# Presentation: 768534

## DEVELOPMENT OF DOCUMENTS STANDARD OPERATING PROCEDURES (SOPS) IN ZAMBIAGABERONE, BOTSWANA28TH JULY 2003

- Presented by:
- Grace C. Kahenya MSC. FIBMS
- Laboratory Specialist
- Central Board of Health
- Lusaka, Zambia

## Map of Zambia showing 9 provinces

***Map of Zambia showing 9 provinces***

## Background

Location – Southern Africa
Total area – 752,614 square kilometers 
Administrative Division   9 Provinces
                                            72 Districts
Capital city – Lusaka 
Languages – English official 
                       – 73  Local languages 
Population 10.3 million   

- Location – Southern Africa
- Total area – 752,614 square kilometers
- Administrative Division   9 Provinces
-                                             72 Districts
- Capital city – Lusaka
- Languages – English official
-                        – 73  Local languages
- Population 10.3 million

## Adult HIV/AID prevalence rate 16%

Incidence of new smear positive TB cases 512 / 100,000 cases population

60% of TB patients are HIV sero positive

Life Expectancy at birth – 37 years.

- Incidence of new smear positive TB cases 512 / 100,000 cases population
- 60% of TB patients are HIV sero positive
- Life Expectancy at birth – 37 years.

**Background, cont’d**

## Zambia Public Heath Laboratories

**Total number of Laboratories 154**

- Ministry of Health

- Central Board Of health
- (Laboratory Specialist)

- Level III Laboratories  **4**

- Level II Laboratories **14**

- Level I Laboratories **74**

- Health Center Laboratories **47**

**Specialized Laboratories**
- Chest Diseases Laboratory
- Zambia National Blood Transfusion Service
- Virology Laboratory
- Occupation Health Board
- Tropical Diseases Research Center

**Notes:**
Medical Laboratory services in Zambia are provided by Government, Missions, industry, military and private Institution at various level of Care.
154 Medical Laboratories in the public sector.
Services have four main levels of care; Health centre level I, level II and Level III ( Central / specialist and referral centers) at the apex. 

## Back ground of Laboratory Services in Zambia

- In 1994 Medical Laboratory Policy project was initiated by Ministry of Health and supported by Ireland Aid.
- Objectives of the project were :-
-   - to conduct a situation analysis of Laboratory services in
-      Zambia
-   - to develop standards
-   - to develop policies and strategies to guide the development of the service within the context of health Reforms.

## Summary of Situation Analysis findings

- Majority of laboratories failed to deliver the most critical elements of the Basic Health Care package.
- Inadequate skills and competences of the few available laboratory staff.
- Lack of equipment, supplies and national standards.
- Poor laboratory infrastructure.
- The results provided a framework for policy
- development.

## National Medical Laboratory Policy

Process of development
   - working groups were formed in all areas of the major
     constraints in the situation analysis study.
Goals of Policy
   - To improve and maintain Laboratory services at an
     optimum standards through the development and 
     implementation of a comprehensive and co-ordinated
     policy.
  - To provide national technical guidelines for the 
    improvement and provision of Laboratory services at 
    each level of health care delivery.

**Process of development**
-    - working groups were formed in all areas of the major
-      constraints in the situation analysis study.
**Goals of Policy**
-    - To improve and maintain Laboratory services at an
-      optimum standards through the development and
-      implementation of a comprehensive and co-ordinated
-      policy.
-   - To provide national technical guidelines for the
-     improvement and provision of Laboratory services at
-     each level of health care delivery.

## Policy Components

   - Test selection and use – guides rational use of
      Laboratory tests.
   - Basic inputs – main functional requirements of 
     Laboratory.
   - Quality Assurance – quality of service, Quality control,
     External Quality assessment and Monitoring and
     Evaluation.
   - Safety
   - Ethic
   - Research and development
   - Local, Regional and international collaboration.

-    - Test selection and use – guides rational use of
-       Laboratory tests.
-    - Basic inputs – main functional requirements of
-      Laboratory.
-    - Quality Assurance – quality of service, Quality control,
-      External Quality assessment and Monitoring and
-      Evaluation.
-    - Safety
-    - Ethic
-    - Research and development
-    - Local, Regional and international collaboration.

##  Implementation Plan of Policy 
(5 years)

Short term plan (priority)
     - Basic inputs (equipment, supplies, human resource
       and infrastructure)
Long-term Plan 
     - Full implementation of the policy and development of a
       sustainable system to support the services at all levels.

  The situation analysis provides baseline indicators against which progress could be measured. 
 The policy was launched in March 1997 and implementation started same year.

**(5 years)**
**Short term plan (priority)**
-      - Basic inputs (equipment, supplies, human resource
-        and infrastructure)
**Long-term Plan **
**    ** - Full implementation of the policy and development of a
-        sustainable system to support the services at all levels.
-   The situation analysis provides baseline indicators against which progress could be measured.
-  The policy was launched in March 1997 and implementation started same year.

## Achievements on the Development of Documents

Guidelines developed:
Integrated logistic and supply management and quantification.
Rational use of Laboratory tests at Health centre level.
Standard equipment list and specification at each level of care.
Basic maintenance of laboratory equipment.
Test profiles and standard operating procedures at all levels of care.
Standards of laboratory building designs at all levels of care.
Rationalise the existing staff through redeployment training and development of standards.
Upgrading of existing certificate schools to Diploma level with increased output by 2005.
Establish a degree course at UNZA.

- Guidelines developed:
- Integrated logistic and supply management and quantification.
- Rational use of Laboratory tests at Health centre level.
- Standard equipment list and specification at each level of care.
- Basic maintenance of laboratory equipment.
- Test profiles and standard operating procedures at all levels of care.
- Standards of laboratory building designs at all levels of care.
- Rationalise the existing staff through redeployment training and development of standards.
- Upgrading of existing certificate schools to Diploma level with increased output by 2005.
- Establish a degree course at UNZA.

## Quality System DocumentationQuality Manual

- Procedures / work Instructions

- Processes

- Policies

- “What to do”

- “How it happens”

- “how to do it”
- (SOP’s)

## Standard Operating Procedures (SOPs) 

- List of test profiles to support the Basic Health care package at each level.
- SOP for each test to standardise the methods used at each level
- Identify inputs – Training, staff, supplies and equipment.
- List of equipment and specification at each level of care.
- Standard design of laboratories at each level of care.

## 
Develop SOP’s that are:
   - appropriate to the local environment
   - Cost effective and utilize reagents and
     equipment that are readily available.
   - Support the Basic Health care package
   - Provide Laboratory staff with user 
     friendly guidelines.

- Develop SOP’s that are:
-    - appropriate to the local environment
-    - Cost effective and utilize reagents and
-      equipment that are readily available.
-    - Support the Basic Health care package
-    - Provide Laboratory staff with user
-      friendly guidelines.

**Standard Operating Procedures (SOPs)**

## Development Process

- Development process was participatory involving all stakeholder at the various levels of care.
- Working committee in all the medical laboratory science displines were formed.
- Guidelines based on the results of the situation analysis were developed and given to the working committees.
- A format for the SOP was provided to all working committee.
- A schedule work plan was developed and given to the working committee.

## References

- Serve as a source of the information
- The references used in Zambia were from
- Text books e.g.
-       1.  District laboratory, Practice in Tropical countries, Part 1 &
-            2 by Monica Cheesbrough 1998
-       2.  Practical Laboratory Manual for Health Centres in
-            Eastern Africa 1994 by Jane Cater and O. Lema
- Published standards and guidelines
- Laboratory information technology manuals
- Unpublished information obtained from experts in the field
- Applicable regulations

## Approval

- An Editorial committee consisting of subject experts was formed to edit the draft SOPs.
- Edited SOPs were pre-tested for user friendliness and reproducibility.
- Final editing was done before the approval by a team of experts.
- Implementation of SOPs.
-    Health Centre – 2000
-    District Level I – 2002
-    District Level II and III – 2003

## Distribution

- Training of the users was conducted for use and orientation of documents.
- Distribution was through the Provincial Health Office Starting with the Health Centres
- The SOPs provided reference material for most laboratories.

## Revisions

- The Central Board of Health through the Laboratory specialist office have the mandate to institute revision.
- Revisions of SOPs will only be done after the evaluation.

## Way Forward

- Review the National Medical Laboratory Policy – 2004
- Establish Continuining Professional Development. – 2003
- Establish National Quality Assurance Programme – 2004
- Monitoring and Evaluation of SOPs for Health centre and level 1 – 2003

- THANK YOU

- THANK YOU