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A cost-effective point of care solution for the entire healthcare enterprise 1 November 2010 1. A Patient-centred Approach. June 2009 Advance For Respiratory.

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Presentation on theme: "A cost-effective point of care solution for the entire healthcare enterprise 1 November 2010 1. A Patient-centred Approach. June 2009 Advance For Respiratory."— Presentation transcript:

1 a cost-effective point of care solution for the entire healthcare enterprise 1 November 2010 1. A Patient-centred Approach. June 2009 Advance For Respiratory Care & Sleep Medicine epoc ® blood analysis:

2 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

3 epoc ® System epoc ® Host Mobile Computer epoc ® Reader epoc ® BGEM Test Card

4 epoc ® System: epoc ® Data Manager (server-based)

5 epoc ® Host Components Touch screen for navigation, using stylus Barcode scanner Battery-powered for portability

6 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

7 epoc ® BGEM Test Card Analytes

8 Test Menu – Calculated Values

9 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

10 epoc ® Reader Components

11 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

12 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

13 epoc Data Management (EDM) software: Web-based (accessible via any network) Manages the entire epoc system (reports, inventory management, can be interfaced) Features

14 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)

15 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)

16 epoc ® Wireless Communication EPOC Web-based Data Manager Remote workstation LIS / HIS Existing Wi-Fi Access Points

17 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

18 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.

19 Navigating through the Reader Screens

20 Log In and Start Up Screens Start Up Screen –upon reset of Host (initiates program, reads files & configures software)

21 Main Reader Screen Lock icon (dedicated readers always listed) EDM Sync appears only when Host configured to EDM (exchange info)

22 Indicators

23 Navigation Lightly press stylus on Reader icon or list for menu Tap for selection

24 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

25 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)

26 Test Pages 2 nd 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)

27 Additional Test Information Pages

28 Additional Test Information Pages cont.

29 Screens when Running a Patient Sample Calibration process takes approx. 165 secs

30 Screens when Running a Patient Sample cont.

31 Timing of Sample Introduction After calibration, message displayed to insert sample Bar indicates time remaining Sample must be introduced within 5mins

32 Screens when Running a Patient Sample cont.

33 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

34 Basis for epoc ® Measurements Potentiometric – Measures voltage Ion selective electrodes Sodium Potassium Ionized calcium pH pCO 2 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

35 Quality Controls

36 Overview Reader/Host Quality Controls Barcode Scanner Thermal System Operating Environment iQC Test Card Quality Controls Card Temperature Monitors Verification of card shipment External Liquid Quality Controls What QCs do I run How often How to run controls 36

37 Reader/Host Quality Control Barcode Scanner Section 5.12: Barcode Scanner 37

38 Reader/Host Quality Control Thermal System Section 5.13: Thermal System 38

39 Reader/Host Quality Controls Operating Environment Temperature Internal ambient temperature monitor 15°C – 30°C Atmospheric pressure Internal barometric pressure sensor 400 – 825 mmHg Relative humidity Electronic QC checks leakage current Humidity must be <85% at 30°C Section 5.14: Operating Environment 39

40 Reader/Host Quality Controls 3 phases of Internal QC testing (iQC) Initialisation Performed upon connection and at start of test before calibration In-Calibration Performed after the calibrator is delivered to the sensor array During Sample Measurement Monitor procedure and sample integrity Section 11.6.2: Overview of epoc System Internal QC (iQC) 40

41 Test Card Quality Controls Section 4.2.2: Shipping Controls as shipped from Canada. 41 Card Temperature Monitors

42 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

43 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

44 External Liquid Quality Controls Frequency As 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

45 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 45 Section 9.4: Aqueous Fluid Handling

46 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 46 Section 9.4.6: Procedure

47 External Liquid Quality Controls Procedure (cont) 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 47 Section 9.4.7: Procedure

48 External Liquid Quality Controls Value Assignment Datasheet Contain Target values, ranges. Never use values/ranges from pack insert 48 Section 9.5: Value Assignment Datasheet

49 External Liquid Quality Controls Value Assignment Datasheet 49 Section 9.5: Value Assignment Datasheet

50 Thank you. 50


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