1. POCT: Radiometer ABL90 FLEX

2. 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

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

4. 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

5. 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

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

7. 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) : ◦ C

8. 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)

9. 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.

10. 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

11. 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

12. 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

13. 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

14. 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.

15. 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

16. Credit for Consumables
Attach printout, complete form
and fax or to

17. 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

18. 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

19. 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.

20. 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

21. 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

22. 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

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

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

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

26. Logging On
Log on using your JHED ID

27. 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.

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

29. 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

30. 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

31. 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

32. 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.

33. 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

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

35. Patient Results

36. 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

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

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

39. Troubleshooting ABL 90 Fluidic Path – Inlet to Solution Pack

40. Troubleshooting ABL 90 FLEX
If you are unable to resolve an instrument error, please contact technical service at

41. 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.

42. 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.

43. 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

44. 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!

45. Resources
You can find the ABL90 Point of Care procedure on Hopkins Policies Online:
POCTM031 Radiometer ABL90 FLEX Analyzer
Or on the POCT website:
POCT Office phone , office hours M-F 7:00AM – 3:30PM
Off hours page the POCT Office at “POCT Consult”