1. Name
   First Name : TIMOCI
   Last Name : VAKATAWA
2. Date
   02/14/2024
3. Type of Assessment
   6 Months

Objectives

• To demonstrate knowledge and competency on the performance of bacterial culture (aerobic and anaerobic as required) and antibiotic sensitivity from clinical specimens such as blood, wound, body fluids, urine and stool from pre­analytical phase to post­analytical phase
• To demonstrate knowledge and competency in the processing of parasitology specimen and skills in the screening and or identification of parasite(s) and fungus
• To demonstrate skills in the handling of reagents/chemicals, sample specimens and other tools or instruments related to the identification of microorganism
• 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, 2. Establishing Quality Control Plan for each test analyte as applicable, 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 Instruments or Analyzers (BacT/Alert Sytem, Vitek 2, Previ Gram Stain)
   1. Instrument’s start-up procedure and familiarization of the basic system hardware and software, 2. Calibration and QC/ verification and quality assurance, 3. Demonstrate test performance on patient sample from preanalytical to postanalytical phase, 4. Maintenance and troubleshooting

Specific Observation Guide

1) Instrument’s start-up procedure and familiarization of the basic system hardware and software 

• Locate, turn on/off power switches of the machine
• Locate fill door, front user access door, top user access door, load door, waste collection door, optical sensor, filler station, cassette load/unload station, waste collection bin, user interface screen, and LED indicators (Vitek 2)
• Describe the cassettes and the principle of test operation (Vitek 2)
• Locate configuration menu and describe how to set up (Vitek 2)
• Knowledge of the (basic software) instrument display icons, instrument faults, cell status screen, setting up screen function with password protected (BacT Alert)
• Demonstrate loading bottle entry, changing maximum test time (individual), and unloading bottles (BacT Alert)
• Demonstrate handling anonymous bottle, unconfirmed positive bottle (False Positive), and editing bottle’s status on Edit Test Result (BacT Alert)
• Show how to view patient bottle data information and optional printing or exporting test data (BacT Alert)
• Describe how the system detects bacterial growth (BacT Alert)
• Setting up module incubation temperature and calibration (BacT Alert)
• Enumerate and show reagent channel and waste container (Previ Gram Stain)
• Demonstrate removing the carousel lid, inserting or loading slides into the carousel, and placing back into the machine (Previ Gram Stain) 
• Demonstrate familiarity with the front panel keys (Previ               Gram Stain)
• Demonstrate purging and priming of the nozzles and performing pattern test (Previ Gram Stain)
• Demonstrate process, logging, and documentation of receipt of the reagents used for PREVI Color Gram
• Demonstrate slide preparation, alcohol fixation (ethanol or methanol, 99.8% pure) using automated or manual, loading slides into the carousel, and running the stains (Previ Gram Stain)

2) Calibration and QC/ verification and quality assurance

• Demonstrate performing instrument cell calibration (BacT Alert
• Locating a cell which failed calibration (BacT Alert)
• Show procedure of recording Certificate of Conformance for blood culture bottles (SA, SN, FA, FN, and PF) (BacT Alert)
• Demonstrate QC procedure and recording of blood culture bottles (BacT Alert)
• Describe calibration process and QC, show how to access QC status and the process of recording or documenting (Vitek 2)
• Demonstrate calibration and QC of DensiCHECK before use and recording process (Vitek 2)
• Describe the procedure of QC performance including frequency and documentation for every test card (Vitek 2 – Compliance with CLSI® M50­A standard)
• Familiarization of the performance characteristics and limitation of every test cards
• Show how to calibrate and perform QC on Previ Gram Stain and record (documentation)
• Describe process how to verify the performance (accuracy and precision)
• Show documentation of verification or validation periodically (every 6 months)
• Describe the quality control plan (show diagram or process on how to deal with unacceptable control)
• Monitoring and auditing specimen process
• Monitoring timing (TAT), appropriateness, and completeness of report
• Monitoring adequate and immediate notification process

3) Demonstrate test performance on patient sample from preanalytical to postanalytical phase

• Preparation of patient sample including logging or tracking, labeling, aliquoting or diluting before loading into the machine, show worksheet documentation
• Culturing, subculturing, and morphological identification of bacteria
• Monitoring culture growth and interpretation
• Evaluating the gram stained smear and troubleshooting
• Interpretation of gram stain
• Show how to use of Vitek 2 ID cards with controls
• Describe processing test card workflow for working with the VITEK® 2 Compact instrument (loading / unloading cassette, removing ejected test card, and removing the waste)
• Alternative testing method when Vitek 2 is unavailable and other limitations
• How to deal with suspicious incompatible results, and uncommon or rare microorganism species
• Selection of antibiotics and performance of AST
• Demonstrate retrieving result, recording, printing, and validating the result before releasing the official report into eHR
• Proper disposition of used reagents, media materials, and patient specimens including storing requirements if needed

4) Maintenance and troubleshooting

• Describe BacT/Alert instrument preventive maintenance and documentation
• Describe spill cleanup (decontamination) procedure
• Locate software maintenance procedure when malfunction occurs
• Show how to check thermometer, checking the incubation temperature and recording
• Demonstrate temperature check on the screen and manually validating the trueness reading of the instrument thermometer
• Locating troubleshooting table when error messages appear
• Demonstrate how to resolve error flags or fault codes encountered
• Show how to perform diagnostic tests as applicable
• Demonstrate unlocking of front user access door (Vitek 2)
• Demonstrate cleaning of carousel, cassettes, optics, instrument exterior and interior components, and instrument shutdown
• Alternative gram stain procedure or process to use when PREVI Color Gram machine is NOT available
• Show documentation of maintenance log daily, monthly, and periodic professional service

1. Checklist for AFB, Fungal and Parasitology Smears
   1. Overview of the materials and instrumentation, 2. Demonstrate steps performance from preclinical to postanalytical phase of the test, 3. Describe quality assurance (QA) process

Specific Observation Guide

1) Overview of the materials and instrumentation

• Pipette, tube, stopper, tube rack, slides, slide rack, timer, alcohol lamp, and stains
• Type of specimen, sample stability, preservative if any, and volume requirement

2) Demonstrate steps performance from pre­clinical to postanalytical phase of the test

• Specimen collection, transport and storage condition, receipt and labeling, logging/tracking (recording), and rejection criteria
• Specimen processing and materials needed
• Demonstrate quality control process and documentation
• Evaluating the smear and troubleshooting
• Interpretation of result and limitations
• Validating, reporting, and verifying results into electronic patient health record
• Recording, documenting, and storing of reports/worksheets
• Disposition of patient’s sample, used reagents, and slides

3) Describe quality assurance (QA) process

• Monitoring and auditing specimen process i.e. comparison with peers
• Monitoring timing (TAT), appropriateness, and completeness of report
• Monitoring adequate and immediate notification process

1. Checklist for Test of Chlamydia & Gonorrhea (GeneXpert)
   1. Instrument’s startup procedure and familiarization of the instrument hardware, 2. Demonstrate performance of verification, calibration and QC, 3. Demonstrate running test on patient sample and validating result from pre-analytical to post-analytical phase, 4. Maintenance and disposition of materials and sample specimen

Specific Observation Guide

1) Instrument’s startup procedure and familiarization of the instrument hardware 

• Starting the instrument (Turning on to power up and logging  onto the system)
• Familiarization with the touch screen, menu, and use of virtual keyboard
• Exiting the software and proper turning off the system

2) Demonstrate performance of verification, calibration and QC

• Performance of verification and linearity if applicable
• Describe instrument calibration
• Handling and preparation of QC samples
• Running QC and interpretation
• Recording and documentation

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

• Sample and reagent preparation
• Logging patient’s data onto the system
• Loading sample and system operation
• Resulting process, interpretation, verification, and uploading to LIS (if any)
• Troubleshooting error messages or error flags
• Recording and documentation process into eHR
• Recalling or retrieving results/records and optional reprinting

4) Maintenance and disposition of materials and sample specimen

• Used pipette, swabs, tubes, and other consumables
• Specimen sample
• Documentation (maintenance log of the instrument)

1. Checklist for Test of H. pylori, Influenza, RSV, Rapid Strep A, and for Other Waived Tests
   1. Demonstrate process, logging, and documentation of receipt of the test or reagent material, verification of performance, calibration and QC as required by the manufacturer, 2. Demonstrate test performance on patient sample from preanalytical to postanalytical phase

Specific Observation Guide

1) Demonstrate process, logging, and documentation of receipt of the test or reagent material, verification of performance, calibration and QC as or if required by the manufacturer

• Assessing the test reagent/kit, recording lot/batch number and expiry date, certificate of conformance or analysis and proper storage prior to use
• Demonstrate verification process and limitation of the test as applicable
• Demonstrate process of calibration and QC as applicable

2) Demonstrate test performance on patient sample from preanalytical to postanalytical phase

• Specimen collection, preparation, and logging/ tracking, worksheet if any
• Demonstrate knowledge of the procedure
• Evaluating and interpretation of the result and troubleshooting for flags, if any
• Validating, reporting, and verifying results into electronic patient health record
• Recording, documenting, and storing of reports/worksheets
• Disposition of patient’s sample, and used reagents or items

1. Checklist for test kits or biochemical test(s) use as aid in the identification or confirmation of microorganism
   1. Describe how the handling of the test kit is done and documented from the time received in the laboratory, 2. Describe specimen collection/preparation of primary culture and the testing procedure

Specific Observation Guide

1) Describe how the handling of the test kit is done and documented from the time received in the laboratory

• Recording the condition of the test kit and documentation of lot/batch number and expiry date
• Checking and filing of the certificate of conformance or certificate of analysis
• Demonstrate the performance of validation/verification as specified in CLSI M­50A
• Demonstrate performance, monitoring, and documenting streamlined QC
• Demonstrate process of calibration and QC as applicable

2) Describe specimen collection/preparation of primary culture and the testing procedure

• Demonstrate patient sample preparation
• Demonstrate the actual testing with the Kit (internal QC, temperature requirement, labeling, use of loop, mixing/ resuspension, pipetting, and etc..)
• Describe the quality control plan, limitations of the test kit and how to deal with these limitations 
• Interpretation of result
• Demonstrate recording and filing (worksheet and documentation)
• Proper disposition of used reagents, materials, and patient specimens including storing requirements if needed

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 (%)
   90

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
   TIMOCI VAKATAWA
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
   SEINI BIUKOTO, MLT (ASCP)CM – Technical Supervisor Delegate