MINISTRY OF HEALTH

ZAMBIA HIV POINT OF CARE

CERTIFICATION FRAMEWORK
Ensuring the Reliability and Accuracy of Point of Care Test Results

2019
©2019 Ministry of Health
TABLE OF CONTENTS

FOREWORD .............................................................................................. v
ACKNOWLEDGEMENT ................................................................................ vii
ABBREVIATIONS AND ACRONYMS .................................................................... ix
GLOSSARY OR TERMS .................................................................................. x
1. PURPOSE, AUDIENCE AND SCOPE............................................................... 1
1.1. Purpose ..................................................................................... 1
1.2. Audience .................................................................................... 1
1.3. Scope ........................................................................................ 1
2. BACKGROUND ..................................................................................... 2
3. GOAL AND OBJECTIVES OF THE POCT CERTIFICATION PROGRAMME ...................... 4
3.1. Goal ......................................................................................... 4
3.2. Objectives .................................................................................. 4
4. NATIONAL POINT OF CARE TESTING CERTIFICATION PROGRAM ........................... 5
4.1. Governance structure ..................................................................... 5
4.2. National level – Ministry of Health: ..................................................... 6
4.3. Health Professions Council Of Zambia (HPCZ) ........................................ 6
4.4. National Reference Level ................................................................ 6
4.5. Provincial Health Office (PHO) .......................................................... 7
4.6. District Health Office (DHO) ............................................................. 7
4.7. Facilities and POCT sites (public and private) ........................................ 8
4.8. Standards for POCT certification ........................................................ 9
4.9. Training of auditors ....................................................................... 9
4.10. Auditing for compliance with standards ............................................... 9
5. POCT TESTER CERTIFICATION ................................................................ 10
5.1. Roles and Responsibilities .............................................................. 10
5.2. Training and maintenance of certification .......................................... 11
5.3. National training program .............................................................. 11
5.4. Mentorship ................................................................................ 11
5.5. Continuing Education ................................................................... 11
5.6. Certification examinations ............................................................. 12
5.7. Tester certification criteria ............................................................ 12
5.8. POCT Tester certification process .................................................... 12
6. POCT SITE CERTIFICATION .................................................................... 14
6.1. POCT Site Certification Stakeholders and Roles .................................... 14

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 6.2. Site certification process ............................................................... 15
7. MONITORING AND EVALUATION .............................................................. 18
REFERENCES .......................................................................................... 19

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TABLE OF FIGURES

Figure 1. POCT across the tiered national health care system.. ............................... 1

Figure 2. Governance structure for the POCT certification programme....................... 5

Figure 3. Stakeholder responsibilities for POCT site certification. ........................... 14

Figure 4. Summary of the POCT site certification process. ................................... 17

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FOREWORD

HIV and AIDS is a public health concern in Zambia and the Government of the Republic
of Zambia and its partners have continued to prioritise investment into the HIV
response. It is encouraging that Zambia has remained on course in attaining HIV
epidemic control but it’s important that we sustain all the gains made so far beyond
epidemic control.

The HIV incidence in the 15 to 59 year olds in the country reduced from 77,500 in
2010 to 43,000 in 2016 (ZAMPHIA, 2019) while from a total of 1,2 million people living
with HIV, 1 million were on ART as at first quarter of 2019 (HMIS Report 2019).

HIV testing is the gateway to HIV prevention, treatment, care and other support
services. People’s knowledge of their HIV status through HIV testing services is key to
the success of the HIV response. Despite the remarkable increase in the knowledge of
places to get an HIV test, the uptake of HIV testing remains low in both women (46%)
and men (37%) who had tested in the past 12 months and received results (ZDHS,
2013-14).

According to the Zambia National Health Strategic Plan 2017 – 2021, one of the goals
of the HIV programme over the next five years is to reduce new HIV infections and
AIDS related mortality by 75%. Accurate HIV diagnosis will be crucial if this ambitious
goal was to be achieved.

The UNAIDS 90–90–90 targets call for 90% of all people with HIV to be diagnosed,
provision of anti-retroviral therapy (ART) to 90% of people diagnosed with HIV, and
90% of those on ART to have a suppressed viral load by 2020 (UNAIDS, 2016). The
diagnosis of HIV (first 90%) is essential to the second 90% (initiation of ART) among
people with HIV and the ultimate outcome of the third 90 (viral load suppression)
among people on ART.

In order to increase access to HIV testing services, the Ministry of Health working with
stakeholders introduced innovative approaches which include point of care testing
(POCT), among others. The recently released WHO handbook on Improving the Quality
of HIV Related Point-of-Care Testing: Ensuring the Reliability and Accuracy of Test
Results was developed to address the weaknesses identified in existing HIV related
point-of-care testing (POCT) programmes. One of the innovative minimum standards
emphasized in the handbook is the certification program for POCT testers and sites.

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These guidelines have been developed to provide guidance to national, provincial and
district health management staff on the implementation of the certification
programme that will ensure quality and reliable HIV test results. Accurate HIV test
results are critical to the achievement of MOH legacy goal number 6 which sets out to
achieve epidemic control, reduce HIV new infection from 43,000 to less than 5,000.

The District Health Offices are called upon to spearhead the implementation of this
programme by identifying the gaps at the HIV testing sites that cause the issuance of
unreliable HIV test results, providing corrective action and recommending sites for
certification. The District Health Offices are also called upon to ensure that all HIV
test providers are competent to perform HIV rapid testing.

This inaugural POCT certification framework for testers and sites describes the
minimum standards aimed at promoting and ensuring quality assurance (QA) and
quality improvement (QI) processes for HIV-related POCT in Zambia.

It is my expectation that this HIV Point of Care certification framework shall be fully
utilised for us to enhance the quality of HIV testing services offered to our people.

Hon. Dr. Chitalu Chilufya, MP.

Minister of Health

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ACKNOWLEDGEMENT

The Ministry of Health wishes to extend its deepest thanks to all those who have,
directly or indirectly, contributed to the development of this first edition of the
Zambia Point of Care Testing (POCT) Certification Framework.

The Ministry acknowledges with gratitude, the support from the Centers for Disease
Control and Prevention (CDC) and the Foundation for Innovative New Diagnostics
(FIND). The Ministry appreciates the committed partnership it enjoys with these and
many other stakeholders.

The team of contributors that was assembled from different stakeholders to provide
the real-world experiences that were necessary to render this framework a practical
document is recognized for their input.

The Ministry of Health wishes to extend its deepest thanks to all those who have,
directly or indirectly, contributed to the development of this first edition of the
Zambia Point of Care Testing (POCT) Certification Framework.

Dr. Kennedy Malama

Permanent Secretary – Technical Services
Ministry of Health

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LIST OF CONTRIBUTORS

Dr Moses Sakala University Teaching Hospital Laboratory

Dr Hamakwa Mantina University Teaching Hospital Laboratory
Mr Mutale Mubanga University Teaching Hospital Laboratory
Ms Inonge Ellen Wamulume University Teaching Hospital Laboratory
Mrs Chinda Goma Mwiinga Biomedical Society of Zambia
Mrs Eunice A Masi National AIDS Council
Dr Virginia Walubita National AIDS Council
Mr Peter Ndemena National AIDS Council
Mr Moses Chimfwembe Health Professions Council of Zambia
Mrs Njeleka Banda Chabala Centers for Disease Control and Prevention (CDC)
Nsofwa D.M. Mphande Centers for Disease Control and Prevention (CDC)
Mr Kennedy Nkwemu Centers for Disease Control and Prevention (CDC)
Ms Chilweza Muzongwe Ministry of Health – Policy and Planning
Mr Davy Nsama Ministry of Health – Laboratory Services Unit
Mrs Fales Mwamba Ministry of Health – Laboratory Services Unit
Mrs Veronica Muntanga Ministry of Health
Mr Cunningham Kafweta Project Concern International (PCI), Zambia

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ABBREVIATIONS AND ACRONYMS

ASCP American Society for Clinical Pathology

CLSI Clinical and Laboratory Standards Institute
CQI Continuous Quality Improvement
EQA External Quality Assessment
HTC HIV testing and counselling
HTS HIV testing services
ISO International Organization for Standardization
JCI Joint Commission International
M&E Monitoring and evaluation
MOH Ministry of Health
NGO Nongovernmental organization
NRL National reference laboratories
POCT Point-of-care testing
PPE Personal protective equipment
QA Quality assurance
QC Quality control
QI Quality improvement
QMS Quality management system
QSE Quality system essential
RDT Rapid diagnostic test
SPI-POCT Stepwise Process for Improving the Quality of HIV-related Point-of-Care
Testing
SPI-RT Stepwise Process for Improving the Quality of HIV Rapid Testing
TB Tuberculosis
WHO World Health Organization

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GLOSSARY OR TERMS

Certification The process by which an independent and authorized agency assess the
quality system of a facility/site and/or competency of a tester on the
basis of certain pre-defined standards.

Facility Includes hospital, clinic, health centre, health post.

Tester Person performing HIV point of care testing

Testing site Place where point of care testing for HIV is taking place, e.g.
maternity ward, ART clinic, etc.

POCT Point of care testing. Testing performed near or at the site of a

patient,
with the result leading to possible change in the care of the patient.
(ISO 22870:2016)

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1. PURPOSE, AUDIENCE AND SCOPE

1.1. PURPOSE
The purpose of this document is to establish a framework for the national certification of
POCT sites and testers.

1.2. AUDIENCE
This certification framework is intended for use by Ministry of Health (MOH) technical
officers, policy makers, programme managers, implementing partners involved in in policy
development, planning, and implementation of POCT. The framework is also intended for
POCT site supervisors/coordinators involved in the oversight and execution of POCT services
at site level.

1.3. SCOPE
This certification framework is applicable to HIV rapid testing across the tiered national
health system levels (Figure 1) and applies to both laboratory and non-laboratory settings.
This certification programme shall also apply to HIV POCT in all private facilities and non-
governmental organisations which oversee or incorporate HIV-related POCT for patient care
and management.

NRL, central hospital lab and clinics. Lab

professionals. HCWs, Supervisory team, QA officers
Central

Lab and non-lab testing sites. Lab professionals,

Province HCWs, supervisory team/ QA officers

Lab and non-lab testing sites, Lab professionals,

District HCWs.

Primary care Non-lab testing sites. HCWs. Counselors

Community Mobile and door-to-door testing. Counselors, lay

counselors

Figure 1. POCT across the tiered national health care system. Lab. Laboratory; NRL. National Reference
Level. HCW. Health Care Workers. QA. Quality Assurance.

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2. BACKGROUND

Rapid diagnostic and recently POCT technologies have become widely available in the last
few years and have shown to play a major role in achieving increased access to diagnostics.
As access to POCT expands, there is need for simple, practical and low cost innovative
approaches to ensure sustainable quality assurance practices that lead to accurate and
reliable patient results and improved public health outcomes. However, challenges remain
regarding the implementation of quality assurance programs for POCT. Limited human
resources, unavailability of testing supplies and the under-utilization of testing data for
timely corrective action in most resource-limited settings have hindered the complete and
seamless implementation of certification-related monitors for quality systems.

Although concerns may be raised about cost of implementing quality assurance programs for
POCT, the cost of failing to assure accurate and reliable test results are inestimable.
Therefore, an investment in a national certification program for POCT may not only prove to
be a healthcare cost savings, but also an expansion of quality of care.

There is now a growing need for innovative methods and practices to assist testing sites and
testers with the improvement and maintenance of quality, while leveraging existing
resources. The clinical governance would allow health-care providers to be accountable for
improved quality of POCT services and safeguard high standards of care. The
implementation and maintenance of a POCT site and tester certification programme will
improve credibility of patient results.

The national certification programme for POCT sites and testers will provide an umbrella
under which all aspects of HIV testing quality can be gathered and continuously monitored.
Site certification, including regular on-site supervision, mentoring and site audit, has been
identified as an important method to meet and maintain quality in countries with growing
numbers of rapid diagnostic and POCT sites.

Likewise, tester certification along with standardised hands-on training, ongoing supervision
and competency assessment are critical to ensuring accurate and reliable rapid diagnostic
and POCT results. National site and tester certification can be used to verify that the site is
equipped and personnel are competent to conduct testing according to established national
and/or international quality standards.

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Quality improvement requires reassessing and addressing current weaknesses across all
quality system essentials. Addressing the common quality-related causes of incorrect results
and errors requires making a concerted effort at all levels to systematically improve and
assure the quality of testing.

A systematic approach that includes development of appropriate policies, processes, and

procedures around the quality of POCT should be adopted and a stepwise process including
proper planning and implementation should be considered at all levels by national
programs.

Therefore, this document underscores the need for strong leadership, dedicated funding for
quality assurance, advocacy, new innovations and better coordination for continuous quality
monitoring and improvement in HIV-related POCT.

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3. GOAL AND OBJECTIVES OF THE POCT CERTIFICATION
PROGRAMME

3.1. GOAL

To ensure the quality of HIV-related POCT services through certification of testing

sites and testers in order to safeguard high standards of care and credibility of HIV
POCT results.

3.2. OBJECTIVES

• To certify POCT sites every two years

• To certify POCT testers every two years

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4. NATIONAL POINT OF CARE TESTING CERTIFICATION PROGRAM

4.1. GOVERNANCE STRUCTURE

The vision of the Ministry of Health (MOH) is to provide Zambians with equity of access to
effective quality health care services as close to the family as possible, through the Primary
Health Care Strategy which includes POCT such as HIV testing as stipulated in the 2017 –
2021 National Health Strategic Plan (NHSP). The national certification programme, and
health care in general, require good leadership and governance that provides vision and
policy direction. This is important to ensure efficient and effective programming that
guarantees reliability and accuracy of test results as well as encourage a culture of
continuous quality improvement for the programme.

National Level (Ministry of Health)

Overall national oversight and advisory services

Health(Health
Certifying Body Professions Council of
Professions Zambia of Zambia)
Council
Certification of POCT sites and testers
Provides standards, performs assessments, certifies sites and testers

National Reference Level, e.g. NAC NRLs, ZNPHI, BSZ,

Private Hospital representative
Provides technical support e.g. training, new technologies/QMS
implementation and audits

Provincial level
Provide provincial technical and management support to districts
and facilities/sites

District level
Provide district technical and management support to
facilities/sites

Facility level
Testing and implementing QMS

Figure 2. Governance structure for the POCT certification programme . QMS. Quality management system;
NAC. National Aids Council; POCT. Point of care testing; ZNPHI. Zambia National Public Health Institute; BSZ.
Biomedical Society of Zambia. NRLs. National Reference Laboratories.

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4.2. NATIONAL LEVEL - MOH:

4.2.1. Composition
• Permanent Secretary – Technical Services
• Director – Clinical Care and Diagnostic Services
• Director – Public Health
• Director – Health Promotion\\get full title
• Director – National Public Health Institute
• National Coordinator - Pathology and Laboratory Services

4.2.2. Responsibilities
• Provides overall national oversight and advisory services on POCT

4.3. HEALTH PROFESSIONS COUNCIL OF ZAMBIA (HPCZ)

4.3.1. Responsibilities
• The HPCZ shall be the certifying body
• Issue certificates of compliance and competency to testing sites and testers that
meet certification criteria, respectively.
• Maintain database of certified and uncertified sites
• Maintain database of certified testers
• Submit quarterly reports on certification of sites and testers to the permanent
secretary.

4.4. NATIONAL REFERENCE LEVEL

4.4.1. Composition
• National reference laboratories i.e. all University Teaching Hospital Laboratories
• National AIDS Council (NAC);
• Zambia National Public Health Institute (ZNPHI);
• Biomedical Society of Zambia (BSZ),
• Private Hospitals Representative(s)

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4.4.2. Responsibilities
• Develop training plans, training curricula, training tools and audit checklists
• Providing technical support e.g. training, new technologies/QMS implementation
and audits
• Coordinate annual stakeholders meeting for evaluation and dissemination of
performance data
• Participate in baseline and subsequent auditing of sites
• Assess technical competency of testers
• Provide quality management mentorship to testing sites/testers and help them
implement corrective actions
• Determine eligibility of sites and testers for certification
• Recommend sites and testers to HPCZ for certification
• Recommend sites and testers to HPCZ for suspension/withdrawal of certification

4.5. PROVINCIAL HEALTH OFFICE (PHO)

4.5.1. Composition
• The Provincial Health Director
• Provincial Biomedical Scientist

4.5.2. Responsibilities
• Assess sites and testers for eligibility for certification
• Coordinate public and private POCT sites in respective provinces
• Collaborate with the district to identify testing sites and testers
• Perform other duties as assigned by the national reference level

4.6. DISTRICT HEALTH OFFICE (DHO)

4.6.1. Composition
• District Health Director (DHD)
• District Laboratory Coordinator

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4.6.2. Responsibilities
• Coordinate public and private POCT sites in respective districts
• Provide technical support to facilities/sites in their respective districts
• Ensure implementation of corrective actions arising from audits
• Perform other duties as assigned by the provincial level

4.7. FACILITIES AND POCT SITES (PUBLIC AND PRIVATE)

4.7.1. Management commitment and responsibilities

• Ensure all POCT sites are implementing continuous quality improvement
• Prioritize sites to for certification
• Educate site personnel on site certification requirements.
• Ensure that sites and testers meet minimum requirements for certification.
• Develop internal audit procedures
• Ensure that internal audits are performed as per schedule and followed by
necessary corrective actions.
• Develop a contingency plan for continued service if assessments reveal unsafe
(unreliable) testing.

4.7.2. Responsibilities of personnel at POCT site level:

• Comply with all applicable national, sub-national, and facility POCT policies and
regulations
• Use appropriate tools available to perform internal audits at least once a year.
• Perform corrective actions according to audit findings
• Register with HPCZ and maintain valid practicing licence

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4.8. STANDARDS FOR POCT CERTIFICATION

The National Reference Level (see Figure 2) is responsible for adapting and developing POCT
standards for Zambia. The standards for the POCT certification programme in Zambia shall
be based on latest versions of the ISO 22870 Point-of-care testing (POCT) — Requirements
for quality and competence and ISO15189 “Medical Laboratories — Requirements for
Quality and Competence”. ISO15189 provides standards for quality management systems in
medical laboratories while ISO 22870 provides standards for quality testing and technical
competency of testers in the context of POCT. Applicable requirements in the two
standards will be consolidated into training materials, assessment checklists and tools that
will be used for site and tester certification.

4.9. TRAINING OF AUDITORS

Auditors will be trained and certified by the National Reference Level. The following are the
minimum qualifications for an individual to be trained as an auditor:

• Medical laboratory professional (minimum diploma)

• Minimum 2 years practical experience in a clinical laboratory
• should preferably be familiar with the POCT method/procedure currently adopted
in Zambia

4.10. AUDITING FOR COMPLIANCE WITH STANDARDS

In order to ensure smooth implementation of POCT certification programme, the National

Reference Level (Figure 2) shall develop implement the POCT standards and quality systems
through provincial and district medical offices. The certification of a tester or site means
that they have met the standards and requirement to perform POCT for a period of up to
two years. Site and tester re-certification will be done every two years upon satisfactory
compliance with the POCT standards.

As sites and testers may not achieve certification upon initial audit or competency
assessment and in order to ensure quality of testing, corrective actions must be
implemented with the aim of achieving certification within three months after receiving the
report of the initial audit.

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5. POCT TESTER CERTIFICATION

National tester certification is intended to ensure that all testing personnel are properly
trained and competent to conduct POCT and produce accurate and reliable test results.
When a POCT tester successfully completes training as well as passes the examination
process within the certification framework, this will result into personal achievement,
personal confidence, professional recognition and ultimately client satisfaction.
Furthermore, participation in tester certification shows continued demonstration of
theoretical knowledge and practical testing skills.

5.1. ROLES AND RESPONSIBILITIES

5.1.1. Management at the Testing Site
• Supervise testing personnel and provide annual performance feedback to testing
personnel.
• Promote and facilitate annual competency assessments for all testing personnel.
• Maintain training files/documentation for all testing staff, which includes the
following:

o Initial training completed on POCT and related quality assurance

o Initial certification documentation
o Refresher trainings and continuing education completed
o competency assessment results (at periodic intervals not exceeding 12
months).
o Recertification status and documentation
o Corrective action and remediation plan, if necessary

• Serve as invigilators during written and practical examinations.

• Serve as site points-of-contact) during certification, mentoring, and
recertification activities.
• Recognize/commend testing personnel who successfully complete national
tester certification and recertification processes.
• Track/Monitor recertification progress

5.1.2. Testing site personnel (testers)

• Complete national certification and re-certification processes.

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5.2. TRAINING AND MAINTENANCE OF CERTIFICATION

POCT devices may vary and can include rapid diagnostic tests (RDTs) and automated/semi-
automated machines. Eligibility requirements needed for candidates to be trained and sit
for the certification examination will depend on the complexity of the test and the
curriculum requirements.

5.3. NATIONAL TRAINING PROGRAM

The Ministry of Health will develop a nationally approved training curriculum for point of
care testers. All stakeholders will be required to use this training package which, at a
minimum, will stipulate:

• the duration
• minimum entry qualification
• mode of teaching, i.e. classroom didactic and practical sessions that will include
field observations during the testing process.

Ministry of Health will identify and certify a pool of trainers for POCT and all implementing
agencies will utilise the services of these nationally approved trainers.

Individuals trained by non-approved trainers will not be certified.

5.4. MENTORSHIP

Mentorship will be a strong component of the certification program as this is important for
the recertification process, remediation as well as corrective action processes. Experienced
and certified testers will serve as mentors during certification and recertification processes
and also serve as evaluators during written and practical examinations (competency
assessments and direct observation.) Management, supportive supervision team and quality
officers will also provide onsite mentorship as required.

5.5. CONTINUING EDUCATION

Continuing education will be provided based on approved curriculum and gaps that are
identified from audits. Continuing education will also be provided by professional bodies as
appropriate to the training needs. This will assist in maintaining POCT tester’s skills,
knowledge and competency.

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Refresher training covering POCT and related quality assurance issues will be based on
previously taught topics from the approved curriculum. Any new topics such as new
technologies introduced during refresher training sessions will be assessed as if it is an
initial training. Refresher training will be provided either on site or in a formal/classroom
setting. Length of the refresher training will vary based on the topics to be covered

5.6. CERTIFICATION EXAMINATIONS

All certification examinations will include both written and practical sessions. Standardized
written examination content (multiple-choice questions) and practical skills assessment
content (e.g. checklist items) will be part of the criteria to enable assessment of theoretical
knowledge and hands-on skills for all POCT testers. The examination will comprise the
following:
• Written: 25 multiple-choice questions
• Practical: Minimum of 5 unknown specimens

5.7. TESTER CERTIFICATION CRITERIA

All POCT personnel must pass both certification examination types (written and practical) in
order to be eligible for certification. In case of unsatisfactory score in any of the
examination types, POCT personnel will be mentored/coached to ensure that all POCT and
related quality components are well-understood before attempting to retake the
examination within a month following the previous examination. This examination will be
administered immediately after retraining.

The minimum pass criteria for initial certification and recertification is 80% for written
examinations and 100% for practical assessments.

5.8. POCT TESTER CERTIFICATION PROCESS

5.8.1. Initial Certification

• Tester will undergo MOH approved tester training.
• Following the training, the tester will have to sit for written and practical
examinations.
• Upon successful completion of training programme and examination, tester will
be recommended for certification by HPCZ.
• Certificate is valid for a maximum of two years.

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5.8.2. Re-certification
• Required every two years;
• Granted upon meeting acceptable performance criteria in competency
assessment.
• Will be granted upon completion of the following recertification requirements in
combination with the written examination:

o Direct observation
o Proficiency testing (minimum of five samples) all of which must be tested
correctly

5.8.3. Remediation Plan

In the event of poor performance in the certification/recertification examination,
the tester shall review the findings of the examinations and work with the
supervisor and/or the mentor to commence corrective actions within 30 days after
the assessment. After corrective actions have been implemented, the tester will
have to re-sit the certification examination within 3 months from the previous
examination/assessment. Remediation actions can involve any of the following
components as applicable:

• Mentoring.
• Annual competency assessments (two-parts: written and practical).
• Direct observation by site/testing supervisor.
• Proficiency testing (minimum of five samples).
• Refresher training.
• Continuing education (e.g., seminar, workshops/conferences, etc.).

5.8.4. Withdrawal of certification

Some circumstances warranting withdrawal of tester certification are listed below.

• Repeated failure (two times) to meet minimum pass requirements during

certification examination process and competency assessments
• Breach of ethical code of conduct.

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 6. POCT SITE CERTIFICATION

Site certification will ensure that compliance with standards and quality improvement
processes are continuously implemented in POCT sites. Certification will also ensure
recognition of sites as authorised to perform HIV POCT. The certificate issued by the HPCZ
will bear the scope of certification i.e. will show which tests the site is authorised to
perform.

6.1. POCT SITE CERTIFICATION STAKEHOLDERS AND ROLES

With regard to site certification, the roles of the different stakeholders are highlighted in
Fig. 3 below:

Provincial/ MOH/National
Sites Auditors HPCZ
District office Reference Level

Implement site- Conduct Monitor site Overall national

Certify sites
specific QMS certification audits performance oversight

Determine Help sites to

Conduct internal Maintain database
eligibility for site address audit Advisory services
audits of certified sites
certification nonconformities

Recommend sites Withdraw/

Implement Provide technical Developing POCT
to HPCZ for suspend
corrective actions support to sites standards
certification certification

Recommend
changes to audit Provide technical Submit quarterly Train auditors
tools support to sites reports to the PS

Figure 3. Stakeholder responsibilities for POCT site certification.HPCZ. Health Professions Council of Zambia;
MOH. POCT. Point of care testing Ministry of Health; QMS. Quality management system.

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6.2. SITE CERTIFICATION PROCESS

6.2.1. Site certification eligibility criteria

Eligibility for certification will be based on the adapted Stepwise Process for Improving the
Quality of HIV Rapid Testing (SPI-RT) Checklist (See Appendix). The SPI-RT checklists set
minimum standards for POCT and provide guidelines for continuous quality improvement.
The SPI-RT checklists scoring is based on percentage points representing the maximum
points possible. The scores are divided into five steps that correspond to quality compliance
levels. The sites audited are recognized as operating at one of the levels of compliance
(Table 1).

Table 1 Five-point level for compliance with quality standards for POCT sites
certification using the SPI checklists
Levels % Score Description
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% Needs improvement in specific areas
Level 3 80% - 89% Needs improvement in specific areas
Level 4 ≥ 90% Eligible for certification

6.2.2. Initial certification

Once notified by the DMO, the PMO will identify a team of certified auditors to audit the
POCT sites that would have obtained 90% score in the readiness audits conducted by the
DMO. Facility management and testing sites will be notified of the date of the certification
audit by the PMO. The team of certified auditors sent by the PMO will conduct the audit
perform the following tasks:

• Review internal audit reports.

• Review previous certification audit reports.
• Perform and document audit findings.

If the site meets all certification requirements, the site will be issued with a certificate by
HPCZ to conduct testing in the examination procedures audited

Note: Certification will not be granted if the site unduly delays, limits, or denies auditors access to the
testing site facility, processes, or records needed to verify conformance with certification requirements.

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6.2.3. Re-certification
In order to maintain continued conformity with certification criteria, the POCT sites will
seek re-certification through the DMO. The re-certification interval will be 2 years.

6.2.4. Remediation Plan

Site management shall review the findings of the audit and begin the process of
implementing the recommended corrective actions to address the deficiencies within 30
days of the audit. The site shall be reassessed within 3 months since the last audit. Where
possible, the site will just be required to send verifiable evidence of having addressed the
nonconformances which the PHO will review for verification of having resolved the audit
queries satisfactorily.

6.2.5. Withdrawal of site certification

If a certified site no longer meets the minimum criteria for certification, and audit findings
negatively impact on the reliability of test results, then the certification will be suspended
or withdrawn by HPCZ until nonconformances are addressed as required. Examples of
circumstances that can lead to withdrawal of the site’s certification are listed below:

• Major deviations on one or more certification requirements that are not resolved
by the site within 3 months in acceptable manner.
• Site delays, limits, or denies access to records, documentation, or facility to the
auditors thus making it difficult to verify compliance with site certification
requirements.

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Figure 4. Summary of the POCT site certification process.

Start

Site applies to the DHO

for certification

DHO audits site for

certification readiness

DHO and site Site recommended for

implement corrective NO certification audit?
actions

YES

PHO audits site for Recertification

certification every two years

Site recommended for

NO certification?

YES

HPCZ issues
certificate

Certified sites database

updated

End

P a g e | 17
7. Monitoring and Evaluation

At a minimum, HIV testing programs shall monitor and evaluate the performance of the
following indicators:

• Number of testers certified during a specific time period

• Percent of testers certified during a specific time period
• Number of testers recertified during a specific time period
• Percent of testers recertified during a specific time period
• Distribution of scores for the quality components
• Percent of testers with low scores by testing/quality components

P a g e | 18
REFERENCES

1. Ministry of Health (2016). Zambia Population-Based HIV Impact Assessment (ZAMPHIA)

2015-2016.

2. Ministry of Health, Central Statistical Office, (2014). Zambia Demographic and Health
Survey 2013–2014.

3. UNAIDS (2014). 90-90-90: An ambitious treatment target to help end the AIDS epidemic.
http://www.unaids.org/sites/default/files/media_asset/90-90-90_en.pdf. Accessed on
12th December 2017.

4. Ministry of Health (2017). Zambia National Health Strategic Plan 2017–2021. Lusaka,
Zambia.

5. WHO (2014). Users’ Guide for Site Assessment Using the Stepwise Process for Improving
the Quality of HIV Rapid Testing (SPI-RT) Checklist. 2nd Edition. Geneva. Switzerland

P a g e | 19
APPENDIX. STEPWISE PROCESS FOR IMPROVING THE QUALITY OF HIV RAPID TESTING (SPI-RT) CHECKLIST

Level (Circle One and specify name)

Region/Province: Affiliation (Circle One)
District: Government
Referral center: Private
Health center: Faith-based Organization
Dispensary: Non-governmental organization
Health Post: Other:
Other:

Name of Testing Facility:

Type of Testing Site (Circle One): □VCT □PITC □PMTCT □TB Center □Lab □Care & Treatment Center
□Other (specify):
Location/Address:
Name of the Assessor:
Signature of Assessor: Date of Assessment:

Levels % Score
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 site certification)
Level 4 = 90% or higher (Eligible for certification)

Page | 20
For each of the sections listed below, please check Yes, Partial or No, where applicable. Indicate “Yes” only when all
elements are satisfactorily present. Provide comments for each “Partial” or “No” response. State N/A in the comments
section if “not applicable” where appropriate (*).

SECTION YES Partial NO Comments Score

1.0 PERSONNEL TRAINING AND CERTIFICATION 11
Have the providers received a comprehensive
1.1
training on HIV rapid test?
Are the providers trained on the use of
1.2
standardized registers/logbooks?
Are the providers trained on proficiency testing
1.3
(PT) process?
Are the providers trained on quality control (QC)
1.4
process?
Are the providers trained on safety and waste
1.5
management procedures?
Are there signed records of all procedures read
1.6
and understood by HIV rapid testing personnel?
Is periodic (i.e. every two years) HIV rapid test
1.7
refresher training offered for testing personnel?
Is there evidence that providers received
1.8 adequate, specific training prior to patient testing
to ensure competence?
If there is a national certification program, are
1.9
providers certified?
Are only certified providers allowed to perform
1.10
testing?
Are certified providers required re-certifications
1.11
periodically (i.e. every two years)?

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2.0 PHYSICAL FACILITY 5
YES Partial NO Comments Score

2.1 Is there a designated area for HIV testing?

Is the testing area clean and organized for HIV

2.2
rapid testing?
Is sufficient lighting available in the designated
2.3
testing area?
Is there continuous power supply available (If the
2.4
kits are required to be stored in a refrigerator)?
Is there sufficient and secure storage space for
2.5
test kits and other consumables?

3.0 SAFETY 9
YES Partial NO Comments Score
Are there SOPs and/or job aides in place to ensure
3.1 that providers know to implement safety practices
(apron, gloves, etc.)?
Are there SOPs and/or job aides in place on how to
3.2
dispose of infectious and non-infectious waste?
Are there SOPs and/or job aides in place to
3.3
manage spills of blood and other body fluids?
Are there SOPs and/or job aides in place to
address occupational exposure to potentially
3.4
infectious body fluids through a needle stick
injury, splash or other sharps injury?
Are appropriate safety gears (i.e. gloves, lab coats
3.5
or aprons) available for the providers?

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 Are appropriate safety gears (i.e. gloves, lab coats
3.6
or aprons) consistently used by the providers?
Are there clean water and soap available for hand
3.7
washing?
Is there an appropriate disinfectant (i.e. bleach,
3.8
alcohol, etc.) available?
Are sharps, infectious and non-infectious wastes
3.9
handled properly?

4.0 PRE-TESTING PHASE 12

YES Partial NO Comments Score
Are there national testing guidelines specific to
4.1
the program available at the testing site?

4.2 Is the national testing algorithm being used?

Are there SOPs and/or job aides in place for each

4.3
HIV rapid test used in the testing algorithm?
Are only MOH approved HIV rapid kits available for
4.4
use?
Are test kits stored according to manufacturer
4.5
recommendations?
Is there a process in place for inventory
4.6 management (receiving and monitoring supplies,
handling expired kits, etc.)?
Are reagents used within expiration date (First
4.7
Expired, First Out principle)?
Are test kits labeled with date received, date
4.8
opened, and initials?

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 Is there a process in place for alternative testing
4.9 algorithm, in case of expired or shortage of test
kit(s)?
Are job aides on specimen collection available and
4.10
posted at the facility?
Are there sufficient supplies available for
4.11 specimen collection (i.e. lancets, gauze, alcohol
swabs, plaster, etc.)?
Are sharps (e.g., lancets and needles) disposed
4.12 into appropriate containers after the blood
collection procedure is performed?

5.0 TESTING PHASE 9

YES Partial NO Comments Score
Are job aides on HIV testing procedures available
5.1
and posted at the testing site?
Are timers available and used routinely for HIV
5.2
rapid testing?
Are test devices properly labelled with client ID
5.3
during testing?
Are sample collection devices (capillary tube,
5.4
loop, disposable pipettes etc.) used accurately?
Are testing procedures adequately followed (during
5.5
observation)?
Are positive and negative quality control (QC)
5.6 specimens routinely used (i.e. daily or weekly)
according to country guidelines?

5.7 Is QC results properly recorded?

P a g e | 24
 Are appropriate steps documented and taken when
5.8
QC results are incorrect and/or invalid?

5.9 Are QC records reviewed by a supervisor routinely?

6.0 POST-TESTING PHASE 4

YES Partial NO Comments Score
Are test results properly recorded in
6.1
register/logbook?

6.2 Are test devices disposed of properly after testing?

6.3 Is testing area properly cleaned and disinfected?

6.4 Are waste containers emptied regularly?

7.0 DOCUMENTS AND RECORDS 7

Is there a national standardized HIV rapid testing
7.1
register/logbook available and in use?
Are all the elements in the HIV rapid testing
registers/logbooks captured correctly (i.e., kit
7.2 names, lot numbers, expiration dates, client
demographics, tester name, individual and final
HIV results, etc.)?
Are invalid test results recorded in the
7.3
registers/logbooks, and then repeated?
Is the end of each page total summary for the
7.4
registers/logbooks complied accurately?

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 Are all registers/logbooks and other documents
7.5
kept in a secure location?
Are registers/logbooks properly labelled/numbered
7.6
and archived when full?
Does the testing site ensure confidentiality of
7.7 client information throughout all phases of the
testing process?

8.0 EXTERNAL QUALITY ASSESSMENT (PT, RETESTING AND SITE SUPERVISION) 13

YES Partial NO Comments Score
8.1 Is the testing site enrolled in an EQA/PT program?

Do all providers at the testing site participate in

8.2
the EQA/PT program?
Does head of facility or testing site review EQA/PT
8.3
results before submission to NRL?

8.4 Is EQA/PT feedback report received and reviewed?

Does the site implement corrective action in case

8.5
of unsatisfactory results?
Does the site receive periodically supervisory
8.6
team?
Is a direct observation of client testing performed
8.7
during site supervision?

8.8 Are providers retrained during site supervision?

Note: Those marked with an asterisk (*) may be optional questions; please indicate N/A in the comments section if not
applicable.

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 Assessor’s Summation Report for SPI-RT Assessment

Site Name: ____________________________________ No. of Testers: ____________ Total Scored (exclude N/A) = a

Site Type: ____________________________________ Length of Assessment: ______ Total Score = b

Staff Assessed Name: ___________________________ % Score = (a/b) x 100

Section No. Deficiency Correction Type Assessor’s Recommendations

(SPI-RT (Onsite or Follow Comments (Timeline, person responsible
checklist) up) etc.)

Staff Assessed Name and Signature: ______________________________________ Date: ______________________

Site Supervisor Name and Signature: ______________________________________

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