# Presentation: 352929

## Zimbabwe National Quality Assurance Programme (ZINQAP)

**Zimbabwe National Quality Assurance Programme (ZINQAP)**

- Eve C Gadzikwa, FIMLS - Director Sibongile Makhanda – Sr. MLS

## ZIMBABWE

**ZIMBABWE**

**Notes:**
Slightly larger than state of Montana
Capital Harare
Parliamentary democracy
8 provinces, 2 cities (Bulawayo, Harare)
12.5 million

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## Sections

- BACKGROUND
-  HIV PT DESCRIPTION
-  FUTURE PLANS

## Mission

- To assist medical laboratories to assess and improve the quality of laboratory results they produce in order to maintain a high standard of performance.
- The purpose ultimately ensures that results being sent out by medical laboratories and point of service testing centres are reliable and timely for  maximum benefit to the patient.

## Historical Background

- 1991 - UZ Chemical Pathology Dept in Medical School Established ZEQAS, A Clinical Chemistry EQA Programme
- 1993 -  PHL QA Strategy Workshop
- 1994 -  ZINQAP Formulated & Funded By DANIDA
- 1998 -  Became A Trust

## Organisational Structure

- Board of trustees(6)
- Management Board (9)
- Director (FIMLS)
- Technical staff (2xMLS)
- Administrative secretary
- Driver

## PARTNERSHIPS

- DANIDA (Donor Organisation)
- UKNEQAS (EQA software & Clinical chemistry samples)
- LABQUALITY (Training assistance)
- MOH&CW/PHL (Largest stakeholder)
- CDC/WHO (Technical & training support)
- USAID (Training)
- SAZ (ISO Body)
- NACP/PSI (Kit evaluations)

## Rationale

- Increase in awareness in the public and public sector on the need for QA
- The development of accreditation standards
- Need for patients to have confidence in results
- Need to assess the ability of labs to competently perform
- Patients are now demanding value for money due to economic hardships

## Long Term Objectives

-   Strengthen and reinforce Internal Quality Control (IQC) procedures through the use of the standard operating procedures
- Institute a comprehensive EQA programme to cover all lab disciplines
-   Assist laboratories in Zimbabwe to improve performance by the use of SOPs

## Short Term Objectives

- Improve internal operational and communication systems
- Develop a QA model for conventional HIV testing for medical labs
- Develop a QA model for point of service HIV testing

## Activities

- Analysis and producing reports for EQA
- Regular on site visits to participating labs
- Workshops to rectify non-conformance
- QA training programs
- Producing laboratory standards
- Collaborating with other health related organisations on QA

## Schemes

**Haematology** – FBC,DIFF,WBC & RBC
**Blood Transfusion** _ ABO and RH D Typing, Crossmatching, Ab screening & Identification
**Serology**- RPR/TPHA, HBsAg, HIV, Pregnancy
**Microbiology**- Gram, Parasitology, TB, Microscopy, culture
**Histopatholgy/Cytology** – Processing and Staining
- Clinical Biochemistry- x12 Parameters

## APPENDIX 1-CALENDAR 2002

## HIV PT Description

- 31 labs registered on ELISA HIV PT scheme
- Central Hospital labs 3
- Provincial Hospital labs 8
- District Hospital labs 3
- Infectious Disease labs 2
- Army lab 1
- Private Labs 11
- Research Organisations 3

## Distribution of Laboratories Participating in ELISA HIV SchemeTotal # Labs = 31

**Distribution of Laboratories Participating in ELISA HIV Scheme****Total # Labs = 31**

## Distribution of Laboratories Participating in Rapid HIV SchemeTotal # Labs = 74

## PT Testing Protocol - Rapid Tests	

- Test samples using at least 2 methods
- Record results on data sheet
- Type of kit and expiry date
- Tie Breaker to be used in the event of discordant results
- Tie breaker kit name and expiry date
- Return results to ZINQAP within 2 weeks

## PT PROCESS

- Sample acquisition-NBTS
- IQC –3 x labs Plus ZINQAP
- Dispatch
- Response
- ELISA -  38.7% ( 31  labs)
- Rapid HIV  - 52.7% (74 labs)
- Performance
- ELISA 91.3 % correct
- Rapid 100% correct

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## Achievements

- 10 Participating laboratories in 1995 to 87 laboratories in 2002
- Well trained staff and on-going staff development
- Upgraded Computers for EQA
- ZINQAP Day and Annual Scientific Conference
- Sustainability due to Co-operative agreement with CDC/PHPPO and continued donor funding by DANIDA

## Challenges

- Access to Reference Materials
- Cost of Consumables
- Lack of Government support
- Lack of Office and Laboratory equipment
- Political Challenges
- Political Factors
- Lack of Appropriate Packaging Materials
- Poor Response Rate

## FUTURE PLANS

- Seek mentoring partnerships with regional PT providers in SADC
- Produce improved HIV panels
- Develop Quality Manual and SOP for ZINQAP
- Develop Standards for all labs in Zimbabwe
- Train inspectors for on-site evaluations
- Purchase of vehicle and other laboratory equipment
- Accreditation of ZINQAP & Laboratories

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