a cost-effective point of care solution for the entire healthcare enterprise 1 november 2010 1. a...
TRANSCRIPT
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a cost-effective point of care solution for the entire healthcare enterprise1
November 20101. A Patient-centred Approach. June 2009 Advance For Respiratory Care & Sleep Medicine
epoc® blood analysis:
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Contents:
• System components• Test card analytes• Features and benefits• Sample requirements• How to perform a test• Wireless capabilities
• Operational specifications
• QC requirements• Navigating through the
reader screens• Quality Controls
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epoc® System
• epoc® Host Mobile Computer
• epoc® Reader
• epoc® BGEM Test Card
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epoc® System:
epoc® Data Manager (server-based)
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epoc® Host Components
•Touch screen for navigation, using stylus•Barcode scanner•Battery-powered for portability
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epoc® Test Cards: Smartcard Technology
TEST CARD - BOTTOM
Measurement region
Sensor module: sensor surface
valve
Blood waste chamber
Sealed calibrator reservoir
Sample entry port
TEST CARD - TOP
Sensor module: contact surface
Test Panel type
Bar Code
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epoc® BGEM Test Card Analytes
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Test Menu – Calculated Values
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Test Cards
• Easy to use• Room temperature storage• ~92uL WB sample• Integrated calibration and quality checks• Results in about 30 seconds after patient sample addition• Bar-coded for error-free panel identification, lot number,
expiry and inventory records• 12 analyte capacity on one test card
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epoc® Reader Components
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• Host:• Integrated, modular barcode scanner
• Wireless Communication - Bi-directional communication with epoc Data Manager &
Readers via Wi-Fi and Bluetooth
• Flexible epoc Host Software:
–Reference and critical ranges by sample type
–Respiratory and vent parameters
–Automated Critical result handling
–Automated Reporting (read back)
–Operator / Patient / QC lockouts
Features
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• Reader:• Patient test time of ~30 seconds • Automated, internal equivalent QC• No maintenance• Offers portable or fixed functionality • A/C Power or Rechargeable Battery• Sensor electronics:
• Amperometric- measures current• Conductometric- measures conductivity• Potentiometric- measures voltage
• Bluetooth technology built-in
Features
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• epoc Data Management (EDM) software:• Web-based (accessible via any network)
• Manages the entire epoc system (reports, inventory management, can be interfaced)
Features
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Sample requirements
• >92 µL sample (non-volumetric)• Whole blood
• Arterial, venous, capillary
• Syringes or evacuated tubes for sample collection• Evacuated tubes not recommended for ABGs
• Without anticoagulant or with lithium, sodium, or balanced heparin
• Must use balanced heparin if analyzing iCa
• epoc Care-Fill capillary tubes with balanced heparin (90 µL)
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epoc® Test Process:• Scan operator ID and enter password• Insert test card into reader to start calibration (165 sec)• Data entry (scan patient ID, enter patient temp, vent data,
etc.)• Collect blood sample (whole blood from arterial, venous or
capillary sources)• Introduce sample into card (within 5 min of calibration)• View result (after 30-second test time)• Transmit result to EDM and LIS via WiFi (1-2 seconds)
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epoc® Wireless Communication
EPOC™ Web-basedData Manager
Remote workstation
LIS / HIS Existing Wi-Fi Access Points
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Operational Specifications
• Operation: AC or rechargeable battery• Operating temperature: 15° to 30° C• Relative humidity: 85% non-condensing• Barometric pressure: 400 – 825 mmHg• Operation on fully-charged battery: ~50
cards• Time to recharge Reader: ~4 hours
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QC requirements
• Verification of Newly Received Test Cards• Cards shipped to Australia with temperature monitors
• Verification of Reader Performance• When a connection between the Reader and the
Host is established, an electronic self-check is performed.
• If the connection is still established after 8 hours, the Host will disconnect from the Reader. Upon reconnect, another self-check will be performed.
• Every device is calibrated prior to specimen testing, eliminating the need for daily controls.
• External controls are run when a new lot is started and every 30 days thereafter or as required.
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Navigating through the Reader Screens
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Log In and Start Up Screens
• Start Up Screen –upon reset of Host (initiates program, reads files & configures software)
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Main Reader Screen
• ‘Lock’ icon (dedicated readers always listed)• EDM Sync appears only when Host configured to EDM (exchange info)
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Indicators
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Navigation
• Lightly press stylus on Reader icon or list for menu
• Tap for selection
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Reader Screen
• Print not enabled during test• Save button enabled after test complete. Info entered after test saved.• Close Reader connection button – cancel test and close connection
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epoc® Host Application User Interface
• Tool bar (Bottom of screen)• Screens (Bottom – Connected Readers + Open Test Record)• Multiple Pages (Upper left- Tabs. Greyed out=Not for Use)
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Test Pages
•2nd ID•Hemodilution (hematocrit correction)
•Sample (Unknown, arterial, venous, mixed venous, cord, capillary)
•Temp (patient body temp for pH, pCO2 & pO2 corrected values)
•Test Selection (Select all, Clear all, Gases, Electrolytes)
•Test in Progress (progress bar)•Test Results (Measured, Calculated,Corrected)
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Additional Test Information Pages
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Additional Test Information Pages cont.
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Screens when Running a Patient Sample
Calibration process takes approx. 165 secs
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Screens when Running a Patient Sample cont.
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Timing of Sample Introduction
• After calibration, message displayed to insert sample• Bar indicates time remaining• Sample must be introduced within 5mins
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Screens when Running a Patient Sample cont.
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Critical Values Action
• Reporting of critical range failure
• On screen at the time of event
• Simple drop-down menu• Simplifies reporting• Assures compliance• Unique feature• Requested by customer
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Basis for epoc® Measurements
Potentiometric – Measures voltage• Ion selective electrodes
• Sodium• Potassium• Ionized calcium• pH• pCO2
• Nernst equation is used to convert the voltage into the assay values
• epoc measures either current, voltage, or conductance
Amperometric – Measures current• pO2• Glucose
Conductometric – Measures conductivity• Hematocrit
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Quality Controls
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Overview• Reader/Host Quality Controls
Barcode Scanner
Thermal System
Operating Environment
iQC
• Test Card Quality ControlsCard Temperature Monitors
Verification of card shipment
• External Liquid Quality Controls• What QCs do I run
• How often
• How to run controls
36
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Reader/Host Quality Control
Barcode Scanner
Section 5.12: Barcode Scanner 37
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Reader/Host Quality Control
Thermal System
Section 5.13: Thermal System 38
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Reader/Host Quality Controls
Operating Environment• Temperature
Internal ambient temperature monitor
15°C – 30°C
• Atmospheric pressure
Internal barometric pressure sensor400 – 825 mmHg
• Relative humidity
Electronic QC checks leakage current
Humidity must be <85% at 30°C
Section 5.14: Operating Environment 39
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Reader/Host Quality Controls
3 phases of Internal QC testing (iQC)
• InitialisationPerformed upon connection and at start of test
before calibration
• In-CalibrationPerformed after the calibrator is delivered to the
sensor array
•During Sample MeasurementMonitor procedure and sample integrity
Section 11.6.2: Overview of epoc System Internal QC (iQC) 40
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Test Card Quality Controls
Section 4.2.2: Shipping Controls as shipped from Canada. 41
Card Temperature Monitors
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External Liquid Quality Controls
Verification of Card Shipment
From each lot analyse 2 levels of fluid controls in duplicate on any verified reader.
Section 9.2.1: Verification of newly Received Test Cards 42
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External Liquid Quality Controls
Control Fluids•Bio-Rad Liquichek Blood Gas Plus EGL
• Level 1 and Level 3• Used for BGEM
•Eurotrol BGEM• Level 1 and Level 3• Used for BGEM
•Mission Diagnostics Hematocrit• Level A and Level B• Used for Hematocrit
Section 9.2.3: Control Fluids 43
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External Liquid Quality Controls
FrequencyAs per verification of card shipment:
• With each shipment cards must be analysed in duplicate with 2 levels on any verified reader.
(Take average, compare to Value Assignment Datasheets)
In keeping with any accrediting
bodies, federal, state/territory
guidelines
AACB WP, AACB QC/QA Draft Guidline (April ‘10) 44
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External Liquid Quality Controls
Precautions• Follow manufacturer's storage instructions• Allow equilibration (4 hours min)
• For Blood Gas QC• Handle fluid carefully• Once opened analyse immediately • Multiple tests only if using multiple readers
• Hematocrit QC• Not gas sensitive
45Section 9.4: Aqueous Fluid Handling
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External Liquid Quality Controls
Procedure
Tests must be run as ‘QA test’QA test results are stored separately from Blood Test Results in epoc Data Manager.
• Shake ampoule - 5 to 10 secs• Hold at tip and at bottom with forefinger and thumb• Tap, if necessary• Snap ampoule off at neck• Immediately transfer into syringe• Transfer into test card
46Section 9.4.6: Procedure
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External Liquid Quality Controls
Procedure (con’t)
Recommendations•1mL or 3mL sterile syringe•16-20 gauge blunt (drawing up) needles
•Draw 1mL from bottom of ampoule
•If air bubble present, do not invert syringe
47Section 9.4.7: Procedure
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External Liquid Quality Controls
Value Assignment Datasheet
• Contain Target values, ranges.
• Never use values/ranges from pack insert
48Section 9.5: Value Assignment Datasheet
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External Liquid Quality Controls
Value Assignment Datasheet
49Section 9.5: Value Assignment Datasheet
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Thank you.
50