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Coagulation Testing

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					         Coagulation Testing
                What is it?
           Why do we need it POC?

                        Marcia L. Zucker, Ph.D.
                        Director of Clinical Research


Educational Services,
Edison, NJ
Coagulation Testing
   Monitoring hemostasis




       Bleeding             Clotting
              Anticoagulants
                                        Monitor with PT

Monitor                         Extrinsic Pathway
with aPTT
or ACT
                              WARFARIN
                                       DXaI
                          X       Xa
            Common Pathway    II         IIa LMWH
               Monitor with   (thrombin) Hirudin &
                 ?????                   DTI
                                 CLOT
 Coagulation is Complex




Picture from
DiaPharma.com
Common(?) Coagulation Tests
   Laboratory            Point   of Care
                  PT..
                 aPTT
                  TT..
                  Fib.
                           – ACT
    – Anti Xa                 » Celite®
    – Anti IIa                » Kaolin
    – Factor Assays           » Glass beads
                              » Silica
                              » thromboplastin
Differences in test methods

Standard   Laboratory       Point   of Care
  – Platelet Poor Plasma       – Whole Blood
  – Sodium Citrate             – No Added
    Anticoagulant                Anticoagulant
  – 1:9 Dilution               – No Dilution
  – Variable Preanalytical     – No Preanalytical
    Delay                        Delay
POC Coagulation Analyzers
 HEMOCHRON 401 / 801 / Response
 HEMOCHRON Jr. Signature / Signature +
 ProTime / 3
 Medtronic HMS/HMS+/ HemoTec ACT II / ACTPlus
 CoaguChek / S / Pro / Pro DM
 i-STAT
 Helena Actalyke
 Hemosense INRatio
 Others?
POC Coag Analyzers Differ
   Test   methodology
    – Sample size and application
       » Microliters to milliliters
    – Sample measurement
       » Manual vs automated
    – Clot detection method
       » Enzyme detection method
               Thrombin generation
    – Reagent composition
    – Results
Clinical Applications
  Operating Room
   – Cardiac Surgery
   – Interventional Cardiology and Radiology
  Critical Care
  Satellite Sites
    –   Dialysis
    –   ECMO
    –   Emergency Room
    –   Anticoagulation Clinic
History of the ACT
Lee-White   clotting time
 – Manual
 – No activator
 – Very slow
1966   –Hattersley- Activated Clotting Time
 – Diatomaceous earth activator
 – Operator defined mixing and clot detection
 – Global assay - Contact activation of cascade
Activated
Clotting
Time
Particulate Contact Activation
 Initiation   of intrinsic coagulation cascade
   – Factor XII (Hageman factor)
   – Prekallikrein (Fletcher factor)
 Dramatically shortens contact activation
  period over Lee-White time
 Proposed as both screening assay for
  coagulation defects and for heparin
  monitoring
ACT Automation - 1969
HEMOCHRON          introduced
 – semi-automated
 – less operator dependence
 – two assays
   » CA510 (later FTCA510)
      diatomaceous earth
       activated
   » P214 glass bead activated
2 assays for separate applications
                        700

                        600
                                  C-ACT
  Clotting Time (sec)




                        500       P214
                        400

                        300

                        200

                        100         CATH
                              ECMO         PTCA                 CPB
                          0
                            0
                             Dialysis 1      2           3        4   5
                                           Heparin (units/ml)
  1980’s HemoTec ACT
   Liquid kaolin activator
   Different technology
                – Different results
          700
          675
          650
          625
Seconds




          600
          575
          550                    Hemochron
          525                    Hemotec
          500
          475

                Pre 15    30    45    60     75    90    105
                CPB min   min   min   min    min   min   min
ACT Differences
Recognized    in literature >20 years
  – Clinical evaluations of Hemochron
    appeared in journals mid 1970’s
  – By 1981, papers appeared showing little
    correlation between ACT and heparin level
  – By 1988, papers clearly showed clinically
    different results between Hemochron and
    HemoTec
Differences   ignored by clinicians
Why are there so many different ACTs?
                          700
                                    C-ACT
                          600       K-ACT
    Clotting Time (sec)




                          500       ACT+
                                    P214
                          400       ACT-LR
                          300

                          200

                          100            CATH
                               CCU              PTCA                 CPB
                            0
                              Dialysis
                                0         1       2           3        4   5
                                                Heparin (units/ml)
Monitoring - ACT
   Benefits
    – Industry Standard Since 1970s
    – Recommended as primary method in
      AmSECT guidelines (perfusion)
    – Easy to run
   Disadvantages
    – Each system yields different numbers
    – High sensitivity to hypothermia and
      hemodilution (with exceptions)
    – Little or no correlation to heparin level
       » especially true for pediatric patients
Heparinized ACT - CPB
              700
              675
              650
              625                                                 Hemochron
    Seconds




              600                                                 Hemotec
              575                                                 TAS
              550                                                 HMS
              525
              500
              475

                    Pre 15    30    45    60    75    90    105
                    CPB min   min   min   min   min   min   min

Data from Huffman, et.al. 1998 AmSECT meeting
Pharmaceutical Intervention
  Amicar    or Tranexamic Acid
   – No effect on standard celite ACT
  Aprotinin
    – Significant elevation of celite ACT
    – Two dosing regimens
      » Full or Half Hammersmith
      » Both independent of patient size
ACT Monitoring-Aprotinin Treatment
   Celite   ACT
    – Not recommended
    – Still used with target times of >750 seconds
   Kaolin   ACT
    – Unaffected by moderate doses of aprotinin
    – Used with target times of > 480 seconds
   ACT+
    – Unaffected by ALL doses of aprotinin
    – Used with target times of > 400 seconds
  Monitoring in CPB - Aprotinin
                                              C-ACT                                                                                      ACT+
                                                                                              1200
1200
                                                                              Trasylol        1000
1000                                                                                                                                                                    Trasylol
                                                                              Placebo
                                                                                                                                                                        Placebo
                                                                                              800
800
                                                                                              600
600
                                                                                              400
400
                                                                                              200
200
                                                                                                0
    0




                                                                                                     Baseline


                                                                                                                PostBolus


                                                                                                                            PostBolus2


                                                                                                                                           OnPump


                                                                                                                                                    OnPump2


                                                                                                                                                              OnPump3


                                                                                                                                                                            PostProt.
          Baseline



                     PostBolus



                                 PostBolus2



                                                 OnPump



                                                          OnPump2



                                                                    OnPump3



                                                                                  PostProt.




       Data from clinical evaluation, on file, ITC
Other POC Coag in the OR
 aPTT   / PT
  – Pre- and post-procedural screening
 Fibrinogen
  – Pre- and post-procedural screening
 Dosing   Assays
  – Customize heparin and protamine for each patient
     » HEMOCHRON HRT / PRT
     » Hepcon HMS
  – Measure heparin level
     » Relationship to coagulation status unclear
Other POC Coag in the OR
Heparin   neutralization verification
  – Ensure complete removal of circulating
    heparin
    » aPTT
    » PDA-O - ACT based
    » TT / HNTT - Thrombin Time based
    » heparinase ACT
Outcome studies - POC in OR
 Reduced   Blood Loss/Transfusion
  – Use of HRT and PRT (RxDx System)
 Reduced   Cost Resulting from Use of POC Assays
  – RxDx combined with TT / HNTT
 Reduced   Complication Rates
  – TT / HNTT
  – Re-Exploration for Bleeding Reduced from 2.5% to
    1.1%
  – Re-Exploration for Coagulopathy Reduced from
    1.0% to 0.0.
Clinical Applications
  Operating Room
   – Cardiac Surgery
   – Interventional Cardiology and Radiology
  Critical Care
  Satellite Sites
    –   Dialysis
    –   ECMO
    –   Emergency Room
    –   Anticoagulation Clinic
Procedures
Diagnostic
  – Catheterization
    » locate and map vessel blockage(s)
    » determine need for interventional procedures
  – Electrophysiology
  – Interventional Radiology
Interventional
  – Balloon angioplasty
  – Atherectomy (roto-rooter)
Diagnostic – Low dose heparin
Catheterization and   Electrophysiology
  – 2500 - 5000 unit bolus dose
  – frequently not monitored
  – if monitored –
    » ACT
    » aPTT
Interventional – Moderate dose
 Angioplasty and         Atherectomy
  – Heparin
     » 10,000 unit bolus dose or
     » 2 - 2.5 mg/kg
     » target ACT 300 - 350 seconds
           200 – 300 in presence of ReoPro
  – Angiomax (bivalirudin)
     » ACT >300
           Hemochron (ACT-LR or FTCA510) trials
     » Measure post-bolus to ensure drug on board
     » Required in patients with renal impairment
Why use platelet inhibitors?
 Angioplasty promotes   aggregation
Adhesion
   •shape change
   • release                                 3 sec
                               ADP release

Aggregation

                                             10 sec

Coagulation
   •Fibrin
   formation                                 5 min
Need to inhibit restenosis / reocclusion
Platelet Inhibitors
  ReoPro
     – elevates ACTs
     – target time = 250 sec with ReoPro
       » determined using FTCA510 tube
  Integrelin
     – No reported clinically significant
       effects on ACT
  Aggrastat
     – No reported effects on ACT
Clinical Applications
  Operating Room
   – Cardiac Surgery
   – Interventional Cardiology and Radiology
  Critical Care
  Satellite Sites
    –   Dialysis
    –   ECMO
    –   Emergency Room
    –   Anticoagulation Clinic
ACT or aPTT
Determine      when to pull the femoral sheath
  – Premature sheath pull can lead to bleeding.
  – Delayed removal can increase time in CCU.
  – Target set at each site.
    » ACT targets range from 150 – 220 seconds
    » aPTT targets range from 40 – 70 seconds
        Must   be linked to heparin sensitivity of reagent used
ACT vs aPTT
                      120
                      110           y = 0.57x - 28.44
                      100               R = 0.896
      aPTT (J103) (sec)



                          90
                          80
                          70
                          60
                          50
                          40
                          30
                          20
                               50        100       150      200   250
                                            FTCA510 (sec)


 Single site comparison, ACT tube vs HE Jr Sig aPTT
ACT or aPTT
Monitor   heparin therapy
 – Target times determined by each facility
 – APTT outcome study
   » Reduce time to result (112 vs <5 minute)
   » Reduce time to stabilization
   » Reduce dose adjustments
   » Reduce length of stay
   » By using POC aPTT instead of lab
       Poster   at AACC 2000 – Staikos, et.al.
Activated Partial Thromboplastin Time

                          Extrinsic Pathway




               Common Pathway


                   CLOT
Activated Partial Thromboplastin Time
     NOT a PTT
      –   PTT is the predecessor of the aPTT
      –   Not used anymore
     Laboratory or Point of Care
     High APTT values
      – presence of heparin
          » treat by giving protamine
      – underlying coagulopathy
          » treat by giving FFP
     Monitor heparin / Coumadin® cross-over
Heparin versus Warfarin
                        Mechan-    Moni-
 Drug      Action                           Effective
                         ism       toring

           Direct
                         ATIII     APTT
Heparin Inhibition of                       Immediate
                        cofactor   ACT
         Thrombin
         Decreases
                                             Delay
Warfarin Production Vitamin K       PT
                                            3-5 days
          of factors
Prothrombin Time

                        Extrinsic Pathway


                   PT

           Common Pathway


               CLOT
  Prothrombin Time
 Monitor  warfarin therapy
 Monitor heparin/warfarin crossover                         ISI
                                      PTpatient         
 Target times are set by     INR                     
                                                         
     International Normalized Ratio (INR)  PTmeannormal 
     ISI = international Sensitivity Index
  – INR target ranges are specified by patient populations
     » DVT, Afib, Atrial MHV: INR= 2.0 - 3.0
     » Mitral mechanical heart valve: INR= 2.5 – 3.5
     » Hypercoagulable disorders: INR= 1.5 – 2.5?
Will POC Results Match the Lab?




            (Probably Not)
         but it WILL Correlate
Correlate Does Not Mean Match

                  140       y = 0.737x + 22.2
                                R = 0.920
                  120
 Signature APTT




                  100

                  80

                  60

                  40

                  20

                   0
                        0                 50    Lab APTT   100   150
Coag is NOT Chemistry
                                 Dade Actin / MLA                                                          Organon Technika / MDA
            70                                                                                  70
                             y = 0.72x + 11.5                                                               y = 1.02x + 4.1
            60                  R = 0.883                                                       60             R = 0.942
Signature




                                                                                    Signature
            50                                                                                  50
            40                                                                                  40
            30                                                                                  30
            20                                                                                  20
                  20           30           40   lab 50                60      70                    20      30        40      lab 50         60     70


                150.0
                                 IL aPTT C / ACL #3                                                          IL aPTT SP / ACL #2
                                                                                           150.0
                                y = 0.44x + 22.2                                                            y = 0.59x + 16.0
                130.0                                                                      130.0
                                   R = 0.9533                                                                  R = 0.961
    Signature




                110.0                                                                      110.0
                                                                                    Signature
                 90.0                                                                       90.0
                 70.0                                                                       70.0
                 50.0                                                                       50.0
                 30.0                                                                       30.0
                 10.0                                                                       10.0
                        10      30     50        70         90   110    130   150                     10    30    50     70lab 90       110   130   150
                                                      lab
                                  IL aPTT C /ACL #1                               IL aPTT SP / ACL #1
              100.0                                                100.0
                                     y = 0.45x + 17.9                                 y = 0.35x + 22.1
                   80.0                                                    80.0
                                        R = 0.929                                        R = 0.928

Compare




                                                               Signature
           Signature
                   60.0                                                    60.0

                   40.0                                                    40.0


for your           20.0
                       0.0
                              0          50    lab 100   150
                                                                           20.0

                                                                            0.0
                                                                                  0          50    lab 100     150


site.             100.0
                                  IL aPTT C / ACL #2

                                      y = 0.47x + 20.2
                                                                      100.0
                                                                                  IL aPTT SP / ACL #2

                                                                                      y = 0.59x + 16.0
                       80.0              R = 0.942                         80.0          R = 0.961
           Signature




                                                               Signature
                       60.0                                                60.0

Same                   40.0
                       20.0
                                                                           40.0
                                                                           20.0


System /
                        0.0                                                 0.0
                              0           50   lab 100   150                      0           50   lab 100     150

                                  IL aPTT C / ACL #3                              IL aPTT SP / ACL #3

Multiple        100.0
                       80.0
                                  y = 0.44x + 22.2
                                     R = 0.953
                                                                  100.0
                                                                           80.0
                                                                                  y = 0.40x + 23.3
                                                                                     R = 0.912




                                                               Signature
           Signature




                       60.0                                                60.0

Sites                  40.0
                       20.0
                                                                           40.0
                                                                           20.0

                        0.0                                                 0.0
                              0           50                                      0           50         100   150
                                               lab 100   150                                       lab
Are differences important?
       Sometimes         no - aPTT C
   Signature   site 1      site 2     site 3
          30         27          21         18
          40         49          42         41
          50         71          63         64
          60         94          84         87
          70        116         105        109
          80        138         127        132
          90        160         148        155
 Sometimes      VERY - aPTT SP
Signature   site 1     site 2     site 3
       30         23         24         33
       40         51         41         82
       50         80         57        130
       60        109         74        179
       70        138         91      >200
       80        167        108      >200
       90        196        125      >200
Lot to Lot Reproducibility
                          Cuvette Lot a
       80                                                    Signature   Lot a     Lot b
       70        y = 1.35x - 14.2                                   30        26        29
                     R=.909
       60                                                           40        40        43
 Lab




       50                                                           50        53        57
       40
                                                                    60        67        70
       30
                                                                    70        80        84
       20
            20               40               60        80
                                                                    80        93        98
                             Signature                              90       107       112
                          Cuvette Lot b
       80
                 y = 1.39x - 12.8
       70            R=0.934
       60
 Lab




       50
       40
       30
       20
            20              40               60    80
                                 Signature
Clinical Applications
  Operating Room
   – Cardiac Surgery
   – Interventional Cardiology and Radiology
  Critical Care
  Satellite Sites
    –   Dialysis
    –   ECMO
    –   Emergency Room
    –   Anticoagulation Clinic
Dialysis / ECMO
ACT      (or nothing in dialysis)
  – Majority use P214 glass activated ACT
  – Some use ACT-LR; HemoTec LR ACT
Better Control of Anticoagulation Leads to
 Increased Dialyzer Reuse
  – Potential for Long Term Cost Savings
  – No Compromise in Dialysis Efficacy (Kt/V)
    » Ouseph, R. et.al. Am J Kidney Dis 35:89-94; 2000
Emergency Room
 ACT;aPTT; PT; Fibrinogen
 Immediate Identification of Coagulopathies
  – Optimization of Critical Decision Pathways
 ACT Allows Early Detection of Traumatic
  Coagulopathy
  – Allows Early Treatment Decisions
  – Aids Damage Control Decisions
     » Aucar, J. et.al. 1998 SW Surgeons Congress
 Optimize   Staffing During Off Hours
Anticoagulation Clinics
 Results Available    While Patient is Present
  – Improved Anticoagulation Management
  – Improved Standard of Care
  – Staff Efficiency
 Immediate   Retesting (if needed)
  – Fingerstick Sampling
 Same  System for Clinic and Home Bound
  Patients
  – Standardized ISI / PT normal
     » Test System Specific
Anticoagulation Clinics
 Potential   for Self-Testing
   – High Risk Patients
   – Patients Who Travel Frequently
   – Home-Bound
   – Patients in Rural Areas Far from Clinic
 Improved  Outcomes Through More
  Frequent Testing
Will POC Results Match the Lab?




    (It will be a lot closer than for aPTT)
             but it WILL Correlate
How to Compare INR Results

                  Lower  dose?
                  Keep same dose?
                  Raise Dose?


                  Test Again?
                  Test more often?
Lab to Lab Comparison
                             1.5
                                                 Mean difference = 0.3 INR
                               1
    Difference (TPC - INN)




                             0.5


                               0
                                    0   1    2      3      4      5    6     7
                             -0.5


                              -1


                             -1.5
                                            Mean Innovin and TPC INR
INR Expectations
INR within 0.4 of lab > 80%
INR within 0.7 of lab > 90%
INR within 1.0 of lab > 95%

   (values shown are   Pairs within    Pairs within
        ranges)
     AACC 2002
                         0.4 INR         0.7 INR
     Lab to Lab        85.4 – 97.9 %   94.8 – 99.0 %
    POC to Lab         74.7 – 89.9 %   87.9 – 99.0 %
    POC to POC         89.9 – 94.9 %   97.0 – 99.5 %
Why Bother with POC Coag?
Improved     TAT - Turn Around Time
  – Defined from the Clinician, not Lab view
  – When is Turn Around Important
    » Emergency Room
    » ICU/CCU Dose Adjustments
    » Operating Room / Cath Lab
  – STAT Testing Turn Around
STAT Testing TAT
   Lab (min) CPB (N=40) PVS (N=45)
      Median    90.0         90.0
        Mean    78.5         74.0
    Minimum     38.0         21.0
   POC (min)       All Groups
      Median          2.23
    Minimum           0.33
    Maximum           6.97

 Fitch, et.al, J. Clin Monit & Comput. 1999. 15:197-204
Standardized Clinical Interpretation
 Defined   Assay Sensitivity
  – Requires Lot to Lot Reproducibility
 Defined   Reagent Variability
  – Identical Instrumentation and Reagents at All
    Testing Sites
 Defined   Critical Clinical Decision Points
  – No Change of Normal Ranges or Target Times
    Between Lots of Test Reagents or Testing
    Locations
What’s the catch?


  1.   Regulatory compliance
  2.   Connectivity
Regulatory compliance - Who sets the rules?
   – JCAHO
     » Joint Commission on Accreditation of Health Care Orgs
   – CAP
     » College of American Pathologists
   – FDA
     » Food and Drug Administration
     » CDRH
           Center for Devices and Radiological Health
   – CMS
     » Centers for Medicare and Medicaid Services
   – CDC
     » Centers for Disease Control
CLIA Applies to ALL Testing Areas
  Central  Laboratory
  Satellite Labs
    – Critical Care
    – Surgical Suite
  Clinics
  Bedside testing
  Doctor’s office
CLIA Regulations for Coagulation
 Central Laboratory     can hold the CLIA license
  – Satellites can have independent licensure
 Moderately Complex       tests
  – Except – ProTime, Coaguchek, INRatio are waived
 Requires
  –   Certified Laboratory Director
  –   Record Keeping
  –   Training
  –   Quality Policy
Implementing POC coag requires:
    Method Validation - accuracy
     – Comparison to current standard
        » NCCLS Guideline EP-09 recommends 40 samples
     – Linearity may be used if no current standard
     – Is assay performance appropriate to clinical needs?
    Precision
     – Controls may be used to establish within and between run
       variability
    Training
     – Document training of all personnel
        » high school equivalence or higher education level
     – competency evaluations at predetermined intervals
Implementing POC coag requires:
 Linearity NOT required for coag
 Calibration “does not apply to unit test systems that
  cannot be adjusted”
 Calibration verification
    • Current assumption:
    – Equivalent to CAP POC.05450
       » If the laboratory has more than one method-system for performing
         tests for a given analyte, are they checked against each other at least
         twice a year for correlation of patient results?
    – CLIA requires at least 3 point check
New CLIA Regulations
   Work in progress
    –   New rules published January 2003
    –   Rules in effect March 23, 2003
    –   Interpretive guidelines published Jan 2004
    –   Inspections using new regulations now
         » 2 year grace period to adapt new rules
         » Ends Jan 2005
   Quality Assessment Program - Lab Responsibilities
    – Establish & follow policies/procedures addressing ongoing
      QA activity.
    – Take corrective actions as necessary.
         » Review their effectiveness.
         » Revise policies/procedures as necessary to prevent recurrence.
    – Communicate to staff.
    – Document all assessment activities.
New CLIA Regulations
   Proficiency testing
    – Changed consensus for PT program grading from 90% to 80%.
   Quality Assessment replaces Quality Assurance.
    – Quality Assessment is interspersed throughout the regulation.
    – Creates one set of nonwaived QC requirements.
   Subpart K - Quality System for Nonwaived Testing
    – Laboratory is ultimately responsible for ensuring that all
      components of the analytic process are monitored.
    – Each laboratory that performs nonwaived testing must meet
      the applicable analytic systems requirements; unless HHS
      approves a procedure, specified in the Interpretive Guidelines,
      that provides equivalent quality testing
Equivalent Quality Testing
   Traditional:
    – Testing two levels of external control materials
      each day of testing
    – Except coag and blood gases
       » every 8 hours of use
   Equivalent QC     Options
    – #2 -Test systems with internal/procedural
      controls that monitor a portion of the analytic
      components, and if the lab successfully
      completes a thirty day evaluation process, the
      lab may reduce the frequency of external quality
      control materials to once per calendar week.
Equivalent Quality Testing
    Option #2
     – Perform the test system’s internal control procedure(s) in
       accordance with the manufacturer’s instructions (but not
       less frequently than once each day of testing) and test two
       levels of external control material daily for 30 consecutive
       days of testing.
    EQC AND LQC daily (NOT every 8 hours) for 30 days
     – Then OK to use EQC daily, LQC weekly
        » Unless manufacturer requires more
     – Send comments to: Judith Yost
        » Director, Division of Laboratory Services, CMS
        » JYost@cms.hhs.gov
        » (410) 786-3407
Routine Quality Control
 Instrument Performance        Verification
  – Electronic Quality Control with Numeric Output
  – Two levels per 8 hour shift (CLIA reg)
 Assay   Performance Verification
  – Wet QC as per Manufacturer’s Recommendation
     » Varies by system
             external QC required for ProTime / INRatio in
           No
           most States
     » Within system may vary by waived or moderate
       complexity licensure
Ensuring Compliance
  Required identification
   – Mandatory operator ID
      » Password control
      » Reuse IDs for some applications
   – Mandatory patient ID
      » Reuse IDs for some applications
  Lockout
   – Force QC at specific times
      » QC must pass to run patient samples
   – Lockout non-compliant or untrained operators
   – Disallow specific assays
Connectivity
  Multiple   definitions
    – Download to computer
      » To LIS or to HIS or to both or to data
        management software
      » Real time and / or batch
      » QC data, patient data, or both
Connectivity
  Bidirectional      communication
    – Send data to instrument
      » Reset lockouts
      » Load configurations
          Operatortables
          QC frequency

          QC ranges

          Reuse availability

      » Vary configuration by clinical setting
Solutions
    System specific configuration
     – e.g. HCM for Signature+
           HRDM for Response
    System specific data management
     – e.g. ReportMaker for Signature / +
            HRDM for Response
           RapidLink for Bayer RapidPoint
           DataCare for Roche CoaguChek / S / DM / Pro
    Link to systems designed for glucose
     – Abbott and Roche state they will connect with any POC
       instrumentation
Solutions
   Manufacturer neutral interface
    – MAS RALS-plus
    – Telcor Quick Serv
    – Manufacturer works with interface supplier to
      ensure compatibility
    – Interface supplier works with LIS / HIS
      supplier to ensure compatibility
    – Likely more options as CIC guidelines
      implemented (NCCLS POCT1-A)
Why Bother with POC Coag?

Once  compliance issues
 addressed –
  –Improved Clinical Outcome
  –Reduced LOS – Length of Stay
  –Improved, timely patient care