minimum standards for laboratories in sadc regions · module objectives ... minimum standards for...

Minimum Standards

for Laboratories in

SADC Regions

Participant Guide

Day 1 Minimum Standards for NRL, National Policies and SADC

Guidelines

MINIMUM STANDARDS FOR LABORATORIES IN SADC REGIONS

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Table of Contents 1. Learner Information .................................................................................................... 5

2. About this Course ...................................................................................................... 6

3. Learning Styles .......................................................................................................... 7

4. Keys to Icons ............................................................................................................. 9

5. Course Agenda ........................................................................................................ 10

6. Pre – course questionnaire ...................................................................................... 13

7. Module Objectives ................................................................................................... 14 SADC Guidelines – Protocol on Health (1999) ................................................................................ 15 Article 3 - Objectives ........................................................................................................................ 22 Article 4 – Institutional Mechanisms ................................................................................................. 24 Article 5 – Financial Provision .......................................................................................................... 33 Article 6 – Health Systems research and surveillance ..................................................................... 35 Article 7 – Health Information Systems ............................................................................................ 36 Article 8 – Health Promotion and Education .................................................................................... 37 Article 9 – Communicable Disease Control...................................................................................... 38 Article 10 – HIV/AIDS and sexually transmitted disease ................................................................. 40 Article 11 – Malaria Control .............................................................................................................. 43 Article 12/13 – Tuberculosis and non communicable disease control ............................................. 44 Article 14/15 – Chronic diseases and conditions of older persons and disabilities.......................... 46 Article 17- Childhood and adolescent health.................................................................................... 47 Article 18 – Health Human Resource Development ........................................................................ 48 Article 19/20 – Health care resources & traditional health practitioners .......................................... 49 Article 21 Prevention and treatment of trauma................................................................................. 50 Article 22 – Mental Health ................................................................................................................ 51 Article 23/24 – Environmental and Occupational Health .................................................................. 52 Article 25 – Emergency Health Services and Disaster Management .............................................. 53 Article 26 – Health Laboratory Services ........................................................................................... 54 Article 27 – Health Technology and equipment ............................................................................... 55 Article 28 – Referral Systems ........................................................................................................... 56 Article 29 – Referral Pharmaceuticals .............................................................................................. 57 Article 29/30 – Settlement of disputes and sanctions ...................................................................... 58 Articles 32 to 35 ................................................................................................................................ 59 Article 36/37 – Withdrawal & Depositary .......................................................................................... 60


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Articles 38 to 40 ................................................................................................................................ 61 Overview on the Assessment Report on Reference Laboratories in the SADC Region ................. 64 Background ....................................................................................... Error! Bookmark not defined. Assessments .................................................................................................................................... 68 Assessment Findings – Policies regulating Laboratory Operations in Member States ................... 70 Assessment Findings – Human Resources ..................................................................................... 72 Assessment Findings – Financing of Laboratory Services .............................................................. 76 Assessment Findings – Information Management ........................................................................... 77 Assessment Findings – Quality Management .................................................................................. 78 Assessment Findings – Equipment used in NRL ............................................................................. 79 Assessment Findings ....................................................................................................................... 82 Recommendations ........................................................................................................................... 85 Summary .......................................................................................................................................... 87 Functions and minimum standards for National reference laboratories in the SADC region .......... 90 Objectives ......................................................................................................................................... 91 WORKSHEET 1 ............................................................................................................................... 92 Background ...................................................................................................................................... 93 Functions of National Reference Laboratories (NRL’s) ................................................................... 94 Minimum Standards for National Reference Laboratories - Policies ............................................. 100 Activity 2 ......................................................................................................................................... 102 Standard personnel requirements of national reference laboratories ............................................ 103 HR – Minimum Standards for National Reference Laboratories .................................................... 104 Minimum Standards for National Reference Laboratories – Human Resource Policy .................. 105 Minimum Standards for National Reference Laboratories - QMS.................................................. 106 Minimum Standards for National Reference Laboratories- Information Management .................. 107 Minimum Standards for National Reference Laboratories – Organisation and structure of laboratory services ......................................................................................................................... 108 Minimum Standards for National Reference Laboratories – NRL Equipment ............................... 110 Minimum Standards for National Reference Laboratories – Sample transportation logistics ........ 111 Minimum Standards for National Reference Laboratories – Funding of laboratory services ........ 112 Minimum Standards for National Reference Laboratories – Monitoring and evaluation ............... 113 Implementation Mechanisms for the Regional Minimum Standards – Stakeholder roles and responsibilities ................................................................................................................................ 114 Implementation Mechanisms for the Regional Minimum Standards – M & E and reporting ......... 115 Implementation Mechanisms for the Regional Minimum Standards – M & E and Reporting ........ 116 Summary ........................................................................................................................................ 117


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Functions and Minimum Standards for Supranational Reference Laboratories and Regional Centres of Excellence in the SADC Region ................................................................................... 118 Objectives ....................................................................................................................................... 119 Background .................................................................................................................................... 121 Definition and scope ....................................................................................................................... 123 Quiz ................................................................................................................................................ 126 Supranational Reference Laboratories in the SADC Region ......................................................... 127 Functions and minimum standards ................................................................................................ 128 Diagnostic functions of SNRL ........................................................................................................ 129 Public Health Functions of SNRL ................................................................................................... 132 Public Health Functions of SNRL ................................................................................................... 133 Regional Centres of Excellence in the SADC Region .................................................................... 140 Roles, Functions and Minimum Standards for Regional Centres of Excellence............................ 141 RCE - HR........................................................................................................................................ 143 RCE - HR........................................................................................................................................ 144 RCE – Quality Management........................................................................................................... 145 RCE – Information Management, Surveillance and Research ...................................................... 148 Summary ........................................................................................................................................ 150 Activity for Module1: ....................................................................................................................... 152

Summary of related SADC Minimum Standards ............................................................................ 156 Objectives ....................................................................................................................................... 157 Background .................................................................................................................................... 158 Minimum Standard, Purpose and summary description ................................................................ 160 Minimum Standard/ Framework, Purpose and summary description ............................................ 163

8. Post – course questionnaire .................................................................................. 175

9. Summary ............................................................................................................... 178

10. References and Links ............................................................................................ 179


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Learner Information

Details Please Complete details Name of Learner

Participant’s Country

Job Title

Facilitators Minimum Standards for NRL, National Policies and SADC Guidelines

Adrian Puren Patience Dabula Henry Julius


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About this Course

The National Health Laboratory Services welcomes you to the Minimum Standards for National Reference Laboratories in SADC Regions course. In this course the Participant will learn about the different Learning Styles, understand the Key Icons used in the manual and will be taken through the training material developed for Day 1 of this course on the Minimum Standards required to run an effective National Reference Laboratory. The Course includes discussions, activities and workshop sessions. At the beginning and end of the course, participants will be required to write a Pre-course Assessment and a Summative Assessment at the end. The Modules covered in Day 1 are as follows:

1. Minimum Standards for NRL, National Policies and SADC Guidelines This guide covers Minimum Standards for NRL, National Policies and SADC Guidelines


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Learning Styles

What are learning styles?

Learning styles are simply different approaches or ways of learning.

The different types of learning styles are as follows:

Visual Learners: learn through seeing...

These learners need to see the teacher's body language and facial expression to fully understand the content of a lesson. They tend to prefer sitting at the front of the classroom to avoid visual obstructions (e.g. people's heads). They may think in pictures and learn best from visual displays including: diagrams, illustrated text books, overhead transparencies, videos, flipcharts and hand-outs. During a lecture or classroom discussion, visual learners often prefer to take detailed notes to absorb the information.

Auditory Learners: learn through listening...

They learn best through verbal lectures, discussions, talking things through and listening to what others have to say. Auditory learners interpret the underlying meanings of speech through listening to tone of voice, pitch, speed and other nuances. Written information may have little meaning until it is heard. These learners often benefit from reading text aloud and using a tape recorder.


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Tactile/Kinesthetic Learners: learn through moving, doing and touching...

Tactile/Kinesthetic persons learn best through a hands-on approach, actively exploring the physical world around them. They may find it hard to sit still for long periods and may become distracted by their need for activity and exploration.

Read / Write Learners: learn through reading and writing...

Read / Write persons prefer to learn and memorize through reading and writing things down.


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Keys to Icons

The following icons are used throughout the study guide to indicate specific functions:

ACTIVITY

Written activities to be completed

DISCUSSION

Take part in the discussion

IMPORTANT / TAKE NOTE

This icon indicates information of particular importance

Notes

The participant should write notes, should he/she wish to do so


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Course Agenda

Agenda for Day 1

Minimum Standards for NRL, National Policies and SADC

Times Topic Duration Presenter 08:00 Registration 30 minutes 08:30

Welcome and Opening remarks 30 minutes

SADC Innocent / NHLS CEO

09:00

Awareness Module - Introduction, Expectations, Course Outcomes

30 minutes

Thinyane Molelle

09:30

Pre Course Questionnaire & Health Protocol

1 hour 15 minutes

Adrian Puren

10:45 Tea 15 minutes

11:00 SADC Assessment Report on the Reference Laboratories

1 hour 45 minutes

Adrian Puren

12:45 Lunch 45 minutes

13:30

Minimum Standards for NRL and functions for a National Reference Laboratory

1 hour 30 minutes

Patience Dabula

15:00 Tea 15 minutes

15:15

Minimum Standards and Functions for a National Supranational Laboratory and Regional Centre of Excellence

45minutes

Patience Dabula

16:00 Activity 15 minutes Henry Julius 16:15

SADC Summary of Minimum Standards and Activity

30 minutes

Henry Julius

16:45

Post Course Questionnaire & Day 1 Summary wrap up

15 minutes

Henry Julius


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SPECIALIST

TALK


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Pre – course questionnaire Please indicate whether the following statements are true or false No. Statement True False 1 The roles players involved in developing the minimum standards included

experts from the various Member States and their ministries of health

2 A total number of 18 minimum standards, frameworks and guideline were developed

3 Documents were subjected to regional validation and consensus building process by experts from Member States and therefore did not need ministerial approval

4 SADC Member States signed the Protocol on Health on the 18th of August 1999 to coordinate regional efforts on epidemic preparedness, mapping prevention, control and where possible the eradication of communicable and non- Communicable diseases.

5 Education and training, efficient laboratory services and common strategies to address the health needs of women, children and vulnerable groups are discussed within the Health Protocol.

6 The Protocol on Health calls upon Member States to cooperate, harmonise and, where appropriate, standardise policies for sharing technical expertise.

7 The Protocol on Health is not a legal document and merely serves as a guide to promote good ideas on how to manage health within the various Member States.

8 The Protocol on Health shall remain open for accession by any Member State.

9 The Supranational Laboratories (SNRL)serves as support to laboratories where essential diagnostic tests cannot currently be performed within a particular Member State.

10 Regional Centres of Excellence (RCE) are disease-oriented institutes and are not required to have capacities to strengthen national reference laboratories

11 The capacity of the Supranational Laboratories (SNRL) is to provide back-up service and should be robust

12 Supranational reference laboratories should perform drug sensitivity testing

13 National reference laboratories (NRL) must provide services that are specialised and superior to those available in the national laboratory network

14 National reference laboratories (NRL) do not have to participates in the formulation of laboratory policy on an national level.

15 Public health functions of national reference laboratories includes Health and safety


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Module Objectives

At the end of this module, participants will be able to:

Have an overview on the SADC Health Protocol Assess the progress of where the individual Member States are with regard to

The Health Protocol Better understand the assessment report on the Reference laboratories Be familiar with the minimum standards and functions of a NRL and SNRL


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SADC Guidelines – Protocol on Health (1999)

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A healthy population is essential for sustainable human development and increased productivity. The Protocol on Health promotes “cooperation among Member States on key health issues. It recognizes that this cooperation is essential for the control of Communicable and Non-communicable Diseases and for addressing common health concerns, including emergency health services, Disaster Management and bulk purchasing of Essential Drugs”. (SADC website)

Education and training, efficient laboratory services and common strategies to address health needs are discussed within the Protocol.

Communicable Diseases

With a high level of poverty in Southern Africa, communicable diseases are a serious concern for social and human development in the region. The SADC region accounts for one-third of all people living with HIV and AIDS worldwide; eight SADC Member States are among those countries with the highest rates of tuberculosis; and 75% of the SADC population is at risk of contracting malaria.

Article 9 of the Protocol on Health addresses communicable disease control, while Articles 10, 11, and 12 specifically concern HIV and AIDS, malaria, and tuberculosis.

Note the slide below that talks about some of the statistics on HIV, TB and Malaria.

Important Articles in the Protocol


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Overview of the SADC Health Protocol

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Overview of the SADC Health Protocol

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Article 1- Definitions and Abbreviations

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Article 2 - Principles

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Article 3 - Objectives

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Article 4 – Institutional Mechanisms

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Article 5 – Financial Provision

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Article 6 – Health Systems research and surveillance

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Article 7 – Health Information Systems

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Article 8 – Health Promotion and Education

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Article 9 – Communicable Disease Control

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Article 9: Communicable Disease Control 1. States Parties shall co-operate to harmonise, and where appropriate, standardise

policies in the areas of:-

a) Case definitions for diseases; b) Notification systems; and c) Treatment and management of major communicable diseases.

2. States Parties shall co-operate in the establishment of regional reference laboratories and in sharing technical expertise in order to ensure high immunisation rates to reduce, eliminate, and where possible eradicate communicable diseases.

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Article 10 – HIV/AIDS and sexually transmitted disease

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Article 10: HIV/AIDS and Sexually Transmitted Diseases (STDS) 1. In order to deal effectively with the HIV / AIDS / STDs epidemic in the Region and

the interaction of HIV/AIDS/STDs with other diseases, States Parties shall:- a) Harmonise policies aimed at disease prevention and control, including co-

operation and identification of mechanisms to reduce the transmission of stds and HIV infection;

b) Develop approaches for the prevention and management of HIV/AID/stds to be implemented in a coherent, comparable, harmonised and standardised manner;

c) Develop regional policies and plans that recognise the intersectoral impact of HIV/AIDS/STDs and the need for an intersectoral approach to these diseases

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Article 11 – Malaria Control

Article 11: Malaria Control 1. States Parties shall establish efficient mechanisms for the effective control of malaria

in the Region.

2. States Parties shall co-operate and assist one another in order to reduce the prevalence of malaria, and with support from stakeholder, ensure the optimal use of resources for, inter alia a) Sharing scarce technical resources and operational research; b) Harmonising goals, policies, guidelines, protocols, interventions and treatment

regimens; c) Integrating malaria control mechanisms into Primary Health Care Services.

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Article 12/13 – Tuberculosis and non communicable disease control

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Article 12: Tuberculosis Control In view of the seriousness of tuberculosis in the Region, States Parties shall co-operate and assist one another:

a) To develop strategies for the sustained control of tuberculosis, including the efficient supply and delivery of drugs; and

b) To ensure, where appropriate, the harmonisation of tuberculosis control activities and HIV/AIDS programmes.


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Article 14/15 – Chronic diseases and conditions of older persons and disabilities

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Article 17- Childhood and adolescent health

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Article 18 – Health Human Resource Development

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Article 19/20 – Health care resources & traditional health practitioners

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Article 21 Prevention and treatment of trauma

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Article 22 – Mental Health

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Article 23/24 – Environmental and Occupational Health

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Article 25 – Emergency Health Services and Disaster Management

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Article 26 – Health Laboratory Services

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Article 27 – Health Technology and equipment

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Article 28 – Referral Systems

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Article 29 – Referral Pharmaceuticals

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Article 29/30 – Settlement of disputes and sanctions

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Articles 32 to 35

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Article 36/37 – Withdrawal & Depositary

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Articles 38 to 40

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Overview on the Assessment Report on Reference Laboratories in the SADC Region


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Background


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Assessments


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70

Assessment Findings – Policies regulating Laboratory Operations in Member States

Notes:

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71

Notes:

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72

Assessment Findings – Human Resources

Notes:

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73

Notes:

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74

Notes:

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75

Notes:

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76

Assessment Findings – Financing of Laboratory Services

Notes:

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77

Assessment Findings – Information Management

Notes:

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78

Assessment Findings – Quality Management

Notes:

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79

Assessment Findings – Equipment used in NRL

Notes:

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80

Notes:

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81

Notes:

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82

Assessment Findings

Notes:

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83

Notes:

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84

Notes:

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85

Recommendations

Notes:

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86

Notes:

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87

Summary

Notes:

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88


89

Notes:

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90

Functions and minimum standards for National reference laboratories in the SADC region


91

Objectives


92

WORKSHEET 1

1. What are National Reference Laboratories ? ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

2. Which major communicable diseases did the SADC assessment evaluate the capacity of national reference laboratories ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________

3. What are the functions of national reference laboratories ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

4. Which international transport rules should the national reference laboratories comply with as they transport biological samples across member states? ____________________________________________________________________________________________________________________________________________________________________________________________________________


93

Background

Notes:

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94

Functions of National Reference Laboratories (NRL’s)

Notes:

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95

Notes:

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96

Notes:

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97

Notes:

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98

Notes:

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99

Notes:

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100

Minimum Standards for National Reference Laboratories - Policies

Notes:

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101

Notes:

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102

Activity 2

Notes:

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103

Standard personnel requirements of national reference laboratories

Notes:

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104

HR – Minimum Standards for National Reference Laboratories

Notes:

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105

Minimum Standards for National Reference Laboratories – Human Resource Policy

Notes:

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106

Minimum Standards for National Reference Laboratories - QMS

Notes:

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107

Minimum Standards for National Reference Laboratories- Information Management

Notes:

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108

Minimum Standards for National Reference Laboratories – Organisation and structure of laboratory services

Notes:

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109

Notes:

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110

Minimum Standards for National Reference Laboratories – NRL Equipment

Notes:

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111

Minimum Standards for National Reference Laboratories – Sample transportation logistics

Notes:

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112

Minimum Standards for National Reference Laboratories – Funding of laboratory services

Notes:

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113

Minimum Standards for National Reference Laboratories – Monitoring and evaluation

Notes:

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114

Implementation Mechanisms for the Regional Minimum Standards – Stakeholder roles and responsibilities

Notes:

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115

Implementation Mechanisms for the Regional Minimum Standards – M & E and reporting

Notes:

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116

Implementation Mechanisms for the Regional Minimum Standards – M & E and Reporting

Notes:

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117

Summary

Notes:

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118

Functions and Minimum Standards for Supranational Reference Laboratories and Regional Centres of Excellence in the SADC Region

Notes:

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119

Objectives

Notes:

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120

Notes:

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121

Background

Notes:

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122

Notes:

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123

Definition and scope

Notes:

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124

Notes:

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125

Notes:

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126

Quiz

Notes:

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127

Supranational Reference Laboratories in the SADC Region

Notes:

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128

Functions and minimum standards

Notes:

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129

Diagnostic functions of SNRL

Notes:

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130

Notes:

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131

Notes:

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132

Public Health Functions of SNRL

Notes:

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133

Public Health Functions of SNRL

Notes:

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134

Notes:

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135

Notes:

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136

Notes:

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137

Notes:

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138

Notes:

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139

Notes:

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140

Regional Centres of Excellence in the SADC Region


141

Roles, Functions and Minimum Standards for Regional Centres of Excellence


142

Notes:

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143

RCE - HR

Notes:

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144

RCE - HR

Notes:

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145

RCE – Quality Management

Notes:

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146

Notes:

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147

Notes:

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148

RCE – Information Management, Surveillance and Research

Notes:

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149

Notes:

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150

Summary

Notes:

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151


152

Activity for Module1:

Please match the Policy on your left with the correct description on your right Pol Minimum Standards

Framework Number Purpose and summary description

A

Regional Minimum Standards for Harmonized Guidance on HIV Testing and Counseling (HTC) in the SADC Region.

1 Provides minimum standards in clinical case management guidelines for managing STI-associated syndrome, as well as STI conditions that are not prevented as syndromes. The framework can be used by service providers as a guide for designing evaluation and supervision tools, for assessing and improving the quality of care and for designing and implementing STI surveillance system.

B

Regional Minimum Standards for Harmonized Approaches to the Prevention of Mother-to-Child. Transmission of HIV in the SADC Region.

2 Presents minimum standards for effective TB case management including diagnosis, case definition, treatment, paediatric TB, TB/HIV co-infection, and drug-resistant TB. Minimum standards are also presented for key cross-cutting issues relating to TB control, including laboratory services, cross-border control and TB infection and prevention control.

C

Harmonized Minimum Standards for Prevention, Treatment and Management of Tuberculosis in the SADC Region.

3 Provides a harmonized framework for addressing key PMTCT issues as follows: prevention of HIV in women and couples, preventing unintended pregnancies, preventing transmission of HIV from infected woman to their infants, and the provision of care and support for HIV-infected woman, their infants and families, as well as the integration of PMTCT into maternal and child health services and sexual and reproductive health services.


153

D

Framework for the Prevention and Control of Sexually Transmitted Infections in the SADC Region.

4 Identifies malaria control standards across various prevalence zones focusing on vector control measures; and surveillance. Also addresses cross cutting issues for effective malaria prevention and treatment i.e. policy formulation M&E, drug procurement and supply as well as community participation.

E

SADEC Regional Minimum Standards for Prevention Treatment and Management of Malaria.

5 This approach sought to harmonize procurement strategies for essential medicines. Pooled procurement contributes to improved availability of essential medicines in the region, enhanced through the establishment of minimum standards for procurement and supply management.

F

Regional Minimum Standards for Harmonised Control of HIV and AIDS, Tuberculosis and Malaria in Militaries in the SADC Region.

6 A framework for addressing TB, HIV and other respiratory diseases within the mining sector. Provides a focus on policy and programme.

G

Functions and Minimum Standards for National Reference Laboratories in the SADC Region.

7 Harmonized framework for preventing and controlling HIV and AIDS, TB and malaria in all SADC Member State militaries. Sets out minimum standards for policy and programming, Training, Prevention strategies, Diagnostic tools and methods, Case management Treatment and care, referral systems, data collection and M&E. Primarily targets Governments, Military health personnel and policy makers

H

Functions and Minimum Standards for Supranational Reference Laboratories in the SADC Region.

8 Presents optional models of supranational laboratory services and regional centers of excellence. Recommends general roles and functions, organization, staffing profiles, coordination, and financing modalities of r supranational reference laboratories. Provides recommendation on specialized roles relevant to the diagnosis and public health services provision in HIV and AIDS, TB and Malaria.


154

I

SADC Gender Mainstreaming Guidelines for Communicable Diseases.

9 Sets out minimum standards that must be achieved by national reference laboratories. Provides detailed guidelines on human resources management; organization and management; quality management; laboratory physical infrastructure; specimen transportation and handling; managing laboratory equipment and M&E.

J

Harmonised Surveillance Framework for HIV and AIDS, Tuberculosis and Malaria in the SADC Region.

10 Establish minimum requirements for prisons to effectively prevent treat and control HIV and AIDS, TB, Hepatitis B and C, and STIs.

K

Declaration on TB in the mining sector.

11 This framework to facilitate harmonized reporting on HIV and AIDS, TB and Malaria using a set of core indicators that track progress in regional, continental and global commitment to the three diseases. Information collected also helps in assessing progress in the implementation of the SADC Protocol on Health.

L

Minimum Standards for HIV and AIDS, TB, Hepatitis B and C, and Sexually Transmitted Infections Prevention, Treatment, Care and Support in Prisons in the SADC Region.

12 Guidelines for minimum service package on HIV, TB and malaria targeting children and adolescents. They aim to strengthen child and adolescent specific policies and programmatic frameworks in HIV, TB and Malaria, to guide the integration of HIV, TB and Malaria services/programs within primary health care (PHC) and within basic child care services.

M

Minimum standards for child adolescent HIV, TB and Malaria Continuum of care & treatment 2013-2017.

13 Sets out Minimum standards for establishing an enabling environment: informed consent, HCT for children, and the various HTC approaches (including provider -initiated testing and counseling). Also specifies capacity building of HTC service providers, the accreditation of HTC sites, and M&E of HTC programs.


155

N

Strategy for pooled procurement of essential medicines and health commodities (2013-2017).

14 Promotes better access to quality HIV, TB and Malaria health services for both men and woman in the SADC region through recognition of unique vulnerabilities of men and woman Provides a standard framework for gender-sensitive policy and strategic development, programming, research, and M&E.

Answers:

Minimum STD

Purpose and

Description A

B

C

D

E

F

G

H

I

J

K

L

M

N


156

Summary of related SADC Minimum Standards


157

Objectives

Notes:

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158

Background

Notes:

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Minimum Standard, Purpose and summary description

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Minimum Standard/ Framework, Purpose and summary description

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Post – course questionnaire Please indicate whether the following statements are true or false


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No. Statement True False 1 The roles players involved in developing the minimum standards included

experts from the various Member States and their ministries of health

2 A total number of 18 minimum standards, frameworks and guideline were developed

3 Documents were subjected to regional validation and consensus building process by experts from Member States and therefore did not need ministerial approval

4 SADC Member States signed the Protocol on Health on the 18th of August 1999 to coordinate regional efforts on epidemic preparedness, mapping prevention, control and where possible the eradication of communicable and non- Communicable diseases.

5 Education and training, efficient laboratory services and common strategies to address the health needs of women, children and vulnerable groups are discussed within the Health Protocol.

6 The Protocol on Health calls upon Member States to cooperate, harmonise and, where appropriate, standardise policies for sharing technical expertise.

7 The Protocol on Health is not a legal document and merely serves as a guide to promote good ideas on how to manage health within the various Member States.

8 The Protocol on Health shall remain open for accession by any Member State.

9 The Supranational Laboratories (SNRL)serves as support to laboratories where essential diagnostic tests cannot currently be performed within a particular Member State.

10 Regional Centres of Excellence (RCE) are disease-oriented institutes and are not required to have capacities to strengthen national reference laboratories

11 The capacity of the Supranational Laboratories (SNRL) is to provide back-up service and should be robust

12 Supranational reference laboratories should perform drug sensitivity testing

13 National reference laboratories (NRL) must provide services that are specialised and superior to those available in the national laboratory network

14 National reference laboratories (NRL) do not have to participates in the formulation of laboratory policy on an national level.

15 Public health functions of national reference laboratories includes Health and safety

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Notes

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Summary

Let us sum up what has been covered in the module National Policies, Standards and

Guidelines.

Health Protocol

SADC Assessment report on the Reference Laboratories

Minimum Standards and functions for a National Reference Laboratory (NRL)

Minimum Standards and functions for a National Supranational Laboratory (SNRL) and regional centre of excellence


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References and Links

REFERENCES

Assessment Report on Reference Laboratories in the SADC Region November 2009

Functions And Minimum Standards For National Reference Laboratories In The SADC Region. November 2010

LINKS

Protocol on Health (1999)

http://www.sadc.int/documents-publications/show/804 https://www.k4health.org/toolkits/sadc/resources


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