1. Name
   First Name : BARBARA
   Last Name : MAFUA
2. Date
   09/23/2023
3. Type of Assessment
   Annual

Objectives

• To demonstrate knowledge and skills in the day-to-day operation of the section, and ensure corrective actions are taken whenever test systems deviate from the laboratory’s established performance specifications
• To demonstrate leadership by showing how to evaluate, monitor, maintain, and document the quality performance of subordinate personnel
• 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 for day-to-day oversight of the section
   1. Describe the daily process of operation and activities, 2. Provide documentations of staff performance activity records and assessment, 3. Demonstrate monitoring process to maintain quality essentials including inventory of supplies, 4. Provide example of corrective active actions being implemented and monitored
2. 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)

Be able to train testing personnel on the test system and demonstrate patient’s sample analysis including recording, reporting and maintenance of test environment.

1. Checklist for main analyzers (Cobas e411, Beckman Access 2)
   1. Instrument’s start-up procedure, 2. Knowledge of basic system software, 3. Manage reagents, 4. Demonstrate testing patient sample from preanalytical to postanalytical phase, 5. Process of verifying accuracy, precision and linearity; calibration and QC, 6. Perform maintenance of the analyzers and associated equipment, 7. Documentation and recording, 8. Disposition of materials and sample specimen

Specific Observation Guide

1) Instrument’s start-up procedure

• Locate, turn on/off power switches of the machines
• Enumerate major system components/parts
• Water supply requirements, as applicable
• Operating temperature and humidity
• Reagent packs and barcode label
• Calibrator and control kits
• Familiarity with the control unit software, printer, and data storage
• Familiarity with the “Checklist for daily operation”

2) Knowledge of basic system software

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

3) Manage reagents

• Receiving reagents or materials needed, recording/ documenting condition, lot/batch number, expiration, and storing process  including opened and unopened containers, onboard in the analyzer and outside analyzer

4) Demonstrate testing patient sample from pre­analytical to post­analytical phase

• Receiving patient sample, logging/tracking, labeling, specimen processing before run, assessing specimen stability, rejection criteria
• Reagent/ material requirements and pre­run preparation  of the machine including calibration and QC, loading sample, dilution if needed
• Validating patient result process, and appropriately verifying into patient electronic records
• Troubleshooting on error flag/s encountered
• Notification of critical results, flagging if any, and reporting into  eHR
• Recording and storing process of the reports

5) Process of verifying accuracy, precision and linearity; calibration and QC

• Perform verification or validation of accuracy and precision
• Perform linearity or reportable range study
• Perform comparison study, as applicable
• Establishing QC ranges
• Procedure when changing lot number
• Interpretation of QC result and corrective action based on design rule protocol
• Know what the quality control plan is

6) Perform maintenance of the analyzers and associated equipment

• Perform maintenance (Daily, Weekly or Scheduled)
• Show documentation of preventive maintenance

7) Documentation and recording

• Recording critical results, specimen problem encountered, and  any occurrences affecting standard patient care based on protocol
• Documentation of verification, calibration and QC including daily monitoring, corrective actions, change of bottle and lot number, and manufacturer’s update on the analyzer, reagents, and setup

8) Disposition of materials and sample specimen

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

1. Checklist for test kits (HIV, Dengue, RPR and TPPA, Leptospira and other microbial markers)
   1. Demonstrate process, logging, and documentation of receipt of the test and reagent material, 2. Demonstrate test performance on patient sample from preanalytical to postanalytical phase, 3. Demonstrate performance of verification of accuracy and precision (qualitative), 4. Maintenance and disposition of materials and sample specimen

Specific Observation Guide

1) Demonstrate process, logging, and documentation of receipt of the test and reagent material

• Assessing the test kit, recording lot/batch number and expiry date
• Assessing certificate of conformance or analysis
• Proper storage prior to use

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

• Specimen collection, preparation, and logging/ tracking including worksheet
• Enumerate materials requirement for the test
• Demonstrate knowledge of the procedure
• Running calibration and QC (internal and external) as applicable
• Demonstrate proper temperature of incubation, timing and reading, and correct interpretation of result
• Troubleshooting on error/s encountered
• Validation of result and verification into patient electronic health record
• Notification of critical results, flagging if any
• Recording and storing process of the reports

3) Demonstrate performance of verification of accuracy and precision (qualitative)

• Demonstrate knowledge of test performance characteristics
• Interferences if any, expected result and limitation of procedure
• Performance of verification of accuracy and precision as applicable
• Performance of comparison study, measurement range and/or cut-off concentration as applicable

4) 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, incubator, and centrifuge
• Documentation (maintenance log) for instrument and equipment

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 (%)
   95

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 acting supervisor. Typing my name below will constitute validity of this acknowledgment.

1. Name of Employee
   BARBARA MAFUA, MLS
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
   AMOR GONZALES, MD – DELEGATED TECHNICAL SUPERVISOR