Abbott i-Stat User manual

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. The Procedure Manual is provided on disk for this purpose. This Procedure Manual is not intended to replace the System Manual.

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

Contents
System Overview ..............................................................................................................................................................	1
Analyzers
Analysis Time
Cartridges
Glucose Test Strips
Central Data Station or Data Manager
Supplies and Storage Requirements............................................................................................................................	1-2
Cartridges
Glucose Test Strips
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................................................................................................................................................	6-10
Preparation for Use
Procedure for Cartridge Testing
Procedure for Glucose Test Strip Testing
Alternative Procedure
Results ........................................................................................................................................................................	11-18
Calculations
Displayed Results
Suppressed Results
Printing and Transmitting Results
Reference Ranges and Reportable Ranges
Critical Results
Interferences
Quality Control..........................................................................................................................................................	19-23
Daily Procedures
Monthly Procedures
Periodic Procedures
Calibration......................................................................................................................................................................	23
Clinical Significance .................................................................................................................................................	24-26
Principles of Measurement.......................................................................................................................................	27-28
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References	.......................................................................................................................................................................28
Logs ................................................................................................................................................	i-vii

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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:

Analyzers

Analyzers can be the i-STAT Portable Clinical Analyzer, the i-STAT1 Analyzer, or the Blood Analysis Module, which is used in conjunction with the Philips Medical Systems (formerly Agilent Technologies) CMS and 24/26 Patient Monitor. When a sample-filled i-STAT cartridge is inserted into an analyzer for analysis, the analyzer automatically controls all functions of the testing cycle including fluid movement within the cartridge, calibration and continuous quality monitoring. A MediSense® Precision PCx™ or PCx™ Plus Glucose Test Strip is scanned and inserted into the i-STAT1 Analyzer and a drop of whole blood is applied to the target area of the test strip.

Analysis Time

ACT cartridge: to detection of end point - up to 1000 seconds (16.7 min.)

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

cTnI cartridge: 600 seconds (10 min.)

Other cartridges: typically 130 to 200 seconds

MediSense Precision PCx or PCx Plus Glucose Test Strip: 20 seconds

Cartridges

A single-use disposable cartridge contains microfabricated sensors, a calibrant solution, fluidics system, and a waste chamber. Sensors for analysis of pH, PCO2, PO2, 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, and Troponin I/cTnI (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.

Glucose Test Strips

The i-STAT1 Analyzer is capable of using the Abbott MediSense Precision PCx or PCx Plus Blood Glucose Test Strips.

Central Data Station or Data Manager

A dedicated desktop computer with the i-STAT Central Data Station program provides the primary information management capabilities for the i-STAT System. IR Links for Portable Clinical Analyzers, Downloaders and Downloader/Rechargers for the i-STAT1 Analyzers and a Philips installed server for Blood Analysis Modules allow for transmission of patient records from a widely distributed network of analyzers to the Central Data Station program. 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 to 8°C (35 to 46°F). Do not allow cartridges to freeze. (Freezing will cause higher than expected ionized calcium results). Cartridges may be stored at room temperature (18 to 30°C or 64 to 86°F) for 14 days. Cartridges should not be returned to the refrigerator once they have been at room temperature, and 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 two-week room temperature expiration date. Cartridges should remain in pouches until time of use. Do not use after the labeled expiration date.

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Glucose Test Strips

Test strips are sealed in individual foil packets. Store the strips at a temperature between 4 and 30°C (39 and 86°F). When stored properly, the unopened test strips remain stable until the expiration date printed on the barcode label. Do not freeze and keep out of direct sunlight.

Controls

i-STAT Controls 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 Cardiac Markers

Store at -18°C (-1°F) in a non-defrosting freezer. After thawing, the opened or unopened 1.0 mL vial is stable for 4 hours when capped and stored at 2 to 8°C (35° to 46°F). Do not refreeze

Hematronix Meter Trax™ Whole Blood Reference Controls for hematocrit

Store upright at 2 to 8°C (35° to 46°F). Do not allow to freeze. Ensure control is completely mixed before using. Once opened, bottles may be used for up to 31 days provided they have been resealed and refrigerated immediately after each use. Write the date of opening on the bottle label. Do not use after expiration date on box and vials.

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.

MediSense Precision Glucose Control Solutions for test strips

Store the controls at temperatures between 4 and 30°C (39 and 86°F). Do not freeze. Each bottle of control solution is stable for 90 days after opening. Write the date of opening on the bottle label. Always make sure the cap is returned to the correct bottle and tightly closed immediately 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 (e.g., 1cc syringe and a 16 to 20 gauge needle).

Arterial puncture: Plain syringe or blood gas syringe with heparin and labeled for the assays performed or with the least amount of heparin to prevent clotting (10 U heparin/mL of blood)

Cartridges for ACT

Skin puncture: not recommended

Venipuncture and arterial puncture: plain plastic syringe without anticoagulant

Glucose Test Strips

Skin puncture: lancet and capillary collection tube with lithium heparin, sodium heparin, or EDTA or direct application of sample to test strip

Venipuncture and arterial puncture: collection tube or syringe with lithium heparin, sodium heparin, or EDTA

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Cartridges for PT/INR

Skin puncture: lancet only needed. Cartridge can be filled directly from the finger.

Venipuncture and arterial puncture: plain plastic syringe without anticoagulant.

Cartridges for Troponin I/.cTnI

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.

Blood Volume

See Table 1 below for cartridge volumes. For the glucose test strip, sufficient sample to cover target area - approximately one drop, is required.

Table 1: Cartridge Panel Configurations and Blood Volume

Cartridge

Vol. Lµ

PCO

PO2

iCa

Glu

BUN

Creat

Lact

Hct

ACT

PT/INR

cTnI

HCO3

TCO2

SO2

GapAnion

CG8+

•

EG7+

•

EG6+

•

CG4+

•

G3+

•

EC8+

•

EC4+

•

E3+

•

Crea

•

ACT

•

PT/INR

•

cTnI

•

Shading denotes calculated values

Suitable Specimens for Cartridges for Blood Gases, Electrolytes, Chemistries, and Hematocrit

Fresh whole blood collected in a 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 three to 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.

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Suitable Specimens for Glucose Test Strip

Fresh capillary whole blood collected in a capillary collection tube containing sodium heparin, lithium heparin, or EDTA. Test immediately.

Fresh venous whole blood collected in a collection tube containing sodium heparin, lithium heparin, or EDTA. Test within 30 minutes of collection.

Fresh arterial whole blood collected in a syringe containing sodium heparin, lithium heparin, or EDTA. Test within 30 minutes of collection.

Suitable Specimens for Troponin I/cTnI

Fresh heparinized whole blood or plasma samples collected in syringes or evacuated tubes containing lithium or sodium heparin. Collection tubes must be filled at least half full.

Non heparinized whole blood samples tested within one minute of patient draw collected into a plastic syringe or plastic evacuated tube containing no additives.

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: three 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.

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.

For glucose test strips, fill to capacity a syringe or collection tube containing lithium heparin, sodium heparin, or EDTA.

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 sample collected without anticoagulant immediately. Test samples for ACT and PT/INR immediately. Test samples for lactate within 3 minutes of sample collection. For pH, blood gases 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. For the glucose test strip and 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

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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 because of the potential for decreased measured PCO2 results and calculated HCO3 and TCO2 values.

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 strip testing, EDTA is also an acceptable anticoagulant.

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 and PT/INR immediately. Test samples for lactate within 3 minutes of sample draw. Test samples for pH, PCO2, 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 the glucose test strip and 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 or Troponin I/cTnI.

Criteria For Specimen Rejection

Evidence of clotting

Specimens collected in vacuum tubes with anticoagulant other than lithium or sodium heparin

Specimens for ACT or PT/INR collected in glass syringe or tube or with anticoagulant of any kind

Syringe for pH, PCO2, and PO2 with air bubbles in sample

Incompletely filled vacuum tube for the measurement of ionized calcium or PCO2

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 , and PO2

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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.

Glucose test strips require no preparation for use.

Procedure for Cartridge Testing (other than PT/INR or Tropnin I/cTnI)

1.Remove the cartridge from its pouch. Avoid touching the contact pads or exerting pressure over the calibrant pack in the center of the cartridge.

2.Following thorough mixing of the sample, direct the dispensing tip or capillary tube containing the blood into the sample well.

3.Dispense the sample until it reaches the fill mark on the cartridge and the well is about half full.

4.Close the cover over the sample well until it snaps into place. (Do not press over the sample well.)

5.Insert the cartridge into the cartridge port on the analyzer until it clicks into place. When using an ACT cartridge, the analyzer must remain horizontal during the testing cycle.

6.Never attempt to remove a cartridge while the LCK or “Cartridge Locked” message is displayed.

7.Enter an operator ID number. Repeat if required.

8.Enter the patient ID number. Repeat if required.

9.Select tests to be reported, if prompted.

10.Enter additional parameters on the Chart Page if required:

Patient temperature can be entered as degrees Centigrade or Fahrenheit. (Use the * key on the i-STAT Portable Analyzer for a decimal point.)

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

Fields 1, 2, and 3 are user-defined fields, typically used for ventilator settings such as PIP or PEEP.

Choose the number corresponding to the type of sample used when prompted at the Sample Type field. Select CPB for patient in cardiopulmonary bypass surgery.

11.View results shown on the analyzer’s display screen.

Procedure for the i-STAT1 Analyzer with Information First

1.Turn the analyzer on and press 2 for i-STAT Cartridge.

2.Scan or enter the operator and patient IDs. Repeat if prompted.

3.Remove the cartridge from its pouch. Avoid touching the contact pads or exerting pressure over the calibrant pack in the center of the cartridge.

4.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.

5.Close the cover over the sample well until it snaps into place. (Do not press over the sample well.)

6.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.

7.Select tests to be reported, if prompted.

8.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.

Fields 1, 2, and 3 are user-defined fields, typically used for ventilator settings such as PIP or PEEP.

Patient temperature can be entered as degrees Centigrade or Fahrenheit.

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

Choose 1-YES or 2-NO for CPB.

Press the → key to return to the results page.

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9.View results shown on the analyzer’s display screen.

10.Enter Comment Code if prompted.

Procedure for PT/INR Cartridge Testing

Skin Punctures

1.Remove cartridge from foil pouch and place the cartridge on a flat surface.

2.Prepare lancet device and set aside until needed.

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

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

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

6.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.

7. Apply sample until it reaches the fill mark indicated on the cartridge. 8. Fold the sample closure over the sample well.

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

10. Insert the cartridge into the cartridge port until it snaps into place. 11. Enter an operator ID number. Repeat if required.

12.Enter the patient ID number. Repeat if required.

13.Select tests to be reported, if prompted.

14.Enter additional parameters on the Chart Page, if required.

15.View result on the analyzer’s display screen.

Note: To further simplify the sample application into the test cartridge, it is possible to bring the cartridge to the finger for easier application. Do ensure that the instrument remains on a flat vibration-free surface for testing.

Procedure for Troponin I/cTnI Testing

Note: The i-STAT cTnI cartridges can only be used with the i-STAT 1 Analyzer bearing the symbol.

This symbol is located on the grey casing next to the lower right corner of the analyzer display screen. Before testing cTnI cartridges on the i-STAT 1 Analyzer, the analyzer must be customized through the Central Data Station (CDS) or through the analyzer’s Customization menu for the following options:

1.Cartridge Barcode Required, or

2.Cartridge Information First Required AND Cartridge Lot Number Required.

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Cartridge Test Procedure (Non-Information First Customization)

1.Remove cartridge from portion pack. Do not immediately dispose of the portion pack, as the cartridge lot number listed on it will be scanned into the analyzer during the testing procedure. Handle the cartridge from its edges. Avoid touching the contact pads or exerting pressure over the center of the cartridge.

2.Following thorough mixing of the sample, direct the transfer device (either syringe tip or pipette tip) into the inlet port. Apply a single drop of sample to the inlet port. If the cartridge fill is incomplete as seen via the fill indicator on the cartridge label, apply a second small drop until the sample reaches the fill mark.

3.To close the cTnI cartridge:

a.first anchor the cartridge in place by using the thumb and index finger of one hand to grasp the cTnI cartridge from its side edges away from the sample inlet.

b.use the thumb of the other hand to slide the plastic closure clip to the right until it locks into place over the sample well. Note: When sliding the closure clip, the index finger of that same hand should not be placed directly across from the thumb, as this could result in the sample being pushed onto the user’s glove. This index finger should be placed just above the position of the sliding clip during closure or not used at all.

4.Insert the cartridge into the cartridge port. Do not attempt to remove the cartridge while the Cartridge Locked message is displayed.

5.Scan the Cartridge Lot number from the cartridge portion pack (Screen 1 below).

6.Scan or Enter Operator ID (Screen 2 below). Repeat if prompted.

7.Scan or Enter Patient ID (Screen 3 below). Repeat if prompted.

The analyzer must remain on a level surface with the display facing up during testing. Motion of the analyzer during testing can increase the frequency of suppressed results or quality check codes.

8.Select tests to be reported, if prompted.

9.Enter sample type on chart page if applicable.

10.The Time to Results countdown bar will then be displayed (Screen 4 below). Once time has elapsed, view results on analyzer’s display (Screen 5 below).

11.Remove cartridge after Cartridge Locked message disappears. The analyzer is ready for the next test immediately.

Screen 1 Screen 2 Screen 3 Screen 4 Screen 5

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