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									                           The Johns Hopkins Medical Institutions                     Document
                                                                                      Number:          POC3-207
                           POINT-OF-CARE TESTING PROGRAM
                           POLICIES AND PROCEDURES MANUAL                         Effective Date:        8/13/2007

                           Title:                                                 Page:                    1 of 6

                           PROCEDURE FOR HEMOCHRON®                               Supercedes:            3/22/2007
                           SIGNATURE ELITE ACTIVATED
                           CLOTTING TIME (ACT +)



Purpose                This procedure provides instructions for performing ACT+ testing on the HEMOCHRON
                       Signature Elite. ACT + is used for monitoring patients receiving heparin anticoagulation
                       therapy who attain a blood heparin concentration of more than 1.0 but less than 6.0 units
                       of heparin/cc of blood.


Order                  A physician’s order, standard protocol, or order by other health professional authorized to
                       request laboratory test is required for ACT +.


Materials
                            Reagents                             Supplies                        Equipment
                        HEMOCHRON                    -Latex –free gloves                  -HEMOCHRON Signature
                        ACT Plus cuvettes                                                 Elite    Microcoagulation
                                                     -JHMI approved          biohazard    Instrument
                                                     waste container
                                                                                          -AC/DC Power Module
                                                                                          (ITC Part No. HX1025)



Storage Requirements

                                                         ACT Plus Cuvettes
                                       Temperature                            Expiration Date
                        Refrigerated at 2-8°C (36 -46°)F          Good until manufacturer’s expiration date
                        Room Temperature 15-30°C (59-86°F)        Good for 12 weeks

                       •    Once a pouch is opened, the cuvette (stored in the folded pouch) is stable for only
                            one day under refrigerated (2- 8°C or 36-46°F) conditions.
                       •    Once a box of cuvettes is brought to room temperature, it is required that the box is
                            labeled and re-dated with “Open Date” and new “Expiration Date”.
                       •    Bring cuvettes to room temperature at least one hour prior to testing
                       •    All reagents are obtained from the POCT office.


Specimen
                            •       Blood sample should not be collected until the instrument display indicates
                                    “Add Sample” and “Press Start”
                            •       The cuvette requires a minimum volume of 15 microliters of fresh whole blood
                                    to perform the test, and will display “Sample too small” if insufficient sample is
                                    applied.
                            •       Samples with the following characteristics should be discarded immediately, and
                                    a fresh whole blood sample should be collected.

                                       The Johns Hopkins Hospital
                                          Baltimore, Maryland
                            The Johns Hopkins Medical Institutions                   Document
                                                                                     Number:
                            POINT-OF-CARE TESTING PROGRAM
                            POLICIES AND PROCEDURES MANUAL                        Effective Date:      8/13/2007

                            Title:                                                Page:                 2 of 6

                            PROCEDURE FOR HEMOCHRON®                              Supercedes:          3/22/2007
                            SIGNATURE ELITE ACTIVATED
                            CLOTTING TIME (ACT +)


                                     1.   Sample contamination with tissue thromboplastin
                                     2.   Sample contamination with indwelling intravenous solutions
                                     3.   Sample contamination with alcohol cleansing solution
                                     4.   Samples with visible clotting or debris accumulation

                          Blood samples with any of the above conditions may interfere with the ACT + test.


Safety precautions        Follow Standard Precautions and CDC hand washing guidelines when performing this
                          test.

                           All cuvettes should be considered as potentially infectious, handled with care and
                          disposed of by following standard waste facility disposal policy.


Quality Control           Internal Electronic Temperature Verification (TQC) and Quality Control (EQC) should
                          be run every 8 hours of patient testing.

                           Liquid Quality Control (LQC) should be run weekly. Refer to Quality Control
                          procedure”Quality Control Procedure for Hemochron Signature Elite” POC3-203 for
                          specific guidelines.

                          Document all QC results on the Elite ACT QC log, Form POC3-203F3.

911 Limit                 A maximum of two patients tests are allowed to be run after the specified EQC/LQC
                          lockout interval has been reached. These 911 patient tests are only to be used in dire
                          patient emergencies. The Hemochron Signature Elite will alert the operator that a 911
                          patient test is being used. When the 911 limit is reached, the needed QC must be run to
                          continue to operate the meter. No further 911 testing will be allowed on the meter until
                          the meter is reconfigured. Call the POCT office, 5-2645, to reset (clear) the 911 uses to
                          zero.

Patient Test Procedure Two unique patient identifiers should be available before testing.

                               Step                                          Action
                                1           Insert cuvette.
                                2           Enter or Confirm operator ID. Press Enter.
                                3           Screen will display “PID=______”.
                                4           Enter or Confirm Patient ID.
                                5           “ID stored” will be displayed.
                                6           Instrument displays “Priming Pump…” and “…Warming…”
                                7           The instrument will signal when ready with an audible tone, and screen
                                            will display the messages “Add Sample” and “Press Start”
                                 8          Immediately add sample and then press start.
                                 9          Once finished, meter beeps once and displays results.
                                10          Immediately record results and instrument ID in the patient flow sheet.
                                11          Remove and discard cuvette in a biohazard container
                                          The Johns Hopkins Hospital
                                             Baltimore, Maryland
                            The Johns Hopkins Medical Institutions                        Document
                                                                                          Number:
                            POINT-OF-CARE TESTING PROGRAM
                            POLICIES AND PROCEDURES MANUAL                             Effective Date:     8/13/2007

                            Title:                                                     Page:                 3 of 6

                            PROCEDURE FOR HEMOCHRON®                                   Supercedes:         3/22/2007
                            SIGNATURE ELITE ACTIVATED
                            CLOTTING TIME (ACT +)


                                 12         Instrument is ready for next patient.
Reference/ Interventional
Ranges
                                              Reference / Baseline Ranges           Interventional /Therapeutic Target
                                                         GOR:                       Aprotinin patients: greater than or
                                                                                    equal to 500 seconds
                                                    105 – 167 seconds               ECMO patients: 160 – 200 seconds
                              ACT +
                                                                                    All other patients: greater than or
                                                                                    equal to 400 seconds

Reportable Range        The Reportable Range for ACT Plus has been set by the Medical Director to 700
                        seconds. Results that exceed “700” should be reported as “greater than 700” (>700).


Critical Action Value   There is no Critical Action Value for ACT +.


Result Interpretation
                        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.


Documentation           Upon completion of the test, immediately record the result along with the meter ID, date,
                        time and operator ID on the Cardiopulmonary Bypass Perfusion Record.


Limitations
                             •       Samples with hematocrits less than 20% or greater than 55% may exhibit an
                                     optical density outside the level of detection of the HEMOCHRON Signature
                                     Elite microcoagulation instruments. In such cases a “Sample Not Seen” error
                                     message will be displayed.
                             •       Values less than 67 seconds, or exceeding 1005 seconds are not reported on the
                                     HEMOCHRON Signature Elite analyzers; instead, an “ACT < 67 sec, Repeat”
                                     or “Over-range Hi” message is displayed.
                             •       Aprotinin is an antifibrinolytic drug often administered during cardiac surgery in
                                     order to prevent post surgical bleeding complications. The Celite ACT is
                                     artificially prolonged while the kaolin ACT (including the ACT +) is not
                                     affected by antifibrinolytic therapy (e.g. aprotinin), except at very high (>500
                                     KIU/cc) concentrations.
                             •       Tests may be affected by any of the following conditions:
                                           1. Foaming of the sample (air bubbles)
                                           2. Hemolysis
                                           3. Clotted or partially clotted blood
                                           4. Unsuspected anticoagulation with either heparin or warfarin
                                           5. Presence of a lupus anticoagulant
                                        The Johns Hopkins Hospital
                                           Baltimore, Maryland
                   The Johns Hopkins Medical Institutions                  Document
                                                                           Number:
                   POINT-OF-CARE TESTING PROGRAM
                   POLICIES AND PROCEDURES MANUAL                       Effective Date:       8/13/2007

                   Title:                                               Page:                   4 of 6

                   PROCEDURE FOR HEMOCHRON®                             Supercedes:           3/22/2007
                   SIGNATURE ELITE ACTIVATED
                   CLOTTING TIME (ACT +)



Procedural Notes

                                                              Notes
                        1.    Do not use cuvettes past their expiration date or cuvettes that have been
                              stored improperly
                        2.    Do not force a cuvette into the instrument. If resistance to insertion is
                              encountered, gently remove the cuvette and examine the cuvette slot.
                              Remove any obstruction before attempting further use of the instrument
                        3.    Do not use excessive force in depressing the START key
                        4.    Do not drop the HEMOCHRON Signature Elite microcoagulation
                              instruments
                        5.    Do not expose the HEMOCHRON Signature Elite microcoagulation
                              instruments to extreme temperatures (above 37˚C or 98.6°F). Such exposure
                              could affect the performance of any type of electronic equipment
                        6.    The HEMOCHRON Signature Elite microcoagulation instruments are
                              designed for use only with HEMOCHRON Jr. Signature Plus cuvettes. Test
                              cuvettes must be properly stored according to the instructions in the package
                              insert.
                        7.    The HEMOCHRON Signature Elite test results are affected by poor
                              technique during blood collection and delivery to the sample well. The
                              accuracy of the test is largely dependent upon the quality of the sample
                              collection and the transfer of the blood to the test cuvette.
                        8.    The transformer provided should be plugged in to an appropriate outlet to
                              charge the instrument when it is not in use to maintain battery power level.




Maintenance
                       Step                                       Action
                   1          Inspect and clean cuvette opening as required.
                   2          Remove residual dried blood or other foreign matter using moistened cotton
                              swabs.
                   3          Remove any residual water with a dry cotton swab.
                   4          If a disinfectant is needed, use a 0.5% solution of sodium hypochlorite or a
                              dilution of household bleach in water. Remove residual bleach with a water
                              dampened cloth.
                   5          No other routine maintenance is required.




                              The Johns Hopkins Hospital
                                 Baltimore, Maryland
                        The Johns Hopkins Medical Institutions                   Document
                                                                                 Number:
                        POINT-OF-CARE TESTING PROGRAM
                        POLICIES AND PROCEDURES MANUAL                       Effective Date:        8/13/2007

                        Title:                                               Page:                    5 of 6

                        PROCEDURE FOR HEMOCHRON®                             Supercedes:            3/22/2007
                        SIGNATURE ELITE ACTIVATED
                        CLOTTING TIME (ACT +)



Battery Care            The Hemochron Signature Elite can be operated on internal battery or plugged into an
                      AC outlet using the supplied transformer. It should be allowed to charge for a full 8 hours
                      for adequate charge.


                        Battery Warning                                 Meaning/Action
                        CHARGE                  Displayed intermittently when remaining power is insufficient to
                        BATTERY                 ensure test completetion. Plug into AC power as soon as
                                                possible.
                        BATTERY                 Battery is completely discharged. AC power must be used for
                        FAULT                   additional tests.
                        DISCONNECT              AC power module voltage is too high. Disconnect power to shut
                        AC    ADAPTER           down instrument.
                        IMMEDIATELY



Instrument Downtime    When a particular Hemochron Signature Elite cannot be used for patient testing due to
                      QC failure or mechanical or electronic instrument failure, document problems and
                      attempted corrective actions in the “Comment” section of the QC logsheet. If problems
                      cannot be resolved by the operator, contact the Point-of-Care Testing Program office at 5-
                      2645, CMSC-SB Room 201.

Correlation
Samples               Correlation samples for ACT Plus will be distributed monthly by the Point-of-Care
                      Testing office along with a logsheet. These samples are to be run on all the meters and
                      results returned to the POCT office for evaluation. Refer to the procedure “ACT
                      Correlation Samples Procedure” POC3-210.



Proficiency Testing   Proficiency Testing will be performed three times a year using whole blood samples
                      obtained from an outside CLIA approved proficiency survey program such as the College
                      of American Pathologists (CAP). See Proficiency Testing procedure “ Proficiency
                      Testing Handling, Performance and Documentation” POC3-800 for specific guidelines


Operator Training     Initial training will include the following.

                                    Initial Training                           Ongoing Competency
                        Overview of the meter
                        Successfully perform QC                      Assess competency twice the first year
                        Complete training checklist                  after the initial training.
                        Pass written test


                                   The Johns Hopkins Hospital
                                      Baltimore, Maryland
                        The Johns Hopkins Medical Institutions                  Document
                                                                                Number:
                        POINT-OF-CARE TESTING PROGRAM
                        POLICIES AND PROCEDURES MANUAL                       Effective Date:      8/13/2007

                        Title:                                               Page:                    6 of 6

                        PROCEDURE FOR HEMOCHRON®                             Supercedes:          3/22/2007
                        SIGNATURE ELITE ACTIVATED
                        CLOTTING TIME (ACT +)



Operator Competency   Training records will be kept in the employee’s personnel file. The POCT office will
                      keep a copy of the training and competency records. Each operator’s competency will be
                      assessed annually in the following areas:


                                                JCAHO Required Forms of Competency
                         1.      Routine patient test performance
                         2.      Proper recording and reporting of test results
                         3.      QC, proficiency testing, and maintenance performance
                         4.      Instrument function checks and calibration performance
                         5.      Test performance assessment (correlations and proficiency samples)
                         6.      Assessment of problem-solving skills

Related Documents     POC3-203 Quality Control Procedure for Hemochron Signature Elite
                      POC3-210 ACT Correlation Samples Procedure
                      POC3-800 Proficiency Testing Handling, Performance and Documentation

References
                          A. HEMOCHRON® Whole Blood Microcoagulation Systems Activated Clotting
                             Time (ACT +) NCCLS Formatted Procedure

                          B. HEMOCHRON® Jr. Whole Blood Microcoagulation Systems Activated
                             Clotting Time Plus (ACT +) Package Insert, 2/06

                          C. HEMOCHRON®. Signature Elite Whole Blood Microcoagulation System
                             Operator’s Manual, 05/05

                          D. Procedure for HEMOCHRON®. Signature Elite Activated Clotting Time
                             (ACCT+) Test (Category I)




                                    The Johns Hopkins Hospital
                                       Baltimore, Maryland
                         The Johns Hopkins Medical Institutions                                           Document
                                                                                                          Number:
                         POINT-OF-CARE TESTING PROGRAM
                         POLICIES AND PROCEDURES MANUAL                                            Effective Date:                         8/13/2007

                         Title:                                                                    Page:                                     7 of 6

                         PROCEDURE FOR HEMOCHRON®                                                  Supercedes:                             3/22/2007
                         SIGNATURE ELITE ACTIVATED
                         CLOTTING TIME (ACT +)



                                  Name                                         Signature                                                     Date
                         Lois Phelan MT (ASCP)                                                                                             2/19/2007

Author:

Approvals:
POCT Supervisor :
                         Dr. Thomas Kickler                                                                   Digitally signed by Thomas Kickler M.D.
POCT Director:                                      Thomas Kickler                                            DN: cn=Thomas Kickler M.D., c=US,
                                                                                                              o=Johns Hopkins University School of

                                                    M.D.                                                      Medicien, email=tkickler@jhmi.edu
                                                                                                              Date: 2007.08.08 10:25:31 -04'00'



Issued:

Effective:


 Revision Level                               Reviewed By:                                                                                Review Date
                                                     Digitally signed by William Clarke

                    William Clarke                   DN: cn=William Clarke, c=US, o=Johns Hopkins School of Medicine, ou=Department of
                                                     Pathology, email=wclarke@jhmi.edu
                                                     Date: 2008.11.25 12:30:40 -05'00'




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                                  The Johns Hopkins Hospital
                                     Baltimore, Maryland

								
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