POCT: Radiometer ABL90 FLEX

Objectives After completion of this course the learner will be able : Identify the ABL90 FLEX components and their functions Demonstrate how to replace a sensor cassette and solution pack Demonstrate how to check internal QC and Calibrations and troubleshoot errors Demonstrate how to run External Ampoule based QC State the steps of a proper capillary puncture Demonstrate how to run a patient Verbalize how to troubleshoot analyzer errors Explain the necessary components for maintaining competency and the role of the POCT office in oversight

Important A provider order or documented protocol is required PRIOR to performing any POCT testing.

ABL90 FLEX Overview Printer and handle Color touch screen Integrated barcode reader Self-cleaning inlet aspirates the sample in 5 seconds Sensor cassette compartment behind the door Solution pack with waste pouch, reagents and QC. The QC is built-in and automatic for accuracy and full regulatory compliance. Fully operational on battery and optional rolling stand for added flexibility

Inlet Mode 1-Capillary or syringe modes 2-Handle shown lifted to syringe mode 3-Holder with inlet gasket for sample aspiration (syringe or capillary) 4-Inlet handle position LEDs

ABL90 FLEX Rear Panel Standby button Latch for manual release of the solution pack Main power switch

ABL90 FLEX Consumables Two consumables Storage of Consumables Sensor Cassette (SC) Solution Pack (SP) Storage of Consumables Sensor Cassette (SC) : Refrigerate at 2 - 8◦ C Solution Pack(SP) : 2 - 25◦ C

Sensor Cassette Reference sensor. Do not shake the sensor cassette! There is no need to mix the solution in the reference sensor. Smart chip containing various information, no further scanning of product barcodes necessary Board with sensors. Hemoglobin and bilirubin are measured by the oximetry module built into the analyzer. Sensor Cassette (SC)

Changing Sensor Cassette (SC) Enter Analyzer Status Consumables Replace Replace sensor cassette Starting the video will open door to Sensor compartment Remove cassette, press Action Completed. NOTE: The analyzer needs to condition a new SC after it is installed. This process can take up to 4 hours.

ABL90 FLEX Solution Pack Memory chip New, unused solution pack Solution pack ready for analyzer Memory chip The chip stores lot number, expiration date, solutions calibration and QC data. The analyzer writes the usage status and time onboard to the chip If the SP is placed on another analyzer, all information is read from the chip. The analyzer detects if the internal foil strip registers a current (occurs if solution has leaked). Flow selector The red plastic strip prevents the connection pins from opening the pouches. The label contains all relevant SP information Contains pouches with QC and calibration material, a gas mixture and closed containers to hold liquid waste

Inside of ABL90 FLEX Solution Pack Flow selector controlled by analyzer Barcodes on every solution pouch Foil strip detects a current if solution leaks from pouch Connection tubes have different lengths and penetrate at different times to make it a lighter “press” when connecting the tubes BACK Pump tubing Connection to waste Connection tubes press down into pouch FRONT

Activating New Solution Pack Pull red pin out of the new solution pack Place palms of hands over the edges of the lid as shown Both tabs must click into place foe the solution pack to be activated correctly

ABL90 FLEX Solution Pack Before inserting the solution pack the airtight foil pouches must be opened and connected with the flow selector in the top When the top is pressed down and completely horizontal the solution pack fits to the analyzer Unused solution pack Solution pack ready for analyzer

Changing The Solution Pack Enter Analyzer Status Consumables Replace Replace Solution Pack Lift inlet to capillary position and wait for the solution pack to unlock Remove used solution pack Insert new activated solution pack by pushing in firmly until a click is heard When prompted by analyzer, close the inlet.

Credit for Consumables If it is necessary to remove the sensor cassette or solution pack before it is empty or expired due to QC or Calibration failure print Appendix A: Consumable Credit form found in the POCTM031 Radiometer ABL90 FLEX Analyzer procedure. Print Status Error

Credit for Consumables Attach printout, complete form and fax or email to support@radiometeramerica.com

Analyzer Status Check the top left corner of the screen to ensure READY mode The analyzer will always tell you what it is doing Calibration QC Measurement Green light at the sample port-Ready Orange light – Not ready

Analyzer Status Parameter bar The analyzer is READY when three (3) conditions are present: The analyzer is in the Ready mode The color of the parameter tab is green or yellow The color of the traffic light in the Analyzer Status button is green or yellow The Parameter bar lists all parameters available and activated on your analyzer. A green tab means the status is ok and no problems have been detected. A yellow tab means there is an error associated with the given parameter during the last calibration or QC measurement. You will not receive a result for that parameter. A red tab is a serious error

Analyzer Main Screen Sensor cassette icon shows 9893 test remaining Solution pack icon shows 24 tests remaining Data Logs contain Patient Results, Calibrations, QC and replacements Analyzer Status-the color of the traffic light on the button shows the overall status of the analyzer.

Analyzer status elements The Analyzer Status button (traffic light) when clicked will open up to this screen so you can access detailed information. Recommended Actions Calibrations Quality Control Consumables Other Activities System Messages

Calibrations The green check (√) means the calibration was accepted A red question mark (?) means there were errors during calibration A clock means there are pending or overdue calibrations To start a calibration highlight calibration type and then press Calibration To view calibration results press Result

Calibrations with Errors Notice the yellow traffic light When the traffic light is clicked it opens this screen. You can see there is a problem with a calibration, QC and consumables. tHb is overdue and the red question mark means there was an error during calibration Click Result tab to see next screen

Troubleshooting Calibration Errors The calibration results are shown here. In this example lactate shows an error. For more information press Messages

Troubleshooting Calibration Errors This is the message shown for lactate. Press Troubleshoot for more information

Troubleshooting Calibration Errors The troubleshooting guide will give you an interpretation of the error and actions to take to correct the problem.

Logging On Log on using your JHED ID

QC Built-in QC is run every 8 hours (one of each level) External QC is run after any major system maintenance including sensor and/or solution cartridges, after software upgrades and at least every 30 days. Room temperature QC ampoules are shaken vigorously for 15 seconds and tapped so that all solution collects at bottom. Use ampoule opener to break off ampoule neck. Place in Qualicheck adapter, lift inlet to syringe position and select Ampoule-QC.

QC-continued Place adapter tip against inlet gasket with “R” facing up When prompted by analyzer, remove adapter and close inlet.

QC Status The status for the both the built-in QC and the Ampoule-based QC is shown A green check (√) means the last measurement was accepted A red question (?) mark means there was an error in the last calibration or an analyzer error during the QC measurement To repeat a built-in QC highlight the level to be run and then press Start QC

Obtaining a Capillary Blood Sample Use two patient identifiers to match orders to patient For heal sticks, warm skin in area of puncture 5-10 minutes Wash hands and put on gloves Thoroughly cleanse area with alcohol pad and let dry Using a sterile lancet , puncture skin about 2mm deep Wipe off first drop of blood with gauze Collect the next drops in a heparinized capillary tube, holding it in a horizontal position, slightly downward keeping air from entering tube Fill tube and mix Analyze immediatley

Obtaining a Capillary Blood Sample Children with good blood circulation have capillary samples taken from the fingers The middle and ring finger are preferred Cleanse puncture site with alcohol and allow to dry Puncture depth is 2-4 mm Wipe away first drop of blood with gauze Allow capillary forces to fill capillary tube Do not allow air into capillary tube Mix capillary tube immediately Analyze blood gas immediately

Running a patient-capillary specimen Check that analyzer is in Ready mode. Mix the capillary sample Lift inlet to capillary position and follow on-screen instructions. Place capillary in center of inlet gasket conus.

Sample Processing-syringe mode LIFT Lift the inlet to the syringe position until the green light appears Align syringe with inlet gasket Push the syringe onto the inlet applying pressure to depress the inlet gasket Hold syringe in place while sample is automatically aspirated Remove syringe from inlet when prompted Close the inlet ALIGN PUSH/HOLD

Running a patient -continued When prompted by analyzer, remove capillary and close inlet. Enter information on Patient Identification screen with barcode reader.

Patient Results

Patient Results No marking next to a parameter indicates that it was measured without any fault. “?”- Indicates an error in last QC run or calibration, or because of sample problems Single arrows( ) indicate a result outside reference or normal range Double arrows ( ) indicate a result outside critical limit.(CAV result) Triple arrows ( )indicate a result is outside reportable range

Troubleshooting ABL 90 FELX for Clots Fluidic Path – Inlet to Solution Pack

Troubleshooting ABL 90 FLEX Flush Device for Clots A flush device will be provided with each analyzer ABL90 Flush Device

Troubleshooting ABL 90 Fluidic Path – Inlet to Solution Pack

Troubleshooting ABL 90 FLEX If you are unable to resolve an instrument error, please contact technical service at 1-800-800-7005

Operator Training and Competency Initial training will be provided by the Point of Care Office in conjunction with trainers on each unit. A competency affirmation is to be performed at 6 months from the date of initial training and 1 year after initial training and then yearly thereafter. A lab personnel qualification appraisal form (Appendix B of procedure) is to be completed by new trainee. A copy is kept in the Point of Care Office and original in employees personnel file. A copy of the trainees diploma or transcript from their highest academic achievement must be submitted to the Point of Care Office. Initial training, 6 month affirmation, and yearly competency is documented on the ABL90 Competency Checklist (Appendix C of procedure) and sent to Point of Care Office. A quiz on My Learning is to be completed with initial training, at 6 months, at 1 year and then yearly thereafter.

Proficiency Testing Proficiency testing is performed 3 times a year The AQ proficiency testing is received in March, June and September and is run in the Proficiency mode. The SO proficiency testing is received in April, July and October and is run in the sample mode. Any trained operator can be expected to perform proficiency testing when it is delivered to their testing area.

POCT Office Responsibilities The Point-of Care Testing (POCT) office is responsible for regulatory oversight and quality management of the test system POCT duties include: Ensuring the test system meets federal and state laws as well as the guidelines from accrediting agencies. Validation of new meters Training trainers and assisting them in training and maintaining competency of operators Reviewing analyzer and operator performance through proficiency testing and QC records Ensuring that the testing meets the needs of the care providers

Laboratory Inspections The Laboratory is subject to an unannounced inspection every two years by the College of American Pathologists (CAP). State inspections or “for cause” inspections could happen at any time. As a POCT testing site, you are part of the laboratory and are subject to inspection as well. The POCT office is charged with the responsibility to be in the state of constant inspection-readiness. As a POCT operator, you could be queried or observed by an inspector. Maintaining your competency and reviewing your resources is the best way to be ready and the best way to perform quality testing!

Resources You can find the ABL90 Point of Care procedure on Hopkins Policies Online: POCTM031 Radiometer ABL90 FLEX Analyzer Or on the POCT website: http://pathology.jhu.edu/department/staff/POCT/home.cfm POCT Office phone 5-2645, office hours M-F 7:00AM – 3:30PM Off hours page the POCT Office at “POCT Consult”