Policy/Principle: | Clinical Significance: | Certification: | Specimen: | Materials: | Reagents: | Standardization: N.A. | Procedure: | Limitations: N.A. | Results Derivation: | Expected Result(s) | Quality Control: | Run Electronic | Run Temperature | Battery Care: | References:
This test is performed in the Cardiac Catheterization Unit. It is performed as a definitive function to determine patient’s whole blood ACT. Results of the test could trigger therapeutic interaction without reflex laboratory analysis. The Gem PCL Portable Coagulation Laboratory utilizes a mechanical endpoint clotting mechanism in which testing occurs within the disposable ACT cartridge. A whole blood sample (approximately 50 µl) is placed in the sample well. When the Start key is pressed, 15 µl of whole blood is drawn into the test channel where it is mixed with the reagents in the cartridge. The activation of the blood sample begins immediately upon the mixing of blood with reagents. Timing is initiated at this point. While blood is pumped back and forth within the channel, the speed of flow is observed. Once a clot begins to form, it obstructs the test channel and slows the flow of blood. The instrument detects the clot when the blood movement decreases below a predetermined rate. The whole blood, ACT test result is displayed by the instrument digital timer as the celite equivalent ACT value, in seconds.
1. Orientation, authorization and competency of staff and licensed practitioners performing POCT are provided by the director’s (named on the CLIA certificate) designee as indicated in the “Point of Care (POCT) Program” procedure.
2. Gem PCL ACT testing will be performed by Nursing Service personnel who have been specifically certified:
A. To be certified, the requirements of the Gem PCL ACT; POCT Self-Instructional/Competency documentation packet must be completed.
B. If the individual seeking certification is unable to demonstrate acceptable performance of Quality Control, he/she must be retrained and successfully re-tested for authorization to perform Gem PCL ACT testing.
C. Re-certification is required annually:
a. Re-certification for an individual may be required more often if deemed necessary. When an instructor observes improper technique, he/she may decertify the operator on the spot. Arrangements for re-certification of that individual must then be made through their immediate supervisor.
b. To be re-certified, an operator must successfully complete the Gem PCL ACT; POCT Self-Instructional/Competency documentation packet.
4. The certification records of operators and instructors are reviewed by the Clinical Educators for the department, or the department supervisor and will be maintained on site.
1. Fresh drawn whole blood; minimum of 1.0 ml. Patients on whom an ACT has been ordered will have been prepped with a femoral venous or arterial sheath, which will be used as a specific sample acquisition site. The specimen will be drawn from either sheath and transferred immediately to the test cartridge.
2. Samples with a hematocrit less than 20% or greater than 55% are not recommended due to an optical density outside the level detection of the Gem PCL.
Gem PCL Analyzer
1. Gem PCL ACT Cartridges;
45 individually packaged test cartridges in foil pouches (IL #6260038000)
Cartridges are obtained from United Clinical Laboratory, Materials Management Department. Stock cartridges are stored in the UCL Materials Management Dept. and distributed as needed. Each cartridge consists of a self-contained disposable test chamber preloaded with a dried preparation of silica, kaolin, phospholipid, stabilizers and buffers.
A. Store stock of unopened boxes of cartridges at 2 - 8°C. Stable until the expiration date on the box.
B. Cartridges must be at room temperature to be used for testing (this takes about 60 minutes). When stored at room temperature cartridges are stable for 2 weeks.
C. Five cartridges at a time should be stored at room temperature with the Gem PCL to insure that cartridges will be available when needed. When cartridges are removed from the refrigerator the "Room Temperature Expiration Date" is to be written on the cartridge package with the new 2 week outdate. Re-dating must never exceed the manufacturer's expiration date.
Note: Always use the cartridges with the shortest "Room Temperature Expiration Date" first.
2. Gem Check Coag Normal (IL #6260060500)
A. Store controls at 2 - 8°C. Stable until the expiration date on the box.
B. Controls must be at room temperature to be used for testing.
3. Gem Check Coag Abnormal 3 (IL #6260060300)
A. Store controls at 2 - 8°C. Stable until expiration date on the box.
B. Controls must be at room temperature to be used for testing.
Note: This ACT procedure will be limited to patients in the Cardiac Catheterization Lab or Radiology Angiography Suite, under the direct care of cardiologists or radiologists.
1. Insert cartridge into the opening on the instrument with the blood reservoir facing up. The instrument will automatically identify the test cartridge and display the test type.
2. The test well and cartridge are prewarmed automatically to 37°C when inserted into the instrument. The pre-warm time varies, depending on the time interval between tests, but is typically less than 90 seconds. During the pre-warm stage, observe the display for fault messages.
3. When ready, the instrument will signal with an audible tone. The display will indicate the alternating messages "Add Sample" and "Press Start". The instrument will remain in the ready mode for 5 minutes before a "Start Timeout" will occur, requiring a new cartridge to be placed in the instrument.
4. Obtain whole blood sample according to the "Specimen" section of this procedure.
5. Dispense two drops of blood immediately into the center sample well of the test cartridge filling from the bottom of the well up. A sufficient quantity of blood must be added directly to the center sample well to fill it flush with the top. Should a large drop of blood extend above the center sample well, push it over into the outer sample well.
6. Depress the Start Key. A single beep will signal the start of the test. The instrument displays "Sample too large" or "Sample too small" if an excessive or inadequate sample volume has been provided.
7. Test completion will be indicated by a single beep. Two beeps indicate a fault condition.
8. Upon clot detection the celite equivalent ACT value will be displayed. The test result will remain on the screen until the test cartridge is removed from the instrument and for 120 seconds following its removal.
9. Record the ACT result on the ACT log.
1. Remove Gem Check normal and abnormal control vials from the refrigerator and allow them to come to room temperature. This takes about 60 minutes.
2. Insert cartridge into the cartridge opening of the instrument with the blood reservoir facing up. The instrument will automatically identify the test cartridge and display the test type.
3. The test well and cartridge are prewarmed automatically to 37°C when inserted into the instrument. The pre-warm time varies, depending on the time interval between tests, but is typically less than 90 seconds. During the pre-warm stage, observe the display for fault messages.
4. When ready, the instrument will signal with an audible tone. The display will indicate the alternating messages "Add Sample" and "Press Start". The instrument will remain in the ready mode for 5 minutes before a "Start Timeout" will occur, requiring a new cartridge to be placed in the instrument.
5. Reconstitute control dropper vial:
Note: Reconstitution and mixing whole blood control material should be accomplished quickly and without delay in any step. Once reconstituted, the sample should be used immediately as clotting will occur.
A. Remove the label from the vial.
B. Holding the vial upright, tap the vial on a tabletop to settle the glass ampule to the bottom of the vial.
C. Insert vial into protective sleeve.
D. Crush the inner glass ampule by bending the vial over the edge of a tabletop or crush the vial between two fingers.
E. Immediately repeat the crushing action two additional times to ensure complete breakage of the glass ampule.
F. Shake the vial moderately while holding the vial with the cap facing upright. For the Normal level, shake the control 5 - 7 times. For the Abnormal level, shake the control 20 - 25 times.
G. Invert the vial with the tip down using a downward snapping motion to ensure the control material flows to the dropper tip.
H. Remove and retain the vial cap.
I. Squeeze the vial to discard the first drop into the cap.
6. Immediately dispense 2 - 3 drops to fill the cartridge sample well flush with the top. Should a large dome extend over the top of the center well, push it over into the outer sample well.
7. Press the Start key.
8. Remove the control vial from the protective sleeve. Dispose of the vial and vial cap into a Biohazard container. Retain the protective sleeve for reuse.
9. When the test is completed, the instrument will beep and display the results on the screen. Results are displayed as the celite equivalent clotting time in seconds.
10. Record control result on the Gem PCL QC Log. Acceptable ranges are derived from the control package insert.
11. Write "QC OK" along with date/ time/initials on each box of cartridges for which controls were run and were acceptable.
1. Results are automatically displayed when the test is completed. Results are displayed as the celite equivalent clotting time in seconds.
2. Reportable range for the ACT cartridges is 67 - 1005 seconds.
A. If the result is less than the minimum time "ACT less than 67 sec, Repeat" will be displayed. If this occurs, report as less than 67 sec and enter comment: “Warning, result exceeds analytical range and should be repeated on a new specimen”.
B. If maximum time has been exceeded "ACT greater than 1005 sec" will be displayed. If this occurs, report as greater than 1005 sec. The test should be repeated on a new specimen.
Expected ranges are established by the Cardiologist/Clinician pertinent to the clinical situation.
1. Routine Controls:
A. The Normal and Abnormal Electronic Verification Cartridges must be run once every 8 hours in which the system is used.
B. The Gem PCL Temperature Verification Cartridge must be run once per day on each day of use.
C. The Gem Check Normal and Abnormal controls will be run on each box of cartridges before use.
2. Equivalent QC: The internal QC for this test monitors part of the analytic process; it is second level EQC. Therefore the normal and abnormal controls are routinely run once per week. ACT is a low volume test. Based on patient volume control lot consumption is variable and goes from one to three months generating only five to ten trials per level. Standard internal derivation of control means and ranges per lot is not doable. Package insert ranges are adequate for the clinical application.
3. Criteria for accepting or rejecting a run is stated in the “General Quality Control” protocol in the Quality Assurance manual.
4. Analytical Range: 67 - 1005 seconds
5. Calibration: N.A.
6. Calibration Frequency: N.A.
7. Calibration Verification: The ACT is a test involving an instrument in which calibration is not practical. Therefore the calibration verification requirement does not apply to this test.
8. Control Ranges: Acceptable control ranges are obtained from the manufacturer’s package insert.
The Normal and Abnormal Electronic Simulator Verification Cartridge will be run each shift that the analyzer is used. The Electronic System Verification cartridge will perform timer and endpoint detection checks, and will simulate an endpoint at a predetermined time interval. The instrument should detect the simulated endpoint within the acceptable range shown on the Electronic System Verification Cartridge. An acceptable test result without fault indicators for the Electronic System Verification Cartridge assures that the instrument is functioning properly.
1. Insert the Normal Electronic Simulator Verification Cartridge in the instrument. The instrument will enter a QC mode indicated by an "E-QC...Test" message appearing on the display. The instrument then will perform internal diagnostic checks. The optical and mechanical sensors and heater system will be checked. Any errors that are found in these systems will be displayed followed by a series of audible beeps. If the system is verified as functioning normally, the screen will display a "System OK" message. The message will remain on the screen for 2 seconds. This message will be followed by "Priming Pump" and "Warming".
2. The messages "Press E-QC" and "Start Now" will then appear alternately on the display. Depress the Start button on the Electronic Simulator Verification Cartridge.
3. Results will be displayed on the screen "E-QC= ". Acceptable ranges are printed on the Electronic Simulator cartridge label.
4. Record the Normal Electronic Simulator result on the Gem® PCL Log.
5. Repeat the steps above for the Abnormal Electronic Simulator Verification Cartridge.
6. If any electronic verification procedure yields an on-screen ERROR message, or if the Electronic Simulator Verification Cartridge fails to yield the desired results, discontinue use of the instrument and contact an Instrument Specialist.
The Temperature Verification Cartridge will be run once each day of use.
1. Insert the Temperature Verification Cartridge in the instrument. The instrument will enter a QC mode indicated by an "E-QC...Test" message appearing on the display. The instrument then will perform internal diagnostic checks. The optical and mechanical sensors and heater systems will be checked. Any errors that are found in these systems will be displayed followed by a series of audible beeps. If the system is verified as functioning normally, the screen will display a "System OK" message.
2. This message will be followed by "Priming Pump" and "Warming".
3. Once temperature has been reached, "Remove E-QC" and "Read E-QC Temp" will appear on the display alternately. At this time the Temperature Verification Cartridge should be removed from the instrument and the illuminated temperature observed on the cartridge immediately.
Note: After the Temperature Verification Cartridge is removed, a "Cartridge out" message is displayed; this is normal.
4. The temperature should be 37°. This indicates that the temperature control system is functioning normally.
5. Record the temperature on the Gem® PCL Maintenance/Function Verification Report.
1. To optimize battery life, it is recommended that the Gem® PCL instrument be run on its battery during the day. It can be plugged into a standard AC outlet overnight to allow the batteries to recharge. The life of the nickel-cadmium battery cells is optimized when the battery is exercised in this manner.
2. A fully charged battery will operate the instrument for approximately 2 hours continuously, or for approximately 30 average test cycles.
3. The "Battery is Low" message will appear on the display screen at the beginning of a test to alert the user if the battery is running low. At this point, the instrument has approximately ten minutes of battery time remaining to perform coagulation testing. Once this message appears, plug the instrument in at the earliest possible time.
4. When the batteries are drained to the point that valid testing cannot be performed, the instrument will display "Charge Battery". At this point, the instrument must be plugged in for operation and recharging. Once plugged into an AC outlet, the instrument can be used immediately.
1. Gem PCL Portable Coagulation Laboratory System Operator's Manual. Instrumentation Laboratory. Lexington, MA. Rev.00. 8/98
i. January 2000 L. McGovern
ii. October 2000 L. McGovern (Revised: I., II. added)
iii. May 2001 L. McGovern (Revised: IV.2., VIII. Note)
iv. September 2004 S. Raymond/L. McGovern (Revised: VIII., XII.; language/protocol updated for CMS status)
v. February 2008 L. McGovern (Revised: IV.1.B.)
vi. October 2008 S. Raymond (Revised: XII.2.)
vii. October 2009 L. McGovern (Revised: III.1. added)
Representative: MHC Cardiac Cath
Interim Review: April 2012 L. McGovern (Revised: XIII.; XIV.; XV.; added)