Terms and Conditions

Ministry of Health

National Public Health Laboratories

Kenya External Quality Assessment Scheme (KNEQAS)

Important information to Participants on HIV Serology PT Scope

Dear Participant

Kindly read the following information before you sign up for the program. Note that by registering to the system you agree to our terms and conditions.

Description of HIV serology scope of the proficiency testing scheme

The PT scope is designed to be a quality improvement tool for HIV testing services. It therefore targets

participation from HTS providers working in the various service provision approaches and settings.

Performance evaluation is based on assessment of accuracy in establishing HIV sero-status of

characterized HIV negative and positive samples, adherence to HIV testing algorithm and recording

practices;

1. Charges for participation

Participation to the scheme scope does not attract payment of any fees currently. Considerations

for charging fees may however be made in the future.

2.Description of HIV serology scope of the proficiency testing scheme

The PT scope is designed to be a quality improvement tool for HIV testing services. It therefore targets

participation from HTS providers working in the various service provision approaches and settings.

Performance evaluation is based on assessment of accuracy in establishing HIV sero-status of

characterized HIV negative and positive samples, adherence to HIV testing algorithm and

documentation practices.

Eligibility criteria for participation

Participation is open to individuals who are actively providing HIV testing services at the time of an

operational round.

Confidentiality arrangements

Each participant is issued with a unique identification code. Performance reports are made

available to participants on-line and are accessible to each participant through their access

controlled unique accounts. KNEQAS staff have a commitment to keep participants information,

including performance confidentially. Participants reports will only be shared to institutional quality

officers for the purpose of facilitating quality interventions. If required by a regulator or legal entity

authorities, a participant’s will be duly informed of the request before it is granted.

How to get enrolled for participation.

For a HTS provider to enroll for participation, following procedure applies:

a. Register by:

I. Go to www.rhtpt.or.ke on internet browser.

II. Click the REGISTER button to get started.

III. Click “NO” when the” have you been registered before” message pops up,

IV. Fill in the online registration form that opens up and submit it to KNEQAS for

consideration.(Participants shall provide their full names, e-mail address, phone

numbers, designation, facility KHMFL Code and facility in charge details (Name,

phone and email).

V. Ask your sub county medical lab coordinator (SCMLC) to enable your registration

VI. You will be automatically be allocated a unique identification number by the system

(Tester ID) to confirm registration.

B. An SMS notification is sent to the applicant with his/her Unique Identification Number

(Tester ID).

C. Contact your sub county medical lab coordinator to enrol you for participation in the

current round

Factors which could influence the testing of the proficiency test items

The samples used are dried plasma form and are suitable for testing for a period of at least 30 days when

stored at room temperature. The sample is suitable for testing using serological tests (eg HIV RDTS) after

reconstitution. The stability of the samples is gradually lost if the sample is stored and tested after a period

that exceeds 24 hrs after reconstitution.

Procedure for reconstitution of the dried plasma samples

To prepare the samples for testing, eight drops of reconstitution buffer that is included to the

pack are added to each of the samples using the provided Pasteur pipette. Care must be taken

to prevent sample cross-contamination. The samples should then be left at room temperature

for about 12 – 18 hrs to allow for complete dissolution of the samples.

Safety precautions

The samples are obtained from blood donors and some of them are known to be

HIV positive. Although they have been screened and found to be free of hepatitis B and C,

they should be treated as if they are potentially infectious of any blood borne diseases. All

necessary precautionary bio-safety measures should therefore be taken. Remnant PT

material should be disposed off in a way that takes bio-safety procedures consideration.

Conditions for testing

The PT material should be processed, maintained and tested at room temperature. There is

no cold chain requirement.

Testing of PT panel samples

The PT samples should be treated similarly with clients’ samples. While testing,

participants should use test s that are currently in use at the facility and in adherence to

recommended procedure and algorithm.

Recording of results and other variables

Results for each of the samples tested should be recorded by selecting the applicable reactivity against

each of the samples and test by which the results are obtained eg “reactive”, “non-reactive”, “invalid”. If a

sample is not tested for some reason, “not done” should be selected and an explanation offered at the

comment area of the results submission form. Other required variables should be recorded following the

format outlined on the results submission form. Final results should be entered as “Positive”, “Negative” or

inconclusive depending on interpretation and based on pattern of results obtained upon testing. These

records should be transcribed to the results entry electronic form at www.rhtpt.or.ke and submitted online

(See procedure at www.rhtpt.or.ke. Help desk, User guide,“HIV PT Results Entry and Access to

Feedback in 5 Easy Steps”).

Collusion by participants

Participants are highly advised to work independently. Collusion amongst

participants is highly discouraged. Suspected events of collusion may lead to

de-enrolment from participating in future rounds among other actions.

Deadline for return of return of results

KNEQAS will receive and evaluate results submitted within a period of 21

days following release of the PT panels. Results received there- after may not be

evaluated and performance feedback reports may not be provided to the affected

participants.

Procedure for Appealing Against Evaluation of Performance

If a PT participant has reasonable grounds to believe that PT performance report

Does not reflect his/her performance or notices errors in the report, the below

procedure is available to the affected participant to launch an appeal with KNEQAS:

- Use the contacts for enquiries on page 6 to bring the complaint to the attention of KNEQAS

(Alternatively, post the matter on www.rhtpt.or.ke-help desk)

- Provide participant’s details to include PT enrolment ID

- Describe in details the matter of concern

- KNEQAS will institute an investigation into the matter

- An amended report will be issued if investigation reveal that an error had been made in the

original report

- If no error is found, the original report will be upheld and communication regarding the decision

made.

Contacts for enquiries

Enquires, compliments, comments, assistance can be channeled through any of the

below contacts:

Kenya External Quality Assessment Scheme

National Public Health Laboratories

Kenyatta National Hospital Grounds

P.O Box 20750 – 00202

Nairobi

1. KNEQAS Email – nphlpt@nphl.go.ke

2. Scheme Coordinator/Manager -Charity Maina (0721397766)

3. Scheme quality manager – Pamela Juma (0722427924)

4. Scheme data manager - Geoffrey Bundi (0721825737)

Use help desk at helpdesk.nphl.go.ke