Transcript Hemochron Signature Elite ACT

LABORATORY PROCEDURE STATEMENT
PROCEDURE NAME:
ACTIVATED CLOTTING TIME USING THE HEMOCHRON
SIGNATURE ELITE
EFFECTIVE DATE:
REVIEW / REVISION HISTORY:
I.
3/1/2014
02/2014
CLINICAL SIGNIFICANCE:
ACT Low Range (ACT-LR)
The Hemochron Elite Low Range Activated Clotting Time (ACT-LR) is a quantitative assay for
monitoring heparin anticoagulation during various medical procedures. The Hemochron Elite ACTLR assay demonstrates a linear correlation to the anticoagulation effects of heparin at doses up to
2.5 units/cc of blood. It is intended for use in monitoring low to moderate heparin doses frequently
associated with procedures such as cardiac catherization, Extracorporeal Membrane Oxygenation
(ECMO), hemodialysis and Percutaneous Transluminal Coronary Angioplasty (PTCA) i.e. 5,000 U
of heparin (depending on the patients weight). The ACT-LR test is for in vitro diagnostic use and is
for use with the Hemochron Elite Whole Blood Microcoagulation System. This procedure is
intended for use by units with ACT target values of less than 400 seconds.
II.
PRINCIPLE:
The Hemochron Signature Elite cartridges utilize a mechanical endpoint clotting mechanism in
which testing occurs within the disposable ACT cuvette. Following whole blood sample
introduction, the instrument precisely measures 15 microliters of blood and automatically moves it
into the test channel within the ACT cuvette. The remainder of the blood sample, not needed for
testing, is automatically drawn into the waste channel of the cuvette. Sample/reagent mixing and
test initiation are performed automatically, requiring no operator interaction. After mixing with the
reagent, the sample is moved back and forth within the test channel and monitored by the analyzer
for clot formation. The clot detection mechanism consists of two LED optical detectors aligned with
the test channel of the cuvette. The speed at which the blood sample moves between the two
detectors is measured. As clot formation begins, blood flow is impeded and the movement slows.
The instrument recognizes that a clot endpoint has been achieved when the movement decreases
below a predetermined rate. Electronic optical detection of a fibrin clot in the blood sample
automatically terminates the test. The instrument’s digital timer displays the Celite® equivalent
ACT value in seconds.
III.
EQUIPMENT
MATERIALS/REAGENTS:
Equipment:
1. Hemochron Signature Elite Microcoagulation Instrument
Description:
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The HEMOCHRON Signature Elite instrument is a hand-held device. It contains a
test chamber which warms a test cuvette to the required temperature, and it
performs all operations to measure the clotting time of a whole blood sample after it
is placed in the test cuvette and the test is started by the operator.
Operator instructions are shown on the Display Panel, and the operator enters
commands and information using the Keypad. When the test is completed, the
results are shown on the display panel and stored in system memory for printing or
downloading.
_______________Display Panel
_______________Keypad (Numbers and Action Keys)
_______________Test chamber
The operating environment for the Elite should be between 15C to 30C (59F to
86F). The instrument includes a Barcode Scanner for reading of barcode labels.
_____ Barcode Scanner
_________Barcode Label
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Keypad
The front panel contains a keypad with various action keys as well as a number
pad. The operator uses the keypad to select a command or enter information.
Action Keys display a menu of commands according to the label on the key. For
example, the PRINT/SCAN key displays printing commands and enables
scanning. Number Pad (or Option) keys are used to enter characters for IDs or
numbers for selection of commands.
Note: The 0 (zero) key is used as both a numeral key and an action key.
Charge indicator _____________
Start key___________________
Action keys_______________
Key Purpose:
START
Turn on the instrument or turn off instrument.
Initiate a test after the test cuvette has reached 37 °C ±1.0 °C and the sample is
added.
PRINT/SCAN
Scan a barcode ID when Enter PID, Enter OID, Enter PIN, Enter Cuvette Lot,
Enter QC Lot or Scan Lot is displayed.
ID
Enter a Patient ID or Operator ID.
QC
Specify that the test being run is a normal (level 1) control or an abnormal (level
2) control. (For QC Lockouts) Display the length of time remaining before Quality
Control testing for a particular test must be successfully completed.
DATABASE
Display the number of patient or QC test results that are currently stored in the
instrument and the number of additional test results that can be stored.
Display results of the stored patient or QC tests.
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CANCEL
Cancel an operation and return to the previous state.
ENTER
Accept an entry (e.g., a Patient ID, an Operator ID, a time, or a date).
Display Panel
The instrument communicates with the operator by means of the display panel.
For example, Add Sample and Press Start are alternately displayed after a test
cuvette reaches temperature:
NOTE: The display is illuminated to enhance visibility in low light conditions. To
conserve power during battery operation, the display is not illuminated when the
test well is empty or when a test is running. The display is momentarily
illuminated after a key is pressed or when results of a completed test are
displayed. While a test is running, the display can be momentarily illuminated by
pressing the CANCEL key, the ENTER key, or any numeric key.
Menus
The action keys are used to display and activate various commands for operating
and configuring the system. The principal menus are shown below:
Menu
Main Menu
Access
Press the 0 (zero) key when no tests are
running and no other menu is open and
execute a command by pressing the
action key for that command.
Note: The main menu cannot be accessed if a cuvette is in the test well. If a
cuvette is used to turn on the instrument, it must be removed to access the
main menu.
QC Selects Menu
Press the QC key while a cuvette is inserted
in the instrument.
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QC Status Menu
Press the QC key before a cuvette is
inserted in the instrument (or, select 4 from
the QC Selects menu.)
Notes Menu
Press the NOTE key after a cuvette is
inserted in the instrument
ID Selects Menu
Press the ID key while a cuvette is inserted
in the instrument.
Materials/ Reagents
2. ACT Low Range Reagent Cuvette Material # JACT-LR. Each box contains 45
cuvettes.
a. Cuvettes are good for 3 months at room temp (15°30°C)
b. Cuvettes should not exceed 37°C.
3. ACT Quality Control Material Direct Check: Normal – Material # DCJLR-N
4. ACT Quality Control Material Direct Check : Abnormal – Material # DCJLR-A
a. Un-reconstituted controls are stable for 1 month at room temp and should not
exceed 37°C.
b. Reconstitued QC vials should be used immediately
5. Supplies for sample collection
WARNING:
IV.
All boxes Must be labeled with an opened date and an expiration date
Specimen Type, Collection and Handling Criteria:
The Hemochron Elite ACT using the ACT-LR Cuvette is performed using 0.2 mL of fresh whole
blood. Samples with any of the following characteristics should be discarded immediately, and
a fresh whole blood sample collected prior to performing any test on the Hemochron instrument.
The following characteristics may interfere with the ACT assay.
I. Sample contamination with tissue thromboplastin
II. Sample contamination with indwelling intravenous (I.V.) solutions
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III. Sample contamination with alcohol cleansing solution
IV. Samples with visible clotting or debris accumulation
Blood samples to be used for coagulation testing must be collected according to the following
procedures to assure the integrity of the fresh whole blood sample.
Syringe sample, from indwelling venous bloodline
WARNING:
Do not obtain blood from heparinized access line, lock, or indwelling heparin
lock:
Note: The amount of blood required to adequately flush the line until it is free of
contaminants is dependent on the amount of solution contained within the line. A
typical heparin lock will require approximately 5.0 mL to clear the line. Greater
volumes will be required to clear longer lines.
1. Discontinue fluids drip, if required.
2. Using a 5 mL syringe, collect a minimum 1 mL of fresh whole blood from a
previously flushed access port.
3. From the collection syringe, immediately dispense a drop of blood into the Signature
Elite cuvette.
4. Immediately press start to perform the test.
Syringe sample, from a venipuncture
1. Prepare the venipuncture site by cleansing with alcohol and allowing to air dry
completely.
2. Using a two-syringe technique, fill the first syringe with 2.0 mL of blood and discard.
3. Obtain a minimum 1.0 mL of blood with the second syringe.
4. Immediately dispense a drop of blood into the Signature Elite cuvette.
5. Immediately press start to perform the test.
Extracorporeal blood line port
1. Flush the extracorporeal bloodline by withdrawing and discarding 5 mL of blood.
2. Obtain a 1 mL sample with a second syringe for testing.
3. Immediately dispense a drop of blood into the Signature Elite cuvette.
4. Immediately press start to perform the test.
V.
QUALITY CONTROL:
Electronic Quality Control (EQC) is required at 30 and 300 seconds every 8 hours that an instrument is
in use for patient testing.The Hemochron Signature Elite automatically performs EQC in eight hour
intervals if the instrument is plugged in and turned on. If the analyzer is turned off when EQC is due, the
analyzer will perform EQC when the analyzer is turned on. Avoid delays in patient testing by assuring
EQC status will not expire during any patient case durations. Patient testing is not allowed until an
acceptable EQC is performed beyond an 8 hour period.
Quality Control of ACT test cartridges and validation (Point of Care Testing Coordinator)
Hemochron Signature Elite cartridges are validated by the Point of Care Testing
Department upon arrival and prior to being dispensed for use. Validation of the shipment is
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confirmed as long as the results from the new lot number fall within +/-15% of the last
validated shipment of the previous lot number and subsequent shipments of the current lot
number must fall within +/- 10% of the previous shipment. After two cartridges from each
shipment of cartridges has been verified with the QC procedure, that box of cartridges
should be marked as “Lot Ready for Use
Liquid Quality Controls (LQC) are required every 30 days
EQC (Electronic Quality Control) Procedure
EQC (Electronic QC) is performed automatically by the analyzer once every 8 hours.
If the analyzer was turned off when EQC was due, it will be automatically performed when
the analyzer is turned on.
EQC takes approximately 8 minutes to run.
The operator can also force EQC by pressing the QC button and then pressing the 1 key to
run EQC.
The ACT-LR Test Cuvette AND controls must be allowed to
LQC (Liquid Quality
come to room temperature prior to use.
Control) Procedure
Analyzer Screen
Blank (off)
Flashes Insert……..
Cuvette…….
Enter OID SCAN only
Enter PID
Action
Press and hold START key for 1 second to turn on the
analyzer
Remove cuvette from foil pouch and insert in right side of
analyzer until you hear it click into place. The printed label
on the cuvette should face up. Select correct lot number from
list.
Enter ID by pressing Print/Scan button and holding the
barcode of your ID
1 – 2 inches from the infrared scanner (located on the top
edge above the number 3 key. Your ID can be entered
ONLY by scanning in this manner. Your ID will not work if
you have not been properly trained and entered into the
database. Screen will show “STORED” when ID is
accepted.
DO NOT enter a PID. Instead press the QC key to enter QC
menu.
QC SELECTS
Choose 1 for Normal QC then select lot number from list.
ACT-LR
QC Normal (or
Abnormal)
Remove the plastic seal from the QC vial
Holding the vial upright, tap the vial on the table top to settle
the inner glass ampule to the bottom of the vial
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Countdown m:ss
Add Sample…….
Press Start
Insert the vial into the white protective sleeve and crush the
inner glass ampule, repeat the crushing action several times
to insure that glass ampule is adequately broken.
Vigorously shake the vial for 10 seconds.
Invert vial dispenser tip down and use a downward snapping
motion of the wrist to ensure the control material flows to the
dropper tip.
Remove and retain vial cap.
Squeeze the vial and discard the first drop of control material
into the cap.
Immediately dispense enough control material to fill the
cuvette sample well flush to the top. The drop should not
have a “dome” appearance. If there is a dome use a gloved
finger to push it over into the outer sample well.
Press the START key.
Loading
Sample....Removing
Waste….
You should see the sample begin to migrate into the cuvette.
Once finished, the meter beeps once and displays the QC
Result displayed
result along with a PASSED or FAILED notation. Failed
QC MUST be repeated.
Repeat procedure choosing 2 for Abnormal QC in Step 5 above.
Calibration
Not applicable. Hemochron instruments do not require reagent calibration.
Linearity
Post repair and new analyzers require linearity testing. Linearity testing is performed by
the vendor.
VI.
PROCEDURE:
Patient Testing Procedure
Note: The ACT-LR Test Cuvette must be allowed to come to room temperature prior
to use.
Analyzer Screen
Blank (off)
Flashes Insert…….. Cuvette…….
Enter OID SCAN only
Action
Press and hold START key for 1 second to turn on the
analyzer
Remove cuvette from foil pouch and insert in right side
of analyzer until you hear it click into place. The
printed label on the cuvette should face up. Select
correct lot number from list.
Enter ID by pressing Print/Scan button and holding the
barcode of your ID 1 – 2 inches from the infrared
scanner (located on the top edge above the number 3
key. Your ID can be entered ONLY by scanning in
this manner. Your ID will not work if you have not
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Analyzer Screen
Action
been properly trained and entered into the database.
Screen will show “STORED” when ID is accepted.
Enter the patient ID number and press and hold the
ENTER key (about 1 second). The patient ID must be
the entire patient medical record number
Enter PID
(INCLUDING check digit but excluding leading zeros)
with no spaces or dashes. Screen will show
“STORED” when ID is accepted.
Analyzer is preparing for sample. DO NOT add
sample until prompted to do so by the analyzer. The
……Warming…….Warming……
instrument is ready when you hear an audible beep and
the Add Sample message appears.
Immediately add 1 small drop of sample to the cuvette
Countdown m:ss
and press START. Sample must be fully added to
Add Sample……. Press Start
cuvette BEFORE Start is pressed.**see note below
regarding drop size.
Loading Sample....Removing
You should see the sample begin to migrate into the
Waste….
cuvette.
Once finished, the meter beeps once and displays the
Result displayed
patient result.
Connect instrument via Ethernet cord to the assigned
port (on the left side of the instrument on the top row).
To download results:
Press the database button. Press ‘6’ to transmit the
results.
Note: The size of the drop is very important. Too little or too much sample will cause
an error message. Sample should not form a dome that rises above the edge of
the sample well.
VII.
EXPECTED VALUES:
A.
A Note About Celite Equivalent Clotting Time Values
The unique ACT+ reagent clots a blood specimen more quickly than the corresponding
Celite reagent. The ACT+ clotting time is displayed as a Celite equivalent ACT value
based on a correlation established in a clinical study. The linear regression describing
the relationship of the two tests has been programmed into the Hemochron Signature
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B.
C.
Elite such that the corresponding Celite ACT clotting time is displayed upon completion
of the assay.
A Note About Target Values
Analysis of the post-heparin bolus clotting time during percutaneous transluminal cardiac
angioplasty indicates that the CT+ clotting time may yield target ranges approximately
10% - 15% shorter than corresponding Celite ACT values. This represents
approximately 260 – 270 ACT seconds at a 300 second Celite ACT in percutaneous
transluminal cardiac angioplasty.
Institutions must establish their own normal and target anticoagulation ranges and
review them on a regular basis as potentially influencing medications become
increasingly used in interventional cardiology and cardiac procedures.
Abnormal Results
Results that exceed “400” should be considered beyond clinical significance and the test
should be immediately repeated.
Results that appear to be inconsistent with patient therapy should be viewed as
questionable and the test should be immediately repeated.
Target values at Duke Raleigh Hospital have been established by the DUHS
standards:
Area/ Cuvette
Adult Cardiac Cath Lab
ACT Low Range (ACT LR)
Target Ranges
/
≥250 seconds for angioplasty
<185 seconds during sheath removal
Or, up to the Doctor’s discretion
Method Notes
1. Technique variation can alter performance characteristics; care must be taken to
adhere to the procedures outlined.
2. The temperature of the environment in which these tests are performed will affect the
control test values obtained.
3. When a control is out of the expected range after a repeat of the control analysis, the
cause will usually be one of the following:
o
Testing technique
o
Expired or exposed to excessive heat testing materials.
4. All biohazard safety guidelines pertaining to the handling of human blood, such as
the CDC guidelines of Universal Precautions, should be strictly adhered to when
collecting, handling blood specimens and operating the Hemochron Elite.
5. Used Hemochron test cartridges should be considered as potentially infectious. They
should be handled according to Duke Raleigh Hospital’s policies concerning the
disposal of potentially infectious materials.
6. The transfer of blood to the ACT test cartridge from a syringe should be performed
using a needleless system.
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7. The power plug provided should be plugged into an appropriate outlet to charge the
instrument. To unplug the instrument from the power plug, firmly grasp the plug and
pull. DO NOT remove the plug from the outlet by pulling on the cord.
8. DO NOT use cartridges past their expiration date or that have been stored
improperly. Cartridges must be properly stored according to the package insert.
VIII.
RECORDING AND REPORTING RESULTS:
Results are reported directly to the caregiver and documented on an ACT Patient Result Form.
Any results exhibiting inconsistency with the patient’s clinical status should be repeated or
supplemented with additional test data. Within 4 days, ACT results are manually ordered and
entered into the Hospital Information System for electronic charting.
IX.
LIMITATIONS OF PROCEDURE:
Celite equivalent ACT values less than 65 seconds or greater than 400 seconds are outside of the
reportable range and should be immediately repeated.
Linear regression models measure similarity of test results between different methods but do not assure
identity. Thus, for any similarly conducted side by side comparison of the ACT-LR and a reference ACTLR, actual differences of clotting time may be observed.
Samples with a hematocrit less than 20% or greater than 55% are not recommended due to an optical
density outside the level of detection of the instruments.
Hemochron Signature Elite test results should be scrutinized in light of a specific patient’s condition and
anticoagulant therapy. Any results exhibiting inconsistency with the patient’s clinical status should be
repeated or supplemented with additional test data.
Hemochron test results are affected by
1. Presence of Aprotinin
2. Poor technique during blood collection, including venipuncture and the test procedure
3. Inadequate specimen/reagent mixing may result in reduced precision and accuracy.
4. Improper storage of cartridges such as prolonged exposure to heat outside specified
guidelines
5. Hemodilution
6. Cardioplegic solutions
7. Hypothermia
8. Platelet dysfunction
9. Hypofibrinogenemia and other coagulopathies
10. Clotted or partially clotted blood
11. Unsuspected anticoagulation with either heparin or warfarin
X. MAINTAINENCE
A. Routine Maintenance
Inspect and clean the cuvette opening as required. Remove residual dried blood or other foreign
matter using water-moistened cotton swabs. Remove any residual water with dry cotton swabs.
If a disinfectant is needed, use a 0.5% solution of sodium hypochlorite or a 10% dilution of
household bleach in water. Wipe instrument with a water-dampened cloth to remove residual
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bleach from the plastic surfaces.Apply solution to clean and disinfect areas contaminated with
blood. DO NOT use solvents or strong cleaning solutions as they may damage the instrument’s
plastic components. Routine maintenance other than cleaning normally is not required.
B. Service
The Hemochron Signature Elite instrument is almost completely self-monitoring and has no user
serviceable parts. It monitors internal circuitry and reports problems to the display screen
automatically. Malfunctions are indicated by error messages detailed in the section
“Troubleshooting.”
C. Battery Care
To optimize battery life, it is recommended that the Hemochron Signature Elite instrument be
run on its battery during the day. It can be plugged into a Hospital Grade AC outlet overnight to
allow the batteries to recharge. The life of the lithium battery is optimized when the battery is
exercised in this manner. When the batteries are drained to the point that valid testing cannot
be performed, the instrument will display “CHARGE BATTERY” (see “Troubleshooting”). At this
point, the instrument must be plugged in for operation and recharging. Once plugged into a
Hospital Grade AC outlet, the instrument can be used immediately.
XI. TROUBLESHOOTING
Error Message
Cause
Can not communicate with
RTC....FAULT
external Real Time Clock.
Corrective Action
Contact the Point of Care Testing
Coordinator.
CHARGE
BATTERY
Battery power depleted below
predetermined level.
Connect to AC/DC Power Module and
charge battery for 8 hours.
BATTERY
FAULT
Battery is discharged.
EXTERNAL
TOO HIGH
AC/DC Power Module voltage
exceeds 12.7 volts.
BATTERY
TOO HIGH
Battery voltage exceeds 8.8 volts.
Heater Too
Cool
Incubator remained below 36 °C
after 90 seconds of warming on
external power or for up to 150
seconds on battery.
Heater Too
Hot
Incubator exceeded 38 °C for 2.5
seconds.
Detector Fault
Light path between LED and
detectors is blocked.
Detector
Blocked
Sample Pos
Fault
ASSAY
LOCKED
EQC is being run while a cuvette is
inserted.
Sample has moved outside of
testing area in cuvette.
The QC failure limit has been
exceeded.
Charge battery for 8 hours. If message
persists, contact the Point of Care
Testing Coordinator.
Disconnect the AC/DC Power Module.
Contact the Point of Care Testing
Coordinator.
Disconnect the AC/DC Power Module.
Contact the Point of Care Testing
Coordinator.
Repeat test, then charge battery. If
message persists,
contact the Point of Care Testing
Coordinator.
Repeat test with new cuvette. If message
persists, contact the Point of Care
Testing Coordinator.
Repeat test with new cuvette. If message
persists, contact the Point of Care
Testing Coordinator.
Remove the cuvette and repeat the EQC.
Contact the Point of Care Testing
Coordinator.
Remove the cuvette. Contact the Point of
Care Testing Coordinator.
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CALL
SUPERVISOR
MACHINE
LOCKED
CALL
SUPERVISOR
The EQC failure limit has been
exceeded.
Contact the Point of Care Testing
Coordinator.
Sample Not
Seen
Sample has not reached front
detector in specified time period.
Repeat test with new cuvette. If message
persists, contact the Point of Care
Testing Coordinator.
Cuvette
Removed
Cuvette was prematurely removed
from instrument while testing in
progress.
Repeat test with new cuvette.
Sample Too
Large/
Sample Too
Small
Excess or insufficient sample.
Repeat test with new cuvette.
Premature
Sample
MEMORY
FAULT
START Timed
Out
Sample was detected at front
detector before specified time
period. May occur if sample is
added before pump-priming
sequence is complete.
Malfunction in the computer's
memory.
START key was not pressed
within 5 minutes after entering
ready mode.
Unsupported
Assay
Cuvette cannot be identified by
instrument.
No Data
Stored
User Abort
Operator attempted to print data
when none is stored in database.
The test was aborted by the user.
The barcoded cuvette or QC lot
number label that was scanned was
not recognized.
Invalid Lot #
Lot Expired
Action Denied
The incorrect format was entered
for the lot number.
The lot that was scanned does not
match the cuvette test type.
The cuvette and/or QC material
that is being used has reached its
expiration date.
Date/Time cannot be changed if
QC Lockout is required, or
Date/Time function is denied
through Configuration Manager.
Repeat test with new cuvette. If message
persists, contact the Point of Care
Testing Coordinator.
Contact the Point of Care Testing
Coordinator.
Remove cuvette and repeat test with new
cuvette.
Remove cuvette and repeat test with new
cuvette. Use ITC
cuvettes only.
N/A
Repeat test.
Check the label for damage, then repeat
the scan.
Repeat the entry using the correct format.
Verify the test type, then rescan the lot.
Remove the cuvette and repeat the test
using supplies that are within their
expiration date.
Contact the Point of Care Testing
Coordinator.
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Assay performance has been
prohibited via Configuration
Manager.
Disallowed
Assay
Cannot erase
DB
Out of RangeLo
Out of RangeHi
Check
Time/Date
Dark Photo
Fault
XII.
Contact the Point of Care Testing
The table of cuvette or QC lots is
Coordinator.
empty or contains only expired
lots.
The QC interval is set to zero in
Configuration Manager.
Erasing patient and/or QC database Contact the Point of Care Testing
is not allowed.
Coordinator.
Test result is outside clinical range.
Sample has clotted prematurely, or
Repeat test with new cuvette.
does not mix correctly in cuvette.
Bubbles may be present.
Test result is outside clinical range. Repeat test with new cuvette.
Low Battery or RTC has lost its
Time/Date Tracking.
Hardware malfunction.
Enter or verify Time & Date.
Charge Battery.
Contact the Point of Care Testing
Coordinator.
REFERENCES:Bull, BS, Korpman, RA, Huse, WM, Briggs, BD. (1975). Heparin Therapy
During Extracorporeal circulation: I. Problems Inherent in Existing Protocols. J Thorac
Cardiovasc Surg; 69:674-684.Doty, DB, Knott, HW, Hoyt, JL, Koepke, JA. (1979). Heparin
dose for accurate anticoagulation in cardiac surgery. J Cardiovasc Surg 20: 597-604. Esposito,
RA, Culliford, AT, Colvin, SB, Thomas, SJ, Lackner, II, Spencer, FE. (1983). The role of the
activated clotting time in heparin administration and neutralization for cardiopulmonary bypass.
J Thorac Cardiovasc Surg 85: 174-185. Bull, BS, Korpman, RA, Huse, WM, Briggs, BD.
(1975). Heparin Therapy During Extracorporeal circulation: I. Problems Inherent in Existing
Protocols. J Thorac Cardiovasc Surg; 69:674-684..Doty, DB, Knott, HW, Hoyt, JL, Koepke, JA.
(1979). Heparin dose for accurate anticoagulation in cardiac surgery. J Cardiovasc Surg 20: 597604. Esposito, RA, Culliford, AT, Colvin, SB, Thomas, SJ, Lackner, II, Spencer, FE. (1983).
The role of the activated clotting time in heparin administration and neutralization for
cardiopulmonary bypass. J Thorac Cardiovasc Surg 85: 174-185. Gambino, R. (1982).
Monitoring heparin therapy. Lab Report for Physicians 4: 17-20.Hattersley PG: Activated
Coagulation Time of Whole Blood. JAMA 1966:136-436.Hattersley, PG. (1984). Heparin
anticoagulation. In: Koepke, JA (Ed.). Laboratory Hematology. Churchill Livingstone, 789-818.
Kerensky, R, Azar, G, Bertolet, B, et al. (1996). Venous activated clotting time after intraarterial heparin: Effect of site of administration and timing of sampling. Cath and Cardiovasc.
Diag.; 37: 151-153.Operator’s Manual for the Hemochron Signature Elite.
Historical Record
Original Policy Date and Revisions
Sep 2008/February 2009/March 2010/July 2010/February 2011/December 2013/February 2014
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Adopted from UNC McLendon Labs Point of Care Procedure. Edited by John G.
Toffaletti, PhD. and Penny Zimmerman MT (C) ASCP; November 2, 2012. Adopted
and Edited by Talisha Arnold MT (ASCP, NCA), February 7, 2014
CROSS REFERENCE:
APPLICABLE STANDARDS:
DEVELOPED BY:
POLICY PRIMARY:
SCHEDULED REVIEW DATE:
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