Stepwise Process for Improving the

Quality of HIV Rapid and Recency

Testing (SPI-RRT) Checklist
Users’ Guide for Site Audit Using the for SPI-RRT
Checklist

Version 4.0

3/3/2020

Page 1 of 41
 Users’ Guide for SPI-RRT Checklist

I. Background

The expansion of HIV/AIDS testing, care, and treatment services has been driven by the increasing
need for HIV services including HIV rapid testing, the increasing provision of antiretroviral (ARV)
drugs to treat persons living with HIV, and the demonstrated effectiveness of ARVs taken consistently
to prevent further transmission (e.g., prevention of mother-to-child transmission (PMTCT),
discordant couples, etc.). Considerable effort and resources have focused on expanding and
decentralizing HIV testing services (HTS), PMTCT, and HIV care and treatment services so that HIV
testing is performed at both facility and non-facility levels. As such, a continuous and systematic
approach is needed to ensure good quality, accuracy and reliability of rapid HIV diagnostics for HTS.

To assist ministries of health and national programs, a Stepwise Process for Improving the Quality
of HIV Rapid and Recency Testing (SPI-RRT) checklist has been developed. The checklist provides
guidance on quality assurance (QA) practices for sites using HIV rapid tests to diagnose HIV infection
and for sites using the rapid test for recent infection (RTRI) to determine whether a newly HIV
diagnosed person has been infected within the past 12 months. The SPI-RRT checklist sets minimum
standards for all HIV RT/RTRI testing points and provides guidelines for continuous quality
improvement (CQI). Working through the SPI-RRT Checklist will enable the individuals in charge of
the HIV RRT/RTRI testing points and facilities to recognize quality gaps and shortcomings, identify
areas for improvement and where additional resources may be needed to achieve national
certification.

Using the SPI-RRT checklist, the HIV rapid and recency testing site audits are intended to be effective
means to 1) determine if a testing point is providing accurate and reliable results; 2) determine if HIV
RT/RTRI testing point is well-managed and is adhering to quality practices; and 3) identify areas for
improvement.

II. Purpose of the Users’ Guide for SPI-RRT Checklist

The users’ guide has been developed to provide instructions on how to implement the associated
checklist in an accurate and standardized way. The information should also provide testing point
personnel with a clear indication of the requirements for compliance and some direction on the SPI-
RRT auditors’ expectations.

The rationale for each standard and the methods that should be used to assess them are explained in
this users’ guide. Specifically, the users’ guide outlines the steps and requirements throughout an
audit and provides a description of how and what data should be collected. For elements that require
reviewing records and documents and/or verifying and confirming evidence of compliance, the
user’s guide also explains how it should be done. In some instances, an observation may be
sufficient to assess whether or not there is compliance.
Examples are used to illustrate the methods described in Section IV. Tips on How to Conduct the
Audit.

It is recognized that some of the questions related to personnel competency (Section 1.0) or the
HIV testing registers (Section 6.0) may be outside the purview of the testing point personnel.
However, the data collected from these audits will be used for advocacy and decision making at a
higher level.

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III. Steps and Requirements of the Audit

IV. Tips on How to Conduct the Audit

Review HIV RT/RTRI testing/site records to verify that the HIV RT/RTRI testing site guidelines,
supervisory visit reports, incident reports, logs, Standard Operating Procedures (SOPs), and job
aides are complete, current, and accurate.

Observe the HIV RT/RTRI testing site operations to

ensure: In some instances, a simple
observation may be sufficient to
• All testing follows written procedures in pre-
analytic, analytic and post-analytic phases of assess whether or not there is
testing; compliance. Questions should be
• The HIV rapid testing procedures and/or RTRT are asked for clarification.
appropriate for the test performed;
• Deficiencies and nonconformities identified are For example, Question 4.4. will
adequately investigated and resolved within the only be asked if the job aides are
established timeframe and documented. not available or outdated
Ask open-ended questions to clarify documentation seen
and observations made. Ask questions like, “show me how…” or “tell me about…”. It is often not
necessary to ask all the checklist questions verbatim. An experienced auditor can often learn to
answer multiple checklist questions through open-ended questions with the testing staff.

Follow a specimen through the HIV rapid testing or RTRI procedure whenever possible, from
specimen collection through testing, analyzing, and result reporting.

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V. Structure of the SPI-RRT Checklist

The SPI-RRT Checklist contains four distinct parts. Detailed instructions are provided below on how
to use the checklist to audit HIV RT and/or RTRI testing points.

Part A. Characteristics of the Facility or Testing Point Audited

Part A is a summary table that gathers general information on the testing point to be audited. Because
the nomenclature of the health facilities and the types of testing points vary from country to country,
it is recommended to provide the most accurate information about the facility or testing points to be
audited according to the national guidelines.

Date of audit: Provide the date of the audit, using the format provided.
Audit round: Audit round corresponds to the number of times the testing point was audited, as of
the day of the audit.
Testing facility name: Provide the official name of the facility.
Testing facility ID: Some countries have a listing of the facilities with unique ID assigned, if
available provide the number.
Type of testing point: Circle the type of testing point to be audited that is the most appropriate
one, if not listed specify under “other”. HIV programmatic areas vary from countries to countries.
Therefore, in some instances, countries will have to customize to reflect the program types
available in country.
Physical Address: Provide the complete location or address of the testing facility.
Level: Circle the most appropriate sub-national level of the health tiered systems; if not listed,
specify under “other”. Sub-national levels vary from country to country. Therefore, in some
instances, countries will have to customize to reflect the country context.
Affiliation: circle the most appropriate one; if not listed, specify under “other”
Number of testers: Specify the number of individuals performing testing in the testing point at the
time of the audit.
Number of clients tested for HIV: Provide the number of clients tested for HIV for the past month
and quarter
Number of newly identified HIV positives: Provide the number of newly diagnosed HIV positives
for the past month and quarter.
Number of HIV negatives: Provide the number of clients that tested HIV negative for the past
month and quarter.
Number of newly identified HIV positives tested by RTRI: Provide the number of newly
diagnosed HIV positives tested by RTRI.
Number of Recent by RTRI or RITA: Provide the number of recent clients by the rapid test for
recent infection only or the recent infection testing algorithm (RTRI +viral load)
Name of the auditor 1: Provide the name of the auditor.
Name of the auditor 2: If more than one auditor, provide the name of the second auditor.

Part B. SPI-RRT Checklist

The SPI-RRT Checklist is laid out in sections that align with standard requirements. The checklist
contains eight (8) main sections specific to HIV rapid and recency testing.
• Section 1 Personnel Training and Certification
• Section 2 Physical Facility
• Section 3 Safety

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• Section 4 Pre-Testing Phase

• Section 5 Testing Phase
• Section 6 Post-Testing Phase
• Section 7 External Quality Assessment
• Section 8 HIV-1 Recent Infection Surveillance Using the Rapid Test for Recent
Infection (RTRI)

Part C. Scoring Criteria

This section briefly outlines the scoring criteria

For each of the sections listed below, responses to all questions must either be, “Yes”, “Partial”,
or “No”.
• Indicate “Yes” only when all elements are present, and the evidence of compliance is
present in a tangible and/or observable form (e.g., written material, physical items, etc.)
• Indicate “Partial” if the testing point has a written procedure but there is no evidence of
consistent implementation or if there is evidence of non-adherence.
• Indicate “No” when an element (e.g., SOP or job aides) requires a written procedure but
it is not available at the testing point or there is no evidence of compliance.
• When marking “Partial” or “No”, provide comments for each “Partial” or “No”
response.
• State N/A (not applicable) in the comments field of the Section 8.0 questions (*) if RTRI
is not implemented.
Each element marked will be assigned a point value:
• Items marked “Yes” receive 1 point each.
• Items marked “Partial” receive 0.5 point each.
• Items marked “No” receive 0 point each.
At the end of each section, total points scored for the section should be reported.

The table below describes the total score expected for each section of the checklist. The possible
maximum score a testing point can obtain is either 64 points, if the country has not implemented
RTRI (Section 8.0 questions 8.1 - 8.11) or 75 points if the program does include RTRI.

Audit Score Sheet

Section Section Name Total Points
Section 1 Personnel Training and Certification 10
Section 2 Physical Facility 5
Section 3 Safety 11
Section 4 Pre-Testing Phase 13
Section 5 Testing Phase 9
Section 6 Post-Testing Phase 9
Section 7 External Quality Assessment 8
Section 8 HIV-1 Recent Infection Surveillance 11
TOTAL SCORE 64/75

The percent score obtained by the audited testing point will correspond to a specific performance
level as described in the table below.

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This checklist consists of five different levels to indicate status toward national certification.
Levels % Score Description of results
Level 0 Less than 40% Needs improvement in all areas and immediate remediation
Level 1 40% - 59% Needs improvement in specific areas
Level 2 60%-79% Partially eligible
Level 3 80%-89% Close to national site certification
Level 4 90% or higher Eligible to national site certification

Part D. Summary of Audit Findings

Auditors complete this audit using the methods outlined above to evaluate testing point operations
using the SPI-RRT Checklist and will document findings in detail using the Auditor’s Summation
Report for SPI-RRT Audit. A copy of the summation report will be made available to the head of
facility or testing sites at the end of the audit.

The Auditor’s summation report should include the following information:

Facility name as provided before the audit, the site type, the name of the staff audited. It should also
include the number of testers at the testing point and the time it took to complete the audit.

The overall total points obtained by each HIV testing point audited will be weighed using the
following formula:
Total points scored (exclude all N/A) = a. The auditor will compute all the points obtained for each
section
Total score expected = b. The auditor will decide whether or not to include the 11 questions related to
RTRI. If so, the total score should 75, otherwise the total score to expected will be 64
% Score = (a/b) x 100. The total score obtained weighted in percentage. The percentage obtained by
the testing point will be translated in level of performance.
The correct pre-certification level should be indicated for each site audited.

In the summary table, gaps and areas for improvement should be documented. The section number
should be referenced, immediate corrective actions by testing point or the facility or a follow up
(e.g. higher level) should be noted. The auditor should provide some relevant comments and jointly
with the testing point staffs, agree on actions to be taken, the timeline for completion and identify a
person as point of contact.

The staff audited, the person in charge and the auditors should review, date and endorse the
Auditor’s Summation report. A copy should be retained by the testing point and another copy by
the auditor.

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SECTION
SECTION QUESTIONS WHAT TO ASK FOR? WHAT TO LOOK FOR?
NO
HTS should be offered by only testers with adequate and documented training,
PERSONNEL TRAINING AND
1.0 competent skills, and certified to administer tests and interpret the results, in
CERTIFICATION
accordance with national guidelines, policy and regulations.
- Verify dates of trainings
- Verify training contents including
hands-on sessions
Note: Mark “Yes”, if training documents
are available and content include all
Have all testers received a quality elements (e.g., safety, EQA/PT,
comprehensive training on HIV rapid waste management, inventory, QC
1.1.
testing using the nationally approved documents and records, testing
curriculum? procedures, etc.)
Mark “Partial” if training documents are
available but content does not include all
Ask the following:
quality elements
- How many testers are on site?
Mark “No” if training documents are not
- How many are trained?
available
- Documentation of training (e.g.,
‐ Verify a copy of HIV testing register
certificates) for all testers including any
and check all required elements are
refresher training
filled out correctly by the tester(s)
- Training manual or training competency
Note: Mark “Yes” if all testing QA
Are the testers trained on the use of criteria
elements are accurately documented
1.2. standardized HIV testing
Mark “Partial”, if inconsistent or
registers/logbooks?
inaccurate documentation of QA
elements
Mark “No” if no testing QA elements are
documented
‐ Verify the tester(s) training record
on external quality assessment
Are the testers trained on external
(EQA) or proficiency (PT) process
1.3. quality assessment (EQA) or proficiency
Note: Mark “Yes”, if EQA and PT module
testing (PT) process?
is included in training and tester PT
result are satisfactory

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Mark “Partial”, if EQA and PT module is

included training, but tester PT results
are unsatisfactory
Mark “No” if tester was not trained on
EQA and PT
‐ Verify the testers know about QC
procedures
‐ Verify how QC results are
documented by the tester in QC logs
or HIV testing register
Note: Mark “Yes”, tester is able to
Are the testers trained on quality control accurately describe procedure and logs
1.4.
(QC) process? are properly documented by the tester
Mark “Partial”, tester is able to describe
procedure, but QC logs are not properly
documented
Mark “No”, if tester cannot describe
procedure and QC logs are not properly
documented by the tester
‐ Verify procedures for safe handling
and disposal of waste
Note: Mark “Yes”, tester is able to
accurately describe procedure and there
is a training module on safety and waste
management
Are the testers trained on safety and
Mark “Partial”, if safety and waste
1.5. waste management procedures and
management are part of the national
practices?
training curriculum but the tester is not
following the safety and waste
management procedures or cannot
accurately describe procedure
Mark “No”, if tester cannot describe or
follow the procedures and are not

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trained on safety and waste

management
Verify date (if more than 2 years,
document in the comments field)
Note: Mark “Yes”, testers have received
Have all testers received refresher refresher training the last 2 years
1.6.
training within the last two years? Mark “Partial”, some testers have
refresher training the last 2 years
Mark “No” if none of the testers had
refresher training the last 2 years
‐ Verify documentation of direct
observation of the tester
performing HIV rapid testing by in
charge or supervisor (e.g., signature
and date)
‐ Verify personnel training log
indicating the trainer or supervisor
Are there records indicating all testers Ask the following:
signature and date
1.7. have demonstrated competency in HIV - For documentation of competency
Note: Mark “Yes”, if demonstrated
rapid testing prior to client testing? assessment for all testers
competency is well documented for all
testers
Mark “Partial”, if demonstrated
competency is well documented for some
of the testers
Mark “No” if there is no documentation
of demonstrated competency
- Verify documented evidence of
enrollment in national certification
Ask the following:
program
- If testers are enrolled in the national
Have all testers been certified through a - Verify a copy of the tester
1.8. certification program
national certification program? certification
- For certification of all testers currently
Note: Mark “Yes” if there is evidence of
performing testing
enrollment of all testers in certification
program

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Mark “Partial” if there is evidence of

enrollment of some testers in
certification program
Mark “No” if there is no evidence of
enrollment
- Verify date of issuance certificate of
competency and validity
- Verify requirements for
certification in the national
guidelines if available
- Verify testers signature on the HIV
Ask the following:
testing register to confirm that only
- For evidence for documentation of
certified testers are performing
Are only certified testers performing HIV national certification (e.g., certificate of
1.9. testing
rapid testing at the site? competency, national guidelines)
Note: Mark “Yes” if there is evidence
- Ask how many testers are on site and how
that only certified testers perform
many are certified
testing
Mark “Partial” if there is evidence that
only some testers performing testing are
certified
Mark “No” if none of the testers
performing testing are certified
‐ Verify the date of the most recent
certification
Note: Mark “Yes” if there is evidence of
Ask the following:
Are all testers re-certified periodically recertification of all testers
1.10. - For documentation of re-certification of all
(e.g., every two years)? Mark “Partial” if there is evidence of
testers currently performing testing
recertification of some testers
Mark “No” if there is no evidence of
recertification
SECTION QUESTIONS WHAT TO ASK FOR? WHAT TO LOOK FOR?
2.0 PHYSICAL FACILITY The testing site is adequate to provide safe and effective HTC services.
Ask the following: ‐ Verify that space is adequate for
Is there a designated area for HIV
2.1. - To see where the HIV rapid testing occurs testing, ensures safety and client’s
testing?
confidentiality (e.g., all clients’

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information, a partition is present,

etc.)
Note: Mark “Yes” if there is a designated
area for HIV testing
Mark “Partial”, if there is evidence of a
designated area for HIV testing but the
space is not adequate or does not ensure
safety or client confidentiality
Mark “No” if there is no evidence of a
designated area for HIV testing
‐ Verify that the space is clean and
organized (not cluttered)
Note: Mark “Yes” if testing area is clean
and well organized
Is the testing area clean and organized Mark “Partial” if testing area is not
2.2.
for HIV rapid testing? consistently clean and organized
Mark “No” if the area is dirty and/or
cluttered which could result in a safety
hazard or contamination of items in the
testing area
‐ Verify that the primary light source
(e.g., natural or lamp) is adequate
for testing
Note: Mark “Yes” if testing area is well
Is sufficient lighting available in the lit
2.3.
designated testing area? Mark “Partial” if testing area has a
primary light source but the lighting is
not consistent
Mark “No” if testing area does not have
adequate light for testing
- Verify storage conditions are
Ask the following:
appropriate
Are the test kits stored according to - To see where test kits and other supplies
2.4. - Verify if kits are stored in an area
manufacturers’ instructions? are being stored?
where temperature requirements
are being met (e.g., 2- 30°C) and is

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being monitored regularly using a

thermometer
- Check if kits are being stored away
from direct sunlight or away from
an area with high humidity, etc.
- if applicable, check if kits are being
stored in functioning refrigerator. If
test kit is stored in refrigerator then
the tester takes it out for at least 30
mins to reach room temp prior to
testing
Note: Mark “Yes” if all storage
conditions are met
Mark “Partial” if some of the storage
conditions are met
Mark “No” if none of the storage
conditions are met
- Verify storage space is sufficient,
accessible, and organized
Note: Mark “Yes”, if storage space
(room, cabinets or drawers) is sufficient
Is there sufficient storage space for test
2.5 for all test kits and supplies
kits and other supplies?
Mark “Partial” if storage space is limited
Mark “No”, if storage space is
insufficient, not accessible and/or
disorganized
SECTION QUESTIONS WHAT TO ASK FOR? WHAT TO LOOK FOR?
3.0 SAFETY The testing site implements infection prevention and control processes.
Are there SOPs and/or job aides in place Ask the following: - Review all documents, SOP, and/or
3.1
to implement safety practices? - To see the safety related SOPs/job aides job aides for safety including proper
Are there SOPs and/or job aides in place for: disposal of infectious and non-
to address accidental exposure to ▪ Overall safety guidelines infectious waste, manage blood and
3.2 potentially infectious body fluids ▪ Disposal of infectious and non- other body fluids.
through a needle stick injury, splash or infectious waste - Verify handling infectious and
other sharps injury? ▪ Spill management procedures noninfectious waste

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▪ Exposure management procedures - Verify handling spills

- Verify post-exposure prophylaxis
Note: Mark “Yes”, if the SOP/job aides
clearly outline the different safety
procedures and practice; and these are
understood and implemented by the
Are testers and those visiting the testing tester and anyone that visits the testing
3.3 area following the safety practices area
outlined in the SOPs and/or job aides? Mark “Partial”, if the SOP/job aides do
not clearly outline the different safety
procedures and practice; or they are not
understood or implemented by the tester
or those visiting the testing area
Mark “No” if there are no SOP/job aides
outlining safety practices
- Verify PPEs (apron, gloves,
laboratory coats, etc.)
- Review the stock card or inventory
database and current stock
Ask the following:
Note: Mark “Yes”, if there are
- To see where PPEs (gloves, apron,
Is personal protective equipment (PPE) appropriate PPEs (i.e., gloves, apron/lab
3.4 laboratory coats, etc.) are stored
always available to testers? coats, etc.) available for the providers
- To ask for the stock card or see the supply
Mark “Partial”, if there are gloves,
inventory database
apron/lab coats available but
insufficient
Mark “No”, if gloves, aprons/lab coats
are not available for providers
- Observe if PPE is properly used by
all testers during testing
Note: Mark “Yes”, if gloves and
Is PPE properly used by all testers
Ask the following: apron/lab coats are properly worn at all
3.5 consistently throughout the testing
- How and when is PPE used? times during testing procedure and
process?
gloves changed between clients
Mark “Partial”, if gloves and apron/lab
coats are inconsistently worn during

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testing procedure and gloves not

consistently changed between clients
Mark “No”, if no PPE is worn or if
handling personal items (e.g., cell phone,
key, etc.) with contaminated gloves
- Check that soap and running water
are available
- Check that sinks are functional
and/or bucket (with a faucet, if
applicable) contains water
Note: Mark “Yes”, if soap and running
Is there clean water and soap available Ask the following:
water are available and testers wash
3.6 for hand washing and is it consistently - Availability of soap and water
their hands before and after each client
used? - Do the testers wash their hands
Mark “Partial”, if soap and running
water are available but testers are not
consistently washing their hands before
and after testing each client
Mark “No” if soap and water are not
available
- Verify that bleach (e.g., JIk) and/or
alcohol are available and properly
labeled (expiration date, initials)
Ask the following: Note: Mark “Yes” if disinfectant is
Is there an appropriate disinfectant to
- To see their disinfectant available and properly used to clean
clean the work area and equipment
3.7 - To describe how and when they use it testing area
available?
- To describe the cleaning procedure after Mark “Partial” if disinfectant is available
spills and end of day but not properly used to clean testing
area
Mark “No” if disinfectant is not available
for routine cleaning of testing area

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- - Verify that bleach (e.g., JIk) and/or

alcohol are properly labeled with
content, date of preparation, date of
expiration and initials of who prepared
it
- Note: Mark “Yes” if disinfectant is
Is the disinfectant solution used
properly labeled
3.8 properly labeled with content, date of
Mark “Partial”, if disinfectant is not
preparation and date of expiration?
properly labeled (i.e., some elements
missing from label)
Mark “No”, if there is no label identifying
the product as a disinfectant and no
content, date of preparation, expiration
or initials of who prepared it.

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- Verify that waste is properly

managed (sharps in sharp
containers, infectious vs.
noninfectious disposed of per
national guidelines (e.g., using
correct waste bins and bags)
- Observe that sharps, infectious, and
non-infectious wastes are properly
disposed
- Observe where sharps, infection
Ask the following:
and non-infectious waste are stored
- To see how the site manages waste, is it
prior to disposal (i.e., incineration,
properly segregated?
Are sharps, infectious and non-infectious etc.)
- To see where sharps, infectious, and non-
3.9 waste disposed of according to the Note: Mark “Yes” if wastes and sharps
infectious wastes are stored prior to
segregation instructions? are properly segregated and handled
disposal
throughout testing procedure
Mark “Partial” if wastes or sharps are
inconsistently segregated and handled
throughout testing procedure
Mark “No” if wastes or sharps are not
segregated and handled properly
throughout testing procedure

- Verify whether waste containers

Ask the following: are full or not
Are infectious and non-infectious waste - How frequently the waste containers are - Verify where the wastes are
3.10 containers emptied regularly per the emptied, by whom and how. disposed
SOP and/or job aides? - To see where the infectious waste is Note: Mark “Yes”, if there is evidence
disposed that wastes, and sharps containers
emptied regularly

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Mark “Partial”, if there is evidence that

wastes, or sharps containers are
inconsistently emptied
Mark “No” if wastes or sharps containers
are overflowing and evidence of poor
waste management
SECTION QUESTIONS WHAT TO ASK FOR? WHAT TO LOOK FOR?
All safety and specimen collection procedures are followed, test kits and
4.0 PRE-TESTING PHASE
consumables are adequate to provide accurate and reliable test results
Ask the following: - Verify that national testing
- To see the national guidelines outlining guidelines provided are current
HIV testing and QA procedures Note: Mark “Yes” if national guidelines
are available, current and understood by
Are there national HIV testing guidelines testers
4.1
available at the testing point? Mark “Partial” if national guidelines are
available but not current and/or
understood by testers
Mark “No” if national guidelines are not
available
- Verify that the algorithm described
is correct
- Verify that job aides are current and
correct
- Review HIV testing register
Ask the following: - If there is an alternative algorithm,
- To describe the testing algorithm used at document in the comments section
Is the national HIV testing algorithm(s)
the sites what the approved algorithms are.
4.2 consistently being used at the testing
- To ask if there is an approved alternative Note: Mark “Yes” if the national
site?
algorithm in case of stock out issues algorithm is being used and accurately
- To see the job aides for testing algorithm implemented
Mark “Partial”: if national algorithm is
being used but not consistently
implemented due to stock issues or other
reasons (Note: please document reasons
algorithm is not followed)

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Mark “no” If the national algorithm is

not implemented or does not exist, and
the site is implementing their own
- Verify that SOP and/or job aides for
the test kits and algorithm are
Are SOPs and/or job aides on HIV rapid
available and easily accessible
test procedures and the national HIV
4.3 Note: Mark “Yes” job aides are available
rapid test algorithm(s) available and
Mark “Partial” if only some job aides are
easily accessible at the testing site?
available
Mark “No” if job aides are not available
- Verify that SOP and/or job aides for
Ask the following:
the test kits and algorithm are the
- For the SOPs and/or job aides for the
most current version and that the
national testing algorithm and for each of
information is based on the
the HIV rapid test kits used in the
manufacturer’s most recent
algorithm
Are SOPs and/or job aides on HIV rapid package insert
4.4 test procedures and the national testing Note: Mark “Yes” job aides are up-to-
algorithm up-to-date and accurate? date and accurate
Mark “Partial” if only some job aides are
up-to-date and accurate
Mark “No” if none of the job aides are up-
to-date or accurate or there are none
available
- Verify that test kits available are
currently approved for HIV rapid
testing in-country, including test
kits for the nationally approved
Ask the following: alternative algorithm
- To see each of the HIV rapid tests Note: Mark “Yes” if all the test kits
Are only nationally approved HIV rapid
4.5 currently in use available currently are the ones
test kits available for use?
approved by the national program.
Mark “Partial” if only some of the test
kits available are part of the ones
approved by the national program.
Mark “No” if none of the test kits
available are nationally approved
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- Verify that test kits currently used

are not expired.
Note: Mark “Yes” if all the test kits
currently used are within expiration
Are all the test kits currently in use
4.6 date.
within the expiration date?
Mark “Partial” if some of the test kits
currently used are expired
Mark “No” if none of the test kits used
currently are within expiration date
- Verify that each test kit contains the
required components (i.e., Sample
collection device, buffer, test device,
etc.),
Ask the following: - Review the test kits in the testing
- To see each of the HIV rapid tests area to ensure no component is
currently in use missing.
- To see documentation of receipt of kits - Please note sample collection
(i.e., stock card, inventory form, or kits device means loop, disposable
labeled with date received and initials, pipette, or capillary tube
Are all required test kit components (i.e.,
etc.) Note: Mark “Yes” if the correct
test device, buffer, sample collection
4.7 components required for each kit are
device, etc.) and supplies available prior
- To describe process in place to manage present in the test kit package (i.e.,
to testing?
stock of test kits and supplies at testing correct sample collection device, test
point device and buffer) and all supplies are
- If there is a designated person to manage available prior to testing
stock, if so ask to speak to that person Mark “Partial” if only some of the
supplies are available
Mark “No” if supplies are not available
prior to testing and/or test kit
components are mixed up with other kits
(i.e., Determine chase buffer mixed in
with UniGold test kit, etc.)
- Verify process in place including
Is there a process in place for stock stock documents and/or inventory
4.8
management database (e.g., stock card, order
form)
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 Guidelines for SPI-RRT Checklist

Note: Mark “Yes” if there is evidence that

the process and practice include proper
quantification of stock, an ordering
system and documentation
Mark “Partial” if the stock management
process and practice does not include
quantification of stock or an ordering
system or documentation consistently
Mark “No” if there is no evidence that the
process and practice include
quantification of stock, an ordering
system or documentation
- Verify that the testing point has
documentation that kits are
received, what lot
number/expiration, who received
and date of receipt
Is there a documented inventory system - Verify that test kits are properly
in place at the testing point for test kits labeled with date received and
4.9
received (i.e., who received them, date of initials
receipt, etc.)?? Note: Mark “Yes” if there is
documentation of inventory system for
kits received
Mark “Partial” if documentation is not
consistent
Mark “No” if there is no documentation
- Verify that job aides for blood
collection (e.g., finger-prick, venous
blood, etc.) are available at the
testing site
Are job aides on finger prick or venous Ask the following:
- Verify that the job aides are current
4.10 blood collection available and posted at - To see the SOP and/or job aides that
and accurate
the testing point? describe specimen collection
Note: Mark “Yes” if job aides are
available, up-to-date, accurate and
accessible and there is evidence that they
are adhered to
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 Guidelines for SPI-RRT Checklist

Mark “Partial” if job aides are available

and posted but there is evidence that
they are not accurate or adhered to
consistently
Mark “No” if there are no job aides
available or posted
- Based on testing volume, verify the
site has enough supplies for blood
collection (e.g., lancets, gauze,
alcohol swabs, plaster, tubes, DBS
Ask the following cards, etc.)
Are there sufficient supplies available for
- To see all the supplies for specimen Note: Mark “Yes” if there is evidence that
4.11 finger prick or venous blood collection
collection. all the supplies are in sufficient amounts
(i.e., lancet, gauze, alcohol swab, etc.)?
- To see stock card Mark “Partial” if there is evidence that
some the supplies are insufficient
Mark “No” if there is evidence that
supplies are not sufficient and there are
frequent stock outs
- Verify that the SOP and/or job aide
describes how to record the client
identification in logbooks and on
the test devices
Note: Mark “Yes” if there is evidence of
adherence to national or site level
Are there SOPs and/or job aides guidelines on how to document client
describing how client identification Ask the following identification (e.g., client name vs. code)?
4.12
should be recorded in the HIV testing - To see testing SOP and/or job aides Mark “Partial” if there is evidence of
register? inconsistence adherence to national or
site level guidelines on how to document
client identification
Mark “No” if there is no evidence of
adherence to the national or site level
guidelines on how to document client
identification

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 Guidelines for SPI-RRT Checklist

- Verify that the client identifier

matches the logbook
- If possible, observe testing
procedure and verify that test
devices are labelled with correct
client identifier
Note: Mark “Yes” if there is evidence of
adherence to national guidelines on how
Ask the following: to document client identification (e.g.,
Are client identifiers recorded in the HIV
- To see the logbook client name vs. code) and that test
4.13 testing register and on test devices per
- What unique client identifiers are used? devices are properly labelled?
SOPs and/or job aide?
- How the client test devices are labelled Mark “Partial” if there is some evidence
of inconsistence adherence to national
guidelines on how to document client
identification and test device are
inconsistently labelled
Mark “No” if there is no evidence of
adherence to national guidelines on how
to document client identification or test
devices not labelled
SECTION QUESTIONS WHAT TO ASK FOR? WHAT TO LOOK FOR?
5.0 TESTING PHASE All safety and testing procedures are implemented during throughout testing
- Verify that the job aide is current,
accurate and complete and follows
the national testing algorithm
- If testing can be observed during
Ask the following: audit, verify that the tester refers to
Are SOPs and/or job aides on HIV testing
- If the site has SOPs/job aides on HIV the job aide during testing and the
procedures and the national testing
5.1 testing procedures followed
algorithm being referred to and followed
- To see the location of the job aides at the Note: Mark “Yes” if job aides are
during testing?
testing point referred and adhered to during testing.
Mark “Partial” if job aides are not
adhered to consistently during testing.
Mark “No” if job aides are not being
adhered to during testing.

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 Guidelines for SPI-RRT Checklist

- Verify that a timer or stopwatch is

available and in good operating
Ask the following: conditions
- To see the timers or stopwatch at the Note: Mark “Yes” if timer or stopwatch is
testing site available, working and the tester knows
Are timers available and used them for
5.2 - For a demonstration on how to use the how to use them
HIV rapid testing?
timer Mark “Partial” if timer or stopwatch is
- If the timer is not available what do they available but it is not working, or the
use to time the test? tester does not know how to use it.
Mark “No” if timer or stopwatch is not
available or used for testing.
- If testing can be observed during
audit, verify to see if sample
collection devices are appropriately
used according to manufacturer’s
instructions (e.g., correct specimen
device used from kit, correct
volume collected, avoidance of
bubbles in loop or disposable
pipette, sample collected up to the
Ask the following:
appropriate mark on the capillary
- For a description of the sample collection
Are sample collection devices (e.g., tube).
device and how to use it (e.g., correct
5.3 capillary tube, loop, disposable pipettes, - Please note sample collection
specimen collection device used from the
etc.) used accurately to perform the test? device means loop, disposable
kit, correct volume collected), if testing
pipette, or capillary tube
cannot be observed
Note: Mark “Yes” if specimen collection
devices are available for all test kits and
used accurately
Mark “Partial” if specimen collection
devices are available for only some of the
test kits and used accurately
Mark “No” if no specimen collection
device is available or used accurately

Are testing procedures adequately If testing can be observed during audit,

5.4 Ask the following:
followed? verify the following:
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 Guidelines for SPI-RRT Checklist

- For a description of the testing procedure - Testing procedure is followed

from the time client is received, if testing - Tester does not have multiple test
cannot be observed. devices at the time they are testing
one client
- Tester has pre-set their timer or if
they are using one or more
monitoring time device
- The right volume of sample is being
added
- The right buffer and buffer volume
is being added
- Adherence to the required read
time
Note: Mark “Yes” if there is evidence of
consistent adherence to all testing
procedures.
Mark “Partial” if there is evidence of
inconsistent adherence to all testing
procedures.
Mark “No” if there is evidence of non-
adherence to all testing procedures.
Ask the following: Verify the following:
- If the National Reference Laboratory - Positive and negative controls are
(NRL) or facility laboratory provides available
controls for testing, as recommended by - Expiration date of QC material
country guidelines? - Frequency of QC used according to
Are external positive and negative - When do they receive QC from NRL or country guidelines
quality control (QC) specimens routinely facility laboratory (e.g., weekly, monthly Note: Mark “Yes” if there is evidence of
5.5
used (e.g., daily, weekly, monthly) in a batch, etc.)? consistent use of QC samples per
according to country guidelines? - What type of QC is being used (e.g., serum, guidelines.
plasma, DTS)? Mark “Partial” if there is evidence of
- How often QC is performed based on inconsistent use of QC samples.
country guidelines (e.g., weekly or Mark “No” if there is no evidence of QC
monthly, every new lot, environmental samples being tested.
conditions change)?

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 Guidelines for SPI-RRT Checklist

- Note correct terminology of QC based on

country context. Some countries term it
IQC.
Verify the following:
- Quality controls results are
documented in the QC log or testing
register/logbook
- How the QC results are recorded
and interpreted (Negative/Positive
or non-reactive/reactive)?
5.6 Are QC results properly recorded? - Who does the QC testing?
Note: Mark “Yes” if there is evidence of
consistent documentation of QC results.
Mark “Partial” if there is evidence of
inconsistent documentation of QC
results.
Mark “No” if there is no evidence of
documentation of QC results.
Ask the following: Verify the following:
- To see the quality control logs or testing - Quality controls that have
register/logbook incorrect/invalid results are
documented in the QC log or testing
register/logbook
Note: Mark “Yes” if there is evidence of
consistent documentation of
incorrect/invalid QC results. If testers
Are incorrect and/or invalid QC results state that they never had an
5.7
properly recorded? incorrect/invalid QC result, they should
be able to describe what it looks like and
how would they record it if it happens
Mark “Partial” if there is evidence of
inconsistent documentation of
incorrect/invalid QC results.
Mark “No” if there is no evidence of
documentation of incorrect/invalid QC
results and/or tester does not know what
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 Guidelines for SPI-RRT Checklist

an incorrect/invalid QC result is or how

to document it.

Verify the following:

- Procedures or guidelines on how to
handle QC failures
- Documentation of QC failure and
corrective action
Note: Mark “Yes” if there is evidence of
consistent documentation of steps taken
to troubleshoot QC failures as well as
Ask the following: results of retesting. If testers state that
- To describe the actions taken to address they never had a QC failure, they should
Are appropriate steps taken and
failed or invalid controls received by the be able to describe what steps to take to
5.8 documented when QC results are
lab troubleshoot
incorrect and/or invalid?
- To see the quality controls log or testing Mark “Partial” if there is evidence of
register/logbook inconsistent documentation of steps to
troubleshoot QC failures as well as
results of retesting.
Mark “No” if there is no evidence of
documentation of steps taken to address
QC failures as well as results of retesting.
Or tester does not know what steps to
take to troubleshoot and document QC
failures.
- Verify the signature of the person-
Ask the following:
in-charge or facility lab technician
- To see the quality controls log or testing
Note: Mark “Yes” if there is evidence of
register/logbook to ensure routine review
Are QC records reviewed by the person consistent review of QC records by the in-
5.9 by the person-in-charge or facility lab
in charge routinely? charge or facility lab technician.
technician
Mark “Partial” if there is evidence of
- How often they are supposed to review it
inconsistent review QC results by the in-
and when it is actually done?
charge or facility lab technician.

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 Guidelines for SPI-RRT Checklist

Mark “No” if there is no evidence of

review of QC results by the person in
charge or facility lab technician
SECTION QUESTIONS WHAT TO ASK FOR? WHAT TO LOOK FOR?
POST TESTING DOCUMENTS AND Documents and procedures (SOPs/job aides) regarding reporting and reviewing
6.0
RECORDS results are implemented
Verify the following:
- Tester is aware of the national
standardized HIV testing
register/logbook
- National standardized HIV testing
register/logbook is being used
Is there a national standardized HIV
Note: Mark “Yes” if the nationally
6.1 rapid testing register/logbook available
approved register is available and
and in use?
properly used
Mark “Partial” if the nationally approved
register is available but inconsistently
used
Ask the following: Mark “No” if the nationally approved
- If the site has an HIV testing register is not available or not used
register/logbook - Key elements such as, kit names, lot
- To see the HIV testing register/logbook numbers, expiration dates, client
demographics, tester name, unique
Are all the elements in the HIV rapid ID, individual and final HIV results
testing logbook/register Note: Mark “Yes” if the nationally
recorded/captured correctly? (e.g., kit approved register captures all key QA
6.2
names, lot numbers, expiration dates, elements
client demographics, tester name, Mark “Partial” if the nationally approved
individual and final HIV results, etc.)? register captures some key QA elements
Mark “No” if the nationally approved
register does not capture key QA
elements
Is the total summary at the end of each Verify the following:
6.3 page of the register/logbooks complied - All of the fields are accurately
accurately? completed and the QA elements

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 Guidelines for SPI-RRT Checklist

(e.g., kit names, lot numbers,

expiration dates, client
demographics, tester name,
individual and final HIV results,
etc.) are captured correctly
- Results recorded consistently the
same way every time
- Results recorded based on country
guidelines (e.g., NR/R/INV for
individual results and
NEGATIVE/POSITIVE/
INDETERMINATE or
INCONCLUSIVE for the final result)
- Results are written legibly if they
are not pre-printed in the testing
register/logbook
Note: Mark “Yes” if all key QA elements
are documented consistently and is
properly used and maintained
Mark “Partial” if key QA elements are
documented inconsistently but is
properly maintained
Mark “No” if key QA elements are not
documented or is not properly
maintained
Are invalid test results recorded - Verify that invalid results were
6.4
properly in the register/logbook? recorded
Ask the following: - Verify that the invalid result was
- If tester has recently encountered any properly recorded and repeated
invalid results Note: Mark “Yes” if there is evidence that
- To describe the procedure for addressing invalid results are being recorded
Are appropriate steps taken and
6.5 and documenting invalid test results consistently in the logbook as well as
documented when a result is invalid?
- To see the logbook/testing results of repeat testing. If testers state
register/logbook that they never had an invalid, the tester
should be able to describe the procedure
for troubleshooting an invalid result.

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 Guidelines for SPI-RRT Checklist

Mark “Partial” if there is evidence of

inconsistent documentation of invalid
results including results of repeat testing
Mark “No” if there is no evidence of
documentation of invalid results
including results of repeat testing
and/or tester does not know how to
handle an invalid result
- Verify that the supervisor or person
in-charge reviews and signs at the
end of each logbook page
Note: Mark “Yes” if there is evidence of
consistent review by supervisor or
Are the register/logbook pages routinely Ask the following: person in-charge.
6.6 reviewed for accuracy and completeness - To see the HIV testing Mark “Partial” if there is evidence of
by the person in charge? register/logbook inconsistent review of the
logbook/register pages by the supervisor
or person in-charge
Mark “No” if there is no evidence of
documentation of review by supervisor
or person in-charge
- Verify the client information is
handled to ensure confidentiality
Note: Mark “Yes” if there is evidence all
clients’ information is properly handled
Ask the following: to ensure confidentiality.
Are all client documents and records - To describe the measures taken to ensure Mark “Partial” if there is evidence of
6.7 securely kept throughout all phases of confidentiality of client information inconsistent practice to ensure client
the testing process? throughout each phase of testing (e.g., confidentiality
pretesting, testing, post-testing) Mark “No” if there is evidence that the
clients’ information is not treated as
confidential (e.g., clients demographic
and HIV register accessible to all) and
may result in a confidentiality breach.

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 Guidelines for SPI-RRT Checklist

- Verify location where documents

are stored to ensure they are secure
when testing is not being done.
Note: Mark “Yes” if there is evidence all
documents and records are properly
Ask the following: handled and kept secure (locked cabinet,
Are all registers/logbooks and other - To describe where registers/logbooks and drawer, etc.).
6.8 documents kept in a secure location other testing documents are kept when Mark “Partial” if there is evidence of a
when not in use? they are not testing (e.g., on short breaks, secure location (locked cabinet, drawer,
when testing is completed for the day) etc.) to store documents and records but
they are not kept secure consistently.
Mark “No” if there is no evidence that the
documents and records are properly
handled and kept secure (locked cabinet,
drawer, etc.).
- Verify that the registers are
organized, properly labeled and
easily retrievable (good filing
system)
Ask the following: Note: Mark “Yes” if there is evidence all
Are registers/logbooks properly labeled - To describe the procedure and show registers/logbooks are properly labeled
6.9
and archived when full? where the registers are archived once they and archived when full.
are full Mark “Partial” if there is evidence some
registers/logbooks are not properly
labeled and archived when full.
Mark “No” if there is label and archive
system when registers/logbooks are full
SECTION QUESTIONS WHAT TO ASK FOR? WHAT TO LOOK FOR?
EXTERNAL QUALITY ASSESSMENT Testing sites are periodically audited for performance and Audited if quality
7.0 (PROFICIENCY TESTING AND SITE assurance procedures are followed and documented
SUPERVISION)
Ask the following: - Verify if EQA/PT program is either
Is the testing point enrolled in an - If the site receives specimens (e.g., DTS site specific or tester specific
7.1
EQA/PT program? from the National Reference Laboratory
(NRL) for testing and returns the results to

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 Guidelines for SPI-RRT Checklist

NRL (e.g., central lab in the capital) for - Verify documentation of EQA/PT
scoring participation (e.g., HIV testing
- If the EQA/PT panels are rotated among register, QC log, EQA/PT forms)
multiple testers - Verify the most recent EQA/PT
- If EQA/PT program is specific to results, and if more than one year,
individual testers document in the comments field to
follow-up with the NRL
Note: Mark “Yes” if there is evidence that
the testing point, or all testers are
enrolled and participate regularly in
EQA/PT program.
Mark “Partial” if there is evidence the
testing points and/or testers are enrolled
but do(es) not participate regularly in
EQA/PT program.
Mark “No” if there is no evidence of
enrollment or participation.
- Verify which testers participated in
the most recent round; if no one
participated, document why in the
comment field.
Note: Mark “Yes” if all HIV rapid testers
at the site have had an opportunity to
Ask the following:
Do all testers at the testing point test the - How many testers have performed test EQA/PT panels and returned results
7.2 to the NRL.
EQA/PT samples? EQA/PT testing?
- Documentation of EQA/PT test results Mark “Partial” if not all HIV rapid testers
at the site have had an opportunity to
tested EQA/PT panels and returned
results to the NRL.
Mark “No” if none of the testers at the
site has ever participated in the PT
program.

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 Guidelines for SPI-RRT Checklist

- Verify that the person in charge or

the facility lab technician reviews
the results (e.g., signature and date)
Ask the following: Note: Mark “Yes” if there is evidence of
- If results of EQA/PT samples received
review of EQA/PT results every EQA/PT
Does the person in charge at the testing from NRL (e.g., DTS) are reviewed by the
7.3 point review the EQA/PT results before person in charge or the facility lab distribution.
submission to NRL or designee? technician Mark “Partial” if there is evidence of
- To see results form, if available or QC/QA inconsistent review of EQA/PT results.
log Mark “No” if there is no evidence of
review of EQA/PT results for every
EQA/PT distribution.
Ask the following: - Verify tester and person in charge
- If NRL sends reports on site performance review of the report (e.g., signature
- If the report received by testing point is and date)
reviewed by testers and person in charge Note: Mark “Yes” if there is evidence of
Is an EQA/PT report received from NRL - To see documentation of review of the review of site or testers’ performance for
7.4 and reviewed by testers and/or the EQA/PT reports every EQA/PT distribution.
person in charge at the testing point? Mark “Partial” if there is evidence of
inconsistent review of site or testers’
performance.
Mark “No” if there is no evidence of
review of site or testers’ performance.
Ask the following: - Verify what corrective actions were
- To describe procedures to implement taken, when, and by whom.
corrective actions in case of a low score - Verify evidence of improvement if a
- To see if there is evidence of corrective low score was obtained prior to the
Does the testing point implement actions being implemented last round.
7.5 corrective action in case of - To indicate how long it takes to implement Note: Mark “Yes” if there is evidence that
unsatisfactory results? the corrective actions taken after report is corrective action is implemented
received consistently every EQA/PT distribution.
Mark “Partial” if there is evidence that
corrective action is implemented
inconsistently.

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 Guidelines for SPI-RRT Checklist

Mark “No” if there is no evidence that

corrective action is implemented.

Ask the following: - Verify the site visit report

- If the site receives a supervisory visit from - Verify in the site report if direct
Does the testing point receive periodic
7.6 the region or NRL/Program. observation of client testing was
supervisory visits?
- The frequency and purpose of the visits conducted.
- To see the reports from the visits - Verify if deficiencies are noted and
Ask the following: corrective actions are taken.
- If the visit of the supervisory team occurs - Verify documentation of retraining
Is feedback provided during supervisory
7. 7 during client testing where needed.
visit and documented?
- If so, ask if the team is in the room while Note: Mark “Yes” if there is adequate
HTC services are being offered to client evidence of supervisory visits and
Ask the following: documentation of findings and corrective
- If during the supervisory team visit, actions provided.
testers are retrained on specific aspects of
Mark “Partial” if there is inadequate
If testers need to be retrained, are they HTC (e.g., counseling, specimen collection,
evidence of supervisory visits and
7.8 being retrained during the supervisory testing, documentation, reporting results,
documentation of findings and corrective
visit? etc.), if needed
actions provided.
Mark “No” if there is no evidence of
supervisory visits or documentation of
findings and corrective actions provided.
If the country has implemented HIV-1 Recent Infection Surveillance and the site is performing the Rapid Test for Recent Infection
(RTRI) proceed with questions 8.1-8.10.
Otherwise, STOP here.
HIV-1 RECENT INFECTION
All safety, testing and documentation procedures are implemented during
8.0 SURVEILLANCE USING THE RAPID
throughout the three phases of testing
TEST FOR RECENT INFECTION
- Verify dates of trainings
Have all testers received a
8.1* Ask the following: - Verify training contents including
comprehensive training on RTRI?
hands-on sessions
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 Guidelines for SPI-RRT Checklist

- How many testers are trained on Note: Mark “Yes”, if training documents
RTRI? are available and content include all
- For documentation of training (e.g., quality elements (e.g., safety, EQA/PT,
waste management, inventory, QC
certificates) for all testers including
documents and records, testing
any refresher training procedures, etc.)
- For training manual or training Mark “Partial”, if training documents are
competency criteria available but content does not include all
quality elements or not all testers at the
site that are supposed to perform RTRI
testing are trained
Mark “No” if tester has not been trained
or evidence of training is not available
- Verify documentation of direct
observation of the tester
performing RTRI testing by
trainer, supervisor or person in-
charge (e.g., signature and date)
- Verify personnel training log
indicating the trainer or
Are there records indicating all testers Ask the following:
supervisor signature and date
8.2* have demonstrated competency in RTRI - For documentation of competency
Note: Mark “Yes”, if demonstrated
prior to testing? assessment for all testers
competency is well documented for all
testers
Mark “Partial”, if demonstrated
competency is well documented for some
but not all of the testers
Mark “No” if there is no documentation
of demonstrated competency
- Verify that the relevant job aides
Ask the following:
and/or SOPs on recency testing
- To see all relevant SOPs or job aides on the
Are all current versions of recency SOPs process is available.
following:
8.3* and/or job aids readily available at the - Verify that the job aides/SOPs are
- RTRI testing
site? current, accurate and complete and
- Enrollment and consent process
follows testing algorithm (i.e., RTRI
- Counseling
is run after national testing
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 Guidelines for SPI-RRT Checklist

- Specimen collection and transport (if viral algorithm is completed or run in

load testing is being implemented for parallel with second test in HIV
Recent Infection Testing Algorithm rapid test algorithm)
[RITA]) - If testing can be observed during
- Return of results (if applicable) audit, verify that the tester refers to
- Data collection and management the job aides/SOPs during testing
and the procedures followed
Note: Mark “Yes” if job aides/SOPs are
available, current, referred and adhered
to during testing process.
Mark “Partial” if job aides are available,
current, but not adhered to consistently
during testing process.
Mark “No” if job aides are not available
or current and not being adhered to.
- Based on testing volume, verify
Ask the following
the site has enough RTRI kits
- To see the supply of RTRI test kits
Note: Mark “Yes” if there is evidence that
- To see stock card
the kits are in sufficient amount
Is there a sufficient supply of RTRI tests - For estimated number of tests used
Mark “Partial” if there is evidence that
available at the site? per time period (e.g., per month) or
8.4* supplies of the kits are insufficient or
Please provide number of tests currently check register to estimate number of
inconsistent
available……. patients tested within a particular
Mark “No” if there is evidence that there
time period (to compare to number of
is not enough test kit to perform testing
kits available & gauge whether
at the time of audit and there are
sufficient numbers are available)
frequent stock outs
- Verify storage conditions are
appropriate based on
manufacturer’s instructions (e.g.,
Ask the following: stored between 2-30°C, away from
Are the test kits kept in a temperature-
- To see where test kits and other supplies direct sunlight)
8.5* controlled environment based on the
are being stored? - Thermometer is used to monitor
manufacturers’ instructions?
temperature in storage area and
temperatures are documented
- if applicable, in functioning
refrigerator. If test kit is stored in
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 Guidelines for SPI-RRT Checklist

refrigerator then the tester takes it

out for at least 30 mins to reach
room temp prior to testing
Note: Mark “Yes” if all storage
conditions are met and monitored on a
routine basis
Mark “Partial”, if some storage
conditions are met (i.e., kits located in
temperature-controlled environment,
but temperature is not being monitored
on a regular basis)
Mark “No” if none of the storage
conditions are met
If testing can be observed during audit,
verify the following:
- Testing procedure is followed
- Tester does not have multiple test
devices at the time they are testing
one client
- Tester has pre-set their timer
- The right volume of sample is being
added using the correct specimen
Are RTRI testing procedures being Ask the following: collection device
followed (i.e., right volume of sample - To observe client testing - Right buffer and buffer volume
8.6* using correct sample application device, - For a description of the testing procedure Note: if buffer tube is required (i.e.,
correct read time using timer, correct from the time client is received, if testing Asante) - the test strip is placed
result interpretation)? cannot be observed. correctly in the buffer tube (i.e. -
sample pad down first)
- Adherence to the required read
time
Note: Mark “Yes” if there is evidence of
consistent adherence to all testing
procedures.
Mark “Partial” if there is evidence of
inconsistent adherence to all testing
procedures.
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 Guidelines for SPI-RRT Checklist

Mark “No” if there is evidence of non-

adherence to all testing procedures.
Verify the following:
- All of the fields are accurately
completed and the QA elements
(e.g., kit names, lot numbers,
expiration dates, client
demographics, tester name, etc.) are
captured correctly
- Results recorded consistently the
same way every time
- Recency results recorded correctly
(i.e., field checked for presence of
control line, verification line and
long-term line,
- Final interpretation recorded
Are the RTRI results documented in the
correctly (i.e., Negative, Recent,
data capture form or logbook correctly Ask the following:
Long-term)
(e.g., client demographics, kit name, lot - To see the Recency data capture form or
- Results are written legibly if they
8.7* number, expiration dates, tester name, logbook
are not pre-printed in the testing
RTRI visual results and recency
register/logbook
interpretation) and reviewed by person
- Person in charge signs & dates
in charge?
review of register
Note: Mark “Yes” if all key QA elements
are documented consistently and is
properly used and maintained and
person in charge signs & dates after
review
Mark “Partial” if key QA elements are
documented inconsistently or no
indication that document is reviewed by
person in charge
Mark “No” if key QA elements are not
documented, is not properly maintained
and/or not reviewed by the person in
charge

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Ask the following: Verify the following:

- If the National Reference Laboratory - Long-term (LT), Recent and
(NRL) or facility laboratory provides Negative controls are available for
controls for RTRI testing RTRI testing
- When do they receive QC from NRL or - Expiration date of QC material
Are external quality control (QC)
facility laboratory (e.g., weekly, monthly - Frequency of QC used according to
specimens (i.e., long-term (LT), recent
8.8* in a batch, etc.)? SOP
and negative) routinely used (i.e.,
- What type of QC is being used (e.g., serum, Note: Mark “Yes” if there is evidence of
monthly) for RTRI?
plasma, DTS)? consistent use of QC samples per SOP.
- How often QC is performed (e.g., monthly, Mark “Partial” if there is evidence of
every new lot, environmental conditions inconsistent use of QC samples.
change)? Mark “No” if there is no evidence of QC
samples being tested.
Verify the following:
- Quality control results are
documented in the QC log or testing
register/logbook
- How the QC results are recorded
and interpreted (field ticked for
presence of control line, verification
Are QC results for RTRI properly line and long-term line,
recorded (e.g., kit name, lot number, - Final interpretation recorded
Ask the following:
expiration dates, tester name, RTRI correctly (i.e., Negative, Recent,
8.9* - To see the quality control logs or testing
visual results and recency interpretation Long-term)
register/logbook
for each level of QC) and reviewed by the - Who does the QC testing (i.e.,
person in charge? testing per site or per tester)?
Note: Mark “Yes” if there is evidence of
consistent documentation of QC results.
Mark “Partial” if there is evidence of
inconsistent documentation of QC
results.
Mark “No” if there is no evidence of
documentation of QC results.
Verify the following:
Are appropriate steps taken and
8.10* - Quality controls that have incorrect
documented according to the SOP or
results (QC failure) are documented
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 Guidelines for SPI-RRT Checklist

guidelines when RTRI QC results are in the QC log or testing

incorrect? register/logbook
- Repeat testing of Quality controls
are done if the results are incorrect
Note: Mark “Yes” if there is evidence of
consistent documentation of QC failures
results, repeat testing is done and
recorded
Mark “Partial” if there is evidence of
inconsistent documentation of QC
failures, repeat testing is done and
recorded.
Mark “No” if there is no evidence of
documentation of QC failures and/or the
tester does not know the steps to take if
QC fails.
Verify the following:
- Invalid test results (if any) are
documented in the test result
register or data capture form
- Invalids are repeated (based on
SOP)
Ask the following: Note: Mark “Yes” if there is evidence of
Are appropriate steps taken and
- To see register or data capture form consistent documentation of invalids,
documented according to the SOP or
- For a description of what is done if an repeat testing is done and recorded
8.11* guidelines for invalid RTRI test results?
invalid is obtained as a result, if no invalids Mark “Partial” if there is evidence of
If yes, how many in the last 3
are documented in the register or data inconsistent documentation of invalid
months…………
capture form results or repeat testing is not done and
recorded.
Mark “No” if there is no evidence of
documentation of invalid results and the
tester cannot articulate the proper
procedure to perform when an invalid is
obtained.

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Part D. Auditor’s Summation Report for SPI-RRT Audit

Facility Name: No. of Tester(s): Section 1 2 3 4 5 6 7 8 Total

Site Type: Audit Start Time (hh:mm): Score Received a=

Expected Score 10 5 11 13 9 9 8 11 b=

Site code (if applicable): Audit End Time (hh:mm):

% Score = (a/b) x 100 = (_____________/_________) x 100 = __________%
Staff Audited Name: Duration of Audit:
Performance Level:
0 1 2 3 4
(<40%) (40-59%) (60-79%) (89-90%) (>90%)

Correction Actions Recommendations

Section Auditor’s
Deficiency/Issue observed Timeline / Person
No. Comments Immediate Follow up Actions
responsible

Staff Audited Signature: Auditor Name and Signature:

Person in Charge Name and Signature: Date (dd/mm/yyyy):

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Guidelines for SPI-RRT Checklist

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