ABBOTT LABORATORIES

i-STAT Procedure Manual Oct 2015

Procedure Manual

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

Procedure Manual for the i-STAT® System

This Procedure Manual is intended to be a template for the Procedure Manual required by CLIA and laboratory accreditation bodies. This Procedure Manual should be customized for site-specific policies and procedures. This Procedure Manual is not intended to replace the System Manual.

i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions.

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ART: 714446-00T

PROCEDURE MANUAL FOR THE i-STAT SYSTEM CONTENTS SYSTEM OVERVIEW ... 1 i-STAT 1 Analyzer Analysis Time Cartridges Central Data Station or Data Manager SUPPLIES AND STORAGE REQUIREMENTS ...1-2 Cartridges Controls BLOOD SPECIMENS ...2-5 Blood Collection Equipment Blood Volume Suitable Specimens Specimen Labeling Specimen Collection and Handling Criteria for Specimen Rejection Precautions PROCEDURE FOR ANALYSIS ...5-10 Preparation for Use Customizing the i-STAT Handheld to Run i-STAT Cartridges Procedure for Cartridge Testing Alternative Procedure RESULTS ...11-18 Calculations Displayed Results Suppressed Results Printing and Transmitting Results Reference Ranges, Reportable Ranges, and Test Unit Conversion Critical Results Interferences QUALITY CONTROL ...19-25 Daily Procedures Monthly Procedures Periodic Procedures for Cartridges CALIBRATION ... 25 CLINICAL SIGNIFICANCE ...26-29 PRINCIPLES OF MEASUREMENT...30-32 REFERENCES ... 32 LOGS ... i-vi

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

SYSTEM OVERVIEW The i-STAT System incorporates comprehensive components needed to perform blood analysis at the point of care. The system consists of the following primary components: i-STAT 1 Analyzer When a sample-filled i-STAT cartridge is inserted into the i-STAT 1 handheld for analysis, the handheld automatically controls all functions of the testing cycle, including fluid movement within the cartridge, calibration, and continuous quality monitoring. Analysis Time  ACT cartridge: to detection of end point – up to 1000 sec (16.7 min) 

PT/INR cartridge: to detection of end point – up to 300 sec (5 min)



cTn, BNP, and Total β-hCG cartridges: 600 sec (10 min)



CK-MB Cartridge: 300 sec (5 min)



Other cartridges: typically 130 to 200 sec

Cartridges A single-use disposable cartridge contains micro-fabricated sensors, a calibrant solution, fluidics system, and a waste chamber. Sensors for analysis of pH, PCO2, PO2, TCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, creatinine, urea nitrogen (BUN) and hematocrit are available in a variety of panel configurations. Cartridges are also available for Celite-ACT, Kaolin-ACT, PT/INR, Troponin I/cTnI, CK-MB, BNP, and Total β-hCG (Table 1). A whole-blood sample of approximately 1 to 3 drops is dispensed into the cartridge sample well, and the sample well is sealed before inserting it into the analyzer. Central Data Station or Data Manager A dedicated desktop computer with the i-STAT Central Data Station application provides the primary information management capabilities for the i-STAT System. Downloaders and Downloader/Rechargers for the i-STAT 1 Analyzer allow for transmission of patient records from a widely distributed network of handhelds to the Central Data Station application. Data can be stored, organized, edited, and transferred to a laboratory information system or other computer system. Cartridge usage and efficiency reports can be generated for management of the system.

SUPPLIES and STORAGE REQUIREMENTS Cartridges Cartridges are sealed in individual pouches or portion packs. Store the main supply of cartridges at a temperature between 2 and 8 °C (35 to 46 °F). Do not allow cartridges to freeze. Cartridges may be stored at room temperature (18 to 30 °C, or 64 to 86 °F) for the time frame indicated on the cartridge box. Cartridges should not be returned to the refrigerator once they have been at room temperature, and they should not be exposed to temperatures above 30 °C (86 °F). If the pouch has been punctured, the cartridge should not be used. Write the date on the cartridge box or individual cartridge pouches to indicate the room temperature expiration date. Cartridges should remain in pouches until the time of use. Do not use after the labeled expiration date. Note: See the Check Temperature Monitor section for information regarding the four-window temperature indicator included with cartridges for transit.

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Controls i-STAT Controls, i-STAT CHEM8+ Controls, and i-STAT TriControls for blood gases, electrolytes, and chemistries Store at 2 to 8 °C (35 to 46 °F). Controls may be stored at room temperature (18 to 30 °C, or 64 to 86 °F) for five days. Do not use after expiration date on the box and ampules. i-STAT Controls for ACT and PT/INR Store at 2 to 8 °C (35 to 46 °F). Do not use after expiration date on the box and vials. Controls should be used immediately after reconstitution. i-STAT Controls for cTnI , BNP, CK-MB, and β-hCG These controls require no reconstitution or frozen storage. They are stable until the expiration date on the vial label when stored unopened at 2 to 8 °C (35 to 46 °F). Once opened, the i-STAT cTnI, BNP, CK-MB, and β-hCG Controls are stable for 30 days when stored tightly capped at 2 to 8 °C. RNA Medical Hematocrit Control RNA Medical Hematocrit Control is stable until the expiration date stated on the ampule when stored at a temperature of 2 to 25 °C (35 to 77 °F). Do not freeze or expose ampules to temperatures greater than 30 °C (86 °F). If stored refrigerated, the control material should be equilibrated to room temperature for at least 4 hours prior to testing. Electronic Simulator Store at room temperature and protect contact pads from contamination by replacing the plastic cap and placing the Electronic Simulator in its protective case after use.

BLOOD SPECIMENS Blood Collection Equipment Cartridges for Blood Gas/Electrolytes/Chemistries/Hematocrit  Skin puncture: lancet and capillary collection tube (plain, lithium heparin, or balanced heparin for electrolytes and blood gases)  Venipuncture: lithium or sodium heparin collection tubes and disposable transfer device.  Arterial puncture: Plain syringe or blood gas syringe with heparin and labeled for the assays performed or with the least amount of heparin that will prevent clotting (10 U heparin/mL of blood) Cartridges for ACT  Skin puncture: not recommended  Venipuncture and arterial puncture: plain plastic syringe without anticoagulant Cartridges for PT/INR  Skin puncture: lancet only needed. Cartridge can be filled directly from the finger.  Venipuncture: plain plastic syringe without anticoagulant. Cartridges for Troponin I/ cTnI and CK-MB  Skin puncture: not recommended.  Venipuncture: lithium or sodium heparin collection tubes and disposable transfer device (e.g., 1 cc syringe and a 16 to 20 gauge needle). Alternately, a plain syringe or plain collection tube and disposable transfer device can be used if the sample is tested within one minute of patient draw. Cartridges for BNP  Skin puncture: not recommended.  Venipuncture: plastic EDTA collection tubes and disposable transfer device or plastic EDTA syringe. Cartridges for Total β-hCG  Skin puncture: not recommended.  Venipuncture: plastic collection tubes or syringes with lithium or sodium heparin and a disposable transfer device, e.g., a 1 cc syringe and a 16 to 20 gauge needle.

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 

     

   

    

Anion Gap

BNP

Total β-hCG

cTnI

CK-MB

PT/INR

  

     

SO2

 

TCO2

   

     



    

HCO3

   

ACT



TCO2



Hct

 

Lact

  

Creat



Glu

   

BUN

   

    

iCa

     

PO2

95 95 95 95 95 95 65 65 65 65 65 65 40 20 17 17 17

Vol. (L)

CHEM8+ CG8+ EG7+ EG6+ CG4+ G3+ EC8+ 6+ EC4+ E3+ G Crea ACT PT/INR cTnI CK-MB BNP Total β-hCG

PCO2

Cartridge

Blood Volume (See Table 1) Table 1: Cartridge Panel Configurations and Blood Volume (Shading denotes calculated values)



   



   

       

Suitable Specimens Suitable Specimens for Cartridges for Blood Gases, Electrolytes, Chemistries, and Hematocrit  Fresh whole blood collected in plain capillary collection tube or capillary collection tube with balanced heparin.  Fresh whole blood collected in a collection tube with lithium or sodium heparin anticoagulant. Fill collection tubes to capacity.  Fresh whole blood collected in a plain plastic syringe or in a blood gas syringe labeled for the assays to be performed. Fill syringes for correct blood-to-heparin ratio. Suitable Specimens for ACT  Fresh whole blood without anticoagulant collected in a plastic syringe. If from an indwelling line, flush the line with 5mL saline and discard the first 5mL of blood or six dead space volumes of the catheter.  Fresh whole blood collected in a plastic tube without anticoagulant, clot activators, or serum separators. Device used to transfer sample to cartridge must be plastic. 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. Suitable Specimens for Troponin I/cTnI and CK-MB  Fresh heparinized whole blood or plasma samples collected in syringes or evacuated tubes containing lithium or sodium heparin. Fill collection tube to capacity.  Non heparinized whole blood samples tested within one minute of patient draw collected into a plastic syringe or plastic evacuated tube containing no additives. Suitable Specimens for Total β-hCG  Fresh heparinized whole blood or plasma samples collected in plastic syringes or evacuated tubes containing lithium or sodium heparin. Fill collection tubes to capacity. Suitable Specimens for BNP  EDTA whole blood plasma samples collected in plastic syringes or evacuates tubes containing EDTA. Fill collection tubes to capacity.

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Specimen Labeling Unless the specimen is analyzed immediately after collection and then discarded, the specimen container must be labeled with the following information: Patient name, sex, age Patient ID number Time and date of collection Phlebotomist ID Doctor’s name Specimen Collection and Handling In-Dwelling Line Back flush line with sufficient amount of blood to remove intravenous solution, heparin, or medications that may contaminate the sample. Recommendation: five to six times the volume of the catheter, connectors, and needle. If collecting sample for ACT, clear the line first with 5mL saline and discard the first 5mL of blood or six dead space volumes of the catheter. Arterial Specimens For cartridge testing of blood gases, electrolytes, chemistries, and hematocrit, fill a plain syringe or fill a blood gas syringe, labeled for the assays to be performed, 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 results due to dilution and will decrease ionized calcium results due to binding. For ionized calcium, balanced or low volume heparin blood gas syringes should be used. Do not expose sample to air or PCO2 may decrease, pH may increase and PO2 may decrease if the value is above or increase if the value is below the PO2 of room air (approximately 150 mmHg). For cartridge testing of ACT, use only a plain, plastic syringe without anticoagulant. Mix blood and anticoagulant by rolling syringe between palms for at least 5 seconds each in two different directions, then invert the syringe repeatedly for at least 5 seconds. Discard the first two drops of blood. For blood gas testing, avoid or remove immediately any air drawn into syringe to maintain anaerobic conditions. Test samples collected without anticoagulant immediately. Test samples for ACT and lactate immediately. For pH, blood gases, TCO2 and ionized calcium, test within 10 minutes of collection. If not tested immediately, remix the sample and discard the first two drops of blood from a syringe before testing. Note that it may be difficult to property remix a sample in a 1.0 cc syringe. For other cartridge tests, test sample within 30 minutes of collection. Venous Specimens For cartridge testing of electrolytes, chemistries, and hematocrit, collect sample into an evacuated blood collection tube or a syringe containing sodium, lithium, or balanced heparin anticoagulant. For ionized calcium measurements, balanced heparin or 10 U of sodium or lithium heparin/mL of blood is recommended. Fill tubes to capacity; fill syringes for correct heparin-to-blood ratio. Incomplete filling causes higher heparin-to-blood ratio, which will decrease ionized calcium results and may affect other results. The use of partial-draw tubes (evacuated tubes that are adjusted to draw less than the tube volume, e.g., a 5 mL tube with enough vacuum to draw only 3 mL) is not recommended for blood gas or CHEM8+ cartridges because of the potential for decreased PCO2, HCO3 and TCO2 values. For cartridge testing of Total β-hCG, use only heparinized whole blood or plasma samples collected in plastic syringes or evacuated tubes containing lithium or sodium heparin, filled to capacity. For cartridge testing of ACT or PT/INR, use only a plain, plastic syringe or collection tube containing no anticoagulant. Use a plastic capillary tube, pipette, or syringe to transfer sample from a tube to a cartridge. For glucose cartridge testing, EDTA is also an acceptable anticoagulant. EDTA is the only acceptable anticoagulant for BNP Cartridge testing.

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Mix blood and anticoagulant by inverting a tube gently at least ten times. Roll a syringe vigorously between the palms for at least 5 seconds each in two different directions, then invert the syringe repeatedly for at least 5 seconds, then discard the first two drops of blood. Note that it may be difficult to properly mix a sample in a 1 cc syringe. Test Sample collected without anticoagulant immediately. Test samples for ACT, lactate and PT/INR immediately. Test samples for pH, PCO2, TCO2 and ionized calcium within 10 minutes of sample draw. If not tested immediately, remix the sample before testing and discard the first two drops of blood from a syringe before testing. For other cartridge tests, test sample within 30 minutes of collection. Finger and Heelstick Specimens For tests other than PT/INR, wipe away the first drop of blood, which contains excess tissue fluid which can increase the potassium result and decrease other test results. Avoid drawing air into the capillary tube. Use balanced heparin or plain capillary tubes for ionized calcium. Test samples immediately to avoid clotting (especially in neonates). Capillary samples are NOT recommended for ACT, Troponin I/cTnI, CK-MB, BNP and Total β-hCG. Criteria for Specimen Rejection      

Evidence of clotting Specimens collected in vacuum tubes with anticoagulant other than lithium or sodium heparin (or EDTA for BNP or glucose cartridges) Specimens for ACT or PT/INR collected in glass syringes or tubes or with anticoagulant of any kind Syringe for pH, PCO2, PO2 and TCO2 with air bubbles in sample Incompletely filled vacuum tube for the measurement of ionized calcium, PCO2, HCO3 or TCO2 Other sample types such as urine, CSF, and pleural fluid

Precautions: 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, especially lactate, ACT, and PT/INR Exposing the sample to air when measuring pH, PCO2, PO2 and TCO2

PROCEDURE FOR ANALYSIS Preparation for Use An individual cartridge may be used after standing 5 minutes, in its pouch, at room temperature. An entire box should stand at room temperature for one hour before cartridges are used.

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

Customizing the i-STAT Handheld to Run i-STAT Cartridges Before testing barcoded cartridges, the i-STAT 1 handheld must be customized for the following options:  

Cartridge Information First Required, AND Cartridge Lot Number Required

The procedure to customize the handheld varies, depending on whether the customization is being done directly using the handheld’s keypad, or whether it is being done through the Customization Workspace in Central Data Station (CDS) Version 5 or i-STAT/DE.   

Users who do not have CDS Version 5 or i-STAT/DE  Proceed to Section A Users who have CDS Version 5 or i-STAT/DE  Proceed to Section B Users who have i-STAT/DE  Proceed to Section C

A. Customizing the Handheld for Cartridge Testing Using the Handheld Keypad Cartridge use requires operators to turn on the handheld, enter an Operator ID and a Patient ID, and then scan the cartridge lot number before inserting a cartridge into the handheld for testing. To customize the handheld: 1.

Press

to turn on handheld.

Press

to change screen to Administration Menu.

Press

(Customization).

Press

(Change).

Press

(No password is required).

Press

(Patient Tests).

Press

(Cartridge Information).

Press

to change setting to “Required”.

Press

(Cartridge Lot Number).

10.

Press

to change setting to “Required”.

11.

Both “Cartridge Information” and “Cartridge Lot Number” should now appear on display as “Required”.

12.

Press

to turn handheld off and save the settings. (If settings are not shown a “Required”, return to Step 7.)

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

B. Customizing the Handheld for Cartridge Testing Using CDS Version 5 1.

Click on Main  Open Administration Function  Customization

Type in your Password and click OK. The default password is the word istat. Note: Abbott Point of Care recommends changing the default password.

Make sure the Enable Customization box has a check mark in it.

Also make certain that the Enable Updates box is checked for the particular location to which the i-STAT 1 handheld is assigned.

If the location to which the handheld is assigned has a checkmark under the Use Default Profile column, double-click on the alphanumeric code under Preferences in the Default Customization Profile column. Otherwise, double-click on the alphanumeric code under Preferences for the specific location to which the handheld is assigned.

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Once the Preferences screen opens, click on the Test tab.

At the top of the Test tab screen, check the box next to Require Information before Running Cartridge and the box next to Enter Lot Number.

Click OK and answer YES to the question about changing the preferences.

Download the handheld(s) to the CDS from the downloader in the location to which this handheld is assigned. This action should upload the chosen customization features into the handheld. Repeat Step 8 for all handhelds to be customized from this same location. To customize handhelds from other locations for the same features, return to Step 1.

C. Customizing the Handheld for Cartridge Testing Using i-STAT/DE 1.

Access the Customization Workspace RALS-plus Users  RALS-plus application, choose i-STAT from the drop-down menu  Click on Device Customization Precision/Web Users  Double-click on the desktop shortcut or Internet Explorer Favorites for i-STAT Customization

Make sure the Enable Customization box has a checkmark in it.

Also make certain that the Enable Updates box is checked for the particular location to which this i-STAT 1 handheld is assigned.

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Once the Preferences screen opens, click on the Test tab.

At the top of the Test tab screen, check the box next to Require Information before Running Cartridge and the box next to Enter Lot Number.

Click OK and answer YES to the question about changing the preferences.

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Procedure for Cartridge Testing   

DO NOT insert cartridge to start test. DO NOT open cartridge pouch before scanning the barcode (if applicable). If Quality Check Code 69, 140, or 147 appears, see Analyzer Coded Messages Technical Bulletin for Troubleshooting Information.

Press

to turn on handheld.

Press

for i-STAT.

Follow the handheld prompts.

Scan the lot number on the cartridge pouch.    

Position barcode 3-9 inches from scanner window on handheld. to activate the scanner. Press and hold Align the red laser light so it covers the entire barcode. The handheld will beep when it reads the barcode successfully.

Note: If cartridge pouch does not have a barcode, enter the lot number manually using the numbered keys or press to bypass the prompt. You may ignore any letters in the lot number. 5.

Continue normal procedures for preparing the sample, filling, and sealing the cartridge.

Push the sealed cartridge into the handheld port until it clicks into place. Wait for the test to complete. Note: For ACT, PT/INR, Hct, and immunoassay testing, the handheld must remain on a level surface with the display facing up during testing. A level surface includes running the handheld in the downloader/recharger.

Review results.

Alternative Procedure 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.

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RESULTS Calculations The i-STAT handheld contains a microprocessor that performs all calculations required for reporting results. Displayed Results Results are displayed numerically with their units. Electrolyte, chemistry and hematocrit results are also depicted as bar graphs with reference ranges marked under the graphs. Suppressed Results There are three conditions under which the i-STAT System will not display results: 1. Results outside the System’s reportable ranges are flagged with a < or >, indicating that the result is below the lower limit or above the upper limit of the reportable range respectively. (See the table of Reportable Ranges.) The < > flag indicates that the results for this test were dependant on the result of a test flagged as either > or <. Action: Send specimen(s) to the laboratory for analysis, if necessary. 2. Cartridge results which are not reportable based on internal QC rejection criteria are flagged with ***. Action: Analyze the specimen again using a fresh sample and another cartridge. If the specimen integrity is not in question, the results that are not suppressed should be reported in the usual manner. If the result is suppressed again, send specimen(s) to the laboratory for analysis in accordance with the Laboratory Procedure Manual. 3. A Quality Check message will be reported instead of results if the handheld detects a problem with the sample, calibrant solution, sensors, or mechanical or electrical functions of the handheld during the test cycle. Action: Take the action displayed with the message that identifies the problem. Refer to the i-STAT or i-STAT 1 System Manual’s Troubleshooting section or the “Analyzer Coded Messages” Technical Bulletin if necessary. Printing and Transmitting Results Printing Results from the i-STAT 1 Analyzer to the Martel Portable Printer or to the i-STAT Printer Without Downloader or Downloader/Recharger 1. Turn printer on if green power light is not on. 2. Align IR windows of handheld and printer. 3. Display results. 4. Press the Print key. 5. Do not move handheld or printer until printing is complete. 6. If printer is not powered from a wall outlet, turn printer off. With Downloader or Downloader/Recharger 1. Place handheld in Downloader or Downloader/Recharger that is wired to the printer. 2. Display results. 3. Press the Print key. 4. Do not move handheld or printer until printing is complete.

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Printing more than one result 1. Turn the handheld on. 2. Press the Menu key. 3. Press 2 for Data Review. 4. Press 7 for List. 5. 6. 7.

8. 9.

Scroll through the test records using the and keys. Press the numbered key for the test record(s). (Press the numbered key again to deselect a record.) Align handheld and printer IR window or place in Downloader or Downloader/Recharger attached to printer. Press the Print key. Do not move handheld or printer until printing is complete. If printer is not powered from a wall unit using the AC adapter, turn printer off.

Transmitting Results from the i-STAT 1 Analyzer to the Data Manager 1. Place handheld in a Downloader or Downloader/Recharger. 2. Do not move handheld while the message “Communication in Progress” is displayed.

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM Reference Ranges,1, 2 Reportable Ranges, and Test Unit Conversions Reference range means the range of test values expected from 95% of fasting individuals presumed to be healthy. Reportable range means the range of test values throughout which the measurement system’s results have been shown to be valid. The following table contains the Reference Ranges (for adults) and Reportable Ranges applicable to the i-STAT System.

REFERENCE RANGE ANALYTE

UNIT

(arterial)

(venous)

REPORTABLE RANGE

UNIT CONVERSION

Sodium

mmol/L (mEq/L)

138 – 146

138 - 146

100 – 180

mmol/L x 1 = mEq/L Example: 140 mmol/L = 140 mEq/L

Potassium

mmol/L (mEq/L)

3.5– 4.9

Chloride

mmol/L (mEq/L)

98 – 109

BUN

mg/dL

8 – 26

2.0 – 9.0

mmol/L x 1 = mEq/L

98 – 109

65 – 140

mmol/L x 1 = mEq/L

8 – 26

3 – 140

mg/dL BUN x 0.357 = mmol urea/L

3.5 - 4.9

Example: 20 mg/dL BUN = 7.1 mmol urea/L

UREA

mmol/L

2.9 – 9.4

1 – 50

Glucose

mg/dL

70 – 105

20 – 700

Creatinine

Ionized Calcium

PO2

TCO2 (on the CHEM8+ cartridge only

0.70 – 1.05

0.20 – 7.00

mmol/L

3.9 – 5.8

1.1 – 38.9

g/L x 5.556 = mmol/L

mg/dL

0.6 - 1.3

0.2 - 20.0

mg/dL x 88.4 = µmol/L

µmol/L

53 - 115

18 - 1768

mmol/L

1.12 – 1.32

0.25 – 2.50

mmol/L x 4 = mg/dL

mg/dL

4.5 – 5.3

1.0 – 10.0

Example: 1.13 mmol/L x 4 = 4.52 mg/dL

7.35 – 7.45

7.31 – 7.41

6.50 – 8.20

N/A

mmHg

35 – 45

41 – 51

5 – 130

mmHg x 0.133 = kPa

kPa

4.67 – 6.00 5.47 – 6.80

0.67 – 17.33

Example: 35 mmHg x 0.133 = 4.66 kPa

mmHg

80 – 105

5 – 800

mmHg x 0.133 = kPa

kPa

10.7 – 14.0

0.7 – 106.6

Example: 83 mmHg x 0.133 = 11.04 kPa

5-50

mmol/L x 1 = mEq/L

mmol/L (mEq/L)

23-27

24-29

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Example: 100 mg/dL = 5.55 mmol/L

g/L

pH PCO2

mg/dL x 0.055 = mmol/L

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REFERENCE RANGE ANALYTE

UNIT

(arterial)

(venous)

REPORTABLE RANGE

Hematocrit

% PCV

38 – 51

10 – 75

Fraction

0.38 – 0.51

0.10 – 0.75

% PCV x 0.01 = Volume fraction Example: 40% PCV = 0.40 PCV

mmol/L

0.36 –1.25

0.90-1.70

0.30 – 20.00

mmol/L x 9.01 = mg/dL

mg/dL

3.2 – 11.3

8.1–15.3

2.7 – 180.2

HCO3*

mmol/L (mEq/L)

22 – 26

23 - 28

1.0 – 85.0

mmol/L x 1 = mEq/L

TCO2* (on all cartridges but CHEM8+)

mmol/L (mEq/L)

23 – 27

24 - 29

5 – 50

mmol/L x 1= mEq/L

BE*

mmol/L (mEq/L)

(-2) – (+3)

(-30) – (+30)

Anion Gap*

mmol/L (mEq/L)

10 – 20

(-10) – (+99)

sO2*

95 – 98

Hb*

g/dL

12 – 17

g/L

Lactate

mmol/L sec

Celite ACT

sec

Kaolin ACT

Prothrombin Time/PT

INR

Troponin I/cTnI

ng/mL (µg/L)

UNIT CONVERSION

0 - 100

% x 0.01 = fraction saturated

12 – 17

3.4 – 25.5

g/dL x 10 = g/L

120 – 170

34 – 255

7 – 11

2.1 – 15.8

74 – 125 (PREWRM)

50 - 1000

84 – 139 (NONWRM)

74 – 137 (PREWRM)

82 – 152 (NONWRM)

50 - 1000 0.9-8.0#

0.00 – 0.03**

0.00 –50.00##

ng/mL x 1 = µg/L

0.00 – 0.08*** Creatine Kinase MB/CK-MB

ng/mL (µg/L)

0.0 – 3-5****

0.0-150.0

ng/mL x 1 = µg/L

B-Type Natriuretic Peptide/BNP

pg/mL (ng/L)

<15-50****

15-5000

pg/mL x 1 = ng/L

Total β-hCG

IU/L

<5.0

5.0 – 2000.0

*Calculated values. #Performance characteristics have not been established for INRs above 6.0. **Represents the 0-97.5% range of results. Each facility should establish its own reference range using the i-STAT cTnI assay. ## Performance characteristics have not been established for cTnI values above 35.00 ng/mL. ***Represents the 0-99% range of results. Each facility should establish its own reference range using the i-STAT cTnI assay. ****Represents the 0-95% range of results. Each facility should establish its own reference range using the i-STAT assay

14 REV. DATE: 23-Oct-15

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

Critical Results 3 Critical results are test results that fall outside high and low critical limits that define the boundaries of lifethreatening values for a test. Critical results represent an emergency condition and must be reported immediately to the patient’s attending physician or nurse. ADULT

CHILDREN

NEONATES

ANALYTE (units)

low

high

low

high

low

high

Sodium (mmol/L)

120

158

121

156

121

156

Potassium (mmol/L)

2.8

6.2

2.8

6.4

2.8

6.5

Chloride (mmol/L)

126

121

TCO2 (mmol/L)

–

Ionized Calcium (mmol/L)

0.78

1.58

0.74

1.57

–

7.21

7.59

7.21

7.59

–

PCO2 (mmHg)

–

PO2 (mmHg)

–

124

BUN (mg/dL)

–

104

–

Glucose (mg/dL)

484

445

328

Creatinine

–

7.4

–

3.8

–

Lactate Hematocrit (% PCV) Celite ACT Kaolin ACT PT/INR Troponin I/cTnI Creatine Kinase MB/ CK-MB B-Type Natriuretic Peptide/ BNP Total β-hCG

15 REV. DATE: 23-Oct-15

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

Interferences An interferent is a substance which, if present at significant levels in the blood specimen being analyzed, will produce an error in the result of the analyte being measured. ANALYTE

INTERFERENT

INTERFERENT CONCENTRATION

EFFECT ON ANALYTE RESULT

Sodium

Bromide

37.5 mmol/L

Increase () Na

Nithiodote (sodium thiosulfate)

16.7 mmol/L

Increase () Na

Bromide

37.5 mmol/L

Increased rate of star (***) outs. Increase () K

Nithiodote (sodium thiosulfate)

16.7 mmol/L

Decrease () K

Acetylcysteine

10.2 mmol/L

Increase () Cl

Bromide

37.5 mmol/L

Increase () Cl

Bromide (therapeutic)

2.5 mmol/L

Increase () Cl

Salicylate

4.34 mmol/L

Increase () Cl

Thiocyanate

6.9 mmol/L

Increase () Cl

Nithiodote (sodium thiosulfate)

16.7 mmol/L

Increase () Cl

Acetominophen

1.32 mmol/L

Decrease () iCa

Magnesium

1.0 mmol/L

Increase () iCa by up to 0.04 mmol/L

Acetylcysteine

10.2 mmol/L

Decrease () iCa

Bromide

37.5 mmol/L

Increase () iCa

Lactate

6.6 mmol/L

Decrease () iCa by up to 0.07 mmol/L

Salicylate (therapeutic)

0.5 mmol/L

Decrease () iCa by up to 0.03 mmol/L

Salicylate

4.34 mmol/L

Decrease () iCa

Nithiodote (sodium thiosulfate)

16.7 mmol/L

Decrease () iCa

Thiocyanate

6.9 mmol/L

Decrease (↓) iCa Use Another Method.

Acetominophen

1.32 mmol/L

Increase () glucose

Acetylcysteine

10.2 mmol/L

Decrease () glucose

Bromide

37.5 mmol/L

Decrease () glucose

Bromide (therapeutic)

2.5 mmol/L

Decrease () glucose

pH: per 0.1 pH units below 7.4 @ 37°C

Decrease () glucose by 0.9 mg/dL (0.05 mmol/L)

pH: per 0.1 pH units above 7.4 @ 37°C

Increase () glucose by 0.8 mg/dL (0.04 mmol/L)

Potassium

Chloride

Ionized Calcium

Glucose

16 REV. DATE: 23-Oct-15

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

Lactate

BUN/Urea

Creatinine

<2 mg/dL

>2 mg/dL

Oxygen

PO2 less than 20 mmHg @ 37°C

May decrease () glucose

Hydroxyurea

0.92 mmol/L

Increase () glucose Use Another Method.

Nithiodote (sodium thiosulfate)

16.7 mmol/L

Decrease () glucose

Thiocyanate

6.9 mmol/L

Decrease () glucose

Bromide

37.5 mmol/L

Decrease () lactate

Hydroxyurea

0.92 mmol/L

Increase () lactate Use Another Method.

Glycolic Acid

10.0 mmol/L

Increase () lactate Use Another Method.

Bromide

37.5 mmol/L

Increased rate of star (***) outs. Decrease () BUN/Urea results

Hydroxyurea

0.92 mmol/L

Increase (↑) BUN/Urea results

Nithiodote (sodium thiosulfate)

16.7 mmol/L

Decrease () BUN/Urea results

Acetaminophen

1.32 mmol/L

Increase () creatinine

Ascorbate

0.34 mmol/L

Increase () creatinine by up to 0.3 mg/dL

Bromide (therapeutic)

2.5 mmol/L

Increase () creatinine

PCO2

Above 40 mmHg

Increase () creatinine by 6.9% per 10 mmHg PCO2

Below 40 mmHg

Decrease () creatinine by 6.9% per 10 mmHg PCO2

Above 40 mmHg

Decrease () creatinine by 3.7% per 10 mmHg PCO2

Below 40 mmHg

Increase () creatinine by 3.7% per 10 mmHg PCO2

Hydroxyurea

0.92 mmol/L

Increase () Creatinine Use Another Method.

Acetylcysteine

10.2 mmol/L

Increase () creatinine

Creatine

0.382 mmol/L

Increase () creatinine by up to 0.3 mg/dL

Glycolic Acid

10.0 mmol/L

Decrease (↓) creatinine Use Another Method.

Nithiodote (sodium thiosulfate)

16.7 mmol/L

PCO2

Increase () creatinine

17 REV. DATE: 23-Oct-15

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

Hematocrit

White Blood Count (WBC)

Greater than 50,000 WBC/L

May Increase () hematocrit

For measured Hct<40% For each g/dL below 6.5 For each g/dL above 8.0

Decrease () Hct by 1% PCV Increase () Hct by 1% PCV

For measured Hct40% For each g/dL below 6.5 For each g/dL above 8.0

Decrease () Hct by 0.75% PCV Increase () Hct by 0.75% PCV

Lipids

Abnormally high

Increase () Hct

Bromide

37.5 mmol/L

Increased rate of star (***) outs

Total Protein

Celite ACT

Aprotinin

Falsely extends Celite ACT times

PCO2

Propofol (Diprovan®)

For patients administered propofol or thiopental sodium, APOC recommends the use of G3+, CG4+, CG8+, EG6+, and EG7+ cartridges, which are free from clinically significant interference at all relevant therapeutic doses. APOC does not recommend the use of EC8+ cartridges for patients receiving propofol or thiopental sodium.

Thiopental Sodium

PT/INR

Cubicin (daptomycin for injection)

Falsely extends prothrombin time (PT) and INR

Chlorhexidine Gluconate

May falsely extend prothrombin time (PT) and INR

18 REV. DATE: 23-Oct-15

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