1. Name
   First Name : Ana Maria
   Last Name : Carrillo
2. Date
   02/14/2024
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 performance standard on operation, instrumentation, calibration, quality control, verification of accuracy and precision, linearity as applicable, comparison studies between analyzers, establishing quality controls and quality control plan
• To demonstrate skills in the handling and use of reagents or chemicals, sample specimens, microscopes and other instruments in the department section
• To demonstrate knowledge and competency on the performance and interpretation of blood or body fluid cellular smear from pre­analytical phase to post­analytical phase
• To demonstrate knowledge in cell morphology, parasitology and other elements and their clinical significance
• 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)

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 Hematology Analyzer (Sysmex XN-Series)
   1. Instrument Overview, 2. Start-Up-Procedure, 3. Quality Control, 4. Familiarity with the software, 5. Sample Analysis Mode, 6. Demonstrate test performance on patient sample from preanalytical to postanalytical phase, 7. Maintenance and troubleshooting, 8. Performing calibration and precision runs, 9. Familiarity with the System limitation

Specific Observation Guide

1) Instrument Overview

• Identify the Main Unit, describing the Basic Parts and Function: Front top cover, Front bottom cover, Tube holder, Start switch, Sampler Section: Analysis line, Sampler pool, Rack feed out lever
• Identify the IPU: Display, Keyboard, Mouse, Main Unit
• Identify the Pneumatic Unit: 0.25 MPa regulator, Pilot lamp
• Identify the Reagents: Cellpack DCL, Sulfolyser, Lysercell WNR, Lysercell WDF, Lysercell WPC, CELLCLEAN AUTO, Control blood (XN CHECK), Calibrator (XN CAL), and etc..

2) Start Up Procedure

• Power On Sequence (Instrument inspection, Reagent inspection)
• Log On IPU (Initialization of the mechanical parts, Rinse, Waiting for temperature stabilization, Background check)
• Background Count

3) Quality Control

• Enter New Lot
• Set target and limit values
• Processing QC
• Change Lot
• Check QC Charts
• Save QC for Insight
• Documentation and recording of QC

4) Familiarity with the software

• Controller ­ Reagent Log, Remaining Reagent
• Maintenance and error log
• Finding information and retrieving/reprinting result

5) Sample Analysis Mode

• Auto Mode
• Manual Mode

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

• Specimen collection/inspection, stability, preparation, and logging/ tracking
• Processing the specimen including data input into the IPU
• Receiving and printing result (RBC parameters, WBC &  Differential parameters, Platelets parameter, Abnormal flags)
• Validating result, notification of critical values, and verification of result into eHR
• Documentation and filing records
• Proper disposition of used reagents, materials, and patient specimens including storing requirements if needed

7) Maintenance and troubleshooting

• Daily ­ Shutdown (automatic or manual)
• Replace the waste container
• Perform auto rinse
• Perform cleaning
• Clog removal from the RBC detector
• Rinse the RBC detector aperture
• Drain the waste chamber
• Rinse the waste chamber
• Remove air bubbles from flowcell
• Rinse flowcell
• Drain the reagent from the reaction chamber
• Drain the reagent from the RBC isolation chamber
• Drain the pneumatic trap chamber
• View the maintenance log and document (daily, monthly/ yearly as needed, engineer’s preventive maintenance)
• Locate the troubleshooting guide

8) Performing calibration and precision runs

• Validation or verification of accuracy and precision, and linearity (analytical measurement range, reportable range, normal range), as applicable
• Setting or establishing QC range
• Quality control plan
• Comparison study and peer review, if applicable
• Recording and documentation

9) Familiarity with the System limitation

• Sample interferences on WBC
• Sample interferences on RBC
• Sample interferences on HGB
• Sample interferences on HCT
• Sample interferences on PLT

1. Checklist for Erythrocyte Sedimentation Rate (ESR)
   1. Overview of the materials and instrumentation, 2. Procedure, 3. Disposition of materials and sample specimen

Specific Observation Guide

1) Overview of the materials and instrumentation

• Pipette tube, stopper, tube rack, and timer
• Type of specimen, sample stability, anticoagulation, and volume requirement

2) Procedure

• Demonstrate test performance on patient sample from preanalytical to postanalytical phase
• Calibration and quality control, if applicable
• Knowledge on the sources of error
• Record/ documentation and storage of worksheet result
• Verification and reporting of result into electronic health record

3) Disposition of materials and sample specimen

• Used pipette tube and stopper
• Specimen sample
• Maintenance of non-consumable tools i.e. rack, timer

1. Checklist for Peripheral Blood Smear (Blood Film)
   1. Principle of Wright’s Stain and expected color of cells, parts, and inclusions, 2. Demonstrate proper reading and interpretation of blood film on a patient sample from preanalytical to postanalytical phase

Specific Observation Guide

1) Principle of Wright’s Stain and expected color of cells, parts, and inclusions

• Preparation of stain and quality control procedure
• Maintenance of staining reagents
• Demonstrate performance of making a good quality blood film
• Number of smears to make according to protocol

2) Demonstrate proper reading and interpretation of blood film on a patient sample from pre­analytical to postanalytical phase

• Order request and reflex criteria
• Microscopy procedure and use of proper lenses or objectives
• Identification of normal and abnormal cells and inclusions
• Working sheet recording
• Calculation, if any
• Consulting, referring or reviewing procedure
• Verification (official reporting) of results into patient’s electronic health record
• Proper disposition and storage of smears and worksheets
• Microscope cleaning and maintenance

1. Checklist for Coagulation
   1. Instrument’s start-up procedure, 2. Preparation of reagents and loading inside the machine, 3. Demonstrate test performance on patient sample from preanalytical to postanalytical phase, 4. Maintenance and troubleshooting, 5. Performing calibration and precision runs, 6. Familiarity with the System limitation

Specific Observation Guide

1) Instrument’s start­up procedure

• Locate, turn on/off power switch of the machine
• Locate Front panel, Right front door, Cuvette bin drawer, Product drawer, Sample Drawer, Left front door and barcode reader. Pipetting head equipped with three needles. Cap piercing needle for sample. STA Cleaner solution container, Used liquid container, Cuvette roll drawer, Rinsing wells.
• Switch monitor on. Identify the software icon. Knows the test panel menu and the different tabs and short cut icons.
• Load a new roll of cuvettes and changing the disposal bag.

2) Preparation of reagents and loading inside the machine

• Demonstrate performance on preparation of reagents -dilution, aliquoting, mixing, etc..
• Loading washing solution and discarding used liquid container
• Demonstrate performance on  QC, and documentation
• Recording and documentation

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

• Specimen inspection and stability, preparation, and logging/ tracking
• Processing the specimen, loading in the machine
• Receiving and printing result
• Understanding abnormal flags
• Validating result, notification of critical values, and verification of result into eHR
• Documentation and filing records
• Proper disposition of used reagents, materials, and patient specimens including storing requirements if needed

4) Maintenance and troubleshooting

• Daily maintenance (cleaning the piercing needle, drying the product drawer)
• Weekly maintenance (decontaminating the stirring bar, washing the wells and needle purge, preparation of decontaminating solution, shutdown and startup)
• Installing new printer paper
• Performing cleaning
• Removing waste
• Locating troubleshooting guide and what to do when error or alarm is encountered
• Recording and documentation

5) Performing calibration and precision runs

• Validation or verification of accuracy and precision, and linearity (analytical measurement range, reportable range, normal range), as applicable
• Setting or establishing QC range
• Quality control plan
• Comparison study and peer review, if applicable
• Recording and documentation

6) Familiarity with the System limitation

• Sample interferences and what to do if encountered
• What to do if sample is not coagulating within usual reportable time frame

1. Checklist for Body Fluids Analysis
   1. Overview of the materials and instrumentation, 2. Procedure for serous body fluid, CSF, synovial, and seminal fluid, 3. Disposition of materials and sample specimen

Specific Observation Guide

1) Overview of the materials and instrumentation

• Pipettes, tubes, counting chamber, petri dish, gauze, diluting fluid, timer, and etc..
• Type of specimen, sample stability, anticoagulation if needed and volume requirement
• Preparation of stain and quality control procedure
• Maintenance of staining reagents
• Demonstrate performance of making a good quality smear
• Number of smears to make according to protocol

2) Procedure for serous body fluid, CSF, synovial, and seminal fluid

• Demonstrate test performance on patient sample from preanalytical to postanalytical phase (serous fluid, CSF, synovial, and seminal)
• Calibration and quality control, if applicable
• Knowledge on the sources of error
• Macroscopic examination and physical properties or parameters
• Microscopy procedure, cell counting, and use of proper lenses or objectives
• Identification of normal and abnormal cells and inclusions
• Working sheet recording
• Calculation, if any
• Consulting, referring or reviewing procedure
• Verification (official reporting) of results into patient’s electronic health record
• Record-keeping and storage of smears for each type of body fluid
• Protocol for spermatozoa detection (forensic investigation), chain of custody, and storage of smear (evidence)

3) 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

1. Checklist for Urinalysis
   1. Overview of the materials and instrumentation, 2. Instrument’s startup procedure, 3. Calibration and Quality Control, 4. Demonstrate test performance on patient sample from preanalytical to postanalytical phase, 5. Maintenance and troubleshooting, 6. Disposition of materials and sample specimen

Specific Observation Guide

1) Overview of the materials and instrumentation

• Pipettes, tubes, centrifuge, dipstick instrument, counting chamber, and etc..
• Type of specimen, sample stability, and volume requirement
• Staining reagents if applicable
• Demonstrate performance of making a good quality smear

2) Instrument’s start­up procedure

• Locate power on and off
• Familiarity with the screen display and buttons

3) Calibration and Quality Control

• Preparation of materials for both routine urinalysis and urine  pregnancy test
• Calibration and QC for centrifuge, urinalysis instrument, and pregnancy test, as applicable
• Quality control plan
• Documentation
• Maintenance of non-consumable tools i.e. rack, timer, counting chamber

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

• Specimen collection/inspection, stability, preparation, and logging/ tracking
• Processing the specimen
• Receiving and printing result
• Demonstrate pregnancy test performance
• Knowledge on the sources of error and limitations
• Macroscopic examination and physical properties or parameters
• Microscopy procedure, cell counting, and use of proper lenses or objectives
• Identification of normal and abnormal cells, cast, crystals and other inclusions
• Validating and verification of result into eHR
• Documentation and filing records

5) Maintenance and troubleshooting

• Daily cleaning and other periodic maintenance
• Changing printing roll paper
• Microscope and centrifuge maintenance
• Locate the troubleshooting guide
• Documentation of maintenance

6) Disposition of materials and sample specimen

• Used pipette, tubes, pregnancy kit, urine dipstick, slides, and other consumables
• Specimen sample for routine and for other test procedure i.e. culture, chemistry
• Maintenance of non-consumable tools i.e. rack, timer

1. Checklist for OPTI Medical CCA-TS2 Blood Gas Analyzer
   1. Familiarization, instrument’s startup procedure and maintenance inspection, 2. Knowledge of basic system software, 3. Manage reagents materials and consumables, 4. Demonstrate performance of calibration and QC, 5. Demonstrate skills on handling patient samples, running the test and appropriate storage if applicable, 6. Demonstrate skills on handling and running proficiency test (PT) samples, 7. Documentation and recording, 8. Disposition of materials and sample specimen

Specific Observation Guide

1) Familiarization,  instrument’s start­up procedure and maintenance inspection

• Locate and know how turn on/off power switch of the machine (electrical connector and battery)
• Locate and know how to open/close Sample Measurement Chamber
• Locate gas bottle part and know how to change
• Locate bar code scanner and know how it works
• Locate peristaltic pump
• Know how to use touch screen display
• Know the consumables (OPTI sensor cassette, SRC and OPTI Check Controls, Gas Bottle, Thermal paper, tHB Calibration cassette, Peristaltic pump cartridge and Gas Rubber I/O Port)
• Recognize the function and operation of the system 
• Demonstrate tech’s periodic maintenance of the instrument and recording

2) Knowledge of basic system software

• Icons on the screen display and access to menus (Data Manager, QC Manager, and System Manager) and how to setup QC, Security, Date and Time, Maintenance and Patient Information Entry
• Locating or retrieving result history and printing or reprinting reports

3) Manage reagents materials and consumables

• Know how to receive, inspect, log lot and expiry date, and store properly

4) Demonstrate performance of calibration and QC

• Knowledge of verification of accuracy, precision and linearity (analytical measurement range, reportable range, normal range)
• Perform calibration and QC
• Interpretation of QC result and corrective action based on design QC plan
• Performance of comparison study if using multiple instruments

5) Demonstrate skills on handling patient samples, running the test and appropriate storage if applicable

• Safe handling of specimens and organization
• Perform actual patient sample testing
• Knowledge in the preservation of the sample
• Analyzing, validating results and appropriately verifying into patient electronic records
• Troubleshooting on error flag/s if encountered

6) Demonstrate skills on handling and running proficiency test (PT) samples

• Safe handling of PT samples and following instructions before testing
• Knowledge of the purpose of performing PT test surveys (do’s and don’ts)
• Perform actual PT sample testing
• Know how to do the recording and signing attestation
• Know how to do resulting or reporting into CAP website
• Knowledge in the evaluation of the PT survey’s result (what to do if unacceptable)

7) Documentation and recording

• Recording critical results, specimen problem encountered, and any occurrences affecting standard patient care based on protocol
• Documentation of calibration and QC including daily monitoring, corrective actions, change of bottle and lot number, and manufacturer’s update on the analyzer, reagents, and parameter  setup
• Recording of preventive maintenance of the analyzer and other equipment use in the maintenance of stability of reagents and sample test material as applicable

8) Disposition of materials and sample specimen

• Used syringe, needles, tubes and stopper, expired reagents, empty bottles, etc..
• Specimen sample

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 (%)
   96

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

1. Name of Employee
   Ana Maria Carrillo MT H (ASCPi)cm TECHNICAL SUPERVISOR
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
   Ana Jane Bontia MD Laboratory Director