Competency Based

Certification for HIV

Rapid Testing Personnel

Participant Workbook
 COMPTENCY BASED
CERTIFICATION FOR HIV RAPID
TESTTING PERONNEL
A Skills Training Programme to Assess HIV
Testing Personnel
Table of Contents

Assessor of HIV-RT Personnel: Training Overview ............................................................. 1

Purpose of HIV-RT Competency Certification .................................................................... 7

Requirements to be a Certified Assessors ....................................................................... 15

Knowledge, Skills, Attitude, and Habits of Competent Assessors ..................................... 21

Competency Assessment for Testers: Tools and Scoring .................................................. 33

Electronic Tools: How to Download and Use the Tester Certification App ........................ 39

Being Prepared to Conduct Tester Competency Assessments at Site Visits ....………………. 47

Appendix.……………………………………………………………………………………………………………………. 53
HIV RAPID TESTING PERSONNEL COMPETENCY ASSESSMENT & CERTIFICATION

Assessor of HIV‐RT Personnel Competency:

Training Overview

Facilitators Contact Information

Makhosazana Makhanya Robert Molale

ivo9@cdc.gov robert.molale@nhls.ac.za

Paulah Wheeler Dumisani Mhlongo

obj7@cdc.gov dumisani.mhlongo@nhls.ac.za

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 Goal of the Training

To develop a pool of competent assessors to

assess HIV‐RT personnel competency in
support of the DoH’s initiative to roll‐out
personnel certification; ensuring qualified,
competent testers are performing HIV‐RT.

Training Objectives
Upon successful completion of this workshop, participants will be able
to:
• Identify attributes and competencies of an assessor of HIV‐RT
personnel competency.
• Develop an in‐depth understanding of the personnel competency
assessment tools (written assessment, practical observation, App)
• Demonstrate the required skills/knowledge to perform effective
personnel competency assessments.
• Serve as assessors of HIV‐RT personnel competency.

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 Rationale for Tester Certification

SPI‐RT Assessment Areas % Achieved

Percentage scored 82%
Personnel Training and Certification 46%
Physical Facility 93%
Safety 92%
Pre/testing Phase 87%
Testing Phase 83%
Post/testing Phase & Documentation 86%
External Quality Audit 87%

Tester Certification Overview

Theory and
practical
testing areas
Training of score
Assessors for HIV‐ Written +
RT personnel Exam
Final
competency
performance
score Manual
entry of
competency
results in
Training Program: central
Panel testing database
• 2 days didactic sections final status
(app)
score
(competency assessment +
tools, knowledge and skills Practical Direct
exam Observation
required for assessment, score
providing feedback, etc.)
• 1‐2 days onsite mentorship

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 Agenda Schedule
• Facilitators will present a topic followed by an activity which allows
participants the opportunity to practice using the information in
small / large groups

• There will be one Tea Break and a Lunch Break on each day of in‐
class training

• There will be dedicated time for questions and comments for each
topic. Extra discussion time will occur at the end of the day for
subjects in the “Parking Lot”.

Housekeeping & Expectations

Group decides the ground rules and their individual
expectations for this workshop!

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 Ground Rules
• Show up and CHOOSE to be present
• Silence cell phones
• Participate 100%
• Respect each others’ thinking and value their contributions
• Staying on schedule is everyone’s responsibility; honor time limits
• With transformation, expect anxiety
• Stay open to new ways of doing things
• Success depends on participation – share ideas, ask questions,
draw others out

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Notes
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HIV RAPID TESTING PERSONNEL COMPETENCY ASSESSMENT &
CERTIFICATION

Purpose of HIV-RT Personnel

Competency Certification
RTCQI PROGRAM

BACKGROUND

• In 2006, the HIV Rapid Testing Quality Assurance was

approved

• TQMS, RTQII and eventually RTCQI program introduced in SA

to facilitate the implementation of best practices and
innovative strategies to strengthen the quality of HIV
Counseling and Testing Services (HTS) provided in health care
facilities

• The NDOH, PDOH, NICD, NHLS and DSPs cooperated to

establish the community of HIV rapid test QA networks, while
helping ensure national coverage of HTS

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BACKGROUND

• In 2015, following RTCQI implementation, the outcomes of the baseline

assessment led to various remedial interventions

• These interventions included the integration of CLI and RTCQI programs,

decentralization of technical support to provincial HIV Prevention
Directorates and incorporating CLI/RTCQI program into DSPs workplans
for continuous training and mentoring

BACKGROUND

• Need to ensure every

individual seeking HIV
testing receives an
accurate result
• However, previous
quality measures and
funding commitments
were not sufficient to
ensure the accuracy of
testing
Fewer than
• Innovative strategies
7.7 million 240,000
were key to addressing
people on new HIV
these quality assurance
treatment infections
gaps
annually

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WHO CONTRIBUTIONS TO QA

• WHO-developed handbook
aimed to assist with
addressing the weaknesses
identified in HIV testing
programs

• In addition, it assisted
countries in adhering to a new
set of minimum standards to
promote quality assurance
and quality improvement
processes

BACKGROUND: RTCQI PROGRAMME

To expand upon
To ensure the quality
current in-country
GOALS: of HIV rapid testing
HIV RT quality
nationally
improvement work

5 KEY ACTION AREAS:

Proficiency
Policy Human Standardized Post Market
Testing
Engagement Resources Register Surveillance
Programs

NDOH adopted RTCQI as policy and is seeking to standardise the quality of testing
across the board.

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SPI-RT ASSESEMENT 2019

SPI‐RT Assessment Areas % Achieved

Percentage scored 82%
Personnel Training and Certification 46%
Physical Facility 93%
Safety 92%
Pre/testing Phase 87%
Testing Phase 83%
Post/testing Phase & Documentation 86%
External Quality Audit 87%

GAME CHANGERS

RTCQI training to all

implementers

Robust rollout of personnel certification

program nationwide

Continuous monitoring of QA through the use of the SPI-RT checklist

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HIV RT Personnel Competency
Assessment & Certification Workshop

PURPOSE

This training program aims to develop a pool of

competent assessors for HIV-RT personnel
competency…

…in support of the country’s initiative to roll-out

personnel certification; ensuring qualified, competent
testers are performing HIV RT.

HIV RT Personnel Competency

Assessment & Certification Workshop

OBJECTIVES

• To identify attributes and competencies of an assessor of HIV-RT personnel

competency

• To develop an in-depth understanding of the personnel competency

assessment tools

• To demonstrate the required skills/knowledge to perform effective

personnel competency assessments

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HIV RT Personnel Competency
Assessment & Certification Workshop

EXPECTED OUTCOMES

• There will be a pool of competent assessors identified and certified for the
national certification program

• Competency assessments will be conducted for testing personnel at HTS sites

• Competency data will be reviewed and analyzed in order to develop an

improvement plan

Personnel Training and Certification Process

Demonstrate Initial & Continued

Competency of Testing Personnel

Certify & Re-Certify Testing Personnel

Perform Accurate & Reliable Testing

Results

Ensure Accurate & Reliable Diagnosis

& Treatment

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Activity: Why?

He who has a “why” can endure any “how.”

- Friedrich Nietzsche

What do you currently do to help improve the

performance of HIV testers and/or the quality
of HIV testing?

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Notes
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HIV RAPID TESTING PERSONNEL COMPETENCY ASSESSMENT & CERTIFICATION

Requirements to be a
Certified Assessor

How trainees will be deemed competent and

Certified as Assessors:

1. Complete the training program

2. Pass written exam (pre- and post-test; post-test score must be

>80%)

3. Demonstrate ability to successfully conduct competency

assessment process (Introduction, Observation, Scoring, and
Feedback) during Mock Assessment and Post-Training
Observation

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 Mock Assessment process flow
Facilitator

1
Introductions and
Instructions
Assessor from Group Tester from Group

2a
2b
Complete Practical Perform Practical
Observation form Exam/PT

Remaining workshop
participants 2c
3 Complete PT
Score written Results form
exam
4
Give feedback
to tester

Mock Assessment process

Reflective Practice

Facilitators will provide feedback to

trainees. As a group, we will discuss: Facilitator Assessor and Tester

• Description – What happened?

• Feelings – What were you thinking
and feeling?
• Evaluation: What was good and bad
about the experience?
• Analysis – What sense can you
make of the experience?
• Conclusion – What else could you
have done? Remaining workshop
• Action Plan – Next time, what will participants
you do?

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 Practical Observation Tools

1. Direct Observation 2. PT Results Form

Checklist (paper and app)

Criteria for success in conducting the competency

assessment process

What knowledge, skills, and attitudes would make an assessor

successful in conducting the HIV Rapid Testing Personnel
Competency Assessment?

Activity:
Write down all the knowledge, skills, or attitudes for success that you
can think of on sticky notes (one per sticky).

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 Criteria for success in conducting the competency
assessment process

Knowledge:
The condition of being aware of something. It includes the recall,
recognition, understanding, application, and evaluation of facts,
patterns, and concepts.

Skills:
Skills relate to the ability to physically perform an activity or task.
It includes physical movement, coordination, and the application
of knowledge.

Attitudes:
A way of thinking or feeling about someone or something. It
includes the manner in which a person may deal with things
emotionally, and is reflected in a person’s behavior.

Criteria for success in conducting the competency

assessment process
Assessor Attributes and Performance
Introduction given (of both self and topic)
Comfortable using direct observation checklist, paper or app version
Assistance and guidance to the tester when necessary
Feedback/conclusion/summarization to tester
Organization and preparedness: do they have all components of the Site Visit Documents Package for Assessors

Time management
Subject matter knowledge/command on subject/topic
Communication (language, choice of words, spoke clearly and easily understood)
Assessor Attitude: Confident, ethical, professional

Professionalism exhibited throughout assessment (appropriate dress, not using phone during assessment)

Accurate scoring of tester

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 Post-Training

Upon completion of this workshop:

Participants must complete an assessment under observation
by training facilitators and be deemed a competent assessor

Thank you!

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Notes
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HIV RAPID TESTING PERSONNEL COMPETENCY ASSESSMENT & CERTIFICATION

Knowledge, Attitude, Skills, and Habits

of Competent Assessors

Learning Objectives

At the end of this session, participants will be able to:

• Describe the knowledge, attitude, skills, and habits required
to be a successful assessor of HIV tester competency
• Distinguish between acceptable and unacceptable practices
when conducting a tester competency assessment
• Understand how to continue to improve as an assessor using
reflective practice

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 Do you have KASH?

= Individual Performance

Knowledge Required to be an Assessor

Knowledge is the condition of being aware of something.

It consists of facts, concepts, as well as the
understanding and application of information.

Knowledge is acquired through education, training, and

experience.

Knowledge of facts and concepts form the foundation for

the ability to apply the skills to perform a specific task.

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Knowledge Required to be an Assessor

A competent assessor must:

• Have a general knowledge of quality control & quality assurance
• Possess technical knowledge related to the current national HIV-RT
algorithm
• Understand the tester competency assessment tools, scoring, and
corrective action (remediation)

Assessor’s Attitude

Attitude is a way of thinking or feeling about someone or

something.
A person’s attitude affects feelings, values, appreciation, and
motivation towards something.
If a person has a positive attitude towards a topic, they will
likely be more motivated to learn about that topic and develop
a skill.

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Assessor’s Attitude

Independent Decisive

Unbiased and impartial Ethical

Motivated to do a Concerned about Passionate about

good job quality of HIV RT reducing HIV burden

Skills Required to be an Assessor

Skills relate to the ability to physically perform an activity or task.
Competency and proficiency in the execution of skills requires training
and practice.
Usually a person acquires the knowledge of how to perform a task and
then begins to physically perform the task.

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Skills Required to be an Assessor

• Observant and detail-oriented • Diplomacy and conflict resolution

• Proficiency in providing instructions • Communication
and guidance for the assessment • Leadership
• Proficiency in scoring the tester using • Providing positive reinforcement and
the Direct Observation Checklist paper constructive criticism
form and app; and scoring the written • Professionalism and respectfulness
exam • Problem-solving
• Patience
• Empathy
• Ability to build relationships and trust

Skills Required to be an Assessor: Communication

Activity
How well do you
Mirroring communicate?

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Skills Required to be an Assessor: Communication

Good communication starts with listening.

• What is said may not be what is heard
– Choose your words carefully
– Observe how they are received
• What is heard may not be understood
– Engage in discussion to ensure understanding
• What is understood may not be accepted
– The HIV tester may be defensive during the tester competency
assessment

Skills Required to be an Assessor: Communication

80% of Communication is Non-Verbal

Body Language
• Posture
• Eye contact
• Arm position

Facial Expression
• Eyes
• Mouth

Overall attentiveness

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“Communication is culture and
culture is communication”

Habits of a Successful Assessor

Habits are behaviors that are repeatedly and consistently done.

Excellent performance is a result of doing the appropriate and

most effective actions repeatedly. Skills practiced correctly over
and over develop into habits.

A habit is not something a person learns, but rather it is

something that they create.

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Habits of a Successful Assessor
Be responsible.

Assessors must:
• Have contacted all relevant people in advance of the site
visit to ensure that they are aware of and approve the
assessment date
• Understand the assessment process and be able to provide
clear instructions to the tester
• Bring all necessary materials and forms to the site visit
• Manage time
• Be prepared for questions

Habits of a Successful Assessor

Be professional.

Assessors must be professional:

• Make intelligent, authoritative decisions
• Control conflict between others
• Effectively assess and solve problems
• Attitude and behaviors: Non-judgmental & respectful
• Communication: Address issues not personalities
• Your ethical positions – trustworthy
• Demonstrate investment in improving tester competency by
offering constructive feedback and remediation planning

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 Habits of a Successful Assessor

Be observant.
Assessors must:
• Interpret and apply the appropriate direct observation
checklist items to different tester competency assessment
situations
• Collect relevant, reliable, factual evidence from observing
tester and surroundings
• Be very detail focused
• Exercise sound judgment & analytical skills

Why are these skills, abilities, and actions

important?

= Individual Performance

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 Assessor Do’s & Don’ts
DO:
• Give compliments when deserved
• Encourage staff to achieve competency objectives
• Be fair to all
• Use respectful and tactful language to give feedback
• Remember that quality is generally about
systems/protocols/habits and not personalities
• Remember that tester competency assessments are to
ensure improved reliability and better patient care

Assessor Do’s & Don’ts

DON’T:
• Focus on insignificant issues
• Intimidate and ‘talk down’ to staff
• Try to find only ‘what’s wrong’ and ignore ‘what’s right’
• Stimulate conflict
• Be prescriptive and dogmatic (i.e. only your view counts)
• Give unclear feedback
• Base observations on unvalidated information

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Assessors Practice Reflection to Continuously Improve

Description
What
happened
Feelings
Action Plan
What were
If it arose you thinking
again what and feeling
would you do

Conclusion Evaluation
What was
What else good
could you and bad
have done Analysis about the
What sense experience
can you make
of the experience

Continuously learning from experience…..

Assessment Role Play

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Notes
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HIV RAPID TESTING PERSONNEL COMPETENCY ASSESSMENT &
CERTIFICATION

Competency Assessment for

Testers: Tools and Scoring

Learning Objectives

• Describe the components and tools of a

HIV-RT personnel competency assessment

• Describe how the final assessment score is

calculated and how an assessor determines
if a tester is deemed competent or needs
further training

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 Competency Assessment Components

Introduction
• Assessor and topic/purpose introduced

Practical Observation
• PT Results form (paper, but enter score into app)
• Observation Checklist (paper and app)
Competency • Assistance and guidance only when necessary
Assessment
Written Assessment
• Giving instructions for the written exam
• Enter final scores of each section into the app
Feedback
• Summary, assessment conclusions, remediation
plan

Three Factors…

1. Direct Observation
– 90% or higher required to pass
2. PT Results
– 100% required to pass
3. Written Assessment
– 80% required to pass

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 Direct Observation Score

– x/22 points *100%

– Must get 90% or higher to pass

Practical Observation: Observation Form

Review this form:

Direct Observation Checklist

NOTE:
This form is also in
the app!

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 Practical Observation: PT Results Form

Review this form:

HIV Rapid Testing Result Form

PT Results

– Test Interpretation: 1 point for each sample, based on 6 samples =

6 points
– Final Result: 1 point for each correct result, based on 6 samples =
6 points
– X/12 * 100% = ?
– Must get 100% to pass

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Written Exam

• Must get 80% or higher

to pass (“Satisfactory”)
• X / 25 points * 100
• Must also record number
of points per section

Review this form:

Written Examination Results Sheet

Feedback
• Use the Summary and Remediation
Plan form to provide feedback to the
in-charge

• To be completed for ALL testers on one

form (not one form per tester) –
protect confidentiality of tester
performance
– Individual tester performance can
be found in your app

• Make copy or take a picture for your

records, leave original with in-charge

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Notes
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HIV RAPID TESTING PERSONNEL COMPETENCY ASSESSMENT & CERTIFICATION

Electronic Tools: How to Download

and use the Certification App

Learning Objectives

• Demonstrate how to Download the Certification App

• Use App to enter written exam score

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 DOWNLOAD PROCESS
https://seadsolutions.co.za/apk/seadcollect_v_2.apk
 Please follow the above link and download the application
from our SEAD Solutions platform and follow below step:

SEAD COLLECT SETUP

Step 1:
Application Main Menu
 The application consists of 6 tabs Fill Blank Form, Edit Saved Form, Send
Finalized Form, View Sent Form, Get Blank Form and Delete Saved Form, the
below refers:

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 SEAD COLLECT SETUP
Step 2
Logging in and Connecting to Server
 Select the submenu item option in the right‐hand corner of the application.
 A Drop‐down menu will display, select the General Setting option.
 Select the Server option in General Settings.
 Please type in the Username and Password credentials provided to you by the SEAD
team.
 Password: dog4desk

SEAD COLLECT SETUP

Step 2 (Continued…)

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 SEAD COLLECT SETUP
Step 2 (Continued…)

SEAD COLLECT SETUP

Step 3
Form Management Settings
 Select Form Management
 Select Constraint Processing
 Ensure constraint processing behaviour is “Validate upon forward swipe”

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 SEAD COLLECT SETUP
Step 4
User and Device identity (Anonymous Submission turn off)
 Select menu option
 Select User and device identity
 Select Form Metadata 4.1. Select Username and enter your username provided.
 Select Email and enter your email address

FORM INSTALLATION
Installing the form on your application.
 Select the Get Blank Form option in the Main Menu.
 The Application will connect automatically to the server.
 “Get Blank Form” screen will display with preloaded listed forms marked with blue boxes. Clear all boxes by selecting
the “Clear All” option in the bottom left corner.
 Double check that all the boxes are unticked by scrolling “Up” and “Down”.
 Select the form you are instructed to do your assessments by management a blue ticked boxed should appear next to
the form.
 Select the “Get Selected” option in the bottom right corner
 The application will connect to the server to get the form selected. The red circulation indicates the form being
loaded to the application.
 Select the “OK” option when the Download Result screen appears, the application will navigate to the Main Menu.

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 FORM INSTALLATION
Installing the form (Continued…)

GETTING STARTED
Getting Started
 Select the “Fill Blank Form” option in the main menu.
 Select the form downloaded in the Fill Blank Form, the form will load and take you to
the first page of the form application.
 Your form is now ready to be used.

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 FIRST POINT OF CONTACT
Contact details

Activity: Taking the Written Exam

• All trainees will now take the written assessments which will
be given to testers
• The purpose of this activity is the following:
– All trainees should understand what the testers are being tested on
– Any problems with the written exams should be circled and reported
to facilitators
– Practice scoring and entering tester exam score on the App

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Notes
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HIV RAPID TESTING PERSONNEL COMPETENCY ASSESSMENT & CERTIFICATION

Being Prepared for Conducting

Competency Assessments
at the Site Visit

Learning Objectives

• Describe the items and tools one must bring to an HIV-RT

personnel competency assessment (site visit)
• Understand the appropriate way to dress at the site
• Develop an introduction script

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 Preparation
• Site selection
• Schedule an appointment with sites
– Contact the facility and confirm the date
– Find out how many testers per site
– Check back with facility 1-2 days before visit
• Procure PT panels

How will assessors procure PT panels?

Tools

• Use this form ->

• Bring this form
with you to every
site visit, review
and make sure
you have all tools
listed on this
form!

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 True or False?

Although the assessor can choose to use the paper form of

the Direct Observation Checklist, the assessor must enter
the scores of the practical observation and written
assessment into the app.

Feedback

• Use the Summary and Remediation

Plan to deliver feedback at the end of
the assessment
• Share and make copies of this form for
the in-charge
• To be filled out generally for findings
from assessments of all testers, not
one form per tester (individual tester
data is confidential and can be found
in the app)

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 What should you wear?

From your professional experience and your knowledge of the

community in which you will conduct site visits –

What is the appropriate and professional way to dress? Describe

clothing, shoes, style of hair, and anything else that is relevant.

Activity
Imagine it is your first time visiting a site to perform the HIV RT Personnel
Competency Assessment.

What will you say to the tester?

In groups, develop an introduction script.

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Notes
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52
 APPENDIX

A. Procedure for Administering Tester Competency Assessment (SOP)…page 55

B. Procedure for Remediating Tester Unsatisfactory Performance (SOP)…page 59

C. Site Visit Documents Package for Assessors…page 61

D. Introduction Script for Assessors…page 63

E. Direct Observation Checklist Form…page 65

F. Proficiency Testing Results Form…page 67

G. Written Examination Results Sheet…page 69

H. Summary and Remediation Plan…page 71

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54
 Procedure for Administering Tester Competency Assessment for HIV Rapid Testing
Written Assessment and Practical Assessment

Purpose: To describe how to properly administer both the written and practical assessments to assess tester
competency to perform HIV rapid tests in preparation for the national certification program.

Resources:
1. Tester Certification App (Tablet/Mobile Phone with Android OS)
2. Direct Observation Checklist Form
3. Written Assessment Results Sheet
4. Written Assessment Questions (versions #1 - #5)
5. Written Assessment Memorandums for each version
6. Practical Assessment – PT Sample Panel
7. Practical Assessment – PT Results Form
8. Introduction Script for Assessors

Assessor Criteria:
All assessors must have the minimum qualifications in order to administer tester competency assessment for
HIV rapid testing:

1. Successfully completed a nationally recognized tester competency assessment training or refresher

training within the last two years.
2. Completed a nationally recognized Rapid Test Continuous Quality Improvement (RTCQI) or refresher
training within the last two years.
3. Have knowledge of the three phases of HIV rapid testing, general safety practices, and biohazard waste
management.

Criteria for Individuals to be Assessed:

1. Performs HIV rapid testing: everyone who tests clients must be assessed.
2. Have completed a nationally recognized Rapid Test Continuous Quality Improvement (RTCQI) or
refresher training within the last two years.
o However, if the individual has not completed RTCQI training, they should still be assessed and
a plan for training should be made as part of the remediation process.

Note: Multiple number of testers in a facility can take the written assessment at the same time and, with prior
arrangement, take the written assessment or practical assessment alternatively at a different point in time.

Step Description Resources

1 Planning for the assessment visit: Plan the practical assessment by informing the • E-mail and phone
health facility, the person in-charge, and the testers. Agree on the date and time of the call to health
assessment. Follow up 1-2 days before the scheduled assessment to confirm the visit. facility leadership

Note: Based on the number of testers, the assessor needs to estimate the length of the
assessment and the most efficient procedure (i.e., number of rooms needed, when the
written assessment will be done).

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2 Introduction: The assessor will introduce to the OPM and individual testers the • Introduction
purpose of the assessment including: Script
• Goals and objectives of the assessment
• Components of the assessment
• How the tester will be scored
• General guidelines for the tester during assessment
• How the results for the assessment will be used

3 Registration: Registration is completed using the Tester Certification App and on the • Tester
top portion of the Written Assessment Results Sheet labeled Tester Information. Certification App
or TESTER
Note: Registration should be completed prior to administering the assessment. The INFORMATION
assessor will have to work with the facility management to ensure all testers have section of the
enrolled for competency assessment. The tester will fill out their information on the Written
Written Assessment Results Sheet. Next, they will follow the instructions on the sheet Assessment
to ensure they receive full credit for their assessment. Results Sheet

4 Conducting the Written Assessment: • Written

The assessor will give each tester two documents to complete the written assessment: Assessment
• Written Assessment Question Sheet Question Sheet
• Written Assessment Results Sheet (versions #1- #5)
• Written
Note: give different versions of the question sheet to different testers. Assessment
Results Sheet
The assessor will give instructions for completing the written assessment: • Written
1. The tester completes tester information on the written assessment results Assessment
sheet prior to beginning the assessment. Memorandum
2. The assessor should remind the testers not to write anything on the (for assessor only)
assessment question sheet.
3. The assessor should remind the testers not to communicate during the
assessment.
4. The assessor should remind the testers to read the questions carefully and
choose only ONE correct answer.
5. To complete the results sheet, the assessor should remind the testers to write
ONLY the letter corresponding to a selected answer e.g. D on the column ‘Your
Answer’
6. There is no time limit for completing the written assessment.
7. Once the assessment is completed, the tester will sign and date written
assessment results sheet before turning it to the assessor.
8. The assessor will collect both the QUESTION sheet and RESULTS sheet from
the testers.
9. The assessor will use the written assessment memorandum to mark the
testers’ answers. Note: each question with correct answer will receive ‘1’
point and incorrect answer ‘0’.
10. The assessor will indicate the correct answer in the shaded column ‘Correct
Answer’.

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 11. The assessor will tally and indicate the final percentage score obtained by the
tester and performance (satisfactory or unsatisfactory).
12. The tester performance is graded satisfactory if ≥ 80% or unsatisfactory if <
80% final score was obtained.
13. The assessor will sign and date the written assessment answer sheet.
14. The assessor will enter the score of the written assessment into the app.
15. If the tester is unsuccessful in written assessment, the tester should be given
another opportunity to write on the next available date.

5 Conducting the Practical Assessment • PT Sample Panel

To begin the process of practical assessment, the assessor must: • Direct
• Describe the objectives of the practical assessment Observation
• Instruct the tester on general process and guidelines for completing the Checklist (Form
practical assessment and App)
• PT Sample
Beginning the assessment process: Results Form for
1. The assessor will ask the tester if he or she is ready to begin the assessment. tester to
2. The assessor will provide the tester with the PT Sample Results Form and the complete
PT Sample Panel. • PT Sample
3. The assessor and tester will complete the top part the direct observation answer key (for
checklist (names and date of assessment and training) prior to beginning the
the assessor
assessment.
only)
4. The assessor will instruct the tester to proceed testing using their usual
procedure.
5. Using the direct observation checklist paper form or app, the assessor
observes if the tester is accurately following the testing procedures and
process including safety and the national algorithm for HIV rapid testing.
6. To score each step of the observation checklist, the assessor will assign ‘1’
point if the step is accurately followed or ‘0’ if the step was missed or ‘0.5’ if
the step was partially completed.

If the following issues are observed during the assessment, the assessment will
immediately be stopped:
• Tester uses expired test kits
• Tester uses incorrect test kits (e.g. syphilis test instead of HIV, or
switch the test in the algorithm)
• Tester compromises safety (e.g., not wearing gloves or appropriate
PPE, no waste disposal containers, etc.)
• Tester does not follow the national algorithm
7. If assessment is stopped, the assessor will explain to the tester why it was
stopped.
8. The tester completes the practical assessment results in the PT Results Form.
9. The assessor will tally and indicate the final percentage score obtained by the
tester in both the direct observation and PT sample testing.

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 10. The assessor and the tester will date and sign both the Direct Observation and
PT Sample Results forms, on paper and in the app.
11. A tester’s performance is deemed satisfactory if the tester obtained a score of
≥ 80% on direct observation and 100% on PT sample results.
12. A tester’s performance is deemed unsatisfactory if the tester obtained a score
of < 80% on direct observation and < 100% on PT sample results.
13. The assessor will provide verbal and written feedback to the tester and
document the feedback in the app.
14. Feedback should include:
• The final scores obtained by the tester
• The assessor’s performance recommendation and plan for
remediation (in service training, offsite training, etc.)
• The feedback should be brief and highlight both the areas of
improvement and best practices
• Avoid criticism and embarrassment
15. Summary of performance of all testers assessed should be provided to the
OPM/in-charge.
16. If the tester is unsuccessful in practical assessment, the tester should be given
another opportunity to be assessed in the next available date.

Note: If the tester’s performance is repeatedly unsatisfactory, both on written and

practical assessment, an interview with the tester should be conducted to identify
areas of weaknesses and concern, and further remedial action should be implemented.

Final Score Calculations

Written Assessment: tester score ÷ total points for written assessment (25) x 100 = %
Direct Observation: tester score ÷ total points for direct observation (22) x 100 = %
Practical Sample Testing: tester score ÷ total points for sample testing (6) x 100 = %

Criteria for Tester Competency Satisfaction

Written Assessment: ≥ 80%
Direct Observation: ≥ 80%
Practical Sample Testing: 100%

Remedial Action
An interview with the tester should be conducted to identify areas of weaknesses and concern. Any weakness
identified should be tailored to address the needs of the individual tester. If written language is a barrier, other
means of assessment should be considered e.g. oral evaluation. See the Remedial Action SOP.

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 Procedure for Remediating Tester Unsatisfactory Performance

Purpose: To describe the key players, requirements, processes, tools and procedures needed for the process of
remediation for testers in HIV Rapid Testing who do not meet competency criteria during the first or subsequent
attempts.

Resources: Written assessment results, direct observation results, PT sample results, Competency Assessment
Remediation Plan

Step Description Resources/Tools

1 Identify and document the gaps after the written and practical • Written Assessment
assessment in the Competency Assessment Summary and Results
Remediation Plan. • Direct Observation
• For the written assessment, the topic area(s) where the Results
tester performed unsatisfactory should be documented by • PT Sample Testing
the assessor (e.g. QA, Safety, algorithm, etc.) to be addressed
Results
in the remediation plan.
• Competency
• For the practical assessment, the results from the direct
Assessment Summary
observation checklists and the PT sample testing result form
will inform the topic areas (e.g. testing algorithm, test and Remediation Plan
procedures, recording) that need to be addressed.

2 Develop an improvement plan to address gap(s) identified. Based on • Competency

the gaps identified, the improvement plan may include: Assessment
• initial training if the tester has never been trained Remediation Plan
• refresher training
• onsite coaching/mentoring
• supportive supervision visit by HTS Coordinator

3 In following the Competency Assessment Remediation Plan, the • Competency

assessor will work with the facility in charge or HTS coordinator or Assessment
Support Partner to document and implement further gaps and Remediation Plan
remedial actions taken, as well as the outcomes. • HIV RT Training
Materials and manual
• The remedial action taken should seek to identify tester areas • RTCQI Training
of weaknesses and concern. Any weakness identified should Materials and manual
be tailored to address the needs of the individual tester. If the
assessment approach is in itself a barrier, other means of
assessment should be considered.

59
Step Description Resources/Tools
4 Schedule the next competency assessment for the tester 3 months
following the completion of the remediation process.

Note: For the re-assessment, it will be important to determine who

will be responsible and whether to use the same or different assessor
as the original/previous assessment.

5 The assessor should make a copy of the Competency Assessment

Summary and Remediation Plan for his/her records and leave the
original document with the OPM/in-charge of the facility.

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 South Africa National HIV Tester Certification
Site Visit Documents Package for Assessors

Assessment Package Checklist – 9 items to bring to every assessment!

Item Yes/No
1. Site Visit Documents Package for Assessors (this sheet)

Written Assessment (one of the following for each tester):

2. Blank Written Assessment Results Sheet

3. Written Assessment Questions (bring different versions)
4. Written Assessment Memorandums (only for assessor)

Practical Assessment (one of the following for each tester):

5. PT Results form
6. Direct Observation Checklist Form and App

Feedback:
7. Summary and Remediation Plan
Supplies:
8. PT samples, 1-2 extra sets of samples (in the event of spills
or contamination), and answer key for PT

#9 – a positive attitude!
Remember the purpose of your role: to give an accurate, ethical assessment and provide helpful feedback.

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62
 HIV Rapid Testing Personnel Competency Assessment & Certification
Workshop
Introduction Script for Assessors

To be read to HIV Rapid Testing personnel prior to each assessment.

I. Greeting and Introduction:

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

II. Goals and objectives of the assessment:

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

III. Components of the assessment:

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

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IV. How the tester will be scored:

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

V. General guidelines for the tester during the assessment:

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

VI. How the results of the assessment will be used:

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

VII. Closing remarks (Is there anything else you want the tester to know?):

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

_____________________________________________________________________________________________________________

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 Practical Examination - Direct Observation Checklist
(For use while observing PT sample testing)

______________________________________ __________________________________________________
Name of Tester Name of Evaluator

__________/___________/________________ _____________/__________________/_____________________
Last Training Date Date Direct Observation was Conducted

Scoring Criteria
1 = Step performed correctly; 0 = Step incorrectly performed or skipped; ½ is Partially Correct; N/A= Not applicable

Steps to be observed (Evaluator to score each step observed) Score Comments

Followed all safety precautions as per SOP (lab coat, apron, gloves,
1
etc.…)
Working area is disinfected and organized (i.e., free of clutter)
2
The content of the PT pack is verified
3
The integrity of the PT pack is verified
4
(i.e. PT sample tubes are not leaking)
Check and record expiry date of test kits and buffer
5 Note: Verify if the HIV RT kit lot is within the expiration date. If it has
expired; stop the examination
Correct test kit used to perform testing
6 Note: Verify if the correct HIV RT kit is being used. If the national
algorithm is not being followed; stop the examination
Write PT sample ID on test device?
7
Test 1 -> Correctly set timer before proceeding with testing AND start
8
timer after buffer is added to the last sample
Test 1 -->Use correct Sample Volume using the correct sample
9
collection device
Test 1 -->Use correct Buffer Volume
10
Test 1 -->Record Test Result on PT form only at the end of the wait time
11
Followed the job aid or test procedure while performing Test 1
12
Test 1 -->Use correct result interpretation/documentation (i.e., reactive,
13
non-reactive or invalid)
Test 1 -->Final result
Correctly identify and document non-reactive samples and document
the test result for them as negative.
14 Correctly identify and document reactive samples that need to be
confirmed by Test 2.
Correctly identify and document invalid results.

Test 2--> Correctly set timer before proceeding with testing AND start
15
timer after buffer is added to the last sample

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 Steps to be observed (Evaluator to score each step observed) Score Comments
Note: Verify if the correct HIV RT kit is being used. If the national
algorithm is not being followed; stop the examination
Test 2 --> Use correct Sample Volume using the correct sample
16
collection device
Test 2 -->Use correct Buffer Volume
17
Test 2--> Record Test Result on PT results form, only at the end of the
18
wait time
Followed the job aid or test procedure while performing Test 2
19
Test 2 -->Use correct result interpretation/documentation (i.e., reactive,
20
non-reactive or invalid)
Test 2 -->Final result
21 Correctly identify and document the test result for each sample tested
(i.e., negative, positive)
Disinfect and organize work space at the end of testing and dispose of
22
wastes in correct bin (gloves, wrapper, pipette, test kits, samples, etc.)
Total Points

Direct Observation score: (…………/22)* 100= …………….%

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

PT Sample results score: …………%

[Indicate the score obtained for the panel by the provider – PT Results Column 3, Test Results]
For example if the practical exam include 6 samples to be tested and all sample test results are correct, then score 100%
(=6/6*100)=100%. If only 2 samples results are correct score 33.3% (=4/6*100]

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

Remedial Action (if applicable):

Date Examination completed: _______/_______/________ Tester Signature: ___________________________

Name of Evaluator: _______________________________ Evaluator Signature: _________________________

66
 PROFICIENCY TESTING RESULT FORM
Please make sure all details are completed.
Date of Practical Assessment:

Name of the Tester:

HIV TEST KIT USED BATCH NUMBER EXPIRY DATE

Test 1

Test 2

PLEASE INDICATE WITH  FOR FINAL INTERPRETED RESULTS.

SAMPLE NUMBER H01 H02 H03 H04 H05 H06

KIT Test 1 Test 2 Test 1 Test 2 Test 1 Test 2 Test 1 Test 2 Test 1 Test 2 Test 1 Test 2
□Non-Reactive □Non-Reactive □Non-Reactive □Non-Reactive □Non-Reactive □Non-Reactive □Non-Reactive □Non-Reactive □Non-Reactive □Non-Reactive □Non-Reactive □Non-Reactive
INTERPRETATION □Reactive □Reactive □Reactive □Reactive □Reactive □Reactive □Reactive □Reactive □Reactive □Reactive □Reactive □Reactive
□Invalid □Invalid □Invalid □Invalid □Invalid □Invalid □Invalid □Invalid □Invalid □Invalid □Invalid □Invalid
FINAL RESULT □Positive □Negative □Positive □Negative □Positive □Negative □Positive □Negative □Positive □Negative □Positive □Negative

COMMENTS

Tester Signature_________________________

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Assessor Name__________________________ Assessor Signature______________________
68
 Version of Written Examination: _____________

HIV Tester Certification - Written Examination Results Sheet

TESTER INFORMATION

Last Name ……………………………………..…… First Name: ……………………..…………………. Middle Name: ……………………….…...…

(Surname) (Given name)
Province……………………………………. Facility Name: …………………………………………………………………………………
Date of last training: …………/……………/..……….. Length of training (days): ………………………………………………………………..
Time worked as tester to date (Years or months): ...........................................................................................................
Phone: …………………………………………….………... Email (if available): ………………….………………………………………...

Written Examination Instructions

• Complete the Examination Information section before you begin the examination. Failure to do so will result in not scoring
your test.
• For each question, indicate the question code and write the letter of the correct statement in the column labelled “Your
answer”.
• Make sure to answer all the questions. Each correct answer will receive one (1) point. Incorrect answers or questions left
unanswered will be scored zero (0) point. A total score of 80% (or 20 points) or higher is required to pass the examination.
• Before turning in your Examination Results Sheet, verify that you have answered all the questions, indicated your name,
the date and signed the examination sheet.

Correct Correct
Section S/N Your answer Section S/N Your answer
Answer Answer
1 14
QA 2 15
3 Logbook 16
4 17
Overview 5 18
6 19
PT
7 20
Safety 8 21
9 22
Ethics
10 23
Specimen
11 24
Inventory
12 25
Algorithm
13

Signature of Tester: Examination date: / /

Score to be summarized by Assessor only

Section Title Points Points Section Title Points Points
obtained expected obtained expected
1. Quality assurance 3 6. Record keeping/ Logbook 3
2. Overview of HIV RT 3 7. EQA/PT 4
3. Safety 3 8. Professional ethics 2
4. Specimen collection 2 9. Inventory 2
5. HIV testing algorithm 3
Overall score 25

Final score obtained: …………... % Performance recommendation: Satisfactory Unsatisfactory

Name and Signature of Proctor/Assessor: …………………………………………………………… Date: …….…/…….……/……..……

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70
 HIV Rapid Testing Personnel Competency Assessment
Summary and Remediation Plan

Date of Assessment Assessor’s Name

Number of Testers Assessed Facility Name

WRITTEN EXAM Summary: best practices and/or deficiencies observed.

WRITTEN EXAM Plan for Remediation:

PRACTICAL ASSESSMENT Summary: best practices and/or deficiencies observed.

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PRACTICAL ASSESSMENT Plan for Remediation:

PT SAMPLE RESULTS Summary: best practices and/or deficiencies observed.

PT SAMPLE RESULTS Plan for Remediation:

General comments about the assessment:

Date of Next Training or Remediation Date of Next Assessment (if applicable)

Action (if applicable)

Signature of Assessor Signature of Facility In-Charge

Name of Facility In-Charge

72