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					NURSEQSE5:           Process Control

Title:               i-STAT Point of Care Testing Procedure

Source:              i-STAT System Manual

                     Fundamentals of Clinical Chemistry, N. Tietz, 3rd Ed., pp 426 - 435, 614 - 616, 676 - 678.

                     Clinical Chemistry Theory, Analysis and Correlation, Kaplan/Pesce, 2nd Ed., pp 850 - 856,
                     872 - 875, 884 - 888, 1021 - 1024.

Adopted:             05-18-09

Revised:             07-24-08, 01-16-09, 02-14/2011

Document #:          NURSEQSE5:96

Related Documents:   POCQSE1:01

Definition and       The i-STAT® System incorporates comprehensive components needed to perform
Purpose:             blood analysis at the point of care. The System consists of the following primary
                     components:

                     1.      Analyzers

                             Analyzer is the handheld 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 electrolytes,
                             chemistries, and hematocrit.

                     2.      Cartridges

                             A single-use disposable cartridge contains microfabricated sensors, a calibrant
                             solution, fluidics system, and a waste chamber. Sensors for analysis of sodium,
                             potassium, chloride, ionized calcium, glucose, creatinine, urea nitrogen (BUN),
                             and hematocrit are available in a variety of panel configurations. (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.

                     3.      Point-of-Care QCM3 Data System
                             The i-STAT QCM3 server provides the primary information management
                             capabilities for the i-STAT System. Downloaders for the i-STAT Analyzers allow
                             for transmission of patient records from a widely distributed network of
                             analyzers to the patient’s medical record. Data is stored, organized, edited,
                             and transferred to the laboratory and hospital information system. Cartridge
                             usage and efficiency reports can be generated for QCM3 management of the
                             system.


                                                                                      Page 1 of 20
I-STAT Point of Care Testing Procedure


Responsible Persons:     Anesthesia Doctors, CRNAs, RNs, LPNs, Pathologist, and Laboratory personnel,
                         completing i-STAT training with proven competency. Only trained operators with
                         proven competency may perform tests on the i-STAT analyzer.

Policies for Patient              iSTAT ANALYZERS SHOULD REMAIN ON FLAT SURFACE WHILE TESTING IS IN
Testing:                          PROGRESS!
                         1        Only i-STAT cartridges are approved for testing with the i-STAT instrument.
                         2        Cartridges should be refrigerated and should be used before the box
                                  expiration date.
                         3        Cartridges are good for 14 days after removal from the refrigerator.
                         4        After cartridges have been at room temperature greater than 5 minutes,
                                  never put cartridges back in the refrigerator
                         5        Do not touch the cartridge sensors while handling the cartridge.
                         6        Do not hold the cartridge with finger pressure.
                         7        Take care not to crush silver circle while handling the cartridges.
                         8        Do not overfill the cartridge. Only fresh whole blood samples obtained in the
                                  approved containers may be used to perform i-STAT testing.
                         9        Follow Standard Blood and Body Fluid Precautions.
                         10       Questionable results should be repeated with a new sample and or confirmed
                                  by Laboratory tests.
                         11       Use only 9 volt lithium batteries only.
                         12       Cartridges are good for only one use.
                         13       NEVER attempt to remove a cartridge while the monitor screen shows
                                  “Cartridge Locked”.
                         14       Verify patient identification before testing using the two identifiers required
                                  by Hospital SOP.

Supplies and Storage     Cartridges
Requirements:                    Cartridges are sealed in individual pouches. 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). When you remove a cartridge from the box
                                 stamp or write Expires and the date 14 days from the day it is removed.
                                 Cartridges should remain in pouches until time of use. Do not use after the
                                 labeled expiration date.

                         Electronic Simulator
                                 Used for instrument failure or maintenance, the electronic simulator is stored in
                                 a secure location. Unit managers are responsible for the security and location
                                 of the 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.



                                                                                             Page 2 of 21
I-STAT Point of Care Testing Procedure



Cartridges:       Table 1: Cartridge Panel Configurations and Blood Volume

     Cartridge     Vol.   NA    K    CL   GLU    BUN    CRE     TCO2       iCA   PH    HCT     HGB*     Anion
                                                                                                        Gap *
                    L

     Chem8+         95                                                                          

         G          65                     

       CREA         65                                    

       EG7+         95                                                           

      Lab Only!

    *Calculated


Specimen Collection:      Table 2: Collection Device and Anticoagulant

                                                       Collection Options
     Cartridges
                                                                                                Directly from
                             Syringes             Evacuated Tubes         Capillary Tubes      Skin Puncture
     Cartridges      ● Without anticoagulant    ● With lithium           ● With balanced      ● Not
     which           ● With balanced            heparin                  heparin              recommended
     measure         heparin anticoagulant      anticoagulant (tube      anticoagulant
     ionized         (syringe must be filled    must be filled to
     calcium         to labeled capacity        capacity)
     All other       ● With lithium heparin     ● With lithium           ● With lithium       ● Capillary tube
     cartridges      anticoagulant              heparin                  heparin              is preferred
                                                anticoagulant            anticoagulant        when
                                                                         ● With lithium       transferring a
                                                                         heparin if labeled   sample from a
                                                                         for the              skin puncture to
                                                                         measurement of       a cartridge
                                                                         electrolytes




                                                                                                Page 3 of 21
I-STAT Point of Care Testing Procedure


Essential iSTAT Specimen Collection Techniques:        Table 3
    Sample Type                Venous               Arterial          In-dwelling line        Capillary
Blood Flow             Collection technique resulting in good blood flow must be used. Inadequate blood
                        flow may produce erroneous results.

Fill Requirements              Fill blood collection tubes with and without anticoagulant to capacity.
                               Fill syringes to capacity
See Table 2 for                Only fresh whole blood samples are for use with the
collection device and           i-STAT System.
anticoagulant
information.            Note: Incomplete filling of anticoagulated tubes and syringes will cause higher
                        heparin-to-blood-ratios. This will decrease ionized calcium, CO2 and other results.
Sample Mixing           Gently mix blood immediately to avoid clotting.
                            Invert blood collection tubes at least 10 times
                            Roll syringe vigorously between the palms for at least 5 seconds each in two
                                different directions and then invert repeatedly for 5 seconds

                         Note: It may be difficult to properly mix a sample in a 1cc syringe
Time to Test                 For most accurate results test sample immediately
                             iCA should be tested within 10 minutes of collection
                             Capillary should be tested within 3 minutes of collection
Exposure to Air              Avoid exposing the sample to air for ionized calcium, PH and CO2
                             Expel any air bubbles immediately


Precautions when        1          I.V. Line: Avoid drawing from an arm with an I.V. line. I.V. solutions will
Drawing Blood:                     dilute the sample and may interfere with the tests.
                        2          Tourniquet: Venous stasis (prolonged tourniquet application) and forearm
                                   exercise may increase ionized calcium due to a decrease in pH caused by
                                   localized production of lactic acid.
                                   If a tourniquet is applied for more than one minute while looking for a vein,
                                   release and reapply after two to three minutes.
                                   Allow the tourniquet to remain in place until all blood is withdrawn to
                                   prevent changes in ionized calcium and pH results.
                        3          Muscle Activity: Avoid extra muscle activity, such as clenching and
                                   unclenching the fist, which may increase potassium results.
                        4          Hemolysis: Avoid hemolysis (bursting of red cells) by
                                         Allowing residual alcohol to dry over the puncture site.
                                         Discarding a sample from a traumatic draw.

                                   Hemolysis will cause an increase in potassium results and a decrease
                                   in calcium results.
                        5          Tube Order: Collect blood collection tubes in the prescribed sequence to
                                   avoid interference due to carry-over of additive from one tube to the next:
                                            No additive
                                            Heparin
                                            EDTA

                                                                                            Page 4 of 21
I-STAT Point of Care Testing Procedure


                        6          Sample on Ice: Fill the cartridge before icing the sample for transport. Icing
                                   will increase the potassium and will affect oxygen levels in samples collected
                                   in plastic syringes.
                        7          Repeat Test : If a repeat measurement is needed, a fresh sample must be
                                   obtained.
                        8          Specimen Labeling: The specimen container must be labeled with the
                                   following information if testing does not begin immediately:
                                             Patient first and last name
                                             Patient ID number
                                             Time and date of collection
                                             Phlebotomist ID

Criteria for Specimen    1        Evidence of clotting.
Rejection:               2        Specimens collected in vacuum tubes with anticoagulant other than lithium or
                                  ammonium heparin.
                         3        Syringe with microtainer or capillary tubes with air bubbles in sample.
                         4        Other sample types such as urine, CSF, and pleural fluid.

                                PROCEDURE FOR HANDLING CARTRIDGES

Preparation for          Step     Action
Testing:                 1        Select the cartridge: Select the appropriate cartridge for the test or tests
                                  required. While the cartridge is not fragile, it should be handled to avoid
                                  quality failures.
                         2        Room temperature: A cartridge should not be removed from its protective
                                  pouch until it is at room temperature (18 – 30°C or 64 – 86 °F). For best
                                  results, the cartridge and analyzer should be at the temperature of the room
                                  where they are to be used. Condensation on a cold cartridge may prevent
                                  proper contact with the analyzer. Allow a single cartridge to stand for 5
                                  minutes and a box of cartridges for 1 hour at room temperature before use.
                                  Use a cartridge immediately after removing it from its protective pouch –
                                  prolonged exposure may cause a cartridge to fail a Quality Check. If the
                                  pouch has been punctured, the cartridge should not be used. Once cartridges
                                  have been brought to room temperature, they should not be returned to the
                                  refrigerator. Cartridges may be stored at room temperature for two weeks.
                                  Write the two week expiration date on the package, if it is out more than 5
                                  minutes and not used.
                         3        Contact Pads: Do not contaminate the contact pads with fingerprints or talc
                                  from gloves, as the analyzer may not be able to make proper contact with the
                                  cartridge.
                         4        Calibrant Pack: Do not apply pressure to the central area of the label as the
                                  calibrant pack inside could burst prematurely.
                         5        Air Vent: Do not block the air vent, as the sample will not flow to the fill mark
                                  and the calibrant solution will not flow to the sensors.Air Vent
                         6        Contamination: To avoid contaminating the analyzer, do not use a cartridge
                                  on which blood or any other fluid has spilled. Avoid filling cartridges on
                                  surfaces that may cause the cartridge to pick up fibers, fluid, or debris that
                                  may lodge in the analyzer.
                                                                                              Page 5 of 21
I-STAT Point of Care Testing Procedure



Filling and Sealing      1        Procedure:
Cartridge Using                   a.     Place the cartridge on a flat surface or hold it in a horizontal position.
Transfer Device:                  b.     Direct the tip of the syringe, capillary tube or dispenser into the
                                         sample well.
                                  c.     Dispense sample slowly and steadily until it reaches the fill mark
                                         indicated on the cartridge label. Leave some sample in the sample
                                         well.
                                  d.     Fold the snap closure over the sample well.
                                  e.     Press the rounded end of the closure until it snaps into place.

Inserting and            1        Inserting:
Removing the                      a.      Align the cartridge with the contact pads facing up and toward the
Cartridge from the                        cartridge port.
Analyzer:                         b.      Push the cartridge slowly and smoothly into the cartridge port until it
                                          clicks.
                         2        Removing:
                                  a.      Do not attempt to remove the cartridge while the message “Cartridge
                                          Locked” remains on the screen.
                                  b.      When results are displayed, pull the cartridge straight out of the
                                          analyzer.
                                  c.      Dispose of the cartridge in a container for biohazards, following local,
                                          state, and national regulatory guidelines.

Incorrect Procedure:     The cartridge is designed to fill and seal correctly. However, certain conditions may
                         occur, especially during the training period. If such a condition is not detected by the
                         operator, the analyzer will detect the condition, halt the test cycle and display a cause
                         message followed by the action message,” USE ANOTHER CARTRIDGE.”

Procedure for            Preparation for Use:
Analysis:                An individual cartridge may be used after standing 5 minutes, in its pouch, at room
                         temperature.
                         Procedure for Cartridge Testing:
                         ALWAYS VERIFY THE CARTRIDGE EXPIRATION DATE BEFODRE TESTING!
                         Step     Action
                         1        Press the On/Off key to turn the analyzer on.
                         2        Press two for the i-STAT Cartridge from the Menu
                         3        Scan the operator ID number. Repeat Scan.
                         4        Scan the patient ID number. Repeat Scan
                         5        Remove the cartridge from the pouch. Handle the cartridge by the edge.
                                  Avoid touching the contact pads or exerting pressure over the center of the
                                  cartridge.
                         6        Gently mix blood (whether anticoagulated or not). Invert collection tube at
                                  least 10 times. Roll a syringe vigorously between the palms for at least 5
                                  seconds each in two different directions, then invert the syringe repeatedly
                                  for 5 seconds. Discard first two drops of blood.
                                  NOTE: It may be difficult to mix blood properly in 1 cc syringe.


                                                                                              Page 6 of 21
I-STAT Point of Care Testing Procedure


                         7       Avoid exposing the sample to air when testing venous samples for ionized
                                 calcium and pH. “A full vacutainer must be drawn for the ionized calcium and
                                 pH”. Partial draws are not acceptable specimens for testing iCA and pH.
                         8       For the most accurate results, test samples immediately after drawing.
                                 Samples for pH and ionized calcium should be tested within 10 minutes.
                                 Other analytes should be tested within 30 minutes.
                         9       Fold the snap cover over the sample well until it snaps into place. Press on
                                 round tab, not sample well.
                         10      Insert cartridge into cartridge port. NEVER TRY TO REMOVE THE CARTRIDGE
                                 ONCE THE INSTRUMENT SAYS CARTRIDGE LOCKED!
                         11      Message will appear that states “Identifying Cartridge” Wait until test menu
                                 appears.
                         12      Select the test ordered by the Physician from the cartridge you have chosen.
                                 Note: Choose the cartridge type with the least wastage of test not desired.
                         13      Choose the test you desire and press the corresponding number to select.
                         14      The test you choose will be backlit. If you do not want the test you chose
                                 press the corresponding number to deselect it.
                         15      Use the arrow key to move left or right. Choose the number corresponding to
                                 the type of sample used when prompted at the Sample Type field.
                                 A.       1-Arterial       B.      2-Capillary     C.      3-Arterial
                         16      View results shown on the analyzer’s display screen.




                                                                                         Page 7 of 21
I-STAT Point of Care Testing Procedure


Action Messages:          Table 4


    Display                           Action                             Analyzer Response/Comments

       >           The result falls above the reportable       If an iCA result is displayed as >2.5, the result
                   range of the test.                          should be reported as “greater than 2.5 mmol/L.”

       <           The result falls below the low end of the   If a PH result is displayed as < 6.5, the result should
                   reportable range of the test.               be reported as “less than 6.5.”

      <>           The result is dependent on another test     If a sodium result is displayed as >180, the
                   that has been flagged.                      calculations for potassium, chloride, BUN/Urea and
                                                               hematocrit, which depend upon the sodium
                   The <> flag will also be displayed for      measurement will be flagged < >.
                   TCO2, PH, PCO2, HCO3, anion gap, base
                   excess and sO2 if the TCO2 is outside
                   the reportable range. Because the
                   values outside the reportable range of
                   TCO2 are essentially non-physiological,
                   the TCO2 range check is used as an
                   additional quality check on the validity
                   of underlying PH and PCO2 results.

      ↑            The result is above the high action         If the action ranges for potassium are 3.2 and 5.5,
                   ranges.                                     a result of 6.0 will be displayed as 6.0 

      ↓            The result is below the action range.       If the action ranges for potassium are 3.2 and 5.5,
                                                               a result of 3.0 will be displayed as 3.0 

      ***          The signals from a particular sensor are    The sample should be retested using another
                   uncharacteristic. Uncharacteristic          cartridge and sample.
                   signals can be caused by a compromised
                   sensor or by an interferent in the          If the stars reappear, send a specimen to the
                   sample. This flag also appears for any      Laboratory for analysis in accordance with the
                   test dependent on another test which is     Laboratory Procedure Manual.
                   flagged with stars.

                   Step      Action

                   17        Test results considered as Panics, will display an up arrow for increased results
                             and down arrow for decreased test results. It is always good laboratory practice
                             to verify Panic values by repeat testing before treatment is administered. If the
                             results obtained on the iSTAT are questioned for any reason a second sample
                             should be drawn (draw enough to fill tubes to send to the Laboratory if necessary)
                             and a repeat test done on the iSTAT.
                   18        ENTER COMMENT CODE 1 REPEAT TEST this will notify POC personnel to credit the
                             first cartridge. Should the results still be questioned order the appropriate
                             Laboratory test in Cerner.
                   19        Star outs **** indicate the electronic sensors were compromised. Obtain a new
                                                                                                Page 8 of 21
I-STAT Point of Care Testing Procedure


                           sample and perform the test again.
                           Tests that show the < or > are outside the cartridge reportable range and must be
                           verified by having the test performed in the Laboratory.
                  20       A comment code corresponding to the action taken when panic results are obtained
                           will be requested by the i-STAT. You will not be able to perform another test on
                           the i-STAT until the comment code is entered.
                           Enter the number corresponding to the action taken:
                           a.       0 - No Action Required
                           b.       1 - Repeat Test
                           c.       2 - Procedure Error
                           e.       12 - Dr. Notified
                           f.       10 - Lab Verification Requested
                  21       Warning Message, if testing is disabled due to a warning message, the condition
                           must be corrected and the analyzer must be turned off and back on again before
                           testing is enabled.
                  22       Remove the cartridge after Cartridge-Locked message disappears.
                  23       The i-STAT is ready to perform next test.

Results:          1        Calculations: The i-STAT analyzer contains a microprocessor that performs all
                           calculations required for reporting results.
                  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. Reference ranges are marked on the bars by tic
                           marks. When all tests values are within their reference ranges, the tic marks will be
                           centrally aligned. The bar graphs can be used as a visual cue for distinguishing
                           between “normal” and “abnormal” results. If the value exceeds the reference
                           range, the bar graph may be rescaled to show the reference range and value in
                           relation to the measurement range.
                  3        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 the table of 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.
                                   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.
                            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.

                                                                                            Page 9 of 21
I-STAT Point of Care Testing Procedure


                                   Action:
                                   Take the action displayed with the message that identifies the problem.
                                   Refer to the i-STAT System Manual’s Troubleshooting section if necessary.
                  4        Printing Results from the i-STAT Analyzer to the Portable Printer:

                           a.     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.
                           b.     To print the displayed results, press the Print key.
                           c.     Do not move analyzer or printer until the printout is complete.
                           d.     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.
                           e.     Tone beeps. In this case repeat the transmission process. If unsuccessful
                                  the second time, notify the i-STAT System Coordinator.
                  5        Transmitting Results from the i-STAT Analyzer to the Central Data Station:

                           a.     Place analyzer in a Downloader or Downloader/Recharger.
                           b.     Do not move analyzer while the message “Communication in Progress” is
                                  displayed.
                           c.     The analyzer should be downloaded after use. ALWAYS RETURN THE
                                  ANALYZER TO THE STORAGE LOCATION UPON COMPLETION OF TESTING!
                           d.     If the arrows fail to chase, the transmission was not successful, notify i-
                                  STAT Coordinator or designee.
                  6        References 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 neonates)
                           and Reportable Ranges applicable to the i-STAT System.




                                                                                         Page 10 of 21
I-STAT Point of Care Testing Procedure


  Test Ranges: Table 5
               ANALYTE                 UNIT          REFERENCE RANGE         PHB NEONATAL          REPORTABLE
                                                                            REFERENCE RANGE          RANGE
                                                                               0 – 30 DAYS
               Sodium                 mmol/L              138 - 146             133 – 146            100 - 180
              Potassium               mmol/L               3.5 - 4.9            3.7 – 5.9             2.0 - 9.0

               Chloride               mmol/L               98 - 109              98 - 113             65 - 140
             TCO2                                                                                      5 - 50
                                      mmol/L               26 - 34               13 - 22
      Chem 8 cartridge only

                 BUN                   mg/dL                8 - 26                4 - 19              3 - 140

               Glucose                 mg/dL               70 - 99               50 - 80              20 - 700

              Creatinine               mg/dL               0.6 - 1.3             0.1 - 0.3           0.2 - 20.0

              Hematocrit               %PCV                38 - 51               44 - 64              10 - 75

                 Hb*                    g/dL               12 - 17               14 - 24               3 - 26

       *Calculated values.

            Ionized Calcium           mmol/L             1.12 – 1.32         2 D 1.00 – 1.18        0.25 – 2.50
                                                                             0 D 1.08 – 1.28

                  PH                                 Venous 7.31 – 7.41                             6.50 – 8.20

                                                     Arterial 7.35 – 7.45

              Anion Gap               mmol/L               10 - 20               10 - 20            (-10) – (+99)



        7                     Critical Results 3 (Action Range)

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




                                                                                               Page 11 of 21
I-STAT Point of Care Testing Procedure


Critical Test Values:     Table 6
           ANALYTE (units)                           ADULT                  CHILDREN               NEONATES
                                              low        high         low          high         low          high
             Sodium (mmol/L)                  121            159      121           156         125            150

           Potassium (mmol/L)                 2.6            6.4      2.6           6.4         2.5            7.0

              Glucose (mg/dL)                 41             699      41            174          35            150

             Creatinine (mg/dL)               –              7.4       –             3.9        0.2          2.0

           Hematocrit (%PCV)                  15.1       59.9         15.1         59.9          30            65

       Calcium Ionized (mmol/L                0.79       1.55          0.79        1.55         1.05         1.45

              TCO2 (mmol/L)                    <11           40        <11         40           <11          40

             Chloride (mmol/L)                                                                   86          120


  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. For example, in the table
  below, -hydroxybutyrate at sample concentration level of 16mmol/L would decrease the measured
  sodium by 5 mmol/L.


Interfering Substances:             Table 7

  ANALYTE            INTERFERENT               INTERFERENT                   EFFECT ON ANALYTE RESULT
                                               CONCENTRATION

  Sodium             -hydroxybutyrate         16mmol/L (166mg/dL)           Decrease () Na by 5mmol/L

                     Lactate                   20 mmol/L                     Decrease () NA by 5 mmol/L

                     Bromide                   37.5 mmol/L                   Increase () NA by 5 mmol/L

  Chloride           -hydroxybutyrate         16mmol/L (166mg/dL)           Increase () Cl by 3 mmol/L

                     Bromide                   12.5mmol/L(100mg/dL)          Increase () Cl by 30 mmol/L

                     Lactate                   11mmol/L (100mg/dL)           Increase () Cl by 3.5 mmol/L

                     Salicylate                4mmol/L                       Increase () Cl by 5 mmol/L

                     Thiocyanate               24 mmol/L                     May cause falsely elevated Cl results,
                                                                             or to be suppressed (***)

                                                                                               Page 12 of 21
I-STAT Point of Care Testing Procedure


  ANALYTE          INTERFERENT             INTERFERENT                    EFFECT ON ANALYTE RESULT
                                           CONCENTRATION

  Ionized          Magnesium               1 mmol/L above normal          Increase () iCa by 0.04 mmol/L
  Calcium
                   -hydroxybutyrate       20 mmol/L                      Decrease () iCA by 0.1 mmol/L

                   Lactate                 20 mmol/L                      Decrease () iCA by 0.05 mmol/L

                   Salicylate              4.34 mmol/L                    Decrease () iCA by 0.1 mmol/L

  Glucose          Bromide                 37.5mmol/L (300mg/dl)          Decrease () glucose by 30mg/dL
                   pH                      pH: per 0.1pH units below      Decrease () glucose by 0.9mg/dL
                                           7.4 @ 37° C                    (0.05 mmol/L)
                                           pH: per 0.1pH units above      Increase () glucose by 0.8mg/dL
                                           7.4 @ 37° C                    (0.04 mmol/L)


                   Oxygen                  PO2 < 20 mmHg @ 37°            May Decrease () glucose


                   Hydroxyurea             100mol/L                      Increase () 8mg/dL (0.44mmol/L)
                   Thiocyanate             24 mmol/L                      Decrease () glucose by approx. 23%

    BUN/Urea       Thiocyanate             24 mmol/L (140 mg/dL)          Decrease Urea by approx. 21%

  Creatinine
                   Acetominophen           For every 1 mmol/L             Increase() crea by 0.25 mg/dL
                                           acetominophin

                   Ascorbate               0.227 mmol/L                   Increase () crea by 0.7 mg/dL

                                                                          Increase () creatinine by 0.8mg/dL
                   Bromide                 12.5 mmol/L (100mg/dL)         from an initial Creatinine
                                                                          concentration of 1.0mg/dL

                   PCO2                                                   Increase () creatinine by 6.9% for
                   For Creatinine levels   Above 40 mmHg                  every 10mmHg PCO2
                   below 2 mg/dl:
                                                                          Decrease ()creatinine by 6.9% for
                                                                          every 10mmHg PCO2
                                           PCO2 below 40 mmHg

                                           {CR}corrected=[Cr]istat x {1
                                           – (0.69 x{(PC02 – 40)/10]) }

                   For Creatinine levels                                  Decrease () creatinine by 3.7% for
                   above 2 mg/dl:          PCO2 above 40 mmHg             every 10mmHg PCO2

                                                                                            Page 13 of 21
I-STAT Point of Care Testing Procedure


  ANALYTE          INTERFERENT           INTERFERENT                     EFFECT ON ANALYTE RESULT
                                         CONCENTRATION
                                         PCO2 below 40 mmHg              Increase () creat by 3.7% for every
                                                                         10mmHg PCO2

                                         [Cr]corrected=[Cr]istat x {1-
                                         (0.037 x[(40-Pco2)/10])}


                   Hydroxyurea           100mol/L                       Increase () 1.85mg/dL (164mol/L)

                   Creatine              5 mg/dl (382 mol/L)            Increase () creat by 0.20 mg/dl
                   See note (1) below

                   N-acetylcycteine      16.6 mmol/L                     Increase () creat 0.4 mg/dl

                   Hydroxyurea           Hydroxia may cause              See note (2) for typical uses of this
                   (Droxia , Hydrea    significant errors in the       drug and note (3) below or details of
                                         measurement of creatinine       interference
                                         with the iSTAT system. Use
                                         an alternative method to
                                         measure Creatinine when
                                         patients have been
                                         administered hydroxyurea.
  HCT              White Blood Count        Greater than 50,000          May Increase () hematocrit
                   (WBC)                         WBC/L
                   Total Protein           For measured Hct<40%          Decrease () Hct by 1% PCV
                                           For each g/dL below 6.5       Increase () Hct by 1% PCV
                                           For each g/dL above 8.0
                                           For measured Hct40%          Decrease () Hct by 0.75% PCV
                                           For each g/dL below 6.5       Increase () Hct by 0.75% PCV
                   Lipids                  For each g/dL above 8.0
                                                                         Increase () HCT
                                              Abnormally high




                                                                                            Page 14 of 21
I-STAT Point of Care Testing Procedure



                Diprivan is a registered trademark of the AstraZeneca group of companies.
                Pentothol Sodium is a registered trademark of Abbott Labs, USA.
                Nesodonal Sodium is a registered trademark of Specia, France
                Intraval Sodium is a registered trademark of May and Baker, Ltd. England.
                Trapanal is a registered trademark of Chemische Fabrik Promonta, Germany


Notes:          1        The normal range of creatine concentration in plasma is 0.17 – 0.70mg/dl (13-53
                         mol/L) in males and 0.35 – 0.93 mg/dl (27-71 mol/L) in females. (It is possible that
                         other interfering substances may be encountered. These results are representative
                         and your results may differ somewhat due to test-to-test variation. The degree of
                         interference at concentrations other than those listed might not be predictable)
                         Creatine may be elevated in patients using creatine supplements, experiencing muscle
                         trauma or other primary or secondary myopathies, taking statins for hyperlipidemea
                         control; or in patients with hyperthyroidism or a rare genetic defect of the creatine
                         transporter protein.
                2        Hydroxyurea is a DNA synthesis inhibitor used in the treatment of various forms of
                         cancer, sickle cell anemia, and HIV infection. This drug is used to treat malignancies
                         including melanoma, metastatic ovarian cancer, and chronic myelogenous leukemia.
                         It is also used in the treatment of polycythemia vera, thrombocytopenia, and
                         psoriasis. At typical doses ranging from 500 mg to 2 gms per day, concentrations of
                         hydroxyurea in patients’ blood may be sustained at approximately 100 to 500 mol/L.
                         Higher concentrations may be observed soon after dosing or at higher therapeutic
                         doses.
                3        For every 100 mol/L hydroxyurea in the whole blood sample, creatinine will be
                         increased by approximately 1.85 mg/dl (164 mol/L) up to a whole blood hydoxyurea
                         concentration of at least 921 mol/L (maximum concentration tested). The
                         magnitude of the bias is independent of the creatinine level over a range of at least
                         1.0mg/dl (88mol/L_ to 12.4 mg/dl (1096 mol/L).
                4        Bicarbonate up to 40 mmol/L, bilirubin up to 20 mg/dl, (342mol/L), calcium up to 5.0
                         mg/dl (1.25mmol/L), dopamine up to 13mg/dl (0.85 mmol/L), methyldopa up to
                         2.5mg/dl (118.4 mol/L ), salicylate up to 77.5mg/dl (4.34 mmol/L), sarcosine up to
                         1.0 mmol/L, and uric acid up to 20 mg/dl (1190 mol/L) were tested and found not to
                         interfere with creatinine results.

                                          QUALITY CONTROL

Daily Procedures:       Electronic Simulator: An internal electronic check will be performed once a day on the
                        i-STAT analyzer when in use. The internal electronic check is initiated every 8 hours
                        when a cartridge is inserted into the cartridge port that contains a HCT test. Cartridges
                        without a HCT test will initiate the internal simulator to run every 24 hours, i.e. glucose
                        only cartridges. When you insert a cartridge and the message appears that an internal
                        check is being done, you verify that the analyzer does not show the message Locked
                        Cartridge then:
                        1         Remove the cartridge. (Make sure cartridge locked message is not on the
                                  screen.) When the internal simulator test is done you may reinsert your
                                  cartridge and proceed with testing.
                                                                                            Page 15 of 21
I-STAT Point of Care Testing Procedure


                        2        If the internal Electronic Simulator is used, the “PASS” message will not be
                                 displayed on the analyzer screen. The “PASS” record will appear in the
                                 analyzer’s stored results for transmission to the Central Data Station. Follow
                                 analyzer instructions after the internal test is complete to proceed with
                                 testing.
                        3        If FAIL is displayed for the internal simulator, reinsert the cartridge. If the test
                                 fails again, the external procedure must be followed.

External Electronic      1       Turn the analyzer on.
Simulator Procedure:     2       Press the Menu key to access the Administration Menu.
                         3       Press the 3 key for QualityTests.
                         4       Press the 4 key for Simulator.
                         5       Scan or enter the Operator ID.
                         6       Enter the Simulator ID (serial number).
                         7       Insert the simulator into the cartridge port.
                         8       View the results on the analyzer’s screen.
                         9       If PASS is displayed, follow instructions below under actions.
                         10      If FAIL is displayed for the external simulator, reinsert the simulator.

                                 If FAIL is displayed a second time, do not use the analyzer and contact the
                                 Point of Care Coordinator or designee.

                                 a.      Action:

                                            If PASS is displayed on the analyzer screen (after using the external
                                            Electronic Simulator):

                                               Remove the Electronic Simulator after the LCK or Simulator
                                                Locked message disappears from the display screen.
                                               Download the iSTAT so the result can be stored.
                                               Use the analyzer as required.

                                 b.      Remedial Action:

                                            If FAIL is displayed on the analyzer screen:

                                               Repeat the procedure with the same Electronic Simulator or rerun
                                                the cartridge if the internal Electronic Simulator is being used. If
                                                PASS is displayed use the analyzer as required.

                                               If FAIL is displayed, call the Point of Care Coordinator/Technician
                                                to see if another ISTAT is available.




                                                                                              Page 16 of 21
I-STAT Point of Care Testing Procedure


Quality Control for i-   1       New shipment of cartridges:
STAT Cartridges:
                                 a.       Verify that the transit temperature was satisfactory using the four
                                          window temperature indicator strip.
                                 b.       Enter the date and time received.
                                 c.       Write ok in the appropriate block matching temperature window to
                                          column.
                                 d.       Initial column.
                                 e.       Temperature records will be kept on site for 2 years.
                                 f.       Cartridges from each lot number received should be tested using,
                                          Level one two and three controls.
                                 g.        Obtain a fresh whole blood specimen to run patient test on each new
                                          lot cartridge type.
                                 h.        Run test on old cartridge lot number as well to compare against each
                                          new lot number.
                                 i.        Whole blood test comparison should agree within percentages set by
                                          CLIA 88. (See attachment A)
                         2       Daily refrigerator check:

                                 All locations storing iSTAT Cartridges will verify the refrigerator storage
                                 temperature daily. Refrigerator temperatures must be maintained at 2 to 8
                                 degrees C (35 to 46 degrees F).
                         3       Monthly quality control (liquid QC):

                                 a.      All iSTAT testing locations will participate in performing quality control
                                         using liquid controls monthly.
                                 b.      QC will include participation from as many iSTAT users as possible,
                                         including all shifts.
                                 c.      All cartridge types will be included in the monthly quality control
                                         check.
                         4       Performing i-STAT quality control using liquid quality control (Performed by
                                 testing personnel)

                                 Performing iSTAT Quality Control Using Liquid Quality Control (Performed by
                                 Testing Personnel)

                                 Handle all control products using the same safety precautions used when
                                 handling any infectious material.

                                 a.      Controls should be removed from the refrigerator along with iSTAT
                                         cartridges to be tested and brought to room temperature.
                                 b.      Point of Care will distribute the quality control material and cartridges
                                         to be tested to the units.
                                 c.      Prepare the iSTAT for performing quality control.
                                 d.      Turn iSTAT on.
                                 e.      Press menu.
                                 f.      Press 3, Quality Test.
                                 g.      Press 1, Control.

                                                                                            Page 17 of 21
I-STAT Point of Care Testing Procedure


                                  h.      Scan operator ID.
                                  i.      Scan ID again.
                                  j.      Enter control Lot #, press enter.
                                  k.      Enter cartridge Lot # , by scanning barcode on package.
                                  l.      Immediately before use, shake the control ampule vigorously for 5 to
                                          10 seconds. To shake, hold the ampule at the tip and bottom with
                                          forefinger and thumb to minimize increasing the temperature of the
                                          solution.
                                  m.      Protect fingers with gauze, tissue, or glove to snap off the ampule at
                                          the neck.
                                  n.      Immediately transfer the solution from the ampule into a syringe and
                                          then into a cartridge.
                                  o.      Immediately seal the cartridge and insert it into the analyzer.

                                  DO NOT REMOVE CARATRIDGE WHEN LOCKED MESSAGE IS DISPLAYED.

                                  p.     When results display, compare the result to the allowable ranges on
                                         the QC target sheet provided by Point of Care.
                                  q.     Results that exceed the target values must be repeated. Obtain a new
                                         vial of QC material and repeat e through o.
                                  r.     If QC fails again, notify Point of Care immediately. No testing can be
                                         performed on the iSTAT until troubleshooting is done.
                         5        Troubleshooting out-of-range results:

                                  Verify that the following conditions are met, and then repeat the test.
                                   The correct expected values insert is being used, and the correct cartridge
                                      type and lot number listing is being used.
                                   Expiration date printed on the cartridge pouch and control ampule or vial
                                      have not been exceeded.
                                   Room temperature date for cartridge and control has not been exceeded.
                                   Cartridge and control have been stored correctly.
                                   The control has been handled correctly.
                                   The analyzer being used passes the electronic simulator test.

                                  If the results are still out of range, repeat the test using a new box of control
                                  solutions and cartridges. If the results are still out, call Point of Care; and
                                  someone will call Abbott Support Services.

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

Routine Care of the      1        Drying a Wet Analyzer or Downloader: If the analyzer is placed on a wet
Analyzer or                       surface or if any liquid is spilled onto it, dry the analyzer immediately. If liquid
Downloader:                       enters the following compartments, the analyzer may be damaged:

                                  a.      The electronics compartment
                                  b.      The battery compartment
                                  c.      The cartridge port
                                                                                               Page 18 of 21
I-STAT Point of Care Testing Procedure


                         2       Cleaning the Analyzer and Downloader: Use Cavi Wipes Only!
                         3       Caution: Exercise standard safety precautions at all times when handling the
                                 analyzer, cartridges, and peripherals to prevent exposure to blood-borne
                                 pathogens.

                                 The analyzer is NOT designed to be sterilized or autoclaved by any method,
                                 including those using gas, (e.g. steam, ethylene oxide, etc…) high heat, bead,
                                 radiation, or other chemical processes. The analyzer is splash resistant, but
                                 should not be immersed in any liquids.

                                 Dispose of analyzer, peripheral electronics, and batteries according to local,
                                 state, and/or national guidelines.

                                 If the analyzer is not to be used for an extended period of time, the batteries
                                 should be removed to prevent leakage.

                                 Decontaminate the analyzer or downloader whenever a specimen is spilled
                                 onto it, or if the item is to be returned to i-STAT for repair by using a Cavi
                                 wipe.

                         4       Removing and Replacing Disposable Batteries

                                 a.      Slide the battery compartment door off.

                                 b.      Tilt the analyzer slightly to slide out the battery carrier which contains
                                         the two 9-volt batteries.

                                 c.      Remove the old batteries from the carrier. Pull each battery out to
                                         the side and then lift back and out.

                                 d.      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.

                                 e.      Note the orientation of the battery carrier illustrated on the 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 the
                                         instrument as shown on the label. If the carrier is inserted incorrectly,
                                         the battery door will not close.

                                 f.     Slide the battery compartment door back into place.
                         5       Caution: A falling instrument may cause injury. Place the instrument on a flat
                                        and stable surface at all times to ensure the instrument does not fall.


                                                                                             Page 19 of 21
I-STAT Point of Care Testing Procedure


Safety for Cartridge     The following cautions should be taken to prevent damage to the analyzer and to
Testing:                 ensure the safety of the operator and the integrity of results.
                         1       Never look into the barcode scanner beam or point it toward anyone’s eye.
                                 The beam could cause permanent eye damage.
                         2       Do not attempt to remove a cartridge during the testing cycle. The force that
                                 would be necessary to do so could damage the analyzer. The message
                                 “Cartridge Locked” will remain on the screen until the analyzer unlocks the
                                 cartridge.
                         3       Do not test cartridges while analyzer is in Downloader/Recharger.
                         4       A falling analyzer may cause injury. Always place the analyzer and peripherals
                                 on a stable surface or in a location where it will not cause injury if dropped.
                         5       The analyzer may be rendered inoperative by damage due to mishandling,
                                 such as dropping, by exhausting the batteries or by other causes.
                         6       The analyzer should not be used in environmental conditions that exceed the
                                 operating temperature and humidity specifications. An analyzer that has
                                 been exposed to extreme environmental conditions must be allowed to come
                                 to equilibrium with the operating environment prior to use. Note: the
                                 analyzer will display the message “Temperature Out of Range” until it has
                                 reached its operating temperature.
                         7       The analyzer and its peripherals are not listed by any authority with respect to
                                 suitability for use in Oxygen enriched atmospheres.
                         8       Proper procedure must be used to ensure correct manual entry of patient ID,
                                 operator ID, sample type, and other data that may affect the clinician’s
                                 interpretation of results.




                                                                                           Page 20 of 21
I-STAT Point of Care Testing Procedure


Attachment A
CLIA 88 Analytical Quality Requirements Federal Register February 28, 1992;57(40):7002-186
Note: Analytical Quality Requirements are a plus/minus percentage.
             Routine Chemistry

            Test or Analyte                           Acceptable Performance
                                                      Target value ± 0.3 mg/dL or ± 15%
            Creatinine
                                                      (greater)
                                                      Target value ± 6 mg/dL or ± 10%
            Glucose
                                                      (greater)
            Potassium                                 Target value ± 0.5 mmol/L
            Sodium                                    Target value ± 4 mmol/L
                                                      Target value ± 2 mg/dL or ± 9%
            Urea Nitrogen
                                                      (greater)
            Hematocrit                                Target ± 6%
            Hemoglobin                                Target ± 7%
            Chloride                                  Target value ± 5%
            PH                                        Target value ± 0.04
                                                      Target value ± 3 SD or ± 0.05 mmol/L
            Calcium, Ionized (iSTAT)
                                                      whichever is greater
            TCO2 (iSTAT Chem 8+)                      Target value ± 3 SD




                                                                                             Page 21 of 21

				
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