled expiration date. Samples: Ideally, all patient samples should be tested immediately. Samples may be held up to 30 minutes before processing. Run lactate specimens immediately. Quality Control and Calibration Verification: 1. Internal electronic control (simulator) with 2 levels of resistance each eight (8) hours. This is automatically activated when a cartridge is inserted after the eight hour interval is reached. The analyzer is programmed to block testing when the control fails. 1. Daily external electronic control (simulator) with 2 levels of resistance. Documentation of this step will be logged on the simulator QC sheet. The analyzer reminds the operator when testing with the simulator is indicated with a: i-stat Simulator Test Required 1 - Continue message displayed on the screen. From the analyzer Main Menu: 1. Select # 3 (Quality Tests). 2. Select # 4 (Simulator). 3. Enter/scan the operator ID. 4. Enter/scan the Simulator ID. 5. PASS or FAIL results will appear 5

6 3. Should an electronic or liquid quality control run fail, it may be re-run once. Should this run fail, the analyzer will be placed out-of-service and the Supervisor notified. The Supervisor will then conduct further trouble shooting as outlined in the i-stat user s manual. 4. Two different levels (Level 1 and Level 3) liquid (Assayed Liquid Controls from Abbott) quality control are run with of each newly received shipment of cartridges and monthly. Cardiopulmonary and Respiratory Therapy Personnel perform quality control testing on the EG7+, G3+, and CG4+ cartridges, rotating samples so that every operator performs quality control. 5. Testing results must fall within the upper and lower limits established by the manufacturer of the assayed control material. Control results are documented on the Cartridge Quality Control Log. All data is reviewed by the Supervisor of Cardiopulmonary before new lots are placed in use. 6. All Quality Control results must be verified for acceptability before patient results are reported. 7. CLEW/JAMS software updates are performed twice a year that re-establishes standardization values and incorporates refinements to the internal quality monitoring system. 8. Semi-annual calibration verification using 5 levels of calibrators covering the entire spectrum of reportable ranges for the test involved. Acceptable results are provided with the calibrators, which is also the reportable range for the analyzer and cartridge. This is performed by laboratory personnel on a subset of analyzers. All results must be within range published for that lot of calibration verification material.. Proper calibration of analyzers outside the subset will be inferred by successful correlation to one or more of the verified analyzers. Calibration verification using 3 levels of calibrators will be performed upon the receipt of a new or replacement analyzer, if liquid QC is unsatisfactory, or if there is a major change in cartridge/software configuration. 9. Semi-annual main analyzer correlation/internal survey processed by personnel ordinarily using the analyzer. Acceptable results are: Na +/- 5 mmol/l of chemistry analyzer K +/- 0.5 mmol/l of chemistry analyzer 6

7 HCT +/- 5% of hematology analyzer Lac +/- 20% of chemistry analyzer 10. Correlation between i-stat analyzers is undertaken every six months. Acceptable results are: ph- target value + or PCO2- target value + or - 5 mmhg or 8% of target value, whichever is greater PO2- Target value + or 5 mmhg to 50, then 10% of target above 50 K + - Na + Ca ++ Lac Target value + or meq/l Target value + or mmol/l Target value + or 0.25 mmol/l Target value + or 20% of target value All analytes r 2 > A semi-annual Thermal Probe Check of each analyzer is performed to insure proper internal temperature. Results are logged in the i-stat QC Manual. 12. There are Problem/Resolution Forms, QC Problem Resolution Forms, and Equipment Maintenance Records available in the i-stat QC Manual to record any problems and corrective action that is experienced with the instrument. 13. Description of control materials. i-stat Liquid Controls (assayed 2 levels) i-stat Liquid Calibrators (assayed 3 levels) Eurotrol Liquid Hyperbaric Calibrator (assayed, 1 level) Eurotrol Liquid Hypoxic Calibrator (assayed, 1 level) Storage- Controls are to be stored at C. Temperature of ampules should be equilibrated at degrees C at least 4 hours before use. Controls are 7

8 stable at room temp 5 days. Control solutions are light sensitive. Store in dark area. The lot number and expiration date are printed on each control. Do not use after the labeled expiration date. Container- Controls are packaged 2.5cc in glass ampules. Survey Participation: 1. The laboratory personnel participate in 3 CAP Survey challenges per year for the blood gas EG7+ and CG4+ cartridges. Samples are rotated amongst personnel trained in the performance of duties related to blood gas analysis using the EG7+ and CG4+ cartridges. Survey samples are run simultaneously on a prescribed subset of i-stat analyzers as determined by the Clinical Laboratory s Point-of- Care Coordinator. Criteria for acceptable performance- ph- target value + or PCO2- PO2- K + - Na + Ca ++ Lac target value + or - 5 mmhg or 8% of target value, whichever is greater 3 PT group standard deviations (3SDI) Target value + or meq/l Target value + or mmol/l Target value + or - 2 SDI Target value + or 20% of target value All results will be reviewed by supervisory personnel. Results are acceptable if 80% of data are correct within a given analyte (i.e. ph) and 80% are corrected across all analytes (ph, PCO2, PO2). If PT fails, remedial actions will be taken as directed by the Medical Director. 8

9 2. Survey results are reviewed by the Point of Care Coordinator, with follow up action (if necessary) with employees. Procedure For Performing Quality Control: EG7+,G3+ and CG4+ Cartridges: 1. Remove ampule(s) and cartridge(s) from the refrigerator and allow to come to room temperature (minimum of 4 hours). Holding ampule at the top and bottom with fore finger and thumb, shake the ampule vigorously for 10 seconds to equilibrate the liquid and gas phases. Tap the top of the ampule to send any 2. solution back into the body. Carefully snap off the neck of the ampule and draw solution from the body of the ampule using a sterile 3 ml syringe with a 20 gauge blunt tip needle. It is important not to expose the solution to room air since this will alter the results. If air is trapped near the plunger, do not invert the syringe to expel is; this air will not affect solution to be used at the tip of the syringe. If bubbles are continually drawn in the syringe and near the tip, discard and use a fresh ampule and syringe. Expel 2 drops from the syringe into a gauze pad. Then place two to four drops of the solution into the cartridge. Be sure the solution reaches the fill line. Close the cartridge and insert into the analyzer. a. Display the analyzer Main Menu. b. Select # 3 (Quality Tests). c. Select # 1 (Control). d. Enter/scan the operator ID. e. Enter/scan Control Lot #. f. Enter/scan Cartridge Lot #. g. Insert cartridge and testing will begin. 3. Continue with the standard procedure for testing patient samples. 4. Compare results to the published values. Check that the lot number on the control ampule matches the lot number on the package insert, and that the software version listed on the insert matches the software installed in the analyzer. If all results are within expected ranges use the cartridges as needed. Remedial Action (If any results are outside the published expected ranges) Do not use from the suspect lot Quarantine the suspected lot 9

10 Notify the Supervisor of Cardiopulmonary (Ext. 5262) and POC Coordinator Record the QC failure in the i-stat QC Manual Calibration is automatically performed as part of the test cycle on each cartridge. Patient Specimen Analysis Procedure: 1. Allow EG7+, G3+, and CG4+ cartridges to equilibrate to room temperature (1 hour for box and 5 minutes for single cartridge). Never return cartridges to the refrigerator. 2. Remove the cartridge from its pouch. Avoid touching the contact pads or exerting pressure over the calibration pack in the center of the cartridge. 3. Review the order and identify the patients by checking their arm band for correct name and patient account number prior to collection and processing of specimens. Scan or enter User ID into analyzer (5 digits). Repeat for verification if manually entered. Scan or enter Patient Account number (also known as Visit number or Billing number) (10 digits) into the analyzer. Repeat for verification if manually entered. 4. Direct the dispensing tip of the syringe or capillary tube containing the sample into the sample well. Avoid filling cartridge on surfaces that contain fibers, fluids or debris that may lodge in the analyzer. 5. Dispense the sample until it reaches the FILL TO mark on the cartridge. Samples are usually obtained percutaneously or from an in-dwelling arterial line. 6. Close the cover over the sample well until in snaps into place. Close cover using the flap on the cartridge cover. 7. Insert the cartridge into the cartridge door of the analyzer until it clicks into place. 8. Do not attempt to remove a cartridge during analysis. Display reads CARTRIDGE LOCKED. 9. Enter the applicable CHART PAGE entries for all specimens. 10

11 Base : Pt: Scan or Enter Data Choices: Press MENU Sample Site DelSys Rpt Time Rpt To Allen s Pt Temp Accept/ Cancel? Press: Press: Enter: Scan or Enter: Enter: Enter: Selection Lists: MENU button for selection lists ENT button for next item Time in military time for Rept Time Employee number or physician name for Rept To Patient temp only if temperature corrected results are desired C from ABC button on analyzer for cancellation of transmission of results to LIS Sample 1- ABG 2- VBG 3- MVB 4- Ca++ only 5- Cord Art 6- Cord Vein 7- Fluid ph 8- ABG/ Lactate Site 1- R Radial 2- L Radial 3- A Line 4- R Brachial 5- L Brachial 6- R Femoral 7- L Femoral 8- Vein 9- UAC Site 1- Heel stick 2- Pul Artery 3- RAtrium 4- RVentricle 5- Vena Cava 6- DP Artery 7- Pleural 8- Pericardial 9- Other More More 11

12 Del Sys 1- No Entry 2- Room Air 3- Cannula 4- Ventilator 5- BIPAP 6- Mask CPAP 7- VentiMask 8- NRB Mask 9- SimpleMask Del Sys 1- AerosolNeb 2- Trach Mask 3- BVM 4- High FR NC 5- T Piece 6- Mist Tent 7- Tot Hut 8- Oxyhood 9- OR Del Sys 1- Face Tent 2- Other More Selection Lists (cont.) More More Allen s 1- Pos 2- Neg 3- Deferred Del Sys Ventilator Mode Selection 12

13 Mode 1- VCV A/C 2- VCV SIMV 3- PCV AC 4- PCV SIMV 5- spont 6- VCV+ AC 7- VCV+ SIMV 8- NIV 9- BILEVEL Del Sys Parameter Selection s 1- FIO2 2- LPM Flowrate 1- FIO2 2- IPAP 3- EPAP BIPAP m-cpap 1- FIO2 2- PEEP/ CPAP 13

14 VC 1- FIO2 2- RATE 3- VT 4- PEEP/ CPAP 5- PSV PC 1- FIO2 2- RATE 3- PC 4- PEEP/ CPAP 5- ITIME 6- PSV spont 1- FIO2 2- PEEP/ CPAP 3- PSV Del Sys Parameter Selection s (cont.) VC+ 1- FIO2 2- RATE 3- VT 4- PC 5- PEEP/ CPAP 6- ITIME 7- PSV BiLEVEL 1- FIO2 2- RATE 3- PC 4- PEEP hi 5- PEEP/ CPAP 6- ITIME 7- PSV 14

15 Action Range (Critical Value) Comment Code Prompt Action Range Flag Scan or Enter Code 37.0 C ph PCO2 PO2 BEecf HCO3 TCO2 so2% Enter or scan the appropriate critical value Comment code: 1- Verified, called to nurse, RB 2- Verified, called to physician, RB 3- Verified, shown to nurse 4- Verified, shown to physician 5- Verified, Reported to OR personnel 6- Called to L&D, RB 7- Improperly collected specimen 8- Stability limit exceeded when received 9- Procedural error 10- Result(s) outside reportable range 11- Repeat 10. View results shown on the analyzer display screen. Normal values and critical values will print with results in LIS, the HIS, and on printed copies. 11. Printed copies of all results performed can be printed on the portable printers. These copies may serve as interim reports. 12. Disinfect exterior of analyzer between patients with a hospital approved disinfectant, i.e. Super Sani- Cloth (2 minute wet time). Alternative Procedure: Should the i-stat systems become inoperable for any reason, or if quality control or calibration verification procedures produce unsatisfactory results, specimens should be collected and submitted to the laboratory in accordance with the General Laboratory Procedures. A follow-up call to Abbott is required, as is corrective action, when problems arise with one of the i-stat analyzers is the main number. Analyzers are 15

16 generally not repairable by the user. Analyzer replacement is the usual method of corrective action, with a repeat calibration verification prior to implementation. For in-house assistance, call the Cardiopulmonary supervisor at Ext. 5262, or the on-call Senior Cardiopulmonary technologist. Procedural Notes: 1. The i-stat System automatically runs a comprehensive set of quality checks of analyzer and cartridge performance each time a sample is tested. This internal quality system will suppress results if the analyzer or cartridge does not meet internal specifications. 2. There are three conditions under which the I-STAT system will not display results. a. Results outside the system s reportable ranges are flagged with < or > indicating that the result is below the lower limit or above the upper limit of the reportable range. See Table of Reportable Ranges. Action: Recommend a sample sent to laboratory for analysis of electrolytes. b. Results that are un-reportable based on internal QC rejection criteria are flagged with ***. Action: Analyze the specimen again using another cartridge. If the results are not suppressed, report per established procedure. If the result is suppressed again, recommend sending specimen to the laboratory for analysis in accordance with the Laboratory Procedure Manual. c. Test cycle not completed due to a problem with the sample, calibration solution, and sensors, mechanical or electrical functions of the analyzer. Action: Take the action displayed by the message on the display screen. Return the i-stat to the Department for troubleshooting if necessary. 2. Calibration verification and controls are to be performed on each analyzer as it is normally used. The Outpatient Surgery analyzer is not used for blood gas analysis. Conversely, the analyzers used for blood gas analysis are not used by Outpatient Surgery personnel. Should unusual circumstances dictate that an analyzer be used for tests that it has not had calibration verification performed, this will be accomplished immediately. Calibration materials are kept in stock. 16

17 3. The i-stat system uses 2 nine volt lithium batteries. Use of any other type of battery will damage the system. 4. The analyzer must remain on a level, vibration free surface with the display facing up during testing. 5. Avoid filling cartridges on surfaces that contain fibers, fluid, or debris that may lodge in analyzer. Reporting Results: Blood Gas Laboratory 1. Results are downloaded via the hospital network to the point-of-care database. Results that have been accepted for transmission are sent across an HL7 interface to the Sunquest LIS system for storage and immediate re-transmission to the hospital HIS system. Results are displayed in the HIS patient record along with reference ranges, action range notifications, and technical (reportable) range failures. Operator tech code entered/scanned into the I-STAT is sent to the POC Data Manager and the LIS. 2. Documentation of notification of clinical personnel is recorded within the i-stat analyzer and is available on printed and displayed reports within the POC Data Manager, the LIS, and the HIS. They become part of the patient s permanent record. The person performing the test will be denoted by tech code/initials. 3. All results are reviewed on the next working day by the Supervisor of Cardiopulmonary or designated personnel. 4. Critical values are reported in the manner described in the Clinical Lab policy for Critical Values with the following differences: a. The employee number is commonly used to identify the operator reporting the critical result(s) b. The employee number is commonly used to identify the caregiver receiving the reported critical value(s) c. The date of notification of the critical value(s) will be the test report date unless otherwise noted 17

18 Normal Values Analyte Units Reportable Range (Linearity) Reference Range (Arterial) Reference Range (Venous) Na mmol/l K mmol/l HCT % PCV Male Female Children Neonate Male Female Children Neonate ph PCO2 mmhg PO2 mmhg BE (ecf) mmol/l Calculated HCO3 mmol/l Calculated TCO2 mmol/l Calculated ica mmol/l Lac mmol/l i-stat Critical Values Analyte Adult Children Sodium (mmol/l) Potassium (mmol/l) Ionized Calcium (mmol/l) ph pco2 (mmhg) po2 (mmhg) 50 NA 50 NA Hematocrit (%PCV) Lactate NA > 4.00 NA > 4.00 Interferences Interferent Effect Sodium Β- hydroxybutyrate 16 mmol/l (166 mg/dl) will decrease result by 5 mmol/l Bromide 37.5 mmol/l will increase result by 5 mmol/l 18

19 Lactate 20 mmol/l will decrease result by 5 mmol/l Potassium Hemolysis Increases result Hematocrit/ Elevated WBC Hemoglobin Total Protein Grossly elevated levels increase results Result TP <6.5 g/dl TP > 8.0 g/dl Hct <40%PCV Hct decreased by ~ 1 % PCV for each Hct increased by ~ 1% PCV for each increase of decrease of 1 1 g/dl TP g/dl TP Hct >40 %PCV Hct decreased by ~ 0.75 % PCV for each decrease of 1 g/dl TP Hct increased by ~ 0.75 % PCV for each increase of 1 g/dl TP Lipids Sodium Abnormally high lipids may increase results, use another method Abnormal levels may affect measured conductivity, use another method Ionized Β- hydroxybutyrate 20 mmol/l (166 mg/dl) will decrease result by 0.1 Calcium mmol/l Lactate 20 mmol/l will decrease result by 0.05 mmol/l Magnesium 1.0 mmol/l above normal will increase result by 0.04 mmol/l Salicylate 4.34 mmol/l will decrease result by 0.1 mmol/l Lactate Bromide 37.5 mmol/l will decrease result, use another method Glycolic Acid 10.0 mmol/l will increase result, use another method Hydroxyurea 0.92 mmol/l will increase result, use another Method 19

20 5. In the case of suspected interference, specimens should be collected and submitted to the laboratory in accordance with the General Laboratory Procedures. Laboratory Personnel Authorized to Perform POCT on EG7+ Cartridge 1. Personnel records for personnel authorized to perform POCT on EG7+ and G3+ cartridges are available in the personnel records in the Respiratory Therapy department. Passwords are is set to allow only those with valid operator security rites to perform or review analyses. Reference: 1. i-stat 1 Systems Manual, i-stat Corporation, Arterial Blood Gas Reference Values for Sea Level and an Altitude of 1,400 Meters, ROBERT O. CRAPO, ROBERT L. JENSEN, MATHEW HEGEWALD, and DONALD P. TASHKIN, Am J Respir Crit Care Med Vol 160, pp ,