Competency Assessment Form Serology - Testing Personnel First Name *Last Name *Date *Type of Assessment *Select One Type of AssessmentInitial6 MonthsAnnualObjectives 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 associated documentation Checklist on operation and regulation *1. Corrective process when error is committed in entering report into eHR2. Establishing Quality Control Plan for each test analyte as applicable3. Notification of critical value and documentation4. Checking and completing incomplete reports in the eHR5. Documentation of problem or occurrence if encountered6. Time frame storage requirement for patient’s reports, analytical studies i.e. QC, calibration and verification, operating procedures and other documentations7. Procedures for receiving proficiency test (PT) surveys, delegations, performance, reporting electronically, reviewing and evaluating the resultsKeep up to date with the Standard Operating Procedure (SOP)Checklist for main analyzers (Cobas e411, Beckman Access 2) *1. Instrument's start-up procedure2. Knowledge of basic system software3. Manage reagents4. Demonstrate testing patient sample from preanalytical to postanalytical phase5. Process of verifying accuracy, precision and linearity; calibration and QC6. Perform maintenance of the analyzers and associated equipment7. Documentation and recording8. Disposition of materials and sample specimenSpecific Observation Guide1) 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 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 material2. Demonstrate test performance on patient sample from preanalytical to postanalytical phase3. Demonstrate performance of verification of accuracy and precision (qualitative)4. Maintenance and disposition of materials and sample specimenSpecific Observation Guide1) 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 Evaluation of previously analyzed specimens, internal blind testing samples, or external PT samples *- Performed and passed -Problem-Solving Knowledge and SkillsPlease take the assessment test to demonstrate knowledge and skills on problem-solving and come back here to post the result.Demonstrating knowledge and skills on problem-solving (Passing score is at least 80%) *Select TypeWritten ExamPractical ExamPercent (%) *Employee's AcknowledgementI 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.Name of Employee *CLIA Assessment Elements1. Direct observation of routine patient test performance2. Monitoring the recording and reporting of test results, including critical values3. Review of intermediate test results, worksheets, QC records, PT results, and preventive maintenance records4. Direct observation of performance of instrument maintenance and function checks5. Evaluation of previously analyzed specimens, internal blind testing samples, or external PT samples6. Demonstrate problem-solving skills i.e. written exam, practical examCompetency Assessment ReportYes, demonstrates competency and meets standard.No, fails competency and needs remedial action.Name and Signature of Laboratory Director or Authorized Delegate *I hereby attest that I assessed and observed the employee above to the best of my knowledge. I further declare that the information and the competency assessment report provided is true and correct.Submit Form
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