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Practical Examination - Direct Observation Checklist

(For Use while observing Asante Rapid HIV-1 Recency Assay testing)

______________________________________ _______________________________________________
Name of Tester Name of Assessor

_____________________________________________________ _____________/__________________/_____________________
Name/Code of Test Site Date of Direct Observation (DD/MM/YY)

Scoring Criteria
Step performed correctly, 1 point; Step incorrectly performed or skipped, 0 point

Quality Standard Element (QSE) to be observed Expected

Score Comments
(Assessor to score each step observed) Score
Followed all safety precautions as per SOP (lab coat, apron,
1 1
gloves, etc.…)
Working area is clean and organized
Note: Free of clutter with all the supplies properly assembled,
2 including Job Aide, Timer, regular pen, marker pen, benchtop 1
waste bag and holder, paper towel, test strip, buffer tube and
holder, sample device (loop), testing Logbook, and samples )
The samples are verified
3 Note: Verify that the plasma tubes are properly labelled, and 1
they are the correct samples in good condition)
Check and record expiry date of test kits on the kit package
4* Note: Verify if the HIV RT kit lot is within the expiration date. If 1
it has expired; stop the examination
5 Write sample ID on buffer tube 1
6 Uncapped buffer tube is placed upright on proper holder 1
7 Set timer correctly before proceeding with testing (20 min) 1
Transfer sample using the correct sample collection device
8 provided by test kit (loop) 1
Note: Verify that loopful plasma is collected
Sample is well mixed into sample buffer by agitating or stirring
9 1
the loop in buffer
The integrity of test strip is verified before opening pouch
10 Note: Verify there is no damage of pouch or strip and 1
desiccant pack is present inside pouch.
Handle test strip properly while placing it into buffer tube
(optional: properly label strip with sample ID on the white
end)
11 1
Note: Only handle the white end of strip without touching
anywhere else. Strip is placed into buffer with arrow pointing
down (red end inside buffer)
12 Start the time immediately once strip is placed in buffer tube 1
13 Record test result ONLY at the end of waiting time without 1
delay
Note: Record result on Recency Testing Logbook (QC Testing

Provider Direct Observation Checklist Page 1 of 2

 Quality Standard Element (QSE) to be observed Expected
Score Comments
(Assessor to score each step observed) Score
Logbook for QC testing), immediately after 20min. One strip at
a time: blot, record, discard. Tick the present line.
14 Refer to Job Aides while performing Test 1
Properly dispose of waste into benchtop biohazard bag
15 through testing (Lancet should be disposed of in sharp 1
container if applicable)
Record results in Recency Testing Logbook (or QC Testing
16 Logbook) correctly (All required information is correctly 1
captured)
Disinfect and clean workspace at the end of testing and
17 dispose of wastes in correct waste bins (gloves, wrappers, 1
benchtop waste. etc.)
Total Points 17
*Stop the examination if Steps 4 is not followed. Stop examination if major safety measures are not implemented

Direct Observation score: (…………/17)* 100= ……………. %

[Indicate the score obtained for the direct observation by assessor]
For example if the tester got all of the direct observation questions correct, then score 100%.

Final Practical Examination: ð Pass ð Fail

Overall Comments:
(Document whether the tester demonstrated competency and indicate areas of improvement if any)

Remedial Action (if applicable):

Tester Signature: ___________________________

Assessor Signature: _________________________

Provider Direct Observation Checklist Page 2 of 2