bassett healthcare point of care i-stat 1 procedurestore at 2 to 8 c. do not use after expiration...

Shares3\lab\POCT\PROCEDURES-POC CURRENT\i-STAT Procedure – Rev: 12/12/2016 of 38

Bassett Healthcare

Point of Care

i-STAT 1 PROCEDURE

A. PRINCIPLE

The i-STAT System incorporates comprehensive components needed to perform blood

analysis at the point of care. The System consists of the i-STAT analyzer, with the

docking station and printer, test cartridges, and middleware, RALS 3.

B. METHOD

1. i-STAT Analyzer

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.

Results are reported in approximately 120 seconds for cartridges with sensors for

blood gases, electrolytes, chemistries and hematocrit. ACT and PT/INR cartridge

results within the time it takes to complete the test. The Troponin cartridge takes 10

minutes to complete the test.

2. Cartridges

A single-use disposable cartridge contains microfabricated sensors, a calibrant

solution, a fluidics system, and a waste chamber. Sensors for analysis of pH, pCO2,

pO2, sodium, potassium, chloride, ionized calcium, glucose, creatinine, urea nitrogen

(BUN), lactate and hematocrit are available in a variety of panel configurations.

Reactions for a particular test are the same across cartridges. Cartridges are also

available for ACT, PT/INR and troponin.

3. Point-of-Care Central Workstation (Database or middleware)

A dedicated desktop computer with the i-STAT program provides the primary

information management capabilities for the i-STAT System. IR links for Portable

Clinical Analyzers, down loaders for the i-STAT 1 Analyzers and RALS allow for

transmission of patient records from a widely distributed network of analyzers. Data

is stored, organized, edited, and transferred to the laboratory information system or

other computer system. Cartridge usage and efficiency reports can be generated for

management of the system.

C. SPECIMEN REQUIREMENTS - A whole blood sample of approximately 1 to 2 drops,

sample size from 17 ul to 95 ul, is dispensed into the cartridge sample well and the sample

well is sealed.

I. MODERATELY COMPLEX TESTS

a. REQUIRED for G3, EG7, and CG4, pH, pCO2, PO2 (blood gas component

only) - Acceptable Samples: Arterial, Venous, Cord, Capillary and Mixed Venous

TEST IMMEDIATELY:

Fresh whole blood collected in a plastic syringe, no anticoagulant – run

immediately


TEST WITHIN 30 MINUTES:

Fresh whole blood collected in a Lithium Heparinized plastic syringe -

minimum draw 0.8 ml. If testing is delayed stored capped, NOT on ice. Mix

well and dispense 1-2 drops before sampling.

Fresh whole blood collected in a Lithium Heparinized Vacutainer submitted at

room temperature submitted to the Clinical Lab ONLY.

Fresh whole blood collected in a Balanced Heparin capillary collection tube at

room temperature.

b. SUITABLE for EG7, Chem8 and CG4 for Electrolytes only, ICAL,

Hematocrit. Troponin and Lactate

Fresh whole blood collected in a Lithium Heparin (light green) Vacutainer

tube. Minimum draw half full. Test within 30 minutes.

NOTE: Lactate is drawn without a tourniquet and an unclenched fist.

c. SUITABLE for Troponin and CG4


tube. Minimum draw half full. Test within 30 minutes.

d. SUITABLE for PT/INR – Testing for patients on Sodium Warfarin therapy only.

NOTE: Do not excessively squeeze patient finger. Pre-warm hands to increase

capillary perfusion.

Fingerstick specimens (preferred sample): Using a lancet, follow fingerstick

protocol to obtain a capillary sample. Gently squeeze the finger to develop a

hanging drop of blood. DO NOT WIPE away the first DROP. Collect sample

in i-STAT sample well (20 uL). Test immediately.

Fresh whole blood without anticoagulant collected in a plastic syringe. If

from an indwelling 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. Test

immediately.

e. SUITABLE for ACT

Fresh whole blood without anticoagulant collected in a plastic syringe. If

from an indwelling 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. Test

immediately.

II. WAIVED TESTS

a. REQUIRED for E3


tube. Minimum draw half full. Test within 30 minutes. Transfer the sample

with a needless device or a pipette.


b. SUITABLE for Creatinine


tube. Minimum draw half full. Test within 30 minutes. Transfer the sample

with a needless device or a pipette.

NOTE: Waived cartridges – E3 and Creatinine must be tested on venous

samples collected in evacuated tubes with Lithium Heparin.

Specimen Labeling

Unless the specimen is analyzed immediately after collection and then discarded, the

specimen container must be labeled with the following information:

Patient first and last name

Patient ID number (visit #)

Time and date of collection

Phlebotomist ID

Sample Volumes

E3 – 65 uL G3 – 95 uL

Creatinine – 65 uL CG4 – 95 uL

Chem8 – 95 uL EG7 – 95 uL

ACT – 40 uL Tropo nin – 17 uL

PT/INR – 20 uL

TABLE #1 – SPECIMEN TYPES BY TEST

Heparin

Syringe

No Anticoagulant

Syringe

Capillary Fingerstick Lithium

Heparin

Vacutainer

Measured Analyte

pH X X X Lab Only

pCO2 X X X Lab Only

pO2 X X X Lab Only

ICAL X X X** X

Hct X X X X

Na X X X X

K X X X** X

Troponin X X X

Lactate X X X

Creatinine X* X X

BUN X X X

CL X X X

Glucose X X X

TCO2 X X X

PT X

ACT X

*Chem8 cartridge only

**Capillary blood is known to show statistically different values to venous blood in glucose,

potassium and calcium.

Criteria for Specimen Rejection


Evidence of clotting

Specimens collected in vacuum tubes with anticoagulant other than lithium or

sodium heparin

Specimen for ACT 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 fluid types such as urine and CSF – POC use only. (Lab may analyze

fluids according to outlined procedure)

Syringes sent to laboratory with needle attached

Creatinine patient receiving Hydroxyurea

D. REAGENTS AND MATERIALS/INSTRUMENTATION

1. Cartridges

a. Storage:

Cartridges are sealed in individual pouches. Cartridges must be used within 10

minutes from removal of original packaging. Store the main supply of cartridges

refrigerated at 2C to 8C. Remove cartridges from refrigeration prior to use, allow

to equilibrate at room temperature. Cartridges cannot be returned to the refrigerator

once they have been at room temperature. Do not allow cartridges to freeze.

Freezing will cause higher than expected ionized calcium results. Do not store

cartridges at temperatures greater than 30C.

NOTE:

Cartridges for testing must acclimate to room temperature.

1 cartridge = 5 minutes

1 box cartridges – 1 hour

Date all boxes with RT (room temperature) expiration date

Date individual cartridges with RT (room temperature) expiration date

DO NOT USE cartridges after labeled expiration date OR manufacturer’s

expiration date

TABLE #2 – CARTRIDGE STABILITY AT ROOM TEMPERATURE

Cartridges Room Temp Storage

Moderately Complex

ACT - Activated clotting time 14 Days

*PT/INR – INR 14 Days

cTnI – Troponin 14 Days

G3+ - pH, pCO2, pO2 2 Months

CG4 - pH, pCO2, pO2, Lactate 2 Months

CHEM 8 - NA, K, CL, TCO2, iCal, Glucose, Bun,

Creat 14 Days

Waived

Crea - Creatinine 14 Days

E3+ - Na, K, HCT 2 Months


*PT/INR cartridges are only used in the CVRU, MRI and ASU for pre-procedure

clearance for patients taking Sodium Warfarin. Any INR’s >1.9 require a venous

confirmation.

i-STAT Testing Locations and Approved Test by Site: i-STAT testing is approved by patient

care area. Please refer to Table 3 to confirm approved testing.

TABLE #3 – APPROVED TESTS BY LOCATION MIBH POC

TEST SITE G3 or EG7 ACT CG4 PT/INR Troponin

Creatinine

E3

ASU X

X

Cardiac OR X X

Cath Lab X X X

CVRU X

X

ED

X X

GI Lab

X

ICU X X X

Little Falls

Dialysis

X

OB InPt X

OR X X

OSS Dialysis

X

PACU OPCU X X X

Respiratory X X

MRI/CT Scan

X X

b. Cartridge Storage Conditions

Refrigerated Cartridges – Store 2-8C

Verify that the cartridges stored in the refrigerator are within the

expiration date printed on the boxes. Discard expired cartridges.

Verify that the refrigerator did not exceed the limits of 2 to 8C. Do not

use cartridges stored below 2C, discard. Cartridges stored above 8C

must be dated for room temperature expiration.

Document refrigerator temperature on the temperature log daily.

Room Temperature Cartridges (18-30°C)

Verify that the cartridges stored at room temperature have not exceeded

the room temperature expiration date or manufacturer’s expiration date.

Discard all cartridges that have expired.

Verify that room temperature is between 18-30°C.

Document temperature on temperature log if applicable.

c. Ordering information:

Cartridges: Notify the Laboratory Point of Care Office at X6728 (M-F

between 0800 and 1630, or the Chemistry Lab at X3731 during other times

when cartridges are required. Cartridges are hand delivered to the testing

location as cartridges cannot be delivered through the pneumatic tube system.

2. i-STAT 1 – Downloadable version (gray) or wireless version (blue).


3. i-STAT 1 Downloader/Recharger Kit – Abbott reference #04P73-04, DRC 300

The Downloader comes in two formats:

Downloader: A low-profile table-top unit with “arms” between which the

analyzer is placed

Downloader/Recharger (DR): A cradle that the analyzer is placed within.

4. Quality Controls

a) TriControls for blood gases, electrolytes, chemistries and hematocrit – Abbott

Manufacturer reference #05P71-01, 05P72-01, 05P73-01

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

Warm a minimum of 4 hours at room temperature before use.

Room temperature storage is 5 days.

b) Controls for ACT and PT/INR – Abbott Manufacturer reference # ACT 06P17-

15, 06P17-16; PT/INR 06P17-13, 06P17-14

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

Warm minimum 45 minutes at room temperature before use.

Room temperature storage is 4 hours.

c) Control for Troponin – Abbott Manufacturer reference #06P17-09, 06P17-10,

06P17-11

Store 2 to 8C.

Use immediately, return to refrigerator.

Open expiration date is 30 days.

Do not use after expiration date on the vials and box.

5. Linearity – Tricontrols Abbott Manufacturer reference #05P70-01 – 5 levels.

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

Warm a minimum of 4 hours at room temperature before use.

Room temperature storage is 5 days.

6. 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.


7. Specimen Collection Equipment a) Blood Gas, Electrolytes, Chemistries and Hematocrit. Lithium Heparin is the

preferred anticoagulant.

NOTE: Sodium Heparin can be used for all tests EXCEPT ELECTROLYTES

(sodium and potassium)

Arterial Puncture – ProVent Arterial Blood Sampling Kit - reference 4699P-1

Smiths Medical. 23.5 IU dry Lithium Heparin – neutralized for ionized

calcium. Minimum sample 0.8 mL or plain untreated plastic syringe.

Line Draw - Line Draw Arterial Blood Sampling Kit – reference 4043W-2

Smiths Medical. 23.5 IU dry Lithium Heparin – neutralized for ionized

calcium. Minimum sample 0.8 ml or plain untreated plastic syringe.

Venipuncture – Lithium Heparinized collection tube and disposable transfer

device (1 cc syringe; 16-20 gauge needle)

Capillary – Safe-T-Fill Balanced Heparin capillary collection – reference 06-

0186 (150 uL). FOR BLOOD GAS ONLY

b) ACT - Untreated plain plastic syringe, NO ANTICOAGULANT.

c) PT/INR – Lancet fingerstick supplies or a plain untreated plastic syringe.

8. Clorox Germicidal Wipes – Warehouse order #554713

9. Rechargeable Battery Pack – Abbott i-STAT reference #06F23-55

10. 9V Lithium Batteries – Warehouse Stock #U9VL

11. Printer Paper – Warehouse Stock #06F17-11

Calibration/Linearity

1. For cartridges, calibration is automatically performed as part of the test cycle on each

cartridge type. Calibration is not required for ACT, PT/INR cartridges

2. Each new meter and each new lot G3, EG7, CG4, Chem8 and Troponin requires

linearity before use. Run the Linearity TriControls five sample calibration

verification kit for G3, EG7, CG4 and Chem8. Run Level 1-3 Troponin QC or

Linearity for Troponin. This procedure is performed by the POC office and the

information is used for instrument correlation as well as linearity.

E. LINEARITY REQUIREMENTS

TABLE #5 – LINEARITY REQUIREMENTS

Analytes Linearity Frequency

G3, EG7, CG4.Chem8 Level 1, Level 2, Level 3. Level 4, Level 5 Each shipment and each new lot #

Troponin Level 1, Level 2, Level 3 Each shipment and each new lot #


PROCEDURE – Linearity

1. Procedure for testing cartridges with i-STAT Level 1-5 Calibration Verification

a) Prior to testing cartridges that measures pO2, ampules should stand at room

temperature a minimum of 4 hours before use. When testing other cartridges,

ampules may be used once the fluid has reached room temperature, approximately

30 minutes for individual ampules. For best results, ampules, cartridges and

analyzers should be at the same temperature.

b) Immediately before use, shake the ampule vigorously for 5-10 seconds to

equilibrate the liquid and gas phases. To shake, hold the ampule at the tip and

bottom with forefinger and thumb to minimize increasing the temperature of the

solution. If necessary, tap the tip of the ampule to send solution back into the

bottom section of the ampule. Protect fingers with gauze, tissue, or glove, or use

an ampullate breaker to snap off the tip of the ampule at the neck.

c) Immediately transfer the solution from the ampule into a syringe.

When using a syringe (1 cc or 3 cc syringes with 16 to 20 gauge needles are

recommended), slowly draw approximately 1 mL of solution from the bottom

of the ampule. If air is trapped between the leading edge of the solution and

the plunger, do not invert the syringe to expel it; this will not affect solution

near the tip of the syringe. If air bubbles are continually drawn into the

syringe, or if a bubble is trapped near the tip of the syringe, discard the

ampule and syringe and use a fresh ampule or syringe. Expel one or two

drops from the syringe before filling the cartridge.

Do not use solution left in the syringe, ampule, or capillary tube for additional

testing of the cartridges that contain sensors for ionized calcium, pH, pCO2 or

pO2. However, cartridges without these sensors may be tested with remaining

fluids if within 10 minutes of opening the ampule.

d) Immediately transfer the solution to the cartridge.

e) On the i-STAT select MENU, #3 Quality Tests, #3 Cal Verification.

Linearity Documentation

Print the linearity record from RALS. Compare each level of linearity to the value

assignment sheet (print at www.abbottpointofcare.com), taking note of appropriate

cartridge, cartridge lot alpha character and CLEW version number. Date and initial

each sheet for review. Complete the i-STAT linearity coversheet. Attach i-STAT

linearity coversheet and the value assignment sheet to the linearity record printouts.

File completed record in the i-STAT linearity file cabinet by cartridge type. Sticker

cartridge boxes “This lot is Ready for Use” (green).

Remedial Action:

If any results are outside the published expected ranges:

DO NOT USE cartridges from the suspect lot.

Quarantine the suspected lot.

POC will follow up with technical support.

http://www.abbottpointofcare.com/


F. QC REQUIREMENTS

TABLE #4 – EXTERNAL QC

From each lot of cartridges received, run the appropriate levels of control material. Controls

must be run before putting cartridges into use and monthly thereafter on each lot available.

See below for Point of Care stickers indicating use. The QC samples must be rotated amongst

all testing personnel from all testing sites. The Point of Care Team will coordinate the

scheduling of staff and maintain quality control documentation in the laboratory.

1. Internal Calibration The performance of each handheld analyzer in the i-STAT system is verified by the

internal Electronic Simulator with every cartridge use. If Simulator FAIL is

displayed on the analyzer screen, run the external simulator.

2. External Simulator – The external electronic simulator is a quality control device for

the analyzer’s cartridge signal-reading function. It simulates two levels of electrical

signals that stress the analyzer’s cartridge signal detection function both below and

above measurement ranges.

Remedial Action:

Turn the analyzer on

Select menu

#3 Quality Tests

#4 Simulator

Scan or enter operator ID

Scan or enter simulator ID

Insert simulator

Analytes Controls Frequency

WAIVED

E3 Level 1, Level 2, Level 3 3 levels, once per shipment

Creatinine Level 1, Level 2, Level 3 3 levels, once per shipment

MODERATELY COMPLEX

G3, EG7, CG4 Level 1, Level 2, Level 3 3 levels monthly, each lot in use

ACT Level 1 and Level 2 ACT Control 2 levels monthly, each lot in use

PT/INR Level 1 and Level 2 PT/INR

Control

2 levels monthly, each lot in use

Troponin Troponin Level 1, Level 2, Level 3 2 levels monthly – one normal

level, one abnormal level, each

lot in use

Chem8 Level 1, Level 2, Level 3 3 levels monthly, each lot in use

Refrigerate Immediately Store 2-8C, do not allow to come to room temperature

DO NOT USE this lot number QC has not been run, do not use for patient testing

This lot is ready for use QC has been run, satisfactory for patient testing


Allow simulator to complete 60 second test cycle. Verify that the simulator has

passed.

Remove by paging to #1 Test Options.

If PASS is displayed use the analyzer as required.

If FAIL is displayed repeat the procedure with a different external Electronic

Simulator.

If PASS is displayed with the second Electronic Simulator:

Use the analyzer as required.

If FAIL is displayed with the second Electronic Simulator:

DO NOT analyze patient samples with the analyzer. Return i-STAT and

Simulator to the POC office.

G. PROCEDURE – QC

1. Procedure for testing cartridges with i-STAT TriControls Level 1, 2 and 3

Controls

a) Prior to testing cartridges that measures pO2, ampules should stand at room

temperature a minimum of 4 hours before use. When testing other cartridges,

ampules may be used once the fluid has reached room temperature, approximately

30 minutes for individual ampules. For best results, ampules, cartridges and

analyzers should be at the same temperature.

b) Immediately before use, shake the ampule vigorously for 5-10 seconds to

equilibrate the liquid and gas phases. To shake, hold the ampule at the tip and

bottom with forefinger and thumb to minimize increasing the temperature of the

solution. If necessary, tap the tip of the ampule to send solution back into the

bottom section of the ampule. Protect fingers with gauze, tissue, or glove, or use

an ampullate breaker to snap off the tip of the ampule at the neck.

c) Immediately transfer the solution from the ampule into a syringe.

When using a syringe (1 cc or 3 cc syringes with 16 to 20 gauge needles are

recommended), slowly draw approximately 1 mL of solution from the bottom

of the ampule. If air is trapped between the leading edge of the solution and

the plunger, do not invert the syringe to expel it; this will not affect solution

near the tip of the syringe. If air bubbles are continually drawn into the

syringe, or if a bubble is trapped near the tip of the syringe, discard the

ampule and syringe and use a fresh ampule or syringe. Expel one or two

drops from the syringe before filling the cartridge.

Do not use solution left in the syringe, ampule, or capillary tube for additional

testing of the cartridges that contain sensors for ionized calcium, pH, pCO2 or

pO2. However, cartridges without these sensors may be tested with remaining

fluids if within 10 minutes of opening the ampule.

d) Immediately transfer the solution to the cartridge.

e) On the i-STAT select MENU, #3 Quality Tests, #1 Control.

f) Compare the results to the value assignment sheets taking note of appropriate

cartridge, cartridge lot alpha character and CLEW version. QC ranges that have

been uploaded to RALS for eVAS should be corrected and appear on the QC

report.


g) Remedial Action:

If any results are outside the published expected ranges:

DO NOT USE cartridges from the suspect lot.

Quarantine the suspected lot.

POC will follow up with technical support.

2. Procedure for testing cartridges with i-STAT Level 1 and Level 2 ACT and

PT/INR Control: a) On the i-STAT select MENU, #3 Quality Test, #1 Control.

b) Prior to use, allow one vial each of the lyophilized plasma and calcium chloride

reconstituting fluid to stand at room temperature for a minimum of 45 minutes.

c) Remove the cap and stopper from the vials and pour the entire contents of the

calcium chloride vial into the lyophilized plasma vial. Place the stopper back on

the reconstituted vial.

d) Allow the vial to sit for 1 minute and then mix the contents by swirling gently for

1 minute, then inverting slowly for 30 seconds.

e) Use a plastic pipette, syringe, or capillary tube without anticoagulant to transfer

the solution to an ACT cartridge.

f) Immediately seal the cartridge and insert it into an analyzer. This process must be

completed within 30 seconds of the complete reconstitution of the control sample.

g) Compare the results to the value assignment sheets taking note of appropriate


been uploaded to RALS for eVAS should be correct and appear on the QC report.

h) Remedial Action: If any results are outside the published expected ranges:

Quarantine and DO NOT USE cartridges from the suspect lot.

Record the QC failure in the i-STAT QC Action Log along with the action

taken.

3) Procedure for testing cartridges with i-STAT cTnl (Troponin) Control Level 1, 2

and 3:

a) On the i-STAT select MENUS, #3 Quality Test, #1 Control.

b) Remove vial from refrigerator, run immediately.

c) Thoroughly mix by gently swirling the bottle. Avoid foaming of the sample.

d) Dispense a drop of sample directly from vial into the i-STAT cTnl cartridge and

seal the cartridge. Tightly recap the bottle immediately after all sampling is

complete and store at 2-8C. Open vials are stable for 30 days at 2-8C.

e) Compare the results to the value assignment sheets taking note of appropriate


been uploaded to RALS for eVAS should be corrected and appear on the QC

report.

f) Remedial Action: If any results are outside the published expected ranges:

Quarantine and DO NOT USE cartridges from the suspect lot.

Record the QC failure in the i-STAT QC Action Log along with the action

taken.

H. QC DOCUMENTATION: Print QC record from RALS for each lot of QC run. Date

and initial each sheet for review. Acceptable ranges should appear on QC record. If

ranges are not available, notify technical specialist and refer to value assignment sheet


(print at www.abbottpointofcare.com). Place in monthly i-STAT QC book. File by

cartridge type.

I. EPIC ORDER CODES

Arterial blood gas line draw (RT85)

Arterial blood gas puncture (RT43)

POC i-STAT blood gas other (POC215) – (cord, venous, mixed venous or

capillary)

J. PROCEDURE FOR ANALYSIS

1. Procedures for Specimen Collection a) In-Dwelling Line

Back fill the 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 5 mL saline

and discard the first 5mL of blood.

b) Venous Sample

Collect the sample using phlebotomy procedure. Use appropriate collection

device for cartridge/test required. Refer to Table 1.

NOTE: Mix blood and anticoagulant by rolling the syringe between palms for at least

5 seconds and inverting the syringe 5 seconds. Mix vacutainer by inverting for 5

seconds. Remove blood from tube using needless transfer pipette.

Precautions for Sample Collection

Do not draw from an arm with an IV.

Do not draw from a site if tourniquet is left on greater than one minute.

Do not have patient pump fist.

Avoid traumatic puncture – hemolysis.

Do not ice the samples.

Do not delay before closing cartridge – ACT or PT/INR.

Do not expose the sample to AIR.

Do not draw a lactate sample using a tourniquet.

2. Procedures for Patient Testing

a) Turn on the instrument

b) Select #2 – iSTAT cartridge

c) Scan or enter correct operator ID number.

d) Scan or enter the patient ID number (billing/visit #). MIB patients have a blue

wristband

e) Scan the cartridge lot #

f) Remove the cartridge from its pouch. Avoid touching the contact pads or exerting

pressure over the calibrant pack in the center of the cartridge.

g) Direct the dispensing tip, the capillary tube containing the blood or a hanging

drop from a fingerstick into the sample well.

h) Dispense the sample until it reaches the fill mark on the cartridge and the well is

about half full.

http://www.abbottpointofcare.com/


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

pressure over the calibrant pack)

j) Insert the cartridge into the cartridge port until it clicks into place. Never attempt

to remove a cartridge while the message “Cartridge Locked” is displayed. Place

the instrument on a stationary surface. Do not move during testing. The analyzer

must remain horizontal during the testing cycle.

k) Enter additional parameters on the Chart Page

Required Field

Sample Type: Choose the number corresponding to the sample type used

when prompted at the Sample Type field. Select CPB for patient in

cardiopulmonary bypass surgery (only available on specific cardiac OR

instruments)

Optional Field

Patient temperature must be entered as degrees C (Celsius only). Only

values between 10 and 45 are interpreted as degrees Celsius. Use the

. (period) key on the i-STAT Portable Analyzer for a decimal point.

Temperature corrected results will be calculated.

FIO2 can be entered as the number of liters or as a percentage of the

oxygen a patient is receiving. Enter this only if analyzing a blood gas

sample.

Fields 1, 2, and 3 are user-defined fields, typically used for ventilator

settings such as PIP or PEEP.

l) If partial results are shown, any parameter(s) resulting with * repeat with a new

cartridge selecting the entire panel.

m) At the completion of the test cycle (audible alarm), view results shown on the

analyzer’s display screen.

n) If Action Range Flag, Scan or Enter Code ____ appears, enter “1” as the comment

code for critical values. Critical values are indicated with or following the

value(s). Print results option will not work until Comment Code is entered.

o) Remove the cartridge after testing. Scroll until Test Options appears on the

bottom of the screen, Enter “1”. Follow prompt for continued testing.

p) Clean the i-STAT analyzer after each patient use. Wipe exterior with Clorox

Germicidal wipes for 1 full minute or 3 minutes for isolation patients. Refer to

Point of Care Device Cleaning and Disinfecting Guide.

3. Alternative Procedure Should the i-STAT System become inoperable for any reason, specimens other than

ACT can be collected and submitted to the laboratory in accordance with the

Laboratory Procedure Manual.


K. REFERENCE RANGE/REPORTABLE RANGE/CRITICAL VALUE

TABLE #6 – REFERENCE AND REPORTABLE RANGES

Test Units Bassett

Reportable Range

Measured Reference Range

Critical Values

Arterial Venous Cord Arterial Cord

Venous Capillary Below Above

Na mmol/L 100-180 135-145 135-145 120 155

K mmol/L 2.0-9.0 3.4-4.5 3.4-4.5 2.8 6.0

Chloride

BUN

Glucose Fasting

Glucose Random

Creatinine***

iCal

Hct

mmol/L

mg/dL

mg/dL

mg/dL

mg/dl

%PCV

65-140

3-140

25-600

0.1-20.0

1.0-10.0

15-68

98-110

70-100

70-139

F 7-17

M 9-20

4.2-5.4

F 34-46

M 35-50

98-110

70-100

70/139

4.2-5.4

F 34-46

M 35-50

40

3.0

21

450

6.5

60

pH 6.5-8.0 7.35-7.48 7.33-7.43 7.20-7.45

CV <7.10

7.20-7.45

CV <7.10

7.35-7.45 7.25 7.60

PCO2 mmHg 20-110 32-48 40-50 38-54 38-54 32-48 23 (art) 60 (art)

PO2 mmHg 10-500 83-108 29-49 10-24 10-24 80-90 45

(art/cap)

Lactate

Troponin

mmol/L

ng/mL

0.3-18.0

0.1-35

0.4-1.3

0.9-1.7

<0.1

>3.9

>0.6

HCO3*

TCO2*

SO2*

BE*/**

mmol/L

mmol/L

%

mmol/L

1-85

5-50

0-100

(-30)-(+30)

21-28

19-32

95-98

(-2)-(3)

22-29

22-34

60-85

<3

15-25

20-34

60-98

(-6.2)-(-0.5)

15-25

20-34

60-98

(-6.2)-(-0.5)

22-27

33-43

90-100

Below**

* = Calculated values

**= Newborn-1 week=(-10)-(-2), 1 week-1 yr=(-7)-(1), 1-16 yr=(-4)-(+2), >16 yr=(-3)-(+3)

***=GFR calculation uses the IDMS-traceable MDRD equation.

GFR (ml/min/1.73m2) = 186 x (PCR)

-1.154 x (Age)

-0.203 x (0.742 if female) x (1.210 if African American)

Test Units Reportable

Range

Reference Range Critical Values

Arterial Venous Capillary Below Above

ACT Sec. 50-1000 Baseline 100-140 Cath Lab Interventional Cases Therapeutic Range=200-300 sec. Cardiac OR Baseline 100-140 sec.

100-140

INR**** <0.9-1.9 Routine Oral-Anticoagulants Mechanical Valves Normal Range

2.0-3.0 2.5-3.5 0.9-1.1

4.4

****Send Confirmatory sample to lab when INR >1.9

Reference Ranges , Reportable Ranges: 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 table contains the Reference Ranges (for adults) and Reportable Ranges applicable to

the i-STAT System.


L. RESULTS REPORTING

1. Calculations

The i-STAT analyzer contains a microprocessor that performs all calculations

required for reporting results. BE, HCO3, CO2, O2 SAT and Hgb are calculated.

2. 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.

3. Point of Care Testing Critical Value Reporting:

The i-STAT instrument will prompt the operator when there is a critical value. The

critical value comment code must be entered before proceeding to print or download

results. Enter comment code “1”, “Critical Value Policy Followed.” The appropriate

comment will appear in Epic after downloading. i-STAT values are considered

definitive and no confirmations are required, EXCEPT for any INR’s >1.9 require a

venous confirmation.

The Acute Care Nursing areas and Respiratory Therapy have protocols for repeating

and reporting critical values based on patient condition and history. For non-acute

care nursing units, critical values are reported to the provider within 30 minutes.

4. Suppressed Results

There are three conditions under which the i-STAT System will not display results:

a) Results outside the System’s reportable ranges are flagged with a < or >,

indicating that the result is below the lower limit or above the upper limit of the

reportable range, respectively. (See Table 6 Reportable Ranges.) The <> flag

indicates that the results for this test were dependent on the result of a test flagged

as either > or <.

Action:

Send specimen(s) to the laboratory for analysis.

b) 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. Retest

for the full panel. If the result is suppressed again, send specimen(s), other than

ACT, to the laboratory for analysis in accordance with the Laboratory Procedure

Manual.

c) A Quality Check message will be reported instead of results if the analyzer

detects a problem with the sample, calibrant solution, sensors, or mechanical or

electrical functions of the analyzer during the test cycle.

Action:


Squeeze cup lid to gain access to paper roll

Take the action displayed with the message that identifies the problem. Contact

the Point of Care office at 6728 who will then refer to i-STAT System Manual’s

Troubleshooting section if necessary.

5. Printing and Transmitting Results

a) Printing Results from the i-STAT Analyzer to the Portable Printer:

Align the IR windows of the analyzer and the portable printer within 1 to 6

inches of each other or place analyzer in a Downloader or

Downloader/Recharger if printer attached.

To print the displayed results, press the Print key.

Do not move analyzer or printer until the printout is complete.

Optional: Write the patient’s name on the “Pt Name” line and the physician’s

name on the “Physician” line.

Note: Results printed on thermal paper will fade with time and are therefore not

acceptable as a permanent chartable record.

6. Uploading to RALS: Upload i-STAT non-wireless (gray) results after each test by placing the analyzer in

the table top downloader or downloader/recharger. View the analyzer connecting,

“Communication in Progress” is displayed and return to idle. DO NOT remove i-

STAT downloader during transmission (arrows form a circle). Remove i-STAT from

table top downloader. Wireless units (blue) will automatically upload following

completion of testing. Allow i-STAT to remain in downloader/recharger if the

instrument has a rechargeable battery. Dock analyzer if wireless network is down.

7. Data Review:

a. Last result

Turn meter on

Choose number 1 – Last result

The most recent result performed will display

b. All results

Turn meter on

Press “menu” button

Choose #2 – Data Review

Choose #1 – If Patient ID known

Choose #6 – To list all tests beginning with most recen

M. MAINTENANCE

1. Cleaning:

a. Clean the display screen and the exterior of the i-STAT using the Clorox

Germicidal wipes. Refer to the Point of Care Devices – Cleaning/Disinfecting

Guide for specific instructions and dwell.

2A. Martel Printer – paper replacement a. To replace the paper, open the paper cup

lid by squeezing the lid as shown in the


1.

illustration and remove any remaining

paper by pressing the paper feed button.

Do not pull paper through the printer

mechanism. b. Reel off a few centimeters from a new roll

of paper and check that the end has clean

straight edge.

c. Slide the leading edge of the paper

through the paper entry slot, with the

leading edge of the paper feeding

forwards from the bottom of the roll, until

you feel resistance.

d. Press the paper feed button, and feed the

paper through the printer mechanism.

e. Keep the paper feed button depressed

until enough paper is fed through the

printer mechanism to pass through the

paper exit slot.

f. Sit the new paper roll in the paper cup and

close the lid.

POSITION OF PAPER ROLL IN PRINTER

2B. i-STAT Printer – Paper Replacement a. The STATUS indicator will illuminate to indicate the print status:

Ready: Green

Out of Paper: Orange

Error: Red

b. Paper for the i-STAT Printer can be installed or replaced as follows:

1) Open the paper compartment lid by pulling the release lever as shown in the

printer illustration and remove any remaining paper.

2) Reel off a few centimeters of paper from the new paper roll, with the leading

edge of the paper feeing forward from the bottom of the roll.

3) Sit the new paper roll in the compartment such that the leading edge is resting

outside the compartment on the printer casing.


4) Close the lid until it snaps into place.

Note 1: Should the printer become creased or misaligned, simply reload the paper as

described above ensuring that the paper has a clean, straight edge.

Note 2: When removing a printout from the printer, pull the printout toward the front

of the printer and tear from one side to the other across the serrated edge.

3. Replacing Batteries

a. Battery Compartment is located at the display end of the analyzer.

b. Wait until any test in progress is completed, and turn off the analyzer before

replacing the batteries or the most recent set of results may be lost. Stored

results will not be lost when replacing the batteries.

c. Lithium batteries are available from the warehouse.

d. Slide the battery compartment door off.

e. Tilt the analyzer slightly to slide out the

battery carrier, which contains two 9-volt

lithium batteries.

f. Remove old batteries from the carrier. Pull

each battery out to the side, then lift back and

out.

g. Note the battery orientation symbol molded into the

carrier on each side of the center wall. Starting with

one side, orient the new battery so it matches the

symbol. Slide the battery into the carrier, pushing the

terminal end in first, under the plastic bar, and slide it

up as far as it will go. Then push the bottom of the

battery inward. The terminals of the battery should be

underneath the protective bar on the carrier. Repeat for

the second battery on the other side of the carrier.


h. Note orientation of the battery carrier illustrated on

label on the carrier. The label faces up and the electrical

contact end of the carrier goes into the instrument first.

Insert the carrier into instrument as shown on label. If

carrier is inserted incorrectly, battery door will not

close.

i. Slide the battery compartment door back into place.

N. TROUBLESHOOTING

Overview

When the analyzer is turned on using the On/Off key, the analyzer performs self-checks.

If a condition that should be corrected in the near future, but that will not affect results is

detected, a warning is displayed. The operator presses the 1 key to continue with testing.

Technical Support Analyzer coded messages can be found in the Point of Care i-STAT procedure manual.

Call the Point of Care Office at X6728 for technical assistance.

O. REFERENCES

1. Statland, B.E., Clinical Decision Levels for Lab Tests. Medical Economics Books,

1987.

2. Tietz, N.W., Tietz Textbook of Clinical Chemistry, second edition, Ed. C.A. Burtis,

E.R. Ashwood, W.B. Saunders Company, Philadelphia, 1994. Table 41-20,

Appendix.

3. Kost, Gerald J. Using critical limits to improve patient outcome. Medical Laboratory

Observer. March 1993; 25(3): 22-27.

4. i-STAT System Manual

5. Fundamentals of Clinical Chemistry, N. Tietz, Third Edition, Pages: 426-435, 614-

616, and 676-678.

6. Clinical Chemistry Theory, Analysis & Correlation, Kaplan/Pesce, 2nd

Edition, Pages

850-856, 872-875, 884-888, and 1021-1024.


APPENDIX A

INTEFERING SUBSTANCES

The following substances are known not to significantly interfere with the i-STAT Lactate

assay at the stated test concentrations:

Substance Test Concentration

(mmol/L)

Acetaldehyde 0.04517

Acetaminophen 1.32

Acetylcysteine 10.2

Ascorbate 0.34

Bromide (therapeutic) 2.518-20

Dopamine 0.006

Formaldehyde 0.13317

Β-Hydroxybuterate 6.021

Pyruvate 0.31

Salicylate 4.34

Uric Acid 1.4

The following substances are known to interfere with the i-STAT Creatinine assay:


(mmol/L) Interference

Acetaminophen 1.32 Increased i-STAT creatinine results.

Acetylcysteine 10.2 Increased i-STAT creatinine results.

Ascorbate 0.34 Increased creatinine results by

approximately 0.3 mg/dL.

Bromide 37.5 Increased i-STAT creatinine results.

Creatine 0.382 Increased i-STAT creatinine results

by approximately 0.2 mg/dL.

Hydroxyurea 0.92 Increased i-STAT creatinine results.

Use another method.

The following substances are known to interfere with the i-STAT Ionized Calcium assay:



Acetaminophen 1.32 Decreased i-STAT ionized calcium

results.

Acetylcysteine 10.2 Decreased i-STAT ionized calcium

results.

Bromide 37.5 Increased i-STAT ionized calcium

results.

Magnesium 1.0

Increased i-STAT ionized calcium

results by approximately 0.04

mmol/L.

Lactate 6.6

Decreased i-STAT ionized Calcium


mmol/L.

Salicylate 4.34 Decreased i-STAT ionized Calcium

results.

Salicylate (therapeutic) 0.510

Decreased i-STAT ionized Calcium


mmol/L. .


APPENDIX A – CONTINUED

INTERFERING SUBSTANCES

The following substances are known to interfere with the i-STAT glucose assay:



Acetaminophen 1.32 Increased i-STAT glucose

results.

Acetylcysteine 10.2 Decreased i-STAT glucose

results.

Bromide 37.5 Decreased i-STAT glucose

results.

Bromide (therapeutic) 2.58,9,10

Decreased i-STAT glucose

results by approximately 5

mg/dl.

Hydroxyurea 0.92 Increased i-STAT glucose

results. Use another method.

Thiocyanate 6.9

Decreased i-STAT glucose

results by approximately 7

mg/dl.

The following substances are known to interfere with the i-STAT chloride assay:



Acetylcysteine 10.2 Decreased i-STAT chloride

results.

Bromide 37.5 Increased i-STAT chloride


Bromide (therapeutic) 2.58,9.10

Increased i-STAT chloride


Salicylate 4.34 Increased i-STAT chloride


Thiocyanate 6.9 Increased i-STAT chloride


The following substances are known to interfere with i-STAT sodium assay:



Bromide 37.5 Increased i-STAT sodium

results.


ER TROPONIN TESTING TIP SHEET

Initial i-STAT Troponin and lab Troponin will be collected on

appropriate chest pain patients in green top tubes and labeled

appropriately – one tube for each.

Scan the patient wristband when prompted for the patient ID.

Mix the sample gently, uncap, fill a syringe or pipette with about 1

ml. of blood, and insert immediately into the cartridge. If not

testing immediately, make sure the sample is well mixed again prior

to filling the cartridge.

After completion of the test, download the instrument, and print

results.

Only ONE initial i-STAT Troponin can be run on each patient.

Results >35 ng/ml should not be reported as the actual value. They

are reported as >35 ng/ml.

If the results error out, the test should not be repeated on the i-

STAT. Wait for the laboratory result.

Once the test is done, send the labeled i-STAT Troponin sample to

the laboratory so it can be saved for the appropriate length of time.

No paperwork is required.

Cartridges are available from the Point of Care office by calling

6728 between 8 – 4:30 Monday through Friday and 3731 off hours.

Store cartridges refrigerated until manufacturer’s outdate or at

room temperature for up to 2 weeks. Label cartridges stored at

room temperature with the room temperature outdate.

bassett healthcare point of care i-stat 1 procedurestore at 2 to 8 c. do not use after expiration...

Documents