1. Name
   First Name : MOALA
   Last Name : KOROI
2. Date
   01/03/2024
3. Type of Assessment
   Initial

Objectives

• To demonstrate knowledge and competency on the instrument operation, test kits, and other form of test device from preanalytical phase to postanalytical phase
• To demonstrate skills in the handling of reagents/chemicals, sample specimens and other equipment related to the performance of tests
• To demonstrate problem-solving skills on instrumentation, calibration and QC, and verification or validation of patient or blind sample results
• To describe how to maintain equipment and the associated documentation

1. Checklist on operation and regulation
   1. Corrective process when error is committed in entering report into eHR, 3. Notification of critical value and documentation, 4. Checking and completing incomplete reports in the eHR, 5. Documentation of problem or occurrence if encountered, 6. Time frame storage requirement for patient’s reports, analytical studies i.e. QC, calibration and verification, operating procedures and other documentations, 7. Procedures for receiving proficiency test (PT) surveys, delegations, performance, reporting electronically, reviewing and evaluating the results

Keep up to date with the Standard Operating Procedure (SOP)

1. Checklist for main analyzer (AU Beckman Coulter Series)
   1. Instrument’s start-up procedure, 2. Recognize the function and operation of system components, 3. Knowledge of basic system software, 4. Manage reagents, 5. Demonstrate skills on handling patient samples, separation of serum/plasma from red cells, and appropriate storage, 6. Demonstrate analyte setup to include ISE and associated specific rack barcoding, 7. Demonstrate performance of calibration and QC, 9. Demonstrate processing and resulting of samples, 10. Perform maintenance of the analyzer and other related equipment, 11. Documentation and recording, 12. Disposition of materials and sample specimen

Specific Observation Guide

1) Instrument’s start-up procedure

• Locate, turn on/off power switches of the machine
• Locate, open/close deionized water supply valve
• Logging into the system and creating new index
• Perform maintenance inspection

2) Recognize the function and operation of system components

• Main power buttons
• Racks and tube sensors/barcodes
• Photometry lamp, cuvette wheel, and cuvette wash nozzle unit
• Water & detergent tanks and reagent/sample dispense components
• Predilution bottles and mix bar unit
• ISE compartment

3) Knowledge of basic system software

• Icons on the screen and access to menus, analyzer modes and status, and help options
• Locating results, result history, and printing reports

4) Manage reagents

• Reagent compartment grouping, reagent status screen, and lot/bottle numbers
• Fixed and auto position, reagent ID, and position sequence
• On board stability and calibration stability
• Test count, loading and removing reagents including ISE
• Checking all positions, use of specified positions, resetting in the main and ISE/ Stat

5) Demonstrate skills on handling patient samples, separation of serum/plasma from red cells, and appropriate storage

• Safe handling of specimens and organization
• Perform pipetting, aliquoting, loading of sample/s, and data input (routine and stat)
• Knowledge in the storage of specimen

6) Demonstrate analyte setup to include ISE and associated specific rack barcoding

• Specific test parameters, calibration parameters, QC parameters, and reportable ranges
• Calculation-based setup
• Other parameters, if required, i.e. contamination parameters
• Know how to troubleshoot incompatibility or errors flag encountered

7) Demonstrate performance of calibration and QC

• Perform calibration and QC
• Know what to do when changing to new lot number and/or new reagents
• Interpretation of QC result and corrective action based on design rule plan protocol

8) Demonstrate performance of verification of accuracy, precision, linearity, reportable range, normal range, and comparison study

• Perform/ demonstrate verification or validation of accuracy and precision
• Perform/  demonstrate linearity, reportable and normal range study
• Perform comparison study as applicable
• Establish QC ranges

9) Demonstrate processing and resulting of samples

• Loading of samples in correct container, rack and barcode orientation if applicable
• Troubleshooting on error flag/s encountered
• Analyzing, validating results and appropriately verifying into patient electronic records

10) Perform maintenance of the analyzer and other related equipment

• Perform maintenance (Daily, Weekly or Scheduled)
• Replacing water filters, photometer lamp, ISE electrodes and standard references
• Replacing detergents and pre-dilution deionized water
• Inspecting and cleaning ISE valve tubing, buffer syringes, nozzle, sample pot, and replacing consumable parts as needed or applicable
• Performing a buffer and mid standard prime verifying reagent flow for ISE
• Performing ISE clean when necessary and a total prime

11) Documentation and recording

• Recording critical results, specimen problem encountered, and any occurrences
• Documentation of verification, calibration and QC including daily monitoring
• Documentation of corrective actions
• Recording change of bottle and lot number, and manufacturer’s update
• Recording of preventive maintenance of the main analyzer and other equipment use in the maintenance of stability of reagents and sample test material such as deionized water purifier, pipettes, centrifuge and refrigerator/freezer

12) Disposition of materials and sample specimen

• Used pipette, tubes and stopper, expired reagents, and empty bottles
• Specimen sample
• Maintenance of non-consumable tools, i.e. rack, timer

1. Checklist for Hemoglobin A1c (Bio-Rad D10)
   1. Instrument’s start-up procedure, 2. Recognize the function and operation of system components on System Check, 3. Performance of Daily Maintenance Pre-Run Checklist, 4.Demonstrate performance of Calibration and QC, 6. Demonstrate patient or sample run and retrieving results, 7. Performing maintenance, 8. Disposition of materials and sample specimen

Specific Observation Guide

1) Instrument’s start-up procedure

• Locate, turn on/off power switches of the machine
• Installing the update kit, if needed
• Placing the system in sleep state
• Installing elution buffers and wash/diluent solution
• Resetting Buffer Volume in the display screen
• Performing system flush
• Placing system in Standby state
• Priming new cartridge
• Performing Decontamination procedure
• Knowing 7 states of D-10 system status

2) Recognize the function and operation of system components on System Check

• Buffer 1, Buffer 2, and Wash/Diluent
• Waste
• Cartridge
• Temperature
• Calibration
• Internal Waste Circuit

3) Performance of Daily Maintenance Pre-Run Checklist

• Check correct Method (HbA1c) is installed
• Check buffer/wash levels, lot numbers, and line positions
• Check reagent onboard expiration dates
• Check cartridge injection count and lot number
• Check pump pressure (15-75 kg/cm2)with pump running (Maintain screen)
• Check for leaks during pressure check
• Check external waste tank level
• Check printer paper supply

4) Demonstrate performance of Calibration and QC

• Preparation of whole blood primer, calibrator and QC materials including reconstitution or dilution
• Data input/ logging and running the samples
• Know what to do when changing to new lot number and/or new reagents
• Interpretation of QC result and corrective action based on design rule plan protocol

5) Demonstrate performance of verification of accuracy, precision, linearity, reportable and normal range, and comparison study

• Performance of verification and linearity, reportable and normal range, and comparison study, if applicable
• Establish QC ranges
• Recording and documentation

6) Demonstrate patient or sample run and retrieving results

• Preparation of patient samples
• Typing patient sample information into the screen (worklist entries)
• Showing and reprinting reports
• Validation and verification of result into the electronic health record
• Locate troubleshooting guide and understanding error flags or messages

7) Performing maintenance

• Daily pre-run and post-run log
• Monthly maintenance log
• Periodic maintenance (replacing sample probe) and engineer’s service log
• Replacing printing paper supply

8) Disposition of materials and sample specimen

• Used consumables i.e. expired reagents, waste
• Specimen sample
• Maintenance of non-consumable tools i.e. rack

1. Checklist for Quidel Triage BNP and Troponin
   1. Instrument’s start-up procedure, 2. Recognize the function and operation of system components, 3. Demonstrate performance of verification, calibration and QC, 4. Demonstrate running test on patient sample and validating result from pre-analytical to post-analytical phase, 5. Maintenance and disposition of materials and sample specimen

Specific Observation Guide

1) Instrument’s start-up procedure

• Power on and self-test
• Installation of Standard Code Chip Modules (Reagent Test Code Chip, QC Device Code Chip, Supervisor Code Chip, ..)
• Setting parameters, user ID, and installing paper

2) Recognize the function and operation of system components

• Power button, print button, delete button, enter button, and exit button
• Keypad, arrow buttons, thermal printer, power supply port, and LCD screen
• Test device insertion port, code chip module port, and printer cover

3) Demonstrate performance of verification, calibration and QC

• Performance of verification and linearity if applicable
• Handling and preparation of QC samples
• Running QC Device and QC samples
• Recording and documentation

4) Demonstrate running test on patient sample and validating result from pre-analytical to post-analytical phase

• Handling and preparation of patient’s specimen
• Pipetting specimen into the BNP Test Device
• Entering patient ID and running the test
• Reviewing and verification of results into the eHR
• Recalling or retrieving results/records and optional reprinting
• Locating troubleshooting guide for message or error flags

5) Maintenance and disposition of materials and sample specimen

• Used pipette, tubes and other consumables
• Specimen sample
• Maintenance of non-consumable tools i.e. rack, timer, counting chamber
• Documentation (maintenance log)

1. Evaluation of previously analyzed specimens, internal blind testing samples, or external PT samples
   – Performed and passed –

Problem-Solving Knowledge and Skills

Please take the assessment test to demonstrate knowledge and skills on problem-solving and come back here to post the result.

1. Demonstrating knowledge and skills on problem-solving (Passing score is at least 80%)
   Written Exam
2. Percent (%)
   80

Employee’s Acknowledgement

I acknowledged knowing and/ or performing all above applicable listed checklists while being observed by my supervisor. I understood that failure to pass this competency assessment would result to remedial training and therefore, this would affect my performance on my position to carry out my duties and responsibilities as testing personnel. Typing my name below will constitute validity of this acknowledgment.

1. Name of Employee
   MOALA F T KOROI MLT
2. CLIA Assessment Elements
   1. Direct observation of routine patient test performance, 2. Monitoring the recording and reporting of test results, including critical values, 3. Review of intermediate test results, worksheets, QC records, PT results, and preventive maintenance records, 4. Direct observation of performance of instrument maintenance and function checks, 5. Evaluation of previously analyzed specimens, internal blind testing samples, or external PT samples, 6. Demonstrate problem-solving skills i.e. written exam, practical exam
3. Competency Assessment Report
   Yes, demonstrates competency and meets standard.
4. Name and Signature of Laboratory Director or Authorized Delegate
   Eleanor Victoria Amanda N. Villorente, MLS(AMT)- Technical Supervisor