title: i-stat operations and testing procedure cross ... operations and...electronic quality control...

POCT ProgramMassachusetts General Hospital - Pathology Service

55 Fruit Street, Boston, MA 02114Title: i-STAT Operations and Testing ProcedureCross References: i-STAT Operator Training Checklisti-STAT INR Fingerstick Training and Assessment Recordi-STAT Competency Assessment 6-month and Annuali-STAT Instrument Competency-Written Testi-STAT Cartridge Temperature Storage Logi-STAT Instrument Corrective Action Logi-STAT Instrument Validation Logi-STAT Record of Receipt-QC Documentation Logi-STAT Training GuidePOCT Inter-Laboratory Correlation ProcedurePOCT QC Storage Ordering and Documentation GuidePOCT Proficiency Testing ProcedurePOCT Proficiency Testing Evaluation Worksheeti-STAT CLEW update formPOCT EPIC Results Reporting Audit Guidelines

Title (with LTR): i-STAT Operations and Testing Procedure (LTR44806)Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 2/1/2018 12:00:03 PM)

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Contents:

Purpose................................................................................................................................................................... 2Scope ...................................................................................................................................................................... 2Policy and Procedure Statement............................................................................................................................. 2Proficiency Testing (ACT, PT/INR, CG4, CG8 Cartridges)..................................................................................... 2Regulatory Requirements ....................................................................................................................................... 3Competency Assessment ....................................................................................................................................... 3Limitations/Interferences ......................................................................................................................................... 4Test Kit/Supplies/Equipment ................................................................................................................................... 7Calibration ............................................................................................................................................................... 7Calibration Verification/Correlations........................................................................................................................ 8Electronic Quality Control........................................................................................................................................ 8Liquid Quality Control .............................................................................................................................................. 9Barcode Scanning................................................................................................................................................. 10Calculations........................................................................................................................................................... 10Reporting results ................................................................................................................................................... 10Preventive Maintenance........................................................................................................................................ 10Instrument Replacement Policy ............................................................................................................................ 11Troubleshooting .................................................................................................................................................... 11Alternative method ................................................................................................................................................ 12References............................................................................................................................................................ 12Reference Ranges ................................................................................................................................................ 12ACT (Kaolin) Cartridge Procedure ........................................................................................................................ 15CG8+, CG4+, and G3+ Cartridges Procedure ...................................................................................................... 18Creatinine Cartridge Procedure ............................................................................................................................ 22PT/INR Cartridge Procedure ................................................................................................................................. 25Chem 8+ Cartridge Procedure .............................................................................................................................. 29

Written By: Kim Gregory MT(ASCP) Date: 7/08 Nancy Toscano MT (ASCP) Date: 12/09 Caylee Cunningham, M (ASCP) Date: 6/16


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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.


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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 MarchMay 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 name2. Medical Record Number3. Patient’s gender4. Patient’s age or date of birth5. Date & time test collected, performed and reported6. Ordering Physician7. Responsible physician (if not 6)8. Reference or Target Range9. Test Performed10. Test units11. Lab name

III. Additional information that must be retained for four years:

1. Testing personnel records2. Quality control results 3. Product information (i.e. serial number, lot numbers, expiration dates, etc.), information on quality control

and any remedial action4. 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


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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

InterferencesAn 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

Bromide 37.5 mmol/L Increased (↑) i-STAT Sodium resultsSodium

Nithiodote (sodium thiosulfate)

16.7 mmol/L Increased (↑) i-STAT Sodium results

Bromide 37.5 mmol/L Increased (↑) rate of star (***) outsPotassium


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.

Chloride


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

BUN/Urea


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.

Glucose

PH Values < 7.4 @ 37°C Decrease (↓) glucose by 0.9 mg/dL per 0.1 pH units


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Values > 7.4 @ 37°C Decrease (↓) glucose by 0.8 mg/dL per 0.1 pH units

PO2 PO2 less than 20 mmHg @37°C

Decreased (↓) i-STAT Glucose results

Thiocyanate 6.9 mmol/L Decreased (↓) i-STAT Glucose results


16.7 mmol/L Decreased (↓) i-STAT Glucose results

WBC Grossly elevated Increased (↑) i-STAT hematocrit results

Total Protein/Lipids Increased TP or Lipids

Decreased (↓) i-STAT hematocrit results

Decreased TP


16.7 mmol/L Increased (↑) i-STAT Sodium results

Bromide 37.5 mmol/L Increased rate of star (***) outs

Hematocrit

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.


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

Ionized Calcium

(iCA)

Thiocyanate 6.9 mmol/L Decreased (↓) i-STAT Ionized Calcium results - use another method

PCO2 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

PO2

Cold cartridge Decreased (↓) i-STAT PO2 results

Exposure to air Decreased (↓) i-STAT TCO2 results TCO2

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

Creatinine

Bromide (therapeutic) 2.5 mmol/L Increase (↑) Creatinine results


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CO2 When Creat < 2mg/dL:

pCO2 >40 mmHg Increased (↑) Creat by 6.9%/10mmHg

pCO2 < 40 mmHg Decrease (↓) Creat by 6.9%/10mmHg

When Creat >2mg/dL:

pCO2 >40 mmHg Decrease (↓) Creat by 3.7%/10mmHg

pCO2 < 40 mmHg Increase (↑) Creat by 3.7%/10mmHg

Creatine 0.382 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.


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

Lactate

Hydroxyurea 100 μmol/L Use an alternative method to measure when patients have been administered hydroxyurea.

Incorrect handling Analyzer not maintained on a level surface during testing

Results may be affected by >10%

ACTExogenously added heparin, citrate, oxalate or EDTA

Heparinized syringe Will interfere with results

Cubicin (daptomycin for injection)

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

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.

Lupus Anticoagulant Antibodies

If the presence of lupus anticoagulant antibodies is known or suspected, use an alternate testing method.

PT/INR

Incorrect handling Analyzer not maintained on a level surface during testing

Erroneous results


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Test Kit/Supplies/Equipment

Product Vendor Manufacturer # Tests Storage requirement

I-STAT TRI Controls –Level 1Level 2Level 3

i-STAT05P71-00105P72-00105P73-001

Na, K, Cl, BUN, Glu, Crea, iCa, Lactate, pH, PCO2, PO2, TCO2, Hematocrit

Store at 2-8ºC

i-STAT TRI ControlsCalibration Verification

i-STAT 05P70-01

Na, K, Cl, BUN, Glu, Crea, iCa, Lactate, pH, PCO2, PO2, TCO2, Hematocrit

Store at 2-8ºC

Hyperbaric QC Eurotrol/Fisher NC0165448 High PO2 Room temperature

storage

CG8+ Cartridge i-STAT 03P88-25

Na, K, iCa, Glucose, pH, PCO2, PO2, calculated parameters: TCO2, HCO3, BE, sO2

See individual cartridge procedure

CG4+ Cartridge i-STAT 03P85-25Lactate, pH, PCO2, PO2,calculated parameters: TCO2, HCO3, BE, sO2


G3+ Cartridge i-STAT 03P78-25pH, PCO2, PO2,calculated parameters: TCO2, HCO3, BE, sO2


Chem 8+ Cartridge i-STAT 03P91-025

Na, K, Cl, BUN, Glu, Crea, iCa, TCO2, Hematocrit calculated parameters: Anion Gap, Hgb


Creatinine Cartridge i-STAT 03P84-25 CreatinineSee individual cartridge procedure

ACT Liquid ControlsLevel 1Level 2

i-STAT 06P17-1506P17-16

ACT (Kaolin)See individual cartridge procedure

ACT (Kaolin) Cartridge i-STAT 03P87-25 ACT (Kaolin)See individual cartridge procedure

PT/INR Cartridge i-STAT 03P89-24 PT/INRSee individual cartridge procedure

INR Liquid ControlsLevel 1Level 2

i-STAT06P17-1306P17-14

PT/INRSee individual cartridge procedure

Electronic simulator i-STAT 06F11-01 N/ARoom Temperature

Syringes 1 ml BD 309602Room Temperature

Syringes 3 ml Portex 4041Room Temperature

Luerlock syringe Portex 4042-2Room Temperature

I-STAT1 9V NiMH Battery

I-STAT 06F23-55Room Temperature

Calibration

Calibration is performed automatically as part of the test cycle on each cartridge type. Operator intervention is not necessary.


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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 instrument2. With each instrument that required major maintenance3. Every 6 months4. 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 thetests 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 15-20 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:


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1. The analyzer has been dropped2. Every six months after the CLEW software update3. 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:

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.

C. Thermal Probe Check

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 testing2. On every new lot number and every new shipment of cartridges3. When there’s a suspected cartridge or storage problem4. On any back up analyzer placed in use before patient testing5. 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


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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. Email: mghpoctcoordinators, pager: 35058

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


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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 instrument3. 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 testing6. 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: Email: mghpoctcoordinators, pager: 35058

3. 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 18-30° 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.


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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: Email: mghpoctcoordinators, pager: 35058. (This problem may have been caused by improper cartridge storage).

Technical support may be contacted 24 hours x 7 days at 1-800-366-8020.

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 2016B. Gornall, A.G.: Applied biochemistry of clinical disorders, Chapter 6, Respiratory Disorders, p. 94, 1980.C. Gradwohl’s Blood gas analysis and acid-base balance: Principles & Techniques, Chapter 17, p. 351, 1980.

Fleisher & Schwartz.D. Pesce, A. and Kaplan, Methods in Clinical Chemistry, C.V. Mosby Co., St. Louis, MO, 1987.E. Tietz, Norbert W., Editor, Fundamentals of Clinical Chemistry, W.B. Saunders Co., Philadelphia, PA, 1986.

Reference RangesThe tested ranges are those ranges that were tested during functional sensitivity and linearity testing.


13

*Clinical policy and Procedure Manual Laboratory Results: Guidelines for Retrieving and Reporting.

Test Reference RangeCritical Value Range(Approved by Med Poll

Committee)*

Analytical Range

Calcium, ionized 1.14 - 1.30 mmol/L <0.8 or >1.54 mmol/L 0.25 – 2.50

PCO2 (arterial, venous, mix, capillary) mmHg

Art: 14D, 35 - 42Art: 0 30 - 35

Ven: 38 - 50Mix: 35 - 50Cap: 35 - 42

<20 or >75 mmHg, first only (within past 24 hours)

5 - 130

pH (arterial, venous, mix, capillary)

Art: 7.35 - 7.45Ven: 7.30 - 7.40Mix: 7.32 – 7.45Cap: 7.35 – 7.45

<7.10 or >7.59 units, first only (within past 24 hours)

6.5 - 8.2

PO2 (arterial, venous, mix, capillary) mmHg

Art: 0-14 D: 60 - 80Art: >14 D: 80 - 100

Mix: 40 - 90Ven: 35 - 50Cap: 45 - 60

<40 mmHg

5 - 800

Glucose (Adult) 70-110 mg/dL <50 or >400 20 - 700

Glucose, plasma (newborn) 60-100 mg/dL <40 or >500 mg/dL 20 - 700

PotassiumAdult: 3.4 – 4.8 mmol/L<1 mo: 4.0 - 5.6 mmol/L <2.8 or >6.0 mmol/L

2 - 9

Sodium 135 - 145 mmol/L <120 or >160 mmol/L 100 - 180

Chloride 100 – 108 mmol/L None 65 - 140

Lactate 0.5- 2.2 mmol/L None 0.30 - 20.0

TCO2Adult: 23.0 – 32 mmol/L

14 days-1 yr: 22.0 – 27.0 mmol/L<14 days: 19.0 – 22.0 mmol/L

<11.0 or >40.0 mmol/L5 - 50

Urea Nitrogen/BUN 8 - 25 mg/dL None 3 - 140

Hematocrit 41.0 – 53.0%>56% within 30 days

< or = 20% within 30 days10 – 75 %PCV

Hemoglobin (calculated) 12.0 – 16.0 gm/dL <7.0 3.4 – 25.5

Anion Gap (calculated) 10 – 20 mmol/L None (-10) – (+99)

HCO3 (calculated)> 1 year: 24 - 30 mmol/L

14 days-1 yr: 22 - 27 mmol/L0 - 14 days: 19 - 22 mmol/L

None1.0 - 85.0

BE (calculated) None None (-30) - (+30)

SO2 (calculated) None None 0 - 100

PT/INR PT 11.0-13.7 sec (age 6 months to adult); PT-INR values for Warfarin Anti-Coag Therapy: Standard Intensity 2.0-3.0; High Intensity 2.5-3.5EP 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

INR >5 POCTINR >5 Core Lab

0.9-8.0

Creatinine 0.6-1.5 mg/dL<10 yr: 0.3-1.0 mg/dL

None 0.5-14.0


14

Patient Addressograph

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.

To remain in the Medical Record Reviewed by: K Lewandrowski, MD Date: 2/2/10

Location Qualifier or Description

Typical Target RangeUsed at MGH

Neuro-Radiology Target Range is patient-specific and

subject to physician’s discretion

during the case.

1.5-2.0 times the baseline value.

EP laboratory 250-330 seconds

Respiratory: The Target Range is determined for

each patient in the doctor’s order.

200-220 seconds with an upper limit of

240 seconds

Catheterization Lab The Target Range is procedure and

patient-specific.

Interventional Catheterizations: 170-200 (upper limit 230) for patients on

platelet G2b-3a inhibitors and 200-220

(upper limit 240) for patients off platelet

G2b-3a inhibitors

Patients undergoing Diagnostic

Catheterizations

Patient will receive 0-4000 units heparin,

regardless of ACT level.

Cardiac Surgery:Target ranges may vary with

procedure.

Baseline: 90 - 130 seconds

Therapeutic heparin drip: 160 - 180 seconds

(or 2 - 2.5 control aPTT + 100 seconds to

convert to an ACT value)

On Cardiopulmonary bypass

regardless of the surgical procedure:>450 seconds

Off Cardiopulmonary bypass CABG: >400 seconds

Therapeutic bivalirudin for CPB: Initial ACT: >400 seconds


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 four-window 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.


16

B. Room Temperature Cartridges:

Cartridges at room temperature 18 to 30°C (64 to 86 °F) are good for 14 days. Mark theroom 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.


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 observation2. Supervisor monitoring of the recording and reporting of test results3. Supervisor review of intermediate test results, QC, proficiency tests, and preventative

maintenance performance4. Successful performance of instrument maintenance function checks and calibration, verified by direct

observation5. Testing previously analyzed samples, proficiency testing samples, internal blind testing samples6. 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 CaCl2 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 minute5. 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 key3. Press the Menu key4. 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.


17

5. Press 1 to select Control.6. Press “Scan” to scan Operator ID7. Press “Scan” to scan Control Lot number8. 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 2.11. Results will appear. At the bottom of one of the result pages, you will see 1- Test Options

Select 1.12. You will now have the following options:

1- Next level2- Repeat level3- History

Using these options will allow you to continue your Quality Control testing without having to start again at the top of the QC menu.

Control Evaluation:

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 Email: mghpoctcoordinators, pager: 35058. 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 thecalibrant 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.


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, pCO2, and pO2, while calculating values for hemoglobin, TCO2, HCO3, BE and sO2. The CG4+ cartridge directly measures pH, pCO2, and pO2, and lactate and calculates values for TCO2, HCO3, BE and sO2. The G3+ is similar to the CG4+, except that lactate is not measured.

Sodium, Potassium, Ionized Calcium, pH, and pCO2

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. pCO2, along with pH, is used to assess acid-base balance. pCO2 is the respiratory component of acid-base

balance. pCO2 represents the balance between cellular production of CO2 and ventilatory removal of CO2. Causes of primary respiratory acidosis (increase in pCO2) 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. pO2, a measurement of the pressure of oxygen dissolved in the blood, is measuredamperometrically. The oxygen permeates through a gas permeable membrane from the sampleinto an internal electrolyte solution where it is reduced at the cathode. The oxygen reductioncurrent is proportional to the dissolved oxygen concentration.Decreased pO2 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:


19

Fresh whole blood collected in a plain capillary collection tube or capillary collection tube balanced with heparin

Fresh whole blood collected in a collection tube with lithium or sodium heparin. Fill tube to capacity Fresh whole blood collected in a plain plastic syringe or in a blood gas syringe.

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 the measurement of ionized calcium Other sample types such as urine, CSF and pleural fluid

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 Exposing the sample to air when measuring pH, PCO2 and PO2


Verification of Cartridge Storage Conditions during Shipment On receipt of new cartridges, verify that the transit temperatures were satisfactory using the four-

window 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 /QC Documentation Log that comes with each box

and attach the receipt with strip, in the space shown on the 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


cartridges should stand at room temperature for one

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.

B. Room temperature cartridges: Cartridges at room temperature 18 to 30°C (64 to 86 °F) are good for 2 months. 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 2 month room temperature stability to the site coordinator


C. i-STAT Tri-Controls Level 1, 2, and 3

Store at 2 to 8 C. Do not use after expiration date on box and ampoules.


20

Aqueous liquid controls used for oxygen measurement must stand at room temperature a minimum of 4 hours before use. Controls used for all other analytes must equilibrate for 30 minutes at room temperature.

Record date and time removed from refrigeration. Aqueous liquid controls expire 5 days after removal from refrigeration.


All operators must read the procedure manual and complete the “Operator Training Checklist” after initialtraining. For Blood Gases and Lactate, the competency assessment process is done following initial training, after 6 months during the first year, then annually thereafter.


1. Successful performance of routine patient testing, verified by direct observation2. Supervisor monitoring of the recording and reporting of test results3. Supervisor review of intermediate test results, QC, proficiency tests, and preventative maintenance

performance4. Successful performance of instrument maintenance function checks and calibration, verified by direct

observation5. Testing previously analyzed samples, proficiency testing samples, or internal blind testing samples.6. Assessment of problem-solving skills

Quality Control


i-STAT Tri-Controls Level 1, 2, and 3

1. Aqueous liquid controls require different temperature stabilization times depending on whether or not oxygen is to be measured. If oxygen is to be measured, equilibrate the ampoule for 4 hours. If not, equilibrate the ampoule for approximately 30 minutes at room temperature.

2. Hold the ampoule at the top, bottom (with forefinger and thumb), and shake 15-20 times (about 10 seconds) to mix the solution. Tap the ampoule to restore the liquid to the bottom of the ampoule.

3. Open the ampoule by snapping off the tip. Protect fingers with gauze or use an ampoule breaker.4. Immediately transfer control to syringe as follows: Use a clean 3 mL syringe. Replace attached needle with

a 19-gauge blunt tip needle.5. Aspirate the control from the ampoule into the syringe. Be careful that air is not drawn in with the liquid.

Expel one or two drops of liquid before filling the cartridge. If desired, you may detach the blunt tip needle before filling the cartridge.

6. Immediately transfer the solution into a cartridge.7. Immediately seal the cartridge and insert it into an analyzer.8. Do not use the solution left in a syringe or ampoule for additional testing of cartridges that contain sensors

for ionized calcium, pH, PCO2, or PO2. Open a new ampoule.Running the controls:



5. Press 1 to select Control.6. Press “Scan” to scan Operator ID7. Select 1-APOC for Fluid Vendor8. Select Fluid Level9. Press “Scan” to scan Control Lot number

10. Press “Scan” to scan the cartridge lot number from the cartridge pouch.11. Fill cartridge with the control (see below). Insert cartridge.12. Enter 1 for i-STAT Level 1. Enter 2 for i-STAT Level 2.


21

13. Results will appear. At the bottom of one of the result pages, you will see 1- Test Options Select 1.

14. You will now have the following options:1- Next level2- Repeat level3- History


Control Evaluation:


2. The operator performing the quality controls is responsible for evaluating the controls andperforming any necessary corrective actions. If the results are out of range, corrective actionmust 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 whenfinished.

4. The result statistics will be reviewed monthly by the Medical director or Designee.



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 the 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 - Email: mghpoctcoordinators, pager: 35058. An investigation will be done to determine the cause of failure.

Testing Procedure1. Follow hand hygiene protocol and put on gloves.


3. Scan or enter the operator ID and patient’s CSN. Repeat if prompted.



6. Following thorough mixing of the sample, direct the dispensing tip or capillary tube containing theblood into the sample well and dispense the sample until it reaches the fill mark on the cartridgeand the well is about half full.


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.




Patient temperature can be entered as degrees Centigrade or Fahrenheit FIO2 can be entered as the numbers of liters or as a percentage of oxygen a patient is receiving Press the → key to return to the results page




Documentation


22


Creatinine Cartridge Procedure

Creatinine is measured amperometrically. Hydrogen peroxide, which is produced through various enzymatic reactions within the cartridge, is oxidized at the platinum electrode to produce a current which is proportional to the sample creatinine concentration. Elevated levels of creatinine are mainly associated with abnormal renal function and occur whenever there is a significant reduction in glomerular filtration rate or when urine elimination is obstructed.

Specimen Collection

Suitable Specimens for measuring creatinine:

Venous whole blood collected in a collection tube with lithium or sodium heparin. Fill tube to capacity

Criteria for Specimen Rejection:

Evidence of clotting Specimens collected in a syringe Specimens collected in vacuum tubes with anticoagulant other than lithium or sodium heparin Other sample types such as urine, CSF and pleural fluid



23



window 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


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


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.


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 Tri-Controls, Levels 1 and 3

Store at 2° to 8 C. Do not use after expiration date on box and ampules. Aqueous liquid controls used for oxygen measurement must stand at room temperature a minimum

of 4 hours before use. Controls used for all other analytes must equilibrate for 30 minutes at room temperature.



All operators must read the procedure manual and complete the “Operator Training Checklist” after initialtraining. Competency is assessed at orientation and annually using at least two of the following methods:

1. Performing a test on a blind specimen.2. Supervisor observes performance of routine work.3. Each user’s quality control performance is monitored.4. Written testing specific to the method.

Quality Control

Prior to performing quality control, determine if additional control material preparation is required.

i-STAT Tri-Controls Levels 1 and 3

1. Aqueous liquid controls require different temperature stabilization times depending on whether or not oxygen is to be measured. If oxygen is to be measured, equilibrate the ampoule for 4 hours. If not, equilibrate the ampoule for approximately 30 minutes at room temperature.

2. Hold the ampoule at the top, bottom (with forefinger and thumb), and shake 15-20 times (about 10 seconds) to mix the solution. Tap the ampoule to restore the liquid to the bottom of the ampoule.


24

3. Open the ampoule by snapping off the tip. Protect fingers with gauze or use an ampoule breaker.4. Aspirate the control from the ampoule into a clean 3 ml syringe, until it is half full.5. Expel three drops of liquid before filling the cartridge6. Immediately transfer the solution into a cartridge.7. Immediately seal the cartridge and insert it into an analyzer.




5. Press 1 to select Control.6. Press “Scan” to scan Operator ID7. Press “Scan” to scan Control Lot number8. Press “Scan” to scan the cartridge lot number from the cartridge pouch.9. Fill cartridge with the control (see below). Insert cartridge.

10. Enter 1 for i-STAT Level 1. Enter 3 for i-STAT Level 3.11. Results will appear. At the bottom of one of the result pages, you will see 1- Test Options

Select 1.12. You will now have the following options:



Control Evaluation:


2. The operator performing the quality controls is responsible for evaluating the controls andperforming any necessary corrective actions. If the results are out of range, corrective action must be documented on the Record of Receipt /QC Documentation Log.




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 the Record of Receipt /QC Documentation Log4. If new control solutions fail a second time, analyzer, control solutions and cartridges should be pulled from

use and the POCT program notified Email: mghpoctcoordinators, pager: 35058. An investigation will be done to determine the cause of failure.

Testing Procedure

Note: Use only VENOUS blood collected in a Sodium or Lithium Heparin tube for Creatinine testing!!





25



6. Following thorough mixing of the sample, direct the dispensing tip into the sample well and dispense the sample until it reaches the fill mark on the cartridge and the well is about half full.


8. Insert the cartridge into the cartridge port until it clicks into place.



Choose the number corresponding to the type of sample used when prompted at the Sample Type field. Patient temperature can be entered as degrees Centigrade or Fahrenheit Press the → key to return to the results page.




Documentation


PT/INR Cartridge Procedure

The i-STAT® PT/INR test is a whole blood determination of the prothrombin time used for monitoring oralanticoagulant (warfarin) therapy. The test determines the time required for complete activation of theextrinsic pathway of the coagulation cascade when initiated (activated) with a thromboplastin.The PT/INR test result is reported as an International Normalized Ratio (INR) and, optionally, in seconds. TheINR is the recommended method of result reporting for monitoring of oral anticoagulant therapy.

Specimen Collection

Suitable Specimens for PT/INR Fresh whole blood without anticoagulant collected in a plastic syringe or plastic evacuated tube without

clot activators or serum separators. Device used to transfer sample to cartridge must be plastic. Fresh capillary whole blood dispensed directly into the cartridge from the finger

Criteria for Specimen Rejection Contamination with Chlorahexadine Gluconate Evidence of clotting Specimens collected in glass syringes or tubes or with anticoagulant of any kind Other sample types such as urine, CSF, and pleural fluid


26

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


Verification of Cartridge Storage Conditions during Shipment

On receipt of new cartridges, verify that the transit temperatures were satisfactory using the four-window 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




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.


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


C. i-STAT PT/INR 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.


All operators must read the procedure manual and complete the “Operator Training Checklist” after initialtraining. For PT/INR, the competency assessment process is done following initial training, after 6 months during the first year, then annually thereafter.


1. Successful performance of routine patient testing, verified by direct observation2. Supervisor monitoring of the recording and reporting of test results


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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 testing samples.6. Assessment of problem-solving skills

Quality Control



PT/INR Control Level 1 and Level 2

1. i-Stat PT/INR 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 CaCl2 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 minute5. 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 PT/INR cartridge. NOTE: additional PT/INR cartridges may be tested with the remaining fluid if used within 30 seconds of complete reconstitution of the sample.




5. Press 1 to select Control.6. Press “Scan” to scan Operator ID7. Press “Scan” to scan Control Lot number8. Press “Scan” to scan the cartridge lot number from the 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 2.11. Results will appear. At the bottom of one of the result pages, you will see 1- Test Options12. Select 1.13. You will now have the following options:


Using these options will allow you to continue your Quality Control testing without having to start again at the top of the QC menu.Control Evaluation:





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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 Log4. If new control solutions fail a second time, analyzer, control solutions and cartridges should be pulled from

use and the POCT program notified Email: mghpoctcoordinators, pager: 35058. An investigation will be done to determine the cause of failure.

Testing Procedure

Caution: The i-STAT PT/INR cartridge is designed to accept a sample between 20 and 45 micro liters.A single drop of blood from either a finger puncture or as formed at the tip of a syringe will typically be within this range. If a larger volume is delivered to the sample well, use caution when closing the cartridge as excess blood may be expelled from the cartridge. The i-STAT PT/INR test can be performed using capillary or venous samples.

Finger Stick:





5. Remove cartridge from foil pouch and place the cartridge on a flat surface Avoid touching the contact pads or exerting pressure over the calibrant pack in the center of the cartridge.

6. Prepare lancet device and set aside until needed.

7. Clean and prepare the finger to be sampled. Allow finger to dry thoroughly before sampling.

8. Prick the bottom side of the fingertip with the lancet device.

9. Gently squeeze the finger, developing a hanging drop of blood and perform the test with the first drop of blood. Avoid strong repetitive pressure (“milking”) as it may cause hemolysis or tissue fluid contamination of the specimen.

10. Touch the drop of blood against the bottom of the sample well. Once in contact with the sample well, the blood will be drawn into the cartridge.

11. Apply sample until it reaches the fill mark indicated on the cartridge.

12. Fold the sample closure over the sample well.

13. Press the rounded end of the closure until it snaps into place.

14. Insert the cartridge into the cartridge port until it clicks into place. When using a PT/INR cartridge, the analyzer must remain on a level, vibration-free surface with the display facing up during the testing cycle.




Patient temperature can be entered as degrees Centigrade or Fahrenheit

FIO2 can be entered as the numbers of liters or as a percentage of oxygen a patient is receiving

Press the → key to return to the results page




Venipuncture:

If chlorahexadine gluconate is used for skin cleansing, a waste tube must be drawn prior to collection of the POCT sample due to interference with the i-STAT method.


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Collection technique resulting in good blood flow must be used. The sample for testing should be drawn into a plastic collection device (either a plastic syringe or

plastic evacuated tube). The collection device cannot contain anticoagulants such as heparin, EDTA, oxalate, or citrate. The collection device cannot contain clot activators or serum separators. If a second measurement is required, a fresh sample should be obtained.





5. Remove cartridge from foil pouch and place the cartridge on a flat surface Avoid touching the contact pads or exerting pressure over the calibrant pack in the center of the cartridge.

6. Apply sample until it reaches the fill mark indicated on the cartridge.

7. Fold the sample closure over the sample well.

8. Press the rounded end of the closure until it snaps into place.

9. Insert the cartridge into the cartridge port until it clicks into place. When using a PT/INR cartridge, the analyzer must remain on a level, vibration-free surface with the display facing up during the testing cycle.




Patient temperature can be entered as degrees Centigrade or Fahrenheit

FIO2 can be entered as the numbers of liters or as a percentage of oxygen a patient is receiving

Press the → key to return to the results page




Documentation


Chem 8+ Cartridge Procedure

The Chem 8+ cartridge is designed to directly measure glucose, sodium, potassium, chloride, BUN, creatinine, ionized calcium, TCO2 and hematocrit, while calculating values for hemoglobin and anion gap


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Sodium, Potassium, Chloride, Ionized Calcium, BUNThese 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. Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.

3. 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.

4. Blood urea nitrogen (BUN) measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

5. 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.

6. Hematocrit is determined conductometrically. The measured conductivity, after correction for electrolyte concentration, is inversely related to the hematocrit. Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status including, but not limited to, conditions such as anemia, erythrocytosis, and blood loss related to trauma and surgery.

7. The measured TCO2 test method is calibrated to the International Federation of Clinical Chemistry (IFCC) TCO2 reference method1 with an algorithm, based on the Henderson-Hasselbalch equation, which uses pH, PCO2, and ionic strength (Na) measurements. Carbon dioxide is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Specimen Collection

Suitable Specimens:

Venous whole blood collected in a collection tube with lithium or sodium heparin. Fill tube to capacity.

Criteria for Specimen Rejection:

Evidence of clotting Specimens collected in a syringe Specimens collected in vacuum tubes with anticoagulant other than lithium or sodium heparin Other sample types such as urine, CSF and pleural fluid




window 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.


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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



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.

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


C. i-STAT TriControls Levels 1 and 3: Store at 2 to 8 C. Do not use after expiration date on box and ampoules. Aqueous liquid controls used for oxygen measurement must stand at room temperature a minimum

of 4 hours before use. Controls used for all other analytes must equilibrate for 30 minutes at room temperature.



All operators must read the procedure manual and complete the “Operator Training Checklist” after initialtraining. Competency is assessed at orientation and annually using at least two of the following methods:

1. Performing a test on a blind specimen.2. Supervisor observes performance of routine work.3. Each user’s quality control performance is monitored.4. Written testing specific to the method.

Quality Control



Tri-Controls Level 1 and Level 3




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5. Press 1 to select Control.6. Press “Scan” to scan Operator ID7. Press “Scan” to scan Control Lot number8. Press “Scan” to scan the cartridge lot number from the box or manually enter the number using

the keypad and press Enter.9. Dispense a drop of sample directly from the vial into the i-STAT Chem 8+ cartridge and seal the

cartridge. Insert cartridge.10. Enter 1 for i-STAT Level 1. Enter 2 for i-STAT Level 2, etc.11. Results will appear. At the bottom of one of the result pages, you will see 1- Test Options12. Select 1.13. You will now have the following options:



Control Evaluation:



3. If all results are within expected ranges, use the cartridges as needed. Transmit the results when finished.



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 Log4. If new control solutions fail a second time, analyzer, control solutions and cartridges should be pulled from

use and the POCT program notified Email: mghpoctcoordinators, pager: 35058. An investigation will be done to determine the cause of failure

Testing Procedure

1. Follow hand hygiene and put on gloves.





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.


8. Insert the cartridge into the cartridge port until it clicks into place.




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a. Choose the number corresponding to the type of sample used when prompted at the Sample Type field.

b. Patient temperature can be entered as degrees Centigrade or Fahrenheit

11. Press the → key to return to the results page.




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

title: i-stat operations and testing procedure cross ... operations and...electronic quality control...

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