BHR HOSPITALS – POCT

MEDTRONIC ACT PLUS AUTOMATED ACTIVATED CLOTTING TIME

(ACT) SYSTEM AT POINT OF CARE

Paper copy number, when printed:

1.0 PURPOSE / CLINICAL RELEVANCE

The ACT Plus® System is a microprocessor-controlled
electromechanical coagulation instrument designed to
determine coagulation endpoints in fresh and citrated whole
blood samples. The ACT test is commonly used to monitor the
effect of high dose heparin before, during, and shortly after
surgeries that require intense anticoagulation measures, such
as cardiac bypass surgery, cardiac angioplasty, and dialysis. It is
ordered in situations where the PTT test is not clinically useful
(i.e., high-dose heparin therapy or presence of lupus
anticoagulant).

The aim of this document is to describe how to correctly use this device to minimize any risks
to both patients and users, including any limitations of use and quality assurance at point of
care (POCT). This document should be read in conjunction with the documentation supplied
with the instrument together with relevant BHRUT Policies and clinical protocol/guidelines.
For all questions about the ACT plus system that are not answered
in this document, contact the Point-of-Care coordinator and/or the
Operator manual.

Untrained staff are NOT authorized to use this equipment!

This standard operating procedure is relevant to all healthcare

staff throughout BHR University Hospitals Trust who are required
to use the ACT Plus.

2.0 RESPONSIBILITY
2.1 Divisional Director
Has responsibility for ensuring POC investigation procedures, outside the laboratory,
have clearly defined procedural guidance and that the Trust provides/supports the
training required for staff to undertake POCT safely.

2.2 Clinical Leads

The responsibility for patient results obtained by POCT processes lies with the
appropriate Clinical Lead for the ward or department. Any therapeutic decision based on
a POCT result is also the responsibility of the Clinical Lead. The Clinical Lead must decide
for which patient groups the POCT process is appropriate, ensure appropriate
documented systems exists for the management of requesting POCT and provide
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guidelines for interpretation of results and further patient management . These
guidelines should include when it is necessary to compare a result with a laboratory
processed sample, the procedure for communication of results and timeframes.

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MEDTRONIC ACT PLUS AUTOMATED ACTIVATED CLOTTING TIME

(ACT) SYSTEM AT POINT OF CARE

2.3 Heads of Nursing and Matrons

Heads of Nursing/Midwifery and Matrons have a responsibility to ensure correct
procedures are followed at all times. Matrons shall be responsible for the identification
of suitable staff to act as link trainers, the staff that are permitted to use this POCT and
for ensuring staff training & competency is maintained in accordance with Trust Policy
and regulatory requirements.

2.4 Ward or Departmental Managers

The Manager must ensure that all users within the department understand the concept
of POCT and have been trained and assessed as competent to use the POCT device or
process correctly, safely and in accordance with the manufacturer’s recommendations
and Trust policy.

The Manager must ensure users attend regular update training as required, keep records
of training and ensure only competent users operate POCT devices within their Ward or
Department. Managers must be aware of the maintenance arrangements for POCT
devices and action to be taken in the event of breakdowns. Those with managerial
responsibility should initiate the appropriate backup service from Pathology in the event
of devices failure or poor Quality Assurance.

Where there has been an incident involving POCT devices, including inadequate
performance or documentation of patient or Quality Assurance results, Ward or
Departmental managers will investigate the incident and be responsible for reporting this
via the Trust incident reporting procedure. All such incidents should be brought to the
attention of the POCT Coordinator and the POCT committee. Further investigation may
indicate that the incident should be referred to the MHRA and the Medical Devices
Manager and Head of Clinical Governance and Risk must be involved in these
circumstances.

2.5 All Users

All members of staff are responsible for their own safety and for ensuring their POC
training is updated and their competence maintained. The responsibility to correctly and
safely perform any point of care test lies with the person performing the test. Once
deemed competent you are then responsible for the results you obtain including any
actions taken on the results. Staff must always adhere to local policy & clinical protocol
for any actions taken on results, including who should be notified and any relevant
timescales.

2.6 Pathology/POCT Coordinator

Pathology will have overarching responsibility for monitoring device function to ensure
appropriate clinical governance requirements are met and to support its safe use at POC.

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MEDTRONIC ACT PLUS AUTOMATED ACTIVATED CLOTTING TIME

(ACT) SYSTEM AT POINT OF CARE

3.0 REFERENCES
No. Title:
1 Clinical Pathology Accreditation (UK) Ltd. Standards for the Medical Laboratory
v2.1, Mar 2009
2 POCT QA & Audit Framework
3 Additional Standards for POCT facilities v1.0, Apr 2010
4 Point of Care Testing Policy.
th
5 The Retention and Storage of Pathological Records and Specimens (4 Ed.,
2009) Royal College of Pathologists Guidelines
6 Infection Prevention & Control Policy
7 Policy & Guidelines for Safe Handling & disposal of Sharps
8 Policy for Single Use, Single Patient Use and Limited Use Medical devices
9 Document for the Management of Incident Reporting including the
Management and Reporting of Serious Incidents
10 Management of Medical Devices Policy
11 Patient Identification Policy
12 Risk Management strategy & policy
13 COSHH Policy
14 Management of Waste Policy
15 Policy for the Management of Diagnostic Testing Procedures

4.0 DEFINITIONS
Acronym Definition
BHRUT Barking, Havering and Redbridge University Hospital (NHS) Trust
ACT Activated Clotting Time
POC(T) Point of Care (Testing)- At or near the site of the patient, the use of
Medical Devices outside of the traditional laboratory setting for the
testing of patient samples
User Any person who handles a POCT instrument to produce patient results,
carry out maintenance or performs QA checks. This includes Clinicians,
Nursing Staff, Healthcare Scientists and Service Engineers.
SOP Standard Operating Procedure. This is the gold standard protocol that
specifies how, when and by whom the instrument can and should be
used.
QC Quality Control are the routine operational procedures performed to
ensure that the results are continually reliable.
QA Quality Assurance is the sum of the processes or systems that ensure the
instrument is fit for purpose and the results produced are correct and
reliable for the safety of the patient and users
EQA External Quality Assurance. This is a means of determining how a
particular POCT instrument is performing in comparison to other
instruments elsewhere
IVD In Vitro Diagnostic

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MEDTRONIC ACT PLUS AUTOMATED ACTIVATED CLOTTING TIME

(ACT) SYSTEM AT POINT OF CARE

RA Risk Assessment. This is a process for identifying the potential risks

associated with the operation of an instrument and the effectiveness of
controls to mitigate these.
COSHH Care of Substances Hazardous to Health. This is a special form of risk
assessment applied to hazardous chemicals and substances that may be
present or required for use with the instrument.

5.0 DOCUMENTATION
No. Title:
16 ACT Plus Operator Manual
17 Training & Competency Framework for Use of the ACT Plus System for POCT
heparin monitoring
18 ACT Plus Maintenance & Fault Record Log
19 ACT Plus Case record Sheet

6.0 ACTIONS AND METHODS

6.1 Health & Safety / COSHH / Risk Assessment
All samples should be considered potentially infectious and care should always be taken
when handling human specimens and other material prepared from human origin. Even
if these samples are tested for infectious agents and found non-reactive, no method can
offer complete assurance that HIV, Hepatitis B Virus or other infectious agents are
absent.

Personal protective equipment e.g. gloves, should be worn in accordance with recognized
safety procedures when handling samples, control material, equipment and other kit
components as specified within this document and Trust Policy & Procedure
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Waste must be disposed of in accordance with Trust Policy & Procedure

Uses of POCT must be able to demonstrate that QA standards are being met and all risks
associated with the use of the device are minimized. A local Risk Assessment for use of
this POCT should be performed and held on file by the respective clinical area in
accordance with Trust Policy & Procedure10, 12.

This procedure does not use any hazardous chemical components/reagents and is
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therefore exempt from COSHH .

6.2 Principle of examination

The ACT Plus™ is a microprocessor-controlled electromechanical coagulation instrument

intended for determining coagulation endpoints in fresh whole blood and citrated whole
blood samples. The endpoint of a test performed on the ACT Plus™ is formation of fibrin.
Fibrin formation is detected by measuring the rate of fall of the plunger-flag mechanism

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(ACT) SYSTEM AT POINT OF CARE

in each cartridge channel. The plunger assembly falls rapidly at programmed intervals
through an un-clotted sample. The fibrin web formed during clotting impedes the rate of
fall of the plunger and is detected by a photo-optical system located in the actuator
assembly of the instrument. The time to clot formation is known as the ACT. The ACT is
measured in seconds: the longer the time to clot, the higher the degree of clotting
inhibition.
6.2 Personnel to do the task / level of training required
The use of POCT has gained widespread use but if tests are not performed with care
and attention to technique, the results can be erroneous and dangerous. It is therefore
essential that staff undergo formal training. Use of medical devices by untrained staff
can adversely affect the treatment of patients.

Ward/site managers are responsible for the identification of those staff that are qualified
to use this POCT.

6.4 Specimen requirements and means of identification

Patient identification must conform to Trust Policy and a system of positive patient
identification must be in use11. The ACT Plus device is capable of reading linear patient
barcodes to aid in identification. All tests must be recorded using the patient hospital
number when processing an ACT on the actual instrument. Patient details should be
recorded using the ACT Plus Case Record Sheet19.

6.5 Method / Procedure

6.5.1 Patient Preparation
All tests: Blood may be obtained either by venipuncture or from arterial or venous
access lines. The venipuncture must be fast, non-traumatic, and the first 2 to 3 ml of
blood collected discarded in a separate syringe in order to prevent contamination of the
test sample with tissue activator (thromboplastin) and the potential for erroneous
results. Blood should flow quickly into the syringe.

Arterial or Venous Line Collection: Flush the line with 5 ml saline, and using separate,
single use syringes, collect at least 5 ml or 6 dead space volumes of blood and discard
prior to collection of the test sample in order to eliminate the risk of excess dilution and
contamination of the sample with heparin from the catheter or line.

6.5.2 Specimen type

Specimen Type:
High Range ACT (HR-ACT): Fresh Whole Blood, 400 ml per cartridge channel
Low Range ACT (LR-ACT): Fresh Whole Blood, 200 ml per cartridge channel

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Handling Conditions:
Fresh whole blood specimens (HR-ACT, LR-ACT) should be tested as quickly as possible
following sample collection. Test within 60 seconds when there is no anticoagulant on
board. Test within 2 minutes when the sample is heparinized. Citrated whole blood
specimens should be collected using a ratio of 9 parts whole blood to 1 part
anticoagulant and tested within 6 hours of collection when stored at room temperature.

6.5.3 Equipment & Materials

Equipment:
Medtronic ACT Plus™
®
Medtronic ACTtrac
Temperature Verification Cartridge or suitable thermometer

Materials:
Syringes, no larger than 10 ml
19 gauge blunt tip needle or other blood collection needle

6.5.4 Quality Control Testing

Quality Control testing for the ACT Plus is performed using liquid controls and a
combination of liquid and electronic (ACTtrac®) controls. IQC testing shall always be
performed before patient testing to verify correct functioning of the device. Record
Quality Control testing using the ACT Plus Maintenance & Fault form18.
Electronic Control: The ACTtrac® is a battery powered software controlled electro-
mechanical verification device that checks the following functions of the ACT Plus as
they relate to proper test cartridge function: flag sensor function, reagent delivery pin
height, lift wire height, and three levels of clotting times. The ACTtrac® is used to identify
instruments that no longer fall within mechanical calibration specifications.

Liquid Controls: Two levels of liquid control are performed for all ACT tests. All
CLOTtrac controls for ACT testing are prepared from sheep whole blood and are
packaged with vials of deionized water for reconstitution. When used in conjunction
with the ACTtrac® electronic control, liquid controls should be performed every seven
days and with a change in cartridge lot number.

HR-ACT: Two levels of liquid control (the CLOTtrac HR normal and abnormal controls)
are performed for the HR-ACT.

Storage and Stability: Store controls in the refrigerator, between 2° and 10°C. Controls
are stable until the expiration date on the package when stored at refrigeration
temperatures. CLOTtrac controls are stable for 1 hour following reconstitution.

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Preparation:
1) Remove controls and deionized water diluent from the refrigerator and bring to
room temperature for approximately 10 minutes.
2) Add 1.8 ml of deionized water to the lyophilized sheep blood.
3) Allow at least 10 minutes for adequate rehydration. DO NOT AGITATE OR MIX
UNTIL COMPLETELY REHYDRATED.
4) Shake the control vigorously to mix until the red blood cells are uniformly dispersed
and the control is completely reconstituted.
Performance:
1) To perform the HR-ACT control test select or confirm HR-ACT as the cartridge type
in the Main Menu.
2) Select the Quality Control menu to perform the control test. (Note: cartridge and
control lot numbers must be entered prior to testing.)
3) Enter the User ID (if required)
4) Select the Control Type (Normal or Abnormal) and press enter to confirm.
5) Pre-warm the cartridge for at least 3-5 minutes.
6) Tap or shake the HR-ACT cartridge to re-suspend the kaolin activator.
7) Using a syringe and blunt tip needle, fill each cartridge chamber with the
appropriate control to the level between the fill lines (400 mcl per channel).
8) Insert the cartridge into the ACT Plus™, and close the actuator heat block to initiate
the test.
9) The ACT Plus™ will incubate the control sample for 300 seconds, and then begin the
clot detection cycle.
10) Clot formation is signaled by an audible tone, the actuator heat block opens and
the results are displayed.

LR-ACT: Two levels of liquid control (the CLOTtrac CWB Normal and LR-Abnormal
controls) are performed for the LR-ACT.
Storage and Stability: Store controls in the refrigerator, between 2° and 10°C.
Controls are stable until the expiration date on the package when stored at
refrigeration temperatures. CLOTtrac controls are stable for 1 hour following
reconstitution.
Preparation:
1) Remove controls and deionized water diluent from the refrigerator and bring to
room temperature for approximately 10 minutes.
2) Add 1.5 ml of deionized water to the lyophilized sheep blood.
3) Allow at least 10 minutes for adequate rehydration. DO NOT AGITATE OR MIX
UNTIL COMPLETELY REHYDRATED.
4) Shake the control vigorously to mix until the red blood cells are uniformly dispersed
and the control is completely reconstituted.
Performance:
1) To perform the LR-ACT control test select or confirm LR-ACT as the cartridge type in
the Main Menu.

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2) Select the Quality Control menu to perform the control test. (Note: cartridge and
control lot numbers must be entered prior to testing.)
3) Enter your User ID
4) Select the Control Type (CWB or Abnormal) and press enter to confirm.
5) Pre-warm the cartridge for at least 3-5 minutes.
6) Tap or shake the LR-ACT cartridge to re-suspend the kaolin activator.
7) Using a syringe and blunt tip needle, fill each cartridge chamber with the
appropriate control to the level between the fill lines (200 mcl per channel).
8) Insert the cartridge into the ACT Plus™ actuator heat block to pre-warm the
cartridge with the control for 5 minutes. Note: this step must be timed manually.
9) After 5 minutes has elapsed add one drop of CaCl2 (40mcl) from the Medtronic
Calcium dropper bottle to each cartridge channel.
10) Immediately place the cartridge back into the actuator heat block and close to
begin the test.
11) Clot formation is signaled by an audible tone, the actuator heat block opens and
the results are displayed.

6.5.5 Patient Testing

Cartridge Preparation:
Cartridges for ACT testing should be shaken or tapped to re-suspend the kaolin and pre-
warmed for 3 to 5 minutes in the heat block of the ACT PLUS. Cartridges for HR-ACT &
LR-ACT may be pre-warmed for up to 12 hours

HR-ACT Patient Test:

1) To perform an HR-ACT patient test select or confirm HR-ACT as the cartridge type in
the Main Menu.
2) Enter the Patient ID (Note: cartridge and control lot numbers must be entered prior to
testing, and all required quality control tests must be performed before patient testing).
3) Enter your User ID
4) Pre-warm the cartridge for at least 3-5 minutes.
5) Tap or shake the HR-ACT cartridge to re-suspend the kaolin activator.
6) Using a syringe and blunt tip needle, fill each cartridge chamber with the appropriate
patient sample to the level between the fill lines (400 mcl per channel).
7) Insert the cartridge into the ACT Plus™, and close the actuator heat block to initiate the
test.
8) Clot formation is signaled by an audible tone, the actuator heat block opens and the
results are displayed.

LR-ACT Patient Test:

1) To perform the LR-ACT patient test select or confirm LR-ACT as the cartridge type in
the Main Menu.
2) Enter the Patient ID (Note: cartridge and control lot numbers must be entered prior to
testing, and all required quality control tests must be performed before patient testing).
3) Enter your User ID

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4) Pre-warm the cartridge for at least 3-5 minutes.

5) Tap or shake the LR-ACT cartridge to re-suspend the kaolin activator.
6) Using a syringe and blunt tip needle, fill each cartridge chamber with the appropriate
patient sample to the level between the fill lines (200 mcl per channel).
7) Insert the cartridge into the ACT Plus™ and close the actuator heat block to initiate the
test.
8) Clot formation is signaled by an audible tone, the actuator heat block opens and the
results are displayed.

6.6 Reference Ranges

The ACT Plus™ calculates the mean or average clotting time for the duplicate channels
and the difference in seconds between channels is displayed.

HR-ACT: The cartridge is designed to maintain an average population response of

approximately 100 seconds per unit of heparin.
LR-ACT: The cartridge is designed to maintain an average population response of
approximately 250 seconds per unit of heparin.

HR-ACT: Baseline x 2/3.

LR-ACT: Baseline x 2/3

6.7 Limitations of the examination, including interferences, cross reactions and

reportable intervals
All POCT devices have limitations and this should be remembered at all times The ACT
test is generally less sensitive than the aPTT test. The ACT test will only detect a factor
abnormality when there is a 95% or more decrease in single factor activity (less than 5%
normal factor activity). ACT test results may be affected (prolonged) by
thrombocytopenia, thrombopathy and hemodilution.

Interfering Substances:
Activated blood specimens, either in-vivo (patient’s coagulation mechanism activated) or
in-vitro, due to improper sample collection and handling may cause erroneous results.
Sample collection and testing should be repeated.

PROCEDURE NOTES:
HR-ACT: The HR-ACT may be affected by the following: dilution of plasma coagulation
factors, the use of citrated blood products, use of anti-platelet agents, hypothermia,
change in platelet number or function.
LR-ACT: The LR-ACT is intended for use with fresh whole blood samples when the
heparin concentration is between 0 and 1.5 units/ml.

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MEDTRONIC ACT PLUS AUTOMATED ACTIVATED CLOTTING TIME

(ACT) SYSTEM AT POINT OF CARE

Causes of a Prolonged ACT

Heparin
Hypothermia
Hypofibrinogenaemia
Other clotting factor deficiencies
Haemodilution
Aprotinin
Thrombocytopaenia
Qualitative platelet
abnormalities

6.8 Responsibilities of personnel in authorising, reporting and monitoring reports

The responsibility for a test result lies with the person performing the test. All results
(whether normal or abnormal) should be brought to the attention of the responsible
clinician. All test results must be recorded using the ACT Plus Case record form with
actions.
Results Management:
• All abnormal values should be followed up according to local protocol and any actions
taken on abnormal results fully noted in the patients medical record
• Who was informed of the results and the timeline must also be noted, in accordance
with Risk Management Standards
• The operator responsible for the results must be recorded within the patient record
to allow for full audit trail.
It is the responsibility of the person performing the test to ensure that results are correct
and reported in the patient’s notes in accordance with this document and Trust Policy.

6.15 Audit
Users of this POCT are required to regularly monitor and audit its use to ensure
compliance with this document and Trust Policy & Procedure. Audit may also be
undertaken by Pathology and external sources.

6.16 Maintenance
Routine Cleaning: Clean the exposed surfaces of the actuator and dispenser and the
instrument case using a cloth dampened with 10% bleach, isopropyl alcohol, methanol,
ethanol, Liqui-Nox, hydrogen peroxide, or mild detergent.
The ACT Plus™ cleaning kit is used to clean the sensors and lift-wire in the actuator. Cleaning
should be performed at least monthly and more frequently as warranted by use (record using
tha ACT maintenance record log).

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Temperature Verification: Verification of the ACT Plus™ heat block should be performed once
a month and may be done with a Temperature Verification Cartridge that is supplied with the
instrument or with calibrated thermometer and water-filled cartridge.
Using the Temperature Verification Cartridge:
From the Quality Control menu enter User ID if required:
1. Select [Temperature Adjustment].
2. Insert the Temperature Verification Cartridge into the actuator heat block.
3. Press button on the Temperature Verification Cartridge for temperature reading.
4. After about 5 minutes check the Temperature Verification Cartridge reading.
5. Enter the reading from the Temperature Verification Cartridge using the numeric
keypad. The entered value will appear highlighted in the Thermometer Reading on
the display
6. Press Enter to confirm.
7. Select [Repeat Adjustment] variable function key to repeat the temperature
adjustment if necessary.
Using a Thermometer:
From the Quality Control menu enter User ID if required:
8. Remove the plunger assembly from a cartridge and fill with 0.2 to 0.3 ml of water.
9. Insert the cartridge into the actuator heat block.
10. Select [Temperature Adjustment].
11. Place a calibrated thermometer in one of the cartridge reaction chambers.
12. After about 5 minutes check the thermometer reading.
13. Enter the reading from the thermometer using the numeric keypad. The entered
value will appear highlighted in the Thermometer Reading on the display
14. Press Enter to confirm.
15. Select [Repeat Adjustment] variable function key to repeat the temperature
adjustment if necessary.
Note:
• The instrument displayed temperature and thermometer measured temperature
should read between 36.5° to 37.5° C.
• The thermometer temperature should be within ± 0.5° C of the instrument
displayed temperature.
• The time, date and temperatures of the thermometer and the display will be logged
in the instruments temperature log.
• Wait a minimum of 10 minutes before repeat adjustments are performed.
• Values must be between 35 °C and 39 °C.

14.0 Service failure:

All device problems should be reported to the service/ward manager for the clinical area
and/or POCT Coordinator.

It is the responsibility of the clinical unit to ensure suitable contingency procedures exist and
that appropriate server cover is in place.

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