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Policies,Clinical,UWHC Clinical,Department Specific,Point of Care,Hemochron Elite ACT

Hemochron Signature Elite Activated Clotting Time Testing (1595.P007)

Hemochron Signature Elite Activated Clotting Time Testing (1595.P007) - Policies, Clinical, UWHC Clinical, Department Specific, Point of Care, Hemochron Elite ACT

1595.P007

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 1 of 15



Medical Director and Date: Diane Norback, MD 9/4/15
Diane Norback, MD 8/23/17




Effective Date: 9/7/2015
Faculty Director Date Manager Date Technical Reviewer Date
Teresa Darcy, MD 9/3/15 Cheryl Jordan 9/7/15 Sarah Emond 8/25/15
David yang, MD 8/23/17 Leanne Preston 8/18/17 Beth Urban 8/18/17




I. Purpose or Principle

This policy will provide a standard method of performing the Hemochron® Signature
Elite Activated Clotting Time (ACT) at University of Wisconsin Hospital and Clinics to
ensure accurate, quality patient results. This policy will also address testing
requirements such as proper storage and handling of reagents, performance of quality
control tests, proficiency testing, and training and competency assessments. This test
may only be performed by properly trained operators in areas that have been approved
to perform the testing, and that meet the applicable regulatory requirements such as
performing the required quality control and maintaining competency.

Anticoagulation is a necessary therapy for many types of cardiac patients and during
various surgical procedures to counterbalance the natural thrombotic response of blood
such as when it comes into contact with a foreign surface such as the extracorporeal
circuit. Without proper anticoagulant therapy, clot formation would occur within minutes.
ACT point of care testing using the Hemochron® Signature Elite allows the clinician to
monitor and control the level of anticoagulation ensuring clot free blood flow while
minimizing bleeding complications.

Test Measurement
• Utilizes a mechanical endpoint clotting mechanism.
• Precisely measures 15 microliters of whole blood and automatically moves it
into the test channel within the disposable pre-warmed cuvette.
• Sample/reagent mixing and test initiation are performed automatically.
• 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.

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 2 of 15



• 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 and automatically
terminates the test.
• The instrument’s digital timer displays the Celite equivalent ACT value in
seconds in order to provide a familiar clinical format and thus facilitate
accurate clinical test result interpretation.
• There are two types of cuvettes available for ACT testing, depending on
heparin dosing and desired ACT target range.
II. Specimen
A. Patient Preparation
1. Refer to Surgical Services Policy 5.05, Infection Control – Guidelines for
Handling Blood, Body Fluid and Contaminated Items in the OR and
Administrative Policy 13.07, Standard Precautions and Transmission–based
Precautions (Isolation)
B. Specimen
1. 0.5 mL fresh whole blood
2. Do not use glass tubes to collect blood
C. Handling Conditions
1. Test must be performed immediately following blood collection

III. Reagents (or Media), Standards, Supplies and Equipment
A. Reagents and Standards

Reagent Catalog# Storage Stability Preparation
Hemochron® Jr. ACT-LR
Cuvettes

Hemochron® Jr. ACT+
Cuvettes


JACT-LR


JACT+
2 - 8° Celsius



Room
temperature


Opened cuvette
Expiration
date on box


12 weeks



7 days
Bring to room
temperature before use

Redate with new
expiration date on
“Performance Verified”
table on side of box

Reseal cuvette at
opened end and store at
2 - 8° Celsius. Redate
pouch with 7 day
expiration date
directCHECK® Whole DCJLR-N 2 - 8° Celsius Expiration Bring to room

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 3 of 15



Blood Control, ACT-LR
Normal

directCHECK® Whole
Blood Control, ACT+
Normal





DCACT-N



Room
temperature
date on box


4 weeks
temperature at least one
hour before use

Use re-dating label in
box and mark with 4
week expiration date
Reagent Catalog# Storage Stability Preparation
directCHECK® Whole
Blood Control, ACT-LR
Abnormal
directCHECK® Whole
Blood Control, ACT+
Abnormal
DCJLR-A


DCACT-A
2 - 8° Celsius


Room
temperature
Expiration
date on box

4 weeks
Bring to room
temperature at least one
hour before use

Use re-dating label in
box and mark with 4
week expiration date


1. ACT Test Cuvettes
a. ACT-LR Cuvette
• Demonstrates linear correlation to the anticoagulation effects of
heparin up to 2.5 units/mL of blood
• Intended for use in monitoring low to moderate heparin doses
frequently associated with procedures such as cardiac catheterization,
hemodialysis, and Percutaneous Transluminal Coronary Angioplasty
• Not intended for use with patients receiving aprotinin or other
protease inhibitors
• Measuring range is 60 – 400 seconds
b. ACT+ Cuvette
• Demonstrates linear correlation to the anticoagulation effects of
heparin between 1.0 and 6.0 units/mL of blood
• Intended for use in monitoring moderate to high heparin doses
frequently associated with cardiac catheterization and
cardiopulmonary bypass surgery
• Unaffected by aprotinin
• Not sensitive to very low levels of heparin such as those encountered
in critical care
• Measuring range is 67 – 1005 seconds

B. Equipment and Supplies
1. Hemochron® Signature Elite Microcoagulation Instrument


UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 4 of 15




2. Hemochron® ACT-LR or ACT+ test cuvettes (at room temperature)
3. Cuvettes are received monthly from Accriva and pulled from a sequested
lot. Contact Pont of Care is inventory is depleted or borrow from
another testing site.1 mL or 3 mL syringe
4. Gauze
5. Gloves
6. Biohazard and sharps containers
7. Cavi-Wipes
8. directCHECK® ACT Whole Blood Controls
a. Controls are ordered by the Point of Care Testing Coordinators and
stored in the main lab.
b. Call the Point of Care Testing office at 263-8039, 263-5589 or 890-9360
to obtain more controls when needed.

IV. Calibration and Calibration Verification
A. The Signature Elite instrument is calibrated at the manufacturing facility to test
and verify all functions. The instrument is also self-calibrating, as all instrument
functions are continuously monitored and verified by the instrument software
when a test is performed. The instrument does not require additional calibration
by the user.
B. Verification of calibration (analytical measuring range) using at least three
different levels of heparinized blood samples will be coordinated by the Point of
Care Coordinators in the Clinical Laboratories at least every 6 months for each
Hemochron® Signature Elite in use following the manufacturer’s procedure (See
Hemochron® Whole Blood Coagulation Systems Activated Clotting Time
Linearity Procedure).

V. Patient Testing Procedure
A. Verify the appropriate quality control tests have been performed and are
acceptable before proceeding with patient testing (see Section X. Quality
Assurance). Verify expiration dates on cuvettes. Do not use expired materials.
B. Identify the patient using two acceptable identifiers (name and medical record
number or date of birth) before collecting blood sample.
C. Press the green “Start” button to turn the instrument on.
D. Insert a fresh room temperature cuvette into the Hemochron® Signature Elite.
The instrument will display the type of cuvette in the upper left hand corner of the
display screen (ACT+ or ACT-LR).

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 5 of 15



E. The instrument will perform a self-test and begin to warm the cuvette to 37°C.
F. Observe the display for any fault messages before continuing.
G. A prompt to enter the cuvette lot number will be displayed on the Hemochron®
as “Cuvette LOT List”.
H. Any previously used lot numbers will be displayed numerically under “Cuvette
LOT List” (See illustration below.)

I. Choose the correct lot number from the list by pressing the corresponding
number on the key pad or scan the barcode on the cuvette wrapper by
positioning the scanner port approximately 4 inches from the barcode and then
press PRINT/SCAN (see illustrations below).


J. The instrument will display the prompt “Enter OID” (operator ID). Press the
“Print/Scan” button on the instrument and scan the barcode on your employee ID
badge. Press the “Enter” key. If unable to scan your badge, manually enter your
employee ID using the numeric keypad and press and hold the “Enter” key. The
instrument will display the word “Stored” when the information has been saved.
K. The instrument will display the prompt “Enter PID” (patient ID). Press the
“Print/Scan” button on the instrument and scan the patient’s wristband or label,
verifying the correct ID using name and medical record number. If unable to
scan the wristband or label, manually enter the medical record number using the

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 6 of 15



numeric keypad. Press and hold the “Enter” key. The instrument will display the
word “Stored” when the information has been saved.
L. When an audible alarm is heard, the Hemochron® will flash the message "Add
Sample" "Press Start". Do not begin collection of blood until this occurs. The
instrument will remain in this ready mode for five minutes.
M. If the sample is from an indwelling line, the existing Heparin must be flushed to
prevent erroneous results. A typical Heparin lock will require 5 mLs to clear the
line prior to sample removal. Greater volumes will be required to clear longer
lines. If there is any question of heparin contamination, the test should be
repeated.
N. Using a 1 or 3 mL syringe collect a minimum of 0.5 mL whole blood by
venipuncture, from the patient's indwelling IV line (arterial or central), or the
stopcock on the purge line exiting the arterial filter on the heart lung machine.
O. Note: “START TIMED OUT” is displayed if the test is not started within five
minutes. If this occurs, repeat the test using a new cuvette.
P. Immediately dispense blood into the sample well of the test cuvette from the
bottom up. Ensure the well has been completely filled and push any excess
blood into the outer overflow area (see illustration below).

Q. Press the “Start” key. Dispose of the syringe in the appropriate biohazard
container.
R. The elapsed time in seconds is displayed until the sample clots.
S. Note: SAMPLE TOO SMALL, SAMPLE TOO LARGE, or SAMPLE NOT SEEN is
displayed if an incorrect amount of blood was added. The user will then have to
discard this cuvette and begin the process at step D.
T. Test completion will be indicated by an audible beep. Results are displayed in
celite equivalent seconds.
U. Remove and discard the cuvette in the appropriate biohazard container.
V. If result is questionable and should not be posted to the medical record, press
the “NOTE” key and press the #1 key to enter the comment “Invalid – Don’t
Chart.” The result will then be flagged and held in the Clinical Laboratories Point
of Care information system but will not be recorded in the patient’s medical
record.
W. Record the results in the patient’s medical record by downloading the
Hemochron. (See 1595.P7.A1 for instructions.)
VI. Method Specification
A. AMR (Analytic Measuring Range)

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 7 of 15



1. The analytical measuring range for the ACT-LR cuvettes is 60 – 400 seconds
and for the ACT+ cuvettes is 67 – 1005 seconds. Results outside of these
ranges will be displayed as “Out of range – high” or “Out of range – low”.
2. The analytical measuring range of each type of cuvette used for each
Hemochron Elite will be verified every six months by the POC Coordinators
(see Calibration Verification, Section IV.)
B. Interferences
1. Performing testing on samples with a hematocrit of less than 20% or
greater than 55% is not recommended, due to an optical density outside the
detection level of the instrument.
2. The ACT-LR cuvette should not be used on patients receiving aprotinin or
other protease inhibitors. ACT results may be artificially prolonged.
C. Limitations and/or Exceptions
1. The Hemochron Jr. ACT+ and ACT-LR cuvettes are affected by poor
technique including blood collection and the transfer of blood to the sample
well. The quality of the blood specimen may be affected by:
a. Foaming, bubbles or hemolysis of the sample
b. Clotted or partially clotted blood
c. Unsuspected anticoagulation
d. Lupus anticoagulant
2. Variations in ambient temperature should be minimized for consistency of test
performance.
3. 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.

VII. Procedure Notes

A. The transformer should be plugged into an appropriate outlet to charge the
battery. When the message “Charge Battery” is displayed, the instrument must
be plugged in immediately to continue use.
B. Do not force cuvettes into the instrument or use cuvettes past their expiration
date.
C. Always mark each box of cuvettes and liquid quality control with date received,
date opened, and expiration date.

VIII. Result Reporting and Interpretation

A. Guidelines for normal Activated Clotting Times without the presence of Heparin
are 90 to 120 seconds. After heparinization, the level of acceptable ACT varies
according to the procedure.
1. Peripheral vascular procedures should be greater than 200 seconds
depending on the needs of the surgeon and anesthesiologist.
2. The values for monitoring heparin during PTCA, DVI and stent application is
200 – 250 seconds.

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 8 of 15



3. The values for monitoring heparin during electrophysiology is 200 – 300
seconds.
4. During cardiovascular procedures, prior to the initiation of cardiopulmonary
bypass, the acceptable ACT should exceed 400 seconds. Additional Heparin
may be needed if the initial loading dose has failed to move the ACT into this
target range. On cardiopulmonary bypass, the ACT should exceed 480
seconds with additional Heparin administered to achieve this target range.
B. Any result that is questionable or inconsistent with the patient’s clinical status
should be repeated or supplemented with additional diagnostic tests.
C. Result errors of “Sample Not Seen”, “Sample Too Small” or “Sample Too Large”
are invalid and must be repeated.
D. Results displayed on the instrument as “Out of Range – Hi” will be reported as
>400 seconds for the ACT-LR cuvette and >1005 seconds for the ACT+ cuvette.
E. Results displayed on the instrument as “Out of Range – Lo” will be reported as
<60 seconds for the ACT-LR cuvette and <67 seconds for the ACT+ cuvette.
F. Comments are programmed. The cuvette must remain in the instrument.
Press the “NOTE” key and select the number to the corresponding
comment. Press enter. Remove the cuvette. The comment will attach to the
result when the instrument is downloaded. Comments are:
1. Invalid Result – Don’t Chart
2. Repeat Quality Control
3. Wrong QC Level
4. Training/Competency Result
5. Proficiency Testing Sample
G. Record the test result in the patient’s electronic medical record by downloading
the instrument from the appropriate network jack (see 1595.P007.A1).

IX. Safety

A. Blood samples must be collected and handled according to UWHC
Administrative Procedure 13.08, Hand Hygiene, and operating room policy and
procedure # 6.08 Safety Standards for Prevention of Physician, Employees and
Student exposure to Blood-borne Pathogens in the OR Environment.
B. All blood samples and cuvettes should be discarded according to operating room
policy and procedure # 5.05 Infection Control Guidelines for Handling Blood,
Body Fluid, and Contaminated Items in the OR and # 13.07 Standard
Precautions and Transmission-Based Precautions (Isolation).
C. All reagents have been reviewed for risk including reproductive toxicity, acute
toxicity, and carcinogenic potential. None were found.

X. Quality Assurance
A. Electronic Quality Control (EQC) and Temperature Verification Check
1. Two Electronic Quality Controls (Normal and Abnormal) and a temperature
verification check must be performed once every eight hours of patient
testing. This provides a two level check of the instrument.

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 9 of 15



2. The acceptable ranges for the Normal control is 29 – 31 seconds and 299 –
301 seconds for the Abnormal control. The temperature verification must
read 37 ± 1° Celsius.
3. If the EQC has not been run in the previous 8 hours, the Hemochron will lock
out the user and prevent patient testing until the two levels have been run
and are acceptable.
4. The instruments are programmed to automatically run the EQC and
temperature check every 8 hours if left plugged in and turned on.
5. If the instrument is not left plugged in and turned on, it will automatically begin
to perform EQC when turned on if it has been greater than 8 hours since last
done.
6. Ensure cuvettes are removed from the instrument after testing and do not
attempt to insert a test cuvette once the EQC has started. If a cuvette is left
in the instrument, the message “Detector Blocked” is displayed and the EQC
will fail.
7. All the results are downloaded and stored electronically in the Clinical
Laboratories information system.
8. To review and record EQC results run previously, press the “DATABASE”
key, then press #5, Display QC. Press the “ENTER” key to scroll through
previous results.
9. To check when the QC is due, press the “QC” key on the instrument. It will
display the amount of time left until the EQC will automatically run again.
10. To avoid interruption during surgery or a procedure, the EQC can be
manually run by pressing the “QC” key, then the “1” key. The self-test will
proceed and when the system is ready an audible beep will be heard. The
EQC will then be reset to run 8 hours later.
11. To exit QC menu, press “CANCEL” key.
12. If the EQC fails, repeat the test.
13. If the results are still not within the acceptable range or if it gives any error
messages, remove the device from service and do not use for patient testing.
14. Call Accriva Technical Services at 1-800-579-2255 for assistance and notify
the Point of Care Testing Office in the Clinical Laboratories at 263-8039,263-
5589 or 890-9360.
15. A spare Hemochron® Signature Elite will be stored in the Clinical
Laboratories.
16. Call the Point of Care office in the Clinical Laboratories 263-8039 or 263-
5589 Monday – Friday from 7:00 a.m. to 4:00 p.m., to obtain a spare
Hemochron® Signature Elite.
B. directCHECK® Whole Blood Liquid Quality Controls
1. Storage and Handling
a. Each kit of ACT directCHECK® Whole Blood Controls, Levels 1 and 2
contains 15 dropper vials of control, diluent and 4 reusable protective sleeves
for use in crushing ampoules.
b. When stored at 2 - 8°, the controls are good until the expiration date on the
box

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 10 of 15



c. When stored at room temperature, the controls are good for up to four weeks
(the marked expiration date must not be exceeded. Use the redating label in
the control box and mark vials with the new expiration date if storing at room
temperature.
d. Do not expose to temperatures in excess of 37° Celsius.
e. Reconstituted vials should be used immediately.
2. Testing Procedure
a. The Level 1 and Level 2 directCHECK® whole blood liquid controls are
required to be performed:
1. Whenever opening a new box of cuvettes (document results on the
“Performance Verified” box on side panel of box.)
2. Every 30 days thereafter on any opened boxes of cuvettes.
3. Each Hemochron® used for patient testing must have liquid controls
performed at least monthly.
4. The instruments are programmed to lock out the user from patient testing
if the liquid controls are not performed in the required 30 days.
5. The instrument will display “Run LQC” as displayed below.

6. The controls must be performed and within the acceptable ranges before
patient testing can occur.
b. Remove the test cuvettes and control vials from the refrigerator and allow
them to come to room temperature prior to testing. This could require up to
sixty minutes.
c. Verify expiration dates on cuvettes and controls. Do not use expired
materials.
d. Handle test cuvettes and controls as biohazardous materials using standard
precautions. Dispose of used materials in accordance with standard medical
waste disposal policy.
e. Insert cuvette into the cuvette slot on side of instrument.
f. Choose correct cuvette lot number from list or scan barcode on the cuvette
wrapper.
g. Scan or manually enter operator ID.
h. When instrument displays “Enter PID”, press the “QC” key on touch pad. For
Level 1 (Normal), press “1”, for Level 2 (Abnormal), press “2”. (See below.)

i. During pre-warm stage, observe display for fault/warning messages.

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 11 of 15



j. Instrument will display, “QC Lot List.” Select the correct lot number by
pressing the corresponding number on the key pad.

k. The lot number can also be entered by scanning the barcode on the INR
package insert “Acceptable Performance Range(s)” sheet (see illustration
below).


l. The instrument will signal ready with an audible tone, and the display will
indicate "Add Sample" and "Press Start".
m. Reconstitute the vial as follows: (Note: Reconstitution and mixing of the whole
blood control material should be done quickly and without delay in any step.)
1. Remove the label from the vial. Insert vial into white protective sleeve.
2. Holding the vial upright tap the vial to settle glass ampoule to the bottom
of the vial.
3. Crush the inner glass ampoule by bending the vial over the edge of the
tabletop or by crushing between two fingers two to three times.
4. Rotate vial ¼ turn and repeat the crushing two or three times to ensure
complete breakage.
5. Using a downward snapping motion, quickly invert the vial end to end 10
times, ensuring control material flows to dropper tip.
6. Squeeze the vial to discard the first drop into the vial cap.
7. Immediately dispense as many drops of control material as needed to fill
the cuvette sample well flush to the top.
n. Depress the green "START" key.
o. Dispose of used QC vial in a sharps container.
p. Wait for single beep signaling the end of the test. Two beeps indicate a fault
condition.
q. The ACT results will be displayed as well as “QC Passed” or “QC Failed”.
r. Results are stored in the instrument and then downloaded to the Clinical
Laboratories Point of Care Information system.
s. Package inserts for each lot of control are stored in the Point of Care Testing
office for at least two years.
t. Quality control results are reviewed at least monthly by the Point of Care
Testing Coordinator.

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 12 of 15



3. Quality Control Evaluation
a. The acceptable ranges (package insert ranges are used) are programmed into
Point of Care Information system by the Point of Care Testing Coordinator.
b. Repeat any unacceptable (failed) result and document the corrective action by
entering a comment using the “NOTE” key before removing the cuvette (2.
Repeat QC,3. Wrong QC Level, etc.)
Press the “Note”key and select the number to the corresponding comment.
Press enter. Remove the cuvette.
c. If the repeated result is still outside of the acceptable range, do not use the
instrument for patient testing and remove from service.
d. Use an alternate Hemochron® Signature Elite until the appropriate corrective
action has been completed and controls are acceptable.
e. Notify the Point of Care Testing office in the Clinical Laboratories at 263-8039,
o263-5589, 890-9360. Note that a spare Hemochron® Signature Elite will be
stored in the Clinical Laboratories as a back up for testing.
f. Refer to the Hemochron® Signature Elite Operator’s Manual Troubleshooting
section should any error message appear on the display during this procedure.
g. In cases where results are outside of the normal range the cause will likely fall
into one of the following possible categories: Operator Technique, Quality
Control Product/Microcoagulation Test Cuvette, Instrumentation.
h. Refer to the table below when troubleshooting out of range whole blood quality
control results.
Problem Cause Action
Control value is below
published range
Reconstituted control was
not thoroughly mixed






Repeat test, ensuring that
inner glass ampoule is
crushed at least two times
and reconstituted control is
thoroughly mixed by
inverting end to end 10
times
Time period between
control material mixing and
addition to test cuvette was
too long

Repeat test. After mixing,
immediately dispense
control after discarding first
drop.
Problem Cause Action
Control value is above
published range
Rehydrated control was not
thoroughly mixed
Repeat test, ensuring that
rehydrated control is
thoroughly mixed
Inner glass ampoule was
not adequately crushed
Repeat test, ensuring the
inner glass ampoule is
crushed 2 or 3 times
Vial cap is removed prior to
inverting, allowing diluent to
leak from vial.
Repeat test, ensuring that
vial cap is not removed prior
to inverting. Remove vial

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 13 of 15



cap when control material is
to be dispensed into cuvette
well.
Fault message obtained
(see Hemochron
Operator’s manual)
Rehydrated control was not
thoroughly mixed
Repeat test, ensuring that
rehydrated control is
thoroughly mixed
Bubbles are present in
control material when
added to cuvette well
Repeat test, avoiding
excessive agitation during
mixing that may cause
bubbles or foaming.

4. Quality Assurance
a. Proficiency Testing
1. Each testing site will enroll and participate in an approved proficiency
testing program at least two times per year.
2. Proficiency testing should be rotated both among staff that perform
patient testing and Hemochron® Signature Elites used for patient testing.
3. Attestation forms for each proficiency testing event must be signed by the
CLIA Director or Designee and the staff that performed the testing.
4. All proficiency testing reports must be reviewed and signed by the CLIA
Director or designee.
5. Results of 100% are expected and any deviations should be reported to
the medical director and/or manager.
6. For any incorrect results, an investigative review and a follow up
corrective action plan must be documented and signed by the CLIA
Director and attached to the results.
b. Patient Sample Comparisons
1. At least three patient sample comparisons will be performed every six
months during the calibration verification by the Point of Care Testing
Coordinator. Each Hemochron® Signature Elite instrument will be
compared against another Hemochron® Signature Elite.
2. Any results outside the acceptable limits will be investigated. Any
instrument that repeatedly does not meet the comparison criteria will be
sent in for service/repair.
c. Patient Data Review
1. Patient results are reviewed immediately by the provider. The results are
reviewed based on the clinical picture of the patient.
2. Results are reviewed on each working day by the Point of Care Testing
Coordinators.
d. Training and Competency Assessment
1. All staff that perform ACT testing on the Hemochron® Signature Elite are
trained and competent before performing any patient testing. Initial
training is documented and records retained.
2. In their first year of testing, all staff are required to complete two
competency assessments (at around 6 months after start of employment
and at one year.)

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 14 of 15



3. After their first year of testing, all staff are required to complete an annual
competency assessment.
4. Any unsatisfactory competency assessment will be followed up with
retraining. The staff member will not perform any patient testing until
acceptable competence is achieved.
5. Copies of these competency records will be kept in the Point of Care
Office in the Clinical Laboratories. (See 1595.P7.F1 Training and
Competency form.)
XI. Maintenance
A. Inspect and clean the cuvette opening as required. Remove residual dried blood
with or other foreign matter using water moistened cotton swabs.
B. If a disinfectant is needed, use a 10% bleach solution. Wipe instrument with a
water-dampened cloth to remove residual bleach from the plastic surfaces.
C. Do not use solvents or strong cleaning solutions. They may damage plastic
components.
D. Routine maintenance other than cleaning is not required.
XII. Alternate Testing and/or Down Time Procedures
A. If a Hemochron® Signature Elite instrument is malfunctioning or broken, use an
alternate instrument for patient testing.
B. A spare Hemochron® Signature Elite will be stored in the Clinical Laboratories.
Call 263-8039, 263-5589, or 890-9360 to inquire about obtaining the spare
instrument. .
C. Daylight Savings Time Change
At the beginning and end of Daylight Savings Time, the analyzer time must be
changed.
1. Press and hold START to turn on the instrument.
2. Press 0 (zero) to display the main menu)
3. Press 6 for the Configuration menu
4. Press 5 for the Supervisor functions. At the prompt, enter PIN# 1234.
5. Press 3 to display the System Time.
6. Enter the new time, using the 24-hour format (i.e., enter 15:30 for 3:30 pm).
The leading zero is required for single digit times (i.e., enter 06:30 for 6:30
am).
7. Press and hold down ENTER to save the setting.
8. Press CANCEL to exit the menu.

XIV. References
A. Hemochron® Signature Elite operator's manual Accriva Diagnostics, Inc., San Diego,
CA. ACT+ and ACT-LR cuvette package inserts, Accriva Diagnostics, Inc., San
Diego, CA.
B. directCHECK® Whole Blood Controls package insert, Accriva Diagnostics, Inc. San
Diego, CA.

UW Health Clinical Laboratory Original Date: 7/18/11
Radiology, AFCH, Cardiac and Vascular Care, F4/5, F4M5,
D4/5, Surgical Services
Current Version Date: 8/25/2015
Document Title: Hemochron® Signature Elite Activated
Clotting Time

Document ID: 1595.P007 Page 15 of 15



C. CLSI Point-of-care monitoring of anticoagulation therapy; approved guideline.
Document POCT 14-A, July 2014.
XIV. Related Documents
A. Hemochron® Signature Elite ACT Validation Report, Point of Care Testing Office
B. Hemochron® Whole Blood Coagulation Systems Linearity and Precision
Procedure for ACT+ and ACT-LR cuvettes
C. Hospital Administrative Policy 13.07, Standard Precautions and Transmission–
based Precautions (Isolation)
D. Hospital Administrative Policy 13.08, Hand Hygiene
E. Hospital Administrative Policy4.1.10, Sharps Disposal
F. Surgical Services Policy 5.05, Infection Control – Guidelines for Handling Blood,
Body Fluid and Contaminated Items in the OR
G. Surgical Services Policy 6.08, Safety Standards for Prevention of Physician,
Employees and Student Exposure to Bloodborne Pathogens in the OR
Environment
XV. Appendices and Forms
A. 1595.P7.F1 ACT by Hemochron® Signature Elite Training and Competency,
August 2017 1595.P7.F2 ACT Annual Procedure Review and Changes Form, July
2012
B. 1595.P7.F3 Hemochron® Signature Elite Service Log, July 2012
C. 1595.P7.A1 Instructions on How to Download the Hemochron Signature Elite,
August 2015
D. 1595.P7.A2 Hemochron® Signature Elite ACT IQC Plan, August, 2015
XVI. Author and/or Revised By
Beth Urban, MLS (ASCP) Point of Care Testing Coordinator
XVII. Coordination and/or Review
Point of Care Testing Faculty Director
CLIA Laboratory Director UW Health Point of Care Testing