Terms and Conditions
Division of National Laboratories Services
National Public Health Laboratories,
Kenya External Quality Assessment Scheme (KNEQAS)
MOH/DNLS/NPHL/KNEQAS/HIVSER/F/44 Version.1
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KNEQAS Participation Charter
1.
Purpose of the Scheme
The HIV Serology
Proficiency Testing (PT) scheme is a quality
improvement tool
designed to strengthen HIV testing services
across Kenya. Participation is intended for
HIV Testing Services
(HTS) providers in diverse service delivery settings.
2.
Eligibility to Participate
Participation is
open to individuals actively
providing HIV testing services during an
operational PT round.
Institutions must ensure participants are
competent and
authorized to perform HIV testing.
3.
Charges for Participation
Currently,
participation is free of charge. Future considerations for cost recovery may
be
introduced, with prior notification to participants.
4.
Scheme’s Impartiality Commitment
KNEQAS scheme is
committed to ensuring impartiality in the design, operation,
and
implementation of the rapid HIV Serology proficiency testing scheme in line with ISO
17043:2023 requirements and has
put in place the following among others to ensure
the same.
•
Independence of Operations: All proficiency testing activities are
carried out
independently, free from undue influence by
external parties, sponsors, or
participants, in strict accordance
with the scheme
’s governance structures.
•
Conflict of
Interest Management: Staff and evaluators
must declare and document
any potential conflicts of interest. This is
in place to prevent any potential or
actual bias
in the operations of the scheme (such as sample preparation,
distribution,
evaluation, and reporting.)
•
Fair Treatment of Participants: All participants are treated equally,
with no
preferential access
to information, materials, or evaluation criteria.
•
Transparent Procedures: Enrollment, testing, evaluation,
and reporting processes
are
standardized, documented and shared through our resource module of the
system which
is accessible to all participants to ensure
consistency and fairness.
•
Oversight and Accountability: The impartiality of the scheme is monitored by the
scheme’s Technical
Advisory Committee, with corrective actions taken if
impartiality risks are identified.
•
Routine internal audits and systematic risk assessments are carried out to identify
and address potential issues, ensuring the scheme’s operations remain
Division of National Laboratories Services
National Public Health Laboratories,
Kenya External Quality Assessment Scheme (KNEQAS)
MOH/DNLS/NPHL/KNEQAS/HIVSER/F/44 Version.1
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compliant and effective. Report findings
are presented in the Management
review meeting.
5. Confidentiality and Information Management
•
Your information is protected: KNEQAS manages all data
collected during
proficiency testing (PT) activities under strict legal
agreements. You will be told
in advance if any of
your information is planned to be shared publicly.
•
Your identity stays private: Your name and participation details are
kept
confidential. Only staff directly involved in running the PT scheme
will know who
you are, unless you give permission, the law requires
it, or a contract allows it. If
information must be shared,
you will be notified unless the law prevents it.
•
External
staff follow the same rules: Committee members, contractors,
and
anyone working on behalf of the scheme must also
keep all PT information
confidential.
•
Information from others: If a complaint or regulator provides
information about
you, that information will be
kept confidential. The identity of the source will not
be
shared with you unless the source agrees.
•
Public information: If
you choose to make
your own information public, the
scheme shall not be responsible for how
it is used. All other information is
treated as
private and proprietary unless
you and the PT provider agree
otherwise.
6.
Homogeneity and Assigned Values
•
All PT samples are
subjected to homogeneity
testing prior to distribution to ensure
that observed differences
in participant results reflect testing performance
rather
than sample variability. Only batches that meet homogeneity
criteria are released.
•
Assigned values
for PT items are determined using results
from ISO accredited
national reference
laboratories using standardized and validated testing methods.
The process follows
the requirements of ISO 17043:2023 and ISO
13528 to ensure
technical validity, transparency, and comparability. Where
applicable, the uncertainty
associated with the assigned values is
estimated and documented. This ensures that
participant performance is
evaluated against values that are scientifically sound,
traceable,
and impartial.
7. Enrollment Procedure
Participants
must register online via
•
Full name, designation, contact details (email, phone).
Division of National Laboratories Services
National Public Health Laboratories,
Kenya External Quality Assessment Scheme (KNEQAS)
MOH/DNLS/NPHL/KNEQAS/HIVSER/F/44 Version.1
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•
Facility details (KHMFL Code, facility in-charge contact).
•
Approval by the Sub-County Medical Laboratory Coordinator (SCMLC).
•
Upon approval, participants receive a Tester ID via
SMS and wait to be enrolled
in an upcoming cycle. Kindly
contact your SCMLC if you suspect not to have
been enrolled in a proficiency test cycle.
8. Handling of PT Samples
•
PT samples
are provided in dried plasma form, stable
for at least 90 days at
room temperature.
•
After reconstitution, samples must be tested within 12 hours.
•
Reconstitution requires eight drops
of buffer using the provided pippete per
sample, followed by 8
–
12 hours at room temperature for complete dilution.
•
Samples
must be handled as potentially infectious and disposed of
according to
biosafety protocols.
9. Testing Conditions
•
PT materials
should be tested under routine laboratory conditions
at room
temperature.
•
Participants must use the same HIV rapid diagnostic tests (RDTs)
and algorithms
applied in client testing.
•
PT samples must be treated with the same rigor as patient samples.
10. Recording and Submission of Results
•
Results must be recorded as Reactive, Non-Reactive, Invalid, or Not Done.
•
Final interpretation should be entered as Positive, Negative, or Inconclusive.
•
Results must be submitted electronically via
receiving your panel.
•
Timely reporting is
essential for comparability and integrity of the scheme.
Extensions may be
granted only
under exceptional circumstances (e.g., technical
difficulties,
unforeseen operational disruptions),
and must be formally requested
before the
submission deadline.
11. Collusion and Integrity
•
Participants must work independently when testing the proficiency test items.
•
Collusion or falsification of results is strictly prohibited and may
result in de-
enrollment or other disciplinary actions.
•
KNEQAS reserves the right to investigate suspected breaches of integrity.
12. Appeals Process
Participants may appeal performance evaluations
if errors are suspected:
•
Submit a complaint via
Division of National Laboratories Services
National Public Health Laboratories,
Kenya External Quality Assessment Scheme (KNEQAS)
MOH/DNLS/NPHL/KNEQAS/HIVSER/F/44 Version.1
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•
Provide your name and Tester ID and detailed description of the concern.
•
KNEQAS will document, investigate and issue an amended report if errors
are
confirmed.
•
If no error is
found, the original report will
stand and the participant shall be
notified of the same.
13. Performance evaluation is based on:
•
Accuracy in establishing HIV sero-status of characterized HIV-negative
and HIV-
positive samples.
•
Adherence to the national HIV testing algorithm.
•
Compliance with documentation and reporting practices.
14. Safety and Compliance
•
All participants
must adhere to biosafety and ethical standards when handling
PT
materials.
Commitment to Scheme Principles and Policies
By registering to participate in the scheme, participants are
deemed to have accepted and committed
to the
principles and policies outlined herein. Registration
constitutes:
o
Agreement to comply fully with scheme rules, procedures, and confidentiality provisions.
o
Recognition of the scheme’s impartiality and commitment to independence from undue
influence.
o
Acceptance of
responsibilities regarding confidentiality, transparency, and accountability as
defined by
contractual and legal obligations.
o
Acknowledgment that participation reflects a collective responsibility to
uphold the
integrity, credibility, and international compliance
of the scheme.
Contacts for Enquiries
Address
Contact info
Kenya External Quality Assessment
Scheme (KNEQAS)
National Public Health Laboratories
Kenyatta National Hospital Grounds
P.O. Box 20750
–
00202,
Nairobi
•
Email: nphlpt@nphl.go.ke
•
Scheme Coordinator: Solomon Bundi -
0723356803
•
Scheme Data Manager: Geoffrey Bundi
(0721825737)
•
Help Desk: helpdesk.nphl.go.ke