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EQA in the SADC Region

EQA in the SADC Region. E N Sibanda. Assessment of NRL. NRL in MS were assessed at the behest of the SADC The purpose was to assess existing capacity and recommend ways of improving service delivery The major services targeted were HIV and AIDS, Tuberculosis and Malaria. Context.

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EQA in the SADC Region

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  1. EQA in the SADC Region E N Sibanda

  2. Assessment of NRL • NRL in MS were assessed at the behest of the SADC • The purpose was to assess existing capacity and recommend ways of improving service delivery • The major services targeted were HIV and AIDS, Tuberculosis and Malaria

  3. Context • The strengthening of labs is integral component of the • The Millennium Development Goals, • the Abuja Process • the Maputo Declaration • the SADC whose Protocol on Health has outlined strategies and activities for the control of these three diseases. • The latter are premised on the principle that a coordinated regional effort is necessary to compliment national strategies.

  4. Assessment • Visits to MS • Perusal of relevant, availed documentation • Interviews with stakeholders • Observation of the lab. operations

  5. Major Findings • Laboratory policy inconsistent • Human resources inadequate • Organizational structures variable • Vertical programs and horizontal programs • Quality Management poorly understood, poorly implemented and impacting negatively on service delivery

  6. Assessment of QA • SOPs availability, updating • Staff training in QA • Availability of designated QA officer • QA for services provided • Quality Manuals • Participation in EQA • EQA schemes used • Implementation and documentation of corrective measures

  7. QA assessment Score Card • Areas of assessment Target score • QA Management policy 3 • Presence of Quality Officer 2 • Participation in EQA scheme (national or any other) 1 • SOPS available 1 • SOPs updated, signed 1 • Routine IQC with charts displayed 1 • Documentation of corrective action 1 • Total achievable points 10

  8. Specific areas: HIV and AIDS • random sampling and retesting of 10% of all the tests carried out at the VCT site • Retesting with rapid tests or ELISA. • In Namibia 100% samples retested using ELISA • WHO no longer recommends 10% retesting • ELISA assays infrequently performed • documentation confirming participation in QA for ELISA schemes was not always available. • number of countries have started piloting the national EQAs using dried tube specimens

  9. Lymphocyte subsets (CD4) • Most successful EQA program in SADC • WHO supported • Different EQA schemes used • Tanzania & Zambia EQA for CD4 testing is provided by a Canadian scheme. • Namibia EQA is provided by QASI and Thistle in South Africa. • Malawi EQA is provided by UNC, AFREQUAS, REQUAS, and UK-NEQUAS NEQAS • Swaziland EQA is provided by the WHO/NICD scheme. • South Africa and Zimbabwe have national quality assurance schemes.

  10. CD4 EQA • Good uptake • Almost all NRL were participating • Not always understood by people in the labs • Perceived to be a n imposed WHO requirement • Poor implementation of corrective measures • fundamental misunderstanding of the role and usefulness of EQA

  11. TB • Variable practices (best in Lesotho and Madagascar) • SOPs are available and regularly updated • Routine use of approved IQC samples for all cultures. • Central lab supports district laboratories with QC • The mode of QA is on-site testing • designated QA officer from the Central laboratory in Maseru visits the district hospital laboratories • blind re-examination of random samples of smears in the presence the resident microscopist or technician. • Released results are compared with on-site findings • corrective measures necessary implemented in loco

  12. TB • EQA for the Central TB laboratory is through schemes in South Africa. • QC for TB microscopy is provided by the NICD at the NHLS in Johannesburg, South Africa. • Six monthly batches of samples are received for routine microscopy. • The partners in South Africa are overwhelmed by referral work and the turnaround is slow and does not adequately address the needs of the Laboratory in Maseru. • TB culture EQA • is provided by the MRC in South Africa. • 20 samples are provided for culture, identification and detection of organisms. • Problems include the unavailability and appropriateness of basic sample packaging materials that fulfil relevant IATA requirements.

  13. TB Culture • predominantly provided by the MRC in Pretoria. • Zambia, Swaziland, Lesotho, Namibia, Botswana are amongst the countries receiving 6 monthly cycles of culture EQA with the MRC laboratory. • Twenty samples are sent by the MRC scheme for processing and reporting by the national laboratory. • The turn-around of reports was reported as satisfactory in Malawi, Zambia and Namibia. • The NHLS group of laboratories Referral laboratory provides microscopy EQA.

  14. Malaria • The two aspects of QA • QA of the test • QA of the health worker performing the test. • Blind retesting of 10% of slides examined • Madagascar upwardly cascading QA program for malaria. • blind retesting of slides reported as positive or negative by the District tech same proportion sent to a regional and National level facility. • DRC intra-laboratory test accuracy and inter-laboratory QC is co-ordinated by the malaria National Reference laboratory in the INRB. • QC program is affiliated to WHO/NICD EQC & habitually scores 100%. • None of the MS had External Quality assurance for malaria.

  15. Overall recommendations • Four documents produced and accepted by Ministers of health of all SADC MS • Functions and Minimum standards of NRL • Functions and min standards of SNRL • Operationalisation of Regional Centres of Excellence

  16. RCE for Quality Management • Areas of assessment Score • The existence of accredited quality assurance schemes. 4 • Adequate numbers of technically competent personnel 3 • Expertise in development of training modules in QM 2 • Adequate capacity to roll out QA and PT services to MS NRLs 1 • Conducive administrative environment 1 • Logistics necessary to handle potentially infectious materials 1 • Adequate infrastructure to provide training. 1 • Communications (Telephone, E-mail, Internet) 1 • Accessibility 1 • Total 15

  17. Operationalisation • !. Adoption of recommendations by SADC • Call for MS to express an interest in RCE • Dispatch of team of uninterested experts to assess capacity • Generation of a shortlist • Selection of site by Ministers of Health

  18. What are ZINQAP chances? • Very high • One of two accredited EQA schemes in the region • Well staffed, structured, operational • Meet almost all the criteria for assessment • SA schemes overwhelmed

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