1 poc testing: analyzer developments & targeted survey standards michaela cvitkovic, bs.,...
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POC Testing: Analyzer Developments & Targeted Survey Standards
Michaela Cvitkovic, BS., MT(ASCP)Laboratory Compliance ManagerSpecialtyCare, Inc.
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ANALYZER COMPARISONS & DEVELOPMENTS
Bleeding Management:ROTEM delta & TEG 5000
New DevelopmentsQuality ControlPOC analyzer
Blood Gases:epoc & iSTAT1
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CVOR POC Lab Deficiencies
Competency
Credentialing
Q.C. Failures
Temperature Controlled Spaces
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Top Deficiencies Cited by JCAHO and CAP
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COMPETENCY & the NEW employee
Must complete an Initial Training, before patient testing
Must complete semi-annually competency during the first year of duties, by 6 months
Continue with current staff on an annual basis
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COMPETENCYNew Equipment – “non-waived”
testing
Retain Original Training Documents!!
Implementation of new methodologies must have documentation of Initial Training (i.e. iSTAT1 to Gem3500).
Even if the analyzer is an upgrade must retain original training material (i.e. iSTAT 200 to iSTAT1 – Signature Plus to Elite).
Save this documentation as long as the analyzer is available for patient testing.
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CREDENTIALSTesting Personnel Limitations
Perfusion Certification is not a “CLIA defined eligibility route” –
may be asked to produce H.S. Diploma
Know who is permitted to be classified as Testing Personnel.
For example, in CA – Perfusionists are exempt from the lab licensing for patient testing, but staff like Perfusion Assistants or Anesthesia Technicians, are not.
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QUALITY CONTROL
Failures
Two consecutive ‘wet’ failures in a row will trigger a repeat of the 10 or 30 day EQC study – depending on the analyzer.
If have a ‘wet’ failure on an analyzer that uses EQC, carefully determine C.A. before proceeding.
Do not continue to repeat ‘wets’ until get one in-range!
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TEMERATURES Refrigerator & Room
If supplies (cartridges, QC) are being stored in a small local (O.R.) Refrigerator, there must be indication of temperature monitoring. CAP requires daily.
If Refrigerator is not hard wired to Engineering or continuously monitored in some manner, must be manual documentation.
If have supplies kept at Room Temp, such as cartridges, should have a monitoring system also.
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TEMERATURE Documentation
• acceptable range- C or F must be consistent
- tightest range in use, (iSTAT 18-30 RT while Gem Cart 15-25)
• area for corrective action
• daily temp in addition to Min/Max– Daily is specified in CAP Checklist standards!
• monthly review w/ date & initials
• explanation of date w/out temp recorded
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ANALYZER COMPARISON –
POC Blood Gas
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Epocal epoc® System distributed by Alere
HostReader
Test Card
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Epocal epoc® System
– Single-use, self-calibrating, 95 mL WB sample
– Blood gases, electrolytes, metabolites and hematocrit on a single cartridge
Common features vs. comparable POC analyzer:
– Data management
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epoc system
up to 6-month Room Temp shelf-life from date of manufacture
bar coded cards read on insertion
Unique features vs. comparable POC analyzer:
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epoc vs. iSTAT1
Room Temp storage only
Room Temp cart storage for 2 wks
1pt cal before sample added, 165 sec ( 2.75 min )
1 pt cal w/ sample upon cart. insertion
35 secs sample only
Separate ABG, Lytes, Metabolite & Hct QC vials
130-200 secs Cal & sample processing
Available Eurotrol QC ABG, Lytes, Metabolites & Hct one vial
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epoc vs. iSTAT1
Notification of update via e-m and installation from
EDM via WiFi
Updates mailed 2x/yr self-installed
epoc analyzer = Reader & Host- Multiple Readers w/ 1 Host
Analyzer all inclusive
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epoc vs. iSTAT1
Cart read upon insertion; each individually bar
coded
Each cartridge pouch manually
scanned
BGEM: pH, pCO2, pO2, Na, K, iCa, Glucose, Lactate, Hct
CG8+ (No Lactate)
Reader = Lithium Ion rechargeable battery only
Rechargeable or Disposable batteries
Only cartridge is BGEM Multitude of cartridge configurations
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epoc vs. iSTAT1
Automated Internal QC ( iQC ) - No External Sim.
Internal QC & also External Simulator
Host display “Windows”-like
Basic text display
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epoc
Future Developments as related to CVOR:
Coag: ACT, PT, aPTT
Creation of single-vial QC to contain ABG, Lytes, Metabolites & Hct
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New development in QC
ABG, Lytes, Metabolites & Hct in one vial
Eurotrol QC “one ampule all analytes”
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Eurotrol QCHyperbaric
X-High 710 mmHg
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Eurotrol QCHypoxic
X-Low 15 mmHg
Generic for all blood gas analyzers –
one range fits all
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Eurotrol Hyper & Hypoxic
HYPER -– published ranges for iSTAT
– use on any ABG analyzer, but must establish In House ranges
HYPO -– one published range for all analyzers
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ANALYZER COMPARISON –
Bleeding Management
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ROTEM®delta
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ROTEM®delta System
Thromboelastometry
1600 units in clinical use in 50 countries
more than 500 publications
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ROTEMdelta System
Common feature vs. comparable analyzer is the analysis platform:
Clot formation, strength & stability, and subsequent lysis.
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ROTEM® vs. TEG 5000®
GENERAL INFO
– Incorporated in July 2008
– Primarily targeted researchers at the start
– 2-test approval 3/23/10, in-tem & hep-tem
– Additional 3 tests approved 8/12/11
– April 2000 Haemoscope received the 510K
– Purchased by Haemonetics 11/21/07
– 5 tests with different activators
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ROTEM vs. TEG 5000
Classical or ‘Original’ method: Thromboelastography – originally described by H. Hartert in 1948 &
trademarked by Haemoscope. Principle: cuvette is rotated and as
clot forms it links the pin & cup together; movement of the pin is converted to electrical signals
Rotational Thromboelastometry
trademarked by Rotem Principle: pin oscillates as
the cup remains stationary & as clot forms rotation becomes restricted & clot firmness detected optically
PRINCIPLE
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Spring
Rotating axis (+/ - 4.75°)
Light source
Detector
Plastic pin Cuvette with blood Fibrin strands and platelet aggregates between surfaces Heated cuvette holder
Ball bearing
ROTEM delta & TEG 5000PRINCIPLE via graphics
Cup takes 10 seconds per rotation
Electrical detection
Pin makes 13 oscillations per minute
Optical detection
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ROTEM vs. TEG 5000
Control unit integrated Control unit on separate PC
Some leveling requiredNo leveling required (constant monitoring system)
4 channel instrument
COMPONENTS
2 channel instrument
Up to 8 channels can run on one PC
Scan can be viewed remotely using Secure Viewer software Scan can be viewed remotely
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ROTEM vs. TEG 5000
Automated pipette Manual pipetting
Temp can be adjusted for Hypothermia
Temp can be adjusted for Hypothermia
COMPONENTS
Touch screen monitorN/A
(unless computer is set up as such)
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ROTEM vs. TEG 5000
EQC Option 2 –
Aqueous QC’s once/week
Aqueous QC’s every 8 hours of patient testing
QUALITY CONTROL
ROTROL N and ROTROL P
Continuously monitors: Phase Shift, Variance,
Center, Amplitude, Temperature
No continuous monitoring, however eTest verifies and/or maintains the
electronic functioning of the analyzer
Level I and II QC
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ROTEM vs. TEG 5000
Both have available Proficiency Testing with CAP & API
TEG5000 also has PlateletMapping Proficiency Testing with CAP
REGULATORY
CMS reimbursement available
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ROTEM vs. TEG 5000
SAMPLE PREP
Citrated samples – must sit for at least 15 min, but run within 2
hours
Non-Citrated samples – must be run within 4-6 minutes
Once draw into Citrated tube, sample can be run
immediately, or up to 4 hrs later.
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ROTEM vs. TEG 5000
intrinsic pathway in citrated whole blood specimens
TEST MENU
the intrinsic pathway in the presence of unfractionated heparin, in citrated whole blood specimens (open heart)
research and less clinical practicality
- Kaolin activator, Citrated sample- Kaolin activated, non-Citrated
- Kaolin activator, Citrated sample, in Blue Heparinase cup
- Kaolin activated, non-Citrated s. in Blue Heparinase cup
- Non-activated, Citrated sample- Non-activated, non-Citrated s.
in-tem®
hep-tem®
NATEM®
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ROTEM vs. TEG 5000
hemostasis via the extrinsic pathway
TEST MENU
measuring fibrinogen contribution to the clot
detects hyperfibrinolysis
RapidTEG, (TEG-ACT) non-citrated or citratedResearch protocols using Tissue Factor alone
Functional Fibrinogen non-citrated or citrated
LY30 and lysis parameters in all TEG assays
ex-tem®
fib-tem®
ap-tem®
Rotem tests approved 8/12/11
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ROTEM vs. TEG 5000
TEST MENU
Platelet function
PlateletMapping® Assay - Activator F - ADP (tests for GPIIb/IIIa receptors) clopidogrel, etc - Arachidonic Acid (test for
aspirin and other NSAIDs)
N/A
No anticoagulant or activator
(liver transplants)
Native, non-activated non-anticoagulated or citrated
N/A
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ROTEM vs. TEG 5000
ROTEM
- Does offer on-line FUZE Training. Data Interpretation using PowerPoint Presentation.
- Discuss temogram interpretations.
DECISION TREE
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TEG 5000 - Scan
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ROTEM® - Screenshot
Clot Quality
Lysis ML(%)
A20 = Clot Firmness (mm) 20 minutes after CT
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ROTEM vs. TEG 5000
CT - Clot Time, (seconds) R = Reaction time, (minutes) Time to initial fibrin formation
CFT – Clot Formation Time(seconds)
K = Coagulation time, (minutes) Speed of fibrin build up
α Angle – Alpha Angle, (°) a = alpha angle, (°) Speed of clot strengthening
MCF – Maximum Clot Firmness, (mm)
MA = maximum amplitude, (mm) Strength of clot
A (x) – Amplitude at a time point (minutes) 10/15/20/25/30 mm
No equivalent parameter
SCAN PARAMETERS
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ANALYZER WITH PENDING FDA
SUBMISSION & APPROVAL
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HELENA ABRAZO
Must stress For Investigational Use Only at this time
FDA Submission in Sept 2011
Tests to be submitted for FDA Approval: aPTT, PT & Celite ACT
Watch for further developments
Specific contents of this slide approved by Helena
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~ THANK YOU ~
Eurotrol, Inc. 866-234-5754 www.eurotrol.com
Epocal Inc 888-893-6225 www.epocal.com
Rotem 919-941-7777 www.rotem.de
Abbott / iSTAT 800-827-7828 www.abbottpointofcare.com
Helena 888-893-6225 www.helenapoc.com