1. Name
   First Name : Genesis
   Last Name : Garvez
2. Date
   10/10/2023
3. Type of Assessment
   6 Months

Objectives

• To demonstrate knowledge and competency on pretransfusion testing system from preanalytical to to post­analytical phase
• To demonstrate knowledge and competency on the performance of Coombs Test and other immunohematology test to identify presence of specific antigens or antibodies
• To demonstrate skills in the handling of reagents/chemicals, sample specimens and other equipment related to the test procedure
• To demonstrate problem­-solving skills on instrumentation, calibration and QC, and verification or validation of patient or blind sample results particularly on immunohematological discrepancies
• To be able to follow guidelines on blood bank procedures on receiving specimens, recording and labeling, receiving and storing blood units, reserving and releasing blood unit, maintenance and monitoring of equipment, blood transfusion reaction, donor selection and screening, donor bleeding and therapeutic phlebotomy, emergency processes, and other special or as needed immunohematological procedures

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

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

1. Checklist for Instrumentations and Blood Bank equipment (refrigerator, incubator, shaker, centrifuge, scopes and lenses, saline washer, and other related equipment)
   1. Instrument’s or equipment start-up procedure, 2. Process of calibration and QC as applicable, 3. Perform maintenance of instruments and associated equipment

Specific Observation Guide

1) Instrument’s or equipment start­up procedure

• Locate, turn on/off power switches
• Enumerate major system components/parts
• Water supply requirements as applicable
• Operating speed, temperature and humidity as applicable
• Alarm setting as applicable
• Knowledge of trouble-shooting process

2) Process of calibration and QC as applicable

• Demonstrate calibration verification of temperature (refrigeration and incubator)
• Calibration verification of speed (centrifuge)
• Demonstrate process of QC of reagents in blood bank as applicable
• Interpretation of QC result and corrective action based on design rule protocol
• Know what the quality control plan is

3) Perform maintenance of instruments and associated equipment

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

1. Checklist for immunohematology procedures
   1. Demonstrate process, logging, and documentation of receipt of reagents and blood units, 2. Demonstrate testing patient sample from pre-analytical to post-analytical phase, 3. Describe blood transfusion reaction work procedures, 5. Show documentation and recording process, 6. Describe disposition of materials and sample specimen

Specific Observation Guide

1) Demonstrate process, logging, and documentation of receipt of  reagents and blood units

• Assessing the reagents or kits and blood units, recording lot/batch number and expiry date and proper storage
• Show records or documentation

2) Demonstrate testing patient sample from pre­-analytical to post-analytical phase

• Receiving patient sample, logging/tracking, labeling, locating patient or donor/recipient previous records, assessing specimen stability and rejection criteria if any
• Enumerate materials needed for the test procedure
• Demonstrate actual procedure on ABO and Rh typing, antibody screening and specific antibody identification as applicable, complete cross-matching and Coombs test
• Demonstrate other blood bank procedure such as in pediatric transfusion (volume titration), emergency release of unscreened or incomplete screened blood units, and other non-routine or special procedure as applicable
• Demonstrate reading, interpretation of result, recording and  documentation
• Enumerate limitations or factors that may interfere and may  cause false test results
• Demonstrate the process of notification to the wards when the  blood unit is ready
• Notification of critical results, flagging if any, and result reporting into eHR
• Demonstrate the process of releasing the blood unit for  transfusion
• Demonstrate the process of receiving back blood unit from the  wards (empty, used, or unopened unit)
• Recording and storing process of the reports

3) Describe blood transfusion reaction work procedures

• Receiving report and the blood unit from the ward when transfusion reaction occurs
• Procedure investigation of the transfusion reaction (forms, test, attestation)
• Notifying blood bank physician or laboratory director, American Red Cross or Federal Agency if applicable
• Storing process of the documentation

4) Describe donors and therapeutic phlebotomy work process

• Knowledge on selecting and screening donors procedure
• Demonstrate phlebotomy or blood collection for donors or patients
• Donor searching and communications
• Know what to do on emergency, notifying physician or referring action

5) Show documentation and recording process

• Recording critical results, specimen problem encountered, and  any occurrences or incidents affecting standard patient care based on protocol

6) Describe disposition of materials and sample specimen

• Used pipette, tubes and stopper, expired or used reagents, empty bottles, slides
• Specimen sample and storing time frame
• Maintenance of non-consumable tools i.e. rack, timer, incubator, microscopes, etc..

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 testing personnel. Typing my name below will constitute validity of this acknowledgment.

1. Name of Employee
   Genesis Garvez, 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 – Technical Supervisor (Delegate)